Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Calcipotriene Topical Solution, 0.005% (Scalp Solution) is available in 60 mL plastic bottles (NDC 0713-0318-53).; PRINCIPAL DISPLAY PANEL NDC 0713-0318-53 Calcipotriene Topical Solution, 0.005% (Scalp Solution) 60 mL Rx only For Topical Dermatologic Use Only - Not for Ophthalmic, Oral or Intravaginal Use. Cosette Pharmaceuticals, Inc. label tube tube-b
- HOW SUPPLIED Calcipotriene Topical Solution, 0.005% (Scalp Solution) is available in 60 mL plastic bottles (NDC 0713-0318-53).
- PRINCIPAL DISPLAY PANEL NDC 0713-0318-53 Calcipotriene Topical Solution, 0.005% (Scalp Solution) 60 mL Rx only For Topical Dermatologic Use Only - Not for Ophthalmic, Oral or Intravaginal Use. Cosette Pharmaceuticals, Inc. label tube tube-b
Overview
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 C 27 H 40 O 3 , a molecular weight of 412.6, and the following structural formula: formula
Indications & Usage
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.
Dosage & Administration
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.
Warnings & Precautions
WARNINGS 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.
Contraindications
Calcipotriene Topical Solution, 0.005% (Scalp Solution), is contraindicated in those patients with acute psoriatic eruptions or a history of hypersensitivity to any of the components of the preparation. It should not be used by patients with demonstrated hypercalcemia or evidence of vitamin D toxicity.
Adverse Reactions
In controlled clinical trials, the most frequent adverse reactions reported to be related to Calcipotriene Topical Solution, 0.005% (Scalp Solution), use were transient burning, stinging and tingling, which occurred in approximately 23% of patients. Rash was reported in about 11% of patients. Dry skin, irritation and worsening of psoriasis were reported in 1-5% of patients. Skin atrophy, hyperpigmentation, hypercalcemia, and folliculitis were not observed in these studies, but cannot be excluded. To report SUSPECTED ADVERSE REACTIONS, contact Cosette Pharmaceuticals, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Storage & Handling
STORAGE Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Avoid sunlight. Do not freeze. Distributed by: Cosette Pharmaceuticals, Inc. South Plainfield, NJ 07080 8-0318CPLNC1 VC7535 Iss. 02/2021
Similar Drugs
Related medications based on brand, generic name, substance, active ingredients.