Neomycin 500mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Neomycin sulfate

Available from:

Alliance Healthcare (Distribution) Ltd

ATC code:

A07AA01

INN (International Name):

Neomycin sulfate

Dosage:

500mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05010400

Summary of Product characteristics

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