What Dovobet Oint is used for and how to use it
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Dovobet Oint - Consumer Medicine Information

Manufacture: LEO Pharma
Country: Canada
Condition: Atopic Dermatitis, Dermatitis, Dermatological Disorders, Lichen Planus, Lichen Sclerosus, Plaque Psoriasis
Class: Topical steroids
Form: Cream, gel, liniment or balm, lotion, ointment, etc
Ingredients: calcipotriol, betamethasone dipropionate, white soft paraffin, liquid paraffin, polyoxypropylene-11-stearyl ether (contains butylhydroxytoluene), alpha-tocopherol.

calcipotriol and betamethasone dipropionate

About this Medication

What the medication is used for

DOVOBET should be used topically for up to 4 weeks to treat psoriasis plaques on your body.

DOVOBET should not be used on the face.

What it does

DOVOBET contains two active ingredients; calcipotriol, a vitamin D-like agent and; betamethasone, a corticosteroid (“steroid”).

Psoriasis results from skin cells growing and dividing too quickly, causing plaques (scaly, red patches) to form on the skin. Calcipotriol comes from naturally occurring vitamin D and acts to return the growth of skin cells to normal.

The topical steroid betamethasone acts to control the inflammation (redness, swelling) associated with psoriasis.

The combination of calcipotriol and betamethasone in DOVOBET ointment is more effective for the treatment of psoriasis and is faster acting than if these two ingredients were used alone.

When it should not be used

  • Do not use this product if you are allergic to any of the ingredients in DOVOBET ointment, or to components of the tube.
  • DOVOBET is not for use in your eyes.
  • Do not use to treat viral, fungal or bacterial skin infections, tuberculosis of the skin, syphilitic skin infections, chicken pox, eruptions following vaccinations, and in viral diseases such as herpes simplex, varicella and vaccinia because Dovobet contains a steriod.

What the medicinal ingredients are

Calcipotriol (vitamin D analog) and betamethasone dipropionate (corticosteroid).

What the important nonmedicinal ingredients are

White soft paraffin, liquid paraffin, polyoxypropylene-11-stearyl ether (contains butylhydroxytoluene), alpha-tocopherol.

What dosage forms it comes in

DOVOBET is available as a topical ointment containing 50 mcg/g calcipotriol and 0.5 mg/g betamethasone (as dipropionate).

Warnings and Precautions

Calcipotriol, a medicinal ingredient of DOVOBET, when used with ultraviolet radiation (UVR) may increase the risk of developing skin cancer caused by UVR. Calcipotriol alone does not cause cancer.

DOVOBET is not recommended for use during pregnancy or while nursing. Tell your doctor if you are pregnant, nursing, or become pregnant during your treatment.

If you are at high risk of developing high blood calcium levels, you should be monitored with blood tests. If blood calcium levels increase, treatment with DOVOBET should be discontinued until calcium levels return to normal.

DOVOBET is not recommended for children under 18 years of age. Children may be more prone to side effects from the steroid in DOVOBET.

DOVOBET should not be applied to large areas of damaged skin, in skin folds or under air tight bandages/dressings.

It is best if your treatment is broken up occasionally and if one area of your body is treated at a time. The steroid contained in DOVOBET may cause stretch marks or shrinking of the skin or tissues under the skin. If this occurs, treatment should be stopped. There may a return of psoriasis if prolonged use of a steroid is stopped abruptly.

BEFORE you use DOVOBET talk to your doctor or pharmacist if:

  • you have viral, fungal or bacterial skin infections, tuberculosis of the skin, syphilitic skin infections, chicken pox, eruptions following vaccinations, viral diseases such as herpes simplex, varicella and vaccinia.
  • you are currently using other topical corticosteroids.
  • you are using sun tanning beds or sun lamps.
  • you are currently using phototherapy for your psoriasis.
  • you have allergies to any of the ingredients in DOVOBET ointment or to components of the tube.

Interactions with this Medication

There is no clinical trial experience on the interaction of DOVOBET with other drugs for psoriasis.

Proper Use of this Medication

Usual dose

DOVOBET should be gently rubbed onto affected skin areas once a day for up to 4 weeks. You should begin to see an improvement within the first week. The maximum amount of DOVOBET ointment you should use in one week is 100g.

Using the ointment

  • Remove the cap. Check that the aluminium seal has not been broken before you use it for the first time. To break the seal, use the other end of the cap to pierce the seal.
  • Gently rub the ointment on the areas of your skin affected by psoriasis. Wash your hands after using DOVOBET to prevent getting any on your face. You can wear your usual clothes and no special dressing or cover is needed.
  • If you accidentally spread DOVOBET onto surrounding healthy skin, wash it off right away.
  • DOVOBET is not recommended for use on your face. If you accidentally get some on your face, wash it off right away.
  • Do not apply DOVOBET on large areas of damaged skin, in skin folds or under an air tight bandage/dressing. This could increase your risk of side effects.
  • If DOVOBET ointment is used together with DOVONEX® cream, ointment or scalp solution, then the combined total for all products together should not be greater than 100 g per week.

For example, if you use 60 g of DOVOBET ointment, you should not use more than 40 mL of DOVONEX scalp solution.

Overdose

From calcipotriol

The calcipotriol in DOVOBET can lead to increased blood calcium levels if more than the maximum 100g weekly amount of DOVOBET is used. This effect is reversible when treatment is stopped.

From betamethasone

Long term use of topical steroids can lead to symptoms of hypercorticoidism, including Cushing's disease. Recovery is fast and complete once the steroid is stopped.

Missed Dose

If you forget to use DOVOBET at the right time, use it as soon as you remember. Then go on as before.

Side Effects and what to do about them

The most common side effect from the use of DOVOBET is itching which is usually mild.

The calcipotriol in DOVOBET may cause local irritation which is usually mild and temporary. Rare cases of allergic reaction to calcipotriol have been reported. Calcipotriol can lead to high blood calcium levels but this is usually related to using more than 100g of DOVOBET per week. Worsening of your psoriasis can occur.

Side effects from the steroid in DOVOBET are generally local and include dryness, itching, burning, local irritation, thinning of the skin, the appearance of surface veins, stretch marks, various types of skin rashes and red, swollen hair follicles. If applied to the face, an acne-like rash and swelling can occur. In rare cases, your adrenal glands may stop working properly.

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: pustular psoriasis (headache, fever,
chills, arthralgia, malaise, anorexia,
nausea)
X
Rare: adrenal effects (weakness,
increased urination/thirst, fatigue, weight
loss)
X
Rare: skin thinning (visible veins, stretch
marks)
X
Very rare: allergic reaction (rash, itching,
swelling, trouble breathing, dizziness)
X
Very rare: high blood calcium levels
(fatigue, depression mental confusion,
anorexia, nausea, vomiting, constipation,
increased urination and in some patients,
cardiac arrhythmias)
X

This is not a complete list of side effects. For any unexpected effects while taking DOVOBET, contact your doctor or pharmacist.

How to Store it

Store at 5 to 25°C. Use within 12 months of first opening the tube.

  • For easy spreading and to prevent pulling of delicate skin do not refrigerate the ointment.
  • Keep DOVOBET in a safe place where children cannot reach it.
  • Keep DOVOBET away from your pets. The medicine (calcipotriol) can be fatal to dogs if eaten. If your dog eats DOVOBET contact a veterinarian immediately.
  • Do not use DOVOBET past the expiry date marked on the bottom of the tube.

Reporting Suspected Side Effects


To monitor drug safety, Health Canada through the Canada Vigilance Program collects information on serious and unexpected effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Canada Vigilance:

By toll-free telephone: 1-866-234-2345
By toll-free fax: 1-866-678-6789
Online: www.healthcanada.gc.ca/medeffect
By email: CanadaVigilance@hc-sc.gc.ca

By regular mail:
Canada Vigilance National Office
Marketed Health Products Safety and Effectiveness
Information Bureau Marketed Health Products Directorate
Health Products and Food Branch
Health Canada
Tunney‟s Pasture, AL 0701C
Ottawa ON K1A 0K9

NOTE: If you require information related to the management of the side effect, please contact your health care provider before notifying Canada Vigilance. 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: www.leo-pharma.com/canada or by contacting the sponsor, LEO Pharma Inc., at: 1-800-668-7234.

LEO Pharma A/S used under license by LEO Pharma Inc., Thornhill, L3T 7W8