SORILUX 50 ug/g

calcipotriene · AEROSOL, FOAM · Mayne Pharma

No Recall History

Plain English

SORILUX is a aerosol, foam containing calcipotriene at 50 ug/g, taken topical. Manufactured by Mayne Pharma.

Key Facts

Brand Name: SORILUX
Generic Name: calcipotriene
NDC Code (Product): 51862-376
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: 04/11/2017

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective812 reports

psoriasis724 reports

diarrhoea207 reports

arthralgia196 reports

rash191 reports

nausea179 reports

pain171 reports

pruritus171 reports

headache163 reports

off label use159 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE SORILUX Foam is indicated for the topical treatment of plaque psoriasis of the scalp and body in adults and pediatric patients 4 years of age and older. SORILUX ® Foam is a vitamin D analog indicated for the topical treatment of plaque psoriasis of the scalp and body in adults and pediatric patients 4 years of age and older. ( 1 )

Dosage & Administration

2 DOSAGE AND ADMINISTRATION SORILUX Foam is for topical use only. SORILUX Foam is not for oral, ophthalmic, or intravaginal use. Apply a thin layer of SORILUX Foam twice daily to the affected areas and rub in gently and completely. Avoid contact with the face and eyes. For topical use only; not for oral, ophthalmic, or intravaginal use. ( 2 ) Apply twice daily. ( 2 )

Contraindications

4 CONTRAINDICATIONS SORILUX Foam should not be used by patients with known hypercalcemia. Do not use in patients with known hypercalcemia. ( 4 )

Adverse Reactions

6 ADVERSE REACTIONS Adverse reactions reported in ≥ 1% of subjects treated with SORILUX Foam and at a higher incidence than subjects treated with vehicle were application site erythema and application site pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Mayne Pharma at 1-844-825-8500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . ( 6 ) 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. SORILUX Foam was studied in four vehicle-controlled trials. A total of 1094 adult subjects with plaque psoriasis, including 654 exposed to SORILUX Foam, were treated twice daily for 8 weeks. Adverse reactions reported in ≥1% of subjects treated with SORILUX Foam and at a higher incidence than subjects treated with vehicle were application site erythema (2%) and application site pain (3%). The incidence of these adverse reactions was similar between the body and scalp. In an open-label study, 19 pediatric subjects age 12 to less than 17 y…

Frequently Asked Questions

What is SORILUX used for?

SORILUX contains calcipotriene. It is a aerosol, foam taken topical. Consult your doctor for specific uses.

Is SORILUX a controlled substance?

SORILUX is not classified as a controlled substance by the DEA.

What is the generic name for SORILUX?

The generic name for SORILUX is calcipotriene. There are 11 other brand versions of calcipotriene.

What is the NDC code for SORILUX 50 ug/g?

The NDC (National Drug Code) for SORILUX 50 ug/g is 51862-376, listed by Mayne Pharma.

Product NDC

51862-376

Package NDC

51862-376-12

Other Calcipotriene Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)