DailyMed Label: Trionex

DailyMed Label: Trionex

2023

DailyMed Prescription

Trionex

Calcipotriene Cream, 0.005% and Transparent Dressing

V2 Pharma, LLC

NDC: 72835-902

NDC: 72835-902

NDC: 72835-902

TRIONEX is supplied as 4 components in a kit : -1 TUBE OF CALCIPOTRIENE CREAM 0.005%, 60g (NDC 68462-501-65) - 30 SHEETS OF HYDROFILM TRANSPARENT DRESSING (3 BOXES OF 10 SHEETS)

Indicated for the treatment of plaque psoriasis.

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.

Do not use if known hypersensitivity to any of the listed ingredients of any of the components included on the kit.

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. If pregnant or breast feeding, ask a health professional before use.

Store at 20°-25°C (68° to 77°F); Keep away from heat and flame. Protect from freezing. [See USP Controlled Room Temperature.]

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 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 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.

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.

V2 Pharma, LLC TRIONEX NDC 72835-902-02  RX ONLY Trionex Packaging