"Some cryogenic wart removers—which remove warts from the skin by freezing them off—have caught fire during use at home, harming consumers or setting fire to items around the house.
Since 2009, the Food and Drug Administratio"...
clindamycin solution in pledget 1% w/v (as clindamycin phosphate)
This leaflet is designed specifically for consumers. This leaflet is a summary and will not tell you everything about CLINDETS®. Contact your doctor or pharmacist if you have any questions about the drug.
ABOUT THIS MEDICATION
What the medication is used for:
CLINDETS® is a prescription medication used on the skin to treat moderate acne in adults and adolescents 13 years and older. The safety and effectiveness of CLINDETS® in children under the age of 13 are not known.
What it does:
CLINDETS® contains the active ingredient clindamycin, which interferes with bacterial growth, thereby reducing the bacteria associated with acne. This is how CLINDETS® helps to improve your acne condition.
When it should not be used:
Do not use CLINDETS® if you currently have or have had a history of:
- An allergy (hypersensitivity) to clindamycin, lincomycin or any of the other ingredients in CLINDETS® (see What the important nonmedicinal ingredients are).
- Inflammation of the small intestine (regional enteritis).
- Inflammation of the large intestine (colitis), which may be due to the presence of ulcers (ulcerative colitis) or associated with the use of antibiotics.
- Inflammatory bowel disease or antibiotic-associated colitis (severe, prolonged or bloody diarrhea following antibiotic use).
What the medicinal ingredient is:
Clindamycin as clindamycin phosphate USP.
What the important nonmedicinal ingredients are:
Isopropyl alcohol, propylene glycol and purified water.
What dosage forms it comes in:
Topical medicated pads.
WARNINGS AND PRECAUTIONS
CLINDETS® is for external use only.
Keep CLINDETS® away from your eyes, inside the nose, mouth, lips, other mucous membranes or areas of broken skin. If contact occurs, flush areas with large amounts of cool tap water for at least 5 minutes. If discomfort persists, consult your doctor.
Do not use any other acne medications, or other topical medications, unless your doctor instructs you to do so.
If you have recently taken or used other clindamycin or erythromycin-containing medicines, there is an increased chance that CLINDETS® will not work as well as it should.
BEFORE you use CLINDETS® talk to your doctor or pharmacist if you:
- Are pregnant or planning to become pregnant. If you are pregnant, or think you could be, or if you are planning to become pregnant, do not take CLINDETS® without checking with your doctor.
- Are breast-feeding or plan to breast-feed. It is not known whether the ingredients of CLINDETS® can pass into breast milk. If you are breastfeeding, check with your doctor before you use CLINDETS®. If used during breast-feeding, do not apply CLINDETS® to the breast area to avoid accidental ingestion by the infant.
During the first weeks of treatment, you may experience peeling and reddening. These symptoms will normally subside if treatment is temporarily interrupted and restarted after your symptoms have settled.
Avoid alcohol based solutions (e.g., after shave lotions) as they have a drying effect and may irritate your skin.
FLAMMABLE: Due to the flammable nature of CLINDETS®, you should avoid smoking or being near an open flame while you are applying CLINDETS®, and immediately after you have used it.
INTERACTIONS WITH THIS MEDICATION
Know the medicines you take. Keep a list of them and tell your doctor / pharmacist about all the medicines and skin products you use.
Tell your doctor especially if you are taking or using any of the following medicines:
- Neuromuscular blocking agents (medicines used as muscle relaxants when you are given an anaesthetic) – as CLINDETS® has been shown to increase their activity.
- Erythromycin – as it should not be used at the same time as CLINDETS®.
- Other acne or skin preparations including peeling agents (e.g., sulfur, resorcinol, salicylic acid) and abrasive agents as concomitant use with CLINDETS® may increase side effects such as skin irritation.
PROPER USE OF THIS MEDICATION
CLINDETS® should only be applied to your skin.
CLINDETS® should be used for the entire treatment period as instructed by your doctor even if your acne symptoms begin improving after a few days. Stopping your treatment too soon may result in the return of your acne condition.
Do not expect to see immediate improvement of your acne. Be patient and apply your medication as your doctor has directed. Six to eight weeks may be required before improvement is seen. If you do not see improvement after using CLINDETS® for 6-8 weeks, or if your acne becomes worse, contact your doctor.
CLINDETS® consists of a small pad which is medicated with a 1% concentration of clindamycin. The pad also contains alcohol and is enclosed within an aluminum foil, which you must open just before use.
Instructions for applying CLINDETS®:
- CLINDETS® contains alcohol. Wait 30 minutes after shaving before applying CLINDETS® as the alcohol may irritate freshly shaving skin.
- Before you apply CLINDETS®, wash the affected skin gently with a mild, non-irritating cleanser, rinse with warm water, and pat dry.
- Gently apply CLINDETS® to lightly cover the entire affected area of your skin (face) with a thin layer. Avoid eyes, nostrils, mouth, lips, other mucous membranes or areas of broken skin.
- Wash your hands with soap and water after applying CLINDETS®.
- Discard CLINDETS® after use. Do not use if the seal is broken.
- Apply CLINDETS® in the morning and at night or as directed by your doctor.
Remember: CLINDETS® has been prescribed by your doctor for you alone; do not allow other people to use it, even if they have the same condition that you have, as it may not be suitable for them.
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.
If you apply too much CLINDETS®, wash carefully off and seek medical advice.
If you do accidentally swallow CLINDETS®, rinse your mouth immediately with water and seek medical advice. You may get symptoms similar to when you take antibiotics by mouth (an upset stomach).
This product contains a significant amount of isopropyl alcohol and should be considered in case of accidental oral ingestion.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
During the first weeks of using CLINDETS®, you may notice some skin irritation such as rash (including redness, small red bumps), dryness, itching, oiliness, swelling, irritation, stinging, tingling or numbness, burning or peeling. These symptoms will normally subside if treatment is temporarily interrupted and restarted after your symptoms have settled.
Other side effects that have been reported include headache diarrhea and nausea.
If you experience symptoms such as severe diarrhea (bloody or watery) with or without fever, abdominal pain, or tenderness, you may have Clostridium difficile colitis (bowel inflammation). If this occurs, stop taking CLINDETS® and contact a healthcare professional immediately.
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||Severe allergic reaction: raised and itchy rash (hives), swelling of face or lips, causing difficulty in breathing.|
|Rare||Inflammation of intestines, colitis: abdominal or stomach cramps, severe pain, bloating, severe or prolonged watery diarrhea which may be bloody, nausea or vomiting.|
HOW TO STORE IT
Store between 15°C and 25°C. Do not freeze. Contents are flammable. Keep CLINDETS® away from all sources of fire, flame and heat. Do not leave CLINDETS® in direct sunlight. Keep your medicine in a safe place, 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:
$ 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
Postal Locator 0701E
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.
Last reviewed on RxList: 8/16/2016
This monograph has been modified to include the generic and brand name in many instances.
Additional Clindets Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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