NIVEMYCIN

Posology 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. Paediatric population 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. Page 2 For practical reasons, use of the tablets in children under 6 years is not recommended. Hepatic impairment 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. Elderly The elderly dose is the same as for adults. Method of administration For oral use

Adverse reactions are listed as per System Organ Class. The following adverse reactions have been observed at the frequencies defined using Not known frequency (cannot be estimated from the available data). System organ class Undesirable effects Infections and infestations superinfection may occur, especially with prolonged oral treatment Blood and lymphatic system disorders blood disorder haemolytic anaemia Immune system disorders hypersensitivity reactions including dermatitis, pruritus, pyrexia and anaphylactic reaction.

Metabolism and nutrition disorders *electrolyte imbalance Nervous system disorders confusion paraesthesia disorientation nystagmus, Ear and labyrinth disorders Ototoxicity Page 5 Gastrointestinal disorders nausea vomiting diarrhoea salivary hypersecretion stomatitis **malabsorption syndrome with steatorrhoea and diarrhoea Renal and urinary disorders nephropathy toxic Investigation hepatic enzyme increased blood bilirubin increased Cross sensitivity reaction with other aminoglycosides may occur.

*notably hypomagnesaemia but also hypocalcaemia and hypokalaemia have occurred with other aminoglycosides. **which can be severe, may be caused by prolonged oral therapy. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store

The absorption of neomycin is poor from the alimentary tract, with about 97% of an orally administered dose being excreted unchanged in the faeces. 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 aminoglycosides by individual monitoring. Some authorities consider that monitoring is also important in obese patients and those with cystic fibrosis.

Impaired hepatic function or auditory function, bacteraemia, fever, and possibly exposure to loud noises have been reported to increase the risk of ototoxicity, while volume depletion or hypotension, liver disease, or female sex have reported as additional risk factors for nephrotoxicity.

Regular assessment of auditory, vestibular and renal function is particularly necessary in patients with additional risk factors. 1555A>G mutation, including cases where the patient’s aminoglycoside serum levels were within the recommended range.

Some cases were associated with a maternal history of deafness and/or mitochondrial mutation. While no cases were Page 3 identified with neomycin, based on a shared mechanism of action there is the potential for a similar effect with neomycin.

These mitochondrial mutations are rare, and the penetrance of this observed effect is unknown. When used as an adjunct in the management of hepatic coma, care should be taken that administration is of the minimal period necessary, since prolonged exposure to the drug may result in malabsorption.

Neomycin should be used with caution in patients with neuromuscular disorders and Parkinsonism. There is almost complete cross-resistance between neomycin, kanamycin, paromomycin and framycetin. Cross-resistance with gentamicin has also been reported.

1 Neomycin tablets should not be given when intestinal obstruction is present. Hypersensitivity to aminoglycosides. Infants under 1 year. Myasthenia gravis