Nazione: Malesia
Lingua: inglese
Fonte: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
AZITHROMYCIN DIHYDRATE
MEDISPEC (M) SDN.BHD
AZITHROMYCIN DIHYDRATE
1 x 3 Tablets; 2 x 3 Tablets
Sunshine Lake Pharma Co., Ltd.
AZITHROMYCIN-HEC ® 250MG FILM-COATED TABLET AZITHROMYCIN-HEC ® 500MG FILM-COATED TABLET Azithromycin dihydrate equivalent to azithromycin (250mg, 500mg) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What _Azithromycin-HEC _ is used for 2. How _Azithromycin-HEC_ works 3. Before you use _Azithromycin-HEC_ 4. How to use _Azithromycin-HEC _ 5. While you are using it 6. Side effects 7. Storage and Disposal of _Azithromycin-HEC _ 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT _AZITHROMYCIN-HEC _IS USED FOR _Azithromycin-HEC_ is used to treat a number of infections including: Infection of the lungs, sinus, and throat. Skin and soft tissue infection Infection of the ears Treatment of genital infection (eg, _Chlamydia trachomatis, _ chancroid _, _ _Neisseria gonorrhoeae)_ HOW _AZITHROMYCIN-HEC _WORKS Azithromycin is a macrolide antibiotic belonging to the azalide group. The mechanism of action is based upon the suppression of bacterial protein synthesis. BEFORE YOU USE _AZITHROMYCIN-HEC _ _When you must not use it _ - if you are allergic to azithromycin, erythromycin, any macrolide or ketolide antibiotic, or any of the other ingredients of this medicine. - if your children weigh less than 45kg _Pregnancy and lactation _ Do not take _Azithromycin-HEC_ if you are pregnant, trying to get pregnant or think you may be pregnant. Do not take _Azithromycin-HEC_ if you are breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine. - _Before you start to use it _ -Talk to your doctor or pharmacist before taking _Azithromycin-HEC _ tablets • If you have any heart disease _ _ • If you have kidney problems _ _ _ _ • If you have liver problems _ _ • If you have myasthenia gravis (weakness and rapid tiredness of any of the muscles) _ _ • If you have or had any medical problems or any allergies/skin reactions. _ _ • If you are taking medicines derived from ergot alkaloids _ _ • If you have signs of Leggi il documento completo
Page 1 PRODUCT NAME AZITHROMYCIN-HEC 250 MG FILM-COATED TABLETS - Each film-coated tablet contains 262.05 mg azithromycin dihydrate equivalent to 250 mg azithromycin. AZITHROMYCIN-HEC 500 MG FILM-COATED TABLETS - Each film-coated tablet contains 524.1 mg azithromycin dihydrate equivalent to 500 mg azithromycin. PRODUCT DESCRIPTION _Azithromycin-HEC 250 mg film-coated tablets _ White or almost white, capsular shaped film-coated tablets, inscribed “S19” on one side and blank on the other side. _Azithromycin-HEC 500 mg film-coated tablets _ White or almost white, capsular shaped film-coated tablets, inscribed “S5” on one side and scored on the other side. PHARMACOLOGICAL PROPERTIES PHARMACODYNAMIC PROPERTIES Pharmacotherapeutic group: Antibacterials for systemic use; macrolides, ATC Code: J01FA10. Azithromycin is a macrolide antibiotic belonging to the azalide group. The molecule is constructed by adding a nitrogen atom to the Iactone ring of erythromycin A. The chemical name of azithromycin is 9-deoxy-9a-aza-9a-methyl-9a-homo-erythromycin A. The molecular weight is 749.0. _Mechanism of action_ The action mechanism of azithromycin is based upon the suppression of bacterial protein synthesis, by binding to the 50 S subunit and thus inhibiting the translocation of peptides. _Mechanism of resistance_ Generally, the resistance of different bacterial species to macrolides has been reported to occur by three mechanisms associated with target site alteration, antibiotic modification, or altered antibiotic transport (efflux). The efflux in streptococci is conferred by the _mef _ genes and results in a macrolide- restricted resistance (M phenotype). Target modification is controlled by _erm_ encoded methylases. A complete cross-resistance exists among erythromycin, azithromycin, other macrolides and lincosamides for _Streptococcus pneumoniae_ , beta-haemolytic streptococci of group A, _Enterococcus_ spp. and _Staphylococcus aureus_ , including methicillin-resistant _S. aureus_ (MRSA). Penicillin-sensitive _S._ _pneum Leggi il documento completo