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Drug overview for DERMACINRX THERAZOLE PAK (clotrimazole/betamethasone dipropionate/zinc oxide):
Generic name: CLOTRIMAZOLE/BETAMETHASONE DIPROPIONATE/ZINC OXIDE (kloe-TRIM-a-zole/BAY-ta-METH-a-sone)
Drug class: Topical Corticosteroids
Therapeutic class: Dermatological
Betamethasone is a synthetic fluorinated corticosteroid. Clotrimazole, an imidazole derivative, is a synthetic azole antifungal agent.
Betamethasone shares the actions of the other topical corticosteroids and is used for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Generic name: CLOTRIMAZOLE/BETAMETHASONE DIPROPIONATE/ZINC OXIDE (kloe-TRIM-a-zole/BAY-ta-METH-a-sone)
Drug class: Topical Corticosteroids
Therapeutic class: Dermatological
Betamethasone is a synthetic fluorinated corticosteroid. Clotrimazole, an imidazole derivative, is a synthetic azole antifungal agent.
Betamethasone shares the actions of the other topical corticosteroids and is used for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
DRUG IMAGES
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The following indications for DERMACINRX THERAZOLE PAK (clotrimazole/betamethasone dipropionate/zinc oxide) have been approved by the FDA:
Indications:
None.
Professional Synonyms:
None.
Indications:
None.
Professional Synonyms:
None.
The following dosing information is available for DERMACINRX THERAZOLE PAK (clotrimazole/betamethasone dipropionate/zinc oxide):
Betamethasone dipropionate and valerate are applied topically. Betamethasone dipropionate preparations and betamethasone valerate preparations should not be used with occlusive dressings and patients should be warned that treated areas of the skin should not be bandaged or otherwise covered or wrapped as to be occlusive, unless directed by a clinician.
Concentrations of the dipropionate and valerate preparations usually are expressed in terms of betamethasone. Concentration of betamethasone valerate foam is expressed in terms of betamethasone valerate.
Topical preparations of betamethasone dipropionate usually are applied sparingly in thin films and are rubbed gently into the affected area once or twice daily. Because betamethasone dipropionate preparations formulated in an optimized (augmented) vehicle are among the most potent topical corticosteroid preparations currently available, the manufacturers state that dosage of betamethasone dipropionate 0.05% ointments, creams, gels, or lotions in optimized (augmented) vehicles should not exceed 45 g, 45 g, 50 g, or 50 mL per week, respectively.
Some manufacturers also state that duration of therapy with these optimized preparations should not exceed 2 weeks.
Topical betamethasone 0.1% creams and ointments (as valerate) usually are applied sparingly in thin films and are rubbed gently into the affected area 1-3 times daily. However, once- or twice-daily administration of these preparations often is effective.
Topical betamethasone valerate 0.1% solutions are applied sparingly (e.g., a few drops) and are rubbed gently into the affected area twice daily, in the morning and evening. Dosage of the topical solution may be increased in patients with resistant dermatoses.
However, dosing frequency should be decreased to once daily following clinical improvement.
For relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses of the scalp, betamethasone valerate 0.12% foam should be applied twice daily, in the morning and evening. For application to the scalp, the can containing betamethasone valerate foam should be inverted and small amounts of the preparation placed on a saucer or other cool surface.
The foam should not be dispensed directly to the hands since the foam will begin to melt immediately upon contact with warm skin. Small amounts of the preparation should be massaged gently into the scalp until the foam disappears and entire scalp area has been treated.
For the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, or tinea corporis caused by Trichophyton mentagrophytes, T. rubrum, or Epidermophyton floccosum, the fixed-combination cream or lotion containing betamethasone 0.05% and clotrimazole 1% should be applied sparingly and rubbed gently into the affected area twice daily, in the morning and evening.
If clinical improvement does not occur after 1 week in the treatment of tinea cruris or tinea corporis or after 2 weeks in the treatment of tinea pedis, the diagnosis should be reevaluated. The manufacturer states that dosage of the combination cream or lotion should not exceed 45 g or 45 mL per week, respectively, and duration of therapy with these combination preparations should not exceed 2 weeks in the treatment of tinea cruris or tinea corporis or 4 weeks in the treatment of tinea pedis. Occlusive dressings should not be used with these combination preparations.
For the topical treatment of plaque psoriasis (psoriasis vulgaris) in adults 18 years of age or older, the fixed-combination ointment containing betamethasone 0.05% and calcipotriene 0.005% should be applied and rubbed gently into the affected area until absorbed once daily.
The combination ointment should not be applied to greater than 30% of body surface area. The manufacturer states that dosage of the combination ointment should not exceed 100 g per week, and duration of therapy should not exceed 4 consecutive weeks. Occlusive dressings should not be used with the combination preparation, unless directed by a clinician.
The fixed-combination ointment should not be applied to the face, axillae, or groin area. The fixed-combination ointment should not be used in patients with erythrodermic, exfoliative, or pustular psoriasis or in patients with preexisting atrophy at the treatment site. Contact with the eyes should be avoided.
If irritation occurs, therapy with the fixed-combination ointment should be discontinued and appropriate treatment instituted. Patients should wash their hands after applying the drug. The fixed-combination ointment is not for ophthalmic, oral, or intravaginal use.
For the topical treatment of moderate to severe plaque psoriasis (psoriasis vulgaris) of the scalp in adults 18 years of age or older, the fixed-combination suspension containing betamethasone 0.05% and calcipotriene 0.005% should be applied to the affected area(s) on the scalp once daily for 2 weeks or until cleared.
The manufacturer states that dosage of the combination suspension should not exceed 100 g per week, and duration of therapy should not exceed 8 weeks. Occlusive dressings should not be used with the combination preparation, unless directed by a clinician. The combination suspension should not be applied to the face, axillae, or groin area.
In addition, the suspension should not be used in patients with erythrodermic, exfoliative, or pustular psoriasis or in patients with preexisting atrophy at the treatment site. Contact with the eyes should be avoided; eye irritation may occur. The bottle containing the suspension should be shaken prior to each use; patients should wash their hands after applying the drug.
The fixed-combination suspension is not for ophthalmic, oral, or intravaginal use.
Because calcipotriene may increase the effect of ultraviolet radiation to induce skin tumors, patients who apply the fixed-combination ointment or suspension to exposed areas of the body should avoid exposure to natural or artificial (e.g., sunlamps, tanning booths) sunlight and limit or avoid phototherapy.
Concentrations of the dipropionate and valerate preparations usually are expressed in terms of betamethasone. Concentration of betamethasone valerate foam is expressed in terms of betamethasone valerate.
Topical preparations of betamethasone dipropionate usually are applied sparingly in thin films and are rubbed gently into the affected area once or twice daily. Because betamethasone dipropionate preparations formulated in an optimized (augmented) vehicle are among the most potent topical corticosteroid preparations currently available, the manufacturers state that dosage of betamethasone dipropionate 0.05% ointments, creams, gels, or lotions in optimized (augmented) vehicles should not exceed 45 g, 45 g, 50 g, or 50 mL per week, respectively.
Some manufacturers also state that duration of therapy with these optimized preparations should not exceed 2 weeks.
Topical betamethasone 0.1% creams and ointments (as valerate) usually are applied sparingly in thin films and are rubbed gently into the affected area 1-3 times daily. However, once- or twice-daily administration of these preparations often is effective.
Topical betamethasone valerate 0.1% solutions are applied sparingly (e.g., a few drops) and are rubbed gently into the affected area twice daily, in the morning and evening. Dosage of the topical solution may be increased in patients with resistant dermatoses.
However, dosing frequency should be decreased to once daily following clinical improvement.
For relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses of the scalp, betamethasone valerate 0.12% foam should be applied twice daily, in the morning and evening. For application to the scalp, the can containing betamethasone valerate foam should be inverted and small amounts of the preparation placed on a saucer or other cool surface.
The foam should not be dispensed directly to the hands since the foam will begin to melt immediately upon contact with warm skin. Small amounts of the preparation should be massaged gently into the scalp until the foam disappears and entire scalp area has been treated.
For the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, or tinea corporis caused by Trichophyton mentagrophytes, T. rubrum, or Epidermophyton floccosum, the fixed-combination cream or lotion containing betamethasone 0.05% and clotrimazole 1% should be applied sparingly and rubbed gently into the affected area twice daily, in the morning and evening.
If clinical improvement does not occur after 1 week in the treatment of tinea cruris or tinea corporis or after 2 weeks in the treatment of tinea pedis, the diagnosis should be reevaluated. The manufacturer states that dosage of the combination cream or lotion should not exceed 45 g or 45 mL per week, respectively, and duration of therapy with these combination preparations should not exceed 2 weeks in the treatment of tinea cruris or tinea corporis or 4 weeks in the treatment of tinea pedis. Occlusive dressings should not be used with these combination preparations.
For the topical treatment of plaque psoriasis (psoriasis vulgaris) in adults 18 years of age or older, the fixed-combination ointment containing betamethasone 0.05% and calcipotriene 0.005% should be applied and rubbed gently into the affected area until absorbed once daily.
The combination ointment should not be applied to greater than 30% of body surface area. The manufacturer states that dosage of the combination ointment should not exceed 100 g per week, and duration of therapy should not exceed 4 consecutive weeks. Occlusive dressings should not be used with the combination preparation, unless directed by a clinician.
The fixed-combination ointment should not be applied to the face, axillae, or groin area. The fixed-combination ointment should not be used in patients with erythrodermic, exfoliative, or pustular psoriasis or in patients with preexisting atrophy at the treatment site. Contact with the eyes should be avoided.
If irritation occurs, therapy with the fixed-combination ointment should be discontinued and appropriate treatment instituted. Patients should wash their hands after applying the drug. The fixed-combination ointment is not for ophthalmic, oral, or intravaginal use.
For the topical treatment of moderate to severe plaque psoriasis (psoriasis vulgaris) of the scalp in adults 18 years of age or older, the fixed-combination suspension containing betamethasone 0.05% and calcipotriene 0.005% should be applied to the affected area(s) on the scalp once daily for 2 weeks or until cleared.
The manufacturer states that dosage of the combination suspension should not exceed 100 g per week, and duration of therapy should not exceed 8 weeks. Occlusive dressings should not be used with the combination preparation, unless directed by a clinician. The combination suspension should not be applied to the face, axillae, or groin area.
In addition, the suspension should not be used in patients with erythrodermic, exfoliative, or pustular psoriasis or in patients with preexisting atrophy at the treatment site. Contact with the eyes should be avoided; eye irritation may occur. The bottle containing the suspension should be shaken prior to each use; patients should wash their hands after applying the drug.
The fixed-combination suspension is not for ophthalmic, oral, or intravaginal use.
Because calcipotriene may increase the effect of ultraviolet radiation to induce skin tumors, patients who apply the fixed-combination ointment or suspension to exposed areas of the body should avoid exposure to natural or artificial (e.g., sunlamps, tanning booths) sunlight and limit or avoid phototherapy.
Clotrimazole is administered topically to the oropharyngeal area as an oral lozenge, to the skin as a cream or solution, or intravaginally as a vaginal cream. The topical cream and solution are not intended for ophthalmic use. Clotrimazole also is available in fixed combination with betamethasone dipropionate as a cream or lotion; see prescribing information for the combination product for additional details.
Store clotrimazole oral lozenges, topical cream, and topical solution at 20--25degreesC. Avoid freezing oral lozenges.
Store clotrimazole oral lozenges, topical cream, and topical solution at 20--25degreesC. Avoid freezing oral lozenges.
No dosing information available.
No generic dosing information available.
The following drug interaction information is available for DERMACINRX THERAZOLE PAK (clotrimazole/betamethasone dipropionate/zinc oxide):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for DERMACINRX THERAZOLE PAK (clotrimazole/betamethasone dipropionate/zinc oxide):
Drug contraindication overview.
*Known hypersensitivity to clotrimazole or other imidazoles or any ingredient in the formulation.
*Known hypersensitivity to clotrimazole or other imidazoles or any ingredient in the formulation.
There are 0 contraindications.
There are 0 severe contraindications.
There are 2 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Hypothalamic-pituitary insufficiency |
| No disease contraindications |
The following adverse reaction information is available for DERMACINRX THERAZOLE PAK (clotrimazole/betamethasone dipropionate/zinc oxide):
Adverse reaction overview.
Lozenge: nausea, vomiting, unpleasant mouth sensations, and pruritus. Topical cream or solution: blistering, erythema, edema, pruritus, burning, stinging, peeling, urticaria, and general irritation of skin.
Lozenge: nausea, vomiting, unpleasant mouth sensations, and pruritus. Topical cream or solution: blistering, erythema, edema, pruritus, burning, stinging, peeling, urticaria, and general irritation of skin.
There are 30 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. |
Folliculitis Purpura Skin and skin structure infection Skin atrophy |
| Rare/Very Rare |
|---|
|
Abnormal desquamation Adrenocortical insufficiency Anaphylaxis Angioedema Blistering skin Bullous dermatitis Cataracts Central serous chorioretinopathy Dermatitis due to topical drug Dyspnea Edema Erythema Glaucoma Hypersensitivity drug reaction Hypotension Hypothalamic-pituitary insufficiency Ocular hypertension Pruritus of skin Skin hypopigmentation Skin irritation Skin rash Skin striae Skin ulcer Stinging of skin Syncope Urticaria |
There are 24 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Erythema Stinging of skin |
Acute pain at drug application site Blurred vision Headache disorder Paresthesia Pruritus of skin Skin rash Telangiectasia Treatment site sequelae |
| Rare/Very Rare |
|---|
|
Acneiform eruption Alopecia Blistering skin Contact dermatitis Dry skin Dyschromia Glycosuria Hirsutism Hypercortisolism Hyperesthesia Hyperglycemia Miliaria Perioral dermatitis Skin irritation |
The following precautions are available for DERMACINRX THERAZOLE PAK (clotrimazole/betamethasone dipropionate/zinc oxide):
Safety and efficacy of clotrimazole lozenges have not been established in children <3 years of age. Safety and efficacy of prophylactic therapy with clotrimazole lozenges have not been established in children. Clotrimazole topical cream or solution is not recommended for self-medication in children <3 years of age.
Clotrimazole vaginal cream is not recommended for self-medication in children <12 years of age. Preparations containing clotrimazole in fixed combination with betamethasone dipropionate are not recommended for use in children <17 years of age or for diaper dermatitis.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Clotrimazole vaginal cream is not recommended for self-medication in children <12 years of age. Preparations containing clotrimazole in fixed combination with betamethasone dipropionate are not recommended for use in children <17 years of age or for diaper dermatitis.
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
There are no adequate and controlled studies of clotrimazole lozenges in pregnant women; the drug should be used during pregnancy only if the potential benefits justify the potential risks to the fetus. In clinical trials, use of intravaginal clotrimazole in pregnant women in the second and third trimester was not associated with adverse effects; there are no adequate and well-controlled studies in pregnant women in the first trimester. . In animal reproductive studies, clotrimazole demonstrated embryotoxic effects, but was not teratogenic when given in doses significantly higher than the recommended human dose.
It is not known whether clotrimazole is excreted in human milk, caution should be exercised when the drug is used in nursing woman.
There were an insufficient number of patients >=65 years of age in clinical studies of clotrimazole lozenges to determine whether geriatric patients respond differently from younger patients; other reported experience did not find any differences in response between these patients.
The following prioritized warning is available for DERMACINRX THERAZOLE PAK (clotrimazole/betamethasone dipropionate/zinc oxide):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for DERMACINRX THERAZOLE PAK (clotrimazole/betamethasone dipropionate/zinc oxide)'s list of indications:
No ICD codes found for this drug.
No ICD codes found for this drug.
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