Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 24 November 2019

Indication(s)

INDICATIONS AND 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.

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Advisory information

contraindications
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
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.

Usage information

Dosing and administration
DOSAGE AND 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.

More information

Category Value
Authorisation number ANDA077029
Agency product number 143NQ3779B
Orphan designation No
Product NDC 0115-1475
Date Last Revised 01-06-2019
Type HUMAN PRESCRIPTION DRUG
RXCUI 308865
Storage and handling Storage and Handling Store at 20°to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Avoid sunlight. Do not freeze. To report SUSPECTED ADVERSE REACTIONS contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Manufactured by: Tolmar, Inc. Fort Collins, CO 80526 Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 04006128 Rev. 0 12/18
Marketing authorisation holder Amneal Pharmaceuticals of New York LLC