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Drug overview for CALSODORE (calcipotriene):
Generic name: calcipotriene (KAL-si-poe-TRYE-een)
Drug class: Antipsoriatics, Topical
Therapeutic class: Dermatological
Calcipotriene, a synthetic vitamin D3 derivative, is an antipsoriatic agent.
Calcipotriene cream is used topically in the management of plaque psoriasis (psoriasis vulgaris) and calcipotriene solution is used topically for the 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 (KAL-si-poe-TRYE-een)
Drug class: Antipsoriatics, Topical
Therapeutic class: Dermatological
Calcipotriene, a synthetic vitamin D3 derivative, is an antipsoriatic agent.
Calcipotriene cream is used topically in the management of plaque psoriasis (psoriasis vulgaris) and calcipotriene solution is used topically for the 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 CALSODORE (calcipotriene) have been approved by the FDA:
Indications:
None.
Professional Synonyms:
None.
Indications:
None.
Professional Synonyms:
None.
The following dosing information is available for CALSODORE (calcipotriene):
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.
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.
No dosing information available.
No generic dosing information available.
The following drug interaction information is available for CALSODORE (calcipotriene):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for CALSODORE (calcipotriene):
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 0 moderate contraindications.
The following adverse reaction information is available for CALSODORE (calcipotriene):
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 6 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Dermatitis due to topical drug Skin rash |
None. |
| Rare/Very Rare |
|---|
|
Folliculitis Hypercalcemia Hypercalcinuria Skin atrophy |
There are 10 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Abnormal desquamation Dry skin Erythema Pruritus of skin Skin irritation |
Acute pain at drug application site Drug-exacerbated psoriasis |
| Rare/Very Rare |
|---|
|
Blistering skin Dyschromia Miliaria |
The following precautions are available for CALSODORE (calcipotriene):
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 CALSODORE (calcipotriene):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for CALSODORE (calcipotriene)'s list of indications:
No ICD codes found for this drug.
No ICD codes found for this drug.
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