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Calcitriol (topical): Drug information

Calcitriol (topical): Drug information
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For additional information see "Calcitriol (topical): Patient drug information" and "Calcitriol (topical): Pediatric drug information"

For abbreviations, symbols, and age group definitions show table
Brand Names: US
  • Vectical
Brand Names: Canada
  • Silkis
Pharmacologic Category
  • Vitamin D Analog
Dosing: Adult
Plaque psoriasis

Plaque psoriasis: Topical: Apply twice daily to affected areas (maximum: 200 g weekly).

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Calcitriol (topical): Pediatric drug information")

Plaque psoriasis, mild to moderate

Plaque psoriasis, mild to moderate: Topical: Ointment:

Children ≥2 years to <7 years: Apply twice daily to affected area(s); maximum weekly dose: 100 g/week.

Children ≥7 years and Adolescents: Apply twice daily to affected areas; maximum weekly dose: 200 g/week.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%: Endocrine & metabolic: Hypercalcemia (24%)

1% to 10%: Dermatologic: Skin pain (3%)

Postmarketing: Dermatologic: Bullous dermatitis (acute), burning sensation of skin, erythema of skin

Contraindications

There are no contraindications listed in the US manufacturer's labeling.

Canadian labeling: Hypersensitivity to calcitriol or any component of the formulation; ophthalmic or internal use; hypercalcemia or a history of abnormal calcium metabolism; concurrent systemic treatment of calcium homeostasis; severe renal impairment or end-stage renal disease; hepatic impairment.

Warnings/Precautions

Concerns related to adverse effects:

• Hypercalcemia: May cause hypercalcemia; if alterations in calcium occur, discontinue treatment until levels return to normal. Use with caution in patients receiving calcium supplements, high doses of vitamin D, or medications known to cause hypercalcemia (eg, thiazide diuretics).

Other warnings/precautions:

• Appropriate use: For external use only; not for ophthalmic, oral, or intravaginal use. Do not apply to facial skin, eyes, or lips. Absorption may be increased with occlusive dressings. The safety and effectiveness have not been evaluated in patients with known or suspected disorders of calcium metabolism.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Ointment, External:

Vectical: 3 mcg/g (100 g)

Generic: 3 mcg/g (100 g)

Generic Equivalent Available: US

Yes

Pricing: US

Ointment (Calcitriol External)

3 mcg/g (per gram): $7.03 - $10.29

Ointment (Vectical External)

3 mcg/g (per gram): $11.45

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Ointment, External:

Silkis: 3 mcg/g (5 g, 30 g, 60 g, 100 g)

Administration: Adult

Topical: Apply externally; not for ophthalmic, oral, or intravaginal use. Do not apply to eyes, lips, or facial skin. Rub in gently so that no medication remains visible. Limit application to only the areas of skin affected by psoriasis.

Administration: Pediatric

Topical: For external use only; not for ophthalmic, oral, or intravaginal use. Do not apply to eyes, lips, or facial skin. Rub in gently so that no medication remains visible. Limit application to only the areas of skin affected by psoriasis.

Use: Labeled Indications

Plaque psoriasis: Management of mild to moderate plaque psoriasis in adults and pediatric patients ≥2 years of age.

Medication Safety Issues
Sound-alike/look-alike issues:

Calcitriol may be confused with alfacalcidol, Calciferol, calcitonin, calcium carbonate, captopril, colestipol, paricalcitol, ropinirole.

Metabolism/Transport Effects

Substrate of CYP3A4 (minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.

Aminolevulinic Acid (Systemic): Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid (Systemic). Risk X: Avoid combination

Aminolevulinic Acid (Topical): Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid (Topical). Risk C: Monitor therapy

Burosumab: Vitamin D Analogs may enhance the adverse/toxic effect of Burosumab. Risk X: Avoid combination

Calcium Salts: May enhance the adverse/toxic effect of Vitamin D Analogs. Risk C: Monitor therapy

Cardiac Glycosides: Vitamin D Analogs may enhance the arrhythmogenic effect of Cardiac Glycosides. Risk C: Monitor therapy

Methoxsalen (Systemic): Photosensitizing Agents may enhance the photosensitizing effect of Methoxsalen (Systemic). Risk C: Monitor therapy

Multivitamins/Fluoride (with ADE): May enhance the adverse/toxic effect of Vitamin D Analogs. Risk X: Avoid combination

Multivitamins/Minerals (with ADEK, Folate, Iron): May enhance the adverse/toxic effect of Vitamin D Analogs. Risk X: Avoid combination

Porfimer: Photosensitizing Agents may enhance the photosensitizing effect of Porfimer. Risk C: Monitor therapy

Thiazide and Thiazide-Like Diuretics: May enhance the hypercalcemic effect of Vitamin D Analogs. Risk C: Monitor therapy

Verteporfin: Photosensitizing Agents may enhance the photosensitizing effect of Verteporfin. Risk C: Monitor therapy

Vitamin D Analogs: May enhance the adverse/toxic effect of other Vitamin D Analogs. Risk X: Avoid combination

Pregnancy Considerations

Topical agents are recommended for the treatment of psoriasis in pregnancy; however, agents other than calcitriol are preferred. When alternatives are not appropriate, limit use to smallest possible area (AAD-NPF [Elmets 2021]; Maul 2021; Simionescu 2021).

Breastfeeding Considerations

It is not known if calcitriol is present in breast milk following topical application.

According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother; do not apply directly to the nipple and surrounding area if breastfeeding. If maternal use is needed, the breastfed infant should avoid contact with the treated area.

Mechanism of Action

The mechanism by which calcitriol is beneficial in the treatment of psoriasis has not been established.

Pharmacokinetics (Adult Data Unless Noted)

Onset of action: Topical: ~2 weeks (Lebwohl 2007).

Metabolism: Primarily to calcitroic acid and a lactone metabolite.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AR) Argentina: Silcor;
  • (BE) Belgium: Silkis;
  • (BR) Brazil: Silkis;
  • (CH) Switzerland: Silkis;
  • (CL) Chile: Silkis;
  • (CN) China: Silkis;
  • (CO) Colombia: Silcor | Silkis;
  • (CZ) Czech Republic: Silkis;
  • (DE) Germany: Silkis;
  • (ES) Spain: Silkis;
  • (FI) Finland: Silkis;
  • (FR) France: Silkis;
  • (GB) United Kingdom: Silkis;
  • (GR) Greece: Silkis | Votrace;
  • (HK) Hong Kong: Silkis;
  • (HU) Hungary: Silkis;
  • (IE) Ireland: Silkis;
  • (IN) India: Psorafuse | Qsor | Rolsical | Sorvate;
  • (IT) Italy: Silkis;
  • (KW) Kuwait: Silkis;
  • (LU) Luxembourg: Silkis;
  • (MX) Mexico: Silkis;
  • (NL) Netherlands: Silkis;
  • (NO) Norway: Silkis;
  • (PE) Peru: Silkis;
  • (PH) Philippines: Silkis;
  • (PL) Poland: Silkis;
  • (PR) Puerto Rico: Vectical;
  • (PT) Portugal: Silkis;
  • (RU) Russian Federation: Silkis;
  • (SG) Singapore: Silkis;
  • (TW) Taiwan: Calkis | Caltriol | Silkis;
  • (UA) Ukraine: Phorcal;
  • (UG) Uganda: Sorvate;
  • (UY) Uruguay: Silcor;
  • (VE) Venezuela, Bolivarian Republic of: Silkis
  1. Elmets CA, Korman NJ, Prater EF, et al. Joint AAD-NPF Guidelines of care for the management and treatment of psoriasis with topical therapy and alternative medicine modalities for psoriasis severity measures. J Am Acad Dermatol. 2021;84(2):432-470. doi:10.1016/j.jaad.2020.07.087 [PubMed 32738429]
  2. Lebwohl M, Menter A, Weiss J, et al. Calcitriol 3 microg/g ointment in the management of mild to moderate plaque type psoriasis: results from 2 placebo-controlled, multicenter, randomized double-blind, clinical studies. J Drugs Dermatol. 2007;6(4):428-435. [PubMed 17668541]
  3. Maul JT, Anzengruber F, Conrad C, et al. Topical treatment of psoriasis vulgaris: the Swiss treatment pathway. Dermatology. 2021;237(2):166-178. doi:10.1159/000512930 [PubMed 33406520]
  4. Silkis (calcitriol) [product monograph]. Thornhill, Ontario, Canada: Galderma Canada Inc; October 2017.
  5. Simionescu AA, Danciu BM, Stanescu AMA. State-of-the-art review of pregnancy-related psoriasis. Medicina (Kaunas). 2021;57(8):804. doi:10.3390/medicina57080804 [PubMed 34441010]
  6. Vectical (calcitriol) [prescribing information]. Dallas, TX: Galderma Laboratories LP; October 2022.
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