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

Logo METROSTAT 200 mg TABLETS
METROSTAT 400 mg TABLETS

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

METROSTAT 200 mg TABLETS
METROSTAT 400 mg TABLETS

COMPOSITION:
Each tablet contains:
200 mg Tablet: 
Metronidazole         200 mg
Nipastat (preservative) 0,122% m/m
400 mg Tablet: 
Metronidazole         400 mg
Nipastat (preservative) 0,122% m/m

PHARMACOLOGICAL CLASSIFICATION:
A. 20.2.6Antimicrobial (chemo-therapeutic) agents. Medicines against protozoa.

PHARMACOLOGICAL ACTION:
Metrostat hasantiparasitic and antimicrobial properties.

INDICATIONS:
Trichomoniasis in both sexes, amoebiasis and giardiasis as well as for a variety of infections caused by anaerobic bacteria including Bacteroides fragilis.

CONTRA-INDICATIONS:
Contra-indicated in patients with blood dyscrasias or with active disease of the central nervous system, pregnancy and lactating mothers.

WARNINGS:
When given in conjunction with alcohol, metronidazole may provoke a disuifiramlike reaction in some individuals. It also enhances the anticoagulant effect of warfarin. Pseudomembranous colitis has been reported with the use of metronidazole.

DOSAGE AND DIRECTIONS FOR USE:
Tablets should be taken after a meal.
Vaginal trichomoniasis: 600 - 800 mg daily in divided doses for seven (7) days. If the course is to be repeated 4 - 6 weeks should elapse between courses and leucocyte counts should be carried out before, during and after each course of treatment. A single oral dose of 2 g has been reported to be effective. If a male partner is to be treated then the same dosage is to be used over the same 7 day period.
Amoebiasis: 800 mg three times daily for 5 - 10 days. For children the dose is 35 - 50 mg/kg per day in 3 divided doses for 10 days. The treatment is least effective in the asymptomatic passer of cysts. Resistance of E. histomica to metronidazole has not occurred.
Giardiasis: Metronidazole is effective in the same dosage asthat used for the treatment of trichomoniasis. 2 g daily for 3 successive days is also successful.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Gastro-intestinal discomfort, anorexia, nausea, coated tongue, dry mouth and unpleasant taste, headache, pruritus and skin rash may occur.
Less frequently vomiting, diarrhoea, weakness, vertigo, ataxia, depression, insomnia, drowsiness, urethral discomfort and darkening of the urine may occur.
There may be temporary moderate leucopenia. Peripheral neuropathy has been reported in patients on prolonged therapy.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
As under side-effects.
Treatment: Symptomatic and supportive. In case of overdosage consult your doctor or take the patient to the nearest hospital.

IDENTIFICATION:
200 mg tablet:        A white, normal convex, bisected tablet measuring 9,53 mm in diameter.
400 mg tablet:        A white, normal convex, bisected tablet measuring 12,7 mm in diameter.

PRESENTATION:
Containers with 500 tablets.

STORAGE INSTRUCTIONS:
Store below 30°C in wellclosed containers and protect from light. Keep out of reach of children.

REGISTRATION NUMBER:
Metrostat 200 mg tablet - V/20.2.6/12.
Metrostat 400 mg tablet - V/20.2.6/13.

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Adcock Ingram Limited
Adcock Ingram Park
17 Harrison Avenue, Bryanston Ext. 77
Private Bag X69, Bryanston, 2021

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
29/9/88

New addition to this site: May 2004
Source: Pharmaceutical Industry

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