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

Logo ANAEROBYL-GOLD 200 TABLETS
ANAEROBYL-GOLD 400 TABLETS

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

ANAEROBYL-GOLD 200 TABLETS
ANAEROBYL-GOLD 400 TABLETS

COMPOSITION:
ANAEROBYL-GOLD 200 tablets contain 200 mg
metronidazole.
ANAEROBYL-GOLD 400 tablets contain 400 mg metronidazole.

PHARMACOLOGICAL CLASSIFICATION:
A 20.2.6 Medicines against protozoa.

PHARMACOLOGICAL ACTION:
Metronidazole possesses trichamonacidal and amoebacidal activity against T. vaginalis and E. histolytica. Metronidazole is active in-vitro against most obligate anaerobes, but does not appear to have any clinically relevant activity against facultative anaerobes or obligate aerobes.

Metronidazole has been shown to have in-vitro activity against the following:
Anaerobic gram-negative bacilli including Bacteroides species (including the B. fragilis group) and the Fusobacterium species.
Anaerobic gram-positive bacilli including Clostridium species and the susceptible strains of Eubacterium.
Anaerobic gram-positive cocci including Peptococcus species and Peptostreptococcus species.

INDICATIONS:
Symptomatic and asymptomatic trichomoniasis (the asymptomatic consorts of patients should also be treated), amoebiasis and giardiasis.
ANAEROBYL-GOLD is indicated in the treatment of infections caused by susceptible anaerobic bacteria. In a mixed aerobic and anaerobic infection antibiotics appropriate for the treatment of the aerobic infection should be used in addition to ANAEROBYL-GOLD.
Intra-abdominal infections, including peritonitis intra-abdominal abscess and liver abscess, caused by Bacteroides species, including the B. fragilis group, Clostridium species, Eubacterium species, and Peptostreptococcus species.
Skin and skin structure infections, caused by Bacteroides species, Clostridium, Peptococcus, Peptostreptococcus, and Fusobacterium species.
Gynaecologic infections, including endometritis, endomyometritis, tubo-ovarian abscess, and post-surgical vaginal cuff infection, caused by Bacteroides, Clostridium, Peptococcus, and Peptostreptococcus species. Bacterial septicaemia caused by Bacteroides and Clostridium species. Bone and joint infections, as adjunctive therapy, caused by Bacteroides species.
Central nervous system (CNS) infections, including meningitis and brain abscess, caused by Bacteroides species.
Lower respiratory tract infections, including pneumonia, empyema and lung abscess, caused by Bacteroides species.
Endocarditis, caused by the Bacteroides species.

CONTRA-INDICATIONS:
ANAEROBYL-GOLD is contra-indicated in patients with a prior history of hypersensitivity to the drug or other nitroimidazole derivatives.
ANAEROBYL-GOLD is also contra-indicated in patients during the first trimester of pregnancy.

DOSAGE AND DIRECTIONS FOR USE:
Trichomoniasis:
In the female. One day treatment:
2 g of ANAEROBYL-GOLD given either as a single dose or in two divided doses of one gram each, given on the same day.
Seven day treatment:
200 mg three times daily for 7 consecutive days. Some patients may tolerate one regimen better than the other. Pregnant patients should not be treated during the first trimester with either regimen. During the second and third trimesters, the "One Day” regimen should not be used, as it results in higher serum levels, which may reach foetal circulation. When repeated courses of treatment are required, it is recommended that an interval of 4 to 6 weeks elapse between courses, and that the trichomonad be reconfirmed before commencing the next course. Total and differential leukocyte counts should be made before and after re-treatment.

In the Male:
Treatment should be individualised as for the female.

Amoebiasis:
Adults:
For acute intestinal amoebiasis (acute amoebic dysentry) 750 mg ANAEROBYL-GOLD orally three times daily for 5 to 10 days.
For amoebic liver abscess: 500 mg or 750 mg orally three times a day for 5 to 10 days.
Children:
35 - 50 mg/kg/day divided into three doses, orally for 10 days.

Anaerobic Bacterial Infections:
The usual adult oral dose is 7,5 mg/kg every six hours (e.g. approximately 500 mg six hourly for a 70 kg adult). Do not exceed 4 g per 24 hour period. Treatment duration is usually 7 to 10 days. In certain infections longer treatment may be necessary. Patients with severe hepatic disease metabolise ANAEROBYL-GOLD slowly, accordingly lower doses should be administered cautiously.
It is recommended that the tablets be taken during or after a meal. In patients with advanced renal disease or anuria the dose of ANAEROBYL-GOLD should be reduced except in those undergoing dialysis where the medicine is rapidly removed.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-effects reported include gastrointestinal discomfort, anorexia, nausea, coated tongue, unpleasant metallic taste, headaches, skin rashes, and, less frequently, Central Nervous System effects (e.g. convulsive seizures, peripheral neuropathy, dizziness, vertigo, incoordination, ataxia, confusion, irritability, depression, weakness and insomnia (reversible), urethral discomfort, darkening of the urine, and reversible leukopaenia. ANAEROBYL-GOLD should be used only in the 7 day regimen in pregnant patients during the second and third trimesters. When taken in conjunction with alcohol may provoke a disulfiram-type effect. ANAEROBYL-GOLD should not be used in patients with blood dyscrasias or active disease of the Central Nervous System. ANAEROBYL-GOLD has been reported to increase the action of warfarin and other coumarin anticoagulants. ANAEROBYL-GOLD is excreted in the milk and must not be used by lactating women. ANAEROBYL-GOLD may interfere with certain chemical analyses for S.G.O.T. ANAEROBYL-GOLD has shown carcinogenicity in rodents. Although mutagenic activity has been shown in in-vitro assay systems, in-vivo studies in mammals have failed to demonstrate a potential for genetic damage.
Pseudomembranous colitis has been reported with the use of metronidazole.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Symptoms of overdosage include nausea, vomiting and ataxia. There is no specific antidote for ANAEROBYL-GOLD overdose. Therefore treatment of overdose should be symptomatic and supportive.

IDENTIFICATION:
ANAEROBYL-GOLD 200:
White to off-white round biconvex tablets, 9,5 mm in diameter embossed “SEARLE”on one face and breakline with “200”on the other face.

ANAEROBYL-GOLD 400:
White to off-while round biconvex tablets, 12,7 mm in diameter, embossed "SEARLE'" on one side and with a breakline and "400" on the other side.

PRESENTATION:
ANAEROBYL-GOLD 200: Securitainers containing 21 and 500 tablets
ANAEROBYL-GOLD 400: Securitainers containing 10 and 500 tablets

STORAGE INSTRUCTIONS:
Sore in a dry place below 30 °C. Protect from light.
Keep out of reach of children.

REGISTRATION NUMBERS:
ANAEROBYL-GOLD 200: R/20.2.6/300
ANAEROBYL-GOLD 400: R/20.2.6/301

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
G D Searle (South Africa) (Pty) Ltd.
14 Mandy Road
Reuven
Johannesburg

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
January 1986

Code 4044-5-12/92

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