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Drug overview for MICONATATE (miconazole nitrate/tolnaftate):
Generic name: miconazole nitrate/tolnaftate
Drug class: Topical Antifungals
Therapeutic class: Dermatological
Miconazole nitrate, an imidazole derivative, a synthetic azole antifungal Tolnaftate is a synthetic thiocarbamate antifungal agent. agents.
No enhanced Uses information available for this drug.
Generic name: miconazole nitrate/tolnaftate
Drug class: Topical Antifungals
Therapeutic class: Dermatological
Miconazole nitrate, an imidazole derivative, a synthetic azole antifungal Tolnaftate is a synthetic thiocarbamate antifungal agent. agents.
No enhanced Uses information available for this drug.
DRUG IMAGES
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The following indications for MICONATATE (miconazole nitrate/tolnaftate) have been approved by the FDA:
Indications:
Cutaneous candidiasis
Tinea corporis
Tinea cruris
Tinea pedis
Tinea versicolor
Professional Synonyms:
Corporeal ringworm
Cutaneous candidosis
Cutaneous moniliasis
Dermatomycosis pedis
Dhobie itch
Eczema marginatum
Jock itch
Pityriasis versicolor
Tinea circinata
Tinea furfuracea
Tinea glabrosa
Tinea inguinalis
Tinea of the foot
Indications:
Cutaneous candidiasis
Tinea corporis
Tinea cruris
Tinea pedis
Tinea versicolor
Professional Synonyms:
Corporeal ringworm
Cutaneous candidosis
Cutaneous moniliasis
Dermatomycosis pedis
Dhobie itch
Eczema marginatum
Jock itch
Pityriasis versicolor
Tinea circinata
Tinea furfuracea
Tinea glabrosa
Tinea inguinalis
Tinea of the foot
The following dosing information is available for MICONATATE (miconazole nitrate/tolnaftate):
No enhanced Dosing information available for this drug.
Tolnaftate is applied topically to infected skin as a 1% cream, aerosol liquid spray, aerosol powder spray, powder, or solution. Contact with eyes, nose, mouth, and other mucous membranes should be avoided. Tolnaftate should not be used on nail or scalp infections.
Prior to application, the infected area should be cleaned with soap and water and dried thoroughly. The powder or aerosol powder is used alone for the treatment of mild infections or as an adjunct to the cream or solution or systemic antifungal agents when drying of the lesion is desired. A small amount of the cream or powder or 2 or 3 drops of the solution should be rubbed gently into affected areas.
If the aerosol liquid spray or aerosol spray powder is used, a thin layer should be applied. When used for the treatment of tinea pedis, special attention should be paid to applying the drug in the spaces between the toes. In addition, patients with tinea pedis should wear well-fitting, ventilated shoes and change their shoes and socks at least once daily.
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.
Prior to application, the infected area should be cleaned with soap and water and dried thoroughly. The powder or aerosol powder is used alone for the treatment of mild infections or as an adjunct to the cream or solution or systemic antifungal agents when drying of the lesion is desired. A small amount of the cream or powder or 2 or 3 drops of the solution should be rubbed gently into affected areas.
If the aerosol liquid spray or aerosol spray powder is used, a thin layer should be applied. When used for the treatment of tinea pedis, special attention should be paid to applying the drug in the spaces between the toes. In addition, patients with tinea pedis should wear well-fitting, ventilated shoes and change their shoes and socks at least once daily.
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.
No dosing information available.
No generic dosing information available.
The following drug interaction information is available for MICONATATE (miconazole nitrate/tolnaftate):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for MICONATATE (miconazole nitrate/tolnaftate):
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 MICONATATE (miconazole nitrate/tolnaftate):
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 4 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. | None. |
| Rare/Very Rare |
|---|
|
Anaphylaxis Angioedema Blistering skin Skin rash |
There are 14 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Pruritus of skin Skin inflammation Skin irritation |
None. |
| Rare/Very Rare |
|---|
|
Abnormal hair texture Alopecia Cheilitis Dermatitis due to topical drug Dry skin Erythema Hair discoloration Paresthesia Skin irritation Skin rash Stinging of skin |
The following precautions are available for MICONATATE (miconazole nitrate/tolnaftate):
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 |
There are no adequate and controlled studies to date using tolnaftate in pregnant women, and the drug should be used during pregnancy only when clearly needed. 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.
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.
It is not known whether tolnaftate is distributed into milk. Safe use of tolnaftate in nursing women has not been established. It is not known whether miconazole nitrate is distributed into milk. Miconazole nitrate should be used with caution in nursing women.
No enhanced Geriatric Use information available for this drug.
The following prioritized warning is available for MICONATATE (miconazole nitrate/tolnaftate):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for MICONATATE (miconazole nitrate/tolnaftate)'s list of indications:
| Cutaneous candidiasis | |
| B37.2 | Candidiasis of skin and nail |
| Tinea corporis | |
| B35.4 | Tinea corporis |
| Tinea cruris | |
| B35.6 | Tinea cruris |
| Tinea pedis | |
| B35.3 | Tinea pedis |
| Tinea versicolor | |
| B36.0 | Pityriasis versicolor |
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