DESLORA-5 (Desloratadine Tablets)

DESLORA-5 (Desloratadine Tablets)

DESLORA-5 (Desloratadine Tablets)

Antihistamine

Desloratadine is a long-acting tricyclic histamine antagonist with selective H1-receptor histamine antagonist activity. Receptor binding data indicates that at a concentration of 2-3ng/mL (7 nanomolar), desloratadine shows significant interaction with the human histamine H1-receptor. Desloratadine inhibited histamine release from human mast cells in vitro.

Desloratadine exhibits an antihistamine effect by 1 hour, this activity may persist for as long as 24 hours. The clinical relevance of histamine wheal skin testing is unknown.

Indications

Seasonal allergic Rhinitis: Desloratadine is indicated for the relief of the nasal and non-nasal symptoms of seasonal allergic rhinitis in patients 2 years of age and older.

Perennial allergic rhinitis: Deslortadine is indicated for the relief of the nasal and non-nasal symptoms of perennial allergic rhinitis in patients 6 months of age and older.

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Chronic idiopathic urticaria: Desloratadine is indicated for the symptomatic relief of pruritus, reduction in the number of hives and size of hives, in patients with chronic idiopathic urticaria 6 months of age and older.

Contraindications

Desloratadine Tablets are contraindicated in patients who are hypersensitive to this medication or to any of its ingredients or to loratadine.

Special precautions and warning

This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactose deficiency or glucose-galactose malabsorption should not take this medicinal product.

Hypersensitivity reactions including rash, pruritus, urticaria, edema, dyspnea and anaphylaxis may occur after administration of desloratadine. If such a reaction occurs, therapy with Desloratadine should be stopped and alternative treatment should be considered.

Pregnancy: There are no adequate and well-controlled studies in pregnant women. Desloratadine should be used during pregnancy only if clearly needed.

Nursing mothers: Desloratadine pass into milk, therefore, decision should be made whether to discontinue nursing or to discontinue Desloratadinee, taking into account the benefit of the drug to the nursing mother and the possible risk to the child.

Pediatric use: The safety and effectiveness of Desloratadine tablets have not been demonstrated in pediatric patients less than 6 months of age.

Geriatric use: Dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

Renal impairment: Dosage adjustment for patients with renal impairment is recommended.

Hepatic impairment: Dosage adjustment for patients with hepatic impairment is recommended.

Dosage and direction for use

Adults and Adolescents 12 years of age and older: the recommended dose of Desloratadine Tablets is one 5mg tablet once daily

Children 6 to 11 years of Age: The recommended dose of Desloratadine Tablet is 2-5mg tablet once daily.

Adults with hepatic or renal impairment: In adult patients with liver or renal impairment, a starting dose of one 5mg tablet every other day is recommended based on pharmacokinetic data.

Adverse effects

Possible adverse effects related to Desloratadine tablets are mentioned below:

Allergic rhinitis, pharyngitis, Somnolence, myalgia, dysmenorrhea, fatigue, dizziness, dyspepsia, fever, diarrhea, upper respiratory tract infection, rash maculopapular, irritability, bronchitis, coughing, vomiting, anorexia, insomnia, rhinorrhea, erythema, urticaria, edema, dyspnea, anaphylaxis, psychomotor hyperactivity, dystonia, tics, extrapyramidal symptoms, seixures and elevated liver enzymes.

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Drug interactions

Inhibitors of Cytochrome P4503A4: Co-administration of desloratadine with ketoconazole, erythromycin, or azithromycin may result in increased plasma concentrations of desloratadine and 3 hydroxydesloratadine.

Fluoxetine: co-administration of desloratadine with fluoxetine, a selective serotonin reuptake iinhibitor (SSRI), result in increased plasma concentrations of desloratadine and 3 hydroxydesloratadine.

Cimetidine: co-administration of desloratadine with cimetidine, a histamine H2-receptor antagonist, result in increased plasma concentrations of desloratadine and 3 hydroxydeesloratadine,

Overdosage

In the event of overdose, consider standard measures to remove any unabsorbed drug. Symptomatic and supportive treatment is recommended. Desloratadine and 3-hydroxydesloratadine are not eliminated by hemodialysis.

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