CALCIPOTRIENE ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Prasco Laboratories

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 Ointment 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 Ointment should not be used on the face.

Product summary:

Calcipotriene Ointment, 0.005% is available in: 60 gram aluminum tubes NDC 66993-878-61 120 gram aluminum tubes NDC 66993-878-78

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

CALCIPOTRIENE- CALCIPOTRIENE OINTMENT
PRASCO LABORATORIES
----------
CALCIPOTRIENE OINTMENT, 0.005%
FOR TOPICAL DERMATOLOGIC USE ONLY.
NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE.
RX ONLY
DESCRIPTION
Calcipotriene Ointment, 0.005% contains the compound calcipotriene, a
synthetic vitamin D derivative,
for topical dermatological use.
Chemically, calcipotriene 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 412.6, and the following
structural formula:
Calcipotriene is a white or off-white crystalline substance.
Calcipotriene Ointment contains
calcipotriene 50 μg/g in an ointment base of dibasic sodium
phosphate, edetate disodium, mineral oil,
petrolatum, propylene glycol, tocopherol, steareth-2 and 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.
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 enter the fetal circulation,
but it is not known whether it is excreted in human milk. The systemic
disp