Source: Medicines and Medical Devices Safety Authority (NZ) Revision Year: 2022 Publisher: Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics, PO Box 62027, Sylvia Park Auckland 1644, Freecall: 0800 283 684, Email: medinfo.australia@sanofi.com
Flagyl suppositories are unsuitable for initiating treatment of serious conditions owing to slower absorption and lower plasma concentrations of metronidazole.
Flagyl suspension should be taken at least one hour before a meal.
The duration of a course of Flagyl treatment is about 7 days but it will depend upon the seriousness of the patient’s condition as assessed clinically and bacteriologically.
Chiefly in the context of abdominal (especially colorectal) and gynaecological surgery.
Adults: 400 mg at 8-hourly intervals during the 24 hours preceding operation, followed by postoperative intravenous or rectal administration until the patient is able to take oral medication.
Children: 7.5 mg/kg 8-hourly.
Adults: 1 g 8-hourly.
Children: One half or a quarter of a 500 mg suppository 8 hourly.
Elderly: Caution is advised in the elderly, particularly at high doses, although there is limited information available on modification of dosage.
Oral dosage is given in terms of metronidazole or metronidazole equivalent.
Adults: 800 mg followed by 400 mg 8-hourly.
Children: 7.5 mg/kg 8-hourly.
Adults: 1g 8-hourly. Substitute oral medication as early as possible. If rectal administration is prolonged beyond 3 days, reduce dose to 1g 12-hourly for remainder of course.
See table below:
Table 1. Treatment of Protozoal and Other Infections:
| Infection | Duration of dosage in days | Adults and children over 10 years‡ | Children† - 7 to 10 years | Children† - 3 to 7 years | Children† - 1 to 3 years |
|---|---|---|---|---|---|
| Urogenital trichomoniasis (where re-infection is likely, the consort should receive a similar course of treatment concurrently) | 7 | 200 mg 3 x daily | 100 mg 3 x daily | 100 mg twice daily | 50 mg 3 x daily |
| 2 | 800 mg in the am. and 1200 mg in the pm. | - | - | - | |
| 1 | 2.0 g as a single dose | - | - | - | |
| Non-specific vaginitis | 7 | 400 mg twice daily | - | - | - |
| 1 | 2.0 g as a single dose | - | - | - | |
| Amoebiasis | - | - | - | ||
| (a) Invasive intestinal disease in susceptible subjects | 5 | 800 mg 3 x daily | 400 mg 3 x daily | 200 mg 4 x daily | 200 mg 3 x daily |
| (b) Intestinal disease in susceptible subjects and chronic amoebic hepatitis | 5-10 | 400 mg 3 x daily | 200 mg 3 x daily | 100 mg 4 x daily | 100 mg 3 x daily |
| (c) Symptomless cyst passers | 5-10 | 400-800 mg 3 x daily | 200-400 mg 3 x daily | 100-200 mg 4 x daily | 100-200 mg 3 x daily |
| Giardiasis | 3 | 2.0 g once daily | 1.0 g once daily | 600-800 mg once daily | 500 mg once daily |
| Acute ulcerative gingivitis | 3 | 200 mg 3 x daily | 100 mg 3 x daily | 100 mg 2 x daily | 50 mg 3 x daily |
| Acute dental infections | 3-7 | 200 mg 3 x daily | - | - | - |
| Leg ulcers & pressure sores | 7 | 400 mg 3 x daily | - | - | - |
| Anaerobic infections (general) | See Data Sheet Text | ||||
† Children (and infants weighing less than 10 kg) should receive proportionately smaller dosages.
‡ Flagyl is well tolerated by the elderly, but a pharmacokinetic study suggests cautious use of high dosage regimens in this age group.
Symptoms of overdosage are limited to vomiting, ataxia and slight disorientation. Uneventful recovery has followed attempts at suicide and accidental overdoses with quantities of 30 and 60 × 200 mg tablets, and single oral doses of metronidazole, up to 12 g. There is no specific treatment for gross overdosage of Flagyl. Treatment should be symptomatic and supportive.
For general advice on overdose management, contact the National Poisons Centre, 0800 POISON or 0800 764 766.
3 years.
Dilution of Flagyl-S suspension, if necessary, should be carried out with syrup B.P. The diluted suspension has a shelf life of 14 days.
Store at or below 25°C. Protect from light.
Pack size: blister pack 10 suppositories.
Pack size: 100 mL glass bottle.
No special requirements.
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