A glossy, firm thick cream containing 2%w/w miconazole nitrate. Water miscible, pH 2.3 to 4.8.
Miconazole nitrate is a synthetic 1-phenethylimidazole derivative. Miconazole nitrate exhibits in-vitro activity against species of the genus Candida. In-vitro fungicidal activity has been demonstrated particularly against Candida albicans.
Pharmacokinetics
Miconazole nitrate is not significantly absorbed when administered intravaginally.
Resolve Thrush Vaginal Cream 2 % is indicated for the treatment vulvovaginitis due to Candida albicans and other Candida species.
Insert one applicator full of cream (5g), intravaginally once daily (at bedtime) for seven days.
Known sensitivity to miconazole nitrate or any of the other ingredients in the preparation.
Discontinue use if sensitisation or irritation occurs. Resolve Thrush Vaginal Cream 2 % is only effective against vulvovaginitis due to Candida species. Other pathogens commonly associated with vulvovaginitis ( Trichomonas and Haemophilus vaginitis ) should be ruled out by the appropriate laboratory/diagnostic methods. During treatment it is recommended that the patient refrains from sexual intercourse, or that the male partner wears a condom.
Use in Pregnancy:
Miconazole has not shown embryotoxic or teratogenic effects in animals. The safety for use during pregnancy in humans has not been established. Since miconazole is absorbed in very small amounts from 2% vaginal cream preparations, FUNGO Cream should only be used in the first trimester of pregnancy when the physician considers it to be essential to the patient.
Caution should be exercised with the insertion of the applicator during pregnancy.
Miconazole nitrate vaginal preparations are generally well tolerated with few adverse effects. Adverse effects include vulvovaginal irritation, itching or burning (6%), other complaints occur very rarely (<0.2%) these include vaginal burning, pelvic cramps, hives, skin rash and headaches.
Nil.
No reports have yet appeared concerning overdose after oral miconazole administration. The topical absorption of miconazole nitrate through the skin is not significant.
Store below 30degC Keep out of reach of children.
Restricted Medicine
Resolve Thrush Vaginal Cream 2 % 40g, with 5g applicator.
FUNGO contains miconazole nitrate the chemical name for which is 1-[2,4- dichloro-b-(2,4-dichlorobenzyloxy) phenethyl] imidazole nitrate. Miconazole nitrate has a molecular weight and formula of 479.1 and C18H14Cl4N2O.HNO3, respectively. Other ingredients of the cream are: butylene glycol, cetostearyl alcohol, dimethicone, glycerol monostearate, light liquid paraffin, polyoxyl-40-stearate and phenethyl alcohol as a preservative.
Resolve Thrush Vaginal Cream 2 % is distributed in New Zealand by: Douglas Pharmaceuticals Ltd P O Box 45 027 Auckland 0651 New Zealand Phone: (09) 835 0660 Fax: (09) 835 0665
02 September 2011