Deslorat Syrup 60Ml

COMPOSITION

Each film-coated tablet contains: DESLORATADINE 5 mg. Excipients: Croscarmellose Sodium; Powdered Cellulose; Colloidal Silicon Dioxide; Magnesium Stearate; Microcrystalline Cellulose: Opadry Il White (YS-30-18056); Saccharin sodium; Brilliant Blue; Opadry Clear (YS-1-7006). Each 100 ml of syrup contains: DESLORATADINE 50 mg. Excipients: Propylene glycol, sodium citrate, citric acid, sodium benzoate, edetate disodium, sugar, strawberry flavor, banana flavor, sorbitol solution 70%, purified water.

INDICATIONS

Symptomatic relief of allergic rhinitis and urticaria. 

CONTRAINDICATIONS

Known hypersensitivity to any of the ingredients of the formulation. Children under 1 year of age. Pregnancy. Lactation. 

PRECAUTIONS & WARNINGS

Film Coated Tablets: The drug will have to be administered with caution in patients with severe renal failure as an increase in the drug's area under the curve (AUC) may occur. Syrup: Safety and efficacy of DESLORAT has not been established in children under 1 years old. In children under 2 years old. it is difficult to distinguish between allergic rhinitis and other forms of rhinitis; the absence of upper airways infection or structural abnormalities, as well as the clinical history, and laboratory and skin testing, are useful to rule out some forms of the disease. Approximately 6% of adults and children between 2-11 years old are poor metabolizers of DESLORATADINE, suggesting a greater exposure to the drug; however, safety of DESLORAT syrup in children between 2-11 years old with a poor metabolizer phenotype is similar to those children who correctly metabolize the product. Unfortunately, the poor metabolizer phenotype for DESLORAT has not been studied in children under 2 years old. DESLORAT will have to be administered with caution in patients with severe renal failure because an increase in the drug's area under the curve (AUC) may occur. Warn patients against taking higher doses of DESLORAT than recommended as clinical studies did not show a higher efficacy compared to usual doses. This product contains sorbitol; therefore, this drug must not be administered in patients who do not tolerate sugar. 

SIDE EFFECTS

Drowsiness is a significant side-effect with most of the older antihistamines although paradoxical stimulation may accur rarely, especially with high doses or in children and the elderly. Drowsiness may diminish after a few days of treatment and is considerably less of a problem with the newer antihistamines (see also notes above). Side-effects that are more common with the older antihistamines include headache, psychomotor impairment, and antimuscarinic effects such as urinary retention, dry mouth, blurred vision, and gastro-intestinal disturbances. Other rare side-effects os antihistamines include hypotension, palpitation, arrythmias, extrapyramidal effects, dizziness, confusion, depression, sleep disturbances, tremor, convulsions, hypersensitivity reactions (including bronchospasm, angioedema, and anaphylaxis, rashes, and photosensitivity reactions); blood disorders, liver dysfunction, and angle-closure glaucoma.

BAGO GROUP COMPANY