Country: Malasía
Tungumál: enska
Heimild: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
AZITHROMYCIN DIHYDRATE
CIPLA MALAYSIA SDN BHD
AZITHROMYCIN DIHYDRATE
30Tablet Tablets
CIPLA LTD
_CONSUMER MEDICATION INFORMATION LEAFLET _ _ _ AZEE-500 TABLETS Azithromycin 500mg 1 WHAT IS IN THIS LEAFLET 1. What AZEE is used for 2. How AZEE works 3. Before you use AZEE 4. How to use AZEE 5. While you are using it 6. Side effects 7. Storage and Disposal of AZEE 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial number WHAT AZEE IS USED FOR _Azithromycin _ belongs to macrolide antibiotics, known as azalides. It is used to treat bacterial infections. AZEE is used in the treatment o f the following infections: • Lower respiratory tract: bronchitis (inflammation of bronchi) and pneumonia (inflammation of lung’s air sacs). • Upper respiratory tract: sinusitis (inflammation of sinus lining) and pharyngitis/tonsillitis (inflammation of throat/tonsils). • Acute otitis media (ear infection). • Skin and soft tissues. • Sexually-transmitted diseases: Uncomplicated genital infections caused by Chlamydia Trachomatis or Neisseria gonorrhoea, chancroid caused by Haemophilus ducreyi. HOW AZEE WORKS AZEE works by suppressing the protein synthesis in bacteria, by binding to ribosomal subunit 50s which causes inhibition in peptide translocation. BEFORE YOU USE AZEE _ _ _-When you must not use it _ Do not take AZEE if you are allergic to azithromycin, other macrolide or ketolide antibiotics, or any of the excipients of AZEE. _ _ _ _ _ _ _Pregnancy and lactation _ Do not use AZEE if you are pregnant, trying to get pregnant or think you may be pregnant. Do not use AZEE if you are breast- feeding. Ask your doctor or pharmacist for advice before taking any medicine. _-Before you start to use it _ Tell your doctor if you suffer from any of the following illnesses: • If you have a serious kidney condition. • If you have a severe liver condition. • If you are currently taking ergotamine derivatives and azithromycin. • If you have heart disease or have electrolyte abnormalities or prolonged QT interval. • If you have diarrhoea during or after medication. • If Lestu allt skjalið
_For the use of a Registered Medical Practitioner or a Hospital or a Laboratory only OR for _ _Specialist Use only (as applicable) _ AZEE–500 (AZITHROMYCIN TABLETS 500 MG) COMPOSITION Each film-coated tablet contains: Azithromycin (anhydrous)…………500 mg (As Azithromycin Dihydrate USP) Colour: Titanium Dioxide DOSAGE FORM Tablet PRODUCT DESCRIPTION White to off-white film coated capsule shaped biconvex tablets plain on one side and central breakline on the other. PHARMACOLOGY _PHARMACODYNAMICS _ Azithromycin is an azalide, derived from the macrolide class of antibiotics. The mode of action of azithromycin is inhibition of protein synthesis in bacteria by binding to the 50s ribosomal subunit and preventing translocation of peptides. Azithromycin is usually bacteriostatic. However, in high concentrations, azithromycin may be bactericidal against selected microorganisms. Azithromycin is active against many Gram-positive and Gram-negative aerobic and anaerobic bacteria and bacterial pathogens such as _Mycobacterium _ _avium_ complex, _Mycoplasma_ spp., _Borrelia _ _burgdorferi, Chlamydia_ spp. and _Campylobacter _ spp. In addition, azithromycin has activity against protozoan microorganisms such as _Toxoplasma gondii_ . BREAKPOINTS: According to the NCCLS (National Committee on Clinical Laboratory Standards) in 2001 the following breakpoints have been defined for azithromycin: - 2 μg/ml susceptible; 4 μg/ml intermediate; ≥8 μg/ml resistant - _Haemophilus_ spp.: ≤4 μg/ml susceptible - _Streptococcus pneumoniae _ and _ Streptococcus pyogenes_ : ≤0.5 μg/ml susceptible; - 1 μg/ml intermediate; ≥2 μg/ml resistant There are currently no recommended NCCLS breakpoints for Enterobacteriaceae, _Neisseria _ _gonorrhoeae_ , _Moraxella catarrhalis_ and _Mycobacterium avium complex_ . SUSCEPTIBILITY: The prevalence of acquired resistance may vary geographically and with time for selected species and local information on resistance is desirable, particularly when treating severe infections. As necessary, exper Lestu allt skjalið