Ritch 120

Generic

Fexofenadine Hydrochloride

Indications

Ritch® is indicated for relief of symptoms associated with seasonal allergic rhinitis such as sneezing, rhinorrhea, pruritus and lacrimation Perennial allergic rhinitis Urticaria.

Pharmacology

Fexofenadine Hydrochloride is an antihistamine that works by blocking peripheral H1 receptors. After oral administration, it is rapidly absorbed and reaches maximal plasma concentration in 2-3 hours. It doesn't appear to be able to pass through 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

Contraindications

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

Side Effects

Fexofenadine is generally well tolerated. The most common side effects are headache, fatigue, dizziness or drowsiness and nausea. In rare cases, rash, urticaria, pruritus and hypersensitivity reactions such as angioedema, dyspnoea, chest tightness, flushing and systemic anaphylaxis have been reported.

Pregnancy and Lactation

Fexofenadine is pregnancy category B2. There are no adequate and well controlled studies in pregnant women exposed to Fexofenadine alone or through the administration of Terfenadine. Fexofenadine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. 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.

Precautions & Warnings

Studies in the elderly, patients with hepatic impairment and patients with cardiac disease exposed to Fexofenadine through administration of Terfenadine showed no statistically significant differences in pharmacokinetic parameters for Fexofenadine when compares to those pharmacokinetic parameters in healthy individuals. There is only limited data in the elderly and renally or hepatically impaired patients. Fexofenadine should be administered with care in these special groups. Fexofenadine causes drowsiness less than other antihistamines; therefore caution should be advised during drive or operate potentially dangerous machinery.

Therapeutic Class

Non-sedating antihistamines

Storage conditions

Store in a cool and dry place. Protect from light. Keep away from the reach of children.

Pharmaceutical Name

ACI Limited