* The open label study enrolled 324 subjects with psoriasis who were then treated for up to 52 weeks. Adverse events reported at a rate of greater than or equal to 3% of subjects treated with Calcitriol Ointment were lab test abnormality (8%), urine abnormality (4%), [[psoriasis]] (4%), [[hyperciuria]] (3%), and [[pruritus]] (3%). [[Kidney stones]] were reported in 3 subjects and confirmed in two.
* The open label study enrolled 324 subjects with psoriasis who were then treated for up to 52 weeks. Adverse events reported at a rate of greater than or equal to 3% of subjects treated with Calcitriol Ointment were lab test abnormality (8%), urine abnormality (4%), [[psoriasis]] (4%), [[hyperciuria]] (3%), and [[pruritus]] (3%). [[Kidney stones]] were reported in 3 subjects and confirmed in two.
|postmarketing=* The following adverse reactions have been identified during the world-wide post-approval use of Calcitriol Ointment: acute blistering [[dermatitis]], [[erythema]], [[pruritus]], skin burning sensation, and skin discomfort. Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
|postmarketing=* The following adverse reactions have been identified during the world-wide post-approval use of Calcitriol Ointment: acute blistering [[dermatitis]], [[erythema]], [[pruritus]], skin burning sensation, and skin discomfort. Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
|drugInteractions=* Calcitriol Ointment should be used with caution in patients receiving medications known to increase the serum calcium level, such as thiazide diuretics. Caution should also be exercised in patients receiving calcium supplements or high doses of vitamin D.
|drugInteractions=* Calcitriol Ointment should be used with caution in patients receiving medications known to increase the serum calcium level, such as thiazide diuretics. Caution should also be exercised in patients receiving calcium supplements or high doses of vitamin D.
|useInPregnancyFDA=* '''Pregnancy Category'''
|useInPregnancyFDA='''Pregnancy'''
|useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''
'''Teratogenic Effects: Pregnancy Category C'''.
* Calcitriol Ointment contains calcitriol which has been shown to be fetotoxic. There are no adequate and well-controlled studies for Calcitriol Ointment in pregnant women. Calcitriol Ointment should be used during pregnancy only if the potential benefit to the patient justifies the potential risk to the fetus.
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant.
* Teratogenicity studies with calcitriol were performed in which rats were treated orally at dosages up to 0.9 mcg/kg/day (5.4 mcg/m2/day) and in which rabbits received topical application of calcitriol ointment (3 ppm) to 6.4% of the body surface area. No effects on reproductive or fetal parameters were observed in rats. In rabbits, topically applied calcitriol induced a significantly elevated mean post-implantation loss and an increased incidence of minor skeletal abnormalities due to retarded ossification of the pubic bones. A slightly increased incidence of skeletal variation (extra 13th rib, reduced ossification of epiphyses) was also observed. These effects may have been secondary to maternal toxicity. Based on the recommended human dose and instructions for use, it is not possible to calculate human dose equivalents for animal exposures in these studies.
|useInPregnancyAUS=There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant.
|useInLaborDelivery=There is no FDA guidance on use of {{PAGENAME}} during labor and delivery.
|useInLaborDelivery=There is no FDA guidance on use of {{PAGENAME}} during labor and delivery.
|useInNursing=There is no FDA guidance on the use of {{PAGENAME}} with respect to nursing mothers.
|useInNursing=* It is not known whether calcitriol is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when calcitriol Ointment is administered to a nursing woman.
|useInPed=There is no FDA guidance on the use of {{PAGENAME}} with respect to pediatric patients.
|useInPed=* Safety and effectiveness in pediatric patients have not been established.
|useInGeri=There is no FDA guidance on the use of {{PAGENAME}} with respect to geriatric patients.
|useInGeri=* Clinical studies of Calcitriol Ointment did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported experience has not identified differences in responses between the elderly and younger patients.
|useInGender=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations.
|useInGender=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations.
|useInRace=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific racial populations.
|useInRace=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific racial populations.
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Overview
Calcitriol (topical) is a {{{drugClass}}} that is FDA approved for the treatment of mild to moderate plaque psoriasis. Common adverse reactions include lab test abnormality, urine abnormality, hypercalciuria, and pruritus.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Indication
Calcitriol Ointment is indicated for the topical treatment of mild to moderate plaque psoriasis in adults 18 years and older.
Limitations of Use
Calcitriol Ointment should not be applied to the eyes, lips, or facial skin.
Dosage
Apply Calcitriol Ointment to affected areas twice daily, morning and evening. The maximum weekly dose should not exceed 200 grams. Calcitriol Ointment is not for oral, ophthalmic or intravaginal use.
DOSAGE FORMS AND STRENGTHS
Each gram of ointment contains 3 micrograms (mcg/g) of calcitriol.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Calcitriol (topical) in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Calcitriol (topical) in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding FDA-Labeled Use of Calcitriol (topical) in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Calcitriol (topical) in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Calcitriol (topical) in pediatric patients.
Contraindications
None
Warnings
There is limited information regarding Calcitriol (topical) Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rate observed in practice.
Clinical Studies Experience
Calcitriol Ointment was studied in two vehicle-controlled studies (419 subjects), and in one open label study (324 subjects). The table below describes exposure to Calcitriol Ointment in 743 subjects, including 239 exposed for 6 months and 116 exposed for one year.
Four hundred and nineteen subjects were treated with Calcitriol Ointment twice daily for 8 weeks. The population included subjects ages 13 to 87, males (284) and females (135), Caucasians (372) and non-Caucasians (47); with mild (105) to moderate (313) chronic plaque psoriasis.
This image is provided by the National Library of Medicine.
Among subjects having laboratory monitoring, hypercalcemia was observed in 24% (18/74) of subjects exposed to active drug and in 16% (13/79) of subjects exposed to vehicle, however the elevation were less than 10% above the upper limit of normal.
The open label study enrolled 324 subjects with psoriasis who were then treated for up to 52 weeks. Adverse events reported at a rate of greater than or equal to 3% of subjects treated with Calcitriol Ointment were lab test abnormality (8%), urine abnormality (4%), psoriasis (4%), hyperciuria (3%), and pruritus (3%). Kidney stones were reported in 3 subjects and confirmed in two.
Postmarketing Experience
The following adverse reactions have been identified during the world-wide post-approval use of Calcitriol Ointment: acute blistering dermatitis, erythema, pruritus, skin burning sensation, and skin discomfort. Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Drug Interactions
Calcitriol Ointment should be used with caution in patients receiving medications known to increase the serum calcium level, such as thiazide diuretics. Caution should also be exercised in patients receiving calcium supplements or high doses of vitamin D.
Calcitriol Ointment contains calcitriol which has been shown to be fetotoxic. There are no adequate and well-controlled studies for Calcitriol Ointment in pregnant women. Calcitriol Ointment should be used during pregnancy only if the potential benefit to the patient justifies the potential risk to the fetus.
Teratogenicity studies with calcitriol were performed in which rats were treated orally at dosages up to 0.9 mcg/kg/day (5.4 mcg/m2/day) and in which rabbits received topical application of calcitriol ointment (3 ppm) to 6.4% of the body surface area. No effects on reproductive or fetal parameters were observed in rats. In rabbits, topically applied calcitriol induced a significantly elevated mean post-implantation loss and an increased incidence of minor skeletal abnormalities due to retarded ossification of the pubic bones. A slightly increased incidence of skeletal variation (extra 13th rib, reduced ossification of epiphyses) was also observed. These effects may have been secondary to maternal toxicity. Based on the recommended human dose and instructions for use, it is not possible to calculate human dose equivalents for animal exposures in these studies.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Calcitriol (topical) in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Calcitriol (topical) during labor and delivery.
Nursing Mothers
It is not known whether calcitriol is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when calcitriol Ointment is administered to a nursing woman.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
Geriatic Use
Clinical studies of Calcitriol Ointment did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported experience has not identified differences in responses between the elderly and younger patients.
Gender
There is no FDA guidance on the use of Calcitriol (topical) with respect to specific gender populations.
Race
There is no FDA guidance on the use of Calcitriol (topical) with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Calcitriol (topical) in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Calcitriol (topical) in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Calcitriol (topical) in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Calcitriol (topical) in patients who are immunocompromised.
Administration and Monitoring
Administration
Oral
Intravenous
Monitoring
There is limited information regarding Monitoring of Calcitriol (topical) in the drug label.
Description
IV Compatibility
There is limited information regarding IV Compatibility of Calcitriol (topical) in the drug label.
Overdosage
Acute Overdose
Signs and Symptoms
Description
Management
Description
Chronic Overdose
There is limited information regarding Chronic Overdose of Calcitriol (topical) in the drug label.
Pharmacology
There is limited information regarding Calcitriol (topical) Pharmacology in the drug label.
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