Generic Name
Calcipotriene
Brand Names
Trionex, Calcitrene, Sorilux
FDA approval date: October 01, 1996
Classification: Vitamin D Analog
Form: Ointment, Cream, Aerosol, Kit, Solution
What is Trionex (Calcipotriene)?
SORILUX Foam is indicated for the topical treatment of plaque psoriasis of the scalp and body in adults and pediatric patients 4 years of age and older. SORILUX ® Foam is a vitamin D analog indicated for the topical treatment of plaque psoriasis of the scalp and body in adults and pediatric patients 4 years of age and older.
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Related Clinical Trials
A Pilot Clinical Trial Comparing Topical Fluorouracil to Fluorouracil Plus Calcipotriene Field Treatments in Patients With Multiple Actinic Keratoses
Summary: The goal of this clinical research study is to compare the effects of topical fluorouracil alone to topical fluorouracil plus topical calcipotriene in patients with multiple actinic keratoses. Topical means the medication is applied directly to the skin.
Phase I, Dual Arm, Open-Label, Trial of Intralesional 5-Fluorouracil (5FU) and Intralesional 5FU Combined With Topical Calcipotriene in Patients With Squamous Cell Carcinoma (SCC) of the Lower Extremities
Summary: This clinical trial proposes to evaluate a relatively unexplored approach to treatment of squamous cell carcinoma (SCC) on the lower extremities. The strategy is to directly and specifically deliver drug to the tumor. For the proposed phase I clinical trial, the investigators will perform intralesional injections of a well characterized, potent chemotherapeutic agent 5-fluorouracil (5FU) with and ...
Combination of 5-Fluorouracil and Calcipotriene in the Treatment of Superficial Basal Cell Carcinomas and Squamous Cell Carcinomas in Situ
Summary: The investigators will compare the application of two different creams for the treatment of low-risk skin cancers-superficial basal cell carcinoma (sBCC) and squamous cell carcinoma in situ (SCCis). 5-Fluorouracil cream is currently FDA approved for the treatment of superficial basal cell carcinoma and is routinely used by dermatologists across the country and at Boston Medical Center (BMC) for SC...
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Brand Information
Trionex (Calcipotriene Cream, 0.005% and Transparent Dressing)
1TRIONEX DESCRIPTION
TRIONEX is supplied as 4 components in a
-1 TUBE OF CALCIPOTRIENE CREAM 0.005%, 60g (NDC 68462-501-65)
- 30 SHEETS OF HYDROFILM TRANSPARENT DRESSING (3 BOXES OF 10 SHEETS)
2INDICATION AND USAGE
Indicated for the treatment of plaque psoriasis.
3DOSAGE AND ADMINISTRATION
Apply a thin layer of calcipotriene cream to the affected skin 1-2 times daily and rub in gently and completely. The safety and efficacy of calcipotriene cream have been demonstrated in patients treated for eight weeks.
Once calcipotriene has been completely rubbed in completely, apply transparent dressing to the affected area as needed as a protectant.
4WARNINGS
FOR EXTERNAL USE ONLY. Avoid contact with eyes, lips or mucous membranes.
5CONTRAINDICATIONS
Do not use if known hypersensitivity to any of the listed ingredients of
6PRECAUTIONS
Stop use and ask a doctor if redness or irritation develops. Keep this and all other medications out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
6.1PREGNANCY
If pregnant or breast feeding, ask a health professional before use.
7Calcipotriene Cream 0.005%
Rx Only
8DESCRIPTION
Calcipotriene cream, 0.005% contains calcipotriene, USP, a synthetic vitamin D
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
Calcipotriene, USP is a white or almost white crystalline powder. Calcipotriene cream, 0.005% contains 50 mcg/g anhydrous calcipotriene, USP in a cream base of benzyl alcohol, cetostearyl alcohol, ceteth-20, cetostearyl alcohol, disodium hydrogen phosphate dihydrate, glycerin, medium chain triglycerides, mineral oil, monosodium phosphate monohydrate, purified water and white petrolatum.
9CLINICAL 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
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
10CLINICAL STUDIES
Adequate and well-controlled trials of patients treated with calcipotriene cream have demonstrated improvement usually beginning after 2 weeks of therapy. This improvement continued with approximately 50% of patients showing at least marked improvement in the signs and symptoms of psoriasis after 8 weeks of therapy, but only approximately 4% showed complete clearing.
11INDICATIONS AND USAGE
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.
12CONTRAINDICATIONS
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.
13WARNINGS
Contact dermatitis, including allergic contact dermatitis, has been observed with the use of calcipotriene cream.
14ADVERSE REACTIONS
Clinical Trials Experience
In controlled clinical trials, the most frequent adverse experiences reported for calcipotriene cream, 0.005% were cases of skin irritation, which occurred in approximately 10 to 15% of patients. Rash, pruritus, dermatitis and worsening of psoriasis were reported in 1 to 10% of patients.
Postmarketing Experience
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
The following adverse reactions associated with the use of calcipotriene cream have been identified post-approval: contact dermatitis, including allergic contact dermatitis.
15OVERDOSAGE
Topically applied calcipotriene can be absorbed in sufficient amounts to produce systemic effects. Elevated serum calcium has been observed with excessive use of topical calcipotriene. If elevation in serum calcium should occur, discontinue treatment until normal calcium levels are restored (see
16DOSAGE AND ADMINISTRATION
Apply a thin layer of calcipotriene cream to the affected skin twice daily and rub in gently and completely. The safety and efficacy of calcipotriene cream have been demonstrated in patients treated for eight weeks.
17HOW SUPPLIED
Calcipotriene cream, 0.005% is available in:
NDC 68462-501-65 60 gram tube (1 tube per carton)
NDC 68462-501-66 120 gram tube (1 tube per carton)
17.1STORAGE
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 (888) 721-7115
To report SUSPECTED ADVERSE REACTIONS, contact Glenmark Pharmaceuticals Inc., USA at 1 (888) 721-7115 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
March 2021
18PACKAGE/LABEL PRINCIPAL DISPLAY PANEL-60 gm Carton
NDC 68462-501-65
Calcipotriene Cream, 0.005%
60 gm Carton label
19Hydrofilm Transparrent Dressing
30 Sheets of Hydrofilm transparent sterile dressing that contains a transparent, semi-permeable polyurethane polyacrylate top layer and hypoallergenic, polyacrylate adhesive layer. The dressing is used to protect against secondary infection and against mechanical irritation of wounds in later stages of healing.
20PRINCIPAL DISPLAY PANEL - Kit Carton
V2 Pharma, LLC
TRIONEX
NDC 72835-902-02
