Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
SUPPOSITORY
**DOSAGE** One vaginal ovule daily, inserted deep into 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. The applicator should not be used after the 7th month of pregnancy.
VAGINAL
Medical Information
**INDICATIONS** Mixed vaginal infection due to _Trichomonas vaginalis_ and _C. albicans._
**CONTRAINDICATIONS** Hypersensitivity to FLAGYSTATIN (metronidazole and nystatin), or to imidazoles, or any of its constituents, including any non-medicinal ingredient, or component of the container. For a complete listing, see DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_. Combined treatment with oral metronidazole 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.
G01AA01
nystatin
Manufacturer Information
SANOFI-AVENTIS SINGAPORE PTE. LTD.
P.T. Aventis Pharma
Active Ingredients
Documents
Package Inserts
Flagystain Vaginal Ovule PI.pdf
Approved: January 12, 2023