Prescription Required: Registered Medical Practitioner's prescription is required to purchase this product.

Human

Fexoral

Tablet

120 mg

GENERIC NAMEFexofenadine Hydrochloride

MANUFACTURED BYPopular Pharmaceuticals PLC

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Available Pack Sizes:3 Sizes

Purchase Option:Full Pack

Maximum Retail Price (MRP):

Quantity

৳ 81.00/ 10 x 5

(Unit: ৳ 9.00 / 1 Tablet)

16263

Composition

Fexoral 120 Tablet: Each film coated tablet contains 120 mg Fexofenadine Hydrochloride USP.

Fexoral 180 Tablet: Each film coated tablet contains 180 mg Fexofenadine Hydrochloride USP.

Fexoral Suspension: Each 5 ml suspension contains 30 mg Fexofenadine Hydrochloride USP.

Description

Fexofenadine is a pharmacologically active metabolite of Terfenadine, is a non-sedating antihistamine with selective peripheral H₁ receptor antagonist activity. Fexofenadine is rapidly absorbed into the body following oral administration with peak concentration being reached in 2-3 hours. It is about 60% to 70% bound to plasma proteins. About 5% of the total doses is metabolized, mostly by the intestinal mucosa, with only 0.5% to 1.5% of the dose undergoing hepatic biotransformation by the cyto-chrome P450 system. Elimination half-life of 14 hours has been reported although this may be prolonged in patient with renal impairment. Excretion is mainly in the feces with only 10% being present in the urine. Fexofenadine does not appear to cross the blood-brain barrier.

Indications

Seasonal Allergic Rhinitis:

Fexoral tablets are indicated for the relief of symptoms associated with seasonal allergic rhinitis in adult and children of 6 years of age and older.

Fexoral oral suspension is indicated for the relief of symptoms associated with seasonal allergic rhinitis in children of 2 to 11 years of age. Symptom to treat effectively: sneezing, rhinorrhea, itchy nose/palate/throat, itchy/watery/red eyes.

Chronic Idiopathic Urticaria:

Fexoral tablets are indicated for treatment of uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children of 6 years of age and older. Fexoral Oral Suspension is indicated.

for treatment of uncomplicated skin manifestation of chronic idiopathic urticaria in children of 6 months to 11 years of age. Fexofenadine Hydrochloride significantly reduces pruritus and the number of wheals.

Dosage & Administration

For Tablet:

Seasonal Allergic Rhinitis and Chronic Idiopathic Urticaria: Adults and children of 12 Years and older: The recommended dose is 60 mg twice daily or 120 mg once daily or 180 mg once daily with water. A dose of 60 mg once daily is recommended as the starting dose in patients with decreased renal function.

For oral Suspension:

Seasonal Allergic Rhinitis: Children 2 to 11 Years: The recommended dose of oral suspension is 30 mg twice daily. A dose of 30 mg (5 ml) once daily is recommended as the starting dose in pediatric patients with decreased renal function. Shake bottle well, before each use.

Chronic Idiopathic Urticaria: Children 6 months to 11 years: The recommended dose of oral suspension is 30 mg (5 ml) twice daily for patients 2 to 11 years of age and 15 mg (2.5 ml) twice daily for patients 6 months to less than 2 years of age. For pediatric patients with decreased renal function, the recommended starting doses of oral suspension are 30 mg (5 ml) once daily for patients 2 to 11 years of age and 15 mg (2.5 ml) once daily for patients 6 months to less than 2 years of age. Shake bottle well, before each use.

*Prescription only*

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. Fruit juices including grapefruit may reduce the bioavailability of Fexofenadine and use together should be avoided.

Contraindications

Fexofenadine is contraindicated in patients with a known hypersensitivity to Fexofenadine or any of its ingredients.

Side Effects

Fexofenadine is generally well tolerated.

In placebo controlled clinical trials involving seasonal allergic rhinitis and chronic idiopathic urticaria the most commonly reported adverse events were headache (>3%), drowsiness, nausea, fatigue and dizziness (1-3%).

The incidence of these events observed with Fexofenadine Hydrochloride was similar to that observed with placebo and no apparent dose trends were revealed in adverse events.

Adverse events reported in placebo-controlled chronic idiopathic urticaria studies were similar to those reported in placebo-controlled seasonal allergic rhinitis studies.

In placebo controlled trials involving pediatric patients (6-11 years of age), adverse events were similar to those observed in trials involving patients 12 years and older, with incidences similar to placebo.

In controlled clinical trials involving pediatric patients 6 months to 5 years of age, there were no unexpected adverse events in patients treated with Fexofenadine Hydrochloride.

Pregnancy & Lactation

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. It is not known whether Fexofenadine is excreted in human milk or not. Caution should be exercised when Fexofenadine is administered to a nursing woman.

Overdose**.

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 BID for 1 month or 240 mg QID for 1 year were studied in healthy subjects without the development of clinically significant adverse events as compared to placebo.

Storage Conditions

Store at below 30°C in a dry place, protected from light. Keep out of reach of children.

Fexoral • 10 x 5

৳ 81.00