Dosing & Uses
Dosage Forms & Strengths
topical solution
- 0.005% (generic)
topical ointment
- 0.005% (generic)
topical cream
- 0.005% (Dovonex, generic)
topical foam
- 0.005% (Sorilux)
Plaque Psoriasis
Ointment/Cream
- Indicated for plaque psoriasis
- Apply a thin layer of cream BID to affected area
- Safety and efficacy have been established in patients treated for 8 weeks
Solution
- Indicated for chronic, moderately severe psoriasis of the scalp
- Apply solution BID to affected area
- Safety and efficacy have been established in patients treated for 8 weeks
Foam
- Indicated for plaque psoriasis of the scalp and body for patients ≥12 years
- Apply a thin layer of foam BID to affected area
Dosing Considerations
Limitation of use
- Safety and efficacy in dermatoses other than psoriasis have not been established
Dosage Forms & Strengths
topical foam
- 0.005% (Sorilux)
Plaque Psoriasis
Indicated for plaque psoriasis of the scalp and body
<4 years: Safety and efficacy not established
≥4 years: Apply a thin layer of foam BID to affected area
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (0)
Monitor Closely (0)
Minor (0)
Adverse Effects
>10%
Burning
Itching
Skin irritation
1-10%
Dermatitis
Dry skin
Erythema
Peeling
Worsening of psoriasis including facial/scalp
Rash
<1%
Folliculitis
Hypercalcemia
Hyperpigmentation
Skin atrophy
Postmarketing Reports
Contact dermatitis, including allergic contact dermatitis
Warnings
Contraindications
Hypersensitivity
Hypercalcemia
Evidence of vitamin D toxicity
Topical use on the face
Cautions
Hypercalcemia and hypercalciuria reported with topical suspension; if hypercalcemia or hypercalciuria develop, discontinue treatment until parameters of calcium metabolism have normalized; incidence of hypercalcemia and hypercalciuria following topical suspension treatment of more than 8 weeks has not been evaluated
For cream only: Allergic contact dermatitis has been observed with use of topical calcipotriene; such an observation should be corroborated with appropriate diagnostic patch testing
Flammability
- Foam contains a flammable propellant; advise patients to avoid fire, flames, and smoking during and immediately following application
Pregnancy & Lactation
Pregnancy
No data available on drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes in pregnant women exposed to calcipotriene
Foam: Systemic exposure to calcipotriene is likely to be low
Animal data
- In animal reproduction studies, oral administration of calcipotriene to pregnant rats and rabbits during organogenesis resulted in an increased minor skeletal abnormalities, including enlarged fontanelles and extra ribs in rats and an increased incidence of minor skeletal abnormalities, including incomplete ossification of pubic bones and forelimb phalanges in rabbits
Lactation
There are no data on the presence of topically administered calcipotriene in human or animal milk, the effects on the breastfed infant, or the effects on milk production
After topical administration, plasma concentrations of calcipotriene are low, and therefore, concentrations in human milk are likely to be low
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
In vitro evidence suggests drug is roughly equipotent to natural vitamin D in its effects on proliferation & differentiation of various cell types
Absorption
Absorption: 5-6% systemically
Metabolism
Metabolism: converted to inactive metabolites within 24 hr
Excretion
Excretion: bile
Administration
Topical Administration
For topical use only
Not for ophthalmic, oral or intravaginal use
Avoid contact with face and eyes
Wash hands after applying foam, cream, or solution
Cream or ointment: Apply a thin layer of cream to affected area and gently rub in completely
Foam
- Apply a thin layer of foam to affected area and gently rub in completely
- Apply to the scalp when hair is dry
- Avoid fire, flame, and smoking during and immediately following application
Solution
- Comb hair to remove scaly debris and after suitably parting, apply solution only to the lesions, and gently rub in completely, taking care to prevent the solution spreading onto the forehead
Storage
Cream/ointment: Store at room temperature 15- 25°C (59-77°F); do not freeze
Solution: Store at 20-25°C (68-77°F)
Foam
- Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F); flammable
- Contents under pressure
- Do not puncture or incinerate
- Do not refrigerate or freeze
- Do not expose to heat or store at temperatures >120°F (49°C)
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| calcipotriene for the scalp - | 0.005 % solution |  | |
| calcipotriene for the scalp - | 0.005 % solution |  | |
| calcipotriene for the scalp - | 0.005 % solution |  | |
| Dovonex topical - | 0.005 % cream |  | |
| Dovonex topical - | 0.005 % cream |  | |
| calcipotriene topical - | 0.005 % cream |  | |
| calcipotriene topical - | 0.005 % cream |  | |
| calcipotriene topical - | 0.005 % ointment |  | |
| calcipotriene topical - | 0.005 % ointment |  | |
| calcipotriene topical - | 0.005 % cream |  | |
| calcipotriene topical - | 0.005 % cream |  | |
| calcipotriene topical - | 0.005 % cream |  | |
| calcipotriene topical - | 0.005 % ointment |  | |
| calcipotriene topical - | 0.005 % cream |  | |
| calcipotriene topical - | 0.005 % ointment |  | |
| calcipotriene topical - | 0.005 % ointment |  | |
| calcipotriene topical - | 0.005 % ointment |  | |
| calcipotriene topical - | 0.005 % cream |  | |
| calcipotriene topical - | 0.005 % cream |  | |
| Sorilux topical - | 0.005 % foam |  | |
| Sorilux topical - | 0.005 % foam |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
calcipotriene topical
CALCIPOTRIENE - TOPICAL
(KAL-si-poe-TRYE-een)
COMMON BRAND NAME(S): Dovonex, Sorilux
USES: This medication is used to treat psoriasis. Calcipotriene is a form of vitamin D. It works by slowing down the growth of skin cells.
HOW TO USE: Use this medication on the skin only. Apply a thin layer of the medication as directed by your doctor to the affected area and gently rub in, usually once or twice daily for the ointment or twice daily for the cream or the foam. Wash your hands after using, unless you are using this medication to treat the hands. Do not apply the medication on the face, in the eyes, nose, or mouth, or inside the vagina. If you do get the medication in those areas, flush with plenty of water.Do not apply more often or use longer than prescribed. This may increase the risk of side effects.Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time(s) each day.Inform your doctor if your condition does not improve or if it worsens. You should usually begin to see an improvement in your skin condition after 2 weeks of treatment.
SIDE EFFECTS: Burning, itching, rash, irritation, redness, dry skin, or peeling at the application site may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: skin thinning/discoloration, stretch marks, small red bumps on the skin (folliculitis), unusual tiredness, mental/mood changes, unexplained constipation.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before using this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: high calcium/vitamin D levels (hypercalcemia/hypervitaminosis D).This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness. Your doctor may direct you to limit or avoid phototherapy while you use this product. Ask your doctor for details.Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of the drug.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug are: other products containing vitamin D.
OVERDOSE: This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Do not share this medication with others.Laboratory and/or medical tests (such as calcium levels) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.This medication has been prescribed for your current condition only. Do not use it later for another skin condition unless told to do so by your doctor. A different medication may be necessary in that case.
MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.
STORAGE: Store at room temperature away from light. Do not freeze. The foam is flammable. Avoid smoking during and right after applying the foam. Do not puncture the foam can or expose to high heat or open flame. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised September 2022. Copyright(c) 2022 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
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