Rupa Tablet: Each tablet contains Rupatadine Fumarate INN equivalent to Rupatadine 10 mg.
Rupa Oral Solution: Each 5 ml oral solution contains Rupatadine Fumarate INN equivalent to Rupatadine 5 mg.
Indication:
Rupatadine is indicated for the symptomatic treatment of seasonal & perennial allergic rhinitis and urticaria.
Dosage & Administration:
Rupa
Tablet: The recommended dosage is 10 mg once daily, with or without
food.
Rupa Oral Solution: Children aged 2 to 11 year: Children weighing 25 kg
or more : 1 teaspoonful (5 ml) of oral solution once daily with or
without food. Children weighing equal or more than 10 kg to less than 25
kg: 1/2 teaspoonful (2.5 ml) oral solution once daily with or without
food.
Contrainidications:
Hypersensitivity to Rupatadine or to any of the excipients.
Warning & Precautions:
Administration
of a dose of 10 mg daily of Rupatadine has not shown significant
effects on the function of the central nervous system as seen in
specific studies done for psychomotor function. Nevertheless, the
patient should take precaution in driving or managing machines.
Side effects:
The most common undesirable effects are sleepiness, general weakness & fatigue.
Drug interaction:
CYP3A4
inhibitors like Erythromycin & Ketoconazole inhibits both the
presystemic and systemic metabolism of Rupatadine. Due to this potential
interaction, it is not recommended to use Rupatadine in combination
with Ketoconazole or any other inhibitors of CYP3A4. Coadministration of
Rupatadine and CNS depressants or alcohol may increase CNS depressant
effect.
Use in special groups:
Pregnancy
& Lactation: Pregnancy category B2 (by TGA, Australia). There is no
clinical data available on the exposure of Rupatadine during pregnancy.
Pregnant women should therefore not use Rupatadine, unless the
potential benefit outweighs the potential risk for the fetus. No
information is available, whether Rupatadine is excreted in the mother's
milk. Therefore, it should not be used during lactation, unless the
potential benefits for the mother justify the potential risk to the
infant.
Patients with renal or hepatic insufficiency: Use of Rupatadine is not
recommended in patients with renal or hepatic insufficiency, as no
relevant clinical data is available.
Packing:
Rupa Tablet: Each box contains 30's tablets.
Rupa Oral Solution: Each bottle contains 60 ml oral solution.
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