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)
|
A.D.A.M., Inc. is accredited by URAC, also known as the American Accreditation HealthCare Commission (www.urac.org). URAC's
accreditation program
is the first of its kind, requiring compliance with 53 standards of quality and accountability, verified by independent audit. A.D.A.M. is among the first to achieve this important distinction for online health information and services. Learn more about A.D.A.M.'s
editorial process
. A.D.A.M. is also a founding member of Hi-Ethics (www.hiethics.com) and subscribes to the principles of the Health on the Net Foundation (www.hon.ch).
|
The information provided herein should not be used during any medical emergency or for the diagnosis or treatment of any medical condition. A licensed medical professional should be consulted for diagnosis and treatment of any and all medical conditions. Call 911 for all medical emergencies. Links to other sites are provided for information only -- they do not constitute endorsements of those other sites. © 1997-2007
A.D.A.M., Inc. Any duplication or distribution of the information contained herein is strictly prohibited.
