Trionex
Generic: CALCIPOTRIENE CREAM, 0.005% AND TRANSPARENT DRESSING
Basic Information
Manufacturer
V2 Pharma, LLC
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
FDA Set ID
45ac2edf-7ed1-4862-888a-f9dd349f1930
Indications & Usage
INDICATION AND USAGE Indicated for the treatment of plaque psoriasis.
INDICATIONS 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.
INDICATIONS 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.
Warnings
WARNINGS FOR EXTERNAL USE ONLY.
Avoid contact with eyes, lips or mucous membranes.
WARNINGS Contact dermatitis, including allergic contact dermatitis, has been observed with the use of calcipotriene cream.
Avoid contact with eyes, lips or mucous membranes.
WARNINGS Contact dermatitis, including allergic contact dermatitis, has been observed with the use of calcipotriene cream.
Adverse Reactions
ADVERSE 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.
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.