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Metronidazole Ovules 500 mg – Vogyna-M ovules are indicated for the treatment of bacterial vaginosis, Trichomonas vaginalis.
One vaginal ovule, 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.
Vogyna-M should be used for vaginal application only. Insert the ovule using the applicator provided inside the carton of Vogyna-M.
They are infrequent and minor: 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 Vogyna-M local treatment.Other adverse events related to metronidazole, usually observed after oral or I.V. administration of metronidazole include:
Blood and lymphatic system disorders
Transient eosinophilia, neutropenia, cases of agranulocytosis and thrombocytopenia have been reported.
Cardiac disorders
Palpitation and chest pain
Eye disorders
Transient vision disorders such as diplopia, myopia, blurred vision, decreased visual acuity, changes in color vision. Optic neuropathy/neuritis has been reported.
Gastrointestinal disorders
Diarrhea, nausea, vomiting, epigastric distress, epigastric pain, dyspepsia, constipation, coated tongue, dry mouth, taste disorders including metallic taste, oral mucositis. Reversible cases of pancreatitis have been reported.
General disorders and administration site conditions
Thrombophlebitis has occurred with I.V. administration. Fever has been reported.
Where there is evidence of trichomonal infestation in the sexual partner, he should be treated concomitantly with oral metronidazole to avoid reinfestation.
The effectiveness of condoms or diaphragms could be impaired by some of the fatty constituents contained in metronidazole gynaecological ovule, therefore their use during Vogyna-M treatment is not recommended.
Vaginal injection, menstrual tampons and soaps with an acid pH (for personal hygiene use) should not be used during treatment because they may promote fungal replication.
It is possible that adverse effects normally associated with oral administration of metronidazole may occur following the vaginal administration of Vogyna-M.
Patients should be warned against consuming alcohol, during Vogyna-M therapy and for at least one day afterward, because of a possible disulfiram-like reaction related to the metronidazole.
Although no persistent hematologic abnormalities have been observed in clinical studies, total and differential leukocyte counts should be made before and after treatment, especially if a second course of metronidazole therapy is needed.
Patients should be monitored for adverse reactions such as peripheral or central neuropathy (such as paresthesia, ataxia, dizziness, and convulsive seizures) related to metronidazole.
Vogyna-M should be used with caution in patients with active or chronic severe peripheral and central nervous system diseases due to the risk of neurological aggravation related to metronidazole.
Treatment with metronidazole should be discontinued if ataxia or any other symptom of CNS involvement occurs.
Store in cool and dry place at temperature below 25 °C and protect from light.
Keep the medicine out of reach of children.
Aluminum strip pack
Vogyna-M is available in an Aluminum strip (laminated with paper) of 5 ovules. Such 01 strip in a unit carton with package insert and applicator.
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