Patient Medication Information: uses, side effects, how to take - Xolegel
ABOUT THIS MEDICATION
What the medication is used for:
XOLEGEL™ is a prescription medication for the treatment of seborrheic dermatitis, a common inflammatory scaling disease affecting certain areas of the skin.
What it does:
XOLEGEL™ is a topical antifungal agent which helps to kill the fungus believed to be one of the causes of seborrheic dermatitis. It does this by interfering with the growth of the cell membrane of the fungus.
When it should not be used:
XOLEGEL™ should not be used if you are allergic to ketoconazole or any of the other ingredients of XOLEGEL™ GEL (See What the nonmedicinal ingredients are).
XOLEGEL™ is not for ophthalmic, oral, or intravaginal use.
What the medicinal ingredient is:
Ketoconazole
What the nonmedicinal ingredients are:
Alcohol, Ascorbic Acid, Butylated Hydroxytoluene, Citric Acid Monohydrate, Glycerin, Hydroxypropyl Cellulose, Polyethylene Glycol 400, PPG-15 Stearyl Ether, Propylene Glycol, FD&C Yellow No. 6, D&C Yellow No. 10.
What dosage forms it comes in:
XOLEGEL™ comes in a smooth, clear amber gel formulation containing 2% ketoconazole, which will spread evenly and smoothly on affected areas. It contains no artificial fragrance.
WARNINGS AND PRECAUTIONS
Serious Warnings and Precautions Gels are flammable. Note: Keep away from heat and flame. Keep tube tightly closed.
Avoid fire, flame, or smoking during and immediately following application of XOLEGEL™.
BEFORE you use XOLEGEL™ talk to your doctor or pharmacist if:
You are pregnant or likely to become pregnant
- You are breast feeding or planning to breastfeed
- You are allergic to ketoconazole or any of the other ingredients in XOLEGEL™
- You are taking any other medications, including topical corticosteroids.
Avoid contact with the mouth, nose, eyes or open wounds. To avoid any accidental contact, you should wash your hands thoroughly after each application. In the event of accidental contact, the affected area should be rinsed thoroughly with warm water.
INTERACTIONS WITH THIS MEDICATION
While no drug interactions have been reported in clinical studies with XOLEGEL™, no drug-drug interaction studies have been conducted.
PROPER USE OF THIS MEDICATION
Usual Adult Dose: the usual adult dose is a thin layer of gel applied to the affected and immediately surrounding area once a day for 14 days. It is important that you use XOLEGEL™ every day for the full 14 days or as recommended by your doctor, to reduce the possibility of recurrence. You should consult your doctor if your condition worsens or does not improve by the end of treatment.
How to apply XOLEGEL™: Wash your hands before and after applying the medication. Clean the affected area and spread a thin layer of XOLEGEL™ evenly on the affected area(s) with your fingertips. Be sure to cover all affected areas and the immediately surrounding skin. Do not cleanse the areas where medication is applied for at least three hours after application. Wait at least 20 minutes after application before applying routine cosmetics or sunscreens.
XOLEGEL™ should be applied to newly affected areas that appear during the course of treatment. You should avoid applying other products to the treated areas while you are using XOLEGEL™, including medicated shampoos to treat seborrheic dermatitis of the scalp.
If you are taking topical corticosteroids, your doctor may give you directions to gradually lessen your dose over time until you stop taking the corticosteroid, or he/she provides you with other directions.
Missed Dose: If you miss a dose, continue with your usual dosing schedule. Do not double dose.
Overdose: In case of accidental oral ingestion, contact your doctor or local emergency care facility.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
XOLEGEL™ may be irritating to the mouth, nose, eyes and open wounds (See Warnings and Precautions).
No serious adverse events related to XOLEGEL™ were reported in clinical trials. The most common side effect is burning or reaction on the skin where XOLEGEL™ has been applied.
This is not a complete list of side effects. For any unexpected effects while taking XOLEGEL™, contact your doctor or pharmacist.
HOW TO STORE IT
Store XOLEGEL™ at room temperature (15 – 30ºC).
Keep out of reach of children.
REPORTING SUSPECTED SIDE EFFECTS
To monitor drug safety, Health Canada collects information on serious and unexpected effects of drugs . If you suspect you have had a serious or unexpected reaction to this drug you may notify Health Canada by:
toll-free telephone: 866-234-2345 toll-free fax 866-678-6789
By email: cadrmp@hc-sc.gc.ca
By regular mail:
National AR Centre
Marketed Health Products Safety and Effectiveness Information Division
Marketed Health Products Directorate
Tunney’s Pasture, AL 0701C
Ottawa ON K1A 0K9
NOTE: Before contacting Health Canada, you should contact your physician or pharmacist.
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals can be obtained by contacting the sponsor, Barrier Therapeutics Canada Inc., at:
1-800-440- 5507
or
PO Box #2730
Richmond Hill, Ontario
L4E 1A7
Barrier Therapeutics Canada Inc.,