Calcitriol (topical)

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Calcitriol (topical)
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]

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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

Effects on Calcium Metabolism

  • In controlled clinical trials with Calcitriol Ointment, 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 increases in calcium and albumin-adjusted calcium levels were less than 10% above the upper limit of normal.
  • If aberrations in parameters of calcium metabolism occur, treatment should be discontinued until these parameters have normalized. The effects of Calcitriol Ointment on calcium metabolism following treatment durations greater than 52 weeks have not been evaluated. Increase absorption may occur with occlusive use.

Ultraviolet Light Exposure

  • Animal data suggest that the vehicle of calcitriol Ointment may enhance the ability of ultraviolent radiation (UVR) to induce skin tumors [see Carcinogenesis, Mutagenesis, Impairment of Fertility (13.1)] Subjects who apply Calcitriol Ointment to exposed skin should avoid excessive exposure to the treated areas to either natural or artificial sunlight, including tanning booths and sun lamps. Physicians may wish to limit or avoid use of phototherapy in patients who use Calcitriol Ointment.

Unevaluated Uses

  • The safety and effectiveness of Calcitriol Ointment in patients with known or suspected disorders of calcium metabolism have not been evaluated. The safety and effectiveness of Calcitriol Ointment in patients with erythrodermic, exfoliative, or pustular psoriasis have not been evaluated.

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.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): Pregnancy

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.
  • 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

  • Topical

Monitoring

There is limited information regarding Monitoring of Calcitriol (topical) in the drug label.

IV Compatibility

There is limited information regarding IV Compatibility of Calcitriol (topical) in the drug label.

Overdosage

  • Topically applied calcitriol can be absorbed in sufficient amounts to produce systemic effects

Pharmacology

There is limited information regarding Calcitriol (topical) Pharmacology in the drug label.

Mechanism of Action

  • The mechanism of action of calcitriol in the treatment of psoriasis has not been established.

Structure

Calcitriol Ointment, 3 mcg/g is a vitamin D analog intended for topical application to the skin. The chemical name of the active ingredient is (5Z,7E)-9, 10-secocholesta-5,7,10(19)-triene-1α, 3β,25-triol. The structural formula is:

This image is provided by the National Library of Medicine.
  • Calcitriol is a white or almost white crystalline solid. It is practically insoluble in water, soluble in alcohol and in fatty oils. The molecular formula is C27H44O3, and the molecular weight is 416.64.
  • Calcitriol Ointment is a translucent ointment containing 3 mcg/g (0.0003% w/w) of calcitriol, packaged in aluminum tubes with screw caps. Other components of the ointment are mineral oil, dl-α-tocopherol, and white petrolatum.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Calcitriol (topical) in the drug label.

Pharmacokinetics

  • The systemic exposure of calcitriol was assessed in subjects with chronic, plaque psoriasis. In the pivotal pharmacokinetic/pharmacodynamic study, calcitriol ointment 3 mcg/g, was applied twice daily for 21 days (for a total dose of 30 g/day) to 35% of the body surface area (psoriatic + surrounding healthy skin) of subjects with at least 25% of body surface area involvement. At Day 21, the geometric mean plasma concentration values of Cmax increased by approximately 36% over baseline and the geometric mean value of AUC(0-12hr) increased by 44%. There was no correlation between the elevated calcitriol levels and the pharmacodynamic parameters or serum albumin adjusted calcium, serum phosphorus, urinary calcium and urinary phosphorus.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Calcitriol (topical) in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Calcitriol (topical) in the drug label.

How Supplied

Storage

There is limited information regarding Calcitriol (topical) Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Calcitriol (topical) in the drug label.

Precautions with Alcohol

  • Alcohol-Calcitriol (topical) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

  • CALCITRIOL®[1]

Look-Alike Drug Names

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

  1. ↑ "calcitriol ointment".
  2. ↑ "http://www.ismp.org". External link in |title= (help)

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