Calcipotriene (Page 2 of 2)

Geriatric Use

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.

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.

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

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.

HOW SUPPLIED

Calcipotriene Topical Solution, 0.005% (Scalp Solution) is available in 60 mL plastic bottles

NDC 40032-043-60

STORAGE

Store at controlled room temperature 15°C — 25°C (59°F — 77°F). Avoid sunlight. Do not freeze.

Manufactured by:

Novel Laboratories, Inc.

Somerset, NJ 08873

To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

PI0436000101

Rev. 05/2017

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Container Label

container
(click image for full-size original)

Carton Label

carton
(click image for full-size original)
CALCIPOTRIENE
calcipotriene solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:40032-043
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CALCIPOTRIENE (CALCIPOTRIENE) CALCIPOTRIENE 0.05 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
PROPYLENE GLYCOL
ISOPROPYL ALCOHOL
MENTHOL
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
WATER
SODIUM CITRATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:40032-043-60 1 BOTTLE in 1 CARTON contains a BOTTLE
1 60 mL in 1 BOTTLE This package is contained within the CARTON (40032-043-60)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207163 12/26/2017
Labeler — Novel Laboratories, Inc. (793518643)
Registrant — Novel Laboratories, Inc. (793518643)
Establishment
Name Address ID/FEI Operations
Novel Laboratories, Inc. 793518643 ANALYSIS (40032-043), MANUFACTURE (40032-043), PACK (40032-043)

Revised: 12/2018 Novel Laboratories, Inc.

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