INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo NEOMYCIN SULPHATE STERILE INTRAMED (Powder for IM injection)

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

NEOMYCIN SULPHATE STERILE INTRAMED (Powder for IM injection)

COMPOSITION:
A sterile powder for reconstitution with Water for Injections. Each vial contains 500 mg of Sterile
Neomycin Sulphate equivalent to 350 mg Neomycin base.

PHARMACOLOGICAL CLASSIFICATION:
A 20.1 –Antibiotics.

PHARMACOLOGICAL ACTION:
Neomycin sulphate is active in vitro against many strains of Gram-positive and Gram-negative bacteria. Straphylococcus aureus (including stains resistant to other antibiotics), Streptococcus pneumoniae, Str. pyogenes, Escherichia coli, Klebsiella, Haemophilus influenzae, Salmonella typhi, Shigella and Mycobacterium tuberculosis (including strains resistant to streptomycin) are susceptible. It is active against some strains of Proteus vulgaris, Pseudomonas aeruginosa, spirochaetes, actinomycetes and Entamoeba histolytica. It is not active against yeasts, fungi or viruses.

INDICATIONS:
Neomycin sulphate when reconstituted with Water for Injections may be used both topically and by intramuscular injection.
Topically it is used as a solution in infections of the skin and eye, including dermatosis, impetigo, wounds, burns, ulcers, conjunctivitis, blepharitis and sty.
By intramuscular injection, Neomycin sulphate is used in hospitalised patients suffering from serious systemic infections caused by such gram-positive organisms as Klebsiella pneumoniae, Hemophilus influenza, Proteus vulgaris or Pseudomonas aeruginosa and in urinary infections caused by Proteus vulgaris, Pseudomonas aeruginosa, Aerobacter aerogenes or Escherichia coli when these infections resist other less toxic agents.

CONTRA-INDICATIONS:
Neomycin sulphate is contra-indicated, parenterally, when either renal function or hearing is impaired and when sensitivity is produced by its topical use.

WARNINGS:
Renal damage indicated by albuminuria, granular casts and oliguria, partial or total deafness, which may be permanent, and vestibular dysfunction have been reported following parenteral administration of neomycin for a few days.

DOSAGE AND DIRECTIONS FOR USE:
Intramuscular as a sterile solution 10 mg to 15 mg of Neomycin sulphate per kg body mass daily.
Topically as aqueous solution.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
The severity and persistence of symptoms depends on the dosage given and the duration of therapy. The renal symptoms usually disappear when the drug is withdrawn, but the ototoxicity is irreversible.
Its topical application may produce signs of sensitivity or allergic sensitivity.
Blood and urine of patients receiving parenteral neomycin should be examined frequently for evidence of renal damage and audiometric tests should be carried out.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Please see Side-effects and special precautions.

IDENTIFICATION:
A white powder filled into an amber vial.

PRESENTATION:
Single vials, 10 and 100 vials per container.

STORAGE INSTRUCTIONS:
Store below 25°C.
Discard unused portion.
Keep out of reach of children.

APPLICATION NUMBER:
A408 (Act 101/1965)

NAME AND BUSINESS ADDRESS OF APPLICANT:
INTRAMED (Pty) Ltd
6 Gibaud Road
Port Elizabeth 6001

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
August 1968. 12-264/10-94
  Tradepak PE

SAEPI HOME PAGE      TRADE NAME INDEX      GENERIC NAME INDEX      FEEDBACK
Information presented by Malahyde Information Systems © Copyright 1996-2004