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Acetaminophen, Chlorpheniramine, and Pseudoephedrine
Acetaminophen, Chlorpheniramine, and Pseudoephedrine
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Pronunciation
(a seet a MIN oh fen, klor fen IR a meen, & soo doe e FED rin)
U.S. Brand Names
Actifed Cold and Sinus [OTC]; Alka-Seltzer Plus Cold Liqui-Gels [OTC]; Children's Tylenol Plus Cold [OTC]; Comtrex Maximum Strength Sinus and Nasal Decongestant [OTC]; Sinutab Sinus Allergy Maximum Strength [OTC]; Thera-Flu Cold and Sore Throat Night Time [OTC]; Tylenol Allergy Sinus [OTC]
Synonyms
Acetaminophen, Pseudoephedrine, and Chlorpheniramine; Chlorpheniramine, Acetaminophen, and Pseudoephedrine; Chlorpheniramine, Pseudoephedrine, and Acetaminophen; Pseudoephedrine, Acetaminophen, and Chlorpheniramine; Pseudoephedrine, Chlorpheniramine, and Acetaminophen
Generic Available
Yes
Canadian Brand Names
Sinutab Sinus & Allergy; Tylenol Allergy Sinus
Use
Temporary relief of sinus symptoms
Pregnancy Risk Factor
B
Adverse Reactions
See individual agents.
Drug Interactions
Acetaminophen: Substrate (minor) of CYP1A2, 2A6, 2C8/9, 2D6, 2E1, 3A4; Inhibits CYP3A4 (weak)
Chlorpheniramine: Substrate of CYP2D6 (minor), 3A4 (major); Inhibits CYP2D6 (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.
Pharmacodynamics/Kinetics
See individual agents.
Dosage
Oral: Analgesic: Based on acetaminophen component: Children: 10-15 mg/kg/dose every 4-6 hours as needed; do not exceed 5 doses in 24 hours Adults: 325-650 mg every 4-6 hours as needed; do not exceed 4 g/day Antihistamine: Based on chlorpheniramine maleate component: Children: 2-6 years: 1 mg every 4-6 hours (maximum: 6 mg/24 hours) 6-12 years: 2 mg every 4-6 hours (maximum: 12 mg/24 hours) Children >12 years and Adults: 4 mg every 4-6 hours (maximum: 24 mg/24 hours) Decongestant: Based on pseudoephedrine component: Children: 2-6 years: 15 mg every 4 hours (maximum: 90 mg/24 hours) 6-12 years: 30 mg every 4 hours (maximum: 180 mg/24 hours) Children >12 years and Adults: 60 mg every 4 hours (maximum: 360 mg/24 hours) Product labeling: Alka-Seltzer Plus Cold Medicine Liqui-Gels: Children 6-12 years: 1 softgel every 4 hours with water (maximum: 4 doses/24 hours) Children >12 years and Adults: 2 softgels every 4 hours with water (maximum: 4 doses/24 hours) Sinutab Sinus Allergy Maximum Strength: Children >12 years and Adults: 2 tablets/caplets every 6 hours (maximum: 8 doses/24 hours) Thera-Flu Cold and Sore Throat Night Time: Children >12 years and Adults: 1 packet dissolved in hot water every 6 hours (maximum: 4 packets/24 hours)
Dietary Considerations
Children's Tylenol Plus Cold contains phenylalanine 6 mg/tablet.
Thera-Flu Cold and Sore Throat Night Time contains phenylalanine 11 mg/packet.
Dental Health: Effects on Dental Treatment
Key adverse event(s) related to dental treatment: Chlorpheniramine: Significant xerostomia with prolonged use (normal salivary flow resumes upon discontinuation). Pseudoephedrine: Xerostomia (normal salivary flow resumes upon discontinuation).
Dental Health: Vasoconstrictor/Local Anesthetic Precautions
Use with caution since pseudoephedrine is a sympathomimetic amine which could interact with epinephrine to cause a pressor response
Mental Health: Effects on Mental Status
Sedation with chlorpheniramine is countered by the excitability associated with pseudoephedrine; one effect may predominate in any particular patient
Mental Health: Effects on Psychiatric Treatment
Usually none; sedative effect of chlorpheniramine may be potentiated by other CNS depressants and MAO inhibitors
Dosage Forms
Caplet (Actifed Cold and Sinus, Comtrex Maximum Strength Sinus and Nasal Decongestant, Sinutab Sinus Allergy Maximum Strength, Tylenol Allergy Sinus): Acetaminophen 500 mg, chlorpheniramine maleate 2 mg, and pseudoephedrine hydrochloride 30 mg
Capsule, softgel (Alka-Seltzer Plus Cold Liqui-Gels): Acetaminophen 325 mg, chlorpheniramine maleate 2 mg, and pseudoephedrine hydrochloride 30 mg
Gelcap (Tylenol Allergy Sinus): Acetaminophen 500 mg, chlorpheniramine maleate 2 mg, and pseudoephedrine hydrochloride 30 mg
Geltab (Tylenol Allergy Sinus): Acetaminophen 500 mg, chlorpheniramine maleate 2 mg, and pseudoephedrine hydrochloride 30 mg
Powder for oral solution [packet] (Thera-Flu Cold and Sore Throat Night Time): Acetaminophen 650 mg, chlorpheniramine maleate 4 mg, and pseudoephedrine hydrochloride 60 mg [contains phenylalanine 11 mg/packet; lemon flavor]
Suspension (Children's Tylenol Plus Cold): Acetaminophen 160 mg, chlorpheniramine maleate 1 mg, and pseudoephedrine hydrochloride 15 mg per 5 mL (120 mL) [contains sodium benzoate; grape flavor]
Tablet, chewable (Children's Tylenol Plus Cold): Acetaminophen 80 mg, chlorpheniramine maleate 0.5 mg, and pseudoephedrine hydrochloride 7.5 mg [contains phenylalanine 6 mg/tablet; grape flavor]
References
Barker JD Jr, de Carle DJ, and Anuras S, "Chronic Excessive Acetaminophen Use in Liver Damage,"Ann Intern Med, 1977, 87(3):299-301.
Dionne RA, Campbell RA, Cooper SA, et al, "Suppression of Postoperative Pain by Preoperative Administration of Ibuprofen in Comparison to Placebo, Acetaminophen, and Acetaminophen Plus Codeine,"J Clin Pharmacol, 1983, 23(1):37-43.
Licht H, Seeff LB, and Zimmerman HJ, "Apparent Potentiation of Acetaminophen Hepatotoxicity by Alcohol,"Ann Intern Med, 1980, 92(4):511.
Mokhlesi B, Leikin JB, Murray P, et al, "Adult Toxicology in Critical Care: Part II: Specific Poisonings,"Chest, 2003, 123(3):897-922.
International Brand Names
Sinutab Sinus & Allergy (CA); Tylenol Allergy Sinus (CA)
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