NIVEMYCIN Tablets (2014)
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Περιεχόμενα
Name of the medicinal product
Nivemycin Tablets 500mg. Neomycin 500mg Tablets.
Qualitative and quantitative composition
Neomycin sulphate Ph Eur. an amount equivalent to 550mg of material having a potency of 700 units per mg.
Pharmaceutical form
Tablets.
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. ...
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 ...
Contraindications
Neomycin tablets should not be given when intestinal obstruction is present. Hypersensitivity to aminoglycosides. Infants under 1 year. Myasthenia gravis.
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 ...
Interaction with other medicinal products and other forms of interaction
Neomycin may impair absorption of other drugs including phenoxymethylpenicillin, digoxin, methotrexate and some vitamins. Aminoglycosides exhibit synergistic activity with a number of beta lactams, but ...
Pregnancy and lactation
The use of neomycin in pregnancy is not recommended unless the benefits outweigh the potential risks. There are no reports linking the use of neomycin to congenital defects. However, small amounts of the ...
Effects on ability to drive and use machines
Not applicable.
Undesirable effects
Nausea, vomiting, diarrhoea, increased salivation, stomatitis, nephrotoxicity, ototoxicity, rise in serum levels of hepatic enzymes and bilirubin, blood dyscrasias, haemolytic anaemia, confusion, paraesthesia, ...
Overdose
In overdose, exacerbation of the adverse events reported for neomycin (nausea, diarrhoea nephrotoxicity, ototoxicity etc.) is expected. Monitor renal and auditory function. If these are impaired, haemodialysis ...
Pharmacodynamic properties
Neomycin is an aminoglycoside antibiotic. Neomycin acts by binding to polysomes, inhibiting protein synthesis and generating errors in the transcription of the genetic code.
Pharmacokinetic properties
The absorption of neomycin from the alimentary tract is poor: Only 3% of an oral dose is absorbed, neomycin is rapidly excreted by the kidneys in the unchanged form. The plasma half-life in healthy adults ...
Preclinical safety data
Not applicable.
List of excipients
Plasdone K29-32 Isopropyl alcohol Calcium stearate
Incompatibilities
Not applicable.
Shelf life
Shelf life: 3 years.
Special precautions for storage
Store below 30°C in a dry place – protect from light.
Nature and contents of container
An amber glass bottle having a tin-plate screw cap with a waxed aluminium-faced pulpboard liner. The ullage is filled with cotton wool. Pack size: 100 tablets.
Special precautions for disposal and other handling
Not applicable.
Marketing authorization holder
Amdipharm UK Limited, Capital House, 85 King William Street, London, EC4N 7BL, UK
Marketing authorization number(s)
PL 20072/0223
Date of first authorization / renewal of the authorization
11<sup>th</sup> January 1999
Date of revision of the text
04/06/2014
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