Calcitrene

Calcipotriene

Taro Pharmaceuticals U.s.a., Inc.
Human Prescription Drug
NDC 51672-5278

Calcitrene also known as Calcipotriene is a human prescription drug labeled by 'Taro Pharmaceuticals U.s.a., Inc.'. National Drug Code (NDC) number for Calcitrene is 51672-5278. This drug is available in dosage form of Ointment. The names of the active, medicinal ingredients in Calcitrene drug includes Calcipotriene - .05 mg/g . The currest status of Calcitrene drug is Active.

Drug Information:

Drug NDC:	51672-5278
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name:	Calcitrene
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type:	Human Prescription Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name:	Calcipotriene
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Taro Pharmaceuticals U.s.a., Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Ointment
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status:	Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:	CALCIPOTRIENE - .05 mg/g
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	TOPICAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Marketing Category:	ANDA
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Marketing Start Date:	24 Mar, 2010
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	25 Dec, 2025
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number:	ANDA090633
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Listing Expiration Date:	31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Manufacturer Name:	Taro Pharmaceuticals U.S.A., Inc.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	198373 1013636
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
NUI:	M0022797 N0000175849
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:	143NQ3779B
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class EPC:	Vitamin D Analog [EPC]
Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`.
Pharmacologic Class CS:	Vitamin D [CS]
Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient].
Pharmacologic Class:	Vitamin D Analog [EPC] Vitamin D [CS]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
51672-5278-3	1 TUBE in 1 CARTON (51672-5278-3) / 60 g in 1 TUBE	24 Mar, 2010	N/A	No
51672-5278-4	1 TUBE in 1 CARTON (51672-5278-4) / 120 g in 1 TUBE	24 Mar, 2010	N/A	No
51672-5278-5	10 TUBE in 1 CARTON (51672-5278-5) / 5 g in 1 TUBE	24 Mar, 2010	N/A	No
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Other medicines with the same generic name

Calcipotriene

Ointment
Golden State Medical Supply, Inc.
NDC: 51407-606

Sorilux

Calcipotriene

Aerosol, Foam
Mayne Pharma
NDC: 51862-376

Calcipotriene

Solution
Novel Laboratories, Inc.
NDC: 40032-043

Calcitrene

Product Elements:

Calcitrene calcipotriene calcipotriene calcipotriene sodium phosphate, dibasic, dihydrate edetate disodium mineral oil petrolatum propylene glycol .alpha.-tocopherol steareth-2 water

Indications and Usage:

Indications and usage calcitrene Â® (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.

General Precautions:

General use of calcipotriene may cause irritation of lesions and surrounding uninvolved skin. if irritation develops, calcipotriene should be discontinued. for external use only. keep out of the reach of children. always wash hands thoroughly after use. transient, rapidly reversible elevation of serum calcium has occurred with use of calcipotriene. if elevation in serum calcium outside the normal range should occur, discontinue treatment until normal calcium levels are restored.

Dosage and Administration:

Dosage and administration apply a thin layer of calcitrene Â® (calcipotriene) ointment, 0.005% once or twice daily and rub in gently and completely.

Contraindications:

Contraindications calcitrene Â® (calcipotriene) ointment, 0.005%, 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.

Adverse Reactions:

Adverse reactions in controlled clinical trials, the most frequent adverse reactions reported for calcipotriene were burning, itching and skin irritation, which occurred in approximately 10-15% of patients. erythema, dry skin, peeling, rash, dermatitis, worsening of psoriasis including development of facial/scalp psoriasis were reported in 1 to 10% of patients. other experiences reported in less than 1% of patients included skin atrophy, hyperpigmentation, hypercalcemia, and folliculitis. once daily dosing has not been shown to be superior in safety to twice daily dosing.

Use in Pregnancy:

Pregnancy teratogenic effects pregnancy category c studies of teratogenicity were done by the oral route where bioavailability is expected to be approximately 40-60% of the administered dose. in rabbits, increased maternal and fetal toxicity were noted at a dosage of 12 Âµg/kg/day (132 Âµg/m 2 /day); a dosage of 36 Âµg/kg/day (396 Âµg/m 2 /day) resulted in a significant increase in the incidence of incomplete ossification of the pubic bones and forelimb phalanges of fetuses. in a rat study, a dosage of 54 Âµg/kg/day (318 Âµg/m 2 /day) resulted in a significantly increased incidence of skeletal abnormalities (enlarged fontanelles and extra ribs). the enlarged fontanelles are most likely due to calcipotriene's effect upon calcium metabolism. the estimated maternal and fetal no-effect exposure levels in the rat (43.2 Âµg/m 2 /day) and rabbit (17.6 Âµg/m 2 /day) studies are approximately equal to the expected human systemic exposure level (18.5 Âµg/m 2 /day) from dermal a Read more...

pplication. there are no adequate and well-controlled studies in pregnant women. therefore, calcitrene Â® (calcipotriene) ointment, 0.005% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Pediatric Use:

Pediatric use safety and effectiveness of calcipotriene in pediatric patients have not been 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:

Geriatric use of the total number of patients in clinical studies of calcitrene Â® (calcipotriene) ointment, 0.005%, approximately 12% were 65 or older, while approximately 4% were 75 and over. the results of an analysis of severity of skin-related adverse events showed a statistically significant difference for subjects over 65 years (more severe) compared to those under 65 years (less severe).

Overdosage:

Overdosage topically applied calcipotriene can be absorbed in sufficient amounts to produce systemic effects. elevated serum calcium has been observed with excessive use of calcitrene Â® (calcipotriene) ointment, 0.005%.

Description:

Description calcitrene Â® (calcipotriene) ointment, 0.005% contains the compound calcipotriene, a synthetic vitamin d 3 derivative for topical dermatological use. chemically, calcipotriene is (5z,7e,22e,24s)-24-cyclopropyl-9,10-secochola-5,7,10(19),22-tetraene-1Î±,3Î²,24-triol-, with the empirical formula c 27 h 40 o 3 , a molecular weight of 412.6, and the following structural formula: calcipotriene is a white or off-white crystalline substance. calcitrene Â® (calcipotriene) ointment, 0.005% contains calcipotriene 50 Âµg/g in an ointment base of disodium phosphate dihydrate, edetate disodium, mineral oil, petrolatum, propylene glycol, Î±-tocopherol, steareth-2 and purified water. chemical structure

Clinical Pharmacology:

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 3 (cholecalciferol) in the skin. calcipotriene is a synthetic analog of vitamin d 3 . clinical studies with radiolabelled ointment indicate that approximately 6% (Â± 3%, sd) of the applied dose of calcipotriene is absorbed systemically when the ointment is applied topically to psoriasis plaques or 5% (Â± 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-dihyroxy vitamin d 3 (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 metabolite Read more...

s are much less potent than the parent compound. there is evidence that maternal 1,25-dihydroxy vitamin d 3 (calcitriol) may enter the fetal circulation, but it is not known whether it is excreted in human milk. the systemic disposition of calcipotriene is expected to be similar to that of the naturally occurring vitamin.

Carcinogenesis and Mutagenesis and Impairment of Fertility:

Carcinogenesis, mutagenesis, impairment of fertility when calcipotriene was applied topically to mice for up to 24 months at dosages of 3, 10 and 30 Âµg/kg/day (corresponding to 9, 30 and 90 Âµg/m 2 /day), no significant changes in tumor incidence were observed when compared to control. in a study in which albino hairless mice were exposed to both uvr and topically applied calcipotriene, a reduction in the time required for uvr to indicate the formation of skin tumors was observed (statistically significant in males only), suggesting that calcipotriene may enhance the effect of uvr to induce skin tumors. patients that apply calcipotriene to exposed portions of the body should avoid excessive exposure to either natural or artificial sunlight (including tanning booths, sun lamps, etc.). physicians may wish to limit or avoid use of phototherapy in patients that use calcipotriene. calcipotriene did not elicit any mutagenic effects in an ames mutagenicity assay, a mouse lymphoma tk locu Read more...

s assay, a human lymphocyte chromosome aberration assay, or in a micronucleus assay conducted in mice. studies in rats at doses up to 54 Âµg/kg/day (324 Âµg/m 2 /day) of calcipotriene indicated no impairment of fertility or general reproductive performance.

Clinical Studies:

Clinical studies adequate and well-controlled trials of patients treated with calcitrene Â® (calcipotriene) ointment, 0.005% have demonstrated improvement usually beginning after two weeks of therapy. this improvement continued in patients using calcipotriene once daily and twice daily. after 8 weeks of once daily calcipotriene, 56.7% of patients showed at least marked improvements (6.4% showed complete clearing). after 8 weeks of twice daily calcipotriene, 70.0% of patients showed at least marked improvement (11.3% showed complete clearing). subtracting percentages of patients using placebo (vehicle only) from percentages of patients using calcipotriene who had at least marked improvements after 8 weeks yields 39.9% for once daily and 49.6% for twice daily. this adjustment for placebo effect indicated that what might appear to be differences between once and twice daily use may reflect differences in the studies independent from the frequency of dosing. although there was a numerica Read more...

l difference in comparison across studies, twice daily dosing has not been shown to be superior in efficacy to once daily dosing. over 400 patients have been treated in open label clinical studies of calcipotriene for periods of up to one year. in half of these studies, patients who previously had not responded well to calcipotriene were excluded. the adverse events in these extended studies included skin irritation in approximately 25% of patients and worsening of psoriasis in approximately 10% of patients. in one of these open label studies, half of the patients no longer required calcipotriene by 16 weeks of treatment, because of satisfactory therapeutic results.

How Supplied:

How supplied calcitrene Â® (calcipotriene) ointment, 0.005% is available in: 60 gram aluminum tube ndc (51672-5278-3) 120 gram aluminum tube ndc (51672-5278-4) storage store at controlled room temperature 15Â°c-25Â°c (59Â°f-77Â°f). do not freeze.

Information for Patients:

Information for patients patients using calcipotriene should receive the following information and instructions: this medication is to be used as directed by the physician. it is for external use only. avoid contact with the face or eyes. as with any topical medication, patients should wash hands after application. this medication should not be used for any disorder other than that for which it was prescribed. patients should report to their physician any signs of local adverse reactions. patients that apply calcipotriene to exposed portions of the body should avoid excessive exposure to either natural or artificial sunlight (including tanning booths, sun lamps, etc.)

Package Label Principal Display Panel:

Principal display panel - 120 g tube carton ndc 51672-5278-4 120 g calcitrene Â® calcipotriene ointment 0.005% rx only taropharma Â® for topical dermatoligic use only. not for ophthalmic, oral or intravaginal use. keep this and all medications out of the reach of children. taropharma Â® principal display panel - 120 g tube carton

Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.