Sorilux

Name: Sorilux

Sorilux Precautions

  • Do not use Sorilux if you have been told by your doctor that you have a high level of calcium in your blood (hypercalcemia).
  • Keep Sorilux out of your eyes.
  • Do not use Sorilux if you are allergic to any of its ingredients.
  • Avoid excessive exposure of the treated areas to either natural or artificial sunlight, including tanning beds and sun lamps.
  • Avoid fire, flame, or smoking during and immediately following application since Sorilux is flammable.

Sorilux Usage

Apply Sorilux exactly as prescribed.

  • Sorilux is usually applied to the affected skin areas two times each day.
  • Sorilux is for use on the skin only. Do not get the foam in your eyes, mouth or vagina.
  • Sorilux foam is flammable. Avoid fire, flame, or smoking during and right after you apply foam to your skin.
  • Avoid excessive sunlight. Wear a hat and clothes that cover the treated areas of your skin if you have to be in sunlight.

Applying Sorilux foam

  • Before applying Sorilux for the first time, break the tiny plastic piece at the base of the can’s rim by gently pushing back (away from the piece) on the nozzle. 
  • Shake the can before use. 
  • Turn the can upside down and press the nozzle.
  • Dispense a small amount of foam into the palm of your hand.
  • Use enough foam to cover the affected area with a thin layer. Gently rub the foam into the affected area until it disappears into the skin.
  • Avoid getting foam in or near the eyes, mouth, or vagina. Wash hands after applying Sorilux (excluding affected areas of the hands).

 

Other Requirements

  • Do not place Sorilux foam in the refrigerator or freezer.
  • Store at room temperature.
  • Keep this and all medications out of the reach of children.

What happens if I miss a dose?

Apply the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What do I need to tell my doctor BEFORE I take Sorilux?

  • If you have an allergy to calcipotriene or any other part of Sorilux (calcipotriene foam).
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have any of these health problems: High calcium levels or too much vitamin D in the body.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Sorilux with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Overdosage

Topically applied calcipotriene can be absorbed in sufficient amounts to produce systemic effects. Elevated serum calcium has been observed with use of topical calcipotriene [See Warnings and Precautions (5.2).]

Patient Counseling Information

See FDA-approved patient labeling (Patient Information)

Inform the patient to adhere to the following instructions:

  • Avoid excessive exposure of the treated areas to either natural or artificial sunlight, including tanning beds and sun lamps.
  • Avoid contact with the face and eyes. If Sorilux Foam gets on the face or in or near their eyes, rinse thoroughly with water.
  • Apply Sorilux Foam to the scalp when the hair is dry.
  • Talk to your doctor if your skin does not improve after treatment with Sorilux Foam for 8 weeks.
  • Wash your hands after applying Sorilux Foam unless your hands are the affected site.
  • Avoid fire, flame, and smoking during and immediately following application since Sorilux Foam is flammable.
  • Do not place Sorilux Foam in the refrigerator or freezer.

Sorilux is a licensed trademark of Mayne Pharma LLC.

Distributed by:
Mayne Pharma
Greenville, NC 27834
140828

PHARMACIST DETACH HERE AND GIVE INSTRUCTIONS TO PATIENT

What happens if I miss a dose?

Apply the missed dose as soon as you remember. However, if it is almost time for your next dose, skip the dose you missed and apply only your next regularly scheduled dose.

For the Consumer

Applies to calcipotriene topical: topical cream, topical foam, topical ointment, topical solution

Along with its needed effects, calcipotriene topical (the active ingredient contained in Sorilux) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking calcipotriene topical:

More common
  • Skin redness, swelling, or itching
  • skin rash
  • worsening of psoriasis

Some side effects of calcipotriene topical may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Burning, dryness, irritation, peeling, or redness of the skin
Less common
  • Pain at the application site
Less common or rare
  • Darker color in the treated areas of the skin
  • pus in the hair follicles

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