Miconazole Nitrate
Generic: MICONAZOLE NITRATE
Basic Information
Manufacturer
Actavis Pharma, Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
VAGINAL
FDA Set ID
aa9e250b-f317-42cb-b8d2-e85de56f4ef7
Indications & Usage
INDICATIONS AND USAGE Miconazole Nitrate Vaginal Suppositories USP, 200 mg are indicated for the local treatment of vulvovaginal candidiasis (moniliasis).
Effectiveness in pregnancy has not been established.
As miconazole nitrate is effective only for candidal vulvovaginitis, the diagnosis should be confirmed by KOH smear and/or cultures.
Other pathogens commonly associated with vulvovaginitis ( Trichomonas and Haemophilus vaginalis [Gardnerella] ) should be ruled out by appropriate laboratory methods.
Effectiveness in pregnancy has not been established.
As miconazole nitrate is effective only for candidal vulvovaginitis, the diagnosis should be confirmed by KOH smear and/or cultures.
Other pathogens commonly associated with vulvovaginitis ( Trichomonas and Haemophilus vaginalis [Gardnerella] ) should be ruled out by appropriate laboratory methods.
Adverse Reactions
ADVERSE REACTIONS During clinical studies with Miconazole Nitrate Vaginal Suppositories USP, 200 mg, 301 patients were treated.
The incidence of vulvovaginal burning, itching or irritation was 2%.
Complaints of cramping (2%) and headaches (1 .
3%) were also reported.
Other complaints (hives, skin rash) occurred with less than a 0 .
5% incidence.
The therapy-related dropout rate was 0 .
3%.
To report SUSPECTED ADVERSE EVENTS, contact Teva Pharmaceuticals USA, Inc., at 1-888-838-2872 or FDA at 1-800-FDA-1088 or http://www.fda.gov/ for voluntary reporting of adverse reactions.
The incidence of vulvovaginal burning, itching or irritation was 2%.
Complaints of cramping (2%) and headaches (1 .
3%) were also reported.
Other complaints (hives, skin rash) occurred with less than a 0 .
5% incidence.
The therapy-related dropout rate was 0 .
3%.
To report SUSPECTED ADVERSE EVENTS, contact Teva Pharmaceuticals USA, Inc., at 1-888-838-2872 or FDA at 1-800-FDA-1088 or http://www.fda.gov/ for voluntary reporting of adverse reactions.