Semprex-D (Acrivastine / Pseudoephedrine Hydrochloride) - Description

DESCRIPTION

SEMPREX-D Capsules (acrivastine and pseudoephedrine hydrochloride) are a fixed combination product formulated for oral administration. Acrivastine is an antihistamine and pseudoephedrine is a decongestant. Each capsule contains 8 mg acrivastine and 60 mg pseudoephedrine hydrochloride and the inactive ingredients: lactose, magnesium stearate and sodium starch glycolate. The green and white capsule shell consists of gelatin, D&C Yellow No. 10, FD&C Green No. 3, and titanium dioxide. The yellow band around the capsule consists of gelatin and D&C Yellow No. 10. The capsules may contain one or more parabens and are printed with edible black and white inks.

The chemical name of acrivastine is (E,E)-3-[6-[1-(4-methylphenyl)-3-(1-pyrrolidinyl)-1-propenyl]-2-pyridinyl]-2-propenoic acid; the molecular formula is C₂₂H₂₄N₂O₂. As an analog of triprolidine hydrochloride, acrivastine is classified as an alkylamine antihistamine. Acrivastine is an odorless, white to pale cream crystalline powder that is soluble in chloroform and alcohol and slightly soluble in water.

The chemical name of pseudoephedrine hydrochloride is [S-(R *, R *)]-α-[1- (methylamino)ethyl]benzenemethanol hydrochloride; the molecular formula is C₁₀H₁₅NO•HCl. Pseudoephedrine is one of the naturally occurring dextrorotatory diastereoisomers of ephedrine and is classified as an indirect sympathomimetic amine. Pseudoephedrine hydrochloride occurs as odorless, fine white to off-white crystals or powder; the drug is soluble in water, alcohol and chloroform.

Structural formulae for the active ingredients of SEMPREX-D Capsules are as follows: