Ritch 120mg

Tablet
Fexofenadine Hydrochloride
ACI Pharmaceuticals

Other Strength:
- Ritch 60mg
- Ritch 180mg
- Ritch 30mg

Alternative:
- Axodin 120mg
- Fexo® 120mg
- Vifas 120mg
- Xofast 120mg
- Fexoral 120mg
- Afexa 120mg
- Rynofex 120mg
- Alagra 120mg
- Xofedin 120mg
- Axofen 120mg
- Fexon 120mg
- X-Din 120mg
- Alanil 120mg



Ritch
Description
Ritch®is a preparation of Fexofenadine Hydrochloride, the synthetic Hydrochloridesalt of Fexofenadine which is the Carboxylic Acid metabolite of Terfenadine.Fexofenadine isan orally active non-sedating H1receptor antagonist and is effective for the relief of symptoms associated with allergicrhinitisand urticaria. Fexofenadine is rapidly absorbed after oral administrationwith peak plasma concentrationbeing reached in 2 to 3 hours. Fexofenadine is metabolized mostly by intestinal mucosa and only few undergohepatic biotransformation.Fexofenadine is excreted mainly in the faeces with only 10% being present in the urine. Fexofenadine does not appear to cross the blood brain barrier.

Indications and Uses
Ritch®is indicated for relief of symptoms associated with-
Seasonal allergic rhinitis such as sneezing, rhinorrhea, pruritus and lacrimation
Perennial allergic rhinitis
Urticaria

Dosage & administration
Tablet
Adultsand children over 12 yearsSeasonal Allergic Rhinitis: 120 mg(Ritch®120)or 180 mg (Ritch®180)once dailyPerennial Allergic Rhinitis: 60 mg (Ritch®60)twice dailyUrticaria: 180 mg (Ritch®180)once dailyA dose of 60 mg once daily is recommended as the starting dose in patients with decreased renal function. Children aged 6 to 11 yearsSeasonal Allergic Rhinitis: 30 mg twicedailyA dose of 30 mg once daily is recommended as the starting dose in patients with decreased renal function.

Suspension
Children aged 2 to 11 yearsSeasonal Allergic Rhinitis: 30 mg or 5ml (1 teaspoonful) twice dailyA dose of 30 mg or 5 ml (1 teaspoonful) once daily is recommended as the starting dose in pediatric patients with decreased renal function. Chronic Idiopathic Urticaria: 30 mg or 5 ml (1 teaspoonful) twice dailyFor pediatric patients with decreased renal function, the recommended starting dose is 30 mg or 5 ml (1 teaspoonful) once daily.Children aged 6 months to less than 2 yearsChronic Idiopathic Urticaria:15 mgor 2.5 ml(1/2 teaspoonful) twice dailyFor pediatric patients with decreased renal function, the recommended starting dose is 15 mg or 2.5 ml (1/2 teaspoonful) once daily.

Use in pregnancy and lactation
Fexofenadine is pregnancy category B2. There are no adequate and well controlled studies in pregnant womenexposed 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.

Side effects
Fexofenadine is generally well tolerated. The most common side effectsare 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.

Precautions
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 advisedduring drive or operate potentially dangerous machinery.

Drug interactions
Plasma concentrations of Fexofenadine have been increased when given with Erythromycin or Ketoconazole. Fexofenadine had no effect on the pharmacokinetics of Erythromycin or Ketoconazole. Antacid containing Aluminium and Magnesium Hydroxide reduces the absorption of Fexofenadine.It is advisable to leave 2 hours between administration or Fexofenadine and Aluminium and Magnesium Hydroxide containing Antacids.

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

Over dosage
There is no clinical experience with Fexofenadine overdose. The maximum single dose tested in clinical trials is 800 mg in six healthy subjects. In a multiple-dose study, doses of 690 mg every 12 hours for 28.5 days were given to three healthy subjects and, in another study with forty subjects, a dose of 400 mg every 12 hours was given for 6.5 days. No clinical significant adverse events werereported in these studies. In the case of an overdose, standard measures to remove any unabsorbed drug should be employed. Symptomatic and supportive treatment is recommended. Haemodialysis is not an effective means of removing Fexofenadine from plasma.

Pharmaceutical precautions
Store in a cool and dry place. Protect fromlight. Keep away fromthe reach of children.

Presentation
Ritch®60:Eachcoated tablet containsFexofenadine HydrochlorideUSP60 mg,
Ritch®120:Each coated tablet contains Fexofenadine Hydrochloride USP 120 mg,
Ritch®180:Each coated tablet contains Fexofenadine Hydrochloride USP 180 mg,
Ritch®Suspension: Each 5 ml contains Fexofenadine Hydrochloride USP 30 mg

Package quantities
Ritch®60: Carton of 30tablets inblister.
Ritch®120: Carton of 30 tablets inblister.
Ritch®180: Carton of 30 tablets inblister.
Ritch®Suspension: Bottleof 50 ml.

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