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Logo ADCO-METRONIDAZOLE 200 mg Tablets
ADCO-METRONIDAZOLE 400 mg Tablets

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

ADCO-METRONIDAZOLE 200 mg Tablets
ADCO-METRONIDAZOLE 400 mg Tablets

COMPOSITION.
Each ADCO-METRONIDAZOLE 200 mg Tablet contains
metronidazole 200 mg.
Each ADCO-METRONIDAZOLE 400 mg Tablet contains metronidazole 400 mg.

PHARMACOLOGICAL CLASSIFICATION:
A 20.2.6 Medicines against Protozoa

PHARMACOLOGICAL ACTION:
Metronidazole is an anti-protozoal agent effective against Trichomonas vaginalis, Entamoeba histolytica and in giardiasis. Metronidazole is useful for the treatment of infections caused by various anaerobic bacteria, particularly Bacteroides fragilis.

INDICATIONS:
Urogenital trichomoniasis
Amoebiasis
Giardiasis
Ulcerative gingivitis (Vincent's infection)
Infections caused by anaerobic bacteria, especially Bacteroides fragilis.
As a prophylactic in postsurgical abdominal and pelvic infections.

CONTRA-INDICATIONS:
ADCO-METRONIDAZOLE Tablets
should not be used in patients with blood dyscrasias or with active disease of the central nervous system, or during pregnancy or lactation.

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

DOSAGE AND DIRECTIONS FOR USE:
Tablets should preferably be swallowed whole with half a glassful of water during or after meals.
1. UROGENITAL TRICHOMONIASIS
        Both male and female should be treated.
200 mg Tablet:
  Adults:
  10 tablets daily as a single dose for one day; or 1 tablet three times daily for seven days.
  Children 7 - 10 years:
  ½ tablet three times daily for seven days.
  Children 3 - 7 years:
  ½ tablet twice daily for seven days.
  Children 1 - 3 years:
  ¼ tablet three times daily for seven days.
400 mg Tablet:
  Adults:
  5 tablets daily as a single dose for one day; or 1 tablet morning and night for five days.

2. AMOEBIASIS
SUSCEPTIBLE PATIENTS:
200 mg Tablet:
  Adults:
  4 tablets three times daily for five to ten days.
  Children 7 - 10 years:
  2 tablets three times daily for five to ten days.
  Children 3 - 7 years:
  1 tablet four times daily for five to ten days.
  Children 1 - 3 years:
  1 tablet three times daily for five to ten days.
400 mg Tablet:
  Adults:
  2 tablets three times a day for five to ten days;
or 5 tablets daily as a single dose for three days.

LESS SUSCEPTIBLE PATIENTS AND IN CHRONIC AMOEBIC HEPATITIS:
200 mg Tablet:
  Adults:
  2 tablets three times a day for five to ten days or 10 tablets daily as a single dose for two days.
  Children 7 - 10 years:
  1 tablet three times daily for five to ten days.
  Children 3 - 7 years:
  ½ tablet four times daily for five to ten days.
  Children 1 - 3 years:
  ½ tablet three times daily for five to ten days.
400 mg Tablet:
  Adults:
  1 tablet three times a day for five to ten days; or 5 tablets daily as a single dose for two days.

AMOEBIC LIVER ABSCESS AND OTHER FORMS OF EXTRA-INTESTINAL AMOEBIASIS:
200 mg Tablet:
  Adults:
  2½ - 4 tablets three times a day for five to ten days; or 10 tablets daily as a single dose for two days.
  Children 7 - 10 years:
  1 tablet three times daily for five to ten days.
  Children 3 - 7 years:
  ½ tablet four times daily for five to ten days.
  Children 1 - 3 years:
  ½ tablet three times daily for five to ten days.
400 mg Tablet:
  Adults:
  1 - 2 tablets three times daily for five days; or 5 tablets daily as a single dose for two days.

SYMPTOMLESS PATIENTS WHO HAVE PASSED CYSTS:
200 mg Tablet:
  Adults:
  2 - 4 tablets three times a day for five to ten days.
  Children 7 - 10 years:
  1 - 2 tablets three times daily for five to ten days.
  Children 3 - 7 years:
  ½ - 1 tablet four times daily for five to ten days.
  Children 1 - 3 years:
  ½ - 1 tablet three times daily for five to ten days.
400 mg Tablet:
  Adults:
  1 tablet three times daily for five to ten days.

3. GIARDIASIS:
        It may be necessary to repeat the treatment after two weeks of finishing the first course.
200 mg Tablet:
  Adults:
  10 tablets daily as a single dose for three days.
  Children 7 - 10 years:
  5 tablets daily as a single dose for three days.
  Children 3 - 7 years:
  3 - 4 tablets daily as a single dose for three days.
  Children 1 - 3 years:
  2½ tablets daily as a single dose for three days.
400 mg Tablet:
  Adults:
  5 tablets daily as a single dose for three days.

4. ULCERATIVE GINGIVITIS (VINCENT'S INFECTION):
200 mg Tablet:
  Adults:
  1 tablet three times daily for three days.
  Children 7 - 10 years:
  ½ tablet three times daily for three days.
  Children 3 - 7 years:
  ½ tablet twice daily for three days.
  Children 1 - 3 years:
  ¼ tablet three times daily for three days.
400 mg Tablet:
  Adults:
  One tablet night and morning for three days.

5. ANAEROBIC INFECTIONS:
  ADCO-METRONIDAZOLE Tablets may be given either alone or as a supplement to other antibacterial medicines.
TREATMENT:
  Adults:
  400 mg three times daily for seven days.
  Children and Infants:
  7,5 mg/kg bodyweight three times daily, for seven days.
PREVENTION:
  Adults:
  2 g by mouth as a single dose on admission, then 200 mg three times daily for seven days after surgery.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
The side-effects of ADCO-METRONIDAZOLE Tablets include gastro-intestinal discomfort, anorexia, nausea, coated tongue, dryness of the mouth and an unpleasant taste, headaches and skin rashes and, less frequently, vertigo, depression, insomnia, drowsiness, urethral discomfort and darkening of the urine. There may be a temporary decrease in the total white cell count.
ADCO-METRONIDAZOLE Tablets should be avoided during pregnancy. When given in conjunction with alcohol, ADCO-METRONIDAZOLE Tablets may produce a disulfiram-like reaction. ADCO-METRONIDAZOLE Tablets enhance the anticoagulant effect of warfarin.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Early gastric lavage is recommended.

IDENTIFICATION:
200 mg: Convex, white tablet with ADCO embossed on one side.
400 mg: Convex, white tablet with ADCO embossed on one side.

PRESENTATION:
200 mg: Securitainers of 21 and 250 tablets.
400 mg: Securitainers of 10 and 100 tablets.

STORAGE INSTRUCTIONS:
Store below 25°C. Protect from light. Keep out of reach of children.

REGISTRATION NUMBER:
ADCO-METRONIDAZOLE 200 mg Tablets
: R/20.2.6/187
ADCO-METRONIDAZOLE 400 mg Tablets: R/20.2.6/188

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

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
30 May 1988

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

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