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The following indications for MONISTAT 1 (miconazole nitrate) have been approved by the FDA:
Indications:
Vulvovaginal candidiasis
Professional Synonyms:
Vaginal candidiasis
Vulvovaginal candidosis
Vulvovaginal moniliasis
Indications:
Vulvovaginal candidiasis
Professional Synonyms:
Vaginal candidiasis
Vulvovaginal candidosis
Vulvovaginal moniliasis
The following dosing information is available for MONISTAT 1 (miconazole nitrate):
No enhanced Dosing information available for this drug.
Miconazole nitrate is administered topically as a cream, powder, or aerosol powder or tincture, or intravaginally as a vaginal cream or suppository. Miconazole powder or aerosol powder are not recommended for use on the scalp or nails. Tioconazole is administered intravaginally as a 6.5%
ointment. Although the following dosage forms are not commercially available in the US, tioconazole also has been administered intravaginally as a 100- or 300-mg vaginal suppository+, 100-mg vaginal tablet+, 6% vaginal ointment, or 2% vaginal cream+; applied topically to the skin as a 1 or 2% cream+ or 1% lotion+; applied topically to the nails as a 28% lotion+; and applied topically to the feet as a 1% powder+. Commercially available prefilled single-dose applicators containing tioconazole 6.5%
vaginal ointment are intended for intravaginal administration only. Contact with eyes should be avoided. Tioconazole 6.5%
vaginal ointment should be used for self-medication of recurrent vulvovaginal candidiasis only in otherwise healthy, nonpregnant women previously diagnosed by a clinician. Patients should be instructed how to use the vaginal applicators and should be given a copy of the instructions provided by the manufacturer. The applicator should be opened just prior to administration to prevent contamination.
Tioconazole 6.5% vaginal ointment contains a petrolatum base that may interact with rubber or latex products, including condoms or vaginal contraceptive diaphragms, and alternative methods of contraception should be used during the first 72 hours after an intravaginal dose of the drug. Tioconazole vaginal ointment may be administered during menstruation, but sanitary napkins should be used instead of vaginal tampons; some clinicians suggest that use of the vaginal ointment be delayed until after the menstrual flow has ceased.
ointment. Although the following dosage forms are not commercially available in the US, tioconazole also has been administered intravaginally as a 100- or 300-mg vaginal suppository+, 100-mg vaginal tablet+, 6% vaginal ointment, or 2% vaginal cream+; applied topically to the skin as a 1 or 2% cream+ or 1% lotion+; applied topically to the nails as a 28% lotion+; and applied topically to the feet as a 1% powder+. Commercially available prefilled single-dose applicators containing tioconazole 6.5%
vaginal ointment are intended for intravaginal administration only. Contact with eyes should be avoided. Tioconazole 6.5%
vaginal ointment should be used for self-medication of recurrent vulvovaginal candidiasis only in otherwise healthy, nonpregnant women previously diagnosed by a clinician. Patients should be instructed how to use the vaginal applicators and should be given a copy of the instructions provided by the manufacturer. The applicator should be opened just prior to administration to prevent contamination.
Tioconazole 6.5% vaginal ointment contains a petrolatum base that may interact with rubber or latex products, including condoms or vaginal contraceptive diaphragms, and alternative methods of contraception should be used during the first 72 hours after an intravaginal dose of the drug. Tioconazole vaginal ointment may be administered during menstruation, but sanitary napkins should be used instead of vaginal tampons; some clinicians suggest that use of the vaginal ointment be delayed until after the menstrual flow has ceased.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| MONISTAT 1 6.5% OINTMENT | Maintenance | Adults insert 1 applicatorful (4.6 gram) by vaginal route once daily just prior to bedtime |
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| TIOCONAZOLE 1 6.5% OINTMENT | Maintenance | Adults insert 1 applicatorful (4.6 gram) by vaginal route once daily just prior to bedtime |
| TIOCONAZOLE-1 6.5% OINTMENT | Maintenance | Adults insert 1 applicatorful (4.6 gram) by vaginal route once daily just prior to bedtime |
| TIOCONAZOLE 1 6.5% OINTMENT | Maintenance | Adults insert 1 applicatorful (4.6 gram) by vaginal route once daily just prior to bedtime |
| EQL TIOCONAZOLE-1 6.5% OINT | Maintenance | Adults insert 1 applicatorful (4.6 gram) by vaginal route once daily just prior to bedtime |
| CVS TIOCONAZOLE-1 6.5% OINTMNT | Maintenance | Adults insert 1 applicatorful (4.6 gram) by vaginal route once daily just prior to bedtime |
| FT TIOCONAZOLE-1 6.5% OINTMENT | Maintenance | Adults insert 1 applicatorful (4.6 gram) by vaginal route once daily just prior to bedtime |
| EQ TIOCONAZOLE-1 6.5% OINTMENT | Maintenance | Adults insert 1 applicatorful (4.6 gram) by vaginal route once daily just prior to bedtime |
The following drug interaction information is available for MONISTAT 1 (miconazole nitrate):
There are 0 contraindications.
There are 2 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
| Drug Interaction | Drug Names |
|---|---|
| Select Azole Antifungal Agents/Coumarin Anticoagulants SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: The more potent warfarin S-enantiomer is metabolized by CYP2C9 while the weaker R-enantiomer is metabolized by CYP1A2 and CYP3A4. Miconazole is a moderate-strong inhibitor of CYP2C9; fluconazole is a moderate inhibitor of CYP2C9 and CYP3A4; voriconazole and ketoconazole are both weak inhibitors of CYP2C9 and strong inhibitors of CYP3A4. CLINICAL EFFECTS: Concurrent use of select azole antifungals and coumarin anticoagulants may increase the risk for bleeding. PREDISPOSING FACTORS: The antifungal dose and inhibitory potency, particularly for CYP2C9, are drug factors which affect the magnitude of this interaction. The risk for bleeding episodes may be greater in patients with disease-associated factors (e.g. thrombocytopenia). Additional drug associated risk factors include concurrent use of multiple drugs which inhibit anticoagulant/antiplatelet metabolism and/or have an inherent risk for bleeding (e.g. NSAIDs). Azole antifungal inhibition of CYP2C9, may increase the risk of conversion to the CYP2C9 poor metabolizer phenotype. Patients with CYP2C9 intermediate metabolizer genotype are expected to be the most susceptible to this phenoconversion. Patients with a pre-existing CYP2C9 poor metabolizer genotype would be less susceptible to this interaction. However, patients with reduced function genotypes (e.g. CYP2C9 *1/*3, *2/*2, *2/*3, and *3/*3) have an inherently higher risk for bleeding at usual anticoagulant doses and thus generally require lower doses to achieve effective and safe anticoagulation. In addition, CYP2C9 poor metabolizers require more a prolonged time (>2 to 4 weeks) to achieve maximum INR effect for a given dosage regimen than patients without these CYP2C9 variants. PATIENT MANAGEMENT: In patients receiving warfarin when fluconazole, voriconazole, miconazole or ketoconazole is started, anticipate the need for a dose reduction. Check the baseline INR then closely monitor and adjust the dose of warfarin until the INR has stabilized on the combination. After the azole therapy is discontinued, close monitoring is again needed as the INR may fall after removal of the inhibitor. If concurrent therapy is warranted, monitor patients receiving concurrent therapy for signs of blood loss, including decreased hemoglobin, hematocrit, fecal occult blood, and/or decreased blood pressure and promptly evaluate patients with any symptoms. Discontinue anticoagulation in patients with active pathologic bleeding. Instruct patients to report any signs and symptoms of bleeding, such as unusual bleeding from the gums or nose; unusual bruising; red or black, tarry stools; red, pink or dark brown urine; acute abdominal or joint pain and/or swelling. The time of highest risk for a coumarin-type drug interaction is when the precipitant drug is initiated or discontinued. Contact the prescriber before initiating, altering the dose or discontinuing either drug. DISCUSSION: Selected azole antifungal agents can cause an increase in the anticoagulant effects of warfarin. The drug-related risk is dependent on the specific azole, dose and route. A large systematic review was performed on 72 warfarin drug-drug interactions studies that reported on bleeding, thromboembolic events, or death. Most studies were retrospective cohorts. A meta-analysis of 11 of those studies found a higher rate of clinically significant bleeding in patients on warfarin and antimicrobials (OR=1.63; 95% CI 1.45-1.83). Increased bleeding risk was also seen in subgroup analyses with azole antifungals (OR=1.86; 95% CI 1.40-2.47). A retrospective review compared the changes in warfarin effects with coadministration of fluconazole, itraconazole, or voriconazole in 18, 6, and 5 patients, respectively. Mean INR increased from 1.4 to 2.94 in patients taking fluconazole (p<0.001) and increased >20% in 15 out of 18 patients. Mean INR increased from 1.95 to 2.89 in patients taking voriconazole (p<0.05) and increased >20% in 4 out of 5 patients. Mean INR increased slightly from 1.86 to 1.92 in patients taking itraconazole (p=0.37) and did not increase >20% in any patient. In healthy subjects, the administration of voriconazole (300 mg every 12 hours for 12 days) prior to warfarin (30 mg single dose) doubled the prothrombin time when compared to warfarin plus placebo. A large epidemiologic study evaluated the risk for hospitalization due to gastrointestinal (GI) bleeding in warfarin patients treated with or without various anti-infective agents, including fluconazole. Warfarin patients treated with fluconazole had an approximately 2-fold increase in risk for hospitalization due to a GI bleed compared with warfarin patients without infection or warfarin patients receiving alternative anti-infective treatment (e.g. cephalexin, amoxicillin). This risk was highest in patients who received fluconazole 6 to 15 days prior to admission, leading authors to suggest this risk was due to a pharmacokinetic interaction between warfarin and fluconazole, and not due to infection or infection sequelae (e.g. change in diet or gut bacteria). A drug-drug interaction study was performed to evaluate the effect of a single 150 mg dose of fluconazole on prothrombin times in 6 women who had received warfarin therapy for at least 6 months and had stable, therapeutic INRs. Three of 6 women had an INR > 4 or had a bleeding episode: one woman had an INR of 4.6 on day 2, one woman had an INR of 5.2 on day 5, and one woman developed a subconjunctival hemorrhage in the absence of trauma or physical straining on day 6 (INR = 3.4). Miconazole is the most potent known CYP2C9 inhibitor in vivo. In an interaction study in 6 healthy volunteers, oral miconazole 125 mg daily for 18 days increased warfarin exposure (AUC, area-under-curve) 4.7-fold. Black stools have been reported with warfarin and administration of miconazole oral gel. Documentation for oral ketoconazole is less conclusive. However, as ketoconazole is considered a moderate CYP2C9 inhibitor an interaction with warfarin would be expected. |
ANISINDIONE, DICUMAROL, JANTOVEN, WARFARIN SODIUM |
| Tolterodine (Greater Than 1 mg IR or Greater Than 2 mg ER)/Selected CYP3A4 Inhibitors SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Cyclosporine, erythromycin, miconazole, and vinblastine may inhibit the metabolism of tolterodine by CYP3A4.(1,2) CLINICAL EFFECTS: The concurrent administration of tolterodine with cyclosporine, erythromycin, miconazole, or vinblastine may result in elevated levels of tolterodine and signs of toxicity.(1,2) PREDISPOSING FACTORS: Patients who are CYP2D6 poor metabolizers may be at increased risk.(1,2) The risk of QT prolongation or torsades de pointes may be increased in patients with cardiovascular disease (e.g. heart failure, myocardial infarction, history of torsades de pointes, congenital long QT syndrome), hypokalemia, hypomagnesemia, hypocalcemia, bradycardia, female gender, or advanced age.(3) Concurrent use of more than one drug known to cause QT prolongation or higher systemic concentrations of either QT prolonging drug are additional risk factors for torsades de pointes. Factors which may increase systemic drug concentrations include rapid infusion of an intravenous dose or impaired metabolism or elimination of the drug (e.g. coadministration with an agent which inhibits its metabolism or elimination, genetic impairment in drug metabolism or elimination, and/or renal/hepatic dysfunction).(3) The risk of anticholinergic toxicities including cognitive decline, delirium, falls and fractures is increased in geriatric patients using more than one medicine with anticholinergic properties.(4) PATIENT MANAGEMENT: The manufacturer of tolterodine recommends that a maximum tolterodine dosage of 1 mg twice daily of the non extended release dosage form(1) or 2 mg once daily of the extended release dosage form(2) be used in patients receiving concurrent therapy with cyclosporine, erythromycin, miconazole, or vinblastine. If concurrent therapy is warranted, consider obtaining serum calcium, magnesium, and potassium levels and monitoring ECG at baseline and at regular intervals. Correct any electrolyte abnormalities. Instruct patients to report any irregular heartbeat, dizziness, or fainting. DISCUSSION: In a study in eight subjects who were deficient in CYP2D6, the concurrent administration of tolterodine (2 mg) with ketoconazole (200 mg once daily for four days), another inhibitor of CYP3A4, resulted in a 60% decrease in tolterodine clearance.(5) Tolterodine AUC and Cmax increased 2.5-fold and 2-fold, respectively.(2) In a study of the effect of tolterodine immediate release tablets, the effect on the QT interval appeared greater for 8 mg/day (two times the therapeutic dose) compared to 4 mg/day. Tolterodine 2 mg BID and tolterodine 4 mg BID increased the QTcF by 5.01 msec (0.28-9.74 msec) and 11.84 msec (7.11-16.58 msec), respectively. The change in QT interval was more pronounced in CYP2D6 poor metabolizers (PM) than extensive metabolizers (EMs).(1,2) |
TOLTERODINE TARTRATE, TOLTERODINE TARTRATE ER |
There are 1 moderate interactions.
The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.
| Drug Interaction | Drug Names |
|---|---|
| Tolterodine (Less Than or Equal To 1 mg or Less Than or Equal To 2 mg ER)/Selected CYP3A4 Inhibitors SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Cyclosporine, erythromycin, miconazole, and vinblastine may inhibit the metabolism of tolterodine by CYP3A4.(1,2) CLINICAL EFFECTS: The concurrent administration of tolterodine with cyclosporine, erythromycin, miconazole, or vinblastine may result in elevated levels of tolterodine and signs of toxicity.(1,2) PREDISPOSING FACTORS: Patients who are CYP2D6 poor metabolizers may be at increased risk.(1,2) The risk of QT prolongation or torsades de pointes may be increased in patients with cardiovascular disease (e.g. heart failure, myocardial infarction, history of torsades de pointes, congenital long QT syndrome), hypokalemia, hypomagnesemia, hypocalcemia, bradycardia, female gender, or advanced age.(3) Concurrent use of more than one drug known to cause QT prolongation or higher systemic concentrations of either QT prolonging drug are additional risk factors for torsades de pointes. Factors which may increase systemic drug concentrations include rapid infusion of an intravenous dose or impaired metabolism or elimination of the drug (e.g. coadministration with an agent which inhibits its metabolism or elimination, genetic impairment in drug metabolism or elimination, and/or renal/hepatic dysfunction).(3) The risk of anticholinergic toxicities including cognitive decline, delirium, falls and fractures is increased in geriatric patients using more than one medicine with anticholinergic properties.(4) PATIENT MANAGEMENT: The manufacturer of tolterodine recommends that a maximum tolterodine dosage of 1 mg twice daily of the non extended release dosage form(1) or 2 mg once daily of the extended release dosage form(2) be used in patients receiving concurrent therapy with cyclosporine, erythromycin, miconazole, or vinblastine. If concurrent therapy is warranted, consider obtaining serum calcium, magnesium, and potassium levels and monitoring ECG at baseline and at regular intervals. Correct any electrolyte abnormalities. Instruct patients to report any irregular heartbeat, dizziness, or fainting. DISCUSSION: In a study in eight subjects who were deficient in CYP2D6, the concurrent administration of tolterodine (2 mg) with ketoconazole (200 mg once daily for four days), another inhibitor of CYP3A4, resulted in a 60% decrease in tolterodine clearance.(5) Tolterodine AUC and Cmax increased 2.5-fold and 2-fold, respectively.(2) In a study of the effect of tolterodine immediate release tablets, the effect on the QT interval appeared greater for 8 mg/day (two times the therapeutic dose) compared to 4 mg/day. Tolterodine 2 mg BID and tolterodine 4 mg BID increased the QTcF by 5.01 msec (0.28-9.74 msec) and 11.84 msec (7.11-16.58 msec), respectively. The change in QT interval was more pronounced in CYP2D6 poor metabolizers (PM) than extensive metabolizers (EMs).(1,2) |
TOLTERODINE TARTRATE, TOLTERODINE TARTRATE ER |
The following contraindication information is available for MONISTAT 1 (miconazole nitrate):
Drug contraindication overview.
No enhanced Contraindications information available for this drug.
No enhanced Contraindications information available for this drug.
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 |
The following adverse reaction information is available for MONISTAT 1 (miconazole nitrate):
Adverse reaction overview.
No enhanced Common Adverse Effects information available for this drug.
No enhanced Common Adverse Effects information available for this drug.
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 |
The following precautions are available for MONISTAT 1 (miconazole nitrate):
No enhanced Pediatric Use information available for this drug.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
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. For self-medication, miconazole nitrate vaginal suppositories or vaginal cream should not be used in pregnant women unless otherwise instructed by a physician. Follow-up reports from clinical studies during which miconazole vaginal preparations were used for up to 14 days in pregnant women have revealed no adverse effects or complications attributable to therapy with the drug in infants born to these women.
Prolonged gestation has occurred in rats, but not in rabbits, receiving oral miconazole nitrate. In addition, fetotoxicity and embryotoxicity have occurred in rats and rabbits and dystocia in rats in reproduction studies using oral miconazole nitrate dosages of 80 mg/kg and higher; these effects were not observed in rats following intravaginal administration of the drug. 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).
Prolonged gestation has occurred in rats, but not in rabbits, receiving oral miconazole nitrate. In addition, fetotoxicity and embryotoxicity have occurred in rats and rabbits and dystocia in rats in reproduction studies using oral miconazole nitrate dosages of 80 mg/kg and higher; these effects were not observed in rats following intravaginal administration of the drug. 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).
It is not known whether miconazole nitrate is distributed into milk. Miconazole nitrate should be used with caution in nursing women. 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.
The following prioritized warning is available for MONISTAT 1 (miconazole nitrate):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for MONISTAT 1 (miconazole nitrate)'s list of indications:
| Vulvovaginal candidiasis | |
| B37.3 | Candidiasis of vulva and vagina |
| B37.31 | Acute candidiasis of vulva and vagina |
| B37.32 | Chronic candidiasis of vulva and vagina |
Formulary Reference Tool