CALCIPOTRIENE ointment

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

Product summary:

Calcipotriene Ointment USP, 0.005% is available in: 60 gram aluminum tube NDC (68462-310-65) 120 gram aluminum tube NDC (68462-310-66)

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CALCIPOTRIENE- CALCIPOTRIENE OINTMENT
GLENMARK PHARMACEUTICALS INC., USA
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CALCIPOTRIENE OINTMENT USP, 0.005%
RX ONLY
FOR TOPICAL DERMATOLOGIC USE ONLY.
NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE.
DESCRIPTION
Calcipotriene Ointment USP, 0.005% contains the compound
calcipotriene, USP a synthetic vitamin D
derivative for topical dermatological use.
Chemically, calcipotriene, USP
is24-cyclopropyl-(1α,3β,5Z,7E,22E,24S)-9,10-Secochola-
5,7,10(19),22-tetraene-1,3,24-trioI; 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 Ointment USP,
0.005% contains calcipotriene, USP 50 mcg/g in an ointment base of
disodium phosphate dihydrate,
edetate disodium, mineral oil, white petrolatum, propylene glycol,
_dl-_alpha-tocopherol, steareth-2 and
purified water.
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.
3
27
40
3
3
3
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. The primary metabolites are
much less potent than the parent
compound.
There is evidence that maternal 1,25-dihydroxy vitamin D (calcitriol)
may ente