Allegra

[Fexofenadine]

Drug Description
DESCRIPTION

Fexofenadine hydrochloride, the active ingredient of ALLEGRA, is a histamine H1-receptor antagonist with the chemical name (±)-4-[1 hydroxy-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]-butyl]- , -dimethyl benzeneacetic acid hydrochloride. It has the following chemical structure The molecular weight is 538.13 and the empirical formula is C32H39NO4oHCl.

Fexofenadine hydrochloride is a white to off-white crystalline powder. It is freely soluble in methanol and ethanol, slightly soluble in chloroform and water, and insoluble in hexane. Fexofenadine hydrochloride is a racemate and exists as a zwitterion in aqueous media at physiological pH.

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ALLEGRA is formulated as a capsule or tablet for oral administration. Each capsule contains 60 mg fexofenadine hydrochloride and the following excipients: croscarmellose sodium, gelatin, lactose, microcrystalline cellulose, and pregelatinized starch.

The printed capsule shell is made from gelatin, iron oxide, silicon dioxide, sodium lauryl sulfate, titanium dioxide, and other ingredients. Each tablet contains 30, 60, or 180 mg fexofenadine hydrochloride (depending on the dosage strength) and the following excipients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose, and pregelatinized starch.

The aqueous tablet film coating is made from hypromellose, iron oxide blends, polyethylene glycol, povidone, silicone dioxide, and titanium dioxide.