t
(For additional information see "Acetaminophen and tramadol: Patient drug information")
U.S. BRAND NAMES — Ultracet™
PHARMACOLOGIC CATEGORY Analgesic, MiscellaneousAnalgesic, Nonopioid
DOSING: ADULTS — Acute pain: Oral: Two tablets every 4-6 hours as needed for pain relief (maximum: 8 tablets/day); treatment should not exceed 5 days
DOSING: ELDERLY — Refer to adult dosing.
DOSING: RENAL IMPAIRMENT — Clcr <30 mL/minute: Maximum of 2 tablets every 12 hours. Treatment should not exceed 5 days.
DOSING: HEPATIC IMPAIRMENT — Use is not recommended.
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet: Acetaminophen 325 mg and tramadol hydrochloride 37.5 mg
DOSAGE FORMS: CONCISE Tablet: Acetaminophen 325 mg and tramadol 37.5 mg Ultracet™: Acetaminophen 325 mg and tramadol 37.5 mg
GENERIC EQUIVALENT AVAILABLE — Yes
USE — Short-term (5 days) management of acute pain
ADVERSE REACTIONS SIGNIFICANT 1% to 10%: Central nervous system: Somnolence (6%), dizziness (3%), insomnia (2%), anxiety, confusion, euphoria, fatigue, headache, nervousness, tremor Dermatologic: Pruritus (2%), rash Endocrine & metabolic: Hot flashes Gastrointestinal: Constipation (6%), anorexia (3%), diarrhea (3%), nausea (3%), dry mouth (2%), abdominal pain, dyspepsia, flatulence, vomiting Genitourinary: Prostatic disorder (2%) Neuromuscular & skeletal: Weakness Miscellaneous: Diaphoresis increased (4%)
<1% (Limited to important or life-threatening): Allergic reactions, amnesia, anaphylactoid reactions, anaphylaxis, arrhythmia, coma, depersonalization, drug abuse, dysphagia, dyspnea, emotional lability, hallucination, hepatitis, hypertonia, impotence, liver failure, migraine, muscle contractions (involuntary), oliguria, paresthesia, paroniria, pulmonary edema, rigors, seizure, serotonin syndrome, shivering, Stevens-Johnson syndrome, suicidal tendency, stupor, syncope, tinnitus, tongue edema, toxic epidermal necrolysis, urinary retention, urticaria, vertigo
A withdrawal syndrome may occur with abrupt discontinuation; includes anxiety, diarrhea, hallucinations (rare), nausea, pain, piloerection, rigors, sweating, and tremor. Uncommon discontinuation symptoms may include severe anxiety, panic attacks, or paresthesia.
CONTRAINDICATIONS — Hypersensitivity to acetaminophen, tramadol, opioids, or any component of the formulation; opioid-dependent patients; acute intoxication with ethanol, hypnotics, narcotics, centrally-acting analgesics, opioids, or psychotropic drugs; hepatic dysfunction
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. Seizures: Even when taken within the recommended dosage seizures may occur; risk is increased in patients receiving serotonin reuptake inhibitors (SSRIs or anorectics), tricyclic antidepressants, other cyclic compounds (including cyclobenzaprine, promethazine), neuroleptics, MAO inhibitors, or drugs which may lower seizure threshold. Patients with a history of seizures, or with a risk of seizures (head trauma, metabolic disorders, CNS infection, malignancy, or during alcohol/drug withdrawal) are also at increased risk.
Disease-related concerns: Abdominal conditions: May obscure diagnosis or clinical course of patients with acute abdominal conditions. Drug abuse: Use with caution in patients with a history of drug abuse or acute alcoholism; potential for drug dependency exists. 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. Head trauma: Use with extreme caution in patients with head injury, intracranial lesions, or elevated intracranial pressure; exaggerated elevation of ICP may occur. Renal impairment: Use tramadol with caution and reduce dosage in patients with renal impairment. Respiratory disease: Patients with chronic respiratory disorders may be at greater risk of adverse events.
Concurrent drug therapy issues: CNS depressants: Use with caution and reduce dosage when administering to patients receiving other CNS depressants. MAO inhibitors: Should be used only with extreme caution in patients receiving MAO inhibitors.
Special populations: Debilitated patients: Use with caution in debilitated patients; there is a greater potential for critical respiratory depression, even at therapeutic dosages. Elderly: Use with caution in the elderly; may be more sensitive to adverse effects. Decrease initial dose. Pediatrics: Safety and efficacy have not been established in children.
Other warnings/precautions: Dosage limit: Limit acetaminophen dose to <4 g/day. Withdrawal: Tolerance or drug dependence may result from extended use (withdrawal symptoms have been reported); abrupt discontinuation should be avoided. Tapering of dose at the time of discontinuation limits the risk of withdrawal symptoms.
DRUG INTERACTIONS Acetaminophen: Substrate (minor) of CYP1A2, 2A6, 2C9, 2D6, 2E1, 3A4; Inhibits CYP3A4 (weak)
Tramadol: Substrate of CYP2D6 (major), 3A4 (minor)
Amphetamines: May increase the risk of seizures with tramadol.
Anesthetic agents: May increase risk of CNS and respiratory depression; use together with caution and in reduced dosage.
Barbiturates: Barbiturates may increase the hepatotoxic effects of acetaminophen; in addition, acetaminophen levels may be lowered.
Carbamazepine: Carbamazepine decreases half-life of tramadol by 33% to 50%; also have increased risk of seizures; in addition, carbamazepine may increase the hepatotoxic effects and lower serum levels of acetaminophen; concomitant use is not recommended.
CYP2D6 inhibitors: May decrease the effects of tramadol. Example inhibitors include chlorpromazine, delavirdine, fluoxetine, miconazole, paroxetine, pergolide, quinidine, quinine, ritonavir, and ropinirole.
Digoxin: Rare reports of digoxin toxicity with concomitant tramadol use.
Hydantoin anticonvulsants: Phenytoin may increase the hepatotoxic effects of acetaminophen; in addition, acetaminophen levels may be lowered.
MAO inhibitors: May increase the risk of seizures. Use extreme caution.
Naloxone: May increase the risk of seizures (if administered in tramadol overdose).
Neuroleptic agents: May increase the risk of tramadol-associated seizures and may have additive CNS depressant effects.
Narcotics: May increase risk of CNS and respiratory depression; use together with caution and in reduced dosage.
Opioids: May increase the risk of seizures, and may have additive CNS depressant effects. Use together with caution and in reduced dosage.
Phenothiazines: May increase risk of CNS and respiratory depression; use together with caution and in reduced dosage.
Rifampin: Rifampin may increase the clearance of acetaminophen.
Quinidine: May increase the tramadol serum concentrations by inhibiting CYP metabolism.
SSRIs: May increase the risk of seizures with tramadol by inhibiting CYP metabolism (citalopram, fluoxetine, paroxetine, sertraline).
Sulfinpyrazone: Sulfinpyrazone may increase the hepatotoxic effects of acetaminophen; in addition, acetaminophen levels may be lowered.
Tricyclic antidepressants: May increase the risk of seizures.
Warfarin: Acetaminophen and tramadol may lead to an elevation of prothrombin times; monitor.
ETHANOL / NUTRITION / HERB INTERACTIONS Ethanol: Avoid ethanol (increased liver toxicity with concomitant use).
Food: May delay time to peak plasma levels, however, the extent of absorption is not affected.
Herb/Nutraceutical: Acetaminophen: Avoid St John's wort (may decrease acetaminophen levels). Tramadol: Avoid valerian, St John's wort, kava kava, gotu kola (may increase CNS depression).
PREGNANCY RISK FACTOR — C (show table)
PREGNANCY IMPLICATIONS — Tramadol has been shown to cross the placenta. Postmarketing reports following tramadol use during pregnancy include neonatal seizures, withdrawal syndrome, fetal death, and stillbirth. Not recommended for use during labor and delivery.
LACTATION — Tramadol: Enters breast milk/contraindicated
BREAST-FEEDING CONSIDERATIONS — Not recommended for postdelivery analgesia in nursing mothers.
DIETARY CONSIDERATIONS — May be taken with or without food. Avoid use of ethanol and ethanol-containing products.
PRICING — (data from drugstore.com)Tablets (Tramadol-Acetaminophen) 37.5-325 mg (30): $27.67
Tablets (Ultracet) 37.5-325 mg (30): $35.51
MONITORING PARAMETERS — Pain relief, respiratory rate, blood pressure, and pulse; signs of tolerance or abuse
CANADIAN BRAND NAMES — Tramacet
INTERNATIONAL BRAND NAMES — Dolcet (PH); Ixprim (FR); Tramacet (CA, CR, DO, GB, GT, HN, IE, MX, NI, PA, SV); Ultracet (HK, KR, TH); Zaldiar (FR, MX)
MECHANISM OF ACTION Based on acetaminophen component: 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
Based on tramadol component: Binds to µ-opiate receptors in the CNS causing inhibition of ascending pain pathways, altering the perception of and response to pain; also inhibits the reuptake of norepinephrine and serotonin, which also modifies the ascending pain pathway
PHARMACODYNAMICS / KINETICS — See individual agents.
Wednesday, January 16, 2008
Acetaminophen and tramadol: Drug information
t
(For additional information see "Acetaminophen and tramadol: Patient drug information")
U.S. BRAND NAMES — Ultracet™
PHARMACOLOGIC CATEGORY Analgesic, MiscellaneousAnalgesic, Nonopioid
DOSING: ADULTS — Acute pain: Oral: Two tablets every 4-6 hours as needed for pain relief (maximum: 8 tablets/day); treatment should not exceed 5 days
DOSING: ELDERLY — Refer to adult dosing.
DOSING: RENAL IMPAIRMENT — Clcr <30 mL/minute: Maximum of 2 tablets every 12 hours. Treatment should not exceed 5 days.
DOSING: HEPATIC IMPAIRMENT — Use is not recommended.
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet: Acetaminophen 325 mg and tramadol hydrochloride 37.5 mg
DOSAGE FORMS: CONCISE Tablet: Acetaminophen 325 mg and tramadol 37.5 mg Ultracet™: Acetaminophen 325 mg and tramadol 37.5 mg
GENERIC EQUIVALENT AVAILABLE — Yes
USE — Short-term (5 days) management of acute pain
ADVERSE REACTIONS SIGNIFICANT 1% to 10%: Central nervous system: Somnolence (6%), dizziness (3%), insomnia (2%), anxiety, confusion, euphoria, fatigue, headache, nervousness, tremor Dermatologic: Pruritus (2%), rash Endocrine & metabolic: Hot flashes Gastrointestinal: Constipation (6%), anorexia (3%), diarrhea (3%), nausea (3%), dry mouth (2%), abdominal pain, dyspepsia, flatulence, vomiting Genitourinary: Prostatic disorder (2%) Neuromuscular & skeletal: Weakness Miscellaneous: Diaphoresis increased (4%)
<1% (Limited to important or life-threatening): Allergic reactions, amnesia, anaphylactoid reactions, anaphylaxis, arrhythmia, coma, depersonalization, drug abuse, dysphagia, dyspnea, emotional lability, hallucination, hepatitis, hypertonia, impotence, liver failure, migraine, muscle contractions (involuntary), oliguria, paresthesia, paroniria, pulmonary edema, rigors, seizure, serotonin syndrome, shivering, Stevens-Johnson syndrome, suicidal tendency, stupor, syncope, tinnitus, tongue edema, toxic epidermal necrolysis, urinary retention, urticaria, vertigo
A withdrawal syndrome may occur with abrupt discontinuation; includes anxiety, diarrhea, hallucinations (rare), nausea, pain, piloerection, rigors, sweating, and tremor. Uncommon discontinuation symptoms may include severe anxiety, panic attacks, or paresthesia.
CONTRAINDICATIONS — Hypersensitivity to acetaminophen, tramadol, opioids, or any component of the formulation; opioid-dependent patients; acute intoxication with ethanol, hypnotics, narcotics, centrally-acting analgesics, opioids, or psychotropic drugs; hepatic dysfunction
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. Seizures: Even when taken within the recommended dosage seizures may occur; risk is increased in patients receiving serotonin reuptake inhibitors (SSRIs or anorectics), tricyclic antidepressants, other cyclic compounds (including cyclobenzaprine, promethazine), neuroleptics, MAO inhibitors, or drugs which may lower seizure threshold. Patients with a history of seizures, or with a risk of seizures (head trauma, metabolic disorders, CNS infection, malignancy, or during alcohol/drug withdrawal) are also at increased risk.
Disease-related concerns: Abdominal conditions: May obscure diagnosis or clinical course of patients with acute abdominal conditions. Drug abuse: Use with caution in patients with a history of drug abuse or acute alcoholism; potential for drug dependency exists. 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. Head trauma: Use with extreme caution in patients with head injury, intracranial lesions, or elevated intracranial pressure; exaggerated elevation of ICP may occur. Renal impairment: Use tramadol with caution and reduce dosage in patients with renal impairment. Respiratory disease: Patients with chronic respiratory disorders may be at greater risk of adverse events.
Concurrent drug therapy issues: CNS depressants: Use with caution and reduce dosage when administering to patients receiving other CNS depressants. MAO inhibitors: Should be used only with extreme caution in patients receiving MAO inhibitors.
Special populations: Debilitated patients: Use with caution in debilitated patients; there is a greater potential for critical respiratory depression, even at therapeutic dosages. Elderly: Use with caution in the elderly; may be more sensitive to adverse effects. Decrease initial dose. Pediatrics: Safety and efficacy have not been established in children.
Other warnings/precautions: Dosage limit: Limit acetaminophen dose to <4 g/day. Withdrawal: Tolerance or drug dependence may result from extended use (withdrawal symptoms have been reported); abrupt discontinuation should be avoided. Tapering of dose at the time of discontinuation limits the risk of withdrawal symptoms.
DRUG INTERACTIONS Acetaminophen: Substrate (minor) of CYP1A2, 2A6, 2C9, 2D6, 2E1, 3A4; Inhibits CYP3A4 (weak)
Tramadol: Substrate of CYP2D6 (major), 3A4 (minor)
Amphetamines: May increase the risk of seizures with tramadol.
Anesthetic agents: May increase risk of CNS and respiratory depression; use together with caution and in reduced dosage.
Barbiturates: Barbiturates may increase the hepatotoxic effects of acetaminophen; in addition, acetaminophen levels may be lowered.
Carbamazepine: Carbamazepine decreases half-life of tramadol by 33% to 50%; also have increased risk of seizures; in addition, carbamazepine may increase the hepatotoxic effects and lower serum levels of acetaminophen; concomitant use is not recommended.
CYP2D6 inhibitors: May decrease the effects of tramadol. Example inhibitors include chlorpromazine, delavirdine, fluoxetine, miconazole, paroxetine, pergolide, quinidine, quinine, ritonavir, and ropinirole.
Digoxin: Rare reports of digoxin toxicity with concomitant tramadol use.
Hydantoin anticonvulsants: Phenytoin may increase the hepatotoxic effects of acetaminophen; in addition, acetaminophen levels may be lowered.
MAO inhibitors: May increase the risk of seizures. Use extreme caution.
Naloxone: May increase the risk of seizures (if administered in tramadol overdose).
Neuroleptic agents: May increase the risk of tramadol-associated seizures and may have additive CNS depressant effects.
Narcotics: May increase risk of CNS and respiratory depression; use together with caution and in reduced dosage.
Opioids: May increase the risk of seizures, and may have additive CNS depressant effects. Use together with caution and in reduced dosage.
Phenothiazines: May increase risk of CNS and respiratory depression; use together with caution and in reduced dosage.
Rifampin: Rifampin may increase the clearance of acetaminophen.
Quinidine: May increase the tramadol serum concentrations by inhibiting CYP metabolism.
SSRIs: May increase the risk of seizures with tramadol by inhibiting CYP metabolism (citalopram, fluoxetine, paroxetine, sertraline).
Sulfinpyrazone: Sulfinpyrazone may increase the hepatotoxic effects of acetaminophen; in addition, acetaminophen levels may be lowered.
Tricyclic antidepressants: May increase the risk of seizures.
Warfarin: Acetaminophen and tramadol may lead to an elevation of prothrombin times; monitor.
ETHANOL / NUTRITION / HERB INTERACTIONS Ethanol: Avoid ethanol (increased liver toxicity with concomitant use).
Food: May delay time to peak plasma levels, however, the extent of absorption is not affected.
Herb/Nutraceutical: Acetaminophen: Avoid St John's wort (may decrease acetaminophen levels). Tramadol: Avoid valerian, St John's wort, kava kava, gotu kola (may increase CNS depression).
PREGNANCY RISK FACTOR — C (show table)
PREGNANCY IMPLICATIONS — Tramadol has been shown to cross the placenta. Postmarketing reports following tramadol use during pregnancy include neonatal seizures, withdrawal syndrome, fetal death, and stillbirth. Not recommended for use during labor and delivery.
LACTATION — Tramadol: Enters breast milk/contraindicated
BREAST-FEEDING CONSIDERATIONS — Not recommended for postdelivery analgesia in nursing mothers.
DIETARY CONSIDERATIONS — May be taken with or without food. Avoid use of ethanol and ethanol-containing products.
PRICING — (data from drugstore.com)Tablets (Tramadol-Acetaminophen) 37.5-325 mg (30): $27.67
Tablets (Ultracet) 37.5-325 mg (30): $35.51
MONITORING PARAMETERS — Pain relief, respiratory rate, blood pressure, and pulse; signs of tolerance or abuse
CANADIAN BRAND NAMES — Tramacet
INTERNATIONAL BRAND NAMES — Dolcet (PH); Ixprim (FR); Tramacet (CA, CR, DO, GB, GT, HN, IE, MX, NI, PA, SV); Ultracet (HK, KR, TH); Zaldiar (FR, MX)
MECHANISM OF ACTION Based on acetaminophen component: 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
Based on tramadol component: Binds to µ-opiate receptors in the CNS causing inhibition of ascending pain pathways, altering the perception of and response to pain; also inhibits the reuptake of norepinephrine and serotonin, which also modifies the ascending pain pathway
PHARMACODYNAMICS / KINETICS — See individual agents.
(For additional information see "Acetaminophen and tramadol: Patient drug information")
U.S. BRAND NAMES — Ultracet™
PHARMACOLOGIC CATEGORY Analgesic, MiscellaneousAnalgesic, Nonopioid
DOSING: ADULTS — Acute pain: Oral: Two tablets every 4-6 hours as needed for pain relief (maximum: 8 tablets/day); treatment should not exceed 5 days
DOSING: ELDERLY — Refer to adult dosing.
DOSING: RENAL IMPAIRMENT — Clcr <30 mL/minute: Maximum of 2 tablets every 12 hours. Treatment should not exceed 5 days.
DOSING: HEPATIC IMPAIRMENT — Use is not recommended.
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet: Acetaminophen 325 mg and tramadol hydrochloride 37.5 mg
DOSAGE FORMS: CONCISE Tablet: Acetaminophen 325 mg and tramadol 37.5 mg Ultracet™: Acetaminophen 325 mg and tramadol 37.5 mg
GENERIC EQUIVALENT AVAILABLE — Yes
USE — Short-term (5 days) management of acute pain
ADVERSE REACTIONS SIGNIFICANT 1% to 10%: Central nervous system: Somnolence (6%), dizziness (3%), insomnia (2%), anxiety, confusion, euphoria, fatigue, headache, nervousness, tremor Dermatologic: Pruritus (2%), rash Endocrine & metabolic: Hot flashes Gastrointestinal: Constipation (6%), anorexia (3%), diarrhea (3%), nausea (3%), dry mouth (2%), abdominal pain, dyspepsia, flatulence, vomiting Genitourinary: Prostatic disorder (2%) Neuromuscular & skeletal: Weakness Miscellaneous: Diaphoresis increased (4%)
<1% (Limited to important or life-threatening): Allergic reactions, amnesia, anaphylactoid reactions, anaphylaxis, arrhythmia, coma, depersonalization, drug abuse, dysphagia, dyspnea, emotional lability, hallucination, hepatitis, hypertonia, impotence, liver failure, migraine, muscle contractions (involuntary), oliguria, paresthesia, paroniria, pulmonary edema, rigors, seizure, serotonin syndrome, shivering, Stevens-Johnson syndrome, suicidal tendency, stupor, syncope, tinnitus, tongue edema, toxic epidermal necrolysis, urinary retention, urticaria, vertigo
A withdrawal syndrome may occur with abrupt discontinuation; includes anxiety, diarrhea, hallucinations (rare), nausea, pain, piloerection, rigors, sweating, and tremor. Uncommon discontinuation symptoms may include severe anxiety, panic attacks, or paresthesia.
CONTRAINDICATIONS — Hypersensitivity to acetaminophen, tramadol, opioids, or any component of the formulation; opioid-dependent patients; acute intoxication with ethanol, hypnotics, narcotics, centrally-acting analgesics, opioids, or psychotropic drugs; hepatic dysfunction
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. Seizures: Even when taken within the recommended dosage seizures may occur; risk is increased in patients receiving serotonin reuptake inhibitors (SSRIs or anorectics), tricyclic antidepressants, other cyclic compounds (including cyclobenzaprine, promethazine), neuroleptics, MAO inhibitors, or drugs which may lower seizure threshold. Patients with a history of seizures, or with a risk of seizures (head trauma, metabolic disorders, CNS infection, malignancy, or during alcohol/drug withdrawal) are also at increased risk.
Disease-related concerns: Abdominal conditions: May obscure diagnosis or clinical course of patients with acute abdominal conditions. Drug abuse: Use with caution in patients with a history of drug abuse or acute alcoholism; potential for drug dependency exists. 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. Head trauma: Use with extreme caution in patients with head injury, intracranial lesions, or elevated intracranial pressure; exaggerated elevation of ICP may occur. Renal impairment: Use tramadol with caution and reduce dosage in patients with renal impairment. Respiratory disease: Patients with chronic respiratory disorders may be at greater risk of adverse events.
Concurrent drug therapy issues: CNS depressants: Use with caution and reduce dosage when administering to patients receiving other CNS depressants. MAO inhibitors: Should be used only with extreme caution in patients receiving MAO inhibitors.
Special populations: Debilitated patients: Use with caution in debilitated patients; there is a greater potential for critical respiratory depression, even at therapeutic dosages. Elderly: Use with caution in the elderly; may be more sensitive to adverse effects. Decrease initial dose. Pediatrics: Safety and efficacy have not been established in children.
Other warnings/precautions: Dosage limit: Limit acetaminophen dose to <4 g/day. Withdrawal: Tolerance or drug dependence may result from extended use (withdrawal symptoms have been reported); abrupt discontinuation should be avoided. Tapering of dose at the time of discontinuation limits the risk of withdrawal symptoms.
DRUG INTERACTIONS Acetaminophen: Substrate (minor) of CYP1A2, 2A6, 2C9, 2D6, 2E1, 3A4; Inhibits CYP3A4 (weak)
Tramadol: Substrate of CYP2D6 (major), 3A4 (minor)
Amphetamines: May increase the risk of seizures with tramadol.
Anesthetic agents: May increase risk of CNS and respiratory depression; use together with caution and in reduced dosage.
Barbiturates: Barbiturates may increase the hepatotoxic effects of acetaminophen; in addition, acetaminophen levels may be lowered.
Carbamazepine: Carbamazepine decreases half-life of tramadol by 33% to 50%; also have increased risk of seizures; in addition, carbamazepine may increase the hepatotoxic effects and lower serum levels of acetaminophen; concomitant use is not recommended.
CYP2D6 inhibitors: May decrease the effects of tramadol. Example inhibitors include chlorpromazine, delavirdine, fluoxetine, miconazole, paroxetine, pergolide, quinidine, quinine, ritonavir, and ropinirole.
Digoxin: Rare reports of digoxin toxicity with concomitant tramadol use.
Hydantoin anticonvulsants: Phenytoin may increase the hepatotoxic effects of acetaminophen; in addition, acetaminophen levels may be lowered.
MAO inhibitors: May increase the risk of seizures. Use extreme caution.
Naloxone: May increase the risk of seizures (if administered in tramadol overdose).
Neuroleptic agents: May increase the risk of tramadol-associated seizures and may have additive CNS depressant effects.
Narcotics: May increase risk of CNS and respiratory depression; use together with caution and in reduced dosage.
Opioids: May increase the risk of seizures, and may have additive CNS depressant effects. Use together with caution and in reduced dosage.
Phenothiazines: May increase risk of CNS and respiratory depression; use together with caution and in reduced dosage.
Rifampin: Rifampin may increase the clearance of acetaminophen.
Quinidine: May increase the tramadol serum concentrations by inhibiting CYP metabolism.
SSRIs: May increase the risk of seizures with tramadol by inhibiting CYP metabolism (citalopram, fluoxetine, paroxetine, sertraline).
Sulfinpyrazone: Sulfinpyrazone may increase the hepatotoxic effects of acetaminophen; in addition, acetaminophen levels may be lowered.
Tricyclic antidepressants: May increase the risk of seizures.
Warfarin: Acetaminophen and tramadol may lead to an elevation of prothrombin times; monitor.
ETHANOL / NUTRITION / HERB INTERACTIONS Ethanol: Avoid ethanol (increased liver toxicity with concomitant use).
Food: May delay time to peak plasma levels, however, the extent of absorption is not affected.
Herb/Nutraceutical: Acetaminophen: Avoid St John's wort (may decrease acetaminophen levels). Tramadol: Avoid valerian, St John's wort, kava kava, gotu kola (may increase CNS depression).
PREGNANCY RISK FACTOR — C (show table)
PREGNANCY IMPLICATIONS — Tramadol has been shown to cross the placenta. Postmarketing reports following tramadol use during pregnancy include neonatal seizures, withdrawal syndrome, fetal death, and stillbirth. Not recommended for use during labor and delivery.
LACTATION — Tramadol: Enters breast milk/contraindicated
BREAST-FEEDING CONSIDERATIONS — Not recommended for postdelivery analgesia in nursing mothers.
DIETARY CONSIDERATIONS — May be taken with or without food. Avoid use of ethanol and ethanol-containing products.
PRICING — (data from drugstore.com)Tablets (Tramadol-Acetaminophen) 37.5-325 mg (30): $27.67
Tablets (Ultracet) 37.5-325 mg (30): $35.51
MONITORING PARAMETERS — Pain relief, respiratory rate, blood pressure, and pulse; signs of tolerance or abuse
CANADIAN BRAND NAMES — Tramacet
INTERNATIONAL BRAND NAMES — Dolcet (PH); Ixprim (FR); Tramacet (CA, CR, DO, GB, GT, HN, IE, MX, NI, PA, SV); Ultracet (HK, KR, TH); Zaldiar (FR, MX)
MECHANISM OF ACTION Based on acetaminophen component: 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
Based on tramadol component: Binds to µ-opiate receptors in the CNS causing inhibition of ascending pain pathways, altering the perception of and response to pain; also inhibits the reuptake of norepinephrine and serotonin, which also modifies the ascending pain pathway
PHARMACODYNAMICS / KINETICS — See individual agents.
Acetaminophen and pseudoephedrine: Drug information
(For additional information see "Acetaminophen and pseudoephedrine: Patient drug information")
SPECIAL ALERTS Infant Deaths Associated with Cough and Cold Medications - January 2007
The Centers for Disease Control and Prevention (CDC) has released a report concerning the use of cough and cold medications in children <2 years of age. Products containing nasal decongestants (eg, pseudoephedrine), antihistamines (eg, carbinoxamine), cough suppressants (eg, dextromethorphan), and expectorants are often used in this age group. The CDC notes that during 2004 and 2005, ~ 1519 children <2 years of age were seen in emergency departments for adverse effects, including overdose, associated with these medications.
During this time period, 3 infants <6 months of age died. All 3 had postmortem blood levels of pseudoephedrine, ranging from 4743-7100 ng/mL (therapeutic levels for children 2-12 years: 180-500 ng/mL). In one case, the infant received both a prescription product containing pseudoephedrine and an over-the-counter (OTC) product, also containing pseudoephedrine. Alternatives to nasal decongestants in this age group may be softening nasal secretions with saline drops or a cool-mist humidifier and/or the removal of nasal secretions with the use of rubber suction bulb.
Safety and efficacy for the use of cough and cold products in children <2 years of age is limited. The Food and Drug Administration (FDA) notes that there are no approved OTC uses for these products in children <2 years of age. Clinicians are reminded to ask caregivers about the use of OTC products in order to avoid exposure to multiple medications containing the same ingredient. Caregivers are reminded that OTC cough and cold products should not be used in children <2 years of age except under specific direction by their healthcare provider.
For additional information, refer to the following CDC website: 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 — Allerest® Allergy and Sinus Relief [OTC]; Genapap™ Sinus Maximum Strength [OTC]; Mapap Sinus Maximum Strength [OTC]; Medi-Synal [OTC]; Oranyl Plus [OTC]; Ornex® Maximum Strength [OTC]; Ornex® [OTC]; Sinus-Relief [OTC] [DSC]; Sudafed® Multi-Symptom Sinus and Cold [OTC]; Tylenol® Cold Daytime, Children's [OTC]; Tylenol® Cold, Infants [OTC]; Tylenol® Sinus Daytime [OTC]
PHARMACOLOGIC CATEGORY Alpha/Beta AgonistAnalgesic, Miscellaneous
DOSING: ADULTS Pain (Analgesic): Oral; Based on acetaminophen component: 325-650 mg every 4-6 hours as needed; do not exceed 4 g/day
Decongestant: Oral: Based on pseudoephedrine component: 60 mg every 4 hours; do not exceed 360 mg/day
Product labeling: Sudafed® Multi-Symptom Sinus and Cold: 2 capsules every 4-6 hours (maximum: 8 capsules/24 hours) Tylenol® Sinus Daytime: 2 caplets or gelcaps every 4-6 hours (maximum: 8 caplets or gelcaps/24 hours)
DOSING: PEDIATRIC Analgesic: Based on acetaminophen component: Oral: Children: 10-15 mg/kg/dose every 4-6 hours as needed; do not exceed 5 doses in 24 hours
Decongestant: Based on pseudoephedrine component: Oral: Children: 2-6 years: 15 mg every 4 hours; do not exceed 90 mg/day 6-12 years: 30 mg every 4 hours; do not exceed 180 mg/day Children >12 years and Adults: Refer to adult dosing.
Product labeling:
Children's Tylenol® Cold Daytime: Children: 2-5 years (24-47 lb): 1 teaspoonful every 4-6 hours (maximum: 4 doses/24 hours) 6-11 years (48-95 lb): 2 teaspoonfuls every 4-6 hours (maximum: 4 doses/24 hours)
Infants' Tylenol® Cold: Children 2-3 years (24-35 lb): 1.6 mL every 4-6 hours (maximum: 4 doses/24 hours)
Sudafed® Multi-Symptom Sinus and Cold, Tylenol® Sinus Daytime: 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. [DSC] = Discontinued product
Caplet: Allerest® Allergy and Sinus Relief, Ornex®: Acetaminophen 325 mg and pseudoephedrine hydrochloride 30 mg Genapap™ Sinus Maximum Strength, Mapap Sinus Maximum Strength, Ornex® Maximum Strength, Tylenol® Sinus Daytime: Acetaminophen 500 mg and pseudoephedrine hydrochloride 30 mg
Capsule, liquid: Sudafed® Multi-Symptom Sinus and Cold: Acetaminophen 325 mg and pseudoephedrine hydrochloride 30 mg [contains sodium 16 mg]
Gelcap: Tylenol® Sinus Daytime: Acetaminophen 500 mg and pseudoephedrine hydrochloride 30 mg
Liquid: Childrens Tylenol® Cold Daytime: Acetaminophen 160 mg and pseudoephedrine hydrochloride 15 mg per 5 mL (120 mL) [contains sodium benzoate; fruit flavor]
Liquid, oral [drops]: Infants Tylenol® Cold: Acetaminophen 80 mg and pseudoephedrine 7.5 mg per 0.8 mL [contains sodium benzoate; bubble gum flavor]
Tablet: Medi-Synal, Sinus-Relief [DSC]: Acetaminophen 325 mg and pseudoephedrine hydrochloride 30 mg Oranyl Plus: Acetaminophen 500 mg and pseudoephedrine hydrochloride 30 mg
DOSAGE FORMS: CONCISE Caplet: Allerest® Allergy and Sinus Relief, Ornex®: Acetaminophen 325 mg and pseudoephedrine hydrochloride 30 mg Genapap™ Sinus Maximum Strength, Mapap Sinus Maximum Strength, Ornex® Maximum Strength, Tylenol® Sinus Daytime: Acetaminophen 500 mg and pseudoephedrine hydrochloride 30 mg
Capsule, liquid: Sudafed® Multi-Symptom Sinus and Cold: Acetaminophen 325 mg and pseudoephedrine hydrochloride 30 mg
Gelcap: Tylenol® Sinus Daytime: Acetaminophen 500 mg and pseudoephedrine hydrochloride 30 mg
Liquid: Childrens Tylenol® Cold Daytime: Acetaminophen 160 mg and pseudoephedrine hydrochloride 15 mg per 5 mL
Liquid, oral [drops]: Infants Tylenol® Cold: Acetaminophen 80 mg and pseudoephedrine 7.5 mg per 0.8 mL
Tablet: Medi-Synal: Acetaminophen 325 mg and pseudoephedrine hydrochloride 30 mg Oranyl Plus: Acetaminophen 500 mg and pseudoephedrine hydrochloride 30 mg
GENERIC EQUIVALENT AVAILABLE — Yes
USE — Relief of mild-to-moderate pain; relief of congestion
ADVERSE REACTIONS SIGNIFICANT — See individual agents.
DRUG INTERACTIONS — Acetaminophen: Substrate (minor) of CYP1A2, 2A6, 2C9, 2D6, 2E1, 3A4; Inhibits CYP3A4 (weak)
Also see individual agents.
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.
DIETARY CONSIDERATIONS Sudafed® Multi-Symptom Sinus and Cold capsule contains acetaminophen 325 mg, pseudoephedrine hydrochloride 30 mg, and sodium 16 mg.
CANADIAN BRAND NAMES — Contac® Cold and Sore Throat, Non Drowsy, Extra Strength; Dristan® N.D., Extra Strength; Dristan® N.D.; Sinutab® Non Drowsy; Sudafed® Head Cold and Sinus Extra Strength; Tylenol® Decongestant; Tylenol® Sinus
INTERNATIONAL BRAND NAMES — Contac Cold and Sore Throat, Non Drowsy, Extra Strength (CA); Dristan N.D. (CA); Dristan N.D., Extra Strength (CA); Sinutab Non Drowsy (CA); Sudafed Head Cold and Sinus Extra Strength (CA); Tylenol Decongestant (CA); Tylenol Sinus (CA)
PHARMACODYNAMICS / KINETICS — See individual agents.
SPECIAL ALERTS Infant Deaths Associated with Cough and Cold Medications - January 2007
The Centers for Disease Control and Prevention (CDC) has released a report concerning the use of cough and cold medications in children <2 years of age. Products containing nasal decongestants (eg, pseudoephedrine), antihistamines (eg, carbinoxamine), cough suppressants (eg, dextromethorphan), and expectorants are often used in this age group. The CDC notes that during 2004 and 2005, ~ 1519 children <2 years of age were seen in emergency departments for adverse effects, including overdose, associated with these medications.
During this time period, 3 infants <6 months of age died. All 3 had postmortem blood levels of pseudoephedrine, ranging from 4743-7100 ng/mL (therapeutic levels for children 2-12 years: 180-500 ng/mL). In one case, the infant received both a prescription product containing pseudoephedrine and an over-the-counter (OTC) product, also containing pseudoephedrine. Alternatives to nasal decongestants in this age group may be softening nasal secretions with saline drops or a cool-mist humidifier and/or the removal of nasal secretions with the use of rubber suction bulb.
Safety and efficacy for the use of cough and cold products in children <2 years of age is limited. The Food and Drug Administration (FDA) notes that there are no approved OTC uses for these products in children <2 years of age. Clinicians are reminded to ask caregivers about the use of OTC products in order to avoid exposure to multiple medications containing the same ingredient. Caregivers are reminded that OTC cough and cold products should not be used in children <2 years of age except under specific direction by their healthcare provider.
For additional information, refer to the following CDC website: 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 — Allerest® Allergy and Sinus Relief [OTC]; Genapap™ Sinus Maximum Strength [OTC]; Mapap Sinus Maximum Strength [OTC]; Medi-Synal [OTC]; Oranyl Plus [OTC]; Ornex® Maximum Strength [OTC]; Ornex® [OTC]; Sinus-Relief [OTC] [DSC]; Sudafed® Multi-Symptom Sinus and Cold [OTC]; Tylenol® Cold Daytime, Children's [OTC]; Tylenol® Cold, Infants [OTC]; Tylenol® Sinus Daytime [OTC]
PHARMACOLOGIC CATEGORY Alpha/Beta AgonistAnalgesic, Miscellaneous
DOSING: ADULTS Pain (Analgesic): Oral; Based on acetaminophen component: 325-650 mg every 4-6 hours as needed; do not exceed 4 g/day
Decongestant: Oral: Based on pseudoephedrine component: 60 mg every 4 hours; do not exceed 360 mg/day
Product labeling: Sudafed® Multi-Symptom Sinus and Cold: 2 capsules every 4-6 hours (maximum: 8 capsules/24 hours) Tylenol® Sinus Daytime: 2 caplets or gelcaps every 4-6 hours (maximum: 8 caplets or gelcaps/24 hours)
DOSING: PEDIATRIC Analgesic: Based on acetaminophen component: Oral: Children: 10-15 mg/kg/dose every 4-6 hours as needed; do not exceed 5 doses in 24 hours
Decongestant: Based on pseudoephedrine component: Oral: Children: 2-6 years: 15 mg every 4 hours; do not exceed 90 mg/day 6-12 years: 30 mg every 4 hours; do not exceed 180 mg/day Children >12 years and Adults: Refer to adult dosing.
Product labeling:
Children's Tylenol® Cold Daytime: Children: 2-5 years (24-47 lb): 1 teaspoonful every 4-6 hours (maximum: 4 doses/24 hours) 6-11 years (48-95 lb): 2 teaspoonfuls every 4-6 hours (maximum: 4 doses/24 hours)
Infants' Tylenol® Cold: Children 2-3 years (24-35 lb): 1.6 mL every 4-6 hours (maximum: 4 doses/24 hours)
Sudafed® Multi-Symptom Sinus and Cold, Tylenol® Sinus Daytime: 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. [DSC] = Discontinued product
Caplet: Allerest® Allergy and Sinus Relief, Ornex®: Acetaminophen 325 mg and pseudoephedrine hydrochloride 30 mg Genapap™ Sinus Maximum Strength, Mapap Sinus Maximum Strength, Ornex® Maximum Strength, Tylenol® Sinus Daytime: Acetaminophen 500 mg and pseudoephedrine hydrochloride 30 mg
Capsule, liquid: Sudafed® Multi-Symptom Sinus and Cold: Acetaminophen 325 mg and pseudoephedrine hydrochloride 30 mg [contains sodium 16 mg]
Gelcap: Tylenol® Sinus Daytime: Acetaminophen 500 mg and pseudoephedrine hydrochloride 30 mg
Liquid: Childrens Tylenol® Cold Daytime: Acetaminophen 160 mg and pseudoephedrine hydrochloride 15 mg per 5 mL (120 mL) [contains sodium benzoate; fruit flavor]
Liquid, oral [drops]: Infants Tylenol® Cold: Acetaminophen 80 mg and pseudoephedrine 7.5 mg per 0.8 mL [contains sodium benzoate; bubble gum flavor]
Tablet: Medi-Synal, Sinus-Relief [DSC]: Acetaminophen 325 mg and pseudoephedrine hydrochloride 30 mg Oranyl Plus: Acetaminophen 500 mg and pseudoephedrine hydrochloride 30 mg
DOSAGE FORMS: CONCISE Caplet: Allerest® Allergy and Sinus Relief, Ornex®: Acetaminophen 325 mg and pseudoephedrine hydrochloride 30 mg Genapap™ Sinus Maximum Strength, Mapap Sinus Maximum Strength, Ornex® Maximum Strength, Tylenol® Sinus Daytime: Acetaminophen 500 mg and pseudoephedrine hydrochloride 30 mg
Capsule, liquid: Sudafed® Multi-Symptom Sinus and Cold: Acetaminophen 325 mg and pseudoephedrine hydrochloride 30 mg
Gelcap: Tylenol® Sinus Daytime: Acetaminophen 500 mg and pseudoephedrine hydrochloride 30 mg
Liquid: Childrens Tylenol® Cold Daytime: Acetaminophen 160 mg and pseudoephedrine hydrochloride 15 mg per 5 mL
Liquid, oral [drops]: Infants Tylenol® Cold: Acetaminophen 80 mg and pseudoephedrine 7.5 mg per 0.8 mL
Tablet: Medi-Synal: Acetaminophen 325 mg and pseudoephedrine hydrochloride 30 mg Oranyl Plus: Acetaminophen 500 mg and pseudoephedrine hydrochloride 30 mg
GENERIC EQUIVALENT AVAILABLE — Yes
USE — Relief of mild-to-moderate pain; relief of congestion
ADVERSE REACTIONS SIGNIFICANT — See individual agents.
DRUG INTERACTIONS — Acetaminophen: Substrate (minor) of CYP1A2, 2A6, 2C9, 2D6, 2E1, 3A4; Inhibits CYP3A4 (weak)
Also see individual agents.
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.
DIETARY CONSIDERATIONS Sudafed® Multi-Symptom Sinus and Cold capsule contains acetaminophen 325 mg, pseudoephedrine hydrochloride 30 mg, and sodium 16 mg.
CANADIAN BRAND NAMES — Contac® Cold and Sore Throat, Non Drowsy, Extra Strength; Dristan® N.D., Extra Strength; Dristan® N.D.; Sinutab® Non Drowsy; Sudafed® Head Cold and Sinus Extra Strength; Tylenol® Decongestant; Tylenol® Sinus
INTERNATIONAL BRAND NAMES — Contac Cold and Sore Throat, Non Drowsy, Extra Strength (CA); Dristan N.D. (CA); Dristan N.D., Extra Strength (CA); Sinutab Non Drowsy (CA); Sudafed Head Cold and Sinus Extra Strength (CA); Tylenol Decongestant (CA); Tylenol Sinus (CA)
PHARMACODYNAMICS / KINETICS — See individual agents.
Acetaminophen and phenyltoloxamine: Drug information
(For additional information see "Acetaminophen and phenyltoloxamine: Patient drug information")
U.S. BRAND NAMES — Aceta-Gesic [OTC]; Alpain; Dologesic®; Flextra 650; Flextra-DS; Genasec™ [OTC]; Hyflex-DS®; Lagesic™; Percogesic® [OTC]; Phenagesic [OTC]; Phenylgesic [OTC]; RhinoFlex 650; RhinoFlex™; Staflex
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: Flextra-650: 1/2-1 tablet every 6 hours (maximum: 4 tablets/day) Flextra-DS, Hyflex-DS®, RhinoFlex™, RhinoFlex™-650:1/2-1 tablet every 4 hours (maximum: 5 tablets/day) 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: Flextra-650: Children 6 to <12 years: 1/2 tablet every 6 hours (maximum: 2 tablets/day) Children 12 years: Refer to adults dosing. Flextra-DS, Hyflex-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 adults dosing. Percogesic®: Children 6-12 years: 1 tablet every 4 hours (maximum: 4 tablets/24 hours)
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.
Caplet: Alpain: Acetaminophen 500 mg and phenyltoloxamine citrate 60 mg Dologesic®: Acetaminophen 500 mg and phenyltoloxamine citrate 30 mg Staflex: Acetaminophen 500 mg and phenyltoloxamine citrate 55 mg
Caplet, extended release [scored]: Lagesic™: Acetaminphen 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: Acetaminophen 650 mg and phenyltoloxamine citrate 60 mg Flextra-DS, Hyflex-DS®, RhinoFlex™: Acetaminophen 500 mg and phenyltoloxamine citrate 50 mg RhinoFlex™-650: Acetaminophen 650 mg and phenyltoloxamine citrate 50 mg
DOSAGE FORMS: CONCISE Caplet: Alpain: Acetaminophen 500 mg and phenyltoloxamine citrate 60 mg Dologesic®: Acetaminophen 500 mg and phenyltoloxamine citrate 30 mg Staflex: Acetaminophen 500 mg and phenyltoloxamine citrate 55 mg
Caplet, extended release [scored]: Lagesic™: Acetaminphen 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 mg
Tablet: Acetaminophen 325 mg and phenyltoloxamine citrate 30 mg Aceta-Gesic [OTC], Genasec™ [OTC], Percogesic® [OTC], Phenagesic [OTC], Phenylgesic [OTC]: Acetaminophen 325 mg and phenyltoloxamine citrate 30 mg Flextra-650: Acetaminophen 650 mg and phenyltoloxamine citrate 60 mg Flextra-DS, Hyflex-DS®, RhinoFlex™: Acetaminophen 500 mg and phenyltoloxamine citrate 50 mg RhinoFlex™-650: Acetaminophen 650 mg and phenyltoloxamine citrate 50 mg
GENERIC EQUIVALENT AVAILABLE — Yes: Tablet
USE — Relief of mild pain
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.
Special populations: 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.
DRUG INTERACTIONS — Acetaminophen: Substrate (minor) of CYP1A2, 2A6, 2C9, 2D6, 2E1, 3A4; Inhibits CYP3A4 (weak)
Refer to Acetaminophen monograph.
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)
PRICING — (data from drugstore.com)Tablets (Flextra DS) 50-500 mg (30): $22.35
TOXICOLOGY / OVERDOSE COMPREHENSIVE — Refer to Acetaminophen monograph.
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.
U.S. BRAND NAMES — Aceta-Gesic [OTC]; Alpain; Dologesic®; Flextra 650; Flextra-DS; Genasec™ [OTC]; Hyflex-DS®; Lagesic™; Percogesic® [OTC]; Phenagesic [OTC]; Phenylgesic [OTC]; RhinoFlex 650; RhinoFlex™; Staflex
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: Flextra-650: 1/2-1 tablet every 6 hours (maximum: 4 tablets/day) Flextra-DS, Hyflex-DS®, RhinoFlex™, RhinoFlex™-650:1/2-1 tablet every 4 hours (maximum: 5 tablets/day) 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: Flextra-650: Children 6 to <12 years: 1/2 tablet every 6 hours (maximum: 2 tablets/day) Children 12 years: Refer to adults dosing. Flextra-DS, Hyflex-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 adults dosing. Percogesic®: Children 6-12 years: 1 tablet every 4 hours (maximum: 4 tablets/24 hours)
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.
Caplet: Alpain: Acetaminophen 500 mg and phenyltoloxamine citrate 60 mg Dologesic®: Acetaminophen 500 mg and phenyltoloxamine citrate 30 mg Staflex: Acetaminophen 500 mg and phenyltoloxamine citrate 55 mg
Caplet, extended release [scored]: Lagesic™: Acetaminphen 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: Acetaminophen 650 mg and phenyltoloxamine citrate 60 mg Flextra-DS, Hyflex-DS®, RhinoFlex™: Acetaminophen 500 mg and phenyltoloxamine citrate 50 mg RhinoFlex™-650: Acetaminophen 650 mg and phenyltoloxamine citrate 50 mg
DOSAGE FORMS: CONCISE Caplet: Alpain: Acetaminophen 500 mg and phenyltoloxamine citrate 60 mg Dologesic®: Acetaminophen 500 mg and phenyltoloxamine citrate 30 mg Staflex: Acetaminophen 500 mg and phenyltoloxamine citrate 55 mg
Caplet, extended release [scored]: Lagesic™: Acetaminphen 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 mg
Tablet: Acetaminophen 325 mg and phenyltoloxamine citrate 30 mg Aceta-Gesic [OTC], Genasec™ [OTC], Percogesic® [OTC], Phenagesic [OTC], Phenylgesic [OTC]: Acetaminophen 325 mg and phenyltoloxamine citrate 30 mg Flextra-650: Acetaminophen 650 mg and phenyltoloxamine citrate 60 mg Flextra-DS, Hyflex-DS®, RhinoFlex™: Acetaminophen 500 mg and phenyltoloxamine citrate 50 mg RhinoFlex™-650: Acetaminophen 650 mg and phenyltoloxamine citrate 50 mg
GENERIC EQUIVALENT AVAILABLE — Yes: Tablet
USE — Relief of mild pain
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.
Special populations: 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.
DRUG INTERACTIONS — Acetaminophen: Substrate (minor) of CYP1A2, 2A6, 2C9, 2D6, 2E1, 3A4; Inhibits CYP3A4 (weak)
Refer to Acetaminophen monograph.
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)
PRICING — (data from drugstore.com)Tablets (Flextra DS) 50-500 mg (30): $22.35
TOXICOLOGY / OVERDOSE COMPREHENSIVE — Refer to Acetaminophen monograph.
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 pseudoephedrine: Drug information
(For additional information see "Acetaminophen and pseudoephedrine: Patient drug information")
SPECIAL ALERTS Infant Deaths Associated with Cough and Cold Medications - January 2007
The Centers for Disease Control and Prevention (CDC) has released a report concerning the use of cough and cold medications in children <2 years of age. Products containing nasal decongestants (eg, pseudoephedrine), antihistamines (eg, carbinoxamine), cough suppressants (eg, dextromethorphan), and expectorants are often used in this age group. The CDC notes that during 2004 and 2005, ~ 1519 children <2 years of age were seen in emergency departments for adverse effects, including overdose, associated with these medications.
During this time period, 3 infants <6 months of age died. All 3 had postmortem blood levels of pseudoephedrine, ranging from 4743-7100 ng/mL (therapeutic levels for children 2-12 years: 180-500 ng/mL). In one case, the infant received both a prescription product containing pseudoephedrine and an over-the-counter (OTC) product, also containing pseudoephedrine. Alternatives to nasal decongestants in this age group may be softening nasal secretions with saline drops or a cool-mist humidifier and/or the removal of nasal secretions with the use of rubber suction bulb.
Safety and efficacy for the use of cough and cold products in children <2 years of age is limited. The Food and Drug Administration (FDA) notes that there are no approved OTC uses for these products in children <2 years of age. Clinicians are reminded to ask caregivers about the use of OTC products in order to avoid exposure to multiple medications containing the same ingredient. Caregivers are reminded that OTC cough and cold products should not be used in children <2 years of age except under specific direction by their healthcare provider.
For additional information, refer to the following CDC website: 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 — Allerest® Allergy and Sinus Relief [OTC]; Genapap™ Sinus Maximum Strength [OTC]; Mapap Sinus Maximum Strength [OTC]; Medi-Synal [OTC]; Oranyl Plus [OTC]; Ornex® Maximum Strength [OTC]; Ornex® [OTC]; Sinus-Relief [OTC] [DSC]; Sudafed® Multi-Symptom Sinus and Cold [OTC]; Tylenol® Cold Daytime, Children's [OTC]; Tylenol® Cold, Infants [OTC]; Tylenol® Sinus Daytime [OTC]
PHARMACOLOGIC CATEGORY Alpha/Beta AgonistAnalgesic, Miscellaneous
DOSING: ADULTS Pain (Analgesic): Oral; Based on acetaminophen component: 325-650 mg every 4-6 hours as needed; do not exceed 4 g/day
Decongestant: Oral: Based on pseudoephedrine component: 60 mg every 4 hours; do not exceed 360 mg/day
Product labeling: Sudafed® Multi-Symptom Sinus and Cold: 2 capsules every 4-6 hours (maximum: 8 capsules/24 hours) Tylenol® Sinus Daytime: 2 caplets or gelcaps every 4-6 hours (maximum: 8 caplets or gelcaps/24 hours)
DOSING: PEDIATRIC Analgesic: Based on acetaminophen component: Oral: Children: 10-15 mg/kg/dose every 4-6 hours as needed; do not exceed 5 doses in 24 hours
Decongestant: Based on pseudoephedrine component: Oral: Children: 2-6 years: 15 mg every 4 hours; do not exceed 90 mg/day 6-12 years: 30 mg every 4 hours; do not exceed 180 mg/day Children >12 years and Adults: Refer to adult dosing.
Product labeling:
Children's Tylenol® Cold Daytime: Children: 2-5 years (24-47 lb): 1 teaspoonful every 4-6 hours (maximum: 4 doses/24 hours) 6-11 years (48-95 lb): 2 teaspoonfuls every 4-6 hours (maximum: 4 doses/24 hours)
Infants' Tylenol® Cold: Children 2-3 years (24-35 lb): 1.6 mL every 4-6 hours (maximum: 4 doses/24 hours)
Sudafed® Multi-Symptom Sinus and Cold, Tylenol® Sinus Daytime: 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. [DSC] = Discontinued product
Caplet: Allerest® Allergy and Sinus Relief, Ornex®: Acetaminophen 325 mg and pseudoephedrine hydrochloride 30 mg Genapap™ Sinus Maximum Strength, Mapap Sinus Maximum Strength, Ornex® Maximum Strength, Tylenol® Sinus Daytime: Acetaminophen 500 mg and pseudoephedrine hydrochloride 30 mg
Capsule, liquid: Sudafed® Multi-Symptom Sinus and Cold: Acetaminophen 325 mg and pseudoephedrine hydrochloride 30 mg [contains sodium 16 mg]
Gelcap: Tylenol® Sinus Daytime: Acetaminophen 500 mg and pseudoephedrine hydrochloride 30 mg
Liquid: Childrens Tylenol® Cold Daytime: Acetaminophen 160 mg and pseudoephedrine hydrochloride 15 mg per 5 mL (120 mL) [contains sodium benzoate; fruit flavor]
Liquid, oral [drops]: Infants Tylenol® Cold: Acetaminophen 80 mg and pseudoephedrine 7.5 mg per 0.8 mL [contains sodium benzoate; bubble gum flavor]
Tablet: Medi-Synal, Sinus-Relief [DSC]: Acetaminophen 325 mg and pseudoephedrine hydrochloride 30 mg Oranyl Plus: Acetaminophen 500 mg and pseudoephedrine hydrochloride 30 mg
DOSAGE FORMS: CONCISE Caplet: Allerest® Allergy and Sinus Relief, Ornex®: Acetaminophen 325 mg and pseudoephedrine hydrochloride 30 mg Genapap™ Sinus Maximum Strength, Mapap Sinus Maximum Strength, Ornex® Maximum Strength, Tylenol® Sinus Daytime: Acetaminophen 500 mg and pseudoephedrine hydrochloride 30 mg
Capsule, liquid: Sudafed® Multi-Symptom Sinus and Cold: Acetaminophen 325 mg and pseudoephedrine hydrochloride 30 mg
Gelcap: Tylenol® Sinus Daytime: Acetaminophen 500 mg and pseudoephedrine hydrochloride 30 mg
Liquid: Childrens Tylenol® Cold Daytime: Acetaminophen 160 mg and pseudoephedrine hydrochloride 15 mg per 5 mL
Liquid, oral [drops]: Infants Tylenol® Cold: Acetaminophen 80 mg and pseudoephedrine 7.5 mg per 0.8 mL
Tablet: Medi-Synal: Acetaminophen 325 mg and pseudoephedrine hydrochloride 30 mg Oranyl Plus: Acetaminophen 500 mg and pseudoephedrine hydrochloride 30 mg
GENERIC EQUIVALENT AVAILABLE — Yes
USE — Relief of mild-to-moderate pain; relief of congestion
ADVERSE REACTIONS SIGNIFICANT — See individual agents.
DRUG INTERACTIONS — Acetaminophen: Substrate (minor) of CYP1A2, 2A6, 2C9, 2D6, 2E1, 3A4; Inhibits CYP3A4 (weak)
Also see individual agents.
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.
DIETARY CONSIDERATIONS Sudafed® Multi-Symptom Sinus and Cold capsule contains acetaminophen 325 mg, pseudoephedrine hydrochloride 30 mg, and sodium 16 mg.
CANADIAN BRAND NAMES — Contac® Cold and Sore Throat, Non Drowsy, Extra Strength; Dristan® N.D., Extra Strength; Dristan® N.D.; Sinutab® Non Drowsy; Sudafed® Head Cold and Sinus Extra Strength; Tylenol® Decongestant; Tylenol® Sinus
INTERNATIONAL BRAND NAMES — Contac Cold and Sore Throat, Non Drowsy, Extra Strength (CA); Dristan N.D. (CA); Dristan N.D., Extra Strength (CA); Sinutab Non Drowsy (CA); Sudafed Head Cold and Sinus Extra Strength (CA); Tylenol Decongestant (CA); Tylenol Sinus (CA)
PHARMACODYNAMICS / KINETICS — See individual agents.
SPECIAL ALERTS Infant Deaths Associated with Cough and Cold Medications - January 2007
The Centers for Disease Control and Prevention (CDC) has released a report concerning the use of cough and cold medications in children <2 years of age. Products containing nasal decongestants (eg, pseudoephedrine), antihistamines (eg, carbinoxamine), cough suppressants (eg, dextromethorphan), and expectorants are often used in this age group. The CDC notes that during 2004 and 2005, ~ 1519 children <2 years of age were seen in emergency departments for adverse effects, including overdose, associated with these medications.
During this time period, 3 infants <6 months of age died. All 3 had postmortem blood levels of pseudoephedrine, ranging from 4743-7100 ng/mL (therapeutic levels for children 2-12 years: 180-500 ng/mL). In one case, the infant received both a prescription product containing pseudoephedrine and an over-the-counter (OTC) product, also containing pseudoephedrine. Alternatives to nasal decongestants in this age group may be softening nasal secretions with saline drops or a cool-mist humidifier and/or the removal of nasal secretions with the use of rubber suction bulb.
Safety and efficacy for the use of cough and cold products in children <2 years of age is limited. The Food and Drug Administration (FDA) notes that there are no approved OTC uses for these products in children <2 years of age. Clinicians are reminded to ask caregivers about the use of OTC products in order to avoid exposure to multiple medications containing the same ingredient. Caregivers are reminded that OTC cough and cold products should not be used in children <2 years of age except under specific direction by their healthcare provider.
For additional information, refer to the following CDC website: 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 — Allerest® Allergy and Sinus Relief [OTC]; Genapap™ Sinus Maximum Strength [OTC]; Mapap Sinus Maximum Strength [OTC]; Medi-Synal [OTC]; Oranyl Plus [OTC]; Ornex® Maximum Strength [OTC]; Ornex® [OTC]; Sinus-Relief [OTC] [DSC]; Sudafed® Multi-Symptom Sinus and Cold [OTC]; Tylenol® Cold Daytime, Children's [OTC]; Tylenol® Cold, Infants [OTC]; Tylenol® Sinus Daytime [OTC]
PHARMACOLOGIC CATEGORY Alpha/Beta AgonistAnalgesic, Miscellaneous
DOSING: ADULTS Pain (Analgesic): Oral; Based on acetaminophen component: 325-650 mg every 4-6 hours as needed; do not exceed 4 g/day
Decongestant: Oral: Based on pseudoephedrine component: 60 mg every 4 hours; do not exceed 360 mg/day
Product labeling: Sudafed® Multi-Symptom Sinus and Cold: 2 capsules every 4-6 hours (maximum: 8 capsules/24 hours) Tylenol® Sinus Daytime: 2 caplets or gelcaps every 4-6 hours (maximum: 8 caplets or gelcaps/24 hours)
DOSING: PEDIATRIC Analgesic: Based on acetaminophen component: Oral: Children: 10-15 mg/kg/dose every 4-6 hours as needed; do not exceed 5 doses in 24 hours
Decongestant: Based on pseudoephedrine component: Oral: Children: 2-6 years: 15 mg every 4 hours; do not exceed 90 mg/day 6-12 years: 30 mg every 4 hours; do not exceed 180 mg/day Children >12 years and Adults: Refer to adult dosing.
Product labeling:
Children's Tylenol® Cold Daytime: Children: 2-5 years (24-47 lb): 1 teaspoonful every 4-6 hours (maximum: 4 doses/24 hours) 6-11 years (48-95 lb): 2 teaspoonfuls every 4-6 hours (maximum: 4 doses/24 hours)
Infants' Tylenol® Cold: Children 2-3 years (24-35 lb): 1.6 mL every 4-6 hours (maximum: 4 doses/24 hours)
Sudafed® Multi-Symptom Sinus and Cold, Tylenol® Sinus Daytime: 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. [DSC] = Discontinued product
Caplet: Allerest® Allergy and Sinus Relief, Ornex®: Acetaminophen 325 mg and pseudoephedrine hydrochloride 30 mg Genapap™ Sinus Maximum Strength, Mapap Sinus Maximum Strength, Ornex® Maximum Strength, Tylenol® Sinus Daytime: Acetaminophen 500 mg and pseudoephedrine hydrochloride 30 mg
Capsule, liquid: Sudafed® Multi-Symptom Sinus and Cold: Acetaminophen 325 mg and pseudoephedrine hydrochloride 30 mg [contains sodium 16 mg]
Gelcap: Tylenol® Sinus Daytime: Acetaminophen 500 mg and pseudoephedrine hydrochloride 30 mg
Liquid: Childrens Tylenol® Cold Daytime: Acetaminophen 160 mg and pseudoephedrine hydrochloride 15 mg per 5 mL (120 mL) [contains sodium benzoate; fruit flavor]
Liquid, oral [drops]: Infants Tylenol® Cold: Acetaminophen 80 mg and pseudoephedrine 7.5 mg per 0.8 mL [contains sodium benzoate; bubble gum flavor]
Tablet: Medi-Synal, Sinus-Relief [DSC]: Acetaminophen 325 mg and pseudoephedrine hydrochloride 30 mg Oranyl Plus: Acetaminophen 500 mg and pseudoephedrine hydrochloride 30 mg
DOSAGE FORMS: CONCISE Caplet: Allerest® Allergy and Sinus Relief, Ornex®: Acetaminophen 325 mg and pseudoephedrine hydrochloride 30 mg Genapap™ Sinus Maximum Strength, Mapap Sinus Maximum Strength, Ornex® Maximum Strength, Tylenol® Sinus Daytime: Acetaminophen 500 mg and pseudoephedrine hydrochloride 30 mg
Capsule, liquid: Sudafed® Multi-Symptom Sinus and Cold: Acetaminophen 325 mg and pseudoephedrine hydrochloride 30 mg
Gelcap: Tylenol® Sinus Daytime: Acetaminophen 500 mg and pseudoephedrine hydrochloride 30 mg
Liquid: Childrens Tylenol® Cold Daytime: Acetaminophen 160 mg and pseudoephedrine hydrochloride 15 mg per 5 mL
Liquid, oral [drops]: Infants Tylenol® Cold: Acetaminophen 80 mg and pseudoephedrine 7.5 mg per 0.8 mL
Tablet: Medi-Synal: Acetaminophen 325 mg and pseudoephedrine hydrochloride 30 mg Oranyl Plus: Acetaminophen 500 mg and pseudoephedrine hydrochloride 30 mg
GENERIC EQUIVALENT AVAILABLE — Yes
USE — Relief of mild-to-moderate pain; relief of congestion
ADVERSE REACTIONS SIGNIFICANT — See individual agents.
DRUG INTERACTIONS — Acetaminophen: Substrate (minor) of CYP1A2, 2A6, 2C9, 2D6, 2E1, 3A4; Inhibits CYP3A4 (weak)
Also see individual agents.
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.
DIETARY CONSIDERATIONS Sudafed® Multi-Symptom Sinus and Cold capsule contains acetaminophen 325 mg, pseudoephedrine hydrochloride 30 mg, and sodium 16 mg.
CANADIAN BRAND NAMES — Contac® Cold and Sore Throat, Non Drowsy, Extra Strength; Dristan® N.D., Extra Strength; Dristan® N.D.; Sinutab® Non Drowsy; Sudafed® Head Cold and Sinus Extra Strength; Tylenol® Decongestant; Tylenol® Sinus
INTERNATIONAL BRAND NAMES — Contac Cold and Sore Throat, Non Drowsy, Extra Strength (CA); Dristan N.D. (CA); Dristan N.D., Extra Strength (CA); Sinutab Non Drowsy (CA); Sudafed Head Cold and Sinus Extra Strength (CA); Tylenol Decongestant (CA); Tylenol Sinus (CA)
PHARMACODYNAMICS / KINETICS — See individual agents.
Acetaminophen and phenyltoloxamine: Drug information
(For additional information see "Acetaminophen and phenyltoloxamine: Patient drug information")
U.S. BRAND NAMES — Aceta-Gesic [OTC]; Alpain; Dologesic®; Flextra 650; Flextra-DS; Genasec™ [OTC]; Hyflex-DS®; Lagesic™; Percogesic® [OTC]; Phenagesic [OTC]; Phenylgesic [OTC]; RhinoFlex 650; RhinoFlex™; Staflex
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: Flextra-650: 1/2-1 tablet every 6 hours (maximum: 4 tablets/day) Flextra-DS, Hyflex-DS®, RhinoFlex™, RhinoFlex™-650:1/2-1 tablet every 4 hours (maximum: 5 tablets/day) 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: Flextra-650: Children 6 to <12 years: 1/2 tablet every 6 hours (maximum: 2 tablets/day) Children 12 years: Refer to adults dosing. Flextra-DS, Hyflex-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 adults dosing. Percogesic®: Children 6-12 years: 1 tablet every 4 hours (maximum: 4 tablets/24 hours)
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.
Caplet: Alpain: Acetaminophen 500 mg and phenyltoloxamine citrate 60 mg Dologesic®: Acetaminophen 500 mg and phenyltoloxamine citrate 30 mg Staflex: Acetaminophen 500 mg and phenyltoloxamine citrate 55 mg
Caplet, extended release [scored]: Lagesic™: Acetaminphen 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: Acetaminophen 650 mg and phenyltoloxamine citrate 60 mg Flextra-DS, Hyflex-DS®, RhinoFlex™: Acetaminophen 500 mg and phenyltoloxamine citrate 50 mg RhinoFlex™-650: Acetaminophen 650 mg and phenyltoloxamine citrate 50 mg
DOSAGE FORMS: CONCISE Caplet: Alpain: Acetaminophen 500 mg and phenyltoloxamine citrate 60 mg Dologesic®: Acetaminophen 500 mg and phenyltoloxamine citrate 30 mg Staflex: Acetaminophen 500 mg and phenyltoloxamine citrate 55 mg
Caplet, extended release [scored]: Lagesic™: Acetaminphen 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 mg
Tablet: Acetaminophen 325 mg and phenyltoloxamine citrate 30 mg Aceta-Gesic [OTC], Genasec™ [OTC], Percogesic® [OTC], Phenagesic [OTC], Phenylgesic [OTC]: Acetaminophen 325 mg and phenyltoloxamine citrate 30 mg Flextra-650: Acetaminophen 650 mg and phenyltoloxamine citrate 60 mg Flextra-DS, Hyflex-DS®, RhinoFlex™: Acetaminophen 500 mg and phenyltoloxamine citrate 50 mg RhinoFlex™-650: Acetaminophen 650 mg and phenyltoloxamine citrate 50 mg
GENERIC EQUIVALENT AVAILABLE — Yes: Tablet
USE — Relief of mild pain
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.
Special populations: 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.
DRUG INTERACTIONS — Acetaminophen: Substrate (minor) of CYP1A2, 2A6, 2C9, 2D6, 2E1, 3A4; Inhibits CYP3A4 (weak)
Refer to Acetaminophen monograph.
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)
PRICING — (data from drugstore.com)Tablets (Flextra DS) 50-500 mg (30): $22.35
TOXICOLOGY / OVERDOSE COMPREHENSIVE — Refer to Acetaminophen monograph.
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.
U.S. BRAND NAMES — Aceta-Gesic [OTC]; Alpain; Dologesic®; Flextra 650; Flextra-DS; Genasec™ [OTC]; Hyflex-DS®; Lagesic™; Percogesic® [OTC]; Phenagesic [OTC]; Phenylgesic [OTC]; RhinoFlex 650; RhinoFlex™; Staflex
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: Flextra-650: 1/2-1 tablet every 6 hours (maximum: 4 tablets/day) Flextra-DS, Hyflex-DS®, RhinoFlex™, RhinoFlex™-650:1/2-1 tablet every 4 hours (maximum: 5 tablets/day) 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: Flextra-650: Children 6 to <12 years: 1/2 tablet every 6 hours (maximum: 2 tablets/day) Children 12 years: Refer to adults dosing. Flextra-DS, Hyflex-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 adults dosing. Percogesic®: Children 6-12 years: 1 tablet every 4 hours (maximum: 4 tablets/24 hours)
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.
Caplet: Alpain: Acetaminophen 500 mg and phenyltoloxamine citrate 60 mg Dologesic®: Acetaminophen 500 mg and phenyltoloxamine citrate 30 mg Staflex: Acetaminophen 500 mg and phenyltoloxamine citrate 55 mg
Caplet, extended release [scored]: Lagesic™: Acetaminphen 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: Acetaminophen 650 mg and phenyltoloxamine citrate 60 mg Flextra-DS, Hyflex-DS®, RhinoFlex™: Acetaminophen 500 mg and phenyltoloxamine citrate 50 mg RhinoFlex™-650: Acetaminophen 650 mg and phenyltoloxamine citrate 50 mg
DOSAGE FORMS: CONCISE Caplet: Alpain: Acetaminophen 500 mg and phenyltoloxamine citrate 60 mg Dologesic®: Acetaminophen 500 mg and phenyltoloxamine citrate 30 mg Staflex: Acetaminophen 500 mg and phenyltoloxamine citrate 55 mg
Caplet, extended release [scored]: Lagesic™: Acetaminphen 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 mg
Tablet: Acetaminophen 325 mg and phenyltoloxamine citrate 30 mg Aceta-Gesic [OTC], Genasec™ [OTC], Percogesic® [OTC], Phenagesic [OTC], Phenylgesic [OTC]: Acetaminophen 325 mg and phenyltoloxamine citrate 30 mg Flextra-650: Acetaminophen 650 mg and phenyltoloxamine citrate 60 mg Flextra-DS, Hyflex-DS®, RhinoFlex™: Acetaminophen 500 mg and phenyltoloxamine citrate 50 mg RhinoFlex™-650: Acetaminophen 650 mg and phenyltoloxamine citrate 50 mg
GENERIC EQUIVALENT AVAILABLE — Yes: Tablet
USE — Relief of mild pain
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.
Special populations: 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.
DRUG INTERACTIONS — Acetaminophen: Substrate (minor) of CYP1A2, 2A6, 2C9, 2D6, 2E1, 3A4; Inhibits CYP3A4 (weak)
Refer to Acetaminophen monograph.
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)
PRICING — (data from drugstore.com)Tablets (Flextra DS) 50-500 mg (30): $22.35
TOXICOLOGY / OVERDOSE COMPREHENSIVE — Refer to Acetaminophen monograph.
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 diphenhydramine: Drug information
Copyright 1978-2006 Lexi-Comp, Inc. All rights reserved.
(For additional information see "Acetaminophen and diphenhydramine: Patient drug information")
U.S. BRAND NAMES — Excedrin® P.M. [OTC]; Goody's PM® [OTC]; Legatrin PM® [OTC]; Percogesic® Extra Strength [OTC]; Tylenol® PM [OTC]; Tylenol® Severe Allergy [OTC]
PHARMACOLOGIC CATEGORY Analgesic, Miscellaneous
DOSING: ADULTS — Insomnia and pain: Oral: Adults: 50 mg of diphenhydramine HCl (76 mg diphenhydramine citrate) at bedtime or as directed by physician; do not exceed recommended dosage
DOSING: PEDIATRIC — Not for use in children <12 years of age.
DOSING: ELDERLY — Refer to adult dosing.
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.
Caplet: Acetaminophen 500 mg and diphenhydramine hydrochloride 25 mg Excedrin® P.M.: Acetaminophen 500 mg and diphenhydramine citrate 38 mg Legatrin PM®: Acetaminophen 500 mg and diphenhydramine hydrochloride 50 mg Percogesic® Extra Strength: Acetaminophen 500 mg and diphenhydramine hydrochloride 25 mg Tylenol® PM: Acetaminophen 500 mg and diphenhydramine hydrochloride 25 mg [also available in vanilla caplets] Tylenol® Severe Allergy: Acetaminophen 500 mg and diphenhydramine hydrochloride 12.5 mg
Gelcap: Tylenol® PM: Acetaminophen 500 mg and diphenhydramine hydrochloride 25 mg
Geltab: Acetaminophen 500 mg and diphenhydramine hydrochloride 25 mg Excedrin® P.M.: Acetaminophen 500 mg and diphenhydramine citrate 38 mg Tylenol® PM: Acetaminophen 500 mg and diphenhydramine hydrochloride 25 mg
Liquid: Tylenol® PM: Acetaminophen 500 mg and diphenhydramine hydrochloride 25 mg per 15 mL (240 mL) [contains sodium benzoate; vanilla flavor]
Powder for oral solution: Goody's PM®: Acetaminophen 500 mg and diphenhydramine citrate 38 mg [contains potassium 41.9 mg and sodium 3.15 mg per powder]
Tablet: Acetaminophen 500 mg and diphenhydramine hydrochloride 25 mg Excedrin® P.M.: Acetaminophen 500 mg and diphenhydramine citrate 38 mg
DOSAGE FORMS: CONCISE Caplet: Acetaminophen 500 mg and diphenhydramine 25 mg Excedrin® P.M. [OTC]: Acetaminophen 500 mg and diphenhydramine 38 mg Legatrin PM® [OTC]: Acetaminophen 500 mg and diphenhydramine 50 mg Percogesic® Extra Strength [OTC], Tylenol® PM [OTC]: Acetaminophen 500 mg and diphenhydramine 25 mg Tylenol® Severe Allergy [OTC]: Acetaminophen 500 mg and diphenhydramine 12.5 mg
Gelcap: Tylenol® PM [OTC]: Acetaminophen 500 mg and diphenhydramine 25 mg
Geltab: Acetaminophen 500 mg and diphenhydramine 25 mg Excedrin® P.M. [OTC]: Acetaminophen 500 mg and diphenhydramine 38 mg Tylenol® PM [OTC]: Acetaminophen 500 mg and diphenhydramine 25 mg
Liquid: Tylenol® PM [OTC]: Acetaminophen 500 mg and diphenhydramine 25 mg per 15 mL
Powder for oral solution: Goody's PM® [OTC]: Acetaminophen 500 mg and diphenhydramine 38 mg
Tablet: Acetaminophen 500 mg and diphenhydramine 25 mg Excedrin® P.M. [OTC]: Acetaminophen 500 mg and diphenhydramine 38 mg
GENERIC EQUIVALENT AVAILABLE — Yes: Excludes gelcap, powder, and liquid
USE — Aid in the relief of insomnia accompanied by minor pain
ADVERSE REACTIONS SIGNIFICANT — See individual agents.
DRUG INTERACTIONS Acetaminophen: Substrate (minor) of CYP1A2, 2A6, 2C9, 2D6, 2E1, 3A4; Inhibits CYP3A4 (weak)
Diphenhydramine: Inhibits CYP2D6 (moderate)
Also see individual agents.
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.
PHARMACODYNAMICS / KINETICS — See individual agents.
(For additional information see "Acetaminophen and diphenhydramine: Patient drug information")
U.S. BRAND NAMES — Excedrin® P.M. [OTC]; Goody's PM® [OTC]; Legatrin PM® [OTC]; Percogesic® Extra Strength [OTC]; Tylenol® PM [OTC]; Tylenol® Severe Allergy [OTC]
PHARMACOLOGIC CATEGORY Analgesic, Miscellaneous
DOSING: ADULTS — Insomnia and pain: Oral: Adults: 50 mg of diphenhydramine HCl (76 mg diphenhydramine citrate) at bedtime or as directed by physician; do not exceed recommended dosage
DOSING: PEDIATRIC — Not for use in children <12 years of age.
DOSING: ELDERLY — Refer to adult dosing.
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.
Caplet: Acetaminophen 500 mg and diphenhydramine hydrochloride 25 mg Excedrin® P.M.: Acetaminophen 500 mg and diphenhydramine citrate 38 mg Legatrin PM®: Acetaminophen 500 mg and diphenhydramine hydrochloride 50 mg Percogesic® Extra Strength: Acetaminophen 500 mg and diphenhydramine hydrochloride 25 mg Tylenol® PM: Acetaminophen 500 mg and diphenhydramine hydrochloride 25 mg [also available in vanilla caplets] Tylenol® Severe Allergy: Acetaminophen 500 mg and diphenhydramine hydrochloride 12.5 mg
Gelcap: Tylenol® PM: Acetaminophen 500 mg and diphenhydramine hydrochloride 25 mg
Geltab: Acetaminophen 500 mg and diphenhydramine hydrochloride 25 mg Excedrin® P.M.: Acetaminophen 500 mg and diphenhydramine citrate 38 mg Tylenol® PM: Acetaminophen 500 mg and diphenhydramine hydrochloride 25 mg
Liquid: Tylenol® PM: Acetaminophen 500 mg and diphenhydramine hydrochloride 25 mg per 15 mL (240 mL) [contains sodium benzoate; vanilla flavor]
Powder for oral solution: Goody's PM®: Acetaminophen 500 mg and diphenhydramine citrate 38 mg [contains potassium 41.9 mg and sodium 3.15 mg per powder]
Tablet: Acetaminophen 500 mg and diphenhydramine hydrochloride 25 mg Excedrin® P.M.: Acetaminophen 500 mg and diphenhydramine citrate 38 mg
DOSAGE FORMS: CONCISE Caplet: Acetaminophen 500 mg and diphenhydramine 25 mg Excedrin® P.M. [OTC]: Acetaminophen 500 mg and diphenhydramine 38 mg Legatrin PM® [OTC]: Acetaminophen 500 mg and diphenhydramine 50 mg Percogesic® Extra Strength [OTC], Tylenol® PM [OTC]: Acetaminophen 500 mg and diphenhydramine 25 mg Tylenol® Severe Allergy [OTC]: Acetaminophen 500 mg and diphenhydramine 12.5 mg
Gelcap: Tylenol® PM [OTC]: Acetaminophen 500 mg and diphenhydramine 25 mg
Geltab: Acetaminophen 500 mg and diphenhydramine 25 mg Excedrin® P.M. [OTC]: Acetaminophen 500 mg and diphenhydramine 38 mg Tylenol® PM [OTC]: Acetaminophen 500 mg and diphenhydramine 25 mg
Liquid: Tylenol® PM [OTC]: Acetaminophen 500 mg and diphenhydramine 25 mg per 15 mL
Powder for oral solution: Goody's PM® [OTC]: Acetaminophen 500 mg and diphenhydramine 38 mg
Tablet: Acetaminophen 500 mg and diphenhydramine 25 mg Excedrin® P.M. [OTC]: Acetaminophen 500 mg and diphenhydramine 38 mg
GENERIC EQUIVALENT AVAILABLE — Yes: Excludes gelcap, powder, and liquid
USE — Aid in the relief of insomnia accompanied by minor pain
ADVERSE REACTIONS SIGNIFICANT — See individual agents.
DRUG INTERACTIONS Acetaminophen: Substrate (minor) of CYP1A2, 2A6, 2C9, 2D6, 2E1, 3A4; Inhibits CYP3A4 (weak)
Diphenhydramine: Inhibits CYP2D6 (moderate)
Also see individual agents.
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.
PHARMACODYNAMICS / KINETICS — See individual agents.
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