Pseudoephedrine and Ibuprofen

Pronunciation

U.S. Brand Names

Advil® Cold, Children's [OTC]; Advil® Cold & Sinus [OTC]; Dristan® Sinus [OTC]; Motrin® Cold and Sinus [OTC]; Motrin® Cold, Children's [OTC]

Synonyms

Ibuprofen and Pseudoephedrine

Generic Available

Canadian Brand Names

Advil® Cold & Sinus; Dristan® Sinus; Sudafed® Sinus Advance

Use

For temporary relief of cold, sinus and flu symptoms (including nasal congestion, headache, sore throat, minor body aches and pains, and fever)

Pregnancy Risk Factor

Ibuprofen: B/D (3rd trimester)

Contraindications

Hypersensitivity to ibuprofen, pseudoephedrine, or any component of the formulation; hypersensitivity to aspirin or other NSAIDs; use with or within 2 weeks of discontinuing MAO inhibitor; pregnancy (3rd trimester)

Warnings/Precautions

Use caution with heart disease, high blood pressure, thyroid disease, diabetes, enlarged prostate, or GI disease (bleeding or ulcers). Use caution in patients consuming 3 or more alcoholic beverages per day; may increase risk of stomach bleeding. Prior to OTC use, patient should consult healthcare provider if taking any medications (prescription, OTC, herbal products). Patients should be instructed to contact their healthcare provider if symptoms have not improved or worsen. Combination product not recommended for OTC use in children who are not drinking fluids or have lost fluids due to continued nausea and vomiting; children <3 years for the treatment of sore throat with fever; children <2 years or <24 pounds (11 kg).

Adverse Reactions

See individual agents.

Drug Interactions

Ibuprofen: Substrate (minor) of CYP2C8/9, 2C19; Inhibits CYP2C8/9 (strong)

Also see individual agents.

Pharmacodynamics/Kinetics

See individual agents.

Dosage

OTC labeling: Oral:

Children: Ibuprofen 100 mg and pseudoephedrine 15 mg per 5 mL: May repeat dose every 6 hours (maximum: 4 doses/24 hours); dose should be based on weight when possible. Contact healthcare provider if symptoms have not improved within 3 days (2 days if treating sore throat accompanied by fever).

2-5 years or 11 to <22 kg (24-47 pounds): 5 mL

6-11 years or 22-43 kg (48-95 pounds): 10 mL

Children 12 years and Adults: Ibuprofen 200 mg and pseudoephedrine 30 mg per dose: One dose every 4-6 hours as needed; may increase to 2 doses if necessary (maximum: 6 doses/24 hours). Contact healthcare provider if symptoms have not improved within 7 days when treating cold symptoms or within 3 days when treating fever.

Patient Education

Prior to using, prescriber should be consulted for any medical conditions or are taking any medications including OTC, prescription or herbal products. Notify prescriber in case of dizziness, nervousness, sleeplessness, stomach pain or if symptoms do not improve or get worse. Unless instructed by prescriber, do not use in children <3 years for the treatment of sore throat with fever; or in children <2 years or <24 pounds (11 kg). Unless instructed by prescriber, do not use >7 days when treating adult cold symptoms or >3 days when treating adult fever. Unless instructed by prescriber, do not use for >3 days in children or >2 days in children when treating a sore throat accompanied by a fever. Pregnancy/breast-feeding precaution: Do not use during the third trimester of pregnancy; do not use any other time during pregnancy or if breast-feeding unless advised by prescriber.

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

Dizziness, drowsiness, nervousness, and insomnia are common; may rarely cause hallucinations, insomnia, confusion, or depression

Mental Health: Effects on Psychiatric Treatment

Contraindicated with MAO inhibitors; may rarely cause agranulocytosis; use caution with clozapine and carbamazepine; may decrease lithium clearance resulting in an increase in serum lithium levels and potential lithium toxicity; monitor serum lithium levels

Dosage Forms

Caplet:

Advil® Cold and Sinus, Dristan® Sinus: Pseudoephedrine hydrochloride 30 mg and ibuprofen 200 mg [contains sodium benzoate]

Motrin® Cold and Sinus: Pseudoephedrine hydrochloride 30 mg and ibuprofen 200 mg

Capsule, liquid filled (Advil® Cold and Sinus Liqui-gel®): Pseudoephedrine hydrochloride 30 mg and ibuprofen 200 mg [solubilized ibuprofen as free and potassium salt; contains coconut oil]

Suspension:

Advil® Cold, Children's: Pseudoephedrine hydrochloride 15 mg and ibuprofen 100 mg per 5 mL (120 mL) [alcohol free; contains sodium benzoate; grape flavor]

Motrin® Cold, Children's: Pseudoephedrine hydrochloride 15 mg and ibuprofen 100 mg per 5 mL (120 mL) [contains sodium benzoate; berry, dye free berry, and grape flavors]

Tablet (Advil® Cold and Sinus): Pseudoephedrine hydrochloride 30 mg and ibuprofen 200 mg [contains sodium benzoate]

International Brand Names

Advil® Cold & Sinus (CA); Dristan® Sinus (CA); Sudafed® Sinus Advance (CA)

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