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

Logo TRICHAZOLE®-200 TABLETS
TRICHAZOLE®-400 TABLETS

SCHEDULING STATUS:
S4

PROPRIETARY NAME:
(and dosage form)

TRICHAZOLE®-200 TABLETS
TRICHAZOLE®-400 TABLETS

COMPOSITION:
Tablets containing 200 mg and 400 mg
Metronidazole.

PHARMACOLOGICAL CLASSIFICATION:
A 20.2.6 Antimicrobial agents: Medicines against protozoa.

PHARMACOLOGICAL ACTION:
Metronidazole is directly trichomonacidal. It destroys 99% of the micro-organisms in cultures of Trichomonas vaginalis within 24 hours at a concentration of 2,5
 µg/mL. It is also directly amoebicidal in very low concentrations. Metronidazole is usually well absorbed after oral administration. It is active against a variety of anaerobic bacteria, particularly Bacteriodes fragilis.

INDICATIONS:
In the oral treatment of:
Urogenital trichomoniasis.
All forms of amoebiasis except asymptomatic carrier state.
Giardiasis.
Acute phase of Vincents’disease.
Infections caused by anaerobic bacteria.

CONTRA-INDICATIONS:
Sensitivity to metronidazole.
Metronidazole should not be used in patients with blood dyscrasias or with active disease of the central nervous system.
The use of metronidazole should be avoided during pregnancy, especially the first trimester and whilst breast-feeding.

DOSAGE AND DIRECTIONS FOR USE:
(a) In Trichomoniasis
Adults and children over 10 years:
A single dose of 2 g or 200-250 mg three times daily after food for 7 days, or 400 mg twice daily after food for 7 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 blood cell count should be monitored.
Sexual partners should be treated concomitantly.
Children 7-10 years: 100 mg three times daily after food for 7 days.
Children 3-7 years: 100 mg twice daily after food for 7 days.
Children 1-3 years: 50 mg three times daily after food for 7 days.
An alternative children's dose is 15 mg per kg body-weight daily in divided doses for 7 days.

(b) In the treatment of acute and chronic hepatic or intestinal amoebiasis
Adults and children over 10 years:
A single dose of 2 g to 2,4 g may be given for 2 or 3 consecutive days.
Alternatively 400-800 mg three times daily for 5-10 days.
Children - aged 7-10 years: 200-400 mg, three times daily for 5-10 days.
Children - aged 3-7 years: 100-250 mg three times daily for 5-10 days.
Children - aged 1-3 years: 100-200 mg three times daily for 5-10 days.
Alternatively for children, a dose of 35-50 mg per kg body-weight daily in divided doses for 5-10 days has been suggested.
(c) In Giardiasis
Adults and children over 10 years:
2 g daily as a single dose for 3 successive days, or 250 mg three times daily for 5-7 days.
Children - aged 7-10 years: 1 g daily as a single dose for 3 successive days.
Children - aged 3-7 years: 600 mg daily as a single dose for 3 successive days.
Children - aged 1-3 years: 400 mg daily as a single dose for 3 successive days.
An alternative dosage schedule for children is 15 mg per kg body-weight daily in divided doses.
(d) In Vincents' disease (acute necrotising ulcerative gingivitis)
Adults:
200 mg three times daily for 3 days or 400 mg twice daily for 3 days.
(e) Anaerobic bacterial infections
Adults:
An initial dose of 800 mg followed by 400 mg every eight hours for 7 days.
Children:
7,5 mg per kg body-weight every eight hours for 7 days.

The above doses must be taken at regular intervals and prescribed courses must be completed.
The tablets must be taken with or after food. Alcoholic drinks should be avoided while on this medication.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
The adverse effects of metronidazole are generally dose-related. The most common are gastro-intestinal disturbances, especially nausea and an unpleasant metallic taste; abdominal cramps, epigastric discomfort, nausea is sometimes accompanied by headache, anorexia and vomiting. Diarrhoea, dry mouth, a furred tongue, glossitis, and stomatitis may also occur. There have been reports of pseudomembranous colitis associated with metronidazole.
Peripheral neuropathy, usually presenting as numbness or tingling in the extremities, and epileptiform seizures are serious adverse effects on the nervous system that have been associated especially with high doses of metronidazole or prolonged treatment. Weakness, dizziness, ataxia, drowsiness, insomnia, and changes in mood or mental state such as depression or confusion have also been reported. Flushing, dysuria, urticaria and angioneurotic oedema may occur.
Temporary moderate leucopenia may occur in some patients receiving metronidazole.
Skin rashes and pruritis occur occasionally.
Other side-effects include urethral discomfort and darkening of the urine.
Anaphylaxis and raised liver enzymes have been reported.

Special precautions:
All patients receiving metronidazole for more than 10 days should be monitored and treatment discontinued if signs of peripheral neuropathy or CNS toxicity develop.
Doses should be reduced in patients with severe liver damage and in patients with renal failure.
Concomitant use with alcohol should be avoided.
When given in conjunction with alcohol, metronidazole may provoke a disulfiram-like reaction in some individuals.
Metronidazole enhances the effect of warfarin.
Patients receiving phenobarbitone metabolize metronidazole at a greater rate than normal, reducing the half-life to approximately 3 hours.

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

IDENTIFICATION:
200 mg Tablet: A white or off-white biconvex tablet, bisected on one side and engraved with the Lennon logo (mortar and pestle) on the other side.
400 mg Tablet: A white or off-white flat tablet with bevelled edges, bisected on one side and engraved with the Lennon logo (mortar and pestle) on the other side.

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

STORAGE INSTRUCTIONS:
Protect from light and store below 25°C.
KEEP OUT OF REACH OF CHILDREN

REGISTRATION NUMBERS:
200 mg Tablet:
M/20.2.6/194
400 mg Tablet: M/20.2.6/195

NAME AND BUSINESS ADDRESS OF APPLICANT:
Pharmacare Limited
7 Fairclough Road
PORT ELIZABETH
6001

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
15/05/1981
                        G877
        A & S PRINTERS.

Updated on this site: March 2000
Current: December 2004
Source: Community Pharmacy

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