Alanil 180 mg Tablet

Alanil 180 mg Tablet

DESCRIPTION

Fexofenadine Hydrochloride is a selective histamine H1-receptor antagonist.

COMPOSITION

ALANIL 120 Tablet: Each film-coated tablet contains Fexofenadine Hydrochloride USP 120 mg.

ALANIL 180 Tablet: Each film-coated tablet contains Fexofenadine Hydrochloride USP 180 mg.

ALANIL 50 ml Suspension: Each 5 ml suspension contains Fexofenadine Hydrochloride USP 30 mg.

PHARMACOLOGY

Fexofenadine hydrochloride is an antihistamine with selective peripheral H1-receptor antagonist activity, which does not cross the blood-brain barrier. In laboratory animals, no anticholinergic, alpha1- adrenergic or beta-adrenergic-receptor blocking effects were observed. No sedative or other central nervous system effects were observed. It is rapidly absorbed following oral administration and 60% to 70% bound to plasma proteins. Approximately 5% of the total oral dose is metabolized. The mean elimination half-life of fexofenadine is 14.4 hours.

INDICATIONS

Seasonal Allergic Rhinitis ALANIL is indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children. Symptoms to treat effectively: sneezing, rhinorrhea, itchy nose/palate/throat, itchy/watery/red eyes. Chronic Idiopathic Urticaria ALANIL is indicated for treatment of uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children. ALANIL significantly reduces pruritus and the number of wheals.

DOSAGE AND ADMINISTRATION

Tablets Seasonal Allergic Rhinitis and Chronic Idiopathic Urticaria: Adults and Children 12 Years and Older: 120 mg or 180 mg tablet once daily.

Children 6 to 11 Years: 30 mg twice daily. Suspension Seasonal Allergic Rhinitis: Children 2 to 11 Years: 30 mg (5ml) twice daily. Chronic Idiopathic Urticaria: Children 2 to 11 Years: 30 mg (5 ml) twice daily. Children 6 Months to less than 2 Years: 15 mg (2.5 ml) twice daily.

USE IN RENAL IMPAIREMENT

In adult patients with decreased renal function a dose of 60 mg once daily is recommended as the starting dose. For pediatric patients with decreased renal function, the recommended starting dose of fexofenadine is 30 mg once daily for patients 2 to 11 years of age and 15 mg once daily for patients 6 months to less than 2 years of age.

OR AS DIRECTED BY THE PHYSICIAN.

SIDE EFFECTS

Side effects include headache, upper respiratory tract infection, back pain. Other rare side effects are hypotension, palpitation, arrhythmias, sleep disturbances, tremor, convulsions and hypersensitivity reactions.

CONTRAINDICATIONS

ALANIL is contraindicated in patients with known hypersensitivity to any of its ingredients.

USE IN PREGNANCY AND LACTATION

Pregnancy category: C. There are no adequate and well-controlled studies in pregnant women. ALANIL should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Lactation : It is not known if Fexofenadine is excreted in human milk. Caution should be exercised when Fexofenadine is administered to a nursing mother.

DRUG INTERACTIONS

Co-administration of fexofenadine hydrochloride with ketoconazole and erythromycin led to increased plasma levels of fexofenadine hydrochloride. Fexofenadine hydrochloride should not be taken closely in time with aluminum and magnesium containing antacids.

SUPPLY

ALANIL 120 Tablet: Each box contains 3X10 tablets in blister strips.

ALANIL 180 Tablet: Each box contains 3X10 tablets in blister strips.

ALANIL 50 ml Suspension: Each carton contains 50 ml suspension in

glass bottle with a 5 ml calibrated dropper and measuring cup