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
Related APIs
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Montelukast Sodium
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Cetirizine Dihydrochloride
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Desloratadine
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Fexofenadine Hydrochloride (Form 1)
Respiratory
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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.
Disclaimer
No information on this website, including any reference to any product or service constitutes an offer for sale or be construed as representing an offer for sale. Products protected under valid patents are not offered or supplied for commercial use. However, in certain cases, at Dr. Reddy's sole discretion, and subject to local legal requirement, the research quantities of such products may be offered for the purpose of regulatory submissions under Section 107A of the Indian Patent Act (Bolar exemption), wherever such regulatory exemptions exist. The buyers should make their independent evaluation of the product or service including, patent scenario in their respective markets and will be responsible for all patent related liabilities Dr. Reddy's disclaims all warranties, express or implied, including but not limited to warranties of merchantability, fitness for a particular purpose and non-infringement.