Composition
Fenox tablet: Each film coated tablet contains Fexofenadine Hydrochloride USP 120 mg.
Pharmacology
Fexofenadine Hydrochloride is an antihistamine with selective peripheral H1-receptor antagonist activity. This leads to relief of the allergic symptoms. Unlike most other antihistamines, Fexofenadine does not cross Blood Brain Barrier, and therefore, does not cause drowsiness.
Indication
• Seasonal Allergic Rhinitis • Chronic Idiopathic Urticaria
Dosage & administration
Seasonal Allergic Rhinitis and Chronic Idiopathic Urticaria: Adults and Children > 12 years: 60 mg (1/2 tablet) twice daily or 120 mg (1 tablet) once daily or 180 mg (1.5 tablet) once daily. Children 6 to 11 years: 30 mg twice daily.
Contra-indication
Fexofenadine is contraindicated in patients with known hypersensitivity to any of the ingredients.
Warning & precaution
As with most new medicinal products there is only limited data in the elderly and renally or hepatically impaired patients. Fexofenadine hydrochloride should be administered with care in these special groups.
Side effects
Fexofenadine is generally well tolerated. The most commonly reported adverse events are headache, nausea and dizziness.
Use in pregnancy & lactation
There is no adequate and well controlled study in pregnant women. Fexofenadine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Caution should be exercised when Fexofenadine is administered to a nursing woman.
Use in children & adolescents
The efficacy and safety of fexofenadine hydrochloride 120 mg has not been studied in children under 12 years.
The recommended dose of fexofenadine hydrochloride for adolescents aged 12 years and over is 120 mg once daily taken before a meal.
Drug interaction
Plasma concentrations of Fexofenadine have been increased when given with Erythromycin or Ketoconazole. Antacid containing Aluminium and Magnesium Hydroxide reduces the absorption of Fexofenadine.
Overdose
Dizziness, drowsiness, fatigue and dry mouth have been reported with overdose of fexofenadine hydrochloride. The maximum tolerated dose of fexofenadine hydrochloride has not been established.
Standard measures should be considered to remove any unabsorbed medicinal product.
Storage
Keep out of the reach of children. Keep below 30°C, protect from light.
Packing
Fenox tablet: Each box contains 3x10's tablet in blister pack.
