Fenafex

Fenafex ® 120 mg Tablet: Each film-coated tablet contains Fexofenadine Hydrochloride USP 120 mg.

Fenafex ® 50 ml Suspension: Each 5 ml suspension contains Fexofenadine Hydrochloride USP 30 mg.

Fenafex ® tablet is a presentation of Fexofenadine Hydrochloride USP. Fexofenadine Hydrochloride USP is the synthetic hydrochloride salt of Fexofenadine, the carboxylic acid metabolite of terfenadine. It is an orally active non-sedating H1-receptor antagonist and is effective for the relief of symptoms associated with seasonal allergic rhinitis (sneezing, rhinorrhea, pruritus and lacrimation).

Seasonal Allergic Rhinitis: Fenafex ® is indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 6 years of age and older. Symptoms treated effectively were sneezing, rhinorrhea, itchy nose/palate/throat, itchy/watery/red eyes.

Chronic Idiopathic Urticaria: Fenafex ® is indicated for treatment of uncomplicated skin manifestations of Chronic Idiopathic Urticaria in adults and children 6 years of age and older. It significantly reduces pruritus and the number of wheals.

Perennial Allergic Rhinitis: Relief of symptoms associated with Perennial Allergic Rhinitis. Fexofenadine hydrochloride significantly reduces pruritus and the number of wheals.

Tablet

Perennial Allergic Rhinitis

Adults and children aged 12 years and older

The recommended dose of Fexofenadine is 60 mg twice daily as required up to a maximum 120 mg once daily, or 180 mg once daily. 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 of Fexofenadine is 30 mg twice daily. A dose of 30 mg once daily is recommended as the starting dose in pediatric patients with decreased renal function.

Seasonal Allergic Rhinitis

Adults and Children 12 years and older

The recommended dose of Fexofenadine is 60 mg twice daily or as required up to a maximum 120 mg once daily or 180 mg once daily. 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 of Fexofenadine is 30 mg twice daily. A dose of 30 mg once daily is recommended as the starting dose in pediatric patients with decreased renal function.

Chronic Idiopathic Urticaria

Adults and Children 12 years and older

The recommended dose of Fexofenadine is 180 mg once daily. 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 of Fexofenadine is 30 mg twice daily. A dose of 30 mg once daily is recommended as the starting dose in pediatric patients with decreased renal function.

Suspension

Adults and children 12 years and older

60 mg/10 ml twice daily or 120 mg/20 ml once daily or 180 mg/30 ml once daily. 60 mg once

daily is recommended as the starting dose

Children 6-11 years

30 mg/5 ml twice daily. 30 mg/5 ml once daily is recommended.

Children 2-5 years

30 mg/5 ml twice daily. 30 mg/5 ml once daily is recommended.

Children 6 months to less than 2 years

15 mg/2.5 ml twice daily. 15 mg/2.5 ml once daily is recommended.

Fexofenadine is generally well tolerated. In placebo controlled clinical trials the most commonly reported adverse events were headache (>3%), drowsiness, nausea, and dizziness (1-3%). The incidence of these events observed with Fexofenadine hydrochloride was similar to that observed with placebo.  

Co-administration of Fexofenadine hydrochloride with ketoconazole and erythromycin increased plasma levels of Fexofenadine hydrochloride. Fexofenadine hydrochloride had no effect on the pharmacokinetics of erythromycin and ketoconazole. Fexofenadine should not be taken closely in time with aluminum and magnesium containing antacids.

No clinically relevant adverse events have been reported. However in the event of overdosage, symptomatic and supportive treatment is recommended.  Most reports of Fexofenadine hydrochloride overdose contain limited information. However, dizziness, drowsiness and dry mouth have been reported. Single doses up to 800 mg and doses up to 690 mg twice daily for 1 month were studied in healthy subjects without the development of clinically significant adverse events.

Store in a cool and dry place below 30º C. Keep the product away from light.

Fenafex ® 120 mg Tablet: Each box contains 3X10’s tablets in Alu-PVC blister strips.

Fenafex ® 50 ml Suspension: Each bottle contains 50 ml suspension.