Drug Class Description
Antihistamines, non-sedating (piperidine type).

Generic Name
Fexofenadine

Drug Description
Each tablet contains 180 mg of fexofenadine hydrochloride, which is equivalent to 168 mg of fexofenadine

Presentation
Film coated tablets.Peach, capsule-shaped, debossed, film-coated tablet.

Indications
Relief of symptoms associated with chronic idiopathic urticaria.

Adult Dosage
Adults The recommended dose of fexofenadine hydrochloride for adults and children aged 12 years and over is 180 mg once daily taken before a meal.Fexofenadine is a pharmacologically active metabolite of terfenadine.

Child Dosage
Children under 12 years of ageThe efficacy and safety of fexofenadine hydrochloride has not been studied in children under 12.

Elderly Dosage
Special risk groupsStudies 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.

Contra Indications
Hypersensitivity to the active substance or to any of the excipients.

Special Precautions
As with most new drugs 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.Patients with a history of or ongoing cardiovascular disease should be warned that, antihistamines as a drug class, have been associated with the adverse events, tachycardia and palpitations

Interactions
Fexofenadine does not undergo hepatic biotransformation and therefore will not interact with other drugs through hepatic mechanisms. Coadministration of fexofenadine hydrochloride with erythromycin or ketoconazole has been found to result in a 2-3 times increase in the level of fexofenadine in plasma. The changes were not accompanied by any effects on the QT interval and were not associated with any increase in adverse events compared to the drugs given singly.Animal studies have shown that the increase in plasma levels of fexofenadine observed after coadministration of erythromycin or ketoconazole, appears to be due to an increase in gastrointestinal absorption and either a decrease in biliary excretion or gastrointestinal secretion, respectively.No interaction between fexofenadine and omeprazole was observed. However, the administration of an antacid containing aluminium and magnesium hydroxide gels 15 minutes prior to fexofenadine hydrochloride caused a reduction in bioavailability, most likely due to binding in the gastrointestinal tract. It is advisable to leave 2 hours between administration of fexofenadine hydrochloride and aluminium and magnesium hydroxide containing antacids.

Adverse Reactions
In controlled clinical trials the most commonly reported adverse events were headache (7.3%), drowsiness (2.3%), nausea (1.5%) and dizziness (1.5%). The incidence of these events observed with fexofenadine was similar to that observed with placebo.Events that have been reported with incidences less than 1% and similar to placebo in controlled trials and have also been reported rarely during postmarketing surveillance include: fatigue, insomnia, nervousness and sleep disorders or paroniria, such as nightmares, and tachycardia, palpitations, diarrhoea. In rare cases, rash, urticaria, pruritus, and hypersensitivity reactions with manifestations such as angioedema, chest tightness, dyspnea, flushing and systemic anaphylaxis have also been reported.

Manufacturer
sanofi-aventis

Drug Availability
(POM)

Updated
23 June 2009