InnoGen Pharmaceuticals


InnoGen Pharmaceuticals
Full Prescribing Info
Each Film-Coated Tablet contains: Desloratadine 5 mg.
Each 5 mL (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: 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.
Used for the symptomatic relief of allergic conditions including rhinitis and urticaria.
Dosage/Direction for Use
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.
5 mg 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.
Special Precautions
Driving: although drowsiness is rare nevertheless patients should be advised that it can occur and may affect performance of skilled-taste (e.g. driving); excess alcohol should be avoided.
Adverse Reactions
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.
Drug Interactions
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.
MIMS Class
Antihistamines & Antiallergics
ATC Classification
R06AX27 - desloratadine ; Belongs to the class of other antihistamines for systemic use.
FC tab 5 mg x 100's. Syr (bubblegum flavor) 2.5 mg/5 mL x 60 mL x 1's.
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