"The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has recommended restricting the use of codeine for cough and cold in children because there is a risk for serious adverse effects, including respiratory"...
(hydrocodone bitartrate and chlorpheniramine maleate) Oral Solution
Vituz Oral Solution contains hydrocodone bitartrate (a semisynthetic centrally-acting opioid antitussive) and chlorpheniramine maleate (an antihistamine).
Each 5 mL dose of Vituz Oral Solution contains: hydrocodone bitartrate, USP, 5 mg and chlorpheniramine maleate, USP, 4 mg.
Vituz Oral Solution also contains: citric acid anhydrous, glycerin, grape flavor, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sodium saccharin, and sucrose.
Hydrocodone bitartrate is morphinan-6-one, 4,5-epoxy-3-methoxy-17-methyl-, (5α)-, [R-(R*,R*)]2,3-dihydroxybutanedioate (1:1), hydrate (2:5); also known as 4,5α-Epoxy-3-methoxy-17methylmorphinan-6-one tartrate (1:1) hydrate (2:5); a fine white crystal or crystalline powder, which is derived from the opium alkaloid, thebaine; and may be represented by the following structural formula:
Chlorpheniramine maleate is 2-pyridinepropanamine, γ-(4-chlorophenyl)-N,N-dimethyl-,(Z)-2- butenedioate (1:1) and has the following chemical structure:
Last reviewed on RxList: 3/1/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Vituz Information
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