Xyzal: A Levocetirizine Dihydrochloride antihistamine for symptoms of Allergic Rhinitis and Urticaria
Xyzal is an antihistaminic medication. It is used to treat various allergic conditions such as allergic rhinitis or hay fever, conjunctivitis, some skin reactions such as eczema, Urticaria or hives, and reactions to bites and stings. It also relieves watery eyes, runny nose, sneezing, and itching.
Abridged Prescribing Information
XYZAL® Tablets and Oral Solution (Levocetirizine Dihydrochloride)
Name of the Medical Product: 1) Xyzal (Levocetirizine dihydrochloride) 5 mg film-coated tablets. 2) Xyzal (levocetirizine dihydrochloride) 5mg/10ml oral solution. Qualitative And Quantitative Composition: 1) Each film-coated tablet contains 5 mg Levocetirizine dihydrochloride. 2) 1ml of oral solution contains 0.5 mg levocetirizine dihydrochloride. Pharmaceutical Form: Film-coated tablet: White to off-white, oval, film-coated tablet with a Y logo on one side. Oral solution: clear and colourless liquid. Therapeutic indications: For the treatment of Allergic Rhinitis and Chronic Urticaria in children from 6 months of age. Posology and method of administration Children 6 months to 5 years of age: 1.25mg once daily. Children 6 to 11 years of age: 2.5 mg once daily. Adults and children 12 years and older: 5 mg once daily. Contraindications: 1) Hypersensitivity to levocetirizine or any of the other constituents of the formulation, to hydroxyzine or to any piperazine derivatives. 2) Patients with severe renal impairment at less than 10 ml/min creatinine clearance. Special Warnings and Special Precautions for Use: Precaution is recommended with intake of alcohol. Methyl parahydroxybenzoate and propyl parahydroxybenzoate included in the oral solution may cause allergic reactions (possibly delayed). The use of the film-coated tablet formulation is not recommended in children aged less than 6 years since this formulation does not allow for appropriate dose adaptation. It is recommended to use a paediatric for formulation of Levocetirizine. Undesirable Effects: Headache, Somnolence, Mouth dry, fatigue, palpitations, tachycardia, nausea, vomiting, diarrhoea and vomiting. Overdose: Symptoms of overdose may include drowsiness in adults and initially agitation and restlessness, followed by drowsiness in children. Keep out of reach of children.
Please refer to full prescribing information before usage. Available on request from Dr. Reddy's. For further information please write to Dr. Reddy's Laboratories Ltd., 8-2-337, Banjara Hills, Hyderabad- 500 034. India
GGI-CO-A1-AQS-300024439-WM-H22-0760
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