CALCIPOTRIENE solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Amneal Pharmaceuticals of New York LLC

INN (International Name):

CALCIPOTRIENE

Composition:

CALCIPOTRIENE 0.05 mg in 1 mL

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Calcipotriene Topical Solution, 0.005% (Scalp Solution) is indicated for the topical treatment of chronic, moderately severe psoriasis of the scalp. The safety and effectiveness of topical calcipotriene in dermatoses other than psoriasis have not been established. Calcipotriene Topical Solution, 0.005% (Scalp Solution) is contraindicated in those patients with acute psoriatic eruptions or 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.

Product summary:

Calcipotriene Topical Solution, 0.005% (Scalp Solution) is available in 60 mL plastic bottles (NDC 0115-1475-55). Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Avoid sunlight. Do not freeze. To report SUSPECTED ADVERSE REACTIONS contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Manufactured by: Tolmar, Inc. Fort Collins, CO 80526 Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 04006128 Rev. 0 12/18

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CALCIPOTRIENE- CALCIPOTRIENE SOLUTION
AMNEAL PHARMACEUTICALS OF NEW YORK LLC
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CALCIPOTRIENE TOPICAL SOLUTION, 0.005% (SCALP SOLUTION)
RX ONLY
FOR TOPICAL DERMATOLOGIC USE ONLY.
NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE.
DESCRIPTION
Calcipotriene Topical Solution, 0.005% (Scalp Solution) is a colorless
topical solution containing
0.005% calcipotriene in a vehicle of isopropanol (51% v/v), propylene
glycol, hydroxypropyl
cellulose, sodium citrate, menthol and purified water.
The chemical name of calcipotriene is
(5Z,7E,22E,24S)-24-cyclopropyl-9,10-secochola-5,7,10(19),22-
tetraene-1α,3ß,24-triol, with the empirical formula C
H O , a molecular weight of 412.6, and the
following structural formula:
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 .
Although the precise mechanism of calcipotriene’s antipsoriatic
action is not fully understood, _in vitro_
evidence suggests that calcipotriene is roughly equipotent to the
natural vitamin in its effects on
proliferation and differentiation of a variety of cell types.
Calcipotriene has also been shown, in animal
studies, to be 100-200 times less potent in its effects on calcium
utilization than the natural hormone.
Clinical studies with radiolabelled calcipotriene solution indicate
that less than 1% of the applied dose
of calcipotriene is absorbed through the scalp when the solution (2.0
mL) is applied topically to normal
skin or psoriasis plaques (160 cm ) for 12 hours, and that much of the
absorbed calcipotriene is
converted to inactive metabolites within 24 hours of application.
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