CALCIPOTRIENE cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CALCIPOTRIENE (UNII: 143NQ3779B) (CALCIPOTRIENE - UNII:143NQ3779B)

Available from:

Glenmark Pharmaceuticals Inc.,USA

INN (International Name):

CALCIPOTRIENE

Composition:

CALCIPOTRIENE 50 ug in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Calcipotriene cream, 0.005%, is indicated for the treatment of plaque psoriasis. The safety and effectiveness of topical calcipotriene in dermatoses other than psoriasis have not been established. Calcipotriene cream is contraindicated in those patients with 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. Calcipotriene cream should not be used on the face.

Product summary:

Calcipotriene cream USP, 0.005% is available in: 60 gram tube (1 tube per carton), NDC 68462-501-65 120 gram tube (1 tube per carton), NDC 68462-501-66 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 [phone] www.glenmarkpharma-us.com February 2023

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CALCIPOTRIENE- CALCIPOTRIENE CREAM
GLENMARK PHARMACEUTICALS INC.,USA
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CALCIPOTRIENE CREAM USP, 0.005%
RX ONLY
FOR TOPICAL DERMATOLOGIC USE ONLY.
NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE.
DESCRIPTION
Calcipotriene Cream USP, 0.005% contains calcipotriene, USP, a
synthetic vitamin D
derivative, for topical dermatological use.
Chemically, calcipotriene, USP is
(5Z,7E,22E,24S)-24-cyclopropyl-9,10-secochola-
5,7,10(19),22-tetraene-1α,3β,24-triol, with the empirical formula C
H
O , a molecular
weight of 412.62 and the following structural formula:
Calcipotriene, USP is a white or almost white crystalline powder.
Calcipotriene Cream
USP, 0.005% contains 50 mcg/g anhydrous calcipotriene, USP in a cream
base of benzyl
alcohol, ceteth-20, cetostearyl alcohol, disodium hydrogen phosphate
dihydrate,
glycerin, medium chain triglycerides, mineral oil, monosodium
phosphate monohydrate,
purified water and white petrolatum.
3
27
40
3
CLINICAL PHARMACOLOGY
In humans, the natural supply of vitamin D depends mainly on exposure
to the
ultraviolet rays of the sun for conversion of 7-dehydrocholesterol to
vitamin D
(cholecalciferol) in the skin. Calcipotriene is a synthetic analog of
vitamin D .
Clinical studies with radiolabelled calcipotriene ointment indicate
that approximately 6%
(± 3%, SD) of the applied dose of calcipotriene is absorbed
systemically when the
ointment is applied topically to psoriasis plaques, or 5% (± 2.6%,
SD) when applied to
normal skin, and much of the absorbed active is converted to inactive
metabolites within
24 hours of application. Systemic absorption of the cream has not been
studied.
Vitamin D and its metabolites are transported in the blood, bound to
specific plasma
proteins. The active form of the vitamin, 1,25-dihydroxy vitamin D
(calcitriol), is known
to be recycled via the liver and excreted in the bile. Calcipotriene
metabolism following
systemic uptake is rapid, and occurs via a similar pathway to the
natural hormone.
CLINICAL STUDIES
Adequate and well-controlled trials of patien