Ritch^®

Ritch is a preparation of Fexofenadine Hydrochloride which is an antihistamine with selective peripheral H1-receptor antagonist 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 cytochrome 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 feces with only 10% being present in the urine. Fexofenadine does not appear to cross the blood-brain barrier.

No Data

Seasonal allergic rhinitis
Ritch tablets are indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children of 6 years of age and older. Ritch suspension is indicated for the relief of symptoms associated with seasonal allergic rhinitis in children of 2 to 11 years of age. Symptoms to treat effectively like sneezing, rhinorrhea, itchy palate and throat and watery or red eyes.

Chronic idiopathic urticaria
Ritch tablets are indicated for treatment of uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children of 6 years of age and older. Ritch suspension is indicated for treatment of uncomplicated skin manifestations of chronic idiopathic urticaria in children of 6 months to 11 years of age. It also significantly reduces pruritus and number of wheals.

Route of administration: Ritch tablet, ODT and suspension should be taken orally.

Ritch tablet
Seasonal allergic rhinitis and chronic idiopathic urticaria
Adults and children of 12 years and older: The recommended dose of Ritch 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.

Children of 6 to 11 years: The recommended dose of Ritch 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.

Ritch ODT (orodispersible tablet)
Children aged 6 to 11 years
Seasonal allergic rhinitis and chronic idiopathic urticaria: Ritch 30 ODT twice daily. A dose of 30 mg daily is recommended as the starting dose in pediatric patients with decreased renal function. Ritch 30 ODT is designed to disintegrate on the tongue, followed by swallowing with or without water. Ritch 30 ODT should be taken on an empty stomach.

Ritch suspension
Seasonal allergic rhinitis
Children of 2 to 11 years: The recommended dose of Ritch suspension is 30 mg (5 ml) twice daily. A dose of 30 mg (5 ml) once daily is recommended as the starting dose in pediatric patients with decreased renal function.

Chronic idiopathic urticaria
Children of 2 to 11 years: 30 mg (5 ml) Ritch suspension twice daily.
Children of 6 months to less than 2 years of age: 15 mg (2.5 ml) Ritch suspension twice daily. For pediatric patients with decreased renal function, the recommended starting doses of Ritch suspension are 30 mg (5 ml) once daily for patients of 2 to 11 years of age and 15 mg (2.5 ml) once daily for patients of 6 months to less than 2 years of age.
Patients with renal impairment: This drug is known to be substantially excreted by the kidney and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. As elderly patients are more likely to have decreased renal function, care should be taken in dose selection and it may be useful to monitor renal function. Initial dose of fexofenadine hydrochloride in patients with renal impairment should be reduced to 60 mg once dally.

Pregnancy: 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. Caution should be exercised when fexofenadine is administered to a nursing woman.

Use in children and adolescents
Fexofenadine hydrochloride is used in patients 6 to 11 years of age for the treatment of seasonal allergic rhinitis and chronic idiopathic urticaria.

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.

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.

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

Plasma concentrations of fexofenadine hydrochloride 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 simultaneous use should be avoided.

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.

No Data

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

Ritch 60 tablet: Each coated tablet contains Fexofenadine Hydrochloride USP 60 mg.
Ritch 120 tablet: Each coated tablet contains Fexofenadine Hydrochloride USP 120 mg.
Ritch 180 tablet: Each coated tablet contains Fexofenadine Hydrochloride USP 180 mg.
Ritch 30 ODT: Each orodispersible tablet contains Fexofenadine Hydrochloride USP 30 mg.
Ritch Suspension: Each 5 ml contains Fexofenadine Hydrochloride USP 30 mg.

Storage
Store in a cool ( below 30º C) and dry place protected from light. Keep away from the reach of children.

Packing
Ritch 60 tablet: Carton of 50 tablets in blister.
Ritch 120 tablet: Carton of 50 tablets in blister.
Ritch 180 tablet: Carton of 50 tablets in blister.
Ritch 30 ODT: Carton of 50 tablets in blister.
Ritch Suspension: Bottle of 50 ml.