Patient Medication Information: uses, side effects, how to take - Dermatop Ointment
What are DERMATOP OINTMENT and DERMATOP EMOLLIENT CREAM used for?
DERMATOP OINTMENT and DERMATOP EMOLLIENT CREAM are used in certain inflammatory skin conditions to relieve symptoms such as redness and itching.
DERMATOP OINTMENT is for use in adults only.
DERMATOP EMOLLIENT CREAM can be used in adults and children 1 year of age and older.
How do DERMATOP OINTMENT and DERMATOP EMOLLIENT CREAM work?
DERMATOP OINTMENT and DERMATOP EMOLLIENT CREAM belong to a group of medicines called corticosteroids or steroids. Corticosteroids reduce inflammation by decreasing the body’s immune response. This can relieve symptoms such as itching and redness.
What are the ingredients in DERMATOP OINTMENT and DERMATOP EMOLLIENT CREAM?
Medicinal ingredients: prednicarbate
Non-medicinal ingredients:
- Ointment: cithrol GMO 50-LQ-(AP) (made of citric acid, glycerol oleate, propylene glycol), octyldodecanol, white petrolatum.
Emollient Cream: benzyl alcohol, edetate sodium, isopropyl myristate, lactic acid, purified water, wool alcohols ointment, wool wax alcohols.
DERMATOP OINTMENT and DERMATOP EMOLLIENT CREAM come in the following dosage forms:
- Ointment: 0.1% w/w
- Emollient Cream: 0.1% w/w
Do not use DERMATOP OINTMENT and DERMATOP EMOLLIENT CREAM if:
you are allergic to prednicarbate or any of the other ingredients in DERMATOP
- OINTMENT or DERMATOP EMOLLIENT CREAM.
- you are allergic to wool or lanolin. DERMATOP EMOLLIENT CREAM contains wool alcohols ointment and wool wax alcohols.
- you have a bacterial or fungal skin infection or any untreated infection.
- you have tuberculosis of the skin or a syphilitic skin infection.
- you have chickenpox.
- you have herpes simples of the eye or any other eye infection. Do not use DERMATOP OINTMENT or DERMATOP EMOLLIENT CREAM on or near the eyes or eyelids (risk of glaucoma or cataracts).
- you have recently received a vaccine.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you use DERMATOP OINTMENT and DERMATOP EMOLLIENT CREAM. Talk about any health conditions or problems you may have, including if you:
- have or have had an infection (such as herpes simplex, chickenpox, tuberculosis, threadworm). If you or your child is exposed to measles or chickenpox while using DERMATOP OINTMENT or DERMATOP EMOILLIENT CREAM, tell your healthcare professional immediately. Serious or fatal side effects can occur if you or your child have not already had these infections.
- are using or have previously used corticosteroids for the treatment of skin disorders, allergic reactions, arthritis or asthma. Tell your healthcare professional if you have had an allergic reaction or experienced side-effects to these medicines.
- have adrenal gland problems. DERMATOP OINTMENT and DERMATOP EMOLLIENT CREAM can affect how your adrenal glands work.
- have eye problems, such as glaucoma or cataracts.
- have skin problems caused by poor circulation.
- have recently had or are about to have any vaccination.
are pregnant or trying to become pregnant.
- are breastfeeding or planning to breastfeed.
Other warnings you should know about:
- Do not use DERMATOP OINTMENT or DERMATOP EMOLLIENT CREAM for more than 2 weeks.
Adrenal Suppression:
- Too much DERMATOP OINTMENT or DERMATOP EMOLLIENT CREAM passing though your skin can shut down your adrenal glands (adrenal suppression). This may happen if you use too much DERMATOP OINTMENT or DERMATOP EMOLLIENT CREAM or if you use it for too long, but it can happen with correct use. Using DERMATOP OINTMENT or DERMATOP EMOLLIENT CREAM for longer than 2 weeks, over large areas of skin, on broken skin or on the face, scalp, underarms or groin can also increase chances of developing adrenal suppression.
Covering the treated area can increase the amount of medicine absorbed through your skin. This may increase your chance of developing serious adrenal
- suppression. You should not cover the treated skin area with a bandage or other covering unless your healthcare professional tells you to.
- If you suddenly stop using DERMATOP OINTMENT or DERMATOP EMOLLIENT CREAM this can cause adrenal suppression that can lead to death. It can also cause “Withdrawal syndrome”. This includes local symptoms such as redness, burning pain, peeling of the skin and itching. It can also cause symptoms such as anorexia, nausea, vomiting, lack of energy, headache, fever, joint pain, muscle pain, weight loss, and/or low blood pressure.
- Skin Changes: Using DERMATOP OINTMENT or DERMATOP EMOLLIENT CREAM for a long time may cause thinning of the skin or stretchmarks. If you notice your skin thinning, tell your healthcare professional.
- Use with Condoms: DERMATOP OINTMENT and DERMATOP EMOLLIENT CREAM contain paraffin, which can cause leaking or breaking of latex condoms. Contact between this medicine and latex condoms must be avoided.
- Vision Problems: If you experience symptoms such as increased eye pressure, blurred vision or other visual disturbances, tell your healthcare professional. Corticosteroids, like DERMATOP OINTMENT and DERMATOP EMOLLIENT CREAM can cause eye problems.
- Allergic Contact Dermatitis: You may develop contact dermatitis (allergic skin reaction) while using DERMATOP OINTMENT and DERMATOP EMOLLIENT CREAM. Tell your healthcare professional if your skin condition is not healing or gets worse.
Immunosuppression: DERMATOP OINTMENT and DERMATOP EMOLLIENT CREAM can suppress your immune system. This may:
- hide symptoms of infections
- reactivate dormant infections
- cause infections due to lowered body resistance
Tell your healthcare professional if you suspect an infection has occurred while you are using DERMATOP OINTMENT or DERMATOP EMOLLIENT CREAM.
Children (less than 18 years of age):
- DERMATOP OINTMENT is not for use in children
- Children may experience a decrease in the speed of their growth. Their healthcare professional will prescribe the lowest dose of DERMATOP EMOLLIENT CREAM to minimize this risk.
- The healthcare professional will conduct frequent tests on the child if they are using DERMATOP EMOLLIENT CREAM for a long period of time. Using corticosteroids for a long period of time increases the risk of developing a high intracranial pressure (growing pressure in the skull).
- DERMATOP EMOLLIENT CREAM is not to be used to treat diaper rash. It should not be applied to the diaper area of children that wear diapers or plastic pants.
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 DERMATOP OINTMENT and DERMATOP EMOLLIENT CREAM:
- It is NOT known whether DERMATOP OINTMENT or DERMATOP EMOLLIENT CREAM interact with other medication.
Some medicines may affect how DERMATOP OINTMENT or DERMATOP EMOLLIENT CREAM work and may make it more likely that you will have side effects:
- ritonavir (used for HIV infection).
- itraconazole (used for fungal infections).
How to use DERMATOP OINTMENT and DERMATOP EMOLLIENT CREAM:
- DERMATOP OINTMENT and DERMATOP EMOLLIENT CREAM are 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 healthcare professional has told you.
- DERMATOP OINTMENT and DERMATOP EMOLLIENT CREAM are for external use only. Do not take it by mouth. Do not put this medicine on the face, underarms, or groin areas unless your healthcare professional has told you to do so.
- Do not use DERMATOP OINTMENT or DERMATOP EMOLLIENT CREAM on or near the eyes or eyelids. If you get DERMATOP OINTMENT or DERMATOP EMOLLIENT CREAM 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.
- Tell your healthcare professional if your skin condition gets worse or there is no improvement within one week.
- You should not use DERMATOP OINTMENT or DERMATOP EMOLLIENT CREAM for longer than 2 weeks.
Usual dose
Adults (18 years of age and older):
- Apply a small amount of DERMATOP OINTMENT or DERMATOP EMOLLIENT CREAM to affected areas of skin twice daily.
- Rub in gently and completely.
Children (1 year of age to 18 years of age):
- Apply a small amount DERMATOP EMOLLIENT CREAM 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 DERMATOP OINTMENT or DERMATOP EMOLLIENT CREAM, 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 DERMATOP OINTMENT and DERMATOP
EMOLLIENT CREAM?
These are not all the possible side effects you may have when taking DERMATOP OINTMENT or DERMATOP EMOLLIENT CREAM. If you experience any side effects not listed here, tell your healthcare professional.
Side effects may include:
- redness, rash, tears or scrapes
- peeling and oozing of the skin
- itching of the skin
- irritation, swelling
- dryness, scaling or cracking of the skin
- inflamed hair follicles (folliculitis)
- excessive hair growth over the body
- acne
- change in skin pigmentation
- the skin may feel soft, wet or soggy to touch
- spider veins
- heat rash
- blurred vision
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 | ||
| COMMON | |||
| Allergic reaction: rash, hives, swelling of the skin, face, lips, | 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 | ||
|---|---|---|---|
| tongue or throat, difficulty swallowing or breathing | |||
| Cushing's syndrome (high levels of cortisol in the blood): rounded “moon” face, weight gain, pink or purple stretch marks on the skin, fragile skin that bruises easily, slow healing of cuts, severe fatigue, muscle weakness, headache | X | ||
| Adrenal suppression (low levels of cortisol in the blood): worsening fatigue and muscle weakness, loss of appetite, weight loss, nausea, vomiting, diarrhea | X | ||
| Glucosuria (glucose in 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 glucose in the blood): 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 | ||
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 | ||
|---|---|---|---|
| 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 | ||
| 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 | ||
| High blood pressure: headaches or feeling unwell | X | ||
| Pustular form of psoriasis: clearly defined, raised bumps that are filled with a white, thick fluid | X | ||
| Infections: raised temperature and feeling unwell | 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 DERMATOP OINTMENT and DERMATOP EMOLLIENT CREAM:
- 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