Country: Malta
Language: English
Source: Malta Medicines Authority
MIDECAMYCIN
A. Menarini Industrie Farmaceutiche Riunite S.r.L. Via Sette Santi 3, 50131, Florence, Italy
J01FA03
MIDECAMYCIN 600 mg
COATED TABLET
MIDECAMYCIN 600 mg
POM
ANTIBACTERIALS FOR SYSTEMIC USE
Withdrawn
2005-09-23
MIOCAMEN ® MIOCAMYCIN MIOCAMEN 600 MG TABLETS MIOCAMEN 250MG/5ML GRANULATE FOR ORAL SUSPENSION_ _ COMPOSITION _Miocamen 600 mg tablets _ Each film-coated tablet contains: Active ingredient: Diacetyl-midecamycin 600 mg Excipients: hydroxypropylmethyl cellulose, aluminum glycinate, sodium starch glycollate, microcrystalline cellulose, magnesium stearate, polyethylene glycol, talc, titanium dioxide, sunset yellow, erythrosin. _Miocamen granulate for oral suspension _ Each 30 g bottle of granulate contains: Active ingredient: Diacetyl -midecamycin 6 g Excipients: methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, citric acid, anhydrous sodium phosphate, banana flavouring, sodium saccharinate, sunset yellow, hydroxypropylmethyl cellulose, dimeticone, sorbitan palmitate, glyceril stearate, sucrose palmitate, mannitol. FEATURES Miocamycin is a semisynthetic antibiotic of the macrolide family which is active by oral route. The action of this antibiotic, which is based on bacterial protein synthesis inhibition, is exerted on Gram-positive aerobic and anaerobic micro-organism (Streptococci, Staphylococci, Pneumococci, Clostridia, Corynebacteria, Peptococci, Peptostreptococci) and on some Gram-negative ones (B. pertussis, H. influenzae, N. gonorrhoeae, Bacteroides, Chlamydias, Legionella pneumophila), even if beta-lactamase producers. Miocamycin is moreover active on Ureoplasma and on bacterial forms which are wall-less like Mycoplasma pneumoniae and L forms. Miocamycin does not induce crossed resistances towards other macrolide antibiotics and is often active against erythromycin-resistant germs. Miocamycin, which is excellently absorbed orally and in the presence of food, rapidly reaches high blood levels (blood peak after 30’). It binds weakly to plasma proteins; even in the form of active metabolites it diffuses rapidly into biological fluids and tissues where it reaches higher concentrations than in the blood; it is excreted Read the complete document
MIOCAMEN ® SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Miocamen 600- tablets Miocamen granulate 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Miocamen 600- tablets Each coated tablet contains: diacetyl-midecamycin 600 mg. Miocamen granulate Each 30 g bottle of granulate contains: diacetyl-midecamycin 6 g 3. PHARMACEUTICAL FORM Tablets Granulate for oral suspension 4. CLINICAL PARTICULARS. 4.1 THERAPEUTIC INDICATIONS. Infections of the adult and of the child caused by germs susceptible to miocamycin: bronchitis, pneumonia, tonsillitis, pharyngitis, rhinopharyngitis, sinusitis, otitis, otitis media, scarlet fever, furunculosis, pyodermatitis, abscess, phlegmon, etc. It is active also against odontostomatological, genitourinary and biliary tract infections caused by susceptible germs. It is indicated also in patients allergic to penicillin. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION. Children: daily administration is 50 mg/kg/die divided in 2-3 intakes according to the physician's judgment. Body weight Amount of miocamycin to 5 kg 5 to 10 kg 10 to 15 kg 15 to 20 kg 250 mg/die 500 mg/die 750 mg/die 1000 mg/die Adults: daily posology ranges between 900 and 1800 mg divided into 2-3 oral administrations. Average daily administration is 1 tablet of 600 mg every 12 hours. In severe infections, daily dosage may be increased up to 1800 mg in three intakes: 1 tablet of 600 mg every 8 hours. Dosing cup is graduated at 1 to 10 mL corresponding to 50, 100 etc. mg of miocamycin respectively. Preparation of the suspension: slowly add water into the bottle up to the sign and then shake vigorously. The obtained suspension is ready for use and must be stored in refrigerator. Use the suspension within 14 days. Vigorously shake the bottle before each use. 4.3 CONTRA-INDICATIONS. Known hypersensitivity to miocamycin. 4.4 SPECIAL Read the complete document