Ország: Malajzia
Nyelv: angol
Forrás: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
CETIRIZINE DIHYDROCHLORIDE
STADPHARM SDN. BHD.
CETIRIZINE DIHYDROCHLORIDE
50Tablet Tablets
STELLAPHARM J.V. Co., LTD. - BRANCH 1
_ Consumer Medication Information Leaflet (RiMUP) _ C EZTI 10 FILM-COATED TABLET Cetirizine Dihydrochloride 10 mg Page no. 1 WHAT IS IN THIS LEAFLET 1. What Cezti 10 film-coated tablet is used for 2. How Cezti 10 film-coated tablet works 3. Before you use Cezti 10 film-coated tablet 4. How to use Cezti 10 film-coated tablet 5. While you are using it 6. Side effects 7. Storage and Disposal of Cezti 10 film- coated tablet 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT CEZTI 10 FILM-COATED TABLET IS USED FOR Cezti 10 film-coated tablet is used in adults and children of 3 years or above to treat swelling and irritation inside the nose that can occur during specific seasons (seasonal rhinitis) or occur year round (perennial allergic rhinitis) and urticaria of allergic origin (a common allergic disorder in which a red, itchy, lumpy skin rash appears). HOW CEZTI 10 FILM-COATED TABLET WORKS Cetirizine is a drug that inhibits the actions of histamine (an amine found in all body tissues) by competitive binding to the H1 receptor. Histamine is responsible for many of the symptoms caused by allergies. Cetirizine does not inhibit the actions of cholinergic and serotonin (two types of major neurotransmitter systems). So these effects are obtained without sedation nor behavioral changes. Cetirizine also inhibits the skin reaction induced by some peptides that are believed to take part in the allergic reaction. BEFORE YOU USE CEZTI 10 FILM-COATED TABLET _- When you must not take it _ If you are known allergy to any of its ingredients. _- Before you start to use it _ _If any of the situations mentioned below _ _apply to you, you should tell your doctor _ _before taking this drug:_ _ _ - If you do activities requiring mental alertness._ _ - The safety and effectiveness of Cetirizine in pediatric patients under the age of 2 years have not been established. _ _ - Caution should be exercised in patients with mild to moderate renal impairment or impaired liver function_ _ _- Taking oth Olvassa el a teljes dokumentumot
COMPOSITION Active ingredient: One Cezti 10 film-coated tablet contains Cetirizine dihydrochloride 10 mg. PHARMACODYNAMICS In experimental animals, Cetirizine has been shown to be an anti-H1 agent devoid of any significant anticholinergic or antiserotonin effects. At pharmacologically active doses, it induces neither sedation nor behavioral changes. This may be explained by the fact that Cetirizine does not cross the blood-brain barrier. It was shown in human pharmacology studies that Cetirizine would inhibit certain effects produced by endogenous histamine released by an agent, e.g. 48/80. _in vivo_ Finally, it inhibits the cutaneous reaction induced by VIP (Vasoactive Intestinal Polypeptide) and substance P, neuropeptides that are believed to take part in the allergic reaction. Cetirizine markedly reduces bronchial hyper-reactivity to histamine in the asthmatic patients. It also reduces the allergic reaction induced by specific allergens. These effects are obtained without any central effects being demonstrated either by psychometric test or by a quantified EEG. PHARMACOKINETICS Peak blood levels of the order of 0.3 µ g/ml are reached between 30 and 60 minutes after administration of a 10 mg dose of Cetirizine. Its plasma half - life is approximately 11 hours. Absorption is very consistent from one subject to the next. Its renal clearance is 30 ml/minute and the excretion half-life is approximately 9 hours. Cetirizine is strongly bound to plasma proteins. INDICATIONS Adult and children of 3 years or above: Symptomatic treatment of seasonal rhinitis, perennial allergic rhinitis and urticaria of allergic origin. DOSAGE AND ADMINISTRATION ADMINISTRATION Cezti 10 need to be swallowed with a glass of liquid. DOSAGE The recommended dosage in children aged between 3 and 6 years old is 5 mg daily, either 2.5 mg twice daily or 5 mg once daily. Adults and adolescents over 12 years of age: 1 tablet (10 mg) once daily. If drowsiness occurs, the tablets can be administered in the evening. Children 6-12 years: 1 tablet (10 Olvassa el a teljes dokumentumot