Acetaminophen and Pseudoephedrine

Pronunciation

(a seet a MIN oh fen & soo doe e FED rin)

U.S. Brand Names

Alka-Seltzer Plus® Cold and Sinus Liqui-Gels [OTC]; Cetafen Cold® [OTC]; Genapap™ Sinus Maximum Strength [OTC]; Mapap Sinus Maximum Strength [OTC]; Medi-Synal [OTC]; Ornex® [OTC]; Ornex® Maximum Strength [OTC]; Sinus-Relief® [OTC]; Sinutab® Sinus [OTC]; Sudafed® Sinus and Cold [OTC]; Sudafed® Sinus Headache [OTC]; SudoGest Sinus [OTC]; Tylenol® Cold, Infants [OTC]; Tylenol® Sinus, Children's [OTC]; Tylenol® Sinus Day Non-Drowsy [OTC]

Synonyms

Pseudoephedrine and Acetaminophen

Generic Available

Yes

Canadian Brand Names

Dristan® N.D.; Dristan® N.D., Extra Strength; Sinutab® Non Drowsy; Sudafed® Head Cold and Sinus Extra Strength; Tylenol® Decongestant; Tylenol® Sinus

Use

Relief of mild to moderate pain; relief of congestion

Adverse Reactions

See individual agents.

Drug Interactions

Acetaminophen: Substrate (minor) of CYP1A2, 2A6, 2C8/9, 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.

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

Decongestant: Based on pseudoephedrine component:

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: 60 mg every 4 hours; do not exceed 360 mg/day

Product labeling:

Alka-Seltzer Plus® Cold and Sinus:

Children 6-12 years: 1 dose with water every 4 hours (maximum: 4 doses/24 hours)

Adults: 2 doses with water every 4 hours (maximum: 4 doses/24 hours)

Children's Tylenol® Sinus: Children:

Liquid:

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)

Tablet, chewable:

2-5 years (24-47 lb): 2 tablets every 4-6 hours (maximum: 4 doses/24 hours)

6-11 years (48-95 lb): 4 tablets every 4-6 hours (maximum: 4 doses/24 hours)

Sinutab® Sinus: Children >12 years and Adults: 2 doses every 6 hours (maximum: 8 doses/24 hours)

Patient Education

If you consume 3 or more alcoholic drinks per day, ask your prescriber whether you should take acetaminophen, other pain relievers, or fever reducers. Acetaminophen may cause liver damage. Do not exceed recommended dosage.

Cardiovascular Considerations

Sympathomimetic or sympathomimetic-containing combination products may increase blood pressure. These preparations are relatively contraindicated in patients with significant hypertension, particularly in poorly controlled hypertension. In young, healthy patients presenting with new onset blood pressure elevations, it is important to exclude the recent use of sympathomimetics as a cause for the blood pressure elevation.

Dental Health: Effects on Dental Treatment

Key adverse event(s) related to dental treatment: 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

Anxiety, insomnia, excitability common; hallucination may be seen rarely

Mental Health: Effects on Psychiatric Treatment

Hypertensive crisis may result with MAO inhibitor, effects of CNS depressants may be lessened

Dosage Forms

Caplet:

Ornex®: Acetaminophen 325 mg and pseudoephedrine hydrochloride 30 mg

Genapap™ Sinus Maximum Strength, Mapap Sinus Maximum Strength, Ornex® Maximum Strength, Sudafed® Sinus Headache, Tylenol® Sinus Day Non-Drowsy: Acetaminophen 500 mg and pseudoephedrine hydrochloride 30 mg

Capsule, liquid (Alka-Seltzer Plus® Cold and Sinus, Sudafed® Sinus and Cold): Acetaminophen 325 mg and pseudoephedrine hydrochloride 30 mg

Gelcap (Tylenol® Sinus Day Non-Drowsy): Acetaminophen 500 mg and pseudoephedrine hydrochloride 30 mg

Geltab (Mapap Sinus Maximum Strength, Tylenol® Sinus Day Non-Drowsy): Acetaminophen 500 mg and pseudoephedrine hydrochloride 30 mg

Liquid, oral drops (Infants Tylenol® Cold): Acetaminophen 80 mg/0.8 mL and pseudoephedrine 7.5 mg/0.8 mL [contains sodium benzoate; bubble gum flavor]

Suspension (Children's Tylenol® Sinus): Acetaminophen 160 mg and pseudoephedrine hydrochloride 15 mg/5 mL [contains sodium benzoate; fruit flavor]

Tablet:

Cetafen Cold®, Medi-Synal, Sinus-Relief: Acetaminophen 325 mg and pseudoephedrine hydrochloride 30 mg

Sinutab® Sinus, Sudafed® Sinus Headache, SudoGest Sinus: Acetaminophen 500 mg and pseudoephedrine hydrochloride 30 mg

References

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

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)

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