Daivobet ointment is used on the skin to treat plaque psoriasis (psoriasis vulgaris) in adults. Psoriasis is caused by your skin cells being produced too quickly. This results in redness, peeling and thickening of the skin.

Daivobet contains calcipotriol and betamethasone. Calcipotriol helps restore the rate of growth of skin cells to normal, and betamethasone works by reducing inflammation.

PRESENTATION (S) AVAILABLE FOR DAIVOBET 50 ΜG / 0.5 MG / G

3 presentations are available for this drug:

1 tube (s) painted aluminum of 15 g
1 painted aluminum tube (s) of 30 g
1 60 g painted aluminum tube (s)

FEATURE	DESCRIPTION
Pharmaceutical class	psoriasis treatment
Active substance (s)	per 1 g: betamethasone dipropionate (0.643 mg), calcipotriol monohydrate (52.2 micrograms)
General medicine	no
Pharmaceutical form	ointment
Route (s) of administration	cutaneous
Social security reimbursement rate	65%
Laboratory (s)	LEO
Conditions of issue	available by simple prescription

daivobet ointment Dosage

Dosage

Daivobet ointment should be applied once a day to the lesions. The recommended duration of treatment is 4 weeks. There are data on the use of repeated courses of Daivobet for up to 52 weeks. If it is necessary to continue or resume treatment after 4 weeks, treatment should be continued after medical advice and under regular medical supervision.
When using products containing calcipotriol, the maximum daily dose should not exceed 15 g. The body surface area treated with products containing calcipotriol should not exceed 30% (see section Warnings and precautions for use ).

Special populations

Renal and hepatic failure

The safety and efficacy of Daivobet ointment in patients with severe renal impairment or severe hepatic impairment have not been evaluated.

Pediatric population

The safety and effectiveness of Daivobet ointment in children below the age of 18 have not been established. No data is available.

daivobet ointment Contraindications

Known hypersensitivity to the active substances or to any of the excipients.
Daivobet ointment is contraindicated in erythrodermic, exfoliating and pustular psoriasis.
Due to the presence of calcipotriol, Daivobet ointment is contraindicated in patients with a history of calcium metabolism disorders.
Due to the presence of corticosteroids, Daivobet ointment is contraindicated in the following cases: skin lesions of viral origin (for example herpes or chickenpox), infections of fungal or bacterial origin, parasitic infections, related skin damage with tuberculosis or syphilis, perioral dermatitis, skin atrophy, stretch marks, fragility of the cutaneous venous network, ichthyosis, acne vulgaris, acne rosacea, rosacea, ulcers, wounds, peri-anal and genital itching.

How To Take daivobet ointment ?

How to apply Daivobet

Cutaneous use.

Instruction for correct use

Apply the product only to psoriasis and not to skin that does not have psoriasis.
Remove the cap and check that the tube is tightly closed before using the ointment for the first time.
To pierce the seal, use the point on the back of the cap.
Squeeze the ointment out on a clean finger.
Rub gently to work into the skin, covering the area with psoriasis, until most of the ointment is gone in the skin.
Do not cover the treated area with neither a bandage nor a tight bandage.
Wash your hands thoroughly after using Daivobet (unless you are using the ointment to treat your hands. This will prevent accidental transfer of the ointment to other parts of the body (especially to the face, scalp, mouth and eyes). ).
Don’t worry if you accidentally apply the ointment to healthy skin around the psoriasis lesions, but wipe it off if it gets too much.
For optimal effect, it is recommended not to shower or bathe immediately after applying Daivobet ointment.
After applying the ointment, avoid contact with fabrics that are easily stained with grease (such as silk).

Duration of the treatment

Use the ointment once a day. It may be more convenient to apply the ointment in the evening.
The initial treatment period is normally 4 weeks, but your doctor may prescribe a different duration of treatment.
Your doctor may decide to repeat the treatment.
Do not use more than 15 grams per day.

If you are using other products containing calcipotriol, the total calcipotriol should not exceed 15 grams per day and the treated area should not exceed 30% of the total body surface.

What should I expect from my treatment with Daivobet?

Most patients see a clear result after 2 weeks even if the psoriasis has not completely gone away.

how does daivobet ointment work?

Pharmacotherapeutic group: Antipsoriatics. Other anti-psoriatic drugs for topical use, Calcipotriol, combinations, ATC code: D05AX52.

Calcipotriol is an analogue of vitamin D. In vitro data suggest that calcipotriol induces differentiation and inhibits the proliferation of keratinocytes. This is the mechanism proposed to explain its effects in psoriasis.
Like other topical corticosteroids, betamethasone dipropionate has anti-inflammatory, anti-pruritic, vasoconstrictive, and immunosuppressive properties, with no demonstrated curative action. Treatment under occlusion may increase the effect due to greater penetration into the stratum corneum. The incidence of side effects will therefore be increased. The mechanism of action of the anti-inflammatory activity of topical corticosteroids is not fully established.
A safety study in 634 psoriatic patients investigated the effects of repeated courses of Daivobet ointment used once daily as needed, either alone or alternately with Daivonex, for up to 52 weeks compared with Daivonex used alone for 48 weeks afterwards. initial treatment with Daivobet ointment. Adverse effects were reported by 21.7% of patients in the Daivobet ointment group, 29.6% in the Daivobet ointment / Daivonex alternating group and 37.9% in the Daivonex group. The side effects reported by more than 2% of patients in the Daivobet ointment group are pruritus (5.8%) and psoriasis (5.3%). Side effects which may be related to long-term treatment with corticosteroids (e.g. skin atrophy, folliculitis, depigmentation,
The adrenal response to ACTH was determined by measuring cortisol in patients with both extensive scalp and body psoriasis using up to 106 g per week of Daivobet gel in combination with Daivobet ointment. A borderline decrease in cortisol levels 30 minutes after ACTH administration was observed in 5 of 32 patients (15.6%) after 4 weeks of treatment and in 2 of 11 patients (18.2%) who had prolonged treatment up to 8 weeks. In all cases, cortisol levels were at a normal level 60 minutes after the administration of ACTH. No changes in calcium metabolism were observed in these patients. Regarding hypothalamic-pituitary braking, this study demonstrates that

Pediatric population

The adrenal response to ACTH administration was measured in an uncontrolled 4-week study in 33 adolescents aged 12 to 17 years with psoriasis of the body who used up to 56 g per week of Daivobet ointment. . No case of hypothalamic-pituitary axis braking has been reported. No hypercalcaemia was reported, but one patient had an increase in urinary calcium possibly related to treatment.

How To Store daivobet ointment ?

Keep this medication out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the tube or carton after EXP. The expiration date refers to the last day of that month.
Store the product at a temperature not exceeding 25 ° C.
The tube should be discarded 1 year after first use.
Do not throw away any medicines via a wastewater treatment plant or with household waste. Ask your pharmacist how to throw away the medicines you no longer use. These measures will help protect the environment.

daivobet ointment Side Effects

Like all medicines, Daivobet can cause side effects, although not everybody gets them.

About 1 in 10 people may experience side effects, but most are reactions at the site of the ointment application and are usually mild and temporary.

Serious side effects:

The following serious side effects have been reported for Daivobet:

Uncommon (affects less than 1 in 100 people)

Worsening of your psoriasis. If your psoriasis gets worse, talk to your doctor as soon as possible.

Rare (affect less than 1 in 1,000 people)

Pustular psoriasis may occur (a red area with yellowish pustules usually on the hands or feet). If you notice these symptoms, stop using Daivobet and tell your doctor as soon as possible.

Serious side effects are known to be caused by betamethasone (a strong corticosteroid), one of the ingredients of Daivobet. Tell your doctor as soon as possible if a serious side effect occurs:

Your adrenal glands may stop working properly. The symptoms are fatigue, depression and anxiety.
Cataract (signs are blurry or blurred vision, difficulty seeing at night, and sensitivity to light) or increased pressure in the eye (signs are eye pain, red eye, decreased vision or blurred vision).
Infections (because your infection-fighting immune system may be weakened or weakened)
Impact on the control of the metabolism of diabetes mellitus (if you are diabetic you may have fluctuations in your blood sugar).

These side effects most often occur after prolonged use, use in the folds (eg groin, under the arms or under the breasts), use under bandages and dressings or on large areas of skin.

Serious side effects are known to be caused by calcipotriol:

Allergic reactions with severe swelling of the face or other parts of the body such as the hands or feet. Swelling of the mouth and / or throat and difficulty in breathing may occur. If you have an allergic reaction, stop using Daivobet, tell your doctor straight away, or go to the nearest hospital emergency room.
Treatment with this ointment may increase your calcium levels in the blood or urine (usually when too much ointment has been used). Signs of increased calcium in the blood are bone pain, constipation, loss of appetite, nausea, vomiting. This can be serious and you should contact your doctor as soon as possible. However, when treatment is stopped, the levels return to normal.

Less serious side effects:

The following less serious side effects have also been reported with Daivobet.

If any of these effects last a long time or bothers you, tell your doctor or nurse.

Common side effects (affect less than 1 in 10 people):

Itching.
Rashes.
Burning sensation.

Uncommon side effects (affect less than 1 in 100 people):

Skin pain or irritation.
Rash with inflammation of the skin (dermatitis).
Redness of the skin due to the dilation of small blood vessels (erythema).
Inflammation or swelling of the hair roots (folliculitis).
Change in skin color on the areas where you applied the ointment.

Unknown frequency

Rebound effect: worsening of your symptoms / psoriasis after stopping treatment

Less serious side effects caused by betamethasone include the following. You should tell your doctor as soon as possible if you notice them:

Thinning of the skin.
Appearance of surface veins or stretch marks.
Change in hair growth.
Redness around the mouth (perioral dermatitis).
Red rash with inflammation and swelling (allergic contact dermatitis).
Shiny brown botons filled with gel (colloid millium).
Lightening of the skin (depigmentation).

Less serious side effects caused by calcipotriol include the following:

Dry skin.
Sensitivity of the skin to light resulting in a rash has also been reported.
Eczema.

If you notice the side effects described above or other changes during treatment, tell your doctor.

If you experience any of the side effects listed as serious, or if you experience any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Keep out of the reach and sight of children.

daivobet ointment Interactions

No interaction studies have been performed with Daivobet.

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

Effects on ability to Drive and use machines

This medicine is not expected to have any effect on your ability to drive or use machines.

Warnings and Precautions

Take special care with Daivobet

Before using other medicines, ask your doctor / nurse / pharmacist if:

you are taking other medicines that contain corticosteroids as you may have side effects
you have been taking this medicine for a long time and plan to stop the treatment as there is a risk that your psoriasis will get worse or “flare up” when corticosteroids are suddenly stopped)
you have diabetes (diabetes mellitus) because blood sugar / glucose levels may be affected by corticosteroids.
your skin becomes infected because you may need to stop treatment
you have psoriasis of a type called gouty psoriasis
you have severe liver or kidney disease.

Special precautions

Avoid treating more than 30% of the body and using more than 15 grams per day.
Avoid use under bandages or dressings as this increases the absorption of corticosteroids.
Avoid use on large areas of injured skin or in skin folds (groin, under the arms, under the breasts) as this increases the absorption of corticosteroids.
Avoid use on the face or genitals (sexual organs) as these are very sensitive to corticosteroids.
Avoid excessive sun exposure, excessive use of solar cabins or other form of light therapy.

Children

Daivobet is not recommended for children under the age of 18.

PREGNANCY & BREAST-FEEDING & FERTILITY

Pregnancy

There are no relevant data from the use of Daivobet in pregnant women. Animal studies with glucocorticoids have shown reproductive toxicity ( see Preclinical Safety ), but a number of epidemiological studies (less than 300 pregnancies completed) have not shown congenital anomalies in children born to mothers treated with corticosteroids during pregnancy. The potential risk for humans is not known for sure. Therefore, Daivobet should only be used during pregnancy when the potential benefit justifies the potential risk.

Feeding with milk

Betamethasone passes into breast milk, but the risk of an adverse effect in the infant seems unlikely at therapeutic doses. There are no data on the excretion of calcipotriol in human milk. Caution should be exercised when prescribing Daivobet in nursing mothers. Do not use Daivobet on the breasts if breastfeeding.

Fertility

Studies in rats after oral administration of calcipotriol or betamethasone dipropionate have shown no impairment of fertility in males and females ( see Preclinical Safety ).

What happens if I overdose from daivobet ointment ?

The use of doses higher than the recommended dose may lead to an increase in serum calcium, this effect is reversible on discontinuation of treatment. Symptoms of hypercalcemia include polyuria, constipation, muscle weakness, confusion, and coma.
Excessive and prolonged use of topical corticosteroids can lead to hypothalamic-pituitary axis slowing, resulting in secondary adrenal insufficiency which is usually reversible. In this case, symptomatic treatment is indicated.
In the event of chronic toxicity, treatment with corticosteroids should be withdrawn gradually.
A case of misuse has been reported in a patient treated for extensive erythrodermic psoriasis with 240 g of Daivobet ointment per week (corresponding to a daily dose of approximately 34 g) for 5 months (maximum recommended dose 15 g per day); during treatment, the patient developed Cushing’s syndrome followed by pustular psoriasis after abrupt cessation of treatment.

What should I do if I miss a dose?

Do not apply a double dose to make up for the dose you forgot to apply.

What happens if you stop taking daivobet ointment ?

Treatment with DAIVOBET should be stopped as instructed by your doctor. It may be necessary to stop the treatment gradually, especially if you have been using it for a long time.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist for more information.

What is Forms and Composition ?

SHAPES and PRESENTATIONS

Ointment at 50 µg / 0.5 mg / g (whitish to yellow):

Tube of 60 g.

50 µg / 0.5 mg / g gel (almost transparent, colorless to very slightly off-white):

60 g vial, unit box.
60 g cartridge, with applicator, unit box.

COMPOSITION

	*p 1 g*
Calcipotriol	50 µg
(in monohydrate form: 52.20 µg / g)
Betamethasone	0.50 mg
(as dipropionate: 0.643 mg / g)

Excipients: liquid paraffin, polyoxypropylene stearyl ether, all-rac-alpha-tocopherol, white petrolatum, butylhydroxytoluene (E321).
Excipient with known effect: 1 g of ointment contains 50 micrograms of butylhydroxytoluene (E321).

NOT’s

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general information:

Includes a general description of the drug, its use, brand names, FAQs, and relevant news and articles

Additional information:

General explanation about dealing with the medicine: how to take the medicine, the doses and times of it, the start and duration of its effectiveness, the recommended diet during the period of taking the medicine, the method of storage and storage, recommendations in cases for forgetting the dose and instructions to stop taking the drug and take additional doses.

Special warnings:

For pregnant and breastfeeding women, the elderly, boys and drivers, and use before surgery.

Side effects:

It treats possible side effects and drug interactions that require attention and its effect on continuous use.
The information contained in this medicine is based on medical literature, but it is not a substitute for consulting a doctor.

Betamethasone Calcipotriol