Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
LEVOCETIRIZINE DIHYDROCHLORIDE
Asumed Biotech Sdn. Bhd.
LEVOCETIRIZINE DIHYDROCHLORIDE
1 BOTTLE; 20 BOTTLE
Chen Ho Pharmaceutical Co., Ltd. Sinying Plant
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ _ _ LEVOCET SYRUP 0.5MG/ML _ _ Levocetirizine Dihydrochloride 0.5mg P a g e 1 WHAT IS IN THIS LEAFLET 1.What Levocet Syrup 0.5mg/ml is used for 2.How Levocet Syrup 0.5mg/ml works 3.Before you use Levocet Syrup 0.5mg/ml 4. How to use Levocet Syrup 0.5mg/ml 5. While you are using it 6. Side effect 7.Storage and Disposal of Levocet Syrup 0.5mg/ml 8. Product description 1. WHAT LEVOCET SYRUP 0.5MG/ML IS USED FOR Levocetirizine dihydrochloride is the active ingredient of Levocet syrup 0.5mg/ml. Levocetirizine is an antiallergic medication. 2. HOW LEVOCET SYRUP 0.5MG/ML WORKS Levocet Syrup 0.5 mg/ml works for the treatment of signs of illness (symptoms) associated with: - allergic rhinitis - nettle rash (urticaria) 3. BEFORE YOU USE LEVOCET SYRUP 0.5MG/ML WHEN YOU MUST NOT USE IT - If you allergic to levocetirizine dihydrochloride, cetirizine, hydroxyzine or any of the other ingredients of this medicine. - If you have severe impairment of kidney function (severe renal failure with creatinine clearance below 10ml/min). BEFORE YOU START TO USE IT -You should be cautious if you take Levocetirizine at the same time with alcohol as it may cause a reduction in alertness and impairment of performance. -If you have epilepsy or at risk of convulsion, please ask your doctor for advice as use of Levocetirizine may cause seizure aggravation. -If you are likely to be unable to empty your bladder (with conditions such as spinal cord injury or enlarge prostate) please ask your doctor for advice as levocetirizine may increase the risk of urinary retention. -If you are scheduled for allergy testing, ask your doctor if you should stop taking Levocetirizine for several days before testing as this medicine may affect your allergy test result. TAKING OTHER MEDICINES Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. - If you are taking 400mg of theophylline once a day, a small decrease in the cetirizine clearance was observed, while the Baca dokumen lengkap
Page 1 of 3 LEVOCET SYRUP 0.5MG/ML COMPOSITION Active Ingredient: Excipients: Sodium citrate 11mg/ml Sucralose 0.35mg/ml D-Sorbitol Solution (70%) 350mg/ml Grape Flavor 1mg/ml Citric Acid 3.5mg/ml Sodium Benzoate 1mg/ml Purified water Added to 1ml DOSAGE FORM Oral Solution PRODUCT DESCRIPTION Levocet syrup 0.5mg/ml is a colorless to pale yellow clear solution. A sweet taste of sugar, with grape flavor and a smell of grape note. CLINICAL PHARMACOLOGY PHARMACODYNAMICS Pharmacotherapeutic group: Antihistamines for systemic use, piperazine derivatives. Mechanism of action Levocetirizine, the (R) enantiomer of cetirizine, is a potent and selective antagonist of peripheral H1-receptors. Binding studies revealed that levocetirizine has high affinity for human H1-receptors (Ki = 3.2 nmol/l). Levocetirizine has an affinity 2-fold higher than that of cetirizine (Ki = 6.3 nmol/l). Levocetirizine dissociates from H1-receptors with a half-life of 115 ± 38 min. After single administration, levocetirizine shows a receptor occupancy of 90% at 4 hours and 57% at 24 hours. PHARMACOKINETICS Absorption Levocetirizine is rapidly and extensively absorbed following oral administration. In adults, peak plasma concentrations are achieved 0.9 h after dosing. Steady state is achieved after two days. Peak concentrations are typically 270 ng/ml and 308 ng/ml following a single and a repeated 5 mg o.d. dose, respectively. The extent of absorption is dose-independent and is not altered by food, but the peak concentration is reduced and delayed. Distribution No tissue distribution data are available in humans, neither concerning the passage of levocetirizine through the blood-brain-barrier. In rats and dogs, the highest tissue levels are found in liver and kidneys, the lowest in the CNS compartment. In humans, levocetirizine is 90% bound to plasma proteins. The distribution of levocetirizine is restrictive, as the volume of distribution is 0.4 l/kg. Biotransformation The extent of metabolism of levocetirizine in humans is less than 14% of the Baca dokumen lengkap