Fastel 120

Generic

Fexofenadine Hydrochloride

 

Indications

Fexofenadine Hydrochloride is intended for the treatment of symptoms associated with seasonal allergic rhinitis in adults and children. It is also approved for the treatment of simple cutaneous symptoms of chronic idiopathic urticaria.

 

Pharmacology

Fexofenadine Hydrochloride is an antihistamine with selective peripheral H1-receptor antagonistic activity.Fexofenadine is rapidly absorbed after oral doses with peak plasma concentrations 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 patients with renal impairment. Excretion is mainly in the faeces with only 10% being present
in the urine. Fexofenadine does not appear to cross the blood-brain barrier.

 

Dosage & Administration

Seasonal Allergic Rhinitis-

Adults and children 12 years and older:

• Tablet: 60 mg twice daily or 120 mg once daily or 180 mg once daily
• In case of impaired renal function: 60 mg once daily

Children from 6 to 11 years:

• Tablet: 30 mg twice daily or 60 mg once daily
• In case of impaired renal function: 30 mg once daily

Children from 2 to 11 years

• Suspension: 30 mg or 5 ml twice daily
• In case of impaired renal function: 30 mg or 5 ml once daily

Chronic Idiopathic Urticaria-

Adults and children 12 years and older:

• Tablet: 60 mg twice daily or 120 mg once daily or 180 mg once daily 
• In case of impaired renal function: 60 mg once daily

Children from 6 to 11 years:

• Tablet: 30 mg twice daily or 60 mg once daily
• In case of impaired renal function: 30 mg once daily

Children from 6 months to less than 2 years:

• Suspension: 15 mg or 2.5 ml (1/2 tsp) twice daily
• In case of impaired renal function: 15 mg or 2.5 ml (1/2 tsp) once daily

Children from 2 to 11 years:

• Suspension: 30 mg or 5 ml (1 tsp) twice daily
• In case of impaired renal function: 30 mg or 5 ml (1 tsp) once daily

 

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 grapesfruit may reduce the bioavailability of Fexofenadine and use together should be avoided. 

 

Contraindications

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

 

Side Effects

Headache, tiredness, sleepiness, nausea, dry mouth, and gastrointestinal problems are common adverse effects.

 

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. 

 

Precautions & Warnings

Patients over the age of 65 and those with impaired renal function should be treated with caution.

 

Therapeutic Class

Antihistamines that do not sedate

 

Storage Conditions

Store in a cool & dry place, protect from light & moisture. Keep out of reach of children.

 

Pharmaceutical Name

Radiant Pharmaceuticals Ltd.