MONISTAT 1 (miconazole nitrate)

There are 0 contraindications.

There are 0 severe contraindications.

There are 1 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
No disease contraindications

There are 7 severe adverse reactions.

More Frequent	Less Frequent
None.	None.

Rare/Very Rare
Abnormal vaginal bleeding Anaphylaxis Angioedema Bronchospastic pulmonary disease Dyspnea Toxic epidermal necrolysis Urticaria

There are 20 less severe adverse reactions.

More Frequent	Less Frequent
None.	Dysmenorrhea Fever Genital organ pruritus Vaginal discharge

Rare/Very Rare
Acute abdominal pain Chills Contact dermatitis Cystitis Dizziness Facial edema Flu-like symptoms General weakness Headache disorder Nausea Pruritus of skin Skin rash Vaginal burning Vaginal irritation Vaginitis Vulvovaginal pain

There are no adequate and controlled studies evaluating use of intravaginal tioconazole in pregnant women, and the drug should be used during pregnancy only when the potential benefits justify the possible risks to the fetus. A single dose of the commercially available tioconazole 6.5% vaginal ointment has been used in a limited number of pregnant women for the treatment of vulvovaginal candidiasis+, and a single-dose of other tioconazole preparations not commercially available in the US (i.e., 2% vaginal cream, 100-mg vaginal tablet, 300-mg vaginal suppository, 6% vaginal ointment) have been used effectively to treat uncomplicated vulvovaginal candidiasis in pregnant women.

In most cases, the tioconazole dose was administered during the second or third trimester of pregnancy, but some women received the dose during the first trimester. There generally were no apparent adverse effects on the pregnancy, delivery, or fetus following a single intravaginal dose of tioconazole; however, there have been a few reports of adverse pregnancy outcomes (i.e., spontaneous abortion, breech delivery, premature birth). While these effects do not appear to be drug-related, it is difficult to distinguish drug- from disease-related effects.

The optimal regimen for the treatment of vulvovaginal candidiasis in pregnant women has not been identified, and further study is needed to evaluate safety and efficacy of single-dose regimens in these women. If treatment of vulvovaginal candidiasis is considered necessary in pregnant women, the US Centers for Disease Control and Prevention (CDC) and some clinicians recommend use of an intravaginal azole antifungal given for 7 days. Reproduction studies in rats using oral tioconazole hydrochloride in dosages of 55-165 mg/kg daily during the period of organogenesis did not reveal evidence of adverse effects on fetal viability or growth, and there was no evidence of major structural anomalies in offspring.

While there was evidence of a drug-related increase in the incidence of dilated ureters, hydroureters, and hydronephrosis in the fetuses of these rats, these effects were transient and were no longer evident in the pups at 21 days of age; these effects did not occur in rats following intravaginal administration of tioconazole 2% cream in a dosage of 10 mg/kg daily. Similar studies in rabbits using oral tioconazole dosages as high as 165 mg/kg daily or intravaginal 2% cream in a dosage of 2-3 mg/kg daily during organogenesis did not reveal evidence of embryotoxic or teratogenic effects. In rats, when tioconazole administration was extended through parturition, the drug caused dystocia, prolonged gestation, and in utero deaths and resulted in an increase in the number of stillborn pups and a decrease in pup survival; pups that survived developed normally.

These adverse effects on parturition occurred only when the drug was given orally in dosages exceeding 20 mg/kg daily or intravaginally in dosages exceeding 9 mg/kg daily during the last third of pregnancy, and did not occur at lower oral or intravaginal dosages, when tioconazole was terminated before the last third of pregnancy, or when high oral dosage (150 mg) was confined to a few days before delivery. No effect on parturition was noted in pregnant rabbits given oral tioconazole at dosages of 50 mg/kg daily during the last 10 days of pregnancy. Similar effects on parturition (e.g., dystocia, prolonged gestation) also have been reported in animal studies with high doses of other imidazole-derivative azole antifungals (e.g., econazole, ketoconazole, miconazole, sulconazole).

Since it is not known whether tioconazole is distributed into milk, women should temporarily discontinue breast-feeding while they are receiving the drug.

No enhanced Geriatric Use information available for this drug.