Allegra
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Legal Issues
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FDA Labeling Changes
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Uses
ALLEGRA is indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 2 years of age and older.
ALLEGRA is indicated for treatment of uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 months of age and older.
History
There is currently no drug history available for this drug.
Other Information
Fexofenadine hydrochloride, the active ingredient of ALLEGRA Tablets, ALLEGRA ODT and ALLEGRA Oral Suspension, is a histamine H1-receptor antagonist with the chemical name (±)-4-[1 hydroxy-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]-butyl]-α,α-dimethyl benzeneacetic acid hydrochloride. It has the following chemical structure
The molecular weight is 538.13 and the empirical formula is C32H39NO4•HCl.
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.
ALLEGRA is formulated as a tablet for oral administration. 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.
ALLEGRA ODT is formulated for rapid disintegration in the mouth immediately following administration. Each orally disintegrating tablet contains 30 mg fexofenadine hydrochloride and the following excipients: citric acid anhydrous, crospovidone, magnesium stearate, mannitol, methacrylate copolymer, microcrystalline cellulose, povidone K-30, sodium bicarbonate, sodium starch glycolate, aspartame, natural and artificial orange flavor, artificial cream flavor, and alcohol anhydrous; the alcohol is predominantly removed during the manufacturing process.
ALLEGRA Oral Suspension, a white uniform suspension, contains 6 mg fexofenadine hydrochloride per mL and the following excipients: polypropylene glycol, edetate disodium, propylparaben, butylparaben, xanthan gum, poloxamer 407, titanium dioxide, sodium phosphate monobasic monohydrate, sodium phosphate dibasic heptahydrate, artificial raspberry cream flavor, sucrose, xylitol and purified water.
Sources
Allegra Manufacturers
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Sanofi-synthelabo Limited
![Allegra (Fexofenadine Hydrochloride) Tablet, Film Coated [Sanofi-synthelabo Limited]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Allegra | Sanofi-synthelabo Limited
2.1 ALLEGRA tabletsSeasonal Allergic Rhinitis and Chronic Idiopathic Urticaria
Adults and Children 12 Years and Older. The recommended dose of ALLEGRA tablets is 60 mg twice daily or 180 mg once daily with water. A dose of 60 mg once daily is recommended as the starting dose in patients with decreased renal function [see CLINICAL PHARMACOLOGY).
Children 6 to 11 Years. The recommended dose of ALLEGRA tablets is 30 mg twice daily with water. A dose of 30 mg once daily is recommended as the starting dose in pediatric patients with decreased renal function (see CLINICAL PHARMACOLOGY).
2.2 ALLEGRA ODTSeasonal Allergic Rhinitis and Chronic Idiopathic Urticaria
Children 6 to 11 Years. ALLEGRA ODT is intended for use only in children 6 to 11 years of age. The recommended dose of ALLEGRA ODT is 30 mg twice daily. A dose of 30 mg once daily is recommended as the starting dose in pediatric patients with decreased renal function (see CLINICAL PHARMACOLOGY).
ALLEGRA ODT is designed to disintegrate on the tongue, followed by swallowing with or without water. ALLEGRA ODT should be taken on an empty stomach. ALLEGRA ODT is not intended to be chewed.
ALLEGRA ODT should not be removed from the original blister package until the time of administration.
2.3 ALLEGRA oral suspensionSeasonal Allergic Rhinitis
Children 2 to 11 Years : The recommended dose of ALLEGRA oral suspension is 30 mg twice daily. A dose of 30 mg (5 mL) once daily is recommended as the starting dose in pediatric patients with decreased renal function (see CLINICAL PHARMACOLOGY).
Shake bottle well before each use.
Chronic Idiopathic Urticaria
Children 6 Months to 11 years: The recommended dose of ALLEGRA oral suspension is 30 mg (5 mL) twice daily for patients 2 to 11 years of age and 15 mg (2.5 mL) twice daily for patients 6 months to less than 2 years of age. For pediatric patients with decreased renal function, the recommended starting doses of ALLEGRA oral suspension are 30 mg (5 mL) once daily for patients 2 to 11 years of age and 15 mg (2.5 mL), once daily for patients 6 months to less than 2 years of age (see CLINICAL PHARMACOLOGY).
Shake bottle well, before each use.
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Sanofi-aventis U.s. Llc
Allegra | Sanofi-aventis U.s. Llc
2.1 ALLEGRA tablets Seasonal Allergic Rhinitis and Chronic Idiopathic Urticaria Adults and Children 12 Years and OlderThe recommended dose of ALLEGRA tablets is 60 mg twice daily or 180 mg once daily with water. A dose of 60 mg once daily is recommended as the starting dose in patients with decreased renal function [see Clinical Pharmacology (12.3)].
Children 6 to 11 Years.The recommended dose of ALLEGRA tablets is 30 mg twice daily with water. A dose of 30 mg once daily is recommended as the starting dose in pediatric patients with decreased renal function [see Clinical Pharmacology (12.3)].
2.2 ALLEGRA ODT Seasonal Allergic Rhinitis and Chronic Idiopathic Urticaria Children 6 to 11 Years:ALLEGRA ODT is intended for use only in children 6 to 11 years of age. The recommended dose of ALLEGRA ODT is 30 mg twice daily. A dose of 30 mg once daily is recommended as the starting dose in pediatric patients with decreased renal function [see Clinical Pharmacology (12.3)].
ALLEGRA ODT is designed to disintegrate on the tongue, followed by swallowing with or without water. ALLEGRA ODT should be taken on an empty stomach. ALLEGRA ODT is not intended to be chewed.
ALLEGRA ODT should not be removed from the original blister package until the time of administration.
2.3 ALLEGRA oral suspension Seasonal Allergic Rhinitis Children 2 to 11 Years:The recommended dose of ALLEGRA oral suspension is 30 mg twice daily. A dose of 30 mg (5 mL) once daily is recommended as the starting dose in pediatric patients with decreased renal function [see Clinical Pharmacology (12.3)].
Shake bottle well, before each use.
Chronic Idiopathic Urticaria Children 6 Months to 11 Years:The recommended dose of ALLEGRA oral suspension is 30 mg (5 mL) twice daily for patients 2 to 11 years of age and 15 mg (2.5 mL) twice daily for patients 6 months to less than 2 years of age. For pediatric patients with decreased renal function, the recommended starting doses of ALLEGRA oral suspension are 30 mg (5 mL) once daily for patients 2 to 11 years of age and 15 mg (2.5 mL) once daily for patients 6 months to less than 2 years of age [see Clinical Pharmacology (12.3)].
Shake bottle well, before each use.
![Allegra (Fexofenadine Hydrochloride) Tablet, Orally Disintegrating Allegra (Fexofenadine Hydrochloride) Tablet, Film Coated Allegra (Fexofenadine Hydrochloride) Suspension [Sanofi-aventis U.s. Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=7c25b695-bbed-4ad1-aa47-de47091bc808&name=allegra-odt-02.jpg)
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