About Fexofenadine Hydrochloride (Form 1) API
Therapeutic CategoryRespiratory

CAS Number
138452-21-8
API Technology
Synthetic
Dose Form
Oral Solid/Tablets
Dr Reddy's Development Status
Available
Available Regulatory Filing
USDMF, CEP Submitted, Brazil DMF, EUDMF, Japan DMF, Korea DMF
Mechanism of Action
Fexofenadine hydrochloride, the major active metabolite of terfenadine, is an antihistamine with selective H1-receptor antagonist activity. Both enantiomers of fexofenadine hydrochloride displayed approximately equipotent antihistaminic effects. Fexofenadine hydrochloride inhibited antigen-induced bronchospasm in sensitized guinea pigs and histamine release from peritoneal mast cells in rats. The clinical significance of these findings is unknown. In laboratory animals, no anticholinergic or alpha1-adrenergic blocking effects were observed. Moreover, no sedative or other central nervous system effects were observed. Radiolabeled tissue distribution studies in rats indicated that fexofenadine does not cross the blood-brain barrier.
Indication
ALLEGRA is an H1-receptor antagonist indicated for:
- Relief of symptoms associated with seasonal allergic rhinitis in patients ≥ 2 years of age
- Treatment of uncomplicated skin manifestations of chronic idiopathic urticaria in patients ≥ 6 months of age
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