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Drug overview for CALCIPOTRIENE-BETAMETHASONE (calcipotriene/betamethasone dipropionate):
Generic name: CALCIPOTRIENE/BETAMETHASONE DIPROPIONATE (BAY-ta-METH-a-sone/KAL-si-poe-TRYE-een/KAL-si-poe-TRYE-ol)
Drug class: Topical Corticosteroids
Therapeutic class: Dermatological
Betamethasone is a synthetic fluorinated corticosteroid. Calcipotriene, a synthetic vitamin D3 derivative, is an antipsoriatic agent.
Betamethasone shares the actions of the other topical corticosteroids and Calcipotriene cream is used topically in the management of plaque psoriasis (psoriasis vulgaris) and calcipotriene solution is used topically for the is used for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. management of chronic, moderately severe psoriasis of the scalp. Calcipotriene in fixed combination with betamethasone dipropionate is used topically as an ointment for the management of plaque psoriasis and as a suspension for the management of moderate to severe plaque psoriasis of the scalp. Safety and efficacy of calcipotriene preparations in the management of dermatoses other than psoriasis have not been established.
Generic name: CALCIPOTRIENE/BETAMETHASONE DIPROPIONATE (BAY-ta-METH-a-sone/KAL-si-poe-TRYE-een/KAL-si-poe-TRYE-ol)
Drug class: Topical Corticosteroids
Therapeutic class: Dermatological
Betamethasone is a synthetic fluorinated corticosteroid. Calcipotriene, a synthetic vitamin D3 derivative, is an antipsoriatic agent.
Betamethasone shares the actions of the other topical corticosteroids and Calcipotriene cream is used topically in the management of plaque psoriasis (psoriasis vulgaris) and calcipotriene solution is used topically for the is used for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. management of chronic, moderately severe psoriasis of the scalp. Calcipotriene in fixed combination with betamethasone dipropionate is used topically as an ointment for the management of plaque psoriasis and as a suspension for the management of moderate to severe plaque psoriasis of the scalp. Safety and efficacy of calcipotriene preparations in the management of dermatoses other than psoriasis have not been established.
DRUG IMAGES
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The following indications for CALCIPOTRIENE-BETAMETHASONE (calcipotriene/betamethasone dipropionate) have been approved by the FDA:
Indications:
Plaque psoriasis
Professional Synonyms:
None.
Indications:
Plaque psoriasis
Professional Synonyms:
None.
The following dosing information is available for CALCIPOTRIENE-BETAMETHASONE (calcipotriene/betamethasone dipropionate):
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.
Safety and efficacy of calcipotriene alone or in fixed combination with betamethasone dipropionate in pediatric patients have not been established.
For the management of plaque psoriasis, calcipotriene 0.005% cream is applied as a thin film and rubbed gently and completely into the affected area twice daily. Safety and efficacy of calcipotriene cream have been demonstrated in patients receiving the drug for 8 weeks.
For the topical treatment of plaque psoriasis, the fixed-combination ointment containing calcipotriene 0.005% and betamethasone 0.05% should be applied and rubbed gently into the affected area(s), until absorbed, once daily.
The fixed-combination ointment should not be applied to greater than 30% of body surface area. The manufacturer states that dosage of the fixed-combination ointment should not exceed 100 g of ointment per week, and duration of therapy should not exceed 4 consecutive weeks. Occlusive dressings should not be used with the fixed-combination preparation, unless directed by a clinician.
The fixed-combination ointment should not be used in patients with erythrodermic, exfoliative, and pustular psoriasis or in patients with preexisting skin atrophy at the treatment site.
For chronic, moderately severe psoriasis of the scalp, the hair should be combed to remove scaly debris and, after the hair has been parted to reveal the affected area, the 0.005% solution should be applied only to the affected area and rubbed gently and completely into the scalp twice daily. Care should be taken to avoid contact of the drug with the forehead or uninvolved scalp margins.
The solution should not be used in patients with acute psoriatic eruptions of the scalp.
For the topical treatment of moderate to severe plaque psoriasis of the scalp, the fixed-combination suspension containing calcipotriene 0.005% and betamethasone 0.05% should be applied to the affected area(s) on the scalp once daily for 2 weeks or until clearing of psoriatic lesions occurs.
The bottle should be shaken prior to each use. The manufacturer states that dosage of the combination suspension should not exceed 100 g of suspension 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.
In addition, the combination suspension should not be used in patients with preexisting skin atrophy at the treatment site.
Most patients with psoriasis received topical calcipotriene 0.005% cream or solution in adequate well-controlled clinical trials of 8 weeks' duration. Results of controlled clinical studies indicate that twice-daily topical application of calcipotriene 0.005%
cream or solution usually results in apparent improvement within 2 weeks; after 8 weeks of therapy, continued improvement was observed in 50 or 31% of patients receiving the cream or solution, respectively, while only 4 or 14% of patients showed complete clearing of lesions receiving calcipotriene cream or solution, respectively.
In a multicenter, double-blind, controlled study in patients with mild to very severe plaque psoriasis, absent or very mild disease after 4 weeks of treatment was reported in 48, 16.5, 26.3, and 7.6%,
respectively, of patients receiving fixed-combination ointment containing calcipotriene and betamethasone dipropionate, calcipotriene alone, betamethasone dipropionate alone, and vehicle alone. In multicenter, randomized, double-blind studies in patients with moderate to very severe scalp psoriasis, clear or almost clear disease after 8 weeks of once-daily treatment was observed in 67.2-70, 59.6-63.1,
and 36.7-41%, of patients receiving fixed-combination suspension containing calcipotriene and betamethasone dipropionate, betamethasone dipropionate monotherapy, and calcipotriene monotherapy, respectively.
Topically applied calcipotriene may be absorbed in sufficient amounts to produce systemic effects; elevated serum calcium concentrations have been observed with use of topical calcipotriene. If elevations in serum calcium concentration occur, use of calcipotriene preparations should be discontinued until normal serum calcium concentrations have been restored. Preparations containing calcipotriene should not be used in patients with demonstrated hypercalcemia or evidence of vitamin D toxicity (hypervitaminosis D) or in patients with known or suspected disorders of calcium metabolism.
Calcipotriene may increase the effect of ultraviolet radiation to induce skin tumors; patients who apply calcipotriene to exposed areas of the body should minimize exposure to sunlight or artificial ultraviolet light (e.g., sunlamps, tanning booths). In addition, the manufacturer states that clinicians may want to limit or avoid use of phototherapy in patients using calcipotriene alone or in fixed combination with betamethasone dipropionate.
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.
Safety and efficacy of calcipotriene alone or in fixed combination with betamethasone dipropionate in pediatric patients have not been established.
For the management of plaque psoriasis, calcipotriene 0.005% cream is applied as a thin film and rubbed gently and completely into the affected area twice daily. Safety and efficacy of calcipotriene cream have been demonstrated in patients receiving the drug for 8 weeks.
For the topical treatment of plaque psoriasis, the fixed-combination ointment containing calcipotriene 0.005% and betamethasone 0.05% should be applied and rubbed gently into the affected area(s), until absorbed, once daily.
The fixed-combination ointment should not be applied to greater than 30% of body surface area. The manufacturer states that dosage of the fixed-combination ointment should not exceed 100 g of ointment per week, and duration of therapy should not exceed 4 consecutive weeks. Occlusive dressings should not be used with the fixed-combination preparation, unless directed by a clinician.
The fixed-combination ointment should not be used in patients with erythrodermic, exfoliative, and pustular psoriasis or in patients with preexisting skin atrophy at the treatment site.
For chronic, moderately severe psoriasis of the scalp, the hair should be combed to remove scaly debris and, after the hair has been parted to reveal the affected area, the 0.005% solution should be applied only to the affected area and rubbed gently and completely into the scalp twice daily. Care should be taken to avoid contact of the drug with the forehead or uninvolved scalp margins.
The solution should not be used in patients with acute psoriatic eruptions of the scalp.
For the topical treatment of moderate to severe plaque psoriasis of the scalp, the fixed-combination suspension containing calcipotriene 0.005% and betamethasone 0.05% should be applied to the affected area(s) on the scalp once daily for 2 weeks or until clearing of psoriatic lesions occurs.
The bottle should be shaken prior to each use. The manufacturer states that dosage of the combination suspension should not exceed 100 g of suspension 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.
In addition, the combination suspension should not be used in patients with preexisting skin atrophy at the treatment site.
Most patients with psoriasis received topical calcipotriene 0.005% cream or solution in adequate well-controlled clinical trials of 8 weeks' duration. Results of controlled clinical studies indicate that twice-daily topical application of calcipotriene 0.005%
cream or solution usually results in apparent improvement within 2 weeks; after 8 weeks of therapy, continued improvement was observed in 50 or 31% of patients receiving the cream or solution, respectively, while only 4 or 14% of patients showed complete clearing of lesions receiving calcipotriene cream or solution, respectively.
In a multicenter, double-blind, controlled study in patients with mild to very severe plaque psoriasis, absent or very mild disease after 4 weeks of treatment was reported in 48, 16.5, 26.3, and 7.6%,
respectively, of patients receiving fixed-combination ointment containing calcipotriene and betamethasone dipropionate, calcipotriene alone, betamethasone dipropionate alone, and vehicle alone. In multicenter, randomized, double-blind studies in patients with moderate to very severe scalp psoriasis, clear or almost clear disease after 8 weeks of once-daily treatment was observed in 67.2-70, 59.6-63.1,
and 36.7-41%, of patients receiving fixed-combination suspension containing calcipotriene and betamethasone dipropionate, betamethasone dipropionate monotherapy, and calcipotriene monotherapy, respectively.
Topically applied calcipotriene may be absorbed in sufficient amounts to produce systemic effects; elevated serum calcium concentrations have been observed with use of topical calcipotriene. If elevations in serum calcium concentration occur, use of calcipotriene preparations should be discontinued until normal serum calcium concentrations have been restored. Preparations containing calcipotriene should not be used in patients with demonstrated hypercalcemia or evidence of vitamin D toxicity (hypervitaminosis D) or in patients with known or suspected disorders of calcium metabolism.
Calcipotriene may increase the effect of ultraviolet radiation to induce skin tumors; patients who apply calcipotriene to exposed areas of the body should minimize exposure to sunlight or artificial ultraviolet light (e.g., sunlamps, tanning booths). In addition, the manufacturer states that clinicians may want to limit or avoid use of phototherapy in patients using calcipotriene alone or in fixed combination with betamethasone dipropionate.
Calcipotriene alone or in fixed combination with betamethasone dipropionate is applied topically to the skin as a cream or ointment, respectively; calcipotriene also is applied as a solution or as a fixed-combination suspension containing calcipotriene and betamethasone dipropionate to the scalp. The topical cream and solution are for external use only and should not be applied to the face, eyes, or mucous membranes. The topical fixed-combination ointment and suspension also are for external use onlyand should not be applied to the face, eyes, axillae, or groin area. The hands should be washed thoroughly after application of topical calcipotriene preparations.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| CALCIPOTRIENE-BETAMETH DP SUSP | Maintenance | Adults apply to the affected area(s) by topical route once daily |
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| CALCIPOTRIENE-BETAMETH DP SUSP | Maintenance | Adults apply to the affected area(s) by topical route once daily |
The following drug interaction information is available for CALCIPOTRIENE-BETAMETHASONE (calcipotriene/betamethasone dipropionate):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for CALCIPOTRIENE-BETAMETHASONE (calcipotriene/betamethasone dipropionate):
Drug contraindication overview.
No enhanced Contraindications information available for this drug.
No enhanced Contraindications information available for this drug.
There are 1 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Hypervitaminosis D |
There are 2 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Hypercalcemia |
| Hypercalcinuria |
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 |
|---|
| Hypothalamic-pituitary insufficiency |
The following adverse reaction information is available for CALCIPOTRIENE-BETAMETHASONE (calcipotriene/betamethasone dipropionate):
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 21 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Dermatitis due to topical drug Skin rash |
Folliculitis Purpura Skin and skin structure infection Skin atrophy |
| Rare/Very Rare |
|---|
|
Adrenocortical insufficiency Bullous dermatitis Cataracts Central serous chorioretinopathy Folliculitis Glaucoma Hypercalcemia Hypercalcinuria Hypothalamic-pituitary insufficiency Ocular hypertension Skin atrophy Skin hypopigmentation Skin striae Skin ulcer Urticaria |
There are 29 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Abnormal desquamation Dry skin Erythema Pruritus of skin Skin irritation Stinging of skin |
Acute pain at drug application site Blurred vision Drug-exacerbated psoriasis 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 CALCIPOTRIENE-BETAMETHASONE (calcipotriene/betamethasone dipropionate):
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 |
No enhanced Pregnancy information available for this drug.
No enhanced Lactation information available for this drug.
No enhanced Geriatric Use information available for this drug.
The following prioritized warning is available for CALCIPOTRIENE-BETAMETHASONE (calcipotriene/betamethasone dipropionate):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for CALCIPOTRIENE-BETAMETHASONE (calcipotriene/betamethasone dipropionate)'s list of indications:
| Plaque psoriasis | |
| L40.0 | Psoriasis vulgaris |
| L40.9 | Psoriasis, unspecified |
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