Patient Medication Information: uses, side effects, how to take - Topicort
What is TOPICORT used for?
TOPICORT is used in certain skin conditions to relieve symptoms such as redness, swelling and itching.
How does TOPICORT work?
The medicinal ingredient in TOPICORT is desoximetasone. Desoximetasone belongs to a group of medicines called corticosteroids. Corticosteroids reduce inflammation by decreasing the body’s immune response. This can relieve symptoms such as itching, redness and swelling.
What are the ingredients in TOPICORT?
Medicinal ingredients: Desoximetasone
Non-medicinal ingredients:
Cream 0.25% w/w: Isopropyl Myristate, Methylparaben, Propylparaben, Water, Wool Alcohols, and Wool Alcohols Ointment.
- Cream 0.05% w/w: Edetate Disodium, Isopropyl Myristate, Lactic Acid, Methylparaben, Propylparaben, Water, Wool Alcohols, and Wool Alcohols Ointment.
- Gel 0.05% w/w: Alcohol, Carbomer Homopolymer Type C, Docusate Sodium, Edetate Disodium, Isopropyl Myristate, Trolamine and Water.
- Ointment 0.25% w/w: Aluminum Stearates, Beeswax, Dicocoyl Pentaerythrityl, Distearyl Citrate, Propylene Glycol, Sorbitan Sesquioleate, White Petrolatum, and Vitamin E.
TOPICORT comes in the following dosage forms:
- Cream 0.25% w/w.
- Cream 0.05% w/w.
- Gel 0.05% w/w.
- Ointment 0.25% w/w.
Do not use TOPICORT if:
- You are allergic or had a history of allergies to desoximetasone or any of the other ingredients in TOPICORT.
- You have an untreated infection involving the skin from a bacteria, fungus such as tuberculosis or syphilis
- You have a viral disease of the skin, such as chicken pox, smallpox or herpes.
TOPICORT should not be applied:
- to your eyes
to large areas of the body unless advised by your healthcare professional. You may be at a higher risk of experiencing side effects if you apply TOPICORT:
- to large areas of the body
- at high doses
- under an airtight dressing.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you receive TOPICORT. Talk about any health conditions or problems you may have, including if you:
- have stasis dermatitis (inflammation of the skin) and other skin diseases associated with impaired circulation
- have adrenal gland problems. TOPICORT 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 healthcare professional if you notice any change to your eyes or eyesight. Cataracts, glaucoma or central serous chorioretinopathy have been reported in patients using topical corticosteroids. Use with caution if you have lesions (broken skin) close to the eyes
- have a skin infection.
are pregnant or trying to become pregnant.
- are breast feeding.
Other warnings you should know about:
- The use of TOPICORT may cause high blood sugar.
- 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 TOPICORT for long time, over large areas of skin or on broken skin can also increase the amount of medicine absorbed through your skin.
- Using TOPICORT for a long time may cause thinning of the skin. If you notice your skin thinning, speak to your healthcare professional.
- If you experience symptoms such as blurred vision or other visual disturbances, including decrease in visual acuity, see an ophthalmologist for evaluation of any serious eye conditions.
- You may develop contact dermatitis (allergic skin reaction) while using TOPICORT. Tell your healthcare professional if your skin is not healing or worsens.
- If you need to stop taking TOPICORT suddenly after prolonged use make sure you talk to your doctor before stopping the medication.
Long term use to corticosteroids in children may interfere with their growth and development. Children may be at greater risk of experiencing side effects compared to older patients. These side effects may include:
- adrenal gland problems (HPA axis suppression and Cushing’s syndrome)
- build-up of pressure around the brain
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with TOPICORT:
- It is NOT known whether TOPICORT interacts with other medication.
Some medicines may affect how TOPICORT works and may make it more likely that you will have side effects:
- ritonavir (used for HIV infection).
- itraconazole (used for fungal infections).
How TOPICORT is given:
- TOPICORT is to be used only as directed by your healthcare professional. Do not use more of it, do not use it more often, or do not use it for a longer period of time than your doctor has specified.
- TOPICORT is only for external use. Do not take it by mouth. Do not put this medicine on the face, underarms, or groin areas unless your doctor has instructed you to do so.
- Do not use TOPICORT on or near in the eyes or eyelids. If you get TOPICORT in your eye, flush it with cold water right away
- Do not wrap or bandage the treated area unless your healthcare professional has told you to do so.
- Contact your healthcare professional if your skin disease gets worse or there is no improvement in your condition within one week.
Usual dose
- Apply a small amount of TOPICORT to affected areas of skin twice daily.
- Rub in gently and completely.
Overdose:
| If you think you, or a person you are caring for, have used too much TOPICORT, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
What are possible side effects from using TOPICORT?
These are not all the possible side effects you may have when taking TOPICORT. If you experience any side effects not listed here, tell your healthcare professional.
- Stretch marks
- Rash around the mouth
- Redness, rash, tears or scrapes
- Application site pain or burning/stinging sensation
- Peeling and oozing of the skin
- Itching of the skin
- Irritation
- Dryness
- Inflamed hair follicles (folliculitis)
- Excessive hair growth over the body (hypertrichosis)
- Acneiform eruptions, a type of acne
- Change in skin pigmentation
- Maceration of the skin. In this condition, the skin may feel soft, wet or soggy to touch.
- Secondary infection
- Spider veins (telangiectasia)
- Heat rash (miliaria)
- Blurred vision
If you experience symptoms such as blurred vision or other visual disturbances, including decrease in visual acuity, see an ophthalmologist for evaluation of any serious eye conditions.
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 | |||
| Dermatitis: skin rash or sores | X | ||
| 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 | ||
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 | ||
|---|---|---|---|
| COMMON | |||
| Allergic reactions: rash, hives, swelling of the skin | X | ||
| Adrenal suppression (low levels of cortisol in blood): worsening fatigue and muscle weakness, loss of appetite, weight loss, nausea, vomiting diarrhea | X | ||
| Chorioretinopathy (fluid buildup in eye): blurred vision, a dark area in your central vision, straight lines may appear bent, crooked or irregular in your affected eye, objects may appear smaller or further away than they are, when you look at a white object, it may appear to have a brownish tinge or appear duller in color | X | ||
| Cushing's syndrome (excess cortisol secretion): 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 plasma cortisol): Worsening fatigue and muscle weakness, loss of appetite, weight loss, nausea, vomiting, and diarrhea | X | ||
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 | ||
|---|---|---|---|
| Hyperglycemia (excess of glucose in the bloodstream): 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 (skin rash): redness of the skin or mucous membrane | X | ||
| Intracranial hypertension (increased pressure around the brain): a ringing sound heard in one or both ears, horizontal double vision, pain in the arms or legs, blurred vision (with blinds spots in the eyes), temporary visual loss, difficulty seeing to the side, light flashes, problems with balance and spatial awareness | X | ||
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 | ||
|---|---|---|---|
| Pustular psoriasis: pustules (white or yellow, pus-filled, painful bumps) that may be surrounded by inflamed or reddened/discolored skin | X | ||
| Pyoderma (bacterial skin infection): papules, large ulcers, deep ulcers, chronic wounds | 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, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
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:
Store between 15 and 30ºC.
Keep out of reach and sight of children.
If you want more information about TOPICORT:
- 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/drug-product-database.html; the manufacturer’s website (www.bauschhealth.ca), or by calling 1-800-361-4261.
Bausch Health, Canada Inc.
2150 St-Elzear Blvd. West
Laval (Quebec) H7L 4A8
www.bauschhealth.ca