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

Logo NAROBIC CAPSULES

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

NAROBIC CAPSULES

COMPOSITION:
Capsules containing 200 mg
metronidazole.

PHARMACOLOGICAL CLASSIFICATION:
A 20.2.6 Medicines against protozoa.

PHARMACOLOGICAL ACTION:
Metronidazole is trichomonacidal, amoebicidal, and is active against anaerobic bacteria including Bacteroides species.

INDICATIONS:
Urogenital trichomoniasis.
All forms of amoebiasis except asymptomatic carrier state.
Giardiasis.
Acute phase of Vincent's disease.
Infections caused by anaerobic bacteria.

CONTRA-INDICATIONS:
Metronidazole should not be used in patients with blood dyscrasias or with active disease of the central nervous system. Its use should be avoided during the first trimester of pregnancy.

WARNINGS:
Pseudomembranous colitis has been reported with the use of metronidazole.

DOSAGE AND DIRECTIONS FOR USE:
a) In Trichomoniasis
  Adults and children over 10 years:
  200 mg thrice daily after food for 7-10 days. If there is no response a second course of treatment may be given for 7 days after an interval of 4 - 6 weeks. The white cell count should be monitored.
  Children 3 - 10 years:
  200 mg daily in divided doses after food.
b) In the treatment of acute and chronic hepatic or intestinal amoebiasis:
  Adults:
  A single dose of 2 to 2,4 g may be given for 2 or 3 consecutive days. Alternately 400 to 800 mg may be given thrice daily for 5 - 10 days.
c) In Giardiasis:
  Adults:
  2 g daily for 3 successive days.
  Children 3 - 7 years:
  600 mg daily for 3 successive days.
  Children 7 - 10 years:
  1 g daily for 3 successive days.
  Infants:
  400 mg daily for 3 successive days.
d) In Vincent's Disease:
  Adults:
  200 mg thrice daily or 400 mg twice daily is given for 3 days.
e) Anaerobic Infections:
  Adults
  400 mg thrice daily for at least 7 days.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side effects of metronidazole include gastro-intestinal discomfort, anorexia, nausea, coated tongue, dryness of mouth and unpleasant taste, headache, skin rashes, and not as often, vertigo, depression, insomnia, drowsiness, urethral discomfort and darkening of the urine. There may be a temporary decrease in the white-cell count. When given in conjunction with alcohol metronidazole may provoke a disulfiram-like reaction in some individuals. Metronidazole enhances the effect of warfarin and other anticoagulants.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
There is no specific treatment for overdosage, but early gastric lavage is recommended. Further treatment is symptomatic and supportive.

IDENTIFICATION:
Brown and white capsules.

PRESENTATION:
Plastic containers of 21, 100, 250 & 1000 capsules.

STORAGE INSTRUCTIONS:
Store in a cool dry place (under 25°C) and protect from light and moisture.
Keep out of reach of children.

REGISTRATION NUMBER:
R/20.2.6/3.

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
ALLIANCE PHARMA (PTY) LIMITED.
Co. Reg. No. 89/07635/07
17 Faraday Street
Village Main, Johannesburg

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
AUGUST 1983

PM0505 -3/99

Updated on this site: May 2000

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