calcipotriene 50 ug/g
calcipotriene · AEROSOL, FOAM · Mayne Pharma
calcipotriene is a aerosol, foam containing calcipotriene at 50 ug/g, taken topical. Manufactured by Mayne Pharma.
Key Facts
- Brand Name
- calcipotriene
- Generic Name
- calcipotriene
- NDC Code (Product)
51862-512- Manufacturer
- Mayne Pharma
- Strength
- 50 ug/g
- Dosage Form
- AEROSOL, FOAM
- Route
- TOPICAL
- Marketing Status
- Application #
- NDA022563
- Drug Class
- Vitamin D Analog [EPC]
- Marketing Start
- 02/15/2021
Recall History
American Pharmaceutical Ingredients LLC
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
LEO PHARMA INC
Labeling: Incorrect or missing package insert: the affected product was packaged with an out-of-date package insert (PI) dated February 2014.
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Akorn, Inc.
Defective Delivery System: Potential defect that could prevent the product from dispensing as intended.
LEO PHARMA INC
Incorrect/Undeclared excipients: inadvertent omission of a drug excipient from the the Authorized Generic label and also a warning regarding contact dermatitis from the brand product labeling not being incorporated into the Authorized Generic labeling.
Akorn, Inc.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Calcipotriene and Betamethasone Dipropionate Ointment is indicated for the topical treatment of plaque psoriasis in patients 12 years of age and older. Calcipotriene and Betamethasone Dipropionate Ointment is a vitamin D analogue and corticosteroid combination product indicated for the topical treatment of plaque psoriasis in patients 12 years of age and older.
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Apply an adequate layer of Calcipotriene and Betamethasone Dipropionate Ointment to the affected area(s) once daily for up to 4 weeks. Calcipotriene and Betamethasone Dipropionate Ointment should be rubbed in gently and completely. Patients should wash their hands after applying Calcipotriene and Betamethasone Dipropionate Ointment. Therapy should be discontinued when control is achieved. Patients 18 years and older should not use more than 100 g per week and patients 12 to 17 years should not use more than 60 g per week. Treatment of more than 30% body surface area is not recommended. Calcipotriene and Betamethasone Dipropionate Ointment should not be used with occlusive dressings unless directed by a physician. Avoid use on the face, groin, or axillae, or if skin atrophy is present at the treatment site. Calcipotriene and Betamethasone Dipropionate Ointment is not for oral, ophthalmic, or intravaginal use. • Apply Calcipotriene and Betamethasone Dipropionate Ointment to affected area(s) once daily for up to 4 weeks. Discontinue therapy when control is achieved. (2) • Adult patients should not use more than 100 g per week. (2) • Patients ages 12 to 17 y…
Contraindications
4 CONTRAINDICATIONS None. None.
Adverse Reactions
6 ADVERSE REACTIONS Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The most common adverse reactions (≥1%) are pruritus and scaly rash. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Perrigo at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Clinical Trials Conducted in Subjects 18 years and older with Plaque Psoriasis The data described below reflect exposure to calcipotriene and betamethasone dipropionate ointment in 2448 subjects with plaque psoriasis, including 1992 exposed for 4 weeks, and 289 exposed for 8 weeks. Calcipotriene and betamethasone dipropionate ointment was studied primarily in placebo- and active-controlled trials (N = 1176, and N = 1272, respectively). The population was 15-97 years old, 61% males and 39% females, mostly white (97%) and had a baseline disease severity ranging from mild to very severe. Most subjects received once daily application, and the median weekly dose was 24.5 g. The perce…
Frequently Asked Questions
What is calcipotriene used for?
calcipotriene contains calcipotriene. It is a aerosol, foam taken topical. Consult your doctor for specific uses.
Is calcipotriene a controlled substance?
calcipotriene is not classified as a controlled substance by the DEA.
What is the generic name for calcipotriene?
The generic name for calcipotriene is calcipotriene. There are 11 other brand versions of calcipotriene.
What is the NDC code for calcipotriene 50 ug/g?
The NDC (National Drug Code) for calcipotriene 50 ug/g is 51862-512, listed by Mayne Pharma.
Other Calcipotriene Brands
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- Calcipotriene.05 mg/mL0713-0318
- TACLONEX.5 mg/g50222-501
- Calcipotriene and Betamethasone Dipropionate50 mg/g51672-1402
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- Calcipotriene and Betamethasone Dipropionate.5 mg/g66993-938
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)