RHINOGAN 120mg Tablet

Generic Name: Fexofenadine Hydrochloride
Registration Status: registered
Drug Type: ANTI-ALLERGY DRUGS
Principal: BEXIMCO PHARMACEUTICALS LIMITED

Description:
Fexofenadine hydrochloride is a non-sedating H1 antihistamine. Fexofenadine is a pharmacologically active metabolite of terfenadine. Human histamine wheal and flare studies following single and twice daily doses of fexofenadine hydrochloride demonstrate that the drug exhibits an antihistaminic effect beginning within one hour, achieving maximum at 6 hours and lasting 24 hours. There was no evidence of tolerance to these effects after 28 days of dosing. A positive dose-response relationship between doses of 10 mg to 130 mg taken orally was found to exist. In this model of antihistaminic activity, it was found that doses of at least 130 mg were required to achieve a consistent effect that was maintained over a 24 hour period. Maximum inhibition in skin wheal and flare areas were greater than 80%. Clinical studies conducted in allergic rhinitis have shown that a dose of 120 mg is sufficient for 24 hour efficacy. No significant differences in QTc intervals were observed in seasonal allergic rhinitis patients given fexofenadine hydrochloride up to 240 mg twice daily for 2 weeks when compared to placebo. Also, no significant change in QTc intervals was observed in healthy subjects given fexofenadine hydrochloride up to 60 mg twice daily for 6 months, 400 mg twice daily for 6.5 days and 240 mg once daily for 1 year, when compared to placebo. Fexofenadine at concentrations 32 times greater than the therapeutic concentration in man had no effect on the delayed rectifier K+ channel cloned from human heart. Fexofenadine hydrochloride (5-10 mg/kg po) inhibited antigen induced bronchospasm in sensitized guinea pigs and inhibited histamine release at supratherapeutic concentrations (10-100um) from peritoneal mast cells.