Calcipotriene Solution
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Questions & Answers
Side Effects & Adverse Reactions
Avoid contact with the eyes or mucous membranes. Discontinue use if a sensitivity reaction occurs or if excessive irritation develops on uninvolved skin areas.
Drug product is flammable. Keep away from open flame.
PRECAUTIONS
General
Use of Calcipotriene Topical Solution, 0.005% (Scalp Solution) may cause transient irritation of both lesions and surrounding uninvolved skin. If irritation develops, Calcipotriene Topical Solution, 0.005% (Scalp Solution) should be discontinued.
For external use only. Keep out of the reach of children. Always wash hands thoroughly after use.
Reversible elevation of serum calcium has occurred with use of topical calcipotriene. If elevation in serum calcium outside the normal range should occur, discontinue treatment until normal calcium levels are restored.
Patients using Calcipotriene Topical Solution, 0.005% (Scalp Solution) should receive the following information and instructions:
- This medication is to be used only as directed by the physician. It is for external use only. Avoid contact with the face or eyes. As with any topical medication, patients should wash their hands after application.
- This medication should not be used for any disorder other than that for which it was prescribed.
- Patients should report to their physician any signs of adverse reactions.
- Patients that apply Calcipotriene Topical Solution, 0.005% (Scalp Solution) to exposed portions of the body should avoid excessive exposure to either natural or artificial sunlight (including tanning booths, sun lamps, etc.).
When calcipotriene was applied topically to mice for up to 24 months at dosages of 3, 10 and 30 µg/kg/day (corresponding to 9, 30 and 90 µg/m2/day), no significant changes in tumor incidence were observed when compared to control. In a study in which albino hairless mice were exposed to both UVR and topically applied calcipotriene, a reduction in the time required for UVR to induce the formation of skin tumors was observed (statistically significant in males only), suggesting that calcipotriene may enhance the effect of UVR to induce skin tumors. Patients that apply Calcipotriene Topical Solution, 0.005% (Scalp Solution) to exposed portions of the body should avoid excessive exposure to either natural or artificial sunlight (including tanning booths, sun lamps, etc.). Physicians may wish to limit or avoid use of phototherapy in patients that use Calcipotriene Topical Solution, 0.005% (Scalp Solution).
Calcipotriene did not elicit any mutagenic effects in an Ames mutagenicity assay, a mouse lymphoma TK locus assay, a human lymphocyte chromosome aberration assay, or in a micronucleus assay conducted in mice.
Studies in rats at doses up to 54 µg/kg/day (324 µg/m2/day) of calcipotriene indicated no impairment of fertility or general reproductive performance.
Teratogenic Effects: Pregnancy Category C
Studies of teratogenicity were done by the oral route where bioavailability is expected to be approximately 40-60% of the administered dose. Increased rabbit maternal and fetal toxicity was noted at 12 µg/kg/day (132 µg/m2/day). Rabbits administered 36 µg/kg/day (396 µg/m2/day) resulted in fetuses with a significant increase in the incidences of pubic bones, forelimb phalanges, and incomplete bone ossification. In a rat study, oral doses of 54 µg/kg/day (318 µg/m2/day) resulted in a significantly higher incidence of skeletal abnormalities consisting primarily of enlarged fontanelles and extra ribs. The enlarged fontanelles are most likely due to calcipotriene’s effect upon calcium metabolism. The maternal and fetal calculated no-effect exposures in the rat (43.2 µg/m2/day) and rabbit (17.6 µg/m2/day) studies are greater than the expected human systemic exposure level (0.13 µg/m2/day) from dermal application. There are no adequate and well-controlled studies in pregnant women. Therefore, Calcipotriene Topical Solution, 0.005% (Scalp Solution), should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
There is evidence that maternal 1,25-dihydroxy vitamin D3 (calcitriol) may enter the fetal circulation, but it is not known whether it is excreted in human milk. The systemic disposition of calcipotriene is expected to be similar to that of the naturally occurring vitamin. Because many drugs are excreted in human milk, caution should be exercised when Calcipotriene Topical Solution, 0.005% (Scalp Solution) is administered to a nursing woman.
Safety and effectiveness of Calcipotriene Topical Solution, 0.005% (Scalp Solution) in pediatric patients have not been specifically established. Because of a higher ratio of skin surface area to body mass, pediatric patients are at greater risk than adults of systemic adverse effects when they are treated with topical medication.
Of the total number of patients in clinical studies of calcipotriene solution, approximately 16% were 65 or older, while approximately 4% were 75 and over. The results of an analysis of severity of skin-related adverse events showed no differences for subjects over 65 years compared to those under 65 years, but greater sensitivity of some older individuals cannot be ruled out.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Calcipotriene Topical Solution, 0.005% (Scalp Solution) is indicated for the topical treatment of chronic, moderately severe psoriasis of the scalp. The safety and effectiveness of topical calcipotriene in dermatoses other than psoriasis have not been established.
History
There is currently no drug history available for this drug.
Other Information
Calcipotriene Topical Solution, 0.005% (Scalp Solution) is a colorless topical solution containing 0.005% calcipotriene in a vehicle of isopropanol (51% v/v), propylene glycol, hydroxypropyl cellulose, sodium citrate, menthol and purified water.
The chemical name of calcipotriene is (5Z,7E,22E,24S)-24-cyclopropyl-9,10-secochola-5,7,10(19),22-tetraene-1α,3β,24-triol, with the empirical formula C27H40O3, a molecular weight of 412.6, and the following structural formula:
Sources
Calcipotriene Solution Manufacturers
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Global Pharmaceuticals, Division Of Impax Laboratories Inc.
![Calcipotriene Solution [Global Pharmaceuticals, Division Of Impax Laboratories Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Calcipotriene Solution | Global Pharmaceuticals, Division Of Impax Laboratories Inc.
Comb the hair to remove scaly debris and after suitably parting, apply Calcipotriene Topical Solution, 0.005% (Scalp Solution) twice daily, only to the lesions, and rub in gently and completely, taking care to prevent the solution spreading onto the forehead. The safety and efficacy of Calcipotriene Topical Solution, 0.005% (Scalp Solution) have been demonstrated in patients treated for eight weeks.
Keep Calcipotriene Topical Solution, 0.005% (Scalp Solution) well away from the eyes. Avoid application of the solution to uninvolved scalp margins. Always wash hands thoroughly after use.
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E. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.
Calcipotriene Solution | E. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.
Comb the hair to remove scaly debris and after suitably parting, apply Calcipotriene Topical Solution 0.005% (Scalp Solution) twice daily, only to the lesions, and rub in gently and completely, taking care to prevent the solution spreading onto the forehead. The safety and efficacy of Calcipotriene Topical Solution 0.005% (Scalp Solution) have been demonstrated in patients treated for eight weeks.
Keep Calcipotriene Topical Solution 0.005% (Scalp Solution) well away from the eyes. Avoid application of the solution to uninvolved scalp margins. Always wash hands thoroughly after use.
![Calcipotriene Solution [E. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=fff63bc7-6b92-4080-9a11-017124d95162&name=63460907-b494-485c-a557-ec3b472e3e68-02.jpg)
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