Deslogen

Desloratadine.

Each Film-Coated Tablet contains: Desloratadine 5 mg.
Each 5 mL syr (1 teaspoonful) contains: Desloratadine 2.5 mg.
Desloratadine, a peripheral derivative related to azatadine, is a long-acting, non-sedating antihistamine with no significant antimuscarinic activity.

Pharmacology: Desloratadine a peripheral derivative related to azatadine, is a long-acting, non-sedating antihistamine with no significant antimuscarinic activity.
Pharmacodynamics: Desloratadine is a non-sedating, long-acting histamine antagonist with selective peripheral H1-receptor antagonist activity. After oral administration, desloratadine selectively blocks peripheral histamine H1-receptors because the substance is excluded from entry to the central nervous system.
Pharmacokinetics: Desloratadine is rapidly absorbed from the gastrointestinal tract after oral administration, peak plasma concentration is attained in about one hour. Bioavailability is increased and time of peak plasma concentrations is delayed when administered with food. Desloratadine undergoes extensive metabolism. The major metabolite, descarboethoxyloratadine has potent antihistamine activity. Reported mean elimination half-lives for desloratadine and descarboethoxyloratadine are 8.4 and 28 hours respectively. Desloratadine is about 98% bound to plasma proteins; descarboethoxyloratadine is less extensively bound. Desloratadine and its metabolites have been detected in breast milk, but do not appear to cross the blood-brain barrier to a significant extent. Most of a dose is excreted equally in the urine and faeces, mainly in the form of metabolites.

FC tab: Used for the symptomatic relief of allergic conditions including rhinitis and urticaria. Syr: Used for the symptomatic relief of allergy such as hay fever, urticaria.

Film-Coated Tablet: Adults and children 12 years of age and over. 5 mg Film-Coated Tablet once daily or as prescribed by the physician.
Children 6 to 11 years of age: 2.5 mg (½ tablet) once daily or as prescribed by the physician. 2.5 mg/5 mL.
Syrup: Children 1 to 5 years of age: 2.5 mL (1.25 mg) once a day or as prescribed by the physician.
Children 6 to 11 years of age: 5 mL (2.5 mg) once a day or as prescribed by the physician.
In adults and adolescents 12 years of age and over: 10 mL (5 mg) once a day or as prescribed by the physician.
To be taken with or without meal.

In the event of overdose, consider standard measures to remove non adsorbed active substance. Symptomatic and supportive treatment is recommended. Based on a multiple dose clinical trial in adults and adolescents, in which up to 45 mg of Desloratadine was administered (9 times the clinical dose), no clinically relevant effects were observed. Desloratadine is not eliminated by hemodialysis; it is not known if it is eliminated by peritoneal dialysis.

Hypersensitivity to the active substance or to any of the excipients.

Although drowsiness is rare nevertheless patients should be advised that it can occur and may affect performance of skills (e.g., driving); excess alcohol should be avoided.

No overall effect on rat fertility was observed with Desloratadine at an exposure that was 34 times higher than the exposure in humans at the recommended clinical dose. No teratogenic or mutagenic effects were observed in animal trials with Desloratadine. Since no clinical data on exposed pregnancies are available with Desloratadine, the safe use of Desloratadine tablets during pregnancy has not been established. Desloratadine is excreted into breast milk, therefore the use of Desloratadine tablets are not recommended in breast-feeding women.

Antihistamine sometimes cause rashes and hypersensitivity reactions (including bronchospasm, angioedema, and anaphylaxis) and cross-sensitivity to related drugs may occur. Blood disorders including agranulocytosis, leucopenia, haemolytic anaemia & thrombocytopenia although rare, have been reported.
Other adverse effects that have been reported with the antihistamines include convulsions, sweating, myalgia, paraesthesias, extrapyramidal effects, tremor, sleep disturbances, depression, confusion, tinnitus, hypotension and hair loss.

Sedating antihistamines may enhance the sedative effects of central nervous system depressants including alcohol, barbiturates, hypnotics, opioid analgesics, anxiolytic sedatives, and antipsychotics. Sedative interactions apply to a lesser extent with the non-sedating antihistamines; they do not appear to potentiate the effects of alcohol, but it should be avoided in excess.

Store at temperatures not exceeding 30°C.

Antihistamines & Antiallergics

R06AX27 - desloratadine ; Belongs to the class of other antihistamines for systemic use.

Rx