FLAGYSTATIN Vaginal ovules Ref.[50757] Active ingredients: Methronidazole Nystatin

Source: Health Products and Food Branch (CA)  Revision Year: 2018 

Indications and clinical use

Mixed vaginal infection due to Trichomonas vaginalis and Candida albicans.

FLAGYSTATIN has antibacterial and antifungal properties. To reduce the development of drug-resistant bacteria/fungi and maintain the effectiveness of FLAGYSTATIN and other antibacterial/antifungal drugs, FLAGYSTATIN should be used only to treat proven or strongly suspected mixed vaginal infections.

Dosage and administration

One vaginal ovule daily, inserted deep into the vagina, for 10 consecutive days.

If after 10 days of treatment a cure has not been achieved, a second 10-day course of treatment should be given.

If Trichomonas vaginalis has not been completely eliminated, oral metronidazole 250 mg b.i.d. should be administered for 10 days.

The applicator should not be used after the 7th month of pregnancy.

Overdosage

Symptoms

No case of accidental massive ingestion of FLAGYSTATIN has been reported yet. However, single oral doses of metronidazole, up to 12 g have been reported in suicide attempts and accidental overdoses. Symptoms were limited to vomiting, ataxia and slight disorientation.

The administration of massive peroral nystatin doses can as well induce gastro-intestinal disorders (nausea, vomiting, and diarrhoea).

Treatment

There is no specific antidote. Activated charcoal may be administered to aid in the removal of unabsorbed drug. General supportive measures are recommended.

For management of a suspected drug overdose, contact your regional Poison Control Centre.

Storage and stability

Store the vaginal ovules at room temperature between 15-25ยบC and protect from light.

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