Țară: Regatul Unit
Limbă: engleză
Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)
Neomycin sulfate
Alliance Healthcare (Distribution) Ltd
A07AA01
Neomycin sulfate
500mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05010400
1. TRADE NAME OF THE MEDICINAL PRODUCT Nivemycin Tablets 500mg Neomycin 500mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Neomycin sulphate Ph Eur. an amount equivalent to 550mg of material having a potency of 700 units per mg. 3 PHARMACEUTICAL FORM Tablets. 4.1. THERAPEUTIC INDICATIONS Neomycin tablet (Neomycin sulphate BP) is indicated for pre-operative sterilisation of the bowel and may be useful in the treatment of impending hepatic coma, including portal systemic encephalopathy. For oral administration. _4.2 _ _POSOLOGY AND METHOD OF ADMINISTRATION _ Pre-operative sterilisation of the bowel. Adults: 2 tablets every hour for 4 hours; then 2 tablets every 4 hours for two or three days before the operation. Children over 12 years: 2 tablets every 4 hours for 2 or 3 days before the operation. Children from 6 to 12 years: ½ to 1 tablet every 4 hours for 2 or 3 days before the operation. For practical reasons, use of the tablets in children under 6 years is not recommended. In hepatic coma, the adult dose is 4-12 gm/day in divided doses for a period of 5-7 days, whilst for children, 50-100mg/kg/day in divided doses appears appropriate. Chronic hepatic insufficiency may require up to 4gm/day over an indefinite period. The elderly dose is the same as for adults. 4.3. CONTRA-INDICATIONS Neomycin tablets should not be given when intestinal obstruction is present. Hypersensitivity to aminoglycosides. Page 2 Infants under 1 year. Myasthenia gravis _4.4 _ _SPECIAL WARNINGS AND PRECAUTIONS FOR USE _ The absorption of neomycin is poor from the alimentary tract, with about 97% of an orally administered dose being excreted unchanged in the faeces. Impaired G.I. motility however may increase absorption of the drug and it is therefore possible, as with other broad spectrum antibiotics, that prolonged therapy could result in ototoxicity and nephrotoxicity, particularly in patients with a degree of renal failure. In such patients, and infants and the elderly, it is generally desirable to determine dosage requirements of Citiți documentul complet