Land: Malasía
Tungumál: enska
Heimild: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
LEVOFLOXACIN HEMIHYDRATE
DKSH MALAYSIA SDN BHD
LEVOFLOXACIN HEMIHYDRATE
8tablet Tablets
Pymepharco Joint Stock Company
_Consumer Medication Information Leaflet (RiMUP) _ LEVOQUIN FILM COATED CAPLET Levofloxacin hemihydrate (250mg, 500mg) 1 WHAT IS IN THIS LEAFLET 1. What Levoquin is used for 2. How Levoquin works 3. Before you use Levoquin 4. How to use Levoquin 5. While you are using it 6. Side effects 7. Storage and disposal of Levoquin 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision This leaflet refers to Levoquin. Please read it carefully before you start to take it. Because this leaflet does not tell you everything about your medicine, if you have any questions or are not sure about everything, ask your doctor or pharmacist. WHAT LEVOQUIN IS USED FOR Levoquin can be used to treat infections of the: Sinuses Lungs, in people with long-term breathing problems or pneumonia (inflammation of the lungs which causes breathlessness, cough and raised temperature) Urinary tract, including your kidneys or bladder Prostate gland, complication from urinary tract infection, UTI (mild and moderate bacteria infections) Skin and underneath the skin, including muscles. This is sometimes called ‘soft tissue’ HOW LEVOQUIN WORKS Levoquin contains a medicine called levofloxacin. This belongs to a group of medicines called antibiotics. Levofloxacin is a ‘quinolone’ antibiotic. It works by killing the bacteria that cause infections in your body. BEFORE YOU USE LEVOQUIN _-_ _ _ _When you must not use it _ Do not take Levoquin if you are allergic to levofloxacin, or other quinolone antibiotics or any of the product components. _-_ _ _ _Pregnancy and lactation _ Do not take this medicine if: You are pregnant, might become pregnant or think you may be pregnant. You are breast-feeding or planning to breast-feed. Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding. _-_ _ _ _Before you start to use it _ Tell your healthcare provider about all your medical conditions, including if you: Have tendon problem Have central Lestu allt skjalið
LEVOQUIN 250 / 500 COMPOSITION LEVOQUIN 250: _Active Ingredient:_ Each film – coated caplet contains levofloxacin hemihydrate equivalent to 250 mg of levofloxacin. LEVOQUIN 500: _Active Ingredient:_ Each film – coated caplet contains levofloxacin hemihydrate equivalent to 500 mg of levofloxacin. _Other Ingredients:_ Maize starch, lactose, croscarmellose sodium, povidone, sodium starch glycolate, magnesium stearate, colloidal silicon dioxide, HPMC, PEG 6000, titanium dioxide, quinoline yellow and purified water. PHARMACODYNAMICS Levofloxacin is the L-isomer of the racemate, ofloxacin, a quinolone antimicrobial agent. The antibacterial activity of ofloxacin resides primarily in the L-isomer. The mechanism of action of levofloxacin and other fluoroquinolone antimicrobials involves inhibition of bacterial topoisomerase IV and DNA gyrase (both of which are type II topoisomerases), enzymes required for DNA replication, transcription, repair and recombination. PHARMACOKINETICS _ABSORPTION _ Orally administered levofloxacin is rapidly and almost completely absorbed with peak plasma concentrations being obtained within 1 h. The absolute bioavailability is approximately 100 %. Food has little effect on the absorption of levofloxacin. _DISTRIBUTION _ Approximately 30 - 40 % of levofloxacin is bound to serum protein. 500 mg once daily multiple dosing with levofloxacin showed negligible accumulation. There is modest but predictable accumulation of levofloxacin after doses of 500 mg twice daily. Steady-state is achieved within 3 days. _Penetration _ _into _ _Bronchial _ _Mucosa, _ _Epithelial _ _Lining _ _Fluid (ELF)_ Maximum levofloxacin concentrations in bronchial mucosa and epithelial lining fluid after 500 mg p.o. were 8.3 μg/g and 10.8 μg/ml respectively. These were reached approximately one hour after administration. _Penetration into Lung Tissue_ Maximum levofloxacin concentrations in lung tissue after 500 mg p.o. were approximately 11.3 μg/g and were reached between 4 and 6 hours after administration. Th Lestu allt skjalið