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]; GenapapT 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

GenapapT 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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