Rupenta Tablet: Each tablet contains Rupatadine fumarate INN equivalent to Rupatadine 10 mg.
Rupenta Oral Solution: Each 100 ml oral solution contains Rupatadine fumarate INN equivalent to Rupatadine 100 mg.
Rupenta is indicated for the relief of symptoms associated with seasonal and perennial allergic rhinitis, such as sneezing, nasal discharge & itching, congestion/stuffiness, as well as ocular itching, tearing and redness, itching of palate and coughing. Rupenta is also indicated for the relief of symptoms associated with chronic idiopathic urticaria.
Hypersensitivity to Rupatadine or to any of the excipients.
Dosage & Administration
Rupenta Tablet: Adults and adolescents (over 12 years of age): The recommended dose is 10 mg (one tablet) daily, with or without food.Rupenta Oral Solution: Children aged 2 to 11 years: Children weighing equal or more than 10 kg to less 25 kg: 1/2 teaspoonful (2.5 ml) oral solution once a day with or with food.Children weighing 25 kg or more : 1 teaspoonful (5 ml) of oral solution once a day with or without food.
Somnolence, headache, dizziness, dry mouth, fatigue and asthenia.
Rupatadine should be used with caution in patients with known prolongation of the QT interval, patients with uncorrected hypokalemia, patients with ongoing proarrhythmic conditions, such as clinically significant bradycardia, acute myocardial ischemia.
Pregnancy category-B. Clinical data for Rupatadine or other compounds of the class are inadequate to establish safety in pregnancy. It is unknown whether Rupatadine is excreted into breast milk. Until such data are available, Rupatadine should be used in pregnancy and lactation only if the expected benefits clearly outweigh potential risks to mother, foetus and child.
Use in Elderly: Rupatadine should be used with caution in elderly patients (65 years and older).
Use in Renal and Hepatic Impairment: As there is no clinical experience in patients with impaired kidney or liver functions, the use of Rupatadine tablet is at present not recommended in these patients.
The concomitant administration of Rupatadine 20 mg and Ketoconazole or Erythromycin increases the systemic exposure. Rupatadine should be used with caution when it is administered concomitantly with these drug substances and other inhibitors of the isozyme CYP3A4. Rupatadine should be used with caution when it is co-administered with statins or CNS depressants or alcohol.
Rupenta Tablet: Each box containing 3X10\'s tablets in blister pack.Rupenta Oral Solution : Each bottle contains 60 ml oral solution.