About Fexofenadine Hydrochloride (Form 1) API
Therapeutic CategoryRespiratório
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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Related Resources
Tech Sheet – Dr. Reddy’s Fexofenadine API offerings
Fexofenadine hydrochloride, the major active metabolite of terfenadine, is an antihistamine with selective peripheral H1-receptor antagonist activity. Fexofenadine Hydrochloride is indicated for:
- The relief of symptoms associated with seasonal allergic rhinitis in patients ≥ 2 years of age.
- To treat uncomplicated skin manifestations of chronic idiopathic urticaria in patients ≥ 6 months of age.
Dr. Reddy's is among the earliest generic API manufacturers globally to file the US DMF for Fexofenadine Hydrochloride API. In addition to the US DMF, considering the requirement of country-specific regulatory filings, we have diversified our DMFs with regulatory filling in countries such as Europe, Japan, Brazil, Australia, and New Zealand.
To know more about our API offerings, please read the technical sheet on Fexofenadine Hydrochloride by filling the contact from below.
FAQs
Do not take it with juice such as grapefruit, orange, or apple juice . And also should not take antacids that contain aluminum or magnesium hydroxide within 15 minutes of taking this medicine.
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Fexofenadine is a second generation antihistamine that is used for the treatment of allergic rhinitis, angioedema and chronic urticaria.
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Fexofenadine hydrochloride is a BCS class II drug having low bioavailability of 30-40% and a half life of 14 hours.
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Fexofenadine Hydrochloride have DMFs in the US, Brazil, CEP, Europe, Japan and Korea.
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Fexofendaine should be stored at 25ºC room temperature.
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Fexofenadine is available in oral capsule form with 30mg, 120mg and 180 mg strengths.
Aviso legal
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