Patient Medication Information: uses, side effects, how to take - Cutivate
ABOUT THIS MEDICATION
What CUTIVATE® is used for:
CUTIVATE® is used to help relieve the redness and itchiness of certain skin problems in patients over 12 years of age.
What it does:
CUTIVATE® contains fluticasone propionate which belongs to a group of medicines called steroids. Steroids help to reduce the redness, swelling and itchiness of the skin .
“Topical steroids” mean they are put on the skin (and should not be confused with “anabolic steroids” which are taken as tablets or injections, and misused by some body builders).
When it should not be used:
Do not use CUTIVATE® if you are allergic to fluticasone propionate, other corticosteroids, or to any of the other ingredients in CUTIVATE® (see What the nonmedical ingredients are).
Do not use this cream for the following skin problems as it could make them worse, especially:
- Acne.
Bacterial, fungal, viral skin infections (e.g., herpes
simplex, chicken pox), tuberculosis skin infections, or a skin reaction following a recent vaccination.
- Itchiness of the skin which is not inflamed.
- Around the anus / genitals.
- Do not apply in or near the eye.
Rosacea (a facial skin condition where the nose,
cheeks, chin, forehead or entire face are unusually red, with or without tiny visible blood vessels, bumps (papules) or pus-filled bumps (pustules)).
- Dermatitis (rashes) around the mouth.
What the medicinal ingredient is:
Fluticasone propionate
What the nonmedicinal ingredients are:
Imidurea as a preservative. Your body can break down imidurea into formaldehyde that may cause redness and itchiness (see WARNINGS AND PRECAUTIONS).
Other nonmedicinal ingredients include propylene glycol, mineral oil, cetostearyl alcohol, polyoxyl 20 cetostearyl ether, isopropyl myristate, dibasic sodium phosphate, citric acid and purified water.
What dosage forms it comes in:
Cream, 0.05%
WARNINGS AND PRECAUTIONS
BEFORE you use CUTIVATE® talk to your doctor or pharmacist if:
- You ever had to stop using a similar medicine because you were allergic to it or it caused problems.
- You have been told that you are allergic to formaldehyde.
- You have any skin disease around a leg ulcer, use of a topical corticosteroid may increase the risk of an allergic reaction or an infection around the ulcer.
- You have other inflammatory skin diseases in the leg as a result of impaired circulation (stasis dermatitis).
You are pregnant, think you could be pregnant, planning to become pregnant or breastfeeding a baby. If you do use CUTIVATE® when breastfeeding, do not apply CUTIVATE® on your breasts to ensure that the baby does not accidentally get CUTIVATE® in their mouth.
- You have problems with your kidney or liver.
If you are over 65 years of age, use CUTIVATE® with caution.
Only use CUTIVATE® for as long as your doctor recommends. If your condition does not improve within 2 to 4 weeks of treatment, speak to your doctor.
Do not use airtight dressings on treated areas of the skin.
Topical corticosteroids, when used over large areas, on sensitive areas such as the face, in skin-fold areas like the armpit and groin or broken skin, for prolonged periods, are more likely to be absorbed into the bloodstream and cause side effects.
CUTIVATE® should not be used on the face, or in skin fold areas, such as the groin or the armpit.
Avoid getting CUTIVATE® in the eye, or on other mucous membranes.
INTERACTIONS WITH THIS MEDICATION
Some drugs that may affect how CUTIVATE® works, or make it more likely that you will have side effects. Some of these medicines may include:
- Ritonavir (for HIV).
- Itraconazole (for fungal infections).
Tell your doctor or pharmacist about all your other medications, including medicines that you bought without a prescription and natural health products.
PROPER USE OF THIS MEDICATION
For topical use only and not for ophthalmic, oral or intravaginal use.
CUTIVATE® should not be used in children under the ages of 12 years old.
Unless used for treating hands, wash your hands again after using CUTIVATE®.
Allow time for CUTIVATE® to be absorbed before applying a moisturizer.
Usual dose:
Use CUTIVATE® as your doctor has prescribed for you. Check with your doctor or pharmacist if you are unsure how much or how often to use CUTIVATE®. Apply a thin layer once or twice a day (as your doctor has prescribed for you) and gently rub in, using only enough to cover the entire affected area.
You should not use CUTIVATE® more than you are told or over large body areas for a long time.
Overdose:
In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
Missed Dose:
Apply CUTIVATE® as soon as you remember, then continue as before. Do not apply extra CUTIVATE® to make up for missed doses.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Side effects will affect your skin and may affect other parts of your body if a sufficient amount of CUTIVATE® is absorbed through the skin and entered into your blood stream. Some side effects with CUTIVATE® may include:
Common: itching
Uncommon: local skin burning
If you experience local burning or itchiness, or your condition gets worse, there is no need to stop CUTIVATE®, but you should tell your doctor of any of these symptoms as soon as possible.
Side effects with the use of topical corticosteroid include:
- burning, itching, skin irritation, dryness, inflammation of hair follicles, abnormal hair growth
- stretch marks
- secondary infection, acne
- allergic contact dermatitis
- heat rash (miliaria)
- skin thinning, loss of skin color (hypopigmentation)
Serious side effects such as Cushing’s syndrome may be associated with systemic absorption of topical corticosteroids (for example, from long-term, improper or excessive use). Symptoms include: increased weight, moon face / rounding of the face and obesity. Also, look out for delayed weight gain and slow growth in children. Other symptoms that may only show in blood tests or when your doctor gives you a medical examination are: decreased hormone cortisol levels in your blood, increased sugar levels in your blood or urine, high blood pressure, cloudy lens in the eye (cataract), increased pressure in the eye (glaucoma), as well as weakening of the bones through gradual mineral loss (osteoporosis) and additional tests may be needed after
your medical examination to confirm whether you have osteoporosis.
If you have psoriasis, you may get raised bumps with pus under the skin. This can happen very rarely during or after treatment and is known as pustular psoriasis.
Patients should report any signs of local or systemic adverse reactions to their doctor.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | |||
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | |
| Only if severe | In all cases | ||
| Allergic reaction: wheeziness and tightness of chest, swelling of eyelids, face or lips, or develop skin lumps or hives or skin rash (e.g., red spots) | ✓ | ||
Cushing's syndrome: associated with systemic absorption of topical corticosteroids (for example, from long-term, improper or excessive use). | ✓ | ||
This is not a complete list of side effects. For any unexpected effects while taking CUTIVATE®, contact your doctor or pharmacist.
HOW TO STORE IT
Store between 2° and 30°C. Do not freeze. Keep out of reach of children.
If your doctor decides to stop the treatment, do not keep any leftover cream unless your doctor tells you to.
Remember: This medicine is for you. Only a doctor can prescribe it for you. Never give it to someone else. It may harm them even if their symptoms are the same as yours.
REPORTING SUSPECTED SIDE EFFECTS
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
Mail to: Canada Vigilance Program
Health Canada
Postal Locator 0701E Ottawa, Ontario K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at
www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals can be found at:
http://www.stiefel.ca or by contacting the sponsor,
GlaxoSmithKline Inc.
7333 Mississauga Road
Mississauga, Ontario
L5N 6L4
1-800-387-7374
Last revised: August 23, 2011
© 2011 GlaxoSmithKline Inc. All Rights Reserved. ® CUTIVATE is a registered trademark, used under license by GlaxoSmithKline Inc.