Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ERYTHROMYCIN STEARATE
DYNAPHARM (M) SDN BHD
ERYTHROMYCIN STEARATE
1000 Tablet Tablets
DYNAPHARM (M) SDN BHD
Consumer Medication Information Leaflet (RiMUP) DYNA ERYTHROMYCIN TABLET Erythromycin Stearate (250 mg) Page 1 What is in this leaflet 1. What Dyna Erythromycin Tablet is used for 2. How Dyna Erythromycin Tablet works 3. Before you use Dyna Erythromycin Tablet 4. How to use Dyna Erythromycin Tablet 5. While you are using it 6. Side effects 7. Storage and Disposal of Dyna Erythromycin Tablet 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision What Dyna Erythromycin Tablet is used for Dyna Erythromycin Tablet is used in treatment of - Respiratory tract infection. - Ear and eye infections. - Gastrointestinal infection. - Skin and soft tissue infections. - Gonorrhoea / syphilis (sexually transmitted infection) - Whooping cough. How Dyna Erythromycin Tablet works Erythromycin is a macrolide antibiotic. It works by killing bacteria which cause infections. Before you use Dyna Erythromycin Tablet - When you must not use it Do not take Dyna Erythromycin Tablet if: - you are allergic to Erythromycin or any other ingredients of this medicine (listed in Product Description) - you are taking astemizole, terfenadine (used to treat allergic inflammatory conditions) - Before you start use it Pregnancy and lactation Please consult your doctor or pharmacist if you are pregnant, planning for pregnancy or breastfeeding before using any medicine. Erythromycin is secreted into the breast milk. Please consult your doctor or pharmacist before taking Dyna Erythromycin while breastfeeding. Tell your doctor if you have: - Impaired liver function - Heart rhythm disorder - Hearing impairment or problems - Taking other medicines Tell your doctor if you are taking: - Astemizole, terfenadine (medicine to treat allergic inflammatory conditions) - Digoxin (medicine to treat heart rythym disorder) - Ergotamine (medicine to treat migraine) - Penicillin, lincomycin, methenamine (antibiotics) - Lovastatin (medicine to lower cholesterol level) - Alfentanil (medicine to relieve pain) - Blood thinning agent - Hyda Baca dokumen lengkap
DYNA ERYTHROMYCIN TABLET MAL19962105AZ DESCRIPTION: TABLET Colour : Pink Shape : Round / Biconvex Coating : Film-coated EACH TABLET CONTAINS: Erythromycin Stearate ∗ 420 mg equivalent to Erythromycin .................. 250 mg ∗ Approximate potency equivalent to not less than 600 µg of Erythromycin per mg. PHARMACODYNAMICS: Erythromycin is a macrolide antibiotic. It interferes with bacterial protein synthesis by binding to the 50S subunit of ribosomes. It is bacteriostatic or bactericidal depending on its concentration and the type of organism. Activity increases with increases in pH up to about pH 8.5. The minimum inhibitory concentrations of Erythromycin for sensitive micro- organisms have been reported to range from less than 0.1 to about 2 µg per ml. PHARMACOKINETICS: Erythromycin base is unstable in gastric acid and food may reduce the absorption of the base or the stearate. After absorption, Erythromycin diffuses readily into most body fluids. In the absence of meningeal inflammation, low concentrations are normally achieved in the spinal fluid but passage of the drug across the blood-brain-barrier increases in meningitis. In the presence of normal hepatic function, Erythromycin is concentrated in the liver and excreted in the bile; the effect of hepatic dysfunction on excretion of Erythromycin by the liver into the bile is not known. After oral administration, < 5% of the activity of the administered dose can be recovered in the urine. Erythromycin crosses the placental barrier but foetal plasma levels are low. INDICATION: Upper and lower respiratory tract infection, ear and eye infections, gastrointestinal, skin and soft tissue infections. Gonorrhoea, Syphilis and Whooping cough. RECOMMENDED DOSAGE: Adults: Usual dose: 250 mg 4 times daily. Dosage may be increased up to 4 g/day according to the severity of the infection. Children: 30-50 mg/kg/day, in divided doses. For more severe infections, this dose may be doubled. Optimum serum levels of Erythromycin may be reached if taken in the fasting state o Baca dokumen lengkap