Acetaminophen, Chlorpheniramine, and Pseudoephedrine


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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