(Tioconazole) For Vaginal use only
Gyno-Trosyd brand of tioconazole is a member of the imidazole class of compounds. Its chemical name is 1 – 2- ( 2 – chloro – 3 – thienyl ) methoxy -2- ( 2.4 – dichlorophenyl ) ethyl -1 H-imidazole.The molecular formula is C16H13N20SCL3 and the molecular weighs is 387.7 Tioconazole occurs as a white crystalline solid, sparingly soluble in water but soluble in methanol, ethanol, and chloroform.
Gyno-Trosyd is available for vaginal administration as a 2% cream, 100 mg tablets.
Tioconazole is a synthetic broad spectrum antifungal agent which, in vitro, is fungicidal to yeasts and other fungi and also has activity against certain gram positive organisms, including Staphylococcus and Streptococcus spp. Gardnerella vaginal is, Bacteroides spp., and Trichomonas vaginalis.
In clinical studies, tioconazole is effective in the treatment of patients with vaginal yeast infections such as Candida albicans, Other candida species, Torulopsis glabrata and in vaginal infections caused by Trichomonas vaginalis. Systemic absorption after vaginal application is negligible.
Gyno-Trosyd vaginal cream and tablets are indicated for the local treatment of patients with vaginal yeast infections.
Gyno-Trosyd 2% cream may also be used for local application to the vulva concurrent with intravaginal treatment of these patients and for the local treatment of consorts.
Gyno- Trosyd 2% cream is also indicated for the local treatment of patients with vaginal trichomoniasis.
Gyno-Trosyd is contraindicated in individuals who have been shown to be hypersensitive to imidazole antifungal agents or any of the components of the cream or tablet.
Gyno-Trosyd has been shown to be effective in the treatment of vaginal candidiasis associated with pregnancy but as with any new drug, caution should be exercised when prescribing during the first trimester.
ADVERSE REACTIONS :
Gyno- Trosyd is well tolerated upon local application and no systemic adverse reactions have been observed. Symptoms of local irritation have been reported by some patients during the course of treatment and are transient and mild.
DOSAGE AND ADMINISTRATION :
Gyno-Trosyd as 2% cream (5 g equivalent to 100 mg tioconazole base) or tablet (100 mg) should be applied once nightly on retiring for the specified duration of treatment using the applicator supplied. in cases of vaginal candidiasis with scant discharge, the cream formulation should be used In preference to the tablet. Gyno-Trosyd is effective when applied for 3, 6 or 14 days. Three days treatment effects a cure in most patients. A repeat
“Course oH days treatment-may-be effectivein patients who are improved but not cured by the first course.
Gyno-Trosyd 2% cream ( 5 g equivalent to 100 mg tioconazole base) should be applied once nightly on retiring for three consecutive days using the applicator supplied in cases of vaginal trichomoniasis.
Note: All Gyno-Trosyd dosage forms should be inserted deep in the vagina preferably not during menstruation. It may be most convenient to administer before retiring for the night.
HOW SUPPLIED :
– one blister pack containing 3 vaginal tablets 100 mg / tablet with applicator.
– collapsible aluminium tube containing 20 mg cream 2% with 3 disposable applicators.
Manufactured by :
Pfizer – Egypt. S.A.E Cairo A.R.E
Under authority of Pfizer INC. U.S.A.