Valsts: Malaizija
Valoda: angļu
Klimata pārmaiņas: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
AZITHROMYCIN DIHYDRATE
SYNERRV SDN BHD
AZITHROMYCIN DIHYDRATE
3 Tablets
KUSUM HEALTHCARE PVT. LTD.
_Consumer Medication Information Leaflet (RiMUP) _ ZIOMYCIN 250/500 AZITHROMYCIN TABLETS 250MG/500MG 1 WHAT IS IN THIS LEAFLET 1. What Ziomycin is used for 2. How Ziomycin works 3. Before you use Ziomycin 4. How to use Ziomycin 5. While you are using it 6. Side effects 7. Storage and Disposal of Ziomycin 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial number WHAT ZIOMYCIN IS USED FOR _Azithromycin_ belongs to macrolide antibiotics, known as azalides. It is used to treat bacterial infections. Ziomycin is used in the treatment of the following infections: • Of the lower respiratory tract: bronchitis (inflammation of bronchi) and pneumonia (inflammation of lung’s air sacs). • Of the upper respiratory tract: sinusitis (inflammation of sinus lining) and pharyngitis/tonsillitis (inflammation of throat/tonsils). • Acute otitis media (ear infection). • Of the skin and soft tissues. • Sexually-transmitted diseases: Uncomplicated genital infections caused by Chlamydia Trachomatis or Neisseria gonorrhoea, chancroid caused by Haemophilus ducreyi. HOW ZIOMYCIN WORKS Ziomycin works by suppressing the protein synthesis in bacteria, by binding to ribosomal subunit 50s which causes inhibition in peptide translocation. BEFORE YOU USE ZIOMYCIN _When you must not use it _ Do not take Ziomycin if you are allergic to azithromycin, other macrolide or ketolide antibiotics, or any of the excipients of Ziomycin. _Pregnancy and lactation _ Do not use Ziomycin if you are pregnant, trying to get pregnant or think you may be pregnant. Do not use Ziomycin 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 Izlasiet visu dokumentu
ZIOMYCIN ® AZITHROMYCIN TABLETS 250 MG AZITHROMYCIN TABLETS 500 MG _ _ _COMPOSITION _ Each film coated tablet contains; Azithromycin dihydrate 262.05 mg equivalent to Azithromycin USP 250 mg Azithromycin dihydrate 524.10 mg equivalent to Azithromycin USP 500 mg _EXCIPIENTS: _ Microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulphate, povidone, isopropyl alcohol, purified talc, magnesium stearate, opadry yellow 04B520005 and purified water. PRODUCT DESCRIPTION Yellow colored, capsule shaped film-coated tablets with engraved “A250/A500” on one side and plain on other side. PHARMACEUTICAL FORM: Film coated tablets PHARMACOLOGICAL PROPERTIES PHARMACODYNAMIC PROPERTIES: PHARMACOTHERAPEUTIC GROUP: MACROLIDES, ATC CODE J01FA MODE OF ACTION Azithromycin is the first of a subclass of macrolide antibiotics, known as azalides, and is chemically different from erythromycin. Chemically it is derived by insertion of a nitrogen atom into the lactone ring of erythromycin A. The chemical name of azithromycin is 9-deoxy- 9a-aza- 9a- methyl-9a-homoerythromycin A. The molecular weight is 749.0. Azithromycin binds to the 23S rRNA of the 50S ribosomal subunit. It blocks protein synthesis by inhibiting the transpeptidation/translocation step of protein synthesis and by inhibiting the assembly of the 50S ribosomal subunit. CARDIAC ELECTROPHYSIOLOGY Co-administration of azithromycin increased the QTc interval in a dose- and concentration- dependent manner. MECHANISM OF RESISTANCE The two most frequently encountered mechanisms of resistance to macrolides, including azithromycin, are target modification (most often by methylation of 23S rRNA) and active efflux. The occurrence of these resistance mechanisms varies from species to species and, within a species, the frequency of resistance varies by geographical location. The most important ribosomal modification that determines reduced binding of macrolides is post-transcriptional (N6) -dimethylation of adenine at nucleotide A2058 (Escherichia coli numbering system) of t Izlasiet visu dokumentu