Details for: TARO-AMCINONIDE
Company: TARO PHARMACEUTICALS INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02246714 | TARO-AMCINONIDE | AMCINONIDE | 0.1 % | CREAM | TOPICAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
TARO-AMCINONIDE is used to help relieve the redness and itchiness of certain skin problems.
What it does
TARO-AMCINONIDE contains amcinonide which belongs to a group of medicines called steroids. Steroids help to reduce redness, swelling and irritation of the skin.
When it should not be used
Do not use TARO-AMCINONIDE if you are allergic to
amcinonide, other corticosteroids, or to any other ingredients
in TARO-AMCINONIDE (see What the nonmedicinal
ingredients are).
Do not apply TARO-AMCINONIDE on the areas of the
skin that have:
- bacterial, fungal, parasitic, viral skin infections (e.g. herpes simplex, chicken pox), tuberculosis or syphilis skin lesions, or a skin reaction following a recent vaccination.
- acne, 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)), rashes around the mouth, itchy skin which is not inflamed, itchy skin around the anus or genitals.
If you think any of these apply to you, don’t use TAROAMCINONIDE until you have checked with your doctor or pharmacist.
What the medicinal ingredient is
Amcinonide
What the non-medicinal ingredients are
The nonmedicinal ingredients of TARO-AMCINONIDE
Cream are benzyl alcohol, emulsifying wax, glycerin,
isopropyl palmitate, lactic acid, purified water, and sorbitol
solution.
The nonmedicinal ingredients of TARO-AMCINONIDE
Ointment are benzyl alcohol, emulsifying wax, Tenox 2
(butylated hydroxyanisole, citric acid, propyl gallate in
propylene glycol), and white petrolatum.
What dosage form it comes in
TARO-AMCINONIDE ointment is available in 15, 30, and 60 grams laminate tubes. TARO-AMCINONIDE cream is available in 15, 30, and 60 grams laminate tubes, and in 100 grams polypropylene jars.
Warnings and precautions
Apply just enough TARO-AMCINONIDE to cover the
affected areas. TARO-AMCINONIDE can get into the blood
and cause side effects.
Always follow your doctor’s instructions.
Do NOT use TARO-AMCINONIDE with occlusive
dressings such as a bandage, or cover the treated areas
tightly.
TARO-AMCINONIDE is more likely to cause side
effects when used:
- over large areas
- on sensitive areas such as the face, scalp, skin fold areas like the armpit and groin
- on broken skin for a long time
Before using TARO-AMCINONIDE, talk to your doctor or pharmacist if:
- you are pregnant or planning to become pregnant.
- you are breastfeeding. It is not known if TAROAMCINONIDE will appear in breast milk. You should only use TARO-AMCINONIDE while breastfeeding if you and your doctor decide that the benefits to the mother outweigh the risks to the baby. If you do use TARO-AMCINONIDE when breastfeeding, do not use on your breast area to ensure that the baby does not accidentally get it in their mouth. If TARO-AMCINONIDE is used on large areas of body, you should stop breastfeeding.
- you have inflammatory skin diseases in the leg as a result of impaired circulation (such as stasis dermatitis).
- you have problems with your kidney or liver. You may PROPER USE OF THIS MEDICATION Use the minimum quantity of TARO-AMCINONIDE for the need to use a smaller amount of TARO-AMCINONIDEor use it less often.
- 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 develop any skin infection
- you have an allergic reaction
- you develop significant skin irritation
- you experience skin thinning or softening
- your condition worsens or does not improve
- you develop raised bumps with pus under the skin
Avoid applying TARO-AMCINONIDE in or near the eye, or other mucous membranes. In case of contact, wash with water. Absorption in the body may cause increased pressure in the eye (glaucoma), or a cloudy lens in the eye (cataracts).
Children absorb larger amounts of topical corticosteroids and therefore, may be more likely to develop side effects. TAROAMCINONIDE is not recommended for use in children under 18 years of age.
Interactions with this medication
It is NOT known whether TARO-AMCINONIDE interacts with other medication. Some medicines may affect how TARO-AMCINONIDE works, or make it more likely that you’ll have side effects. Examples of these medicines include:
- Ritonavir (for HIV)
- Itraconazole (for fungal infections)
Treatment with TARO-AMCINONIDE in the genital or anal area with the simultaneous use of latex products (e.g. condoms, diaphragms) can result in reduction in the reliability and therefore impairment of the safety of these products.
Proper use of this medication
Use the minimum quantity of TARO-AMCINONIDE for the shortest amount of time necessary to achieve the desired
results. Thisis especially important if you are 65 years or
older or have liver or kidney disease.
Check with your doctor or pharmacist if you are not sure.
TARO-AMCINONIDE is for use on the skin only. It is NOT
for use in the eyes or on other mucous membranes.
Usual Dose
Apply a thin film to the affected areas once or twice a day.
The number of times you use your medicine may be reduced
as your skin gets better or your doctor may prescribe a
weaker steroid for you to use instead.
Use for a maximum of:
- 5 days on the face, scalp, skin-fold areas like the armpit and groin.
- 2-3 weeks on the body. If your condition worsens or no improvement is seen within 2 weeks, contact your doctor.
Use TARO-AMCINONIDE only as directed by your health care provider. Do NOT use more of it, do NOT use it more often and do NOT use it for a longer period of time than your health care provider recommended. Using too much TARO-AMCINONIDE may increase your chances of unwanted and sometimes dangerous side effects.
This medication has been prescribed specifically for you. Do NOT give it to anyone else. It may harm them, even if their symptoms seem to be similar to yours.
How to Apply TARO-AMCINONIDE:
- Apply a thin layer and gently rub in, using only enough to cover the entire affected area.
- Wash your hands after use unless treating the hands.
- Excess product should not be returned to the container, since it may cause contamination.
- If you are also using an emollient (moisturising) preparation allow time for TARO-AMCINONIDE to be absorbed after each application before applying the emollient.
- Your doctor may recommend using a moisturizer as maintenance therapy.
- Do not use occlusive dressings such as a bandage, or cover the treated areas tightly.
Overdose
Missed Dose
If you forget to use TARO-AMCINONIDE, apply it as soon as you remember. If it is close to the time scheduled to apply your next dose, wait and apply your next scheduled dose and then continue as before. Do not apply extra TAROAMCINONIDE to make up for missed doses.
Side effects and what to do about them
Like all medicines TARO-AMCINONIDE can have side
effects although not everybody gets them. Side effects will
affect your skin and may have an effect on other parts of your
body if a sufficient quantity of medicine is absorbed through
the skin and enters your blood stream.
If your skin condition gets worse or your skin becomes
swollen during treatment. You may be allergic to the
medicine or need other treatment. Stop using TAROAMCINONIDEand
tell your doctor as soon as possible.
The following side effects have been reported in patients
using topical corticosteroids:
Common side effects
- itchy skin
- local skin burning or pain
Use of TARO-AMCINONIDE for a long period of time, over a large body surface, or use under an airtight dressing, may cause the following symptoms:
- increased weight
- moon face/rounding of the face, obesity
- skin thinning (this may cause stretch marks), skin wrinkling, skin dryness, the appearance of blood vessels under the surface of your skin (telangiectasia), changes to the colour of your skin, skin infection
- increased body hair, hair loss/lack of hair growth/damaged looking hair
- allergic reaction, irritation, itching or pain at the site of application
- inflammation of hair follicles
- worsening of condition
- redness, rash or hives
- secondary infection
- allergic contact dermatitis/dermatitis(a type of eczema)
- upper abdominal pain
- prickly heat rash
- steroid withdrawal syndrome (symptoms may include weight loss, fatigue, nausea, diarrhea and abdominal pain)
- acne
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 any of the side effects listed becomes severe or troublesome, tell your doctor or pharmacist.
| Symptom / effect | Talk with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist in all cases | Stop taking drug and talk with your doctor or pharmacist |
|---|---|---|---|
| Allergic reactions: rash, hives, swelling of the skin, chills, fever, muscle aches or pains or flu-like symptoms occurring with or before a skin rash. | ✔ | ||
| Cushing's syndrome: weight gain, moon face / rounding of the face and obesity. | ✔ | ||
| Hyperglycemia (increased blood sugar): frequent urination, thirst and hunger. | ✔ | ||
| Glucosuria (sugar in urine): excessive or sweet smelling urine. | ✔ | ||
| Hypertension (high blood pressure): headaches, vision disorders, nausea and vomiting. | ✔ | ||
| Osteoporosis: weakening of the bones potentially leading to an increased risk of bone fracture. | ✔ | ||
| Glaucoma or cataracts: blurred vision, increased pressure in your eyes, eye pain | ✔ |
This is not a complete list of side effects. For any unexpected effects while taking TARO-AMCINONIDE, contact your doctor or pharmacist.
How to store
Store at room temperature (15° - 30°C). Keep the container
tightly closed. Avoid freezing.
Keep out of the sight and reach of children
Reporting 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 three 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 ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM 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.taro.ca
or by contacting the sponsor, Taro Pharmaceuticals Inc., at:
1-800-268-1975
This leaflet was prepared by:
Taro Pharmaceuticals Inc.
130 East Drive
Brampton, Ontario
L6T 1C1
TARO is a registered trademark of Taro Pharmaceuticals Inc.
Last revised: January 15, 2016