País: Malasia
Idioma: inglés
Fuente: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
CLARITHROMYCIN
Y.S.P. INDUSTRIES (M) SDN BHD
CLARITHROMYCIN
100 Tablets
Y.S.P. INDUSTRIES (M) SDN BHD
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ _ _ CLARIMYCIN FILM COATED TABLET Clarithromycin (250mg, 500mg) _ _ 1 WHAT IS IN THIS LEAFLET 1. What CLARIMYCIN FILM COATED TABLET is used for 2. How CLARIMYCIN FILM COATED TABLET works 3. Before you use CLARIMYCIN FILM COATED TABLET 4. How to use CLARIMYCIN FILM COATED TABLET 5. While you are using it 6. Side effects 7. Storage and Disposal of CLARIMYCIN FILM COATED TABLET 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT CLARIMYCIN FILM COATED TABLET IS USED FOR CLARIMYCIN FILM COATED TABLET is used to treat certain bacterial infections, including the following: - Infection of nosepharyns tract (tonsillitis, pharyngitis), and of paranasal sinuses. - Infection of lower respiratory tract such as bronchitis, bacterial pneumonia and atypical pneumonia. - Treatment of skin infections such as impetigo, erysipelas, folliculitis, furunculosis and septic wounds. HOW CLARIMYCIN FILM COATED TABLET WORKS CLARIMYCIN FILM COATED TABLET is an antibiotic that belongs to the group of medicines called macrolides. These medicines work by killing or stopping the growth of bacteria which cause infections. BEFORE YOU USE CLARIMYCIN FILM COATED TABLET - _When you must not use it _ Do not take CLARIMYCIN FILM COATED TABLET if: • You have ever had an allergic reaction to medicines containing clarithromycin and other antibiotics from the macrolide family. Some symptoms of an allergic reaction include skin rash, itching, shortness of breath or swelling of the face, lips or tongue, which may cause difficulty in swallowing or breathing. • You have heart diseases or irregular heartbeat • You have electrolyte disturbances • You are taking medicine such as terfenadine, which is commonly used to treat allergy reaction. - _Before you start to use it _ Tell your doctor if you are allergic to any other medicines, foods, dyes or preservatives. Tell your doctor if you have or have had kidney or liver disease. _Pregnancy and lactation _ Please Leer el documento completo
CLARIMYCIN FILM COATED TABLET INGREDIENT(S): Clarimycin Film Coated Tablet 250mg: Each tablet contains: Clarithromycin ………………….……….………………..……………….………… 250mg Clarimycin Film Coated Tablet 500mg: Each tablet contains: Clarithromycin ………………….……….………………..……………….………… 500mg PHARMACODYNAMICS: 1. Clarithromycin exerts its antibacterial activity by inhibiting the synthesis of proteins, by means of a link with the 50S sub-unit of the cellular ribosome. Clarithromycin has demonstrated excellent _in vitro_ activity against both standard strains of bacteria and clinical isolates. It is highly potent against a wide variety of aerobic and anaerobic gram-positive and gram-negative organisms. PHARMACOKINETICS: 1. ABSORPTION Well absorbed from the gastrointestinal tract; stable in gastric acid; food delays the rate, but not the extent, of absorption; bioavailability is approximately 55% in healthy volunteers. 2. DISTRIBUTION Widely distributed into tissues and fluids; high concentrations found in nasal mucosa, tonsils, and lungs; concentrations in tissues are higher than those in serum because of high intracellular concentrations; readily enters leucocytes and macrophages. Volume of distribution: 243-266 liters. 3. PROTEIN BINDING High (65-75%). 4. BIOTRANSFORMATION Hepatically metabolized via three main pathways, demethylation, hydroxylation, and hydrolysis, to eight metabolites. One metabolite, 14-hydroxyclarithromycin, has _in vitro _antimicrobial activity comparable to that of clarithromycin and may act synergistically with clarithromycin against _Haemophilus _ _influenzae_. Saturation of metabolism involves the demethylation and hydroxylation pathways, and accounts for an increase in serum half-life. 5. HALF-LIFE Clarithromycin: 250mg every 12 hours – 3 to 4 hours. 500mg every 12 hours – 5 to 7 hours. 14-hydroxyclarithromycin: 250mg every 12 hours – 5 to 6 hours. 500mg every 12 hours – approximately 7 hours. Norma Leer el documento completo