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.
Rupatadine is a long-acting, non-sedative antagonist of histamine H1-receptors. It also antagonizes the platelet-activating factor (PAF). Both histamine and PAF cause bronchoconstriction which leads to an increase in the vascular permeability and act as a mediator in the inflammatory process. Rupatadine possesses other anti-allergic properties such as the inhibition of the degranulation of mast cells induced by immunological and non-immunological stimuli and inhibition of the release of cytokines, particularly of the tumor necrosis factor alpha (TNFa) in human mastocytes and monocytes.
Rupatadine is indicated for the symptomatic treatment of seasonal & perennial allergic rhinitis and urticaria.
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.
Hypersensitivity to Rupatadine or to any of the excipients.
The most common undesirable effects are sleepiness, general weakness & fatigue. Other uncommon undesirable effects include, dyspepsia, rash and increased appetite.
Use in Pregnancy: May cause fetal harm.
Lactation: Breastfeeding not recommended during treatment with Ruvan-Z.
Pediatric Use: The safety and effectiveness of Ruvan-Z have not been established in pediatric patients.
Geriatric Use: Dose selection for an elderly patient should be cautious, recognizing the greater frequency of decreased hepatic, renal, or cardiac function, concomitant disease or other drug therapy and the higher risk of myopathy.
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.
Store below 30 C temperature in cool & dry place, protect from light. Keep out of reach of children.