FEXOFIN Tablet

Indications:

Fexofin 120mg tablets: Indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 12 years of age and older. Symptoms treated effectively include sneezing, rhinorrhea, itchy nose/palate/throat, itchy/watery/red eyes.

Fexofin 180mg tablets: indicated for the relief of symptoms associated with chronic idiopathic urticaria.

Dosage:

Fexofin 120mg tablet:

The recommended dose of Fexofin 120mg for adults & children aged 12 years and over is 120mg once daily.

Fexofin 180m tablet:

The recommended dose of Fexofin 180mg for adults & children aged 12 years and over is 180mg once daily.

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

In two separate studies, Fexofenadine Hydrochloride 120mg twice daily (twice the recommended dose) was co-administered with erythromycin 500mg every 8 hours or ketoconazole 400mg once daily under steady state conditions to normal, healthy volunteers (n=24, each study). No differences in adverse events or QTc interval were observed when subjects were administered Fexofenadine Hydrochloride alone or in combination with erythromycin or ketoconazole. Fexofenadine had no effect on the pharmacokinetics of erythromycin or ketoconazole.

Pregnancy: There are no adequate and well-controlled studies in pregnancy women Fexofenadine hydrochloride should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing mothers: There are no adequate and well-controlled studies in women during lactation. Because many drugs are excreted in human milk, caution should be exercised when fexofenadine hydrochloride is administered to a nursing woman.

Fexofenadine, a metabolite of terfenadine, is an antihistamine with selective peripheral H3-receptor antagonist activity. Fexofenadine inhibited antigen-induced brochospasm in sensitized guinea pigs and histamine release from peritoneal mast cells in rats. In laboratory animals, no anticholergic or alpha 1-adrenergic receptor 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.