Product Description.:
MECHANISM OF ACTIONS :
Fungistatic , may be fungicidal , depending on concentration , exact mechanism of action is unknown . Azoles inhibit biosynthesis of ergosterol or other sterols , damaging the fungal cell membrane .
Azoles also inhibit biosynthesis of triglycerides and phospholipids by fungi . In addition , Azoles inhibit oxidative and peroxidative enzyme activity .
PHARMACOKINETICS :
Small amounts absorbed systemically following intravaginal administration and topical administration .
INDICATIONS :
Vulvovaginal candidiasis . Not all species or strains of a particular organism may be susceptible to a specific vaginal azole .
Vaginal azoles are not effective in the treatment of vulvovaginitis caused by other common pathogens such as trichomonas vaginalis .
ADVERSE EFFECTS :
Occasional local irritation and hypersensitivity reaction include mild burning sensation , erythema and itching , headache , hives and skin rash may occur . Treatment should be discontinued if these are severe .
Incidence less frequent or rare : Abdominal or stomach cramps or pain , burning or irritation of penis of sexual partner .
W A R N I N G S :
? Because small amounts of Miconazole nitrate are absorbed from the vagina , the manufacturer states that the vaginal preparations should not be used in the first trimester of pregnancy unless the drug is considered essential to the welfare of the patient .
? Miconazole nitrate should be used with caution in nursing women .
? Usage in pregnancy : category C
? Usage in lactation : safety for use during lactation has not been established .
DOSAGE :
Vaginal dosage form : intravaginal one applicatorful once a day at bedtime for seven days . may be repeated if needed .
HOW SUPPLIED :
Vaginal cream 2% in 45 gram tubes .
STORAGE :
Store below 30? C .
