ORION PHARMA LTD.
Allergic Rhinitis: Desloratadine is indicated for the relief of the nasal and non-nasal symptoms of allergic rhinitis (Both seasonal and perennial) in patients 2 years of age and older. Chronic Idiopathic Urticaria: Desloratadine is also indicated for the symptomatic relief of pruritus, reduction in the number of hives, and size of hives, in patients with chronic idiopathic urticaria 2 years of age and older
Desloratadine is a long-acting, tricyclic, non-sedating, selective peripheral histamine H1-receptor antagonist which inhibits the release of pro-inflammatory mediators from human mast cells and basophils.
Pediatric drops : Child 6 -11 months of age: 2 ml drops once daily Child 1 -2 years of age: 2.5 ml drops once daily Syrup: Child 6-11 months of age: 2 ml once daily Child 1-5 years of age: 2.5 ml once daily Child 6-11 years of age: 5 ml once daily Adults & > 12 years of age: 10 ml once daily Tablet: Adults and children 12 years of age and over: 5 mg daily
Concomitant administration of Erythromycin, Ketoconazole, Azithromycin, Fluoxetine, and Cimetidine with Desloratadine increased the plasma concentration of Desloratadine. But there were no clinically relevant changes in the safety profile of Desloratadine.
Desloratadine is contraindicated in patient having hypersensitivity to this medication or to any of its ingredients or Loratadine.
Desloratadine is generally well tolerated. However, dry mouth, fatigue, somnolence and myalgia are commonly reported side-effects. Less common side-effects may include dizziness, headache and nausea. Rarely rash, pruritus and urticaria may occur.
Pregnancy: There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Desloratadine should be used in pregnancy only if clearly needed. Lactation: Desloratadine passes into breast milk. Therefore, a decision should be made whether to discontinue nursing or to discontinue Desloratadine, taking into account the importance of the drug to the mother.
No clinically relevant adverse events have been reported in case of overdosage. However, in the event of overdosage, symptomatic and supportive treatment is recommended.
Hepatic and renal impairment. Pregnancy and lactation.
Store in a cool and dry place, protected from light.