Xofedin 120mg

Tablet
Fexofenadine Hydrochloride
Amulet Pharmaceuticals

Other Strength:
- Xofedin 180mg

Alternative:
- Axodin 120mg
- Fexo® 120mg
- Vifas 120mg
- Xofast 120mg
- Fexoral 120mg
- Ritch 120mg
- Afexa 120mg
- Rynofex 120mg
- Alagra 120mg
- Axofen 120mg
- Fexon 120mg
- X-Din 120mg
- Alanil 120mg



Xofedin
DESCRIPTION:
XOFEDIN (Fexofenadine Hydrochloride) is a pharmacologically active metabolite of Terfenadine, is a non-sedating antihistamine with selective peripheral H1 receptor antagonist activity.
XOFEDIN (Fexofenadine Hydrochloride) is rapidly absorbed after oral doses with peak plasma concentrations being reached in 2-3 hours. It is about 60 to 70 % bound to plasma proteins. About 5% of the total doses are metabolized, mostly by the intestinal mucosa, with only 0.5 to 1.5% of the dose undergoing hepatic biotransformation by the cytochrome P450 system. Elimination half-life of 14 hours has been reported although this may be prolonged in patients with renal impairment. Excretion is mainly in the faeces with only 10% being present in the urine. Fexofenadine does not appear to cross the blood-brain barrier.

COMPOSITION:
XOFEDIN 120: Each film coated tablet contains Fexofenadine Hydrochloride BP 120 mg.
XOFEDIN 180: Each film coated tablet contains Fexofenadine Hydrochloride BP 180 mg.

INDICATION:
Seasonal Allergic Rhinitis: XOFEDIN Tablets are indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 6 years of age and older.
Chronic Idiopathic Urticaria: XOFEDIN Tablets are indicated for treatment of uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 years of age and older.
Fexofenadine Hydrochloride significantly reduces pruritus and the number of wheals.

DOSAGE & ADMINISTRATION:
Seasonal Allergic Rhinitis and Chronic Idiopathic Urticaria:
Adults and Children 12 Years and older: The recommended dose 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.
Children 6 to 11 Years: The recommended dose 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.

CONTRAINDICATIONS:
XOFEDIN is contraindicated in patients with known hypersensitivity to any of the ingredients.

PRECAUTIONS:
Studies in special risk groups (elderly, renally or hepatically impaired patients) indicate that it is not necessary to adjust the dose of Fexofenadine Hydrochloride in these patients.

USE IN PREGNANCY AND LACTATION:
There are no adequate and well controlled studies in pregnant women. Fexofenadine Hydrochloride should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known if Fexofenadine Hydrochloride is excreted in human milk. Caution should be exercised when Fexofenadine Hydrochloride is administered to a nursing woman.

DRUG INTERACTION:
Plasma concentrations of Fexofenadine Hydrochloride have been increased when given with Erythromycin or Ketoconazole. Antacid containing Aluminium and Magnesium Hydroxide reduces the absorption of Fexofenadine Hydrochloride. Fruit juices including grapefruit may reduce the bioavailability of Fexofenadine and use together should be avoided.

STORAGE:
Store in a cool, dry place, away from light. Keep out of the reach of children.

HOW SUPPLIED:
XOFEDIN 120: Box containing 3×10’s tablets in blister pack.
XOFEDIN 180: Box containing 3×10’s tablets in blister pack.

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