Flagystatin (Metronidazole – Nystatin)


R´ne-Poulenc Rorer

Metronidazole – Nystatin

Trichomonacide – Moniliacide

Indications And Clinical Uses: Mixed vaginal infection due to Trichomonas vaginalis and C. albicans.

Contra-Indications: Hypersensitivity to either of the components. Combined treatment with oral Flagyl should be avoided in cases of active neurological disorders or a history of blood dyscrasia, hypothyroidism or hypoadrenalism unless in the opinion of the physician the benefits outweigh the possible hazard to the patient. See also Flagyl monograph. tag_WarningWarnings

Manufacturers’ Warnings In Clinical States: Nystatin possesses little or no antibacterial activity while metronidazole is selective against certain anaerobic bacteria; therefore, Flagystatin may not be effective in bacterial vaginal infections and should not be prescribed unless there is direct evidence of trichomonal infestation. See also Flagyl monograph.

Precautions: Where there is evidence of trichomonal infestation in the sexual partner, he should be treated concomitantly with oral Flagyl to avoid reinfestation.

It is possible that adverse effects normally associated with oral administration of metronidazole may occur following the vaginal administration of Flagystatin.

See also Flagyl monograph.

Adverse Reactions: Infrequent and minor adverse reactions reported to date include: vaginal burning and granular sensation; bitter taste, nausea and vomiting, already known to occur with metronidazole were mainly seen when oral metronidazole was administered concomitantly with Flagystatin local treatment.

In the course of clinical trials, reactions, not necessarily related to the product, were observed: spots on the skin around the knees, welts all over the body, aching and swelling of wrists and ankles, pruritus, headache, coated tongue and fatigue.

Symptoms And Treatment Of Overdose: Symptoms: No case of accidental massive ingestion of Flagystatin has been reported yet. However, should this occur, symptoms such as nausea, vomiting, diarrhea and slight disorientation may be observed.

Treatment: No specific antidote. Treatment should be symptomatic after gastric lavage.

Dosage And Administration: One vaginal insert or ovule, or 1 applicatorful of cream daily, inserted deep into the vagina, before retiring, for 10 consecutive days. In order to facilitate disintegration, moisten the vaginal tablet under water for a second or two just before introduction in the vagina.

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 should be administered twice daily for 10 days.

Availability And Storage: Vaginal Cream: Each applicatorful of cream delivers: metronidazole 500 mg and nystatin 100 000 units. Nonmedicinal ingredients: glycerin, glyceryl monostearate, methylparaben, propylparaben, purified water, stearic acid and triethanolamine. Tartrazine-free. Tubes of 55 g with applicator.

Vaginal Inserts: Each vaginal insert contains: metronidazole 500 mg and nystatin 100 000 units. Nonmedicinal ingredients: cellulose, colloidal silicon dioxide, dicalcium phosphate, magnesium stearate, polacrilin potassium, sodium oleate and talc. Tartrazine-free. Boxes of 10 with applicator.

Vaginal Ovules: Each ovule contains: metronidazole 500 mg and nystatin 100 000 units. Nonmedicinal ingredients: hydrogenated vegetable glycerides. Tartrazine-free. Boxes of 10 with applicator. (Shown in Product Recognition Section)

FLAGYSTATIN® Rh´ne-Poulenc Rorer Metronidazole – Nystatin Trichomonacide – Moniliacide

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