Calcipotriene (Page 2 of 2)

Geriatric Use

Of the total number of patients in clinical studies of calcipotriene cream, approximately 15% were 65 or older, while approximately 3% were 75 and over. There were no significant differences in adverse events for subjects over 65 years compared to those under 65 years of age. However, the greater sensitivity of older individuals cannot be ruled out.

ADVERSE REACTIONS

Clinical Trials Experience

In controlled clinical trials, the most frequent adverse experiences reported for calcipotriene cream, 0.005% were cases of skin irritation, which occurred in approximately 10 to 15% of patients. Rash, pruritus, dermatitis and worsening of psoriasis were reported in 1 to 10% of patients.

Postmarketing Experience

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

The following adverse reactions associated with the use of calcipotriene cream have been identified post-approval: contact dermatitis, including allergic contact dermatitis.

OVERDOSAGE

Topically applied calcipotriene can be absorbed in sufficient amounts to produce systemic effects. Elevated serum calcium has been observed with excessive use of topical calcipotriene. If elevation in serum calcium should occur, discontinue treatment until normal calcium levels are restored (see PRECAUTIONS).

DOSAGE AND ADMINISTRATION

Apply a thin layer of calcipotriene cream to the affected skin twice daily and rub in gently and completely. The safety and efficacy of calcipotriene cream have been demonstrated in patients treated for eight weeks.

HOW SUPPLIED

Calcipotriene cream, 0.005% is available in:

NDC 51407-605-60 60 gram tube (1 tube per carton)

NDC 51407-605-12 120 gram tube (1 tube per carton)

STORAGE

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Do not freeze.

Manufactured by:

Glenmark Pharmaceuticals Limited

Colvale-Bardez, Goa 403513, India

Manufactured for:

Glenmark Pharmaceuticals Inc., USA

Mahwah, NJ 07430

Questions? 1 (888) 721-7115
www.glenmarkpharma-us.com

To report SUSPECTED ADVERSE REACTIONS, contact Glenmark Pharmaceuticals Inc., USA at 1 (888) 721-7115 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

March 2021

Marketed by:

GSMS, Incorporated

Camarillo, CA 93012 USA

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL-60 gm Carton

NDC 51407-605-12

Calcipotriene Cream, 0.005%

120 gm Carton label

CALCIPOTRIENE calcipotriene cream

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51407-605 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALCIPOTRIENE (CALCIPOTRIENE) CALCIPOTRIENE 50 ug in 1 g

Inactive Ingredients Ingredient Name Strength BENZYL ALCOHOL CETOSTEARYL ALCOHOL CETETH-20 SODIUM PHOSPHATE, DIBASIC, DIHYDRATE GLYCERIN MEDIUM-CHAIN TRIGLYCERIDES MINERAL OIL SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE WATER PETROLATUM

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:51407-605-60 1 TUBE in 1 CARTON contains a TUBE 1 60 g in 1 TUBE This package is contained within the CARTON (51407-605-60) 2 NDC:51407-605-12 1 TUBE in 1 CARTON contains a TUBE 2 120 g in 1 TUBE This package is contained within the CARTON (51407-605-12)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA205772 06/09/2015

Labeler — Golden State Medical Supply, Inc. (603184490)

Establishment
Name	Address	ID/FEI	Operations
Glenmark Pharmaceuticals Limited		677318665	analysis (51407-605), manufacture (51407-605)

Revised: 01/2023 Golden State Medical Supply, Inc.