Calcipotriene and Betamethasone Dipropionate 50 mg/g
Calcipotriene and Betamethasone Dipropionate · SUSPENSION · Sun Pharmaceutical Industries, Inc.
Calcipotriene and Betamethasone Dipropionate is a suspension containing calcipotriene and betamethasone dipropionate at 50 mg/g, taken topical. Manufactured by Sun Pharmaceutical Industries, Inc..
Key Facts
- Brand Name
- Calcipotriene and Betamethasone Dipropionate
- Generic Name
- Calcipotriene and Betamethasone Dipropionate
- NDC Code (Product)
51672-1402- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Strength
- 50 mg/g
- Dosage Form
- SUSPENSION
- Route
- TOPICAL
- Marketing Status
- Application #
- ANDA213269
- Drug Class
- Vitamin D Analog [EPC]
- Marketing Start
- 09/02/2020
Recall History
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Labeling: Incorrect or missing package insert: the affected product was packaged with an out-of-date package insert (PI) dated February 2014.
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 and Betamethasone Dipropionate used for?
Calcipotriene and Betamethasone Dipropionate contains Calcipotriene and Betamethasone Dipropionate. It is a suspension taken topical. Consult your doctor for specific uses.
Is Calcipotriene and Betamethasone Dipropionate a controlled substance?
Calcipotriene and Betamethasone Dipropionate is not classified as a controlled substance by the DEA.
What is the generic name for Calcipotriene and Betamethasone Dipropionate?
The generic name for Calcipotriene and Betamethasone Dipropionate is Calcipotriene and Betamethasone Dipropionate. There are 4 other brand versions of Calcipotriene and Betamethasone Dipropionate.
What is the NDC code for Calcipotriene and Betamethasone Dipropionate 50 mg/g?
The NDC (National Drug Code) for Calcipotriene and Betamethasone Dipropionate 50 mg/g is 51672-1402, listed by Sun Pharmaceutical Industries, Inc..