Patient Medication Information: uses, side effects, how to take - Stieva-A Cream
What the medication is used for:
STIEVA-A® topical cream is used in the treatment of acne. STIEVA-A® is not effective in most cases of severe acne.
STIEVA-A® topical cream is not for use in children under 12 years of age or in adults over 65 years of age.
What it does:
STIEVA-A® topical cream is believed to accelerate skin growth and turn-over of cells and increase the flow of cellular debris such as dead skin cells and oils to the surface for elimination, thereby helping to reduce the acne condition.
When it should not be used:
Do not use STIEVA-A® topical cream if you are allergic to tretinoin, retinoids, or to any of the other ingredients of STIEVA-A® topical cream (see What the nonmedical ingredients are).
What the medicinal ingredients are:
STIEVA-A® topical cream contains 0.01%, 0.025%, 0.05%, or 0.1% (Forte) w/w tretinoin.
What the nonmedicinal ingredients are:
STIEVA-A® topical cream contains polyoxyl stearate, stearyl alcohol, stearic acid, isopropyl palmitate, white petrolatum, butylated hydroxytoluene, butylated hydroxyanisole, propylparaben, methylparaben, edetate disodium, propylene glycol, and purified water; and titanium dioxide in the STIEVA-A® 0.1% (Forte) cream.
What dosage forms it comes in:
STIEVA-A® topical cream is available in strengths of 0.01%, 0.025%, 0.05%, or 0.1% (Forte).
WARNINGS AND PRECAUTIONS
BEFORE you use STIEVA-A® topical cream, talk to your doctor or pharmacist if:
- You are currently or about to start using any other acne or skin medications.
- You have had a previous reaction to any other acne or skin medication.
You have a family history of skin cancer.
- You have any other skin condition, such as eczema any inflammatory skin condition, photoallergy, sensitive skin, or a fair complexion.
- You have any ongoing skin irritation. This irritation should be resolved before starting treatment with STIEVA-A®.
You are pregnant or planning to become pregnant. Topical tretinoin should not be used by pregnant women as rare birth defects have been reported with the use of topical tretinoin. It is not known if the birth defects were caused by topical tretinoin.
- You are breastfeeding or planning to breastfeed.
- You cannot avoid extensive exposure to sunlight, e.g., due to work requirements.
If you are a female of childbearing age, you should only use STIEVA-A® topical cream after consulting your doctor and seeking his/her advice for contraceptive counselling. If you are pregnant or nursing a child, you should discontinue the use of STIEVA-A® topical cream and consult your doctor. There is no information on how STIEVA-A® might affect fertility.
STIEVA-A® topical cream is for external use only. If you accidentally get STIEVA-A® on irritated skin, in the eyes, mouth, or lips, rinse the affected area immediately with plenty of water.
Avoid or minimize exposure to sunlight and sun lamps because STIEVA-A® topical cream heightens the susceptibility of your skin to the adverse effects of the sun. Use of a broad spectrum sunscreen with a sun protection factor (SPF) of at least 15 and protective clothing over treated areas is recommended when exposure cannot be avoided. If you have a sunburn, allow the sunburn to settle before starting treatment with STIEVA-A®. If sunburn occurs while using STIEVA-A®, stop using STIEVA-A® and call your doctor for advice.
Extreme weather (e.g. cold or wind) may irritate your skin, avoid or minimize exposure.
Stop treatment and see your doctor if skin irritation is severe (severe redness, dryness, itching, stinging or burning) or your acne does not improve.
INTERACTIONS WITH THIS MEDICATION
Some medicines, skin procedures, or cosmetic products may affect how STIEVA-A® topical cream works and may make it more likely that you will have side effects. Some of these may include:
- Other acne or skin preparations including peeling agents (e.g. sulfur, resorcinol, salicylic acid). If irritation or dermatitis (redness, peeling, or
- discomfort) occurs, reduce the number of times you apply STIEVA-A® or temporarily stop using STIEVA-A®. Start using STIEVA-A® again when the irritation goes away.
- Drugs that make you more sensitive to light (e.g. thiazides, tetracycline, fluoroquinolones, phenothiazines, sulphonamides).
- Drugs that contain benzoyl peroxide.
- Skin procedures such as depilation, chemical hair treatments, chemical peels, dermabrasion or laser resurfacing. Following these procedures, allow skin to recover before starting treatment with STIEVA-A®.
Cosmetics or skin products that have a strong drying effect (e.g., products with a high alcohol content, astringents, skin drying agents, after shave lotions) as they may irritate your skin. It is best to use only water-based cosmetics.
- Cosmetic products that have a potential irritating effect (e.g., abrasive agents, products containing spices or limes).
Tell your doctor or pharmacist about all your other medications, including those you can buy without a prescription as well as herbal and alternative medications.
PROPER USE OF THIS MEDICATION
STIEVA-A® topical cream should only be applied to your skin.
If your doctor recommends (prescribes) another topical acne product, this should be applied at a different time of day as STIEVA-A® topical cream.
Do not apply STIEVA-A® to areas of skin where you have problems such as eczema, severely inflamed skin or other open lesions.
Do not use on sensitive areas such as irritated skin, eyes, mouth, lips, angles of nose, and corners of eyes and mouth and mucous producing areas.
How to Apply STIEVA-A® Topical Cream:
- 1. Wash your hands thoroughly before applying STIEVA-A®.
- 2. Completely remove any make-up.
- 3. Wash affected area gently with warm water and a mild, non-irritating soap or cleanser, and pat dry.
- 4. Apply STIEVA-A® sparingly and evenly once daily, preferably before bedtime. Use your finger-tip to apply enough to cover the required area, and smooth in. Allow your skin to dry fully before applying cosmetics.
- 5.
Wash your hands thoroughly after applying STIEVA-A®.
- 6. In the morning, wash your face gently using a mild, non-irritating soap or cleanser.
At the beginning, you may experience redness, a burning sensation, peeling, or possibly a worsening of your acne while your skin adjusts to the medication.
Your doctor may recommend a daytime moisturizer if your skin is particularly dry.
To minimize these reactions, your doctor may start you on the mildest strength of STIEVA-A® and go up gradually until you reach the strength that your doctor feels is most suitable for your skin type. Your doctor may advise you to apply the STIEVA-A® less frequently than every day.
It takes several weeks of regular use of STIEVA-A® before you can expect noticeable improvement and 8-10 weeks for optimal results, so be patient. Treat your acne with STIEVA-A® for as long as your doctor tells you.
Applying too much or applying it more frequently will not help your skin clear up more quickly, and may cause skin irritation.
It is important to understand that your doctor has given you a prescription specially suited to your particular needs and skin type. Do not allow others to use it. Always use STIEVA-A® exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Overdose:
| In case of drug overdose, contact your healthcare professional, hospital emergency department, or regional Poison Control Centre immediately, even if there are no symptoms. |
If you accidentally swallow STIEVA-A®, seek medical advice.
Missed Dose:
If you forget to apply STIEVA-A® topical cream at your regular time, apply STIEVA-A® at the next usual time. Do not apply more than once a day to make up for forgotten applications.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
During the first weeks of using STIEVA-A®, you may notice some skin irritation such as redness and skin flaking. These symptoms will normally subside if you use STIEVA-A® less often or stop using it for a few days and then start again.
Other side effects that have been reported are: skin pain, itching/itchy skin, skin irritation, tenderness, warm skin, especially when first applied, stinging or burning sensation, dry skin, swelling at the site of application, rash at the site of application, redness at the site of application, skin blistering, skin crusting, allergic reaction, darkening of skin, lightening of skin, sensitivity to sunlight and skin thinning. Talk to your doctor if any of the side effects become severe or troublesome.
Severe skin reactions (severe burning, peeling or itching of your skin) have also been reported. Stop taking STIEVA-A® and contact your doctor immediately if you get any of these symptoms.
| 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 | |
| Rare | ||
| Allergic reaction: difficulty breathing or swallowing caused by sudden swelling of the throat, face, lips or mouth or notice sudden swelling of hands, feet and ankles, or an itchy rash (hives) | ||
| ✓ | ||
This is not a complete list of side effects. For any unexpected effects while taking STIEVA-A® topical cream, contact your doctor or pharmacist.
HOW TO STORE IT
Store between 15°C and 30°C. Do not freeze. Keep the tube tightly closed when not in use. Keep out of the sight and reach of children.
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: --------------------------------------------------------------------------
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 7, 2015
© 2015 GlaxoSmithKline Inc. All Rights Reserved
STIEVA-A is a registered trademark of GlaxoSmithKline Inc.