MEDICATION SAFETY ISSUES
Sound-alike/look-alike issues:
Ornex® may be confused with Orexin®, Orinase®
Duplicate therapy issues: This product contains acetaminophen, which may be a component of other combination products. Do not exceed the maximum recommended daily dose of acetaminophen.
SPECIAL ALERTS
Health Canada: Labeling Changes for OTC Cough and Cold Preparations - December, 2008
Health Canada has issued an advisory to Canadian consumers regarding upcoming labeling changes for the use of over-the-counter (OTC) cough and cold medicines in children. Specific labeling changes as well as other important information may be found at http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2008/2008_184-eng.php.
Manufacturers Voluntarily Change Pediatric OTC Product Labeling - October 7, 2008
Leading manufacturers of over-the-counter (OTC) pediatric cough and cold products, in consultation with the Food and Drug Administration (FDA), have announced that they are voluntarily transitioning product labeling as it relates to children <4 years of age. The decision to change the labeling followed a meeting on October 2, 2008, conducted by the FDA to gather additional information related to the use of these products in children. The safety of the ingredients in these products was not in question. It was found that dosing errors and accidental ingestions were the leading cause of rare adverse events in children. The new product labeling will state "Do not use in children under four years of age." In addition, products with certain antihistamines will warn parents not to use these products to sedate or make a child sleepy. Labeling of adult products will not change. New product labels will be introduced during the 2008-2009 cough and cold season and some products will have the updated labeling by mid-October. Products with the old labeling will not be removed from the market. Prescription products are not affected.
It is important to note that these medications have not been shown to be unsafe when used correctly. Pharmacists may continue to see health care practitioners recommending these agents for use in pediatric patients, and should help to ensure that they are being used safely and at appropriate dosages. Parents should be advised that OTC cough and cold products are safe and effective when used as directed, but that they should not be used in children <4 years of age unless instructed to do so by their healthcare provider. Counseling tips from the Consumer Healthcare Products Association (CHPA) also include: Always follow dosing instructions exactly and use measuring devices provided with the medicine. Never give 2 medicines at the same time that contain the same active ingredient. Do not give a medicine intended for use in adults to a child.
Additional tips and information related to the labeling changes can be found on the following educational website of the CHPA: http://www.otcsafety.org.
The FDA had previously issued a Public Health Advisory reminding patients and caregivers that OTC cough and cold medications should not be used to treat infants and children <2 years of age. This is in response to the Centers for Disease Control and Prevention (CDC) report which noted that during 2004 and 2005, ~1519 children <2 years of age were seen in emergency departments for adverse effects, including overdose, associated with products containing nasal decongestants (eg, pseudoephedrine), antihistamines (eg, carbinoxamine), and cough suppressants (eg, dextromethorphan). In October of 2007, several manufacturers voluntarily removed these products in order to help reduce dosing errors and overdose in this age group.
For additional information, refer to the following websites:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm094913.htm
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2008/ucm116839.htm
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5601a1.htm, Centers for Disease Control, "Infant Deaths Associated with Cough and Cold Medications - Two States, 2005,"MMWR Morb Mortal Wkly Rep, 2007, 56(01):1-4.
U.S. BRAND NAMES — Ornex® Maximum Strength [OTC]; Ornex® [OTC]
PHARMACOLOGIC CATEGORY
Alpha/Beta Agonist
Analgesic, Miscellaneous
DOSING: ADULTS — Relief of cold, flu or sinusitis symptoms: Oral (Ornex®, Ornex® Maximum Strength): Two caplets every 4-6 hours as needed (maximum: 8 caplets/day)
DOSING: PEDIATRIC
Relief of cold, flu or sinusitis symptoms: Oral:
Children 6-11 years (Ornex®): One caplet every 4-6 hours as needed (maximum: 4 caplets/day)
Children ≥ 12 years: Refer to adult dosing.
DOSING: ELDERLY — Refer to adult dosing.
DOSING: HEPATIC IMPAIRMENT — Use with caution. Limited, low-dose therapy usually well tolerated in hepatic disease/cirrhosis; however, cases of hepatotoxicity at daily acetaminophen dosages <4 g/day have been reported. Avoid chronic use in hepatic impairment.
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Caplet:
Ornex®: Acetaminophen 325 mg and pseudoephedrine hydrochloride 30 mg
Ornex® Maximum Strength: Acetaminophen 500 mg and pseudoephedrine hydrochloride 30 mg
DOSAGE FORMS: CONCISE
Caplet:
Ornex®: Acetaminophen 325 mg and pseudoephedrine 30 mg
Ornex® Maximum Strength: Acetaminophen 500 mg and pseudoephedrine 30 mg
GENERIC EQUIVALENT AVAILABLE — Yes
USE — Temporary relief of nasal congestion, and minor aches and pains associated with colds, flu, sinusitis, or allergies
ADVERSE REACTIONS SIGNIFICANT — See individual agents.
CONTRAINDICATIONS — MAO inhibitor therapy or within 14 days of therapy; concurrent use with other products containing acetaminophen
WARNINGS / PRECAUTIONS
Disease-related concerns: Ethanol use: Use with caution in patients with alcoholic liver disease; consuming ≥ 3 alcoholic drinks/day may increase the risk of liver damage. Hepatic impairment: Use caution in patients with hepatic impairment; acetaminophen may cause severe hepatic toxicity with acute overdose.
Special populations: Pediatrics: Do not exceed pediatric dosing recommendations. If no recommendations exist on OTC labeling for patient's age, the product should not be administered without the guidance of a physician.
Other warnings/precautions: Dosage limit: Limit acetaminophen dose to <4>7 days or are accompanied by fever that lasts for >3 days, consult a physician. Discontinue and contact healthcare provider if nervousness, dizziness, or sleeplessness occur.
METABOLISM / TRANSPORT EFFECTS — Acetaminophen: Substrate (minor) of CYP1A2, 2A6, 2C9, 2D6, 2E1, 3A4; Inhibits CYP3A4 (weak)
DRUG INTERACTIONS
Antacids: May decrease the excretion of Alpha-/Beta-Agonists. Exceptions: Aluminum Hydroxide. Risk C: Monitor therapy
Anticonvulsants (Hydantoin): May increase the metabolism of Acetaminophen. This may 1) diminish the effect of acetaminophen; and 2) increase the risk of liver damage. Risk C: Monitor therapy
Atomoxetine: May enhance the hypertensive effect of Sympathomimetics. Atomoxetine may enhance the tachycardic effect of Sympathomimetics. Risk C: Monitor therapy
Barbiturates: May increase the metabolism of Acetaminophen. This may 1) diminish the effect of acetaminophen; and 2) increase the risk of liver damage. Risk C: Monitor therapy
Bromocriptine: Alpha-/Beta-Agonists may enhance the adverse/toxic effect of Bromocriptine. Including increased blood pressure, ventricular arrhythmias, and seizure. Risk C: Monitor therapy
Cannabinoids: May enhance the tachycardic effect of Sympathomimetics. Risk C: Monitor therapy
CarBAMazepine: May increase the metabolism of Acetaminophen. This may 1) diminish the effect of acetaminophen; and 2) increase the risk of liver damage. Risk C: Monitor therapy
Carbonic Anhydrase Inhibitors: May decrease the excretion of Alpha-/Beta-Agonists. Exceptions: Brinzolamide; Dorzolamide. Risk C: Monitor therapy
Cholestyramine Resin: May decrease the absorption of Acetaminophen. Effect is minimal if cholestyramine is administered 1 hour after acetaminophen. Risk D: Consider therapy modification
Imatinib: May increase the serum concentration of Acetaminophen. Risk D: Consider therapy modification
Iobenguane I 123: Sympathomimetics may diminish the therapeutic effect of Iobenguane I 123. Risk X: Avoid combination
Isoniazid: May enhance the adverse/toxic effect of Acetaminophen. Risk C: Monitor therapy
MAO Inhibitors: May enhance the hypertensive effect of Alpha-/Beta-Agonists (Indirect-Acting). Risk X: Avoid combination
Peginterferon Alfa-2b: May decrease the serum concentration of CYP2D6 Substrates. Risk C: Monitor therapy
Serotonin/Norepinephrine Reuptake Inhibitors: May enhance the tachycardic effect of Alpha-/Beta-Agonists. Serotonin/Norepinephrine Reuptake Inhibitors may enhance the vasopressor effect of Alpha-/Beta-Agonists. Risk D: Consider therapy modification
Spironolactone: May diminish the vasoconstricting effect of Alpha-/Beta-Agonists. Risk C: Monitor therapy
Sympathomimetics: May enhance the adverse/toxic effect of other Sympathomimetics. Risk C: Monitor therapy
Vitamin K Antagonists (eg, warfarin): Acetaminophen may enhance the anticoagulant effect of Vitamin K Antagonists. Most likely with daily acetaminophen doses >1.3 g for >1 week. Risk C: Monitor therapy
ETHANOL / NUTRITION / HERB INTERACTIONS — Ethanol: Excessive intake of ethanol may increase the risk of acetaminophen-induced hepatotoxicity. Avoid ethanol or limit to <3 drinks/day.
CANADIAN BRAND NAMES — Contac® Cold and Sore Throat, Non Drowsy, Extra Strength; Dristan® N.D.; Dristan® N.D., Extra Strength; Sinutab® Non Drowsy; Sudafed® Head Cold and Sinus Extra Strength; Tylenol® Decongestant; Tylenol® Sinus
INTERNATIONAL BRAND NAMES — Panadol Sinus (AU, HK); Sinumax Ped (ZA); Sinutab (BE)
PHARMACODYNAMICS / KINETICS — See individual agents.
Monday, May 17, 2010
Acetaminophen and pseudoephedrine
MEDICATION SAFETY ISSUES
Sound-alike/look-alike issues:
Ornex® may be confused with Orexin®, Orinase®
Duplicate therapy issues: This product contains acetaminophen, which may be a component of other combination products. Do not exceed the maximum recommended daily dose of acetaminophen.
SPECIAL ALERTS
Health Canada: Labeling Changes for OTC Cough and Cold Preparations - December, 2008
Health Canada has issued an advisory to Canadian consumers regarding upcoming labeling changes for the use of over-the-counter (OTC) cough and cold medicines in children. Specific labeling changes as well as other important information may be found at http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2008/2008_184-eng.php.
Manufacturers Voluntarily Change Pediatric OTC Product Labeling - October 7, 2008
Leading manufacturers of over-the-counter (OTC) pediatric cough and cold products, in consultation with the Food and Drug Administration (FDA), have announced that they are voluntarily transitioning product labeling as it relates to children <4 years of age. The decision to change the labeling followed a meeting on October 2, 2008, conducted by the FDA to gather additional information related to the use of these products in children. The safety of the ingredients in these products was not in question. It was found that dosing errors and accidental ingestions were the leading cause of rare adverse events in children. The new product labeling will state "Do not use in children under four years of age." In addition, products with certain antihistamines will warn parents not to use these products to sedate or make a child sleepy. Labeling of adult products will not change. New product labels will be introduced during the 2008-2009 cough and cold season and some products will have the updated labeling by mid-October. Products with the old labeling will not be removed from the market. Prescription products are not affected.
It is important to note that these medications have not been shown to be unsafe when used correctly. Pharmacists may continue to see health care practitioners recommending these agents for use in pediatric patients, and should help to ensure that they are being used safely and at appropriate dosages. Parents should be advised that OTC cough and cold products are safe and effective when used as directed, but that they should not be used in children <4 years of age unless instructed to do so by their healthcare provider. Counseling tips from the Consumer Healthcare Products Association (CHPA) also include: Always follow dosing instructions exactly and use measuring devices provided with the medicine. Never give 2 medicines at the same time that contain the same active ingredient. Do not give a medicine intended for use in adults to a child.
Additional tips and information related to the labeling changes can be found on the following educational website of the CHPA: http://www.otcsafety.org.
The FDA had previously issued a Public Health Advisory reminding patients and caregivers that OTC cough and cold medications should not be used to treat infants and children <2 years of age. This is in response to the Centers for Disease Control and Prevention (CDC) report which noted that during 2004 and 2005, ~1519 children <2 years of age were seen in emergency departments for adverse effects, including overdose, associated with products containing nasal decongestants (eg, pseudoephedrine), antihistamines (eg, carbinoxamine), and cough suppressants (eg, dextromethorphan). In October of 2007, several manufacturers voluntarily removed these products in order to help reduce dosing errors and overdose in this age group.
For additional information, refer to the following websites:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm094913.htm
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2008/ucm116839.htm
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5601a1.htm, Centers for Disease Control, "Infant Deaths Associated with Cough and Cold Medications - Two States, 2005,"MMWR Morb Mortal Wkly Rep, 2007, 56(01):1-4.
U.S. BRAND NAMES — Ornex® Maximum Strength [OTC]; Ornex® [OTC]
PHARMACOLOGIC CATEGORY
Alpha/Beta Agonist
Analgesic, Miscellaneous
DOSING: ADULTS — Relief of cold, flu or sinusitis symptoms: Oral (Ornex®, Ornex® Maximum Strength): Two caplets every 4-6 hours as needed (maximum: 8 caplets/day)
DOSING: PEDIATRIC
Relief of cold, flu or sinusitis symptoms: Oral:
Children 6-11 years (Ornex®): One caplet every 4-6 hours as needed (maximum: 4 caplets/day)
Children ≥ 12 years: Refer to adult dosing.
DOSING: ELDERLY — Refer to adult dosing.
DOSING: HEPATIC IMPAIRMENT — Use with caution. Limited, low-dose therapy usually well tolerated in hepatic disease/cirrhosis; however, cases of hepatotoxicity at daily acetaminophen dosages <4 g/day have been reported. Avoid chronic use in hepatic impairment.
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Caplet:
Ornex®: Acetaminophen 325 mg and pseudoephedrine hydrochloride 30 mg
Ornex® Maximum Strength: Acetaminophen 500 mg and pseudoephedrine hydrochloride 30 mg
DOSAGE FORMS: CONCISE
Caplet:
Ornex®: Acetaminophen 325 mg and pseudoephedrine 30 mg
Ornex® Maximum Strength: Acetaminophen 500 mg and pseudoephedrine 30 mg
GENERIC EQUIVALENT AVAILABLE — Yes
USE — Temporary relief of nasal congestion, and minor aches and pains associated with colds, flu, sinusitis, or allergies
ADVERSE REACTIONS SIGNIFICANT — See individual agents.
CONTRAINDICATIONS — MAO inhibitor therapy or within 14 days of therapy; concurrent use with other products containing acetaminophen
WARNINGS / PRECAUTIONS
Disease-related concerns: Ethanol use: Use with caution in patients with alcoholic liver disease; consuming ≥ 3 alcoholic drinks/day may increase the risk of liver damage. Hepatic impairment: Use caution in patients with hepatic impairment; acetaminophen may cause severe hepatic toxicity with acute overdose.
Special populations: Pediatrics: Do not exceed pediatric dosing recommendations. If no recommendations exist on OTC labeling for patient's age, the product should not be administered without the guidance of a physician.
Other warnings/precautions: Dosage limit: Limit acetaminophen dose to <4>7 days or are accompanied by fever that lasts for >3 days, consult a physician. Discontinue and contact healthcare provider if nervousness, dizziness, or sleeplessness occur.
METABOLISM / TRANSPORT EFFECTS — Acetaminophen: Substrate (minor) of CYP1A2, 2A6, 2C9, 2D6, 2E1, 3A4; Inhibits CYP3A4 (weak)
DRUG INTERACTIONS
Antacids: May decrease the excretion of Alpha-/Beta-Agonists. Exceptions: Aluminum Hydroxide. Risk C: Monitor therapy
Anticonvulsants (Hydantoin): May increase the metabolism of Acetaminophen. This may 1) diminish the effect of acetaminophen; and 2) increase the risk of liver damage. Risk C: Monitor therapy
Atomoxetine: May enhance the hypertensive effect of Sympathomimetics. Atomoxetine may enhance the tachycardic effect of Sympathomimetics. Risk C: Monitor therapy
Barbiturates: May increase the metabolism of Acetaminophen. This may 1) diminish the effect of acetaminophen; and 2) increase the risk of liver damage. Risk C: Monitor therapy
Bromocriptine: Alpha-/Beta-Agonists may enhance the adverse/toxic effect of Bromocriptine. Including increased blood pressure, ventricular arrhythmias, and seizure. Risk C: Monitor therapy
Cannabinoids: May enhance the tachycardic effect of Sympathomimetics. Risk C: Monitor therapy
CarBAMazepine: May increase the metabolism of Acetaminophen. This may 1) diminish the effect of acetaminophen; and 2) increase the risk of liver damage. Risk C: Monitor therapy
Carbonic Anhydrase Inhibitors: May decrease the excretion of Alpha-/Beta-Agonists. Exceptions: Brinzolamide; Dorzolamide. Risk C: Monitor therapy
Cholestyramine Resin: May decrease the absorption of Acetaminophen. Effect is minimal if cholestyramine is administered 1 hour after acetaminophen. Risk D: Consider therapy modification
Imatinib: May increase the serum concentration of Acetaminophen. Risk D: Consider therapy modification
Iobenguane I 123: Sympathomimetics may diminish the therapeutic effect of Iobenguane I 123. Risk X: Avoid combination
Isoniazid: May enhance the adverse/toxic effect of Acetaminophen. Risk C: Monitor therapy
MAO Inhibitors: May enhance the hypertensive effect of Alpha-/Beta-Agonists (Indirect-Acting). Risk X: Avoid combination
Peginterferon Alfa-2b: May decrease the serum concentration of CYP2D6 Substrates. Risk C: Monitor therapy
Serotonin/Norepinephrine Reuptake Inhibitors: May enhance the tachycardic effect of Alpha-/Beta-Agonists. Serotonin/Norepinephrine Reuptake Inhibitors may enhance the vasopressor effect of Alpha-/Beta-Agonists. Risk D: Consider therapy modification
Spironolactone: May diminish the vasoconstricting effect of Alpha-/Beta-Agonists. Risk C: Monitor therapy
Sympathomimetics: May enhance the adverse/toxic effect of other Sympathomimetics. Risk C: Monitor therapy
Vitamin K Antagonists (eg, warfarin): Acetaminophen may enhance the anticoagulant effect of Vitamin K Antagonists. Most likely with daily acetaminophen doses >1.3 g for >1 week. Risk C: Monitor therapy
ETHANOL / NUTRITION / HERB INTERACTIONS — Ethanol: Excessive intake of ethanol may increase the risk of acetaminophen-induced hepatotoxicity. Avoid ethanol or limit to <3 drinks/day.
CANADIAN BRAND NAMES — Contac® Cold and Sore Throat, Non Drowsy, Extra Strength; Dristan® N.D.; Dristan® N.D., Extra Strength; Sinutab® Non Drowsy; Sudafed® Head Cold and Sinus Extra Strength; Tylenol® Decongestant; Tylenol® Sinus
INTERNATIONAL BRAND NAMES — Panadol Sinus (AU, HK); Sinumax Ped (ZA); Sinutab (BE)
PHARMACODYNAMICS / KINETICS — See individual agents.
Sound-alike/look-alike issues:
Ornex® may be confused with Orexin®, Orinase®
Duplicate therapy issues: This product contains acetaminophen, which may be a component of other combination products. Do not exceed the maximum recommended daily dose of acetaminophen.
SPECIAL ALERTS
Health Canada: Labeling Changes for OTC Cough and Cold Preparations - December, 2008
Health Canada has issued an advisory to Canadian consumers regarding upcoming labeling changes for the use of over-the-counter (OTC) cough and cold medicines in children. Specific labeling changes as well as other important information may be found at http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2008/2008_184-eng.php.
Manufacturers Voluntarily Change Pediatric OTC Product Labeling - October 7, 2008
Leading manufacturers of over-the-counter (OTC) pediatric cough and cold products, in consultation with the Food and Drug Administration (FDA), have announced that they are voluntarily transitioning product labeling as it relates to children <4 years of age. The decision to change the labeling followed a meeting on October 2, 2008, conducted by the FDA to gather additional information related to the use of these products in children. The safety of the ingredients in these products was not in question. It was found that dosing errors and accidental ingestions were the leading cause of rare adverse events in children. The new product labeling will state "Do not use in children under four years of age." In addition, products with certain antihistamines will warn parents not to use these products to sedate or make a child sleepy. Labeling of adult products will not change. New product labels will be introduced during the 2008-2009 cough and cold season and some products will have the updated labeling by mid-October. Products with the old labeling will not be removed from the market. Prescription products are not affected.
It is important to note that these medications have not been shown to be unsafe when used correctly. Pharmacists may continue to see health care practitioners recommending these agents for use in pediatric patients, and should help to ensure that they are being used safely and at appropriate dosages. Parents should be advised that OTC cough and cold products are safe and effective when used as directed, but that they should not be used in children <4 years of age unless instructed to do so by their healthcare provider. Counseling tips from the Consumer Healthcare Products Association (CHPA) also include: Always follow dosing instructions exactly and use measuring devices provided with the medicine. Never give 2 medicines at the same time that contain the same active ingredient. Do not give a medicine intended for use in adults to a child.
Additional tips and information related to the labeling changes can be found on the following educational website of the CHPA: http://www.otcsafety.org.
The FDA had previously issued a Public Health Advisory reminding patients and caregivers that OTC cough and cold medications should not be used to treat infants and children <2 years of age. This is in response to the Centers for Disease Control and Prevention (CDC) report which noted that during 2004 and 2005, ~1519 children <2 years of age were seen in emergency departments for adverse effects, including overdose, associated with products containing nasal decongestants (eg, pseudoephedrine), antihistamines (eg, carbinoxamine), and cough suppressants (eg, dextromethorphan). In October of 2007, several manufacturers voluntarily removed these products in order to help reduce dosing errors and overdose in this age group.
For additional information, refer to the following websites:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm094913.htm
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2008/ucm116839.htm
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5601a1.htm, Centers for Disease Control, "Infant Deaths Associated with Cough and Cold Medications - Two States, 2005,"MMWR Morb Mortal Wkly Rep, 2007, 56(01):1-4.
U.S. BRAND NAMES — Ornex® Maximum Strength [OTC]; Ornex® [OTC]
PHARMACOLOGIC CATEGORY
Alpha/Beta Agonist
Analgesic, Miscellaneous
DOSING: ADULTS — Relief of cold, flu or sinusitis symptoms: Oral (Ornex®, Ornex® Maximum Strength): Two caplets every 4-6 hours as needed (maximum: 8 caplets/day)
DOSING: PEDIATRIC
Relief of cold, flu or sinusitis symptoms: Oral:
Children 6-11 years (Ornex®): One caplet every 4-6 hours as needed (maximum: 4 caplets/day)
Children ≥ 12 years: Refer to adult dosing.
DOSING: ELDERLY — Refer to adult dosing.
DOSING: HEPATIC IMPAIRMENT — Use with caution. Limited, low-dose therapy usually well tolerated in hepatic disease/cirrhosis; however, cases of hepatotoxicity at daily acetaminophen dosages <4 g/day have been reported. Avoid chronic use in hepatic impairment.
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Caplet:
Ornex®: Acetaminophen 325 mg and pseudoephedrine hydrochloride 30 mg
Ornex® Maximum Strength: Acetaminophen 500 mg and pseudoephedrine hydrochloride 30 mg
DOSAGE FORMS: CONCISE
Caplet:
Ornex®: Acetaminophen 325 mg and pseudoephedrine 30 mg
Ornex® Maximum Strength: Acetaminophen 500 mg and pseudoephedrine 30 mg
GENERIC EQUIVALENT AVAILABLE — Yes
USE — Temporary relief of nasal congestion, and minor aches and pains associated with colds, flu, sinusitis, or allergies
ADVERSE REACTIONS SIGNIFICANT — See individual agents.
CONTRAINDICATIONS — MAO inhibitor therapy or within 14 days of therapy; concurrent use with other products containing acetaminophen
WARNINGS / PRECAUTIONS
Disease-related concerns: Ethanol use: Use with caution in patients with alcoholic liver disease; consuming ≥ 3 alcoholic drinks/day may increase the risk of liver damage. Hepatic impairment: Use caution in patients with hepatic impairment; acetaminophen may cause severe hepatic toxicity with acute overdose.
Special populations: Pediatrics: Do not exceed pediatric dosing recommendations. If no recommendations exist on OTC labeling for patient's age, the product should not be administered without the guidance of a physician.
Other warnings/precautions: Dosage limit: Limit acetaminophen dose to <4>7 days or are accompanied by fever that lasts for >3 days, consult a physician. Discontinue and contact healthcare provider if nervousness, dizziness, or sleeplessness occur.
METABOLISM / TRANSPORT EFFECTS — Acetaminophen: Substrate (minor) of CYP1A2, 2A6, 2C9, 2D6, 2E1, 3A4; Inhibits CYP3A4 (weak)
DRUG INTERACTIONS
Antacids: May decrease the excretion of Alpha-/Beta-Agonists. Exceptions: Aluminum Hydroxide. Risk C: Monitor therapy
Anticonvulsants (Hydantoin): May increase the metabolism of Acetaminophen. This may 1) diminish the effect of acetaminophen; and 2) increase the risk of liver damage. Risk C: Monitor therapy
Atomoxetine: May enhance the hypertensive effect of Sympathomimetics. Atomoxetine may enhance the tachycardic effect of Sympathomimetics. Risk C: Monitor therapy
Barbiturates: May increase the metabolism of Acetaminophen. This may 1) diminish the effect of acetaminophen; and 2) increase the risk of liver damage. Risk C: Monitor therapy
Bromocriptine: Alpha-/Beta-Agonists may enhance the adverse/toxic effect of Bromocriptine. Including increased blood pressure, ventricular arrhythmias, and seizure. Risk C: Monitor therapy
Cannabinoids: May enhance the tachycardic effect of Sympathomimetics. Risk C: Monitor therapy
CarBAMazepine: May increase the metabolism of Acetaminophen. This may 1) diminish the effect of acetaminophen; and 2) increase the risk of liver damage. Risk C: Monitor therapy
Carbonic Anhydrase Inhibitors: May decrease the excretion of Alpha-/Beta-Agonists. Exceptions: Brinzolamide; Dorzolamide. Risk C: Monitor therapy
Cholestyramine Resin: May decrease the absorption of Acetaminophen. Effect is minimal if cholestyramine is administered 1 hour after acetaminophen. Risk D: Consider therapy modification
Imatinib: May increase the serum concentration of Acetaminophen. Risk D: Consider therapy modification
Iobenguane I 123: Sympathomimetics may diminish the therapeutic effect of Iobenguane I 123. Risk X: Avoid combination
Isoniazid: May enhance the adverse/toxic effect of Acetaminophen. Risk C: Monitor therapy
MAO Inhibitors: May enhance the hypertensive effect of Alpha-/Beta-Agonists (Indirect-Acting). Risk X: Avoid combination
Peginterferon Alfa-2b: May decrease the serum concentration of CYP2D6 Substrates. Risk C: Monitor therapy
Serotonin/Norepinephrine Reuptake Inhibitors: May enhance the tachycardic effect of Alpha-/Beta-Agonists. Serotonin/Norepinephrine Reuptake Inhibitors may enhance the vasopressor effect of Alpha-/Beta-Agonists. Risk D: Consider therapy modification
Spironolactone: May diminish the vasoconstricting effect of Alpha-/Beta-Agonists. Risk C: Monitor therapy
Sympathomimetics: May enhance the adverse/toxic effect of other Sympathomimetics. Risk C: Monitor therapy
Vitamin K Antagonists (eg, warfarin): Acetaminophen may enhance the anticoagulant effect of Vitamin K Antagonists. Most likely with daily acetaminophen doses >1.3 g for >1 week. Risk C: Monitor therapy
ETHANOL / NUTRITION / HERB INTERACTIONS — Ethanol: Excessive intake of ethanol may increase the risk of acetaminophen-induced hepatotoxicity. Avoid ethanol or limit to <3 drinks/day.
CANADIAN BRAND NAMES — Contac® Cold and Sore Throat, Non Drowsy, Extra Strength; Dristan® N.D.; Dristan® N.D., Extra Strength; Sinutab® Non Drowsy; Sudafed® Head Cold and Sinus Extra Strength; Tylenol® Decongestant; Tylenol® Sinus
INTERNATIONAL BRAND NAMES — Panadol Sinus (AU, HK); Sinumax Ped (ZA); Sinutab (BE)
PHARMACODYNAMICS / KINETICS — See individual agents.
Acetaminophen and phenyltoloxamine
MEDICATION SAFETY ISSUES
Sound-alike/look-alike issues:
Percogesic® may be confused with paregoric, Percodan®
Duplicate therapy issues: This product contains acetaminophen, which may be a component of other combination products. Do not exceed the maximum recommended daily dose of acetaminophen.
U.S. BRAND NAMES — Aceta-Gesic [OTC]; Alpain; BeFlex; Dologesic®; Flextra-650; Flextra-DS; Genasec™ [OTC]; Hyflex-DS® [DSC]; Lagesic™ ; Percogesic® [OTC]; Phenagesic [OTC]; Phenylgesic [OTC]; RhinoFlex™ ; RhinoFlex™ -650; Staflex; Vistra 650 [DSC]; Zgesic
PHARMACOLOGIC CATEGORY
Analgesic, Miscellaneous
DOSING: ADULTS
Pain (Analgesic): Oral: Based on acetaminophen component: 325-650 mg every 4-6 hours as needed (maximum: 4 g/day)
Product-specific labeling: Oral:
Dologesic®: 1-2 caplets/capsules or 15-30 mL every 4 hours (maximum: 8 caplets/24 hours or 120 mL/24 hours)
Flextra-650:1/2-1 tablet every 6 hours (maximum: 4 tablets/day)
Flextra-DS, RhinoFlex™ , RhinoFlex™ -650:1/2-1 tablet every 4 hours (maximum: 5 tablets/day)
Lagesic™ , Zgesic: 1-2 caplets/tablets every 8-12 hours (maximum: 6 tablets/24 hours)
Percogesic®: 1-2 tablets every 4 hours (maximum: 8 tablets/24 hours)
DOSING: PEDIATRIC
Analgesic: Oral:
Based on acetaminophen component: 10-15 mg/kg/dose every 4-6 hours as needed (maximum: 5 doses/24 hours)
Product-specific labeling: Oral:
Dologesic®:
Children <12 years: 1 caplet/capsule or 5 mL every 4 hours
Children ≥ 12 years: Refer to adult dosing.
Flextra-650:
Children 6 to <12 years: 1/2 tablet every 6 hours (maximum: 2 tablets/day)
Children ≥ 12 years: Refer to adult dosing.
Flextra-DS, RhinoFlex™ , RhinoFlex™ -650:
Children 6 to <12 years: 1/2 tablet every 4 hours (maximum: 2.5 tablets/day)
Children ≥ 12 years: Refer to adult dosing.
Lagesic™ :
Children 6-12 years: 1/2 to 1 caplet every 12 hours (maximum: 2 caplets/day)
Children ≥ 12 years: Refer to adult dosing.
Percogesic®: Children 6-12 years: 1 tablet every 4 hours (maximum: 4 tablets/24 hours)
Zgesic: Children >12 years: Refer to adult dosing.
DOSING: ELDERLY — Refer to adult dosing.
DOSING: RENAL IMPAIRMENT
Specific dosing adjustment not available. Monitor renal function with severe impairment.
DOSING: HEPATIC IMPAIRMENT — Use with caution. Limited, low-dose therapy is usually well tolerated in hepatic disease/cirrhosis; however, cases of hepatotoxicity at daily acetaminophen dosages <4 g/day have been reported. Avoid chronic use in hepatic impairment.
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Caplet:
Alpain: Acetaminophen 500 mg and phenyltoloxamine citrate 60 mg
BeFlex: Acetaminophen 500 mg and phenyltoloxamine citrate 55 mg
Dologesic®: Acetaminophen 500 mg and phenyltoloxamine citrate 30 mg
Staflex: Acetaminophen 500 mg and phenyltoloxamine citrate 55 mg
Caplet, extended release [scored]:
Lagesic™ : Acetaminophen 600 mg and phenyltoloxamine citrate 66 mg
Capsule:
Dologesic®: Acetaminophen 500 mg and phenyltoloxamine citrate 30 mg
Liquid:
Dologesic®: Acetaminophen 500 mg and phenyltoloxamine citrate 30 mg per 15 mL (180 mL)
Tablet: Acetaminophen 325 mg and phenyltoloxamine citrate 30 mg
Aceta-Gesic, Genasec™ , Percogesic®, Phenagesic, Phenylgesic: Acetaminophen 325 mg and phenyltoloxamine citrate 30 mg
Flextra-650, Vistra 650 [DSC]: Acetaminophen 650 mg and phenyltoloxamine citrate 60 mg
Flextra-DS, Hyflex-DS® [DSC], RhinoFlex™ : Acetaminophen 500 mg and phenyltoloxamine citrate 50 mg
RhinoFlex™ -650: Acetaminophen 650 mg and phenyltoloxamine citrate 50 mg
Tablet, prolonged release, oral:
Zgesic: Acetaminophen 600 mg and phenyltoloxamine citrate 66 mg
DOSAGE FORMS: CONCISE
Caplet:
Alpain: Acetaminophen 500 mg and phenyltoloxamine 60 mg
BeFlex, Staflex: Acetaminophen 500 mg and phenyltoloxamine 55 mg
Dologesic®: Acetaminophen 500 mg and phenyltoloxamine 30 mg
Caplet, extended release [scored]:
Lagesic™ : Acetaminophen 600 mg and phenyltoloxamine 66 mg
Capsule:
Dologesic®: Acetaminophen 500 mg and phenyltoloxamine 30 mg
Liquid:
Dologesic®: Acetaminophen 500 mg and phenyltoloxamine 30 mg per 15 mg
Tablet: Acetaminophen 325 mg and phenyltoloxamine 30 mg
Aceta-Gesic [OTC], Genasec™ [OTC], Percogesic® [OTC], Phenagesic [OTC], Phenylgesic [OTC]: Acetaminophen 325 mg and phenyltoloxamine 30 mg
Flextra-650: Acetaminophen 650 mg and phenyltoloxamine 60 mg
Flextra-DS, RhinoFlex™ : Acetaminophen 500 mg and phenyltoloxamine 50 mg
RhinoFlex™ -650: Acetaminophen 650 mg and phenyltoloxamine 50 mg
Tablet, prolonged release, oral:
Zgesic: Acetaminophen 600 mg and phenyltoloxamine 66 mg
GENERIC EQUIVALENT AVAILABLE — Yes: Tablet
ADMINISTRATION — May be administered with food or milk.
Extended release caplet (Lagesic™ ): Caplet may be broken in half; do not chew or crush.
Prolonged release tablet (Zgesic): Swallow whole; do not chew or crush.
USE — Relief of mild-to-moderate pain
ADVERSE REACTIONS SIGNIFICANT — Frequency not defined.
Central nervous system: Dizziness, drowsiness, lassitude
Dermatologic: Pruritus, rash
Gastrointestinal: Nausea
Ocular: Blurred vision
Miscellaneous: Diaphoresis
CONTRAINDICATIONS — Hypersensitivity to acetaminophen, phenyltoloxamine, or any component of the formulation
WARNINGS / PRECAUTIONS
Concerns related to adverse effects: CNS depression: May cause CNS depression, which may impair physical or mental abilities; patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving). Hepatotoxicity: May cause severe hepatic toxicity on acute overdose; in addition, chronic daily dosing in adults has resulted in liver damage in some patients.
Disease-related concerns: Ethanol use: Use with caution in patients with alcoholic liver disease; consuming ≥ 3 alcoholic drinks/day may increase the risk of liver damage. G6PD deficiency: Use with caution in patients with known G6PD deficiency. Glaucoma: Use with caution in patients with glaucoma. Hepatic impairment: Use with caution in patients with hepatic impairment. Prostatic hyperplasia/urinary stricture: Use with caution in patients with prostatic hyperplasia and/or urinary stricture. Renal impairment: Use with caution in patients with renal impairment. Respiratory disease: Use with caution in patients with pre-existing respiratory compromise (hypoxia and/or hypercapnia), COPD or other obstructive pulmonary disease, and kyphoscoliosis or other skeletal disorder which may alter respiratory function; critical respiratory depression may occur, even at therapeutic dosages.
Concurrent drug therapy issues: Sedatives: Effects may be potentiated when used with other sedative drugs or ethanol.
Special populations: Elderly: Use with caution in the elderly; may be more sensitive to adverse effects. Pediatrics: Safety and efficacy have not been established in children <6 years of age.
Other warnings/precautions: Dosage limit: Limit acetaminophen dose to <4>3 days or for pain lasting >10 days in adults or >5 days in children.
METABOLISM / TRANSPORT EFFECTS — Acetaminophen: Substrate (minor) of CYP1A2, 2A6, 2C9, 2D6, 2E1, 3A4; Inhibits CYP3A4 (weak)
DRUG INTERACTIONS
Anticonvulsants (Hydantoin): May increase the metabolism of Acetaminophen. This may 1) diminish the effect of acetaminophen; and 2) increase the risk of liver damage. Risk C: Monitor therapy
Barbiturates: May increase the metabolism of Acetaminophen. This may 1) diminish the effect of acetaminophen; and 2) increase the risk of liver damage. Risk C: Monitor therapy
CarBAMazepine: May increase the metabolism of Acetaminophen. This may 1) diminish the effect of acetaminophen; and 2) increase the risk of liver damage. Risk C: Monitor therapy
Cholestyramine Resin: May decrease the absorption of Acetaminophen. Effect is minimal if cholestyramine is administered 1 hour after acetaminophen. Risk D: Consider therapy modification
Imatinib: May increase the serum concentration of Acetaminophen. Risk D: Consider therapy modification
Isoniazid: May enhance the adverse/toxic effect of Acetaminophen. Risk C: Monitor therapy
Peginterferon Alfa-2b: May decrease the serum concentration of CYP2D6 Substrates. Risk C: Monitor therapy
Vitamin K Antagonists (eg, warfarin): Acetaminophen may enhance the anticoagulant effect of Vitamin K Antagonists. Most likely with daily acetaminophen doses >1.3 g for >1 week. Risk C: Monitor therapy
ETHANOL / NUTRITION / HERB INTERACTIONS
Ethanol: Excessive intake of ethanol may increase the risk of acetaminophen-induced hepatotoxicity. Avoid ethanol or limit to <3 drinks/day.
Food: Rate of absorption may be decreased when given with food.
PREGNANCY RISK FACTOR — C (show table)
PREGNANCY IMPLICATIONS — Reproduction studies have not been conducted with this combination.
LACTATION — Excretion in breast milk unknown/use caution
BREAST-FEEDING CONSIDERATIONS — Acetaminophen is excreted in breast milk. Excretion of phenyltoloxamine is not known.
DIETARY CONSIDERATIONS — May be taken with food or milk.
PRICING — (data from drugstore.com)
Tablets (Flextra DS)
50-500 mg (30): $18.99
MECHANISM OF ACTION — Acetaminophen inhibits the synthesis of prostaglandins in the central nervous system and peripherally blocks pain impulse generation; produces antipyresis from inhibition of hypothalamic heat-regulating center. Phenyltoloxamine is an antihistamine (H1-blocking agent) which acts primarily to inhibit secretions in the nose, mouth, and pharynx, as well as causing CNS depression.
Sound-alike/look-alike issues:
Percogesic® may be confused with paregoric, Percodan®
Duplicate therapy issues: This product contains acetaminophen, which may be a component of other combination products. Do not exceed the maximum recommended daily dose of acetaminophen.
U.S. BRAND NAMES — Aceta-Gesic [OTC]; Alpain; BeFlex; Dologesic®; Flextra-650; Flextra-DS; Genasec™ [OTC]; Hyflex-DS® [DSC]; Lagesic™ ; Percogesic® [OTC]; Phenagesic [OTC]; Phenylgesic [OTC]; RhinoFlex™ ; RhinoFlex™ -650; Staflex; Vistra 650 [DSC]; Zgesic
PHARMACOLOGIC CATEGORY
Analgesic, Miscellaneous
DOSING: ADULTS
Pain (Analgesic): Oral: Based on acetaminophen component: 325-650 mg every 4-6 hours as needed (maximum: 4 g/day)
Product-specific labeling: Oral:
Dologesic®: 1-2 caplets/capsules or 15-30 mL every 4 hours (maximum: 8 caplets/24 hours or 120 mL/24 hours)
Flextra-650:1/2-1 tablet every 6 hours (maximum: 4 tablets/day)
Flextra-DS, RhinoFlex™ , RhinoFlex™ -650:1/2-1 tablet every 4 hours (maximum: 5 tablets/day)
Lagesic™ , Zgesic: 1-2 caplets/tablets every 8-12 hours (maximum: 6 tablets/24 hours)
Percogesic®: 1-2 tablets every 4 hours (maximum: 8 tablets/24 hours)
DOSING: PEDIATRIC
Analgesic: Oral:
Based on acetaminophen component: 10-15 mg/kg/dose every 4-6 hours as needed (maximum: 5 doses/24 hours)
Product-specific labeling: Oral:
Dologesic®:
Children <12 years: 1 caplet/capsule or 5 mL every 4 hours
Children ≥ 12 years: Refer to adult dosing.
Flextra-650:
Children 6 to <12 years: 1/2 tablet every 6 hours (maximum: 2 tablets/day)
Children ≥ 12 years: Refer to adult dosing.
Flextra-DS, RhinoFlex™ , RhinoFlex™ -650:
Children 6 to <12 years: 1/2 tablet every 4 hours (maximum: 2.5 tablets/day)
Children ≥ 12 years: Refer to adult dosing.
Lagesic™ :
Children 6-12 years: 1/2 to 1 caplet every 12 hours (maximum: 2 caplets/day)
Children ≥ 12 years: Refer to adult dosing.
Percogesic®: Children 6-12 years: 1 tablet every 4 hours (maximum: 4 tablets/24 hours)
Zgesic: Children >12 years: Refer to adult dosing.
DOSING: ELDERLY — Refer to adult dosing.
DOSING: RENAL IMPAIRMENT
Specific dosing adjustment not available. Monitor renal function with severe impairment.
DOSING: HEPATIC IMPAIRMENT — Use with caution. Limited, low-dose therapy is usually well tolerated in hepatic disease/cirrhosis; however, cases of hepatotoxicity at daily acetaminophen dosages <4 g/day have been reported. Avoid chronic use in hepatic impairment.
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Caplet:
Alpain: Acetaminophen 500 mg and phenyltoloxamine citrate 60 mg
BeFlex: Acetaminophen 500 mg and phenyltoloxamine citrate 55 mg
Dologesic®: Acetaminophen 500 mg and phenyltoloxamine citrate 30 mg
Staflex: Acetaminophen 500 mg and phenyltoloxamine citrate 55 mg
Caplet, extended release [scored]:
Lagesic™ : Acetaminophen 600 mg and phenyltoloxamine citrate 66 mg
Capsule:
Dologesic®: Acetaminophen 500 mg and phenyltoloxamine citrate 30 mg
Liquid:
Dologesic®: Acetaminophen 500 mg and phenyltoloxamine citrate 30 mg per 15 mL (180 mL)
Tablet: Acetaminophen 325 mg and phenyltoloxamine citrate 30 mg
Aceta-Gesic, Genasec™ , Percogesic®, Phenagesic, Phenylgesic: Acetaminophen 325 mg and phenyltoloxamine citrate 30 mg
Flextra-650, Vistra 650 [DSC]: Acetaminophen 650 mg and phenyltoloxamine citrate 60 mg
Flextra-DS, Hyflex-DS® [DSC], RhinoFlex™ : Acetaminophen 500 mg and phenyltoloxamine citrate 50 mg
RhinoFlex™ -650: Acetaminophen 650 mg and phenyltoloxamine citrate 50 mg
Tablet, prolonged release, oral:
Zgesic: Acetaminophen 600 mg and phenyltoloxamine citrate 66 mg
DOSAGE FORMS: CONCISE
Caplet:
Alpain: Acetaminophen 500 mg and phenyltoloxamine 60 mg
BeFlex, Staflex: Acetaminophen 500 mg and phenyltoloxamine 55 mg
Dologesic®: Acetaminophen 500 mg and phenyltoloxamine 30 mg
Caplet, extended release [scored]:
Lagesic™ : Acetaminophen 600 mg and phenyltoloxamine 66 mg
Capsule:
Dologesic®: Acetaminophen 500 mg and phenyltoloxamine 30 mg
Liquid:
Dologesic®: Acetaminophen 500 mg and phenyltoloxamine 30 mg per 15 mg
Tablet: Acetaminophen 325 mg and phenyltoloxamine 30 mg
Aceta-Gesic [OTC], Genasec™ [OTC], Percogesic® [OTC], Phenagesic [OTC], Phenylgesic [OTC]: Acetaminophen 325 mg and phenyltoloxamine 30 mg
Flextra-650: Acetaminophen 650 mg and phenyltoloxamine 60 mg
Flextra-DS, RhinoFlex™ : Acetaminophen 500 mg and phenyltoloxamine 50 mg
RhinoFlex™ -650: Acetaminophen 650 mg and phenyltoloxamine 50 mg
Tablet, prolonged release, oral:
Zgesic: Acetaminophen 600 mg and phenyltoloxamine 66 mg
GENERIC EQUIVALENT AVAILABLE — Yes: Tablet
ADMINISTRATION — May be administered with food or milk.
Extended release caplet (Lagesic™ ): Caplet may be broken in half; do not chew or crush.
Prolonged release tablet (Zgesic): Swallow whole; do not chew or crush.
USE — Relief of mild-to-moderate pain
ADVERSE REACTIONS SIGNIFICANT — Frequency not defined.
Central nervous system: Dizziness, drowsiness, lassitude
Dermatologic: Pruritus, rash
Gastrointestinal: Nausea
Ocular: Blurred vision
Miscellaneous: Diaphoresis
CONTRAINDICATIONS — Hypersensitivity to acetaminophen, phenyltoloxamine, or any component of the formulation
WARNINGS / PRECAUTIONS
Concerns related to adverse effects: CNS depression: May cause CNS depression, which may impair physical or mental abilities; patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving). Hepatotoxicity: May cause severe hepatic toxicity on acute overdose; in addition, chronic daily dosing in adults has resulted in liver damage in some patients.
Disease-related concerns: Ethanol use: Use with caution in patients with alcoholic liver disease; consuming ≥ 3 alcoholic drinks/day may increase the risk of liver damage. G6PD deficiency: Use with caution in patients with known G6PD deficiency. Glaucoma: Use with caution in patients with glaucoma. Hepatic impairment: Use with caution in patients with hepatic impairment. Prostatic hyperplasia/urinary stricture: Use with caution in patients with prostatic hyperplasia and/or urinary stricture. Renal impairment: Use with caution in patients with renal impairment. Respiratory disease: Use with caution in patients with pre-existing respiratory compromise (hypoxia and/or hypercapnia), COPD or other obstructive pulmonary disease, and kyphoscoliosis or other skeletal disorder which may alter respiratory function; critical respiratory depression may occur, even at therapeutic dosages.
Concurrent drug therapy issues: Sedatives: Effects may be potentiated when used with other sedative drugs or ethanol.
Special populations: Elderly: Use with caution in the elderly; may be more sensitive to adverse effects. Pediatrics: Safety and efficacy have not been established in children <6 years of age.
Other warnings/precautions: Dosage limit: Limit acetaminophen dose to <4>3 days or for pain lasting >10 days in adults or >5 days in children.
METABOLISM / TRANSPORT EFFECTS — Acetaminophen: Substrate (minor) of CYP1A2, 2A6, 2C9, 2D6, 2E1, 3A4; Inhibits CYP3A4 (weak)
DRUG INTERACTIONS
Anticonvulsants (Hydantoin): May increase the metabolism of Acetaminophen. This may 1) diminish the effect of acetaminophen; and 2) increase the risk of liver damage. Risk C: Monitor therapy
Barbiturates: May increase the metabolism of Acetaminophen. This may 1) diminish the effect of acetaminophen; and 2) increase the risk of liver damage. Risk C: Monitor therapy
CarBAMazepine: May increase the metabolism of Acetaminophen. This may 1) diminish the effect of acetaminophen; and 2) increase the risk of liver damage. Risk C: Monitor therapy
Cholestyramine Resin: May decrease the absorption of Acetaminophen. Effect is minimal if cholestyramine is administered 1 hour after acetaminophen. Risk D: Consider therapy modification
Imatinib: May increase the serum concentration of Acetaminophen. Risk D: Consider therapy modification
Isoniazid: May enhance the adverse/toxic effect of Acetaminophen. Risk C: Monitor therapy
Peginterferon Alfa-2b: May decrease the serum concentration of CYP2D6 Substrates. Risk C: Monitor therapy
Vitamin K Antagonists (eg, warfarin): Acetaminophen may enhance the anticoagulant effect of Vitamin K Antagonists. Most likely with daily acetaminophen doses >1.3 g for >1 week. Risk C: Monitor therapy
ETHANOL / NUTRITION / HERB INTERACTIONS
Ethanol: Excessive intake of ethanol may increase the risk of acetaminophen-induced hepatotoxicity. Avoid ethanol or limit to <3 drinks/day.
Food: Rate of absorption may be decreased when given with food.
PREGNANCY RISK FACTOR — C (show table)
PREGNANCY IMPLICATIONS — Reproduction studies have not been conducted with this combination.
LACTATION — Excretion in breast milk unknown/use caution
BREAST-FEEDING CONSIDERATIONS — Acetaminophen is excreted in breast milk. Excretion of phenyltoloxamine is not known.
DIETARY CONSIDERATIONS — May be taken with food or milk.
PRICING — (data from drugstore.com)
Tablets (Flextra DS)
50-500 mg (30): $18.99
MECHANISM OF ACTION — Acetaminophen inhibits the synthesis of prostaglandins in the central nervous system and peripherally blocks pain impulse generation; produces antipyresis from inhibition of hypothalamic heat-regulating center. Phenyltoloxamine is an antihistamine (H1-blocking agent) which acts primarily to inhibit secretions in the nose, mouth, and pharynx, as well as causing CNS depression.
Acetaminophen and phenylephrine
MEDICATION SAFETY ISSUES
Duplicate therapy issues: This product contains acetaminophen, which may be a component of combination products. Do not exceed the maximum recommended daily dose of acetaminophen.
U.S. BRAND NAMES — Alka-Seltzer Plus® Sinus Formula [OTC]; Cetafen Cold® [OTC]; Contac® Cold + Flu Maximum Strength Non-Drowsy [OTC]; Excedrin® Sinus Headache [OTC]; Mapap® Sinus Congestion and Pain Daytime [OTC]; Sinus Pain & Pressure [OTC]; Sinutab® Sinus [OTC]; Sudafed PE® Sinus Headache [OTC]; Tylenol® Sinus Congestion & Pain Daytime [OTC]; Vicks® DayQuil® Sinus [OTC]
PHARMACOLOGIC CATEGORY
Analgesic, Miscellaneous
Decongestant
DOSING: ADULTS — Sinus pain/pressure: Oral: General dosing guidelines, refer to specific product labeling: Acetaminophen 325 mg and phenylephrine 5 mg/caplet: Take 2 caplets every 4 hours as needed; maximum: 12 caplets/24 hours
DOSING: PEDIATRIC — Children ≥ 12 years: Refer to adult dosing.
DOSING: ELDERLY — Refer to adult dosing.
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Caplet, oral:
Contac® Cold + Flu Maximum Strength Non Drowsy: Acetaminophen 500 mg and phenylephrine hydrochloride 5 mg
Excedrin® Sinus Headache: Acetaminophen 325 mg and phenylephrine hydrochloride 5 mg
Mapap® Sinus Congestion and Pain Daytime, Sinutab® Sinus, Sudafed PE® Sinus Headache: Acetaminophen 325 mg and phenylephrine hydrochloride 5 mg
Tylenol® Sinus Congestion & Pain Daytime: Acetaminophen 325 mg and phenylephrine hydrochloride 5 mg [Cool Burst™ flavor]
Capsule, liquicap, oral:
Vicks® DayQuil® Sinus: Acetaminophen 325 mg and phenylephrine hydrochloride 5 mg [ethanol free]
Gelcap, oral:
Tylenol® Sinus Congestion & Pain Daytime: Acetaminophen 325 mg and phenylephrine hydrochloride 5 mg
Gelcap, rapid release, oral:
Tylenol® Sinus Congestion & Pain Datyime: Acetaminophen 325 mg and phenylephrine hydrochloride 5 mg
Tablet for solution, oral [effervescent]:
Alka-Seltzer Plus® Sinus Formula: Acetaminophen 250 mg and phenylephrine hydrochloride 5 mg [contains sodium 477 mg/tablet and phenylalanine 4.2 mg/tablet; lemon zest flavor]
Tablet, oral:
Cetafen Cold®: Acetaminophen 500 mg and phenylephrine hydrochloride 5 mg
Sinus Pain & Pressure: Acetaminophen 500 mg and phenylephrine hydrochloride 5 mg
DOSAGE FORMS: CONCISE
Caplet, oral:
Contac® Cold + Flu Maximum Strength Non Drowsy [OTC]: Acetaminophen 500 mg and phenylephrine 5 mg
Excedrin® Sinus Headache [OTC], Mapap® Sinus Congestion and Pain Daytime [OTC], Sinutab® Sinus [OTC], Sudafed PE® Sinus Headache [OTC]: Acetaminophen 325 mg and phenylephrine 5 mg
Tylenol® Sinus Congestion & Pain Daytime [OTC]: Acetaminophen 325 mg and phenylephrine 5 mg [Cool Burst™ flavor]
Capsule, liquicap, oral:
Vicks® DayQuil® Sinus [OTC]: Acetaminophen 325 mg and phenylephrine 5 mg
Gelcap, oral:
Tylenol® Sinus Congestion & Pain Daytime [OTC]: Acetaminophen 325 mg and phenylephrine 5 mg
Gelcap, rapid release, oral:
Tylenol® Sinus Congestion & Pain Daytime [OTC]: Acetaminophen 325 mg and phenylephrine 5 mg
Tablet for solution, oral [effervescent]:
Alka-Seltzer Plus® Sinus Formula [OTC]: Acetaminophen 250 mg and phenylephrine 5 mg
Tablet, oral:
Cetafen Cold® [OTC], Sinus Pain & Pressure [OTC]: Acetaminophen 500 mg and phenylephrine 5 mg
GENERIC EQUIVALENT AVAILABLE — Yes: Caplet
ADMINISTRATION — Caplets and gelcaps should be swallowed whole; do not crush, chew, or dissolve. Effervescent tablets should be dissolved in 4 ounces of water.
USE — Temporary relief of sinus/nasal congestion and pressure, headache, and minor aches and pains
ADVERSE REACTIONS SIGNIFICANT — See individual agents.
CONTRAINDICATIONS — Hypersensitivity to acetaminophen, phenylephrine, or any component of the formulation; with or within 14 days of MAO inhibitor therapy
WARNINGS / PRECAUTIONS
Disease-related concerns: Cardiovascular disease: Use with caution in patients with cardiovascular disease (including hypertension and ischemic heart disease). Diabetes: Use with caution in patients with diabetes mellitus. Ethanol use: Use with caution in patients with alcoholic liver disease; consuming ≥ 3 alcoholic drinks/day may increase the risk of liver damage. Hepatic impairment: Use caution in patients with hepatic impairment; acetaminophen may cause severe hepatic toxicity with acute overdose. Prostatic hyperplasia/urinary obstruction: Use with caution in patients with prostatic hyperplasia and/or GU obstruction. Thyroid dysfunction: Use with caution in patients with thyroid dysfunction.
Special populations: Elderly: Use with caution in the elderly; more likely to experience adverse reactions to sympathomimetics. Pediatrics: Use with caution in children; do not exceed pediatric dosing recommendations. Not for OTC use in children <12 years of age.
Dosage form specific issues: Phenylalanine: Some products may contain phenylalanine. Sodium: Some products may contain sodium; use with caution in sodium restricted patients.
Other warnings/precautions: Dosage limit: Limit acetaminophen dose to <4>3 days. Discontinue and contact healthcare provider if nervousness, dizziness, or sleeplessness occur.
METABOLISM / TRANSPORT EFFECTS — Acetaminophen: Substrate (minor) of CYP1A2, 2A6, 2C9, 2D6, 2E1, 3A4; Inhibits CYP3A4 (weak)
DRUG INTERACTIONS
Anticonvulsants (Hydantoin): May increase the metabolism of Acetaminophen. This may 1) diminish the effect of acetaminophen; and 2) increase the risk of liver damage. Risk C: Monitor therapy
Atomoxetine: May enhance the hypertensive effect of Sympathomimetics. Atomoxetine may enhance the tachycardic effect of Sympathomimetics. Risk C: Monitor therapy
Barbiturates: May increase the metabolism of Acetaminophen. This may 1) diminish the effect of acetaminophen; and 2) increase the risk of liver damage. Risk C: Monitor therapy
Cannabinoids: May enhance the tachycardic effect of Sympathomimetics. Risk C: Monitor therapy
CarBAMazepine: May increase the metabolism of Acetaminophen. This may 1) diminish the effect of acetaminophen; and 2) increase the risk of liver damage. Risk C: Monitor therapy
Cholestyramine Resin: May decrease the absorption of Acetaminophen. Effect is minimal if cholestyramine is administered 1 hour after acetaminophen. Risk D: Consider therapy modification
Imatinib: May increase the serum concentration of Acetaminophen. Risk D: Consider therapy modification
Iobenguane I 123: Sympathomimetics may diminish the therapeutic effect of Iobenguane I 123. Risk X: Avoid combination
Isoniazid: May enhance the adverse/toxic effect of Acetaminophen. Risk C: Monitor therapy
MAO Inhibitors: May enhance the hypertensive effect of Alpha1-Agonists. Risk X: Avoid combination
Peginterferon Alfa-2b: May decrease the serum concentration of CYP2D6 Substrates. Risk C: Monitor therapy
Sympathomimetics: May enhance the adverse/toxic effect of other Sympathomimetics. Risk C: Monitor therapy
Tricyclic Antidepressants: May enhance the vasopressor effect of Alpha1-Agonists. Risk D: Consider therapy modification
Vitamin K Antagonists (eg, warfarin): Acetaminophen may enhance the anticoagulant effect of Vitamin K Antagonists. Most likely with daily acetaminophen doses >1.3 g for >1 week. Risk C: Monitor therapy
ETHANOL / NUTRITION / HERB INTERACTIONS — See individual agents.
DIETARY CONSIDERATIONS — Alka-Seltzer Plus® Sinus Formula contains sodium 477 mg/tablet and phenylalanine 4.2 mg/tablet
MECHANISM OF ACTION — Acetaminophen inhibits the synthesis of prostaglandins in the central nervous system and peripherally blocks pain impulse generation. Phenylephrine causes vasoconstriction of the arterioles of the nasal mucosa.
PHARMACODYNAMICS / KINETICS — See individual agents.
Duplicate therapy issues: This product contains acetaminophen, which may be a component of combination products. Do not exceed the maximum recommended daily dose of acetaminophen.
U.S. BRAND NAMES — Alka-Seltzer Plus® Sinus Formula [OTC]; Cetafen Cold® [OTC]; Contac® Cold + Flu Maximum Strength Non-Drowsy [OTC]; Excedrin® Sinus Headache [OTC]; Mapap® Sinus Congestion and Pain Daytime [OTC]; Sinus Pain & Pressure [OTC]; Sinutab® Sinus [OTC]; Sudafed PE® Sinus Headache [OTC]; Tylenol® Sinus Congestion & Pain Daytime [OTC]; Vicks® DayQuil® Sinus [OTC]
PHARMACOLOGIC CATEGORY
Analgesic, Miscellaneous
Decongestant
DOSING: ADULTS — Sinus pain/pressure: Oral: General dosing guidelines, refer to specific product labeling: Acetaminophen 325 mg and phenylephrine 5 mg/caplet: Take 2 caplets every 4 hours as needed; maximum: 12 caplets/24 hours
DOSING: PEDIATRIC — Children ≥ 12 years: Refer to adult dosing.
DOSING: ELDERLY — Refer to adult dosing.
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Caplet, oral:
Contac® Cold + Flu Maximum Strength Non Drowsy: Acetaminophen 500 mg and phenylephrine hydrochloride 5 mg
Excedrin® Sinus Headache: Acetaminophen 325 mg and phenylephrine hydrochloride 5 mg
Mapap® Sinus Congestion and Pain Daytime, Sinutab® Sinus, Sudafed PE® Sinus Headache: Acetaminophen 325 mg and phenylephrine hydrochloride 5 mg
Tylenol® Sinus Congestion & Pain Daytime: Acetaminophen 325 mg and phenylephrine hydrochloride 5 mg [Cool Burst™ flavor]
Capsule, liquicap, oral:
Vicks® DayQuil® Sinus: Acetaminophen 325 mg and phenylephrine hydrochloride 5 mg [ethanol free]
Gelcap, oral:
Tylenol® Sinus Congestion & Pain Daytime: Acetaminophen 325 mg and phenylephrine hydrochloride 5 mg
Gelcap, rapid release, oral:
Tylenol® Sinus Congestion & Pain Datyime: Acetaminophen 325 mg and phenylephrine hydrochloride 5 mg
Tablet for solution, oral [effervescent]:
Alka-Seltzer Plus® Sinus Formula: Acetaminophen 250 mg and phenylephrine hydrochloride 5 mg [contains sodium 477 mg/tablet and phenylalanine 4.2 mg/tablet; lemon zest flavor]
Tablet, oral:
Cetafen Cold®: Acetaminophen 500 mg and phenylephrine hydrochloride 5 mg
Sinus Pain & Pressure: Acetaminophen 500 mg and phenylephrine hydrochloride 5 mg
DOSAGE FORMS: CONCISE
Caplet, oral:
Contac® Cold + Flu Maximum Strength Non Drowsy [OTC]: Acetaminophen 500 mg and phenylephrine 5 mg
Excedrin® Sinus Headache [OTC], Mapap® Sinus Congestion and Pain Daytime [OTC], Sinutab® Sinus [OTC], Sudafed PE® Sinus Headache [OTC]: Acetaminophen 325 mg and phenylephrine 5 mg
Tylenol® Sinus Congestion & Pain Daytime [OTC]: Acetaminophen 325 mg and phenylephrine 5 mg [Cool Burst™ flavor]
Capsule, liquicap, oral:
Vicks® DayQuil® Sinus [OTC]: Acetaminophen 325 mg and phenylephrine 5 mg
Gelcap, oral:
Tylenol® Sinus Congestion & Pain Daytime [OTC]: Acetaminophen 325 mg and phenylephrine 5 mg
Gelcap, rapid release, oral:
Tylenol® Sinus Congestion & Pain Daytime [OTC]: Acetaminophen 325 mg and phenylephrine 5 mg
Tablet for solution, oral [effervescent]:
Alka-Seltzer Plus® Sinus Formula [OTC]: Acetaminophen 250 mg and phenylephrine 5 mg
Tablet, oral:
Cetafen Cold® [OTC], Sinus Pain & Pressure [OTC]: Acetaminophen 500 mg and phenylephrine 5 mg
GENERIC EQUIVALENT AVAILABLE — Yes: Caplet
ADMINISTRATION — Caplets and gelcaps should be swallowed whole; do not crush, chew, or dissolve. Effervescent tablets should be dissolved in 4 ounces of water.
USE — Temporary relief of sinus/nasal congestion and pressure, headache, and minor aches and pains
ADVERSE REACTIONS SIGNIFICANT — See individual agents.
CONTRAINDICATIONS — Hypersensitivity to acetaminophen, phenylephrine, or any component of the formulation; with or within 14 days of MAO inhibitor therapy
WARNINGS / PRECAUTIONS
Disease-related concerns: Cardiovascular disease: Use with caution in patients with cardiovascular disease (including hypertension and ischemic heart disease). Diabetes: Use with caution in patients with diabetes mellitus. Ethanol use: Use with caution in patients with alcoholic liver disease; consuming ≥ 3 alcoholic drinks/day may increase the risk of liver damage. Hepatic impairment: Use caution in patients with hepatic impairment; acetaminophen may cause severe hepatic toxicity with acute overdose. Prostatic hyperplasia/urinary obstruction: Use with caution in patients with prostatic hyperplasia and/or GU obstruction. Thyroid dysfunction: Use with caution in patients with thyroid dysfunction.
Special populations: Elderly: Use with caution in the elderly; more likely to experience adverse reactions to sympathomimetics. Pediatrics: Use with caution in children; do not exceed pediatric dosing recommendations. Not for OTC use in children <12 years of age.
Dosage form specific issues: Phenylalanine: Some products may contain phenylalanine. Sodium: Some products may contain sodium; use with caution in sodium restricted patients.
Other warnings/precautions: Dosage limit: Limit acetaminophen dose to <4>3 days. Discontinue and contact healthcare provider if nervousness, dizziness, or sleeplessness occur.
METABOLISM / TRANSPORT EFFECTS — Acetaminophen: Substrate (minor) of CYP1A2, 2A6, 2C9, 2D6, 2E1, 3A4; Inhibits CYP3A4 (weak)
DRUG INTERACTIONS
Anticonvulsants (Hydantoin): May increase the metabolism of Acetaminophen. This may 1) diminish the effect of acetaminophen; and 2) increase the risk of liver damage. Risk C: Monitor therapy
Atomoxetine: May enhance the hypertensive effect of Sympathomimetics. Atomoxetine may enhance the tachycardic effect of Sympathomimetics. Risk C: Monitor therapy
Barbiturates: May increase the metabolism of Acetaminophen. This may 1) diminish the effect of acetaminophen; and 2) increase the risk of liver damage. Risk C: Monitor therapy
Cannabinoids: May enhance the tachycardic effect of Sympathomimetics. Risk C: Monitor therapy
CarBAMazepine: May increase the metabolism of Acetaminophen. This may 1) diminish the effect of acetaminophen; and 2) increase the risk of liver damage. Risk C: Monitor therapy
Cholestyramine Resin: May decrease the absorption of Acetaminophen. Effect is minimal if cholestyramine is administered 1 hour after acetaminophen. Risk D: Consider therapy modification
Imatinib: May increase the serum concentration of Acetaminophen. Risk D: Consider therapy modification
Iobenguane I 123: Sympathomimetics may diminish the therapeutic effect of Iobenguane I 123. Risk X: Avoid combination
Isoniazid: May enhance the adverse/toxic effect of Acetaminophen. Risk C: Monitor therapy
MAO Inhibitors: May enhance the hypertensive effect of Alpha1-Agonists. Risk X: Avoid combination
Peginterferon Alfa-2b: May decrease the serum concentration of CYP2D6 Substrates. Risk C: Monitor therapy
Sympathomimetics: May enhance the adverse/toxic effect of other Sympathomimetics. Risk C: Monitor therapy
Tricyclic Antidepressants: May enhance the vasopressor effect of Alpha1-Agonists. Risk D: Consider therapy modification
Vitamin K Antagonists (eg, warfarin): Acetaminophen may enhance the anticoagulant effect of Vitamin K Antagonists. Most likely with daily acetaminophen doses >1.3 g for >1 week. Risk C: Monitor therapy
ETHANOL / NUTRITION / HERB INTERACTIONS — See individual agents.
DIETARY CONSIDERATIONS — Alka-Seltzer Plus® Sinus Formula contains sodium 477 mg/tablet and phenylalanine 4.2 mg/tablet
MECHANISM OF ACTION — Acetaminophen inhibits the synthesis of prostaglandins in the central nervous system and peripherally blocks pain impulse generation. Phenylephrine causes vasoconstriction of the arterioles of the nasal mucosa.
PHARMACODYNAMICS / KINETICS — See individual agents.
Acetaminophen and phenyltoloxamine
MEDICATION SAFETY ISSUES
Sound-alike/look-alike issues:
Percogesic® may be confused with paregoric, Percodan®
Duplicate therapy issues: This product contains acetaminophen, which may be a component of other combination products. Do not exceed the maximum recommended daily dose of acetaminophen.
U.S. BRAND NAMES — Aceta-Gesic [OTC]; Alpain; BeFlex; Dologesic®; Flextra-650; Flextra-DS; Genasec™ [OTC]; Hyflex-DS® [DSC]; Lagesic™ ; Percogesic® [OTC]; Phenagesic [OTC]; Phenylgesic [OTC]; RhinoFlex™ ; RhinoFlex™ -650; Staflex; Vistra 650 [DSC]; Zgesic
PHARMACOLOGIC CATEGORY
Analgesic, Miscellaneous
DOSING: ADULTS
Pain (Analgesic): Oral: Based on acetaminophen component: 325-650 mg every 4-6 hours as needed (maximum: 4 g/day)
Product-specific labeling: Oral:
Dologesic®: 1-2 caplets/capsules or 15-30 mL every 4 hours (maximum: 8 caplets/24 hours or 120 mL/24 hours)
Flextra-650:1/2-1 tablet every 6 hours (maximum: 4 tablets/day)
Flextra-DS, RhinoFlex™ , RhinoFlex™ -650:1/2-1 tablet every 4 hours (maximum: 5 tablets/day)
Lagesic™ , Zgesic: 1-2 caplets/tablets every 8-12 hours (maximum: 6 tablets/24 hours)
Percogesic®: 1-2 tablets every 4 hours (maximum: 8 tablets/24 hours)
DOSING: PEDIATRIC
Analgesic: Oral:
Based on acetaminophen component: 10-15 mg/kg/dose every 4-6 hours as needed (maximum: 5 doses/24 hours)
Product-specific labeling: Oral:
Dologesic®:
Children <12 years: 1 caplet/capsule or 5 mL every 4 hours
Children ≥ 12 years: Refer to adult dosing.
Flextra-650:
Children 6 to <12 years: 1/2 tablet every 6 hours (maximum: 2 tablets/day)
Children ≥ 12 years: Refer to adult dosing.
Flextra-DS, RhinoFlex™ , RhinoFlex™ -650:
Children 6 to <12 years: 1/2 tablet every 4 hours (maximum: 2.5 tablets/day)
Children ≥ 12 years: Refer to adult dosing.
Lagesic™ :
Children 6-12 years: 1/2 to 1 caplet every 12 hours (maximum: 2 caplets/day)
Children ≥ 12 years: Refer to adult dosing.
Percogesic®: Children 6-12 years: 1 tablet every 4 hours (maximum: 4 tablets/24 hours)
Zgesic: Children >12 years: Refer to adult dosing.
DOSING: ELDERLY — Refer to adult dosing.
DOSING: RENAL IMPAIRMENT
Specific dosing adjustment not available. Monitor renal function with severe impairment.
DOSING: HEPATIC IMPAIRMENT — Use with caution. Limited, low-dose therapy is usually well tolerated in hepatic disease/cirrhosis; however, cases of hepatotoxicity at daily acetaminophen dosages <4 g/day have been reported. Avoid chronic use in hepatic impairment.
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Caplet:
Alpain: Acetaminophen 500 mg and phenyltoloxamine citrate 60 mg
BeFlex: Acetaminophen 500 mg and phenyltoloxamine citrate 55 mg
Dologesic®: Acetaminophen 500 mg and phenyltoloxamine citrate 30 mg
Staflex: Acetaminophen 500 mg and phenyltoloxamine citrate 55 mg
Caplet, extended release [scored]:
Lagesic™ : Acetaminophen 600 mg and phenyltoloxamine citrate 66 mg
Capsule:
Dologesic®: Acetaminophen 500 mg and phenyltoloxamine citrate 30 mg
Liquid:
Dologesic®: Acetaminophen 500 mg and phenyltoloxamine citrate 30 mg per 15 mL (180 mL)
Tablet: Acetaminophen 325 mg and phenyltoloxamine citrate 30 mg
Aceta-Gesic, Genasec™ , Percogesic®, Phenagesic, Phenylgesic: Acetaminophen 325 mg and phenyltoloxamine citrate 30 mg
Flextra-650, Vistra 650 [DSC]: Acetaminophen 650 mg and phenyltoloxamine citrate 60 mg
Flextra-DS, Hyflex-DS® [DSC], RhinoFlex™ : Acetaminophen 500 mg and phenyltoloxamine citrate 50 mg
RhinoFlex™ -650: Acetaminophen 650 mg and phenyltoloxamine citrate 50 mg
Tablet, prolonged release, oral:
Zgesic: Acetaminophen 600 mg and phenyltoloxamine citrate 66 mg
DOSAGE FORMS: CONCISE
Caplet:
Alpain: Acetaminophen 500 mg and phenyltoloxamine 60 mg
BeFlex, Staflex: Acetaminophen 500 mg and phenyltoloxamine 55 mg
Dologesic®: Acetaminophen 500 mg and phenyltoloxamine 30 mg
Caplet, extended release [scored]:
Lagesic™ : Acetaminophen 600 mg and phenyltoloxamine 66 mg
Capsule:
Dologesic®: Acetaminophen 500 mg and phenyltoloxamine 30 mg
Liquid:
Dologesic®: Acetaminophen 500 mg and phenyltoloxamine 30 mg per 15 mg
Tablet: Acetaminophen 325 mg and phenyltoloxamine 30 mg
Aceta-Gesic [OTC], Genasec™ [OTC], Percogesic® [OTC], Phenagesic [OTC], Phenylgesic [OTC]: Acetaminophen 325 mg and phenyltoloxamine 30 mg
Flextra-650: Acetaminophen 650 mg and phenyltoloxamine 60 mg
Flextra-DS, RhinoFlex™ : Acetaminophen 500 mg and phenyltoloxamine 50 mg
RhinoFlex™ -650: Acetaminophen 650 mg and phenyltoloxamine 50 mg
Tablet, prolonged release, oral:
Zgesic: Acetaminophen 600 mg and phenyltoloxamine 66 mg
GENERIC EQUIVALENT AVAILABLE — Yes: Tablet
ADMINISTRATION — May be administered with food or milk.
Extended release caplet (Lagesic™ ): Caplet may be broken in half; do not chew or crush.
Prolonged release tablet (Zgesic): Swallow whole; do not chew or crush.
USE — Relief of mild-to-moderate pain
ADVERSE REACTIONS SIGNIFICANT — Frequency not defined.
Central nervous system: Dizziness, drowsiness, lassitude
Dermatologic: Pruritus, rash
Gastrointestinal: Nausea
Ocular: Blurred vision
Miscellaneous: Diaphoresis
CONTRAINDICATIONS — Hypersensitivity to acetaminophen, phenyltoloxamine, or any component of the formulation
WARNINGS / PRECAUTIONS
Concerns related to adverse effects: CNS depression: May cause CNS depression, which may impair physical or mental abilities; patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving). Hepatotoxicity: May cause severe hepatic toxicity on acute overdose; in addition, chronic daily dosing in adults has resulted in liver damage in some patients.
Disease-related concerns: Ethanol use: Use with caution in patients with alcoholic liver disease; consuming ≥ 3 alcoholic drinks/day may increase the risk of liver damage. G6PD deficiency: Use with caution in patients with known G6PD deficiency. Glaucoma: Use with caution in patients with glaucoma. Hepatic impairment: Use with caution in patients with hepatic impairment. Prostatic hyperplasia/urinary stricture: Use with caution in patients with prostatic hyperplasia and/or urinary stricture. Renal impairment: Use with caution in patients with renal impairment. Respiratory disease: Use with caution in patients with pre-existing respiratory compromise (hypoxia and/or hypercapnia), COPD or other obstructive pulmonary disease, and kyphoscoliosis or other skeletal disorder which may alter respiratory function; critical respiratory depression may occur, even at therapeutic dosages.
Concurrent drug therapy issues: Sedatives: Effects may be potentiated when used with other sedative drugs or ethanol.
Special populations: Elderly: Use with caution in the elderly; may be more sensitive to adverse effects. Pediatrics: Safety and efficacy have not been established in children <6 years of age.
Other warnings/precautions: Dosage limit: Limit acetaminophen dose to <4>3 days or for pain lasting >10 days in adults or >5 days in children.
METABOLISM / TRANSPORT EFFECTS — Acetaminophen: Substrate (minor) of CYP1A2, 2A6, 2C9, 2D6, 2E1, 3A4; Inhibits CYP3A4 (weak)
DRUG INTERACTIONS
Anticonvulsants (Hydantoin): May increase the metabolism of Acetaminophen. This may 1) diminish the effect of acetaminophen; and 2) increase the risk of liver damage. Risk C: Monitor therapy
Barbiturates: May increase the metabolism of Acetaminophen. This may 1) diminish the effect of acetaminophen; and 2) increase the risk of liver damage. Risk C: Monitor therapy
CarBAMazepine: May increase the metabolism of Acetaminophen. This may 1) diminish the effect of acetaminophen; and 2) increase the risk of liver damage. Risk C: Monitor therapy
Cholestyramine Resin: May decrease the absorption of Acetaminophen. Effect is minimal if cholestyramine is administered 1 hour after acetaminophen. Risk D: Consider therapy modification
Imatinib: May increase the serum concentration of Acetaminophen. Risk D: Consider therapy modification
Isoniazid: May enhance the adverse/toxic effect of Acetaminophen. Risk C: Monitor therapy
Peginterferon Alfa-2b: May decrease the serum concentration of CYP2D6 Substrates. Risk C: Monitor therapy
Vitamin K Antagonists (eg, warfarin): Acetaminophen may enhance the anticoagulant effect of Vitamin K Antagonists. Most likely with daily acetaminophen doses >1.3 g for >1 week. Risk C: Monitor therapy
ETHANOL / NUTRITION / HERB INTERACTIONS
Ethanol: Excessive intake of ethanol may increase the risk of acetaminophen-induced hepatotoxicity. Avoid ethanol or limit to <3 drinks/day.
Food: Rate of absorption may be decreased when given with food.
PREGNANCY RISK FACTOR — C (show table)
PREGNANCY IMPLICATIONS — Reproduction studies have not been conducted with this combination.
LACTATION — Excretion in breast milk unknown/use caution
BREAST-FEEDING CONSIDERATIONS — Acetaminophen is excreted in breast milk. Excretion of phenyltoloxamine is not known.
DIETARY CONSIDERATIONS — May be taken with food or milk.
PRICING — (data from drugstore.com)
Tablets (Flextra DS)
50-500 mg (30): $18.99
MECHANISM OF ACTION — Acetaminophen inhibits the synthesis of prostaglandins in the central nervous system and peripherally blocks pain impulse generation; produces antipyresis from inhibition of hypothalamic heat-regulating center. Phenyltoloxamine is an antihistamine (H1-blocking agent) which acts primarily to inhibit secretions in the nose, mouth, and pharynx, as well as causing CNS depression.
Sound-alike/look-alike issues:
Percogesic® may be confused with paregoric, Percodan®
Duplicate therapy issues: This product contains acetaminophen, which may be a component of other combination products. Do not exceed the maximum recommended daily dose of acetaminophen.
U.S. BRAND NAMES — Aceta-Gesic [OTC]; Alpain; BeFlex; Dologesic®; Flextra-650; Flextra-DS; Genasec™ [OTC]; Hyflex-DS® [DSC]; Lagesic™ ; Percogesic® [OTC]; Phenagesic [OTC]; Phenylgesic [OTC]; RhinoFlex™ ; RhinoFlex™ -650; Staflex; Vistra 650 [DSC]; Zgesic
PHARMACOLOGIC CATEGORY
Analgesic, Miscellaneous
DOSING: ADULTS
Pain (Analgesic): Oral: Based on acetaminophen component: 325-650 mg every 4-6 hours as needed (maximum: 4 g/day)
Product-specific labeling: Oral:
Dologesic®: 1-2 caplets/capsules or 15-30 mL every 4 hours (maximum: 8 caplets/24 hours or 120 mL/24 hours)
Flextra-650:1/2-1 tablet every 6 hours (maximum: 4 tablets/day)
Flextra-DS, RhinoFlex™ , RhinoFlex™ -650:1/2-1 tablet every 4 hours (maximum: 5 tablets/day)
Lagesic™ , Zgesic: 1-2 caplets/tablets every 8-12 hours (maximum: 6 tablets/24 hours)
Percogesic®: 1-2 tablets every 4 hours (maximum: 8 tablets/24 hours)
DOSING: PEDIATRIC
Analgesic: Oral:
Based on acetaminophen component: 10-15 mg/kg/dose every 4-6 hours as needed (maximum: 5 doses/24 hours)
Product-specific labeling: Oral:
Dologesic®:
Children <12 years: 1 caplet/capsule or 5 mL every 4 hours
Children ≥ 12 years: Refer to adult dosing.
Flextra-650:
Children 6 to <12 years: 1/2 tablet every 6 hours (maximum: 2 tablets/day)
Children ≥ 12 years: Refer to adult dosing.
Flextra-DS, RhinoFlex™ , RhinoFlex™ -650:
Children 6 to <12 years: 1/2 tablet every 4 hours (maximum: 2.5 tablets/day)
Children ≥ 12 years: Refer to adult dosing.
Lagesic™ :
Children 6-12 years: 1/2 to 1 caplet every 12 hours (maximum: 2 caplets/day)
Children ≥ 12 years: Refer to adult dosing.
Percogesic®: Children 6-12 years: 1 tablet every 4 hours (maximum: 4 tablets/24 hours)
Zgesic: Children >12 years: Refer to adult dosing.
DOSING: ELDERLY — Refer to adult dosing.
DOSING: RENAL IMPAIRMENT
Specific dosing adjustment not available. Monitor renal function with severe impairment.
DOSING: HEPATIC IMPAIRMENT — Use with caution. Limited, low-dose therapy is usually well tolerated in hepatic disease/cirrhosis; however, cases of hepatotoxicity at daily acetaminophen dosages <4 g/day have been reported. Avoid chronic use in hepatic impairment.
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Caplet:
Alpain: Acetaminophen 500 mg and phenyltoloxamine citrate 60 mg
BeFlex: Acetaminophen 500 mg and phenyltoloxamine citrate 55 mg
Dologesic®: Acetaminophen 500 mg and phenyltoloxamine citrate 30 mg
Staflex: Acetaminophen 500 mg and phenyltoloxamine citrate 55 mg
Caplet, extended release [scored]:
Lagesic™ : Acetaminophen 600 mg and phenyltoloxamine citrate 66 mg
Capsule:
Dologesic®: Acetaminophen 500 mg and phenyltoloxamine citrate 30 mg
Liquid:
Dologesic®: Acetaminophen 500 mg and phenyltoloxamine citrate 30 mg per 15 mL (180 mL)
Tablet: Acetaminophen 325 mg and phenyltoloxamine citrate 30 mg
Aceta-Gesic, Genasec™ , Percogesic®, Phenagesic, Phenylgesic: Acetaminophen 325 mg and phenyltoloxamine citrate 30 mg
Flextra-650, Vistra 650 [DSC]: Acetaminophen 650 mg and phenyltoloxamine citrate 60 mg
Flextra-DS, Hyflex-DS® [DSC], RhinoFlex™ : Acetaminophen 500 mg and phenyltoloxamine citrate 50 mg
RhinoFlex™ -650: Acetaminophen 650 mg and phenyltoloxamine citrate 50 mg
Tablet, prolonged release, oral:
Zgesic: Acetaminophen 600 mg and phenyltoloxamine citrate 66 mg
DOSAGE FORMS: CONCISE
Caplet:
Alpain: Acetaminophen 500 mg and phenyltoloxamine 60 mg
BeFlex, Staflex: Acetaminophen 500 mg and phenyltoloxamine 55 mg
Dologesic®: Acetaminophen 500 mg and phenyltoloxamine 30 mg
Caplet, extended release [scored]:
Lagesic™ : Acetaminophen 600 mg and phenyltoloxamine 66 mg
Capsule:
Dologesic®: Acetaminophen 500 mg and phenyltoloxamine 30 mg
Liquid:
Dologesic®: Acetaminophen 500 mg and phenyltoloxamine 30 mg per 15 mg
Tablet: Acetaminophen 325 mg and phenyltoloxamine 30 mg
Aceta-Gesic [OTC], Genasec™ [OTC], Percogesic® [OTC], Phenagesic [OTC], Phenylgesic [OTC]: Acetaminophen 325 mg and phenyltoloxamine 30 mg
Flextra-650: Acetaminophen 650 mg and phenyltoloxamine 60 mg
Flextra-DS, RhinoFlex™ : Acetaminophen 500 mg and phenyltoloxamine 50 mg
RhinoFlex™ -650: Acetaminophen 650 mg and phenyltoloxamine 50 mg
Tablet, prolonged release, oral:
Zgesic: Acetaminophen 600 mg and phenyltoloxamine 66 mg
GENERIC EQUIVALENT AVAILABLE — Yes: Tablet
ADMINISTRATION — May be administered with food or milk.
Extended release caplet (Lagesic™ ): Caplet may be broken in half; do not chew or crush.
Prolonged release tablet (Zgesic): Swallow whole; do not chew or crush.
USE — Relief of mild-to-moderate pain
ADVERSE REACTIONS SIGNIFICANT — Frequency not defined.
Central nervous system: Dizziness, drowsiness, lassitude
Dermatologic: Pruritus, rash
Gastrointestinal: Nausea
Ocular: Blurred vision
Miscellaneous: Diaphoresis
CONTRAINDICATIONS — Hypersensitivity to acetaminophen, phenyltoloxamine, or any component of the formulation
WARNINGS / PRECAUTIONS
Concerns related to adverse effects: CNS depression: May cause CNS depression, which may impair physical or mental abilities; patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving). Hepatotoxicity: May cause severe hepatic toxicity on acute overdose; in addition, chronic daily dosing in adults has resulted in liver damage in some patients.
Disease-related concerns: Ethanol use: Use with caution in patients with alcoholic liver disease; consuming ≥ 3 alcoholic drinks/day may increase the risk of liver damage. G6PD deficiency: Use with caution in patients with known G6PD deficiency. Glaucoma: Use with caution in patients with glaucoma. Hepatic impairment: Use with caution in patients with hepatic impairment. Prostatic hyperplasia/urinary stricture: Use with caution in patients with prostatic hyperplasia and/or urinary stricture. Renal impairment: Use with caution in patients with renal impairment. Respiratory disease: Use with caution in patients with pre-existing respiratory compromise (hypoxia and/or hypercapnia), COPD or other obstructive pulmonary disease, and kyphoscoliosis or other skeletal disorder which may alter respiratory function; critical respiratory depression may occur, even at therapeutic dosages.
Concurrent drug therapy issues: Sedatives: Effects may be potentiated when used with other sedative drugs or ethanol.
Special populations: Elderly: Use with caution in the elderly; may be more sensitive to adverse effects. Pediatrics: Safety and efficacy have not been established in children <6 years of age.
Other warnings/precautions: Dosage limit: Limit acetaminophen dose to <4>3 days or for pain lasting >10 days in adults or >5 days in children.
METABOLISM / TRANSPORT EFFECTS — Acetaminophen: Substrate (minor) of CYP1A2, 2A6, 2C9, 2D6, 2E1, 3A4; Inhibits CYP3A4 (weak)
DRUG INTERACTIONS
Anticonvulsants (Hydantoin): May increase the metabolism of Acetaminophen. This may 1) diminish the effect of acetaminophen; and 2) increase the risk of liver damage. Risk C: Monitor therapy
Barbiturates: May increase the metabolism of Acetaminophen. This may 1) diminish the effect of acetaminophen; and 2) increase the risk of liver damage. Risk C: Monitor therapy
CarBAMazepine: May increase the metabolism of Acetaminophen. This may 1) diminish the effect of acetaminophen; and 2) increase the risk of liver damage. Risk C: Monitor therapy
Cholestyramine Resin: May decrease the absorption of Acetaminophen. Effect is minimal if cholestyramine is administered 1 hour after acetaminophen. Risk D: Consider therapy modification
Imatinib: May increase the serum concentration of Acetaminophen. Risk D: Consider therapy modification
Isoniazid: May enhance the adverse/toxic effect of Acetaminophen. Risk C: Monitor therapy
Peginterferon Alfa-2b: May decrease the serum concentration of CYP2D6 Substrates. Risk C: Monitor therapy
Vitamin K Antagonists (eg, warfarin): Acetaminophen may enhance the anticoagulant effect of Vitamin K Antagonists. Most likely with daily acetaminophen doses >1.3 g for >1 week. Risk C: Monitor therapy
ETHANOL / NUTRITION / HERB INTERACTIONS
Ethanol: Excessive intake of ethanol may increase the risk of acetaminophen-induced hepatotoxicity. Avoid ethanol or limit to <3 drinks/day.
Food: Rate of absorption may be decreased when given with food.
PREGNANCY RISK FACTOR — C (show table)
PREGNANCY IMPLICATIONS — Reproduction studies have not been conducted with this combination.
LACTATION — Excretion in breast milk unknown/use caution
BREAST-FEEDING CONSIDERATIONS — Acetaminophen is excreted in breast milk. Excretion of phenyltoloxamine is not known.
DIETARY CONSIDERATIONS — May be taken with food or milk.
PRICING — (data from drugstore.com)
Tablets (Flextra DS)
50-500 mg (30): $18.99
MECHANISM OF ACTION — Acetaminophen inhibits the synthesis of prostaglandins in the central nervous system and peripherally blocks pain impulse generation; produces antipyresis from inhibition of hypothalamic heat-regulating center. Phenyltoloxamine is an antihistamine (H1-blocking agent) which acts primarily to inhibit secretions in the nose, mouth, and pharynx, as well as causing CNS depression.
Acetaminophen and phenylephrine
MEDICATION SAFETY ISSUES
Duplicate therapy issues: This product contains acetaminophen, which may be a component of combination products. Do not exceed the maximum recommended daily dose of acetaminophen.
U.S. BRAND NAMES — Alka-Seltzer Plus® Sinus Formula [OTC]; Cetafen Cold® [OTC]; Contac® Cold + Flu Maximum Strength Non-Drowsy [OTC]; Excedrin® Sinus Headache [OTC]; Mapap® Sinus Congestion and Pain Daytime [OTC]; Sinus Pain & Pressure [OTC]; Sinutab® Sinus [OTC]; Sudafed PE® Sinus Headache [OTC]; Tylenol® Sinus Congestion & Pain Daytime [OTC]; Vicks® DayQuil® Sinus [OTC]
PHARMACOLOGIC CATEGORY
Analgesic, Miscellaneous
Decongestant
DOSING: ADULTS — Sinus pain/pressure: Oral: General dosing guidelines, refer to specific product labeling: Acetaminophen 325 mg and phenylephrine 5 mg/caplet: Take 2 caplets every 4 hours as needed; maximum: 12 caplets/24 hours
DOSING: PEDIATRIC — Children ≥ 12 years: Refer to adult dosing.
DOSING: ELDERLY — Refer to adult dosing.
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Caplet, oral:
Contac® Cold + Flu Maximum Strength Non Drowsy: Acetaminophen 500 mg and phenylephrine hydrochloride 5 mg
Excedrin® Sinus Headache: Acetaminophen 325 mg and phenylephrine hydrochloride 5 mg
Mapap® Sinus Congestion and Pain Daytime, Sinutab® Sinus, Sudafed PE® Sinus Headache: Acetaminophen 325 mg and phenylephrine hydrochloride 5 mg
Tylenol® Sinus Congestion & Pain Daytime: Acetaminophen 325 mg and phenylephrine hydrochloride 5 mg [Cool Burst™ flavor]
Capsule, liquicap, oral:
Vicks® DayQuil® Sinus: Acetaminophen 325 mg and phenylephrine hydrochloride 5 mg [ethanol free]
Gelcap, oral:
Tylenol® Sinus Congestion & Pain Daytime: Acetaminophen 325 mg and phenylephrine hydrochloride 5 mg
Gelcap, rapid release, oral:
Tylenol® Sinus Congestion & Pain Datyime: Acetaminophen 325 mg and phenylephrine hydrochloride 5 mg
Tablet for solution, oral [effervescent]:
Alka-Seltzer Plus® Sinus Formula: Acetaminophen 250 mg and phenylephrine hydrochloride 5 mg [contains sodium 477 mg/tablet and phenylalanine 4.2 mg/tablet; lemon zest flavor]
Tablet, oral:
Cetafen Cold®: Acetaminophen 500 mg and phenylephrine hydrochloride 5 mg
Sinus Pain & Pressure: Acetaminophen 500 mg and phenylephrine hydrochloride 5 mg
DOSAGE FORMS: CONCISE
Caplet, oral:
Contac® Cold + Flu Maximum Strength Non Drowsy [OTC]: Acetaminophen 500 mg and phenylephrine 5 mg
Excedrin® Sinus Headache [OTC], Mapap® Sinus Congestion and Pain Daytime [OTC], Sinutab® Sinus [OTC], Sudafed PE® Sinus Headache [OTC]: Acetaminophen 325 mg and phenylephrine 5 mg
Tylenol® Sinus Congestion & Pain Daytime [OTC]: Acetaminophen 325 mg and phenylephrine 5 mg [Cool Burst™ flavor]
Capsule, liquicap, oral:
Vicks® DayQuil® Sinus [OTC]: Acetaminophen 325 mg and phenylephrine 5 mg
Gelcap, oral:
Tylenol® Sinus Congestion & Pain Daytime [OTC]: Acetaminophen 325 mg and phenylephrine 5 mg
Gelcap, rapid release, oral:
Tylenol® Sinus Congestion & Pain Daytime [OTC]: Acetaminophen 325 mg and phenylephrine 5 mg
Tablet for solution, oral [effervescent]:
Alka-Seltzer Plus® Sinus Formula [OTC]: Acetaminophen 250 mg and phenylephrine 5 mg
Tablet, oral:
Cetafen Cold® [OTC], Sinus Pain & Pressure [OTC]: Acetaminophen 500 mg and phenylephrine 5 mg
GENERIC EQUIVALENT AVAILABLE — Yes: Caplet
ADMINISTRATION — Caplets and gelcaps should be swallowed whole; do not crush, chew, or dissolve. Effervescent tablets should be dissolved in 4 ounces of water.
USE — Temporary relief of sinus/nasal congestion and pressure, headache, and minor aches and pains
ADVERSE REACTIONS SIGNIFICANT — See individual agents.
CONTRAINDICATIONS — Hypersensitivity to acetaminophen, phenylephrine, or any component of the formulation; with or within 14 days of MAO inhibitor therapy
WARNINGS / PRECAUTIONS
Disease-related concerns: Cardiovascular disease: Use with caution in patients with cardiovascular disease (including hypertension and ischemic heart disease). Diabetes: Use with caution in patients with diabetes mellitus. Ethanol use: Use with caution in patients with alcoholic liver disease; consuming ≥ 3 alcoholic drinks/day may increase the risk of liver damage. Hepatic impairment: Use caution in patients with hepatic impairment; acetaminophen may cause severe hepatic toxicity with acute overdose. Prostatic hyperplasia/urinary obstruction: Use with caution in patients with prostatic hyperplasia and/or GU obstruction. Thyroid dysfunction: Use with caution in patients with thyroid dysfunction.
Special populations: Elderly: Use with caution in the elderly; more likely to experience adverse reactions to sympathomimetics. Pediatrics: Use with caution in children; do not exceed pediatric dosing recommendations. Not for OTC use in children <12 years of age.
Dosage form specific issues: Phenylalanine: Some products may contain phenylalanine. Sodium: Some products may contain sodium; use with caution in sodium restricted patients.
Other warnings/precautions: Dosage limit: Limit acetaminophen dose to <4>3 days. Discontinue and contact healthcare provider if nervousness, dizziness, or sleeplessness occur.
METABOLISM / TRANSPORT EFFECTS — Acetaminophen: Substrate (minor) of CYP1A2, 2A6, 2C9, 2D6, 2E1, 3A4; Inhibits CYP3A4 (weak)
DRUG INTERACTIONS
Anticonvulsants (Hydantoin): May increase the metabolism of Acetaminophen. This may 1) diminish the effect of acetaminophen; and 2) increase the risk of liver damage. Risk C: Monitor therapy
Atomoxetine: May enhance the hypertensive effect of Sympathomimetics. Atomoxetine may enhance the tachycardic effect of Sympathomimetics. Risk C: Monitor therapy
Barbiturates: May increase the metabolism of Acetaminophen. This may 1) diminish the effect of acetaminophen; and 2) increase the risk of liver damage. Risk C: Monitor therapy
Cannabinoids: May enhance the tachycardic effect of Sympathomimetics. Risk C: Monitor therapy
CarBAMazepine: May increase the metabolism of Acetaminophen. This may 1) diminish the effect of acetaminophen; and 2) increase the risk of liver damage. Risk C: Monitor therapy
Cholestyramine Resin: May decrease the absorption of Acetaminophen. Effect is minimal if cholestyramine is administered 1 hour after acetaminophen. Risk D: Consider therapy modification
Imatinib: May increase the serum concentration of Acetaminophen. Risk D: Consider therapy modification
Iobenguane I 123: Sympathomimetics may diminish the therapeutic effect of Iobenguane I 123. Risk X: Avoid combination
Isoniazid: May enhance the adverse/toxic effect of Acetaminophen. Risk C: Monitor therapy
MAO Inhibitors: May enhance the hypertensive effect of Alpha1-Agonists. Risk X: Avoid combination
Peginterferon Alfa-2b: May decrease the serum concentration of CYP2D6 Substrates. Risk C: Monitor therapy
Sympathomimetics: May enhance the adverse/toxic effect of other Sympathomimetics. Risk C: Monitor therapy
Tricyclic Antidepressants: May enhance the vasopressor effect of Alpha1-Agonists. Risk D: Consider therapy modification
Vitamin K Antagonists (eg, warfarin): Acetaminophen may enhance the anticoagulant effect of Vitamin K Antagonists. Most likely with daily acetaminophen doses >1.3 g for >1 week. Risk C: Monitor therapy
ETHANOL / NUTRITION / HERB INTERACTIONS — See individual agents.
DIETARY CONSIDERATIONS — Alka-Seltzer Plus® Sinus Formula contains sodium 477 mg/tablet and phenylalanine 4.2 mg/tablet
MECHANISM OF ACTION — Acetaminophen inhibits the synthesis of prostaglandins in the central nervous system and peripherally blocks pain impulse generation. Phenylephrine causes vasoconstriction of the arterioles of the nasal mucosa.
PHARMACODYNAMICS / KINETICS — See individual agents.
Duplicate therapy issues: This product contains acetaminophen, which may be a component of combination products. Do not exceed the maximum recommended daily dose of acetaminophen.
U.S. BRAND NAMES — Alka-Seltzer Plus® Sinus Formula [OTC]; Cetafen Cold® [OTC]; Contac® Cold + Flu Maximum Strength Non-Drowsy [OTC]; Excedrin® Sinus Headache [OTC]; Mapap® Sinus Congestion and Pain Daytime [OTC]; Sinus Pain & Pressure [OTC]; Sinutab® Sinus [OTC]; Sudafed PE® Sinus Headache [OTC]; Tylenol® Sinus Congestion & Pain Daytime [OTC]; Vicks® DayQuil® Sinus [OTC]
PHARMACOLOGIC CATEGORY
Analgesic, Miscellaneous
Decongestant
DOSING: ADULTS — Sinus pain/pressure: Oral: General dosing guidelines, refer to specific product labeling: Acetaminophen 325 mg and phenylephrine 5 mg/caplet: Take 2 caplets every 4 hours as needed; maximum: 12 caplets/24 hours
DOSING: PEDIATRIC — Children ≥ 12 years: Refer to adult dosing.
DOSING: ELDERLY — Refer to adult dosing.
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Caplet, oral:
Contac® Cold + Flu Maximum Strength Non Drowsy: Acetaminophen 500 mg and phenylephrine hydrochloride 5 mg
Excedrin® Sinus Headache: Acetaminophen 325 mg and phenylephrine hydrochloride 5 mg
Mapap® Sinus Congestion and Pain Daytime, Sinutab® Sinus, Sudafed PE® Sinus Headache: Acetaminophen 325 mg and phenylephrine hydrochloride 5 mg
Tylenol® Sinus Congestion & Pain Daytime: Acetaminophen 325 mg and phenylephrine hydrochloride 5 mg [Cool Burst™ flavor]
Capsule, liquicap, oral:
Vicks® DayQuil® Sinus: Acetaminophen 325 mg and phenylephrine hydrochloride 5 mg [ethanol free]
Gelcap, oral:
Tylenol® Sinus Congestion & Pain Daytime: Acetaminophen 325 mg and phenylephrine hydrochloride 5 mg
Gelcap, rapid release, oral:
Tylenol® Sinus Congestion & Pain Datyime: Acetaminophen 325 mg and phenylephrine hydrochloride 5 mg
Tablet for solution, oral [effervescent]:
Alka-Seltzer Plus® Sinus Formula: Acetaminophen 250 mg and phenylephrine hydrochloride 5 mg [contains sodium 477 mg/tablet and phenylalanine 4.2 mg/tablet; lemon zest flavor]
Tablet, oral:
Cetafen Cold®: Acetaminophen 500 mg and phenylephrine hydrochloride 5 mg
Sinus Pain & Pressure: Acetaminophen 500 mg and phenylephrine hydrochloride 5 mg
DOSAGE FORMS: CONCISE
Caplet, oral:
Contac® Cold + Flu Maximum Strength Non Drowsy [OTC]: Acetaminophen 500 mg and phenylephrine 5 mg
Excedrin® Sinus Headache [OTC], Mapap® Sinus Congestion and Pain Daytime [OTC], Sinutab® Sinus [OTC], Sudafed PE® Sinus Headache [OTC]: Acetaminophen 325 mg and phenylephrine 5 mg
Tylenol® Sinus Congestion & Pain Daytime [OTC]: Acetaminophen 325 mg and phenylephrine 5 mg [Cool Burst™ flavor]
Capsule, liquicap, oral:
Vicks® DayQuil® Sinus [OTC]: Acetaminophen 325 mg and phenylephrine 5 mg
Gelcap, oral:
Tylenol® Sinus Congestion & Pain Daytime [OTC]: Acetaminophen 325 mg and phenylephrine 5 mg
Gelcap, rapid release, oral:
Tylenol® Sinus Congestion & Pain Daytime [OTC]: Acetaminophen 325 mg and phenylephrine 5 mg
Tablet for solution, oral [effervescent]:
Alka-Seltzer Plus® Sinus Formula [OTC]: Acetaminophen 250 mg and phenylephrine 5 mg
Tablet, oral:
Cetafen Cold® [OTC], Sinus Pain & Pressure [OTC]: Acetaminophen 500 mg and phenylephrine 5 mg
GENERIC EQUIVALENT AVAILABLE — Yes: Caplet
ADMINISTRATION — Caplets and gelcaps should be swallowed whole; do not crush, chew, or dissolve. Effervescent tablets should be dissolved in 4 ounces of water.
USE — Temporary relief of sinus/nasal congestion and pressure, headache, and minor aches and pains
ADVERSE REACTIONS SIGNIFICANT — See individual agents.
CONTRAINDICATIONS — Hypersensitivity to acetaminophen, phenylephrine, or any component of the formulation; with or within 14 days of MAO inhibitor therapy
WARNINGS / PRECAUTIONS
Disease-related concerns: Cardiovascular disease: Use with caution in patients with cardiovascular disease (including hypertension and ischemic heart disease). Diabetes: Use with caution in patients with diabetes mellitus. Ethanol use: Use with caution in patients with alcoholic liver disease; consuming ≥ 3 alcoholic drinks/day may increase the risk of liver damage. Hepatic impairment: Use caution in patients with hepatic impairment; acetaminophen may cause severe hepatic toxicity with acute overdose. Prostatic hyperplasia/urinary obstruction: Use with caution in patients with prostatic hyperplasia and/or GU obstruction. Thyroid dysfunction: Use with caution in patients with thyroid dysfunction.
Special populations: Elderly: Use with caution in the elderly; more likely to experience adverse reactions to sympathomimetics. Pediatrics: Use with caution in children; do not exceed pediatric dosing recommendations. Not for OTC use in children <12 years of age.
Dosage form specific issues: Phenylalanine: Some products may contain phenylalanine. Sodium: Some products may contain sodium; use with caution in sodium restricted patients.
Other warnings/precautions: Dosage limit: Limit acetaminophen dose to <4>3 days. Discontinue and contact healthcare provider if nervousness, dizziness, or sleeplessness occur.
METABOLISM / TRANSPORT EFFECTS — Acetaminophen: Substrate (minor) of CYP1A2, 2A6, 2C9, 2D6, 2E1, 3A4; Inhibits CYP3A4 (weak)
DRUG INTERACTIONS
Anticonvulsants (Hydantoin): May increase the metabolism of Acetaminophen. This may 1) diminish the effect of acetaminophen; and 2) increase the risk of liver damage. Risk C: Monitor therapy
Atomoxetine: May enhance the hypertensive effect of Sympathomimetics. Atomoxetine may enhance the tachycardic effect of Sympathomimetics. Risk C: Monitor therapy
Barbiturates: May increase the metabolism of Acetaminophen. This may 1) diminish the effect of acetaminophen; and 2) increase the risk of liver damage. Risk C: Monitor therapy
Cannabinoids: May enhance the tachycardic effect of Sympathomimetics. Risk C: Monitor therapy
CarBAMazepine: May increase the metabolism of Acetaminophen. This may 1) diminish the effect of acetaminophen; and 2) increase the risk of liver damage. Risk C: Monitor therapy
Cholestyramine Resin: May decrease the absorption of Acetaminophen. Effect is minimal if cholestyramine is administered 1 hour after acetaminophen. Risk D: Consider therapy modification
Imatinib: May increase the serum concentration of Acetaminophen. Risk D: Consider therapy modification
Iobenguane I 123: Sympathomimetics may diminish the therapeutic effect of Iobenguane I 123. Risk X: Avoid combination
Isoniazid: May enhance the adverse/toxic effect of Acetaminophen. Risk C: Monitor therapy
MAO Inhibitors: May enhance the hypertensive effect of Alpha1-Agonists. Risk X: Avoid combination
Peginterferon Alfa-2b: May decrease the serum concentration of CYP2D6 Substrates. Risk C: Monitor therapy
Sympathomimetics: May enhance the adverse/toxic effect of other Sympathomimetics. Risk C: Monitor therapy
Tricyclic Antidepressants: May enhance the vasopressor effect of Alpha1-Agonists. Risk D: Consider therapy modification
Vitamin K Antagonists (eg, warfarin): Acetaminophen may enhance the anticoagulant effect of Vitamin K Antagonists. Most likely with daily acetaminophen doses >1.3 g for >1 week. Risk C: Monitor therapy
ETHANOL / NUTRITION / HERB INTERACTIONS — See individual agents.
DIETARY CONSIDERATIONS — Alka-Seltzer Plus® Sinus Formula contains sodium 477 mg/tablet and phenylalanine 4.2 mg/tablet
MECHANISM OF ACTION — Acetaminophen inhibits the synthesis of prostaglandins in the central nervous system and peripherally blocks pain impulse generation. Phenylephrine causes vasoconstriction of the arterioles of the nasal mucosa.
PHARMACODYNAMICS / KINETICS — See individual agents.
Acetaminophen and pamabrom:
MEDICATION SAFETY ISSUES
Duplicate therapy issues: This product contains acetaminophen, which may be a component of other combination products. Do not exceed the maximum recommended daily dose of acetaminophen.
U.S. BRAND NAMES — Cramp Tabs [OTC]; Midol® Teen Formula [OTC]; Tylenol® Women's Menstrual Relief [OTC]
PHARMACOLOGIC CATEGORY
Analgesic, Miscellaneous
Diuretic, Combination
DOSING: ADULTS — Menstrual symptoms: Oral: Acetaminophen 650-1000 mg and pamabrom 50 mg every 4-6 hours as needed (maximum: 8 caplets/tablets/24 hours)
DOSING: PEDIATRIC — Children ≥ 12 years: Refer to adult dosing.
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Caplet:
Midol® Teen Formula: Acetaminophen 500 mg and pamabrom 25 mg
Tylenol® Women's Menstrual Relief: Acetaminophen 500 mg and pamabrom 25 mg
Tablet:
Cramp Tabs: Acetaminophen 325 mg and pamabrom 25 mg
DOSAGE FORMS: CONCISE
Caplet:
Midol® Teen Formula: Acetaminophen 500 mg and pamabrom 25 mg
Tylenol® Women's Menstrual Relief: Acetaminophen 500 mg and pamabrom 25 mg
Tablet:
Cramp Tabs: Acetaminophen 325 mg and pamabrom 25 mg
GENERIC EQUIVALENT AVAILABLE — Yes
USE — Temporary relief of symptoms associated with premenstrual and menstrual symptoms (eg, cramps, bloating, water-weight gain, headache, backache, muscle aches)
ADVERSE REACTIONS SIGNIFICANT — See Acetaminophen monograph.
WARNINGS / PRECAUTIONS
Concerns related to adverse effects: Hepatotoxicity: Acetaminophen may cause hepatic toxicity with acute overdose; in addition chronic daily dosing has resulted in liver damage in some adults. Hypersensitivity: Discontinue use if hypersensitivity occurs.
Disease-related concerns: Ethanol use: Use with caution in patients with alcoholic liver disease; consuming ≥ 3 alcoholic drinks/day may increase the risk of liver damage.
Special populations: Pediatrics: Not for use in children <12 years of age.
Other warnings/precautions: Dosage limit: Limit acetaminophen dose to <4>10 days.
DRUG INTERACTIONS
Anticonvulsants (Hydantoin): May increase the metabolism of Acetaminophen. This may 1) diminish the effect of acetaminophen; and 2) increase the risk of liver damage. Risk C: Monitor therapy
Barbiturates: May increase the metabolism of Acetaminophen. This may 1) diminish the effect of acetaminophen; and 2) increase the risk of liver damage. Risk C: Monitor therapy
CarBAMazepine: May increase the metabolism of Acetaminophen. This may 1) diminish the effect of acetaminophen; and 2) increase the risk of liver damage. Risk C: Monitor therapy
Cholestyramine Resin: May decrease the absorption of Acetaminophen. Effect is minimal if cholestyramine is administered 1 hour after acetaminophen. Risk D: Consider therapy modification
Imatinib: May increase the serum concentration of Acetaminophen. Risk D: Consider therapy modification
Isoniazid: May enhance the adverse/toxic effect of Acetaminophen. Risk C: Monitor therapy
Peginterferon Alfa-2b: May decrease the serum concentration of CYP2D6 Substrates. Risk C: Monitor therapy
Vitamin K Antagonists (eg, warfarin): Acetaminophen may enhance the anticoagulant effect of Vitamin K Antagonists. Most likely with daily acetaminophen doses >1.3 g for >1 week. Risk C: Monitor therapy
ETHANOL / NUTRITION / HERB INTERACTIONS — Ethanol: Excessive intake of ethanol may increase the risk of acetaminophen-induced hepatotoxicity. Avoid ethanol or limit to <3 drinks/day.
Duplicate therapy issues: This product contains acetaminophen, which may be a component of other combination products. Do not exceed the maximum recommended daily dose of acetaminophen.
U.S. BRAND NAMES — Cramp Tabs [OTC]; Midol® Teen Formula [OTC]; Tylenol® Women's Menstrual Relief [OTC]
PHARMACOLOGIC CATEGORY
Analgesic, Miscellaneous
Diuretic, Combination
DOSING: ADULTS — Menstrual symptoms: Oral: Acetaminophen 650-1000 mg and pamabrom 50 mg every 4-6 hours as needed (maximum: 8 caplets/tablets/24 hours)
DOSING: PEDIATRIC — Children ≥ 12 years: Refer to adult dosing.
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Caplet:
Midol® Teen Formula: Acetaminophen 500 mg and pamabrom 25 mg
Tylenol® Women's Menstrual Relief: Acetaminophen 500 mg and pamabrom 25 mg
Tablet:
Cramp Tabs: Acetaminophen 325 mg and pamabrom 25 mg
DOSAGE FORMS: CONCISE
Caplet:
Midol® Teen Formula: Acetaminophen 500 mg and pamabrom 25 mg
Tylenol® Women's Menstrual Relief: Acetaminophen 500 mg and pamabrom 25 mg
Tablet:
Cramp Tabs: Acetaminophen 325 mg and pamabrom 25 mg
GENERIC EQUIVALENT AVAILABLE — Yes
USE — Temporary relief of symptoms associated with premenstrual and menstrual symptoms (eg, cramps, bloating, water-weight gain, headache, backache, muscle aches)
ADVERSE REACTIONS SIGNIFICANT — See Acetaminophen monograph.
WARNINGS / PRECAUTIONS
Concerns related to adverse effects: Hepatotoxicity: Acetaminophen may cause hepatic toxicity with acute overdose; in addition chronic daily dosing has resulted in liver damage in some adults. Hypersensitivity: Discontinue use if hypersensitivity occurs.
Disease-related concerns: Ethanol use: Use with caution in patients with alcoholic liver disease; consuming ≥ 3 alcoholic drinks/day may increase the risk of liver damage.
Special populations: Pediatrics: Not for use in children <12 years of age.
Other warnings/precautions: Dosage limit: Limit acetaminophen dose to <4>10 days.
DRUG INTERACTIONS
Anticonvulsants (Hydantoin): May increase the metabolism of Acetaminophen. This may 1) diminish the effect of acetaminophen; and 2) increase the risk of liver damage. Risk C: Monitor therapy
Barbiturates: May increase the metabolism of Acetaminophen. This may 1) diminish the effect of acetaminophen; and 2) increase the risk of liver damage. Risk C: Monitor therapy
CarBAMazepine: May increase the metabolism of Acetaminophen. This may 1) diminish the effect of acetaminophen; and 2) increase the risk of liver damage. Risk C: Monitor therapy
Cholestyramine Resin: May decrease the absorption of Acetaminophen. Effect is minimal if cholestyramine is administered 1 hour after acetaminophen. Risk D: Consider therapy modification
Imatinib: May increase the serum concentration of Acetaminophen. Risk D: Consider therapy modification
Isoniazid: May enhance the adverse/toxic effect of Acetaminophen. Risk C: Monitor therapy
Peginterferon Alfa-2b: May decrease the serum concentration of CYP2D6 Substrates. Risk C: Monitor therapy
Vitamin K Antagonists (eg, warfarin): Acetaminophen may enhance the anticoagulant effect of Vitamin K Antagonists. Most likely with daily acetaminophen doses >1.3 g for >1 week. Risk C: Monitor therapy
ETHANOL / NUTRITION / HERB INTERACTIONS — Ethanol: Excessive intake of ethanol may increase the risk of acetaminophen-induced hepatotoxicity. Avoid ethanol or limit to <3 drinks/day.
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