Rupafin (Rupatadine Fumarate)

Rupatadine is a second-generation antihistamine, long-acting histamine antagonist, with selective peripheral H1-receptor antagonist activity. Some of the metabolites (desloratadine and its hydroxylated metabolites) retain an antihistaminic activity and may partially contribute to the overall efficacy of the drug.

Indication

Symptomatic treatment of allergic rhinitis and urticaria.

Dosage

• Adults and adolescents (over 12 years of age): The recommended dose for rupatadine (Rupafin) is 10 mg (one tablet) once a day.
• Oral solution: Children aged 2 to 11 years.
  • Dosage in children weighing equal or more than 25 kg: 5 ml (5 mg of rupatadine) of oral solution once a day, with or without food.
  • Dosage in children weighing equal or more than 10 kg up to less than 25 kg: 2.5 ml (2.5 mg of rupatadine) of oral solution once a day, with or without food.
  • The administration of the product to children aged under 2 years is not recommended due to the lack of data in this population.
  • In adults and adolescents (over 12 years of age), the administration of rupatadine 10 mg tablets is more appropriate.

Direction of Use

Should be swallowed with a sufficient amount of fluid (e.g. one glass of water), with or without food.

Precaution

• Patients with renal or hepatic insufficiency: As there is no clinical experience in patients with impaired kidney or liver functions, the use of rupatadine is at present not recommended in these patients.
• Elderly: Rupatadine (Rupafin) 10 mg tablet should be used with caution in elderly patients (65 years and older).
• Children: Rupatadine (Rupafin) 10 mg tablet is not recommended for use in children below 12 years of age due to a lack of data on safety and efficacy.