Calcipotriene (Page 2 of 2)

Pediatric Use

Safety and effectiveness of calcipotriene in pediatric patients have not been 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.

Geriatric Use

Of the total number of patients in clinical studies of calcipotriene ointment, approximately 12% were 65 or older, while approximately 4% were 75 and over. The results of an analysis of severity of skin-related adverse events showed a statistically significant difference for subjects over 65 years (more severe) compared to those under 65 years (less severe).

ADVERSE REACTIONS

In controlled clinical trials, the most frequent adverse reactions reported for calcipotriene were burning, itching and skin irritation, which occurred in approximately 10-15% of patients. Erythema, dry skin, peeling, rash, dermatitis, worsening of psoriasis including development of facial/scalp psoriasis were reported in 1 to 10% of patients. Other experiences reported in less than 1% of patients included skin atrophy, hyperpigmentation, hypercalcemia, and folliculitis. Once daily dosing has not been shown to be superior in safety to twice daily dosing.

OVERDOSAGE

Topically applied calcipotriene can be absorbed in sufficient amounts to produce systemic effects. Elevated serum calcium has been observed with excessive use of calcipotriene ointment.

DOSAGE AND ADMINISTRATION

Apply a thin layer of calcipotriene ointment once or twice daily and rub in gently and completely.

HOW SUPPLIED

Calcipotriene ointment, 0.005% is available in:

60 gram aluminum tube NDC (51672-4154-3)

120 gram aluminum tube NDC (51672-4154-4)

STORAGE

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

Manufactured by:

Glenmark Generics Ltd.
Colvale-Bardez, Goa 403 513, India

Distributed by:

Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY 10532

November 2011

PRINCIPAL DISPLAY PANEL — 120 g Tube Carton

NDC 51672-4154-4

120 g

Calcipotriene Ointment 0.005%

FOR TOPICAL DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE.

Rx only

Keep this and all medications out of the reach of children.

TARO

PRINCIPAL DISPLAY PANEL -- 120 g Tube Carton
(click image for full-size original)
CALCIPOTRIENE
calcipotriene ointment
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51672-4154
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Calcipotriene (Calcipotriene) Calcipotriene 0.05 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
sodium phosphate, dibasic, dihydrate
edetate disodium
mineral oil
petrolatum
propylene glycol
.alpha.-tocopherol
steareth-2
water
Product Characteristics
Color WHITE Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51672-4154-5 10 TUBE in 1 CARTON contains a TUBE
1 5 g in 1 TUBE This package is contained within the CARTON (51672-4154-5)
2 NDC:51672-4154-3 1 TUBE in 1 CARTON contains a TUBE
2 60 g in 1 TUBE This package is contained within the CARTON (51672-4154-3)
3 NDC:51672-4154-4 1 TUBE in 1 CARTON contains a TUBE
3 120 g in 1 TUBE This package is contained within the CARTON (51672-4154-4)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090633 03/24/2010
Labeler — Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
Name Address ID/FEI Operations
Glenmark Generics Ltd. 677318665 MANUFACTURE (51672-4154)

Revised: 12/2019 Taro Pharmaceuticals U.S.A., Inc.

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