Fixal Oral Suspension 50ml

It is indicated for the relief of symptoms associated with seasonal and perennial allergic rhinitis and chronic idiopathic urticaria.

Non-sedating antihistamines

 

Pharmacology

Fexofenadine Hydrochloride is an antihistamine with selective peripheral H1 receptor antagonist activity. It inhibits histamine release from peritoneal mast cells. No anticholinergic, α-1 adrenergic or β-adrenergic receptor blocking effects has been observed. No sedative or other central nervous system effect has been observed. It does not appear to cross the blood brain barrier.

Fexofenadine is rapidly absorbed after oral administration with peak plasma concentration being reached in 2-3 hours. Elimination half-life of about 14 hours has been reported although this may be prolonged in patients with renal impairment.

Adults-

• Allergic rhinitis: 120 mg once daily or 60 mg twice daily
• Urticaria: 180 mg once daily

Children-

• 2-11 years: 30 mg (1 spoonful) or 5 ml twice daily
• 6 months-2 years: 15 mg (1/2 spoonful) or 2.5 ml twice daily

In case of decreased renal function, care should be taken in dose selection and it may be useful to monitor renal function.

Co-administration of Fexofenadine Hydrochloride with either ketoconazole or erythromycin may cause increased plasma concentration of Fexofenadine. Antacid containing Aluminium and Magnesium may reduce the absorption of Fexofenadine. Fruit juices such as grapefruit, orange and apple may reduce the bioavailability of Fexofenadine.

Fexofenadine is contraindicated in patients with known hypersensitivity to Fexofenadine or any of the ingredients of this preparation.

Fexofenadine is generally well tolerated. The most commonly reported adverse events are headache, drowsiness, nausea, and dizziness. The incidence of these events observed with Fexofenadine hydrochloride was similar to that observed with placebo.

Pregnancy Category B. There are no adequate and well controlled studies in pregnant women. Fexofenadine 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. Because many drugs are excreted in human milk, caution should be exercised when Fexofenadine is administered to a nursing woman.

Studies in the elderly, patients with hepatic impairment and patients with cardiac disease exposed to Fexofenadine showed no statistically significant differences compared to healthy individuals. 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.

In case of an overdose, standard measures to remove any unabsorbed drug should be employed. Symptomatic and supportive treatment is recommended. There has been no reported case of an acute overdose of Fexofenadine hydrochloride.

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.

Store Fexofenadine at controlled room temperature 20-25 °C. Keep all medicines away from reach of children.