Patient Medication Information: uses, side effects, how to take - Taro-Calcipotriol / Betamethasone Gel
ABOUT THIS MEDICATION
What the medication is used for:
Taro-Calcipotriol / Betamethasone Gel is applied to the skin in the treatment of patients 18 years and older with:
- Moderate to severe psoriasis on the scalp for up to 4 weeks, and
- Mild to moderate psoriasis plaques on the body for up to 8 weeks.
What it does:
Taro-Calcipotriol / Betamethasone Gel contains two medicines in one product; calcipotriol (a vitamin D-like substance) and betamethasone (a corticosteroid) that work together to control psoriasis.
Psoriasis lesions are areas of inflamed skin where the production of skin cells is too rapid. This creates red, scaly, thick patches (plaques) of skin. Treatment is targeted at reducing signs of redness and scaling and symptoms such as itching.
Calcipotriol helps to bring the rate of skin cell growth back to normal. Betamethasone works to reduce inflammation (redness, swelling and itching).
When it should not be used:
Do not use Taro-Calcipotriol / Betamethasone Gel:
if you are allergic to any of the ingredients or the container of
Taro-Calcipotriol / Betamethasone Gel
- if you have problems with high calcium levels in your body
- if you have skin infections caused by viruses (e.g. cold sores, chicken pox), a fungus (e.g. athlete’s foot, ringworm), bacteria, parasites (e.g. scabies), tuberculosis or syphilis
on skin areas with perioral dermatitis (red mouth rash), ichthyosis (dry, scaly skin), acne (pimples), rosacea (flushed
facial skin),
- on skin areas that have ulcers, open sores, thin skin, easily damaged veins, stretch marks
- to treat other types of psoriasis
- if you have severe liver disease
- if you have severe kidney disease
- in the eyes or on itchy skin of the genital or anal area.
.
What the medicinal ingredients are:
Calcipotriol monohydrate and betamethasone dipropionate.
Each gram of gel contains 50 mcg calcipotriol (as monohydrate)
and 0.5 mg betamethasone (as dipropionate)
What the nonmedicinal ingredients are:
Alpha-tocopherol, butylated hydroxytoluene, hydrogenated castor oil, mineral oil and polyoxypropylene stearyl ether.
What the container ingredients are:
polyethylene
What dosage forms it comes in:
Taro-Calcipotriol / Betamethasone Gel is an almost clear, colourless to slightly off-white gel. Available in cartons of 1 or 2 bottles of 60 g.
BEFORE you use Taro-Calcipotriol / Betamethasone Gel talk to your doctor or pharmacist if you:
- have diabetes
- have skin infections
use other medicines that contain corticosteroids or calcipotriol
(Vitamin D).
are pregnant or planning to get pregnant
- are breast feeding
Taro-Calcipotriol / Betamethasone Gel is not recommended in children and adolescents under 18 years of age.
Calcipotriol in Taro-Calcipotriol / Betamethasone Gel may increase the risk of developing skin cancer caused by ultraviolet radiation (UVR).
While using Taro-Calcipotriol / Betamethasone Gel, you should avoid excessive exposure to natural or artificial sunlight (UVR) such as phototherapy, tanning beds, sunlamps, etc.
Do not use Taro-Calcipotriol / Betamethasone Gel on your face, skin folds (e.g. groin, armpit, under the breast or in the creases of the buttocks), genitals or on open sores on the skin. Do not use Taro-Calcipotriol / Betamethasone Gel in or near the eyes. Taro-Calcipotriol / Betamethasone Gel may cause eye irritation and irritation of facial skin.
Do not bandage, apply a dressing or wrap the treated skin area after applying Taro-Calcipotriol / Betamethasone Gel on your body.
If used on the scalp, do not cover your scalp with a shower cap, bandages or dressings after applying Taro-Calcipotriol / Betamethasone Gel.
If required, your doctor may recommend a blood test to check your calcium level or the functioning of your adrenal gland.
ACTIONS WITH THIS MEDICATION
ABOUT THIS MEDICATION
WARNINGS AND PRECAUTIONS
Before using Taro-Calcipotriol / Betamethasone Gel tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those you can buy without a prescription, especially medicines that contain a corticosteroid and/or calcipotriol.
PROPER USE OF THIS MEDICATION
Always use Taro-Calcipotriol / Betamethasone Gel exactly as your doctor has told you.
Usual dose:
Apply Taro-Calcipotriol / Betamethasone Gel once daily to the affected areas. Treatment on the body may be continued for up to 8 weeks. Treatment on the scalp may be continued for up to 4 weeks. After discontinuing treatment, if your psoriasis flares up again later, you can begin a new treatment cycle.
The maximum daily dose is 15 g per day, or 100 g per week of Taro-Calcipotriol / Betamethasone Gel and/or any other products containing calcipotriol. The total body surface area treated, including scalp and body should not exceed 30%.
Before Applying Taro-Calcipotriol / Betamethasone Gel:
- Use only on areas of your skin affected by psoriasis and not on skin that does not have psoriasis.
If applying to your scalp, you don’t need to wash your hair
before applying Taro-Calcipotriol / Betamethasone Gel .
SHAKE bottle well
before use. Remove cap.
Using Taro-Calcipotriol / Betamethasone Gel on the body:
Apply a sufficient amount of gel on affected area to cover plaque with an even layer.
It may help to spread the gel in two perpendicular lines forming a cross within a plaque (i.e. cross unit) to ensure the right amount of drug is applied for the size of the plaque.
Do not spread too thinly. Be sure to apply a sufficient amount of gel to cover the plaque. Massage gently until gel has been absorbed into skin.
Using Taro-Calcipotriol / Betamethasone Gel on the scalp:
- Comb dry hair first to remove loose psoriasis scales.
- For long hair, gently part your hair to reveal affected scalp area.
- Squeeze a pea-size drop of Taro-Calcipotriol / Betamethasone Gel onto your fingertip.
- Apply gel with your finger to affected scalp areas that have visible psoriasis.
- For a larger area of plaque or for very thick hair, you may need to re-part hair to expose neighbouring psoriasis area. Repeat until the entire affected area (or plaque) is covered with an even layer of gel.
After applying Taro-Calcipotriol / Betamethasone Gel:
- Wash your hands well after applying Taro-Calcipotriol / Betamethasone Gel
- It is important to leave treatment areas uncovered. Do not bandage, apply a dressing or wrap the skin or scalp.
- Do not wash your body/hair immediately after application in order to achieve optimal effect. Taro-Calcipotriol / Betamethasone Gel should be left on body/scalp until absorbed.
- Taro-Calcipotriol / Betamethasone Gel should not be applied 12 hours before or after colouring, perming or any chemical hair treatments. To help avoid irritation, always ask your doctor about using any hair treatments with scalp psoriasis.
Overdose:
If you think you have applied too much Taro-Calcipotriol / Betamethasone Gel, contact a healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.
Missed Dose:
If you forget to use Taro-Calcipotriol / Betamethasone Gel use it as soon as you remember. Next time, follow your regular application routine. It’s important not to use Taro-Calcipotriol / Betamethasone Gel more than once a day. E
The most common side effect with use of Taro-Calcipotriol / Betamethasone Gel on the scalp as well as on the body is itching. Other less common effects reported for Taro-Calcipotriol / Betamethasone Gel include: burning sensation of the skin, skin pain or irritation, inflammation of hair root, hair loss, rash (with or without pustules), skin infection, eye irritation, redness, acne, dizziness, dry skin, headache, facial swelling, flushing, migraine, outer ear infection, sinus infection, increased blood calcium level, increased blood parathyroid hormone and decreased blood phosphorus level.
FFECTS AND WHAT TO DO ABOUT THEM
INTERACTIONS WITH THIS MEDICATION
PROPER USE OF THIS MEDICATION
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | |||||
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |||
| Uncommon: Worsening of psoriasis (red, scaly, thick patches of skin) | ✓ | ||||
| Rare: Pustular psoriasis (red area with yellowish pustules, headache, fever, chills, arthralgia, malaise, anorexia, nausea) | ✓ | ||||
| Rare: Adrenal effects (weakness, increased urination/thirst, fatigue, weight loss), cataracts, infections | ✓ | ||||
| Very Rare: Allergic reaction (rash, itching, swelling, trouble breathing, dizziness) | ✓ | ||||
| Very Rare: High blood calcium (fatigue, depression, mental confusion, anorexia, nausea, vomiting, constipation, increased urination/thirst) | ✓ | ||||
Side effects caused by long term use of corticosteroid-containing products such as Taro-Calcipotriol / Betamethasone Gel include: thinning of the skin, stretch marks or surface veins, changes in hair growth, red mouth rash, skin rash with inflammation, small white spots, lightening of skin colour.
This is not a complete list of side effects. For any unexpected effects while taking Taro-Calcipotriol / Betamethasone Gel, contact your doctor or pharmacist.
HOW TO STORE IT
Store at 15 °C to 30 °C. Do not refrigerate. Protect from light by keeping the bottle in the carton between applications.
- Keep Taro-Calcipotriol / Betamethasone Gel out of the reach and sight of children and pets.
- Use the medicine within 6 months of first opening the bottle.
Do not use Taro-Calcipotriol / Betamethasone Gel after the expiry date on the label (EXP).
OE INFORMATION
If you want more information about Taro-Calcipotriol /
Betamethasone Gel:
- 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://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website www.taro.ca, or by calling 1-800-268-1975.
Taro Pharmaceuticals Inc.
130 East Drive
Brampton, Ontario L6T 1C1
Last Prepared: February 09, 2022
TARO is a registered trademark of Taro Pharmaceuticals Inc.
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.
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