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Ibuprofen/Chlorpheniramine/Pseudoephedrine

    Brands

    DEA Class; OTC

    Common Brand Names; Advil Allergy Sinus

    Antihistamine/Decongestant/Analgesic Combos

    Oral combination of an antihistamine, non-steroid anti-inflammatory drug (NSAID), and nasal decongestant
    Used for the treatment of symptoms due to the common cold or allergic rhinitis or other respiratory allergies
    May cause increased blood pressure and/or sedation; excitability may occur, especially in children

    For the treatment of symptoms due to the common cold or allergic rhinitis or other respiratory allergies, including mild pain, headache, fever, nasal congestion, rhinorrhea, sneezing, itching of the nose and throat, and itchy, watery eyes.

    Hypersensitivity

    Do not use immediately before or after heart surgery

    Do not use with MAO inhibitors or for 2 weeks after discontinuing MAO inhibitors because of risk for hypertensive crisis

    Drowsiness

    GI upset

    Insomnia

    Urinary retention

    Xerostomia

    Caution with hypertension, heart disease, hepatic or renal impairment, asthma, thyroid disease, diabetes, glaucoma, or BPH

    Ibuprofen

    • There are no adequate and well-controlled studies in pregnant women; data from observational studies regarding potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive

    Chlorpheniramine

    • Antihistamine exposure in first trimester not reported to be associated with increased risk of malformations; animal studies not reported; there are no controlled data in human pregnancy; only recommended for use during pregnancy when benefit outweighs risk

    Pseudoephedrine

    • Avoid, during first trimester; may be associated with possible risk of gastroschisis, small intestinal atresia, and hemifacial microsomia due to pseudoephedrine’s vasoconstrictive effects; magnitude of risk unknown

    • Fetal tachycardia reported following maternal use of extended-release formulation for multiple days

    Lactation

    Ibuprofen

    • No lactation studies have been conducted;

    Chlorpheniramine

    • Excretion into human milk; the manufacturer recommends that caution be used when administering chlorpheniramine to nursing women

    Pseudoephedrine

    • Excreted in breast milk; irritability reported in nursing infants (limited data); milk production may be decreased in some women

    Adults

    12 mg/day PO chlorpheniramine; 1,200 mg/day PO ibuprofen; 180 mg/day PO pseudoephedrine.

    Geriatric

    12 mg/day PO chlorpheniramine; 1,200 mg/day PO ibuprofen; 180 mg/day PO pseudoephedrine.

    Adolescents

    12 mg/day PO chlorpheniramine; 1,200 mg/day PO ibuprofen; 180 mg/day PO pseudoephedrine.

    Children

    12 years: 12 mg/day PO chlorpheniramine; 1,200 mg/day PO ibuprofen; 180 mg/day PO pseudoephedrine.
    1 to 11 years: Safety and efficacy have not been established.

    Infants

    Safety and efficacy have not been established.

    Neonates

    Safety and efficacy have not been established.

    ibuprofen/chlorpheniramine/pseudoephedrine

    Caplet

    • 200mg/2mg/30mg