Calcitrene

Calcitrene is an FDA-registered drug product whose active ingredient is CALCIPOTRIENE. It is labelled by Sun Pharmaceutical Industries, Inc. taken by topical and marketed as a human prescription drug product. Identifiers on file: NDC 51672-5278, application ANDA090633, label effective 20260714. It is one of 6 FDA drug label records sharing the active ingredient CALCIPOTRIENE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing CALCIPOTRIENE are most often described in connection with: usage calcitrene, calcipotriene ointment, treatment plaque, psoriasis adults, effectiveness topical. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

INDICATIONS AND USAGE Calcitrene ® (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.

DOSAGE AND ADMINISTRATION Apply a thin layer of Calcitrene ® (calcipotriene) ointment, 0.005% once or twice daily and rub in gently and completely.

CONTRAINDICATIONS Calcitrene ® (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 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.

FDA lists 6 drug label records with CALCIPOTRIENE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is Calcitrene used for?
INDICATIONS AND USAGE Calcitrene ® (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.

Who makes Calcitrene?
Sun Pharmaceutical Industries, Inc. is the labeler of record for Calcitrene. 6 FDA label records share the active ingredient CALCIPOTRIENE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Calcitrene come in?
administered by topical. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Calcitrene prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing CALCIPOTRIENE?
Yes. 6 FDA drug label records list CALCIPOTRIENE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Calcitrene been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.