Patient Medication Information: uses, side effects, how to take - Stievamycin Regular
What the medication is used for:
STIEVAMYCIN® topical gel is used in the treatment of acne. STIEVAMYCIN® is not effective in most cases of severe acne.
STIEVAMYCIN® topical gel is not for use in children under 12 years of age or in adults over 65 years of age.
What it does:
STIEVAMYCIN® topical gel 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.
The erythromycin component results in a more rapid reduction of the inflammatory lesions of your acne and reduces the burning sensation which may be felt when using tretinoin alone.
When it should not be used:
Do not use STIEVAMYCIN® topical gel if you are allergic to tretinoin, retinoids, erythromycin or to any of the other ingredients of STIEVAMYCIN® topical gel (see What the important nonmedical ingredients are).
What the medicinal ingredients are:
STIEVAMYCIN® Mild topical gel contains 0.01% w/w tretinoin and 4% w/w erythromycin.
STIEVAMYCIN® Regular topical gel contains 0.025% w/w tretinoin and 4% w/w erythromycin.
STIEVAMYCIN® Forte topical gel contains 0.05% w/w tretinoin and 4% w/w erythromycin.
What the important nonmedicinal ingredients are:
STIEVAMYCIN® topical gel contains butylated hydroxytoluene, ethyl alcohol, and hydroxypropyl cellulose.
What dosage forms it comes in:
STIEVAMYCIN® topical gel, tretinoin 0.01, 0.025. 0.05% w/w and erythromycin 4% w/w.
WARNINGS AND PRECAUTIONS
BEFORE you use STIEVAMYCIN® topical gel, 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 recently taken or used other medications on the skin that contain erythromycin or clindamycin.
- 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 STIEVAMYCIN® topical gel.
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 experience symptoms such as severe diarrhea (bloody or watery) with or without fever, stomach cramps, abdominal pain, or tenderness, you may have Clostridium difficile colitis (bowel inflammation). If this occurs, stop taking STIEVAMYCIN® topical gel and contact your healthcare professional immediately.
STIEVAMYCIN® topical gel is for external use only. If you accidentally get STIEVAMYCIN® topical gel 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 STIEVAMYCIN® topical gel heightens the susceptibility of your skin to the adverse effects of the sun. Use 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 STIEVAMYCIN®. If sunburn occurs while using STIEVAMYCIN®, stop using STIEVAMYCIN® topical gel and call your doctor for advice.
Extreme weather (e.g. cold or wind) may irritate your skin.
Stop treatment and see your doctor if skin irritation is severe (severe redness, dryness, itching, stinging or burning) or does not improve.
FLAMMABLE: This product is flammable. Avoid smoking or being near an open flame, during and immediately after application of STIEVAMYCIN® topical gel.
If you are a female of childbearing age, you should only use STIEVAMYCIN® topical gel after consulting your doctor and seeking his/her advice for contraceptive counselling. If you are pregnant, you should discontinue the use of STIEVAMYCIN® topical gel and consult your doctor.
INTERACTIONS WITH THIS MEDICATION
Some medicines, skin procedures, or cosmetic products may affect how STIEVAMYCIN® topical gel works and may make it more likely that you will have side effects. Some of these may include:
- Clindamycin-containing products.
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 STIEVAMYCIN® or temporarily stop using STIEVAMYCIN®. Start using STIEVAMYCIN® 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. If
combination therapy of benzoyl peroxide and STIEVAMYCIN® is required, the products should be applied at different times of the day (e.g. one in the morning and the other in the evening).
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 STIEVAMYCIN®.
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.
Drug interaction studies have not been done for STIEVAMYCIN® topical gel.
PROPER USE OF THIS MEDICATION
STIEVAMYCIN® topical gel 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 STIEVAMYCIN® topical gel.
Do not apply STIEVAMYCIN® topical gel 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 STIEVAMYCIN® Topical Cream:
- 1.
Wash your hands thoroughly before applying
STIEVAMYCIN®.
- 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 STIEVAMYCIN® topical gel 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, if required.
- 5.
Wash your hands thoroughly after applying
STIEVAMYCIN® topical gel.
- 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 STIEVAMYCIN® topical gel 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 STIEVAMYCIN® topical gel less frequently than every day.
Since STIEVAMYCIN® topical gel works from beneath the skin's surface, it takes several weeks of regular use before you can expect noticeable improvement and 8-10 weeks for optimal results.
Always use STIEVAMYCIN® topical gel exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Applying too much or applying it more frequently will not help your skin clear up more quickly, and may cause skin irritation.
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.
This product contains a significant amount of ethanol (alcohol) and should be considered in case of accidental oral ingestion.
Missed Dose:
If you forget to apply STIEVAMYCIN® topical gel at your regular time, apply STIEVAMYCIN® topical gel at the next usual time. Do not apply more than once to make up for forgotten applications.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Like all medications, STIEVAMYCIN® topical gel can cause side effects, but not everybody gets them.
Side effects may include: skin burning sensation, skin peeling, skin redness, itchy skin, irritation, stomach pain, diarrhea, increased sensitivity of the skin to light, dry skin, skin rash, skin thinning, skin discolouration, application site pain, facial swelling.
| 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 STIEVAMYCIN® topical gel, contact your doctor or pharmacist.
HOW TO STORE IT
St
ore between 15°C and 25°C. Do not freeze. Keep the tube tightly closed when not in use. Keep out of reach and sight of children.
STIEVAMYCIN® topical gel has been prescribed for your use only. Do not allow others to use it.
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:
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- 1.
Report online at
www.healthcanada.gc.ca/medeffect
- 2. Call toll-free at 1-866-234-2345
- 3.
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: July 22, 2014
© 2014 GlaxoSmithKline Inc. All Rights Reserved ®STIEVAMYCIN is a registered trade-mark owned by GlaxoSmithKline Inc.