Calcipotriene (Page 2 of 2)

Pediatric Use

Safety and effectiveness of Calcipotriene Topical Solution, 0.005% (Scalp Solution), in pediatric patients have not been specifically 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 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.
To report SUSPECTED ADVERSE REACTIONS, contact G&W Laboratories, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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 0713-0318-53).

STORAGE

Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Avoid sunlight. Do not freeze.

Manufactured by:
G&W Laboratories, Inc.
South Plainfield, NJ 07080

8-0318GW2
Rev. 03/2015

PRINCIPAL DISPLAY PANEL

NDC 0713-0318-53

G&W®

Calcipotriene
Topical Solution,
0.005%
(Scalp Solution)

For Topical Dermatologic Use Only — Not for Ophthalmic, Oral or Intravaginal Use.

Rx only

NET WT. 60 mL

carton
(click image for full-size original)
CALCIPOTRIENE
calcipotriene solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0713-0318
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Calcipotriene (Calcipotriene) Calcipotriene .05 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
Isopropyl Alcohol
Propylene Glycol
Hydroxypropyl Cellulose (type H)
Sodium Citrate
Menthol
Water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0713-0318-53 1 BOTTLE in 1 CARTON contains a BOTTLE
1 60 mL in 1 BOTTLE This package is contained within the CARTON (0713-0318-53)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078468 03/24/2011
Labeler — G&W Laboratories, Inc. (001271188)
Registrant — G&W Laboratories, Inc. (001271188)
Establishment
Name Address ID/FEI Operations
G&W Laboratories, Inc. 001271188 analysis (0713-0318), manufacture (0713-0318), label (0713-0318), pack (0713-0318)

Revised: 05/2018 G&W Laboratories, Inc.

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