Miconazole; petrolatum; zinc oxide (Vusion(TM)) ointment is used as an adjuvant treatment for diaper dermatitis complicated by candidiasis. Candidiasis must be documented with microscopic evidence of pseudohyphae and/or budding yeast prior to initiating treatment; a positive fungal culture for Candida albicans is not adequate evidence of candidal infection, as colonization with C. albicans can result in a positive culture. Vusion(TM) ointment has only been studied in immunocompetent pediatric patients older than 4 weeks of age. Efficacy has not be established in incontinent or debilitated adult populations; preventative use of this product, such as in an adult institutional setting, is not recommended, especially because preventative use may result in antimicrobial resistance. Miconazole; petrolatum; zinc oxide (Vusion(TM)) ointment was approved by the FDA in February 2006.
General Administration Information
For storage information, see the specific product information within the How Supplied section.
Route-Specific Administration
Topical Administration
-The caretaker should be instructed to thoroughly wash hands before and after each application.
-Apply with each diaper change. Before each application, gently cleanse and dry the diaper area with lukewarm water and pat dry with a soft towel. Avoid using any scented soap, shampoos, or lotions.
-Application should be gentle, with the fingertips. Do not rub in to the skin as additional irritation may occur.
-Full course of treatment (7 days) should be completed regardless of apparent improvement. Do not use for longer than 7 days. If symptoms have not improved by day 7, see your health care provider.
Miconazole; petrolatum; zinc oxide ointment was compared to a control group (petrolatum; zinc oxide ointment) in a total of 835 infants and young children during clinical trials. One or more adverse events were reported in 58 (14%) of the patients in the active treatment group, compared to 85 (20%) of the patients in the control group. Adverse events that occurred in >=1% of those treated with miconazole; petrolatum; zinc oxide were approximately the same in type and frequency as those in the control group.
Skin and subcutaneous tissue disorders noted in post-marketing reports of miconazole; petrolatum; zinc oxide include blister, contact dermatitis, diaper dermatitis, dry skin (xerosis), erythema, pruritus, rash (unspecified), and skin exfoliation. Other administration site symptoms noted post-marketing include burning sensation, aggravated condition, inflammation, and pain. Accidental exposure was also reported. If additional skin irritation occurs, ensure that the product is being applied appropriately; rubbing the ointment into the skin can cause additional irritation. If irritation occurs or if the disease worsens, discontinue use of the medication.
Vomiting was noted in post-marketing reports of miconazole; petrolatum; zinc oxide.
The presence of candidal infection should be established by microscopic evaluation, with evidence of pseudohyphae and/or budding yeast, prior to initiating treatment with miconazole; petrolatum; zinc oxide ointment. A positive fungal culture for Candida albicans is not adequate evidence of candidal infection, as colonization with C. albicans can result in a positive culture.
Miconazole; petrolatum; zinc oxide ointment is intended for use as an adjunctive treatment of diaper dermatitis complicated by candidiasis. That is, the treatment regimen should include measures directed at the underlying diaper dermatitis, including gentle cleansing of the diaper area and frequent diaper changes. Do not use as a substitute for frequent diaper changes. Do not be rub the ointment into the skin, as further irritation may occur.
Miconazole; petrolatum; zinc oxide ointment is intended for external use only; not for oral administration, ophthalmic administration, or intra-vaginal administration.
Use of miconazole; petrolatum; zinc oxide ointment is contraindicated in patients with a history hypersensitivity to any component of the product, including patients with azole antifungals hypersensitivity. Discontinue use in any patient in whom hypersensitivity is noted.
Miconazole; petrolatum; zinc oxide ointment is not indicated for use in patients with any form of immunosuppression.
The efficacy of miconazole; petrolatum; zinc oxide ointment has not been established in term neonates; safety and efficacy have not been established in very low birth weight infants. Use in neonates (full-term newborn 0 to 4 weeks of age) is not recommended.
Miconazole; petrolatum; zinc oxide ointment is not indicated for use in the prevention of diaper dermatitis. Regardless of improvement in the condition, the ointment should be used for a full 7-day course of treatment; discontinuation of treatment with the apparent lack of healing and treatment beyond 7 days should be avoided. Using this medication as a preventative, discontinuing treatment early, or prolonged use may result in the development of antimicrobial resistance. The safety of use beyond 7 days has not been established. If skin irritation occurs or there is apparent worsening of the disease, discontinue use.
The safety and efficacy of miconazole; petrolatum; zinc oxide ointment has not been evaluated in incontinent adult or geriatric patients. Do not use to prevent the occurrence of diaper dermatitis, such as in an adult institutional setting; preventative use may result in the development of antimicrobial resistance.
There are no adequate and well-controlled studies regarding the use of miconazole; petrolatum; zinc oxide ointment during pregnancy, and its ability to cause fetal harm or affect reproductive capacity is unknown. In rats, systemic miconazole nitrate administration (100 mg/kg/day, orally; 28-times the maximum possible topical exposure assuming 100% absorption) has been shown to result in prolonged gestation and decreased numbers of live young. In rabbits, systemic miconazole nitrate administration (80 mg/kg/day, orally; 45-times the maximum possible topical exposure assuming 100% absorption) has been shown to result in an increased number of resorptions and decreased number of live young. Instruct pregnant women to exercise appropriate precautions with topical administration.
Data are limited regarding use of miconazole; petrolatum; zinc oxide ointment during breast-feeding, and excretion of its components in human milk is unknown. However, because significant maternal absorption does not occur when the drug is applied topically, excretion in breast milk and the subsequent risk to a breast-fed infant is considered low. To minimize potential oral ingestion by the nursing infant, instruct mothers not to apply the ointment to the breast during times of breast-feeding. Mothers should also exercise appropriate precautions (including washing hands before and after application) when administering the product to any infant. Clotrimazole and nystatin may be potential alternatives to consider during breast-feeding. However, site of infection, local susceptibility patterns, and specific microbial susceptibility should be assessed before choosing an alternative agent. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, health care providers are encouraged to report the adverse effect to the FDA.
Per the manufacturer, this drug has been shown to be active against most strains of the following microorganisms either in vitro and/or in clinical infections: Candida albicans
NOTE: The safety and effectiveness in treating clinical infections due to organisms with in vitro data only have not been established in adequate and well-controlled clinical trials.
For the adjuvant treatment of diaper dermatitis complicated by documented candidiasis in immunocompetent pediatric patients:
Topical dosage:
Infants >= 4 weeks: Gently apply a thin layer of ointment to the affected area at each diaper change for 7 days; do not rub the ointment into the skin as further irritation may occur. The full course of treatment should be completed, even if there is no apparent improvement; safety beyond 7 days of treatment is unknown. Use as part of a treatment regimen that includes measures directed at the underlying diaper dermatitis, including gentle cleansing of the diaper area and frequent diaper changes.
Neonates: Safety and efficacy have not been established.
Maximum Dosage Limits:
-Adults
No maximum dosage information is available.
-Elderly
No maximum dosage information is available.
-Adolescents
No maximum dosage information is available.
-Children
No maximum dosage information is available.
-Infants
No maximum dosage information is available.
-Neonates
Safety and efficacy have not been established.
Patients with Hepatic Impairment Dosing
Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.
Patients with Renal Impairment Dosing
Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.
*non-FDA-approved indication
Desogestrel; Ethinyl Estradiol: (Minor) Miconazole vaginal products may be administered with most hormonal contraceptives containing ethinyl estradiol, as most of the time any increase in ethinyl estradiol AUC is minimal and unlikely to cause significant side effects, though some patients may notice breast tenderness or nausea. In patients using contraceptive vaginal rings, water-based miconazole products are preferred. Oil-based miconazole vaginal products appear to increase ethinyl estradiol exposure from the contraceptive vaginal rings. Water-based miconazole vaginal products or an alternative oral therapy may be used concurrently with vaginal rings containing ethinyl estradiol. In drug interaction studies with ethinyl estradiol-containing vaginal rings, single-dose vaginal administration of a 1,200 mg miconazole suppository increased the systemic exposure of ethinyl estradiol by 16% to 67%, depending on the contraceptive vaginal ring in use. When 200 mg miconazole vaginal suppositories were administered, the ethinyl estradiol systemic exposures were also increased, with a maximal reported increase of 42% on day 3 of miconazole vaginal suppository use. Multiple doses of a 200 mg miconazole nitrate vaginal cream with the etonogestrel; ethinyl estradiol ring increased the mean serum concentration of ethinyl estradiol by up to 40%. Water-based vaginal miconazole cream did not affect the pharmacokinetics of the segesterone acetate; ethinyl estradiol vaginal ring.
Drospirenone; Ethinyl Estradiol: (Minor) Miconazole vaginal products may be administered with most hormonal contraceptives containing ethinyl estradiol, as most of the time any increase in ethinyl estradiol AUC is minimal and unlikely to cause significant side effects, though some patients may notice breast tenderness or nausea. In patients using contraceptive vaginal rings, water-based miconazole products are preferred. Oil-based miconazole vaginal products appear to increase ethinyl estradiol exposure from the contraceptive vaginal rings. Water-based miconazole vaginal products or an alternative oral therapy may be used concurrently with vaginal rings containing ethinyl estradiol. In drug interaction studies with ethinyl estradiol-containing vaginal rings, single-dose vaginal administration of a 1,200 mg miconazole suppository increased the systemic exposure of ethinyl estradiol by 16% to 67%, depending on the contraceptive vaginal ring in use. When 200 mg miconazole vaginal suppositories were administered, the ethinyl estradiol systemic exposures were also increased, with a maximal reported increase of 42% on day 3 of miconazole vaginal suppository use. Multiple doses of a 200 mg miconazole nitrate vaginal cream with the etonogestrel; ethinyl estradiol ring increased the mean serum concentration of ethinyl estradiol by up to 40%. Water-based vaginal miconazole cream did not affect the pharmacokinetics of the segesterone acetate; ethinyl estradiol vaginal ring.
Drospirenone; Ethinyl Estradiol; Levomefolate: (Minor) Miconazole vaginal products may be administered with most hormonal contraceptives containing ethinyl estradiol, as most of the time any increase in ethinyl estradiol AUC is minimal and unlikely to cause significant side effects, though some patients may notice breast tenderness or nausea. In patients using contraceptive vaginal rings, water-based miconazole products are preferred. Oil-based miconazole vaginal products appear to increase ethinyl estradiol exposure from the contraceptive vaginal rings. Water-based miconazole vaginal products or an alternative oral therapy may be used concurrently with vaginal rings containing ethinyl estradiol. In drug interaction studies with ethinyl estradiol-containing vaginal rings, single-dose vaginal administration of a 1,200 mg miconazole suppository increased the systemic exposure of ethinyl estradiol by 16% to 67%, depending on the contraceptive vaginal ring in use. When 200 mg miconazole vaginal suppositories were administered, the ethinyl estradiol systemic exposures were also increased, with a maximal reported increase of 42% on day 3 of miconazole vaginal suppository use. Multiple doses of a 200 mg miconazole nitrate vaginal cream with the etonogestrel; ethinyl estradiol ring increased the mean serum concentration of ethinyl estradiol by up to 40%. Water-based vaginal miconazole cream did not affect the pharmacokinetics of the segesterone acetate; ethinyl estradiol vaginal ring.
Ethinyl Estradiol; Norelgestromin: (Minor) Miconazole vaginal products may be administered with most hormonal contraceptives containing ethinyl estradiol, as most of the time any increase in ethinyl estradiol AUC is minimal and unlikely to cause significant side effects, though some patients may notice breast tenderness or nausea. In patients using contraceptive vaginal rings, water-based miconazole products are preferred. Oil-based miconazole vaginal products appear to increase ethinyl estradiol exposure from the contraceptive vaginal rings. Water-based miconazole vaginal products or an alternative oral therapy may be used concurrently with vaginal rings containing ethinyl estradiol. In drug interaction studies with ethinyl estradiol-containing vaginal rings, single-dose vaginal administration of a 1,200 mg miconazole suppository increased the systemic exposure of ethinyl estradiol by 16% to 67%, depending on the contraceptive vaginal ring in use. When 200 mg miconazole vaginal suppositories were administered, the ethinyl estradiol systemic exposures were also increased, with a maximal reported increase of 42% on day 3 of miconazole vaginal suppository use. Multiple doses of a 200 mg miconazole nitrate vaginal cream with the etonogestrel; ethinyl estradiol ring increased the mean serum concentration of ethinyl estradiol by up to 40%. Water-based vaginal miconazole cream did not affect the pharmacokinetics of the segesterone acetate; ethinyl estradiol vaginal ring.
Ethinyl Estradiol; Norethindrone Acetate: (Minor) Miconazole vaginal products may be administered with most hormonal contraceptives containing ethinyl estradiol, as most of the time any increase in ethinyl estradiol AUC is minimal and unlikely to cause significant side effects, though some patients may notice breast tenderness or nausea. In patients using contraceptive vaginal rings, water-based miconazole products are preferred. Oil-based miconazole vaginal products appear to increase ethinyl estradiol exposure from the contraceptive vaginal rings. Water-based miconazole vaginal products or an alternative oral therapy may be used concurrently with vaginal rings containing ethinyl estradiol. In drug interaction studies with ethinyl estradiol-containing vaginal rings, single-dose vaginal administration of a 1,200 mg miconazole suppository increased the systemic exposure of ethinyl estradiol by 16% to 67%, depending on the contraceptive vaginal ring in use. When 200 mg miconazole vaginal suppositories were administered, the ethinyl estradiol systemic exposures were also increased, with a maximal reported increase of 42% on day 3 of miconazole vaginal suppository use. Multiple doses of a 200 mg miconazole nitrate vaginal cream with the etonogestrel; ethinyl estradiol ring increased the mean serum concentration of ethinyl estradiol by up to 40%. Water-based vaginal miconazole cream did not affect the pharmacokinetics of the segesterone acetate; ethinyl estradiol vaginal ring.
Ethinyl Estradiol; Norgestrel: (Minor) Miconazole vaginal products may be administered with most hormonal contraceptives containing ethinyl estradiol, as most of the time any increase in ethinyl estradiol AUC is minimal and unlikely to cause significant side effects, though some patients may notice breast tenderness or nausea. In patients using contraceptive vaginal rings, water-based miconazole products are preferred. Oil-based miconazole vaginal products appear to increase ethinyl estradiol exposure from the contraceptive vaginal rings. Water-based miconazole vaginal products or an alternative oral therapy may be used concurrently with vaginal rings containing ethinyl estradiol. In drug interaction studies with ethinyl estradiol-containing vaginal rings, single-dose vaginal administration of a 1,200 mg miconazole suppository increased the systemic exposure of ethinyl estradiol by 16% to 67%, depending on the contraceptive vaginal ring in use. When 200 mg miconazole vaginal suppositories were administered, the ethinyl estradiol systemic exposures were also increased, with a maximal reported increase of 42% on day 3 of miconazole vaginal suppository use. Multiple doses of a 200 mg miconazole nitrate vaginal cream with the etonogestrel; ethinyl estradiol ring increased the mean serum concentration of ethinyl estradiol by up to 40%. Water-based vaginal miconazole cream did not affect the pharmacokinetics of the segesterone acetate; ethinyl estradiol vaginal ring.
Ethynodiol Diacetate; Ethinyl Estradiol: (Minor) Miconazole vaginal products may be administered with most hormonal contraceptives containing ethinyl estradiol, as most of the time any increase in ethinyl estradiol AUC is minimal and unlikely to cause significant side effects, though some patients may notice breast tenderness or nausea. In patients using contraceptive vaginal rings, water-based miconazole products are preferred. Oil-based miconazole vaginal products appear to increase ethinyl estradiol exposure from the contraceptive vaginal rings. Water-based miconazole vaginal products or an alternative oral therapy may be used concurrently with vaginal rings containing ethinyl estradiol. In drug interaction studies with ethinyl estradiol-containing vaginal rings, single-dose vaginal administration of a 1,200 mg miconazole suppository increased the systemic exposure of ethinyl estradiol by 16% to 67%, depending on the contraceptive vaginal ring in use. When 200 mg miconazole vaginal suppositories were administered, the ethinyl estradiol systemic exposures were also increased, with a maximal reported increase of 42% on day 3 of miconazole vaginal suppository use. Multiple doses of a 200 mg miconazole nitrate vaginal cream with the etonogestrel; ethinyl estradiol ring increased the mean serum concentration of ethinyl estradiol by up to 40%. Water-based vaginal miconazole cream did not affect the pharmacokinetics of the segesterone acetate; ethinyl estradiol vaginal ring.
Etonogestrel; Ethinyl Estradiol: (Minor) Miconazole vaginal products may be administered with most hormonal contraceptives containing ethinyl estradiol, as most of the time any increase in ethinyl estradiol AUC is minimal and unlikely to cause significant side effects, though some patients may notice breast tenderness or nausea. In patients using contraceptive vaginal rings, water-based miconazole products are preferred. Oil-based miconazole vaginal products appear to increase ethinyl estradiol exposure from the contraceptive vaginal rings. Water-based miconazole vaginal products or an alternative oral therapy may be used concurrently with vaginal rings containing ethinyl estradiol. In drug interaction studies with ethinyl estradiol-containing vaginal rings, single-dose vaginal administration of a 1,200 mg miconazole suppository increased the systemic exposure of ethinyl estradiol by 16% to 67%, depending on the contraceptive vaginal ring in use. When 200 mg miconazole vaginal suppositories were administered, the ethinyl estradiol systemic exposures were also increased, with a maximal reported increase of 42% on day 3 of miconazole vaginal suppository use. Multiple doses of a 200 mg miconazole nitrate vaginal cream with the etonogestrel; ethinyl estradiol ring increased the mean serum concentration of ethinyl estradiol by up to 40%. Water-based vaginal miconazole cream did not affect the pharmacokinetics of the segesterone acetate; ethinyl estradiol vaginal ring.
Levonorgestrel; Ethinyl Estradiol: (Minor) Miconazole vaginal products may be administered with most hormonal contraceptives containing ethinyl estradiol, as most of the time any increase in ethinyl estradiol AUC is minimal and unlikely to cause significant side effects, though some patients may notice breast tenderness or nausea. In patients using contraceptive vaginal rings, water-based miconazole products are preferred. Oil-based miconazole vaginal products appear to increase ethinyl estradiol exposure from the contraceptive vaginal rings. Water-based miconazole vaginal products or an alternative oral therapy may be used concurrently with vaginal rings containing ethinyl estradiol. In drug interaction studies with ethinyl estradiol-containing vaginal rings, single-dose vaginal administration of a 1,200 mg miconazole suppository increased the systemic exposure of ethinyl estradiol by 16% to 67%, depending on the contraceptive vaginal ring in use. When 200 mg miconazole vaginal suppositories were administered, the ethinyl estradiol systemic exposures were also increased, with a maximal reported increase of 42% on day 3 of miconazole vaginal suppository use. Multiple doses of a 200 mg miconazole nitrate vaginal cream with the etonogestrel; ethinyl estradiol ring increased the mean serum concentration of ethinyl estradiol by up to 40%. Water-based vaginal miconazole cream did not affect the pharmacokinetics of the segesterone acetate; ethinyl estradiol vaginal ring.
Levonorgestrel; Ethinyl Estradiol; Ferrous Bisglycinate: (Minor) Miconazole vaginal products may be administered with most hormonal contraceptives containing ethinyl estradiol, as most of the time any increase in ethinyl estradiol AUC is minimal and unlikely to cause significant side effects, though some patients may notice breast tenderness or nausea. In patients using contraceptive vaginal rings, water-based miconazole products are preferred. Oil-based miconazole vaginal products appear to increase ethinyl estradiol exposure from the contraceptive vaginal rings. Water-based miconazole vaginal products or an alternative oral therapy may be used concurrently with vaginal rings containing ethinyl estradiol. In drug interaction studies with ethinyl estradiol-containing vaginal rings, single-dose vaginal administration of a 1,200 mg miconazole suppository increased the systemic exposure of ethinyl estradiol by 16% to 67%, depending on the contraceptive vaginal ring in use. When 200 mg miconazole vaginal suppositories were administered, the ethinyl estradiol systemic exposures were also increased, with a maximal reported increase of 42% on day 3 of miconazole vaginal suppository use. Multiple doses of a 200 mg miconazole nitrate vaginal cream with the etonogestrel; ethinyl estradiol ring increased the mean serum concentration of ethinyl estradiol by up to 40%. Water-based vaginal miconazole cream did not affect the pharmacokinetics of the segesterone acetate; ethinyl estradiol vaginal ring.
Levonorgestrel; Ethinyl Estradiol; Ferrous Fumarate: (Minor) Miconazole vaginal products may be administered with most hormonal contraceptives containing ethinyl estradiol, as most of the time any increase in ethinyl estradiol AUC is minimal and unlikely to cause significant side effects, though some patients may notice breast tenderness or nausea. In patients using contraceptive vaginal rings, water-based miconazole products are preferred. Oil-based miconazole vaginal products appear to increase ethinyl estradiol exposure from the contraceptive vaginal rings. Water-based miconazole vaginal products or an alternative oral therapy may be used concurrently with vaginal rings containing ethinyl estradiol. In drug interaction studies with ethinyl estradiol-containing vaginal rings, single-dose vaginal administration of a 1,200 mg miconazole suppository increased the systemic exposure of ethinyl estradiol by 16% to 67%, depending on the contraceptive vaginal ring in use. When 200 mg miconazole vaginal suppositories were administered, the ethinyl estradiol systemic exposures were also increased, with a maximal reported increase of 42% on day 3 of miconazole vaginal suppository use. Multiple doses of a 200 mg miconazole nitrate vaginal cream with the etonogestrel; ethinyl estradiol ring increased the mean serum concentration of ethinyl estradiol by up to 40%. Water-based vaginal miconazole cream did not affect the pharmacokinetics of the segesterone acetate; ethinyl estradiol vaginal ring.
Norethindrone Acetate; Ethinyl Estradiol; Ferrous fumarate: (Minor) Miconazole vaginal products may be administered with most hormonal contraceptives containing ethinyl estradiol, as most of the time any increase in ethinyl estradiol AUC is minimal and unlikely to cause significant side effects, though some patients may notice breast tenderness or nausea. In patients using contraceptive vaginal rings, water-based miconazole products are preferred. Oil-based miconazole vaginal products appear to increase ethinyl estradiol exposure from the contraceptive vaginal rings. Water-based miconazole vaginal products or an alternative oral therapy may be used concurrently with vaginal rings containing ethinyl estradiol. In drug interaction studies with ethinyl estradiol-containing vaginal rings, single-dose vaginal administration of a 1,200 mg miconazole suppository increased the systemic exposure of ethinyl estradiol by 16% to 67%, depending on the contraceptive vaginal ring in use. When 200 mg miconazole vaginal suppositories were administered, the ethinyl estradiol systemic exposures were also increased, with a maximal reported increase of 42% on day 3 of miconazole vaginal suppository use. Multiple doses of a 200 mg miconazole nitrate vaginal cream with the etonogestrel; ethinyl estradiol ring increased the mean serum concentration of ethinyl estradiol by up to 40%. Water-based vaginal miconazole cream did not affect the pharmacokinetics of the segesterone acetate; ethinyl estradiol vaginal ring.
Norethindrone; Ethinyl Estradiol: (Minor) Miconazole vaginal products may be administered with most hormonal contraceptives containing ethinyl estradiol, as most of the time any increase in ethinyl estradiol AUC is minimal and unlikely to cause significant side effects, though some patients may notice breast tenderness or nausea. In patients using contraceptive vaginal rings, water-based miconazole products are preferred. Oil-based miconazole vaginal products appear to increase ethinyl estradiol exposure from the contraceptive vaginal rings. Water-based miconazole vaginal products or an alternative oral therapy may be used concurrently with vaginal rings containing ethinyl estradiol. In drug interaction studies with ethinyl estradiol-containing vaginal rings, single-dose vaginal administration of a 1,200 mg miconazole suppository increased the systemic exposure of ethinyl estradiol by 16% to 67%, depending on the contraceptive vaginal ring in use. When 200 mg miconazole vaginal suppositories were administered, the ethinyl estradiol systemic exposures were also increased, with a maximal reported increase of 42% on day 3 of miconazole vaginal suppository use. Multiple doses of a 200 mg miconazole nitrate vaginal cream with the etonogestrel; ethinyl estradiol ring increased the mean serum concentration of ethinyl estradiol by up to 40%. Water-based vaginal miconazole cream did not affect the pharmacokinetics of the segesterone acetate; ethinyl estradiol vaginal ring.
Norethindrone; Ethinyl Estradiol; Ferrous fumarate: (Minor) Miconazole vaginal products may be administered with most hormonal contraceptives containing ethinyl estradiol, as most of the time any increase in ethinyl estradiol AUC is minimal and unlikely to cause significant side effects, though some patients may notice breast tenderness or nausea. In patients using contraceptive vaginal rings, water-based miconazole products are preferred. Oil-based miconazole vaginal products appear to increase ethinyl estradiol exposure from the contraceptive vaginal rings. Water-based miconazole vaginal products or an alternative oral therapy may be used concurrently with vaginal rings containing ethinyl estradiol. In drug interaction studies with ethinyl estradiol-containing vaginal rings, single-dose vaginal administration of a 1,200 mg miconazole suppository increased the systemic exposure of ethinyl estradiol by 16% to 67%, depending on the contraceptive vaginal ring in use. When 200 mg miconazole vaginal suppositories were administered, the ethinyl estradiol systemic exposures were also increased, with a maximal reported increase of 42% on day 3 of miconazole vaginal suppository use. Multiple doses of a 200 mg miconazole nitrate vaginal cream with the etonogestrel; ethinyl estradiol ring increased the mean serum concentration of ethinyl estradiol by up to 40%. Water-based vaginal miconazole cream did not affect the pharmacokinetics of the segesterone acetate; ethinyl estradiol vaginal ring.
Norgestimate; Ethinyl Estradiol: (Minor) Miconazole vaginal products may be administered with most hormonal contraceptives containing ethinyl estradiol, as most of the time any increase in ethinyl estradiol AUC is minimal and unlikely to cause significant side effects, though some patients may notice breast tenderness or nausea. In patients using contraceptive vaginal rings, water-based miconazole products are preferred. Oil-based miconazole vaginal products appear to increase ethinyl estradiol exposure from the contraceptive vaginal rings. Water-based miconazole vaginal products or an alternative oral therapy may be used concurrently with vaginal rings containing ethinyl estradiol. In drug interaction studies with ethinyl estradiol-containing vaginal rings, single-dose vaginal administration of a 1,200 mg miconazole suppository increased the systemic exposure of ethinyl estradiol by 16% to 67%, depending on the contraceptive vaginal ring in use. When 200 mg miconazole vaginal suppositories were administered, the ethinyl estradiol systemic exposures were also increased, with a maximal reported increase of 42% on day 3 of miconazole vaginal suppository use. Multiple doses of a 200 mg miconazole nitrate vaginal cream with the etonogestrel; ethinyl estradiol ring increased the mean serum concentration of ethinyl estradiol by up to 40%. Water-based vaginal miconazole cream did not affect the pharmacokinetics of the segesterone acetate; ethinyl estradiol vaginal ring.
Nystatin: (Moderate) The combination of miconazole and nystatin represents duplication of therapy whenever the drugs are used by similar routes and are usually avoided.
Progesterone: (Moderate) Vaginal preparations of progesterone (e.g., Crinone, Endometrin, and Prochieve) should not be used with other intravaginal products (e.g., vaginal antifungals, such as clotrimazole, miconazole nitrate, terconazole, or tioconazole vaginal) as concurrent use may alter progesterone release and absorption from the vagina. Separate the times of administration to avoid the interaction. The manufacturers of Crinone and Prochieve indicate that other intravaginal products can be used as long as 6 hours has lapsed either before or after vaginal administration of progesterone. Endometrin is generally not recommended for use with other vaginal products (e.g., antifungal products) as this may alter progesterone release and absorption from the vaginal insert and the potential for interaction has not been formally assessed; use other vaginal products if medically necessary, but be aware that the response to Endometrin may be altered.
Segesterone Acetate; Ethinyl Estradiol: (Minor) Miconazole vaginal products may be administered with most hormonal contraceptives containing ethinyl estradiol, as most of the time any increase in ethinyl estradiol AUC is minimal and unlikely to cause significant side effects, though some patients may notice breast tenderness or nausea. In patients using contraceptive vaginal rings, water-based miconazole products are preferred. Oil-based miconazole vaginal products appear to increase ethinyl estradiol exposure from the contraceptive vaginal rings. Water-based miconazole vaginal products or an alternative oral therapy may be used concurrently with vaginal rings containing ethinyl estradiol. In drug interaction studies with ethinyl estradiol-containing vaginal rings, single-dose vaginal administration of a 1,200 mg miconazole suppository increased the systemic exposure of ethinyl estradiol by 16% to 67%, depending on the contraceptive vaginal ring in use. When 200 mg miconazole vaginal suppositories were administered, the ethinyl estradiol systemic exposures were also increased, with a maximal reported increase of 42% on day 3 of miconazole vaginal suppository use. Multiple doses of a 200 mg miconazole nitrate vaginal cream with the etonogestrel; ethinyl estradiol ring increased the mean serum concentration of ethinyl estradiol by up to 40%. Water-based vaginal miconazole cream did not affect the pharmacokinetics of the segesterone acetate; ethinyl estradiol vaginal ring.
Warfarin: (Moderate) Concomitant administration of miconazole and warfarin has resulted in enhancement of anticoagulant effect. Closely monitor prothrombin time, International Normalized Ratio (INR), or other suitable anticoagulation tests if topical or vaginal miconazole is administered concomitantly with warfarin. Also monitor for evidence of bleeding. Miconazole is a known inhibitor of CYP2C9 and CYP3A4. The systemic absorption of miconazole following vaginal or topical administration is minimal and plasma concentrations of miconazole are substantially lower than when given intravenously. However, there have been reported cases of bleeding and bruising following the concomitant use of warfarin and topical or intravaginal miconazole.
Topical application of miconazole; petrolatum; zinc oxide provides relief of diaper dermatitis and treats associated candidiasis. Miconazole, an azole antifungal, is active against Candida albicans, an organism typically associated with diaper dermatitis yeast infection. It interacts with the cytochrome P-450 enzyme 14-alpha demethylase, preventing the conversion of lanosterol to ergosterol; ergosterol is an essential component of the fungal cell membrane. Inhibition of ergosterol synthesis results in two proposed mechanisms of cellular destruction. The first is an alteration of the fungal cell membrane, causing increased cellular permeability and leakage of cellular contents. The second is the accumulation of ergosterol precursors and toxic peroxides resulting in cytolysis of the cell.In vitro minimal inhibitory concentration (MIC) test results for C. albicans isolates obtained from treatment failures in Vusion(TM) clinical trials do not appear to indicate that resistance to miconazole as a reason for treatment failure. Petrolatum serves as a vehicle and a topical barrier. Zinc oxide acts as an astringent, weak antiseptic, and topical barrier; the astringent and antiseptic actions are thought to be mediated by precipitation of proteins by zinc ions.
Miconazole; petrolatum; zinc oxide ointment is administered topically to the skin.
-Route-Specific Pharmacokinetics
Topical Route
As petrolatum and zinc oxide are topical barriers, no absorption through the skin is expected. Miconazole may display slight, clinically insignificant systemic absorption. In clinical trials (n=17), the ointment was applied to areas of diaper dermatitis in male and female patients, age 1 to 21 months, at every diaper change for 7 days. At 7 days, miconazole plasma concentrations were not detectable (< 0.5 ng/ml) in 15 of 17 patients and ranged 0.57-0.58 ng/ml in the other 2 patients at a single time point (4 hours after the last application) on Day 7.
-Special Populations
Pediatrics
In clinical trials (n=17), the miconazole; petrolatum; zinc oxide ointment was applied to areas of diaper dermatitis in male and female patients, age 1 to 21 months, at every diaper change for 7 days. At 7 days, miconazole plasma concentrations were not detectable (< 0.5 ng/ml) in 15 of 17 patients and ranged 0.57-0.58 ng/ml in the other 2 patients at a single time point (4 hours after the last application) on Day 7.