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.
Showing posts with label Acetaminophen and phenyltoloxamine. Show all posts
Showing posts with label Acetaminophen and phenyltoloxamine. Show all posts
Monday, May 17, 2010
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.
Wednesday, January 16, 2008
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 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.
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