Patient Medication Information: uses, side effects, how to take - Lyderm (Taropharma, A Division of Taro Pharmaceuticals, Ointment, Gel)
What is LYDERM used for?
LYDERM is used to treat skin rashes that are inflamed, itchy, or caused by allergies caused by certain skin conditions.
How does LYDERM work?
LYDERM provide relief from inflammation and symptoms by blocking the body’s inflammatory response.
What are the ingredients in LYDERM? Medicinal ingredients: Fluocinonide
Non-medicinal ingredients:
Ointment: Glyceryl Monostearate, Propylene Carbonate, Propylene Glycol, White
Petrolatum, and White Wax
Gel: Carbomer, Edetate Disodium, Propylene Glycol, Propyl Gallate, Purified Water and
Sodium Hydroxide (to adjust the pH)
Cream: Citric Acid, Glycerin, 1, 2, 6-Hexanetriol, Polyethylene Glycol 3350, Polyethylene Glycol 8000, Propylene Glycol, and Stearyl Alcohol
LYDERM (Flucinonide) comes in the following dosage forms:
Ointment 0.05% w/w
Gel 0.05% w/w
Cream 0.05% w/w
Do not use LYDERM if you:
are allergic to fluocinonide or any of the other ingredients found in
LYDERM (Flucinonide).
have untreated bacterial, tubercular, fungal, or viral lesions of the skin. This includes herpes simplex, vaccinia, and chickenpox.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take LYDERM. Talk about any health conditions or problems you may have, including if you:
are pregnant or if you think you might be pregnant
are breastfeeding or plan to breastfeed
have other inflammatory skin diseases caused by poor circulation such as stasis dermatitis or chronic ulcers in the legs.
have adrenal gland problems. LYDERM can affect how your adrenal glands
work.
have a condition for which you were previously or are currently taking other corticosteroid drugs. Use of more than one corticosteroid at the same time or close in time may increase your chance of developing adrenal gland problems.
have eye problems, such as cataracts. Talk to your doctor if you notice any change to your eyes or eyesight. Cataracts have been reported in patients using topical corticosteroids. Do NOT use LYDERM in or near the eyes. Take care not to get LYDERM in your eyes. If you get LYDERM in your eye, flush it with cold water right away.
have liver problems
have a skin infection.
Other warnings you should know about:
Covering the treated area can increase the amount of medicine absorbed through your skin.
This may increase your chance of developing adrenal gland problems. You should not cover the treated skin area with a bandage or other covering unless your healthcare professional tells you to. Using LYDERM for long time, over large areas of skin or on broken skin can also increase the amount of medicine absorbed through your skin.
Using LYDERM for a long time may cause thinning of the skin. If you notice your skin thinning, speak to your healthcare professional.
If you have to use LYDERM for a long time, your doctor may stop your treatment for a short period. Your doctor may also treat only one area of your body at a time. Your doctor will tell you exactly how to use LYDERM. Your doctor will also tell you how long you should be using LYDERM for.
You may develop contact dermatitis (allergic skin reaction) while using LYDERM (Flucinonide) . Tell your healthcare professional if your skin is not healing or worsens.
During the use of LYDERM, you may develop other infections, such as bacterial infections of the skin.
The safety and how well LYDERM (Flucinonide) works has not been determined in patients under the age of 18 years.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Tell your healthcare professional if you have used or are currently using any products or medication containing corticosteroids.
The following may interact with LYDERM (Flucinonide):
There are no known interactions with LYDERM (Flucinonide).
How to take LYDERM (Flucinonide):
Use this medicine exactly as directed by your healthcare professional.
Check that the pharmacist has provided you LYDERM (Flucinonide) as prescribed by your
doctor.
LYDERM (Flucinonide) is for external use only.
Do not cover the area with dressings unless instructed to do so by your doctor.
Ointment: the ointment is suitable for dry, itchy or scaly skin
Gel: the gel is used for lesions of the scalp
Cream: the cream is recommended for moist, weeping lesions.
Usual Dose:
Apply a small amount of LYDERM (Flucinonide) to the affected skin area, two to four times a day. Your doctor will tell your exactly how many times a day you should be applying LYDERM (Flucinonide).
Overdose:
If you think you have taken too much LYDERM (Flucinonide), contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.
Missed Dose:
If you missed a dose of this medication, you do not need to make up the missed dose. Skip the missed dose and continue with your next scheduled dose. Do not use extra medicine to make up for the missed dose.
What are possible side effects from using LYDERM (Flucinonide)?
These are not all the possible side effects you may feel when taking LYDERM (Flucinonide). If you experience any side effects not listed here, contact your healthcare professional.
Side effects may include:
red, sore, itchy, blisters or oozing
itching of the skin
redness, rash, tears or scrapes
heat rash (miliaria)
application site pain or burning/stinging sensation
change in skin pigmentation
maceration of the skin. In this condition, the skin may feel soft, wet or soggy to touch
thick and leathery skin
skin dryness and flaking
spider veins (telangiectasia)
excessive hair growth over the body (hypertrichosis)
tingling or prickling skin sensation
inflamed hair follicles (folliculitis)
acneiform eruptions, a type of acne
striae (stretch marks that are red, pink or purple)
| Serious side effects and what to do about them | |||
|---|---|---|---|
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Only if severe | In all cases | ||
| VERY COMMON | |||
| Skin atrophy: thinning of the skin | X | ||
Skin Irritation at the application site: red, sore or peeling skin; burning/stinging sensation; severe itching and/or dryness | X | ||
| Dermatitis: skin rash or sores | X | ||
| COMMON | |||
| Allergic reactions: rash, hives, swelling of the skin | X | ||
Cushing's syndrome (when your body makes too much cortisol hormone): rounded “moon” face, weight gain, pink or purple stretch marks (striae) on the skin, fragile skin that bruises easily, slow healing of cuts, severe fatigue, muscle weakness, headache | X | ||
| Glucocorticosteroid insufficiency (low levels of cortisol hormone): Worsening fatigue and muscle weakness, loss of appetite, weight loss, nausea, vomiting, and diarrhea | X | ||
Glucosuria (excretion of glucose into the urine): feel extremely thirsty or dehydrated feel extremely hungry urinate more than usual urinate accidentally, unexplained weight loss fatigue trouble seeing slow-healing cuts, sores, or other injuries skin darkening in the folds of your neck, armpits, or other areas | X | ||
|---|---|---|---|
Hyperglycemia (high levels of sugar): frequent urination, increased thirst, blurred vision, fatigue, headache, fruity- smelling breath, nausea and vomiting, shortness of breath, dry mouth, weakness, confusion, coma and abdominal pain | X | ||
| UNCOMMON | |||
| Cataracts (clouding of the lens of the eye): clouded or blurred vision, double vision, difficulty in seeing during the night, sensitivity to light and glare, need for brighter than normal, light to read or see objects, seeing halo around lights, seeing objects in faded or yellow color, eye pain, headache due to changes in vision | X | ||
| Erythema: redness of the skin or mucous membrane | X | ||
Gastroenteritis (stomach flu): diarrhea, vomiting stomach pain, cramping, fever, nausea, and headaches | X | ||
Glaucoma (increased pressure in eye): loss of peripheral or side vision, seeing halos around lights, vision loss, redness in the eye, eye that looks hazy, eye pain, narrowed vision | X | ||
| Hypertension (high blood pressure) | X | ||
|---|---|---|---|
| Leukoderma: white patches on the skin | X |
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health
Canada by:
Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/healthcanada/services/drugs-health-products/medeffect- canada.html) for information on how to report online, by mail or by fax; or
Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Storage:
Ointment, Gel and Cream: Store at room temperature 15°C - 30°C.
Keep out of sight and reach of children.
If you want more information about LYDERM (Flucinonide):
Talk to your healthcare professional
Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug- products/drugproduct-database.html); the manufacturer’s website www.taro.com or by calling 1-800-361-4261.
130 East Drive
Brampton, ON, L6T 1C3
www.taro.com
Date of Initial Authorization: December 8, 1997