Страна: Малайзия
Език: английски
Източник: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
MOXIFLOXACIN HCL
SYNERRV SDN BHD
MOXIFLOXACIN HCL
1 x 5 Tablets; 2 x 5 Tablets
Macleods Pharmaceuticals Ltd
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ MOXIMAC 400MG TABLETS MOXIFLOXACIN TABLETS 1 WHAT IS IN THIS LEAFLET? 1. What MOXIMAC is used for 2. How MOXIMAC works 3. Before you use MOXIMAC 4. How to use MOXIMAC 5. While you are using MOXIMAC 6. Side effects 7. Storage and Disposal of MOXIMAC 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT MOXIMAC IS USED FOR Moxifloxacin is used in patients aged 18 years and above for treating the following bacterial infections when caused by bacteria against which moxifloxacin is active. Moxifloxacin should only be used to treat these infections when usual antibiotics cannot be used or have not worked: - Infection of the sinuses, sudden worsening of long term inflammation of the airways or infection of the lungs (pneumonia) acquired outside the hospital (except severe cases). - Mild to moderate infections of the female upper genital tract (pelvic inflammatory disease), including infections of the fallopian tubes and infections of the uterus mucous membrane. You must use Moxifloxacin together with other antibacterial agent. HOW MOXIMAC WORKS Moxifloxacin works by killing bacteria that cause infections. BEFORE YOU USE MOXIMAC _- When you must not use it _ - If you are allergic to the active substance moxifloxacin, any other quinolone antibiotics or any of the other ingredients of this medicine. - If you suffer from myasthenia gravis (abnormal muscle fatigue leading to weakness and in serious cases paralysis), taking moxifloxacin may worsen the symptoms of your disease. Avoid taking moxifloxacin if you suffer from myasthenia gravis. _- Before you start to use it _ Talk to your doctor before taking Moxifloxacin - Moxifloxacin can change your heart’s ECG, especially if you are female, or if you are elderly. If you are currently taking any medicine that decreases your blood potassium levels, consult your doctor before taking moxifloxacin. - If you suffer from epilepsy or a condition which makes you likely to have convulsions ta Прочетете целия документ
FOR THE USE ONLY OF A REGISTERED MEDICAL PRACTITIONER OR A HOSPITAL OR A LABORATORY MOXIMAC 400 MG TABLETS (MOXIFLOXACIN TABLET) COMPOSITION: Each film coated tablet contains: Moxifloxacin Hydrochloride Ph. Eur Equivalent to Moxifloxacin ………. 400 mg DESCRIPTION Moxifloxacin hydrochloride is a synthetic broad spectrum antibacterial agent. Chemically, Moxifloxacin is 1- cyclopropyl-7-[(S,S)2,8-diazabicyclo[4.3.0]non-8-yl]-6-fluoro-8-methoxy-1,4-dihydro-4-oxo-3 quinoline carboxylic acid. Its molecular formula is C21H24FN3O4*HCl, and molecular weight is 437.9. PHARMACOLOGICAL CLASSIFICATION Fluoroquinolones PHARMACEUTICAL FORM Brick red colored, capsule shaped, biconvex, film coated tablets with plain surface on both the sides PHARMACOLOGICAL ACTION PHARMACOKINETICS Absorption and Bioavailability Following oral administration moxifloxacin is rapidly and almost completely absorbed. The absolute bioavailability amounts to approximately 91%. Pharmacokinetics is linear in the range of 50 - 800 mg single dose and up to 600 mg once daily dosing over 10 days. Following a 400 mg oral dose peak concentrations of 3.1 mg/l are reached within 0.5 - 4 h post administration. Peak and trough plasma concentrations at steady-state (400 mg once daily) were 3.2 and 0.6 mg/l, respectively. At steady-state the exposure within the dosing interval is approximately 30% higher than after the first dose. Distribution Moxifloxacin is distributed to extravascular spaces rapidly; after a dose of 400 mg an AUC of 35 m∙gh/l is observed. The steady-state volume of distribution (Vss) is approximately 2 l/kg. _In vitro _ and _ex vivo _ experiments showed a protein binding of approximately 40 - 42% independent of the concentration of the drug. Moxifloxacin is mainly bound to serum albumin. The following peak concentrations (geometric mean) were observed following administration of a single oral dose of 400 mg moxifloxacin: TISSUE CONCENTRATION SITE: PLASMA RATIO Plasma 3.1 mg/l - Saliva 3.6 mg/l 0.75 - 1.3 Blister fluid 1.6 1 mg/l 1.7 1 Bronch Прочетете целия документ