Patient Medication Information: uses, side effects, how to take - Taro-Clotrimazole/Betamethasone Dipropionate
What is TARO-CLOTRIMAZOLE/BETAMETHASONE DIPROPIONATE used for?
TARO-CLOTRIMAZOLE/BETAMETHASONE DIPROPIONATE is used to treat the following skin infections caused by a fungus:
athlete’s foot (tinea pedis)
jock itch (tinea cruris)
ringworm (tinea corporis)
How does TARO-CLOTRIMAZOLE/BETAMETHASONE DIPROPIONATE work?
TARO-CLOTRIMAZOLE/BETAMETHASONE DIPROPIONATE contains two medicines, betamethasone dipropionate and clotrimazole.
Clotrimazole interferes with the growth of the fungus that is causing your skin problem. Betamethasone dipropionate reduces the swelling, redness and itching of your skin.
What are the ingredients in TARO-CLOTRIMAZOLE/BETAMETHASONE DIPROPIONATE?
Medicinal ingredients: betamethasone dipropionate and clotrimazole
Non-medicinal ingredients: purified water, cetostearyl alcohol, white petrolatum, mineral oil, cetomacrogol 1000, phosphoric acid, monobasic sodium phosphate, propylene glycol, benzyl alcohol as preservative and sodium hydroxide to adjust the pH.
TARO-CLOTRIMAZOLE/BETAMETHASONE DIPROPIONATE comes in the following dosage forms:
As a cream containing 0.05 % betamethasone dipropionate and 1.0 % clotrimazole.
Do not use TARO-CLOTRIMAZOLE/BETAMETHASONE DIPROPIONATE if you:
are allergic to betamethasone dipropionate or clotrimazole
are allergic to any of the other ingredients in TARO-CLOTRIMAZOLE/BETAMETHASONE DIPROPIONATE or to a component of the container
are allergic to a medicine similar to that in TARO-CLOTRIMAZOLE/BETAMETHASONE DIPROPIONATE called a corticosteroid or an imidazole
have any untreated skin infection
have certain viral diseases such as herpes simplex, chicken pox or vaccinia
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take TARO-CLOTRIMAZOLE/BETAMETHASONE DIPROPIONATE. Talk about any health conditions or problems you may have, including if you:
are pregnant or planning on becoming pregnant. It is not known if TARO-CLOTRIMAZOLE/BETAMETHASONE DIPROPIONATE can harm your unborn baby. Your health care professional will decide whether giving you TARO-CLOTRIMAZOLE/BETAMETHASONE DIPROPIONATE outweighs the potential risk to the unborn baby.
are breastfeeding or planning to breastfeed. It is not known whether TARO-CLOTRIMAZOLE/BETAMETHASONE DIPROPIONATE can pass into your breastmilk. Your healthcare professional will decide whether you should stop breastfeeding or stop the use of TARO-CLOTRIMAZOLE/BETAMETHASONE DIPROPIONATE.
have diseases of your skin that are caused by poor blood flow. An example is a disease called stasis dermatitis.
Other warnings you should know about:
Use in children:
It is not known if TARO-CLOTRIMAZOLE/BETAMETHASONE DIPROPIONATE is safe and effective in children less than 12 years of age. Use of TARO-CLOTRIMAZOLE/ BETAMETHASONE DIPROPIONATE in children should be limited. Long-term use of this medicine may affect your child’s hormones. This may affect your child’s growth and development. TARO-CLOTRIMAZOLE/BETAMETHASONE DIPROPIONATE cream should not be used to treat diaper rash or redness. You should avoid applying TARO-CLOTRIMAZOLE/BETAMETHASONE DIPROPIONATE cream in the diaper area of a child.
Eyes:
Do not use TARO-CLOTRIMAZOLE/BETAMETHASONE DIPROPIONATE in or near your eyes. Talk to your healthcare professional if you develop blurred vision or other eye problems while using TARO-CLOTRIMAZOLE/BETAMETHASONE DIPROPIONATE.
Skin:
Do not use too much TARO-CLOTRIMAZOLE/BETAMETHASONE DIPROPIONATE on large areas of your body. Talk to your healthcare professional if you develop sensitive skin or irritation, extremely dry skin, scaling or flaking of your skin or stretch marks (striae). These symptoms may happen if you use TARO-CLOTRIMAZOLE/BETAMETHASONE DIPROPIONATE for a long time. Your healthcare professional may need to stop your treatment.
Use of too much TARO-CLOTRIMAZOLE/BETAMETHASONE DIPROPIONATE on large areas of the skin or for too long may lead to serious problems. These include changes in your hormone levels, Cushing’s disease, a condition where your body produces too much cortisol and changes in your sugar levels. You should not use too much TARO-CLOTRIMAZOLE/ BETAMETHASONE DIPROPIONATE on large areas of your skin. Talk to your healthcare professional if you are not sure how to safely apply TARO-CLOTRIMAZOLE/ BETAMETHASONE DIPROPIONATE.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
How to take TARO-CLOTRIMAZOLE/BETAMETHASONE DIPROPIONATE:
Follow all instructions given to you by your healthcare professional.
Apply a thin layer to the affected and surrounding skin area.
Make sure the cream covers the entire affected area.
Do not cover the treated areas with a bandage, plaster or wrap of any kind. This can
lead to serious side effects.
The use of TARO-CLOTRIMAZOLE/BETAMETHASONE DIPROPIONATE for longer than four weeks is not recommended.
Usual dose:
TARO-CLOTRIMAZOLE/BETAMETHASONE DIPROPIONATE should be applied twice a day, in the morning and at night. It is usually applied for two weeks for jock itch (tinea cruris) and ring worm (tinea corporis). It is usually applied for four weeks for athlete’s foot (tinea pedis). Your healthcare professional will tell you exactly for how long you should use TARO-CLOTRIMAZOLE/BETAMETHASONE DIPROPIONATE. It is not recommended that TARO-CLOTRIMAZOLE/BETAMETHASONE DIPROPIONATE be used for longer than four weeks.
Overdose:
If you think you have applied too much TARO-CLOTRIMAZOLE/BETAMETHASONE DIPROPIONATE, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.
Missed dose
If you miss a dose, apply it as soon as possible. However, if it is almost time for the next dose, skip the missed dose and go back to the regular dosing schedule. Do not apply a double dose to make up for a missed dose.
What are possible side effects from using TARO-CLOTRIMAZOLE/BETAMETHASONE
DIPROPIONATE?
These are not all the possible side effects you may feel when using TARO-CLOTRIMAZOLE/ BETAMETHASONE DIPROPIONATE. If you experience any side effects not listed here, contact your healthcare professional.
Side effects may include the following:
Burning, itching, irritation, dryness, blistering, stinging, redness or swelling of the skin
New skin infection
Thinning of the skin
Swelling of the hair follicles
Excessive hair growth
Acne outbreaks that result in redness and blushing
Patches of lighter skin tone
Skin redness around the mouth
Rash
Stretch marks (striae)
Peeling of the skin
Hives
General skin irritation
A feeling of tingling or of pins and needles on your skin (paresthesia)
Blurred vision
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health
Canada by:
Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
Calling toll-free at 1-866-234-2345.
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°C and 30°C.
Keep out of reach and sight of children.
If you want more information about TARO-CLOTRIMAZOLE/BETAMETHASONE DIPROPIONATE:
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://health-products.canada.ca/dpd-bdpp/index-eng.jsp); the manufacturer’s website www.taro.ca, or by calling 1-800-268-1975.
Taro Pharmaceuticals Inc.
130 East Drive
Brampton, Ontario L6T 1C1
TARO is a registered trademark of Taro Pharmaceuticals Inc.