Classes
DEA Class; OTC
Common Brand Names; Advil Allergy Sinus
Antihistamine/Decongestant/Analgesic Combos
Description
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
Indications
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.
Contraindications
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
Adverse Effects
Drowsiness
GI upset
Insomnia
Urinary retention
Xerostomia
Warnings
Caution with hypertension, heart disease, hepatic or renal impairment, asthma, thyroid disease, diabetes, glaucoma, or BPH
Pregnancy and Lactation
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
Maximum Dosage
12 mg/day PO chlorpheniramine; 1,200 mg/day PO ibuprofen; 180 mg/day PO pseudoephedrine.
12 mg/day PO chlorpheniramine; 1,200 mg/day PO ibuprofen; 180 mg/day PO pseudoephedrine.
12 mg/day PO chlorpheniramine; 1,200 mg/day PO ibuprofen; 180 mg/day PO pseudoephedrine.
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.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
ibuprofen/chlorpheniramine/pseudoephedrine
Caplet
- 200mg/2mg/30mg
