Daivobet® (Daivobet®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceBetamethasone + CalcipotriolBetamethasone + Calcipotriol
Dosage form: & nbspointment for external use
Composition:

IN 1 g ointment contains:

active substances: calcipotriol monohydrate 0.052 mg, equivalent to calcipotriol 0.050 mg, betamethasone dipropionate 0.643 mg, equivalent to betamethasone 0.500 mg;

Excipients: paraffin liquid (contains about 10 ppm alpha-tocopherol) 30.0 mg, polypropylene glycol stearate (contains about 0.1% butylhydroxytoluene) 50.0 mg, alpha-tocopherol 0.02 mg, paraffin white soft (contains about 10 ppm alpha-tocopherol) to 1.0 g.

Description:

Homogeneous ointment from almost white to pale yellow.

Pharmacotherapeutic group:Psoriasis treatment
ATX: & nbsp

D.05.A.X.52   Calcipotriol in combination with other drugs

Pharmacodynamics:

Calcipotriol - a synthetic analogue of the active metabolite of a vitamin D. It causes inhibition of proliferation of keratinocytes and accelerates their morphological differentiation.

Betamethasone - Glucocorticosteroid (GCS) for external use; has a local anti-inflammatory, antipruritic, vasoconstrictive and immunosuppressive action, however, the exact mechanisms of anti-inflammatory action of topical steroids are not completely clear.

Pharmacokinetics:

With external application of Daivobet®, the absorption of calcipotriol and betamethasone through intact skin is less than 1%. When applying the drug to psoriatic plaques and occlusal bandages increases absorption of betamethasone. Since the depot is created in the skin, its elimination from the skin occurs within a few days. Betamethasone metabolized in the liver and kidneys with the formation of glucuronides and sulfoesters, excretion is carried out through the intestines and kidneys.

Indications:Chronic vulgar plaque psoriasis.
Contraindications:

- Diseases accompanied by a violation of calcium metabolism;

- hypersensitivity to any of the components of the drug;

- marked renal and hepatic insufficiency;

viral (including herpes or chicken pox), fungal, bacterial and parasitic skin infections, rosacea, acne vulgaris, acne vulgaris, perioral dermatitis, cutaneous manifestations of tuberculosis and syphilis, skin atrophy, skin ulcers, increased fragility of the skin vessels, ichthyosis, perianal and genital itching;

- psoriatic erythroderma, teardrop, exfoliative, pustular psoriasis;

- the experience of using the drug Daivobet ® in children under 18 years is absent.

Pregnancy and lactation:

The safety of the drug Daivobet® during pregnancy and lactation is not established, so the drug can be used only if the potential benefit to the mother exceeds the risk to the fetus or the baby.

Dosing and Administration:

Outwardly. In adults, the ointment is applied a thin layer on the affected areas of the skin 1 time per day.

The maximum daily dose is not more than 15 g; the maximum weekly dose should not exceed 100 g.

The recommended course duration is 4 weeks. Then, Daivobet® can be reused under the supervision of a doctor.

The application area should not exceed 30% of the body surface.

Side effects:

Side effects are classified according to the frequency of occurrence:

most frequent> 1/10

Frequent> 1/100 and <1/10

infrequent> 1/1000 and <1/100

rare> 1/10000 and <1/1000

very rare <1/10000

From the skin and appendages of the skin:

Frequent: itching, rashes, burning sensation.

Infrequent: pain, irritation, dermatitis, erythema, exacerbation of psoriasis, impaired pigmentation in place of ointment application, folliculitis.

Rare: pustular psoriasis.

Calcipotriol can cause local skin irritation, itching, burning, acute pain, dry skin, erythema, rash, dermatitis, eczema and exacerbation of psoriasis.

With a long topical application betamethasone (dipropionate) connect the development of skin atrophy, telangiectasia, striae, folliculitis, hypertrichosis, perioral dermatitis, allergic contact dermatitis, depigmentation, colloidal skin degeneration, and increased risk of generalized pustular psoriasis, hyper- and photosensitivity reactions, including extremely rare cases of angioedema and edema of the face.

Systemic reactions

Bound, using calcipotriol (very rare): hypercalcemia or hypercalciuria.

With prolonged use of local GCS in high doses possibly suppression of adrenal function by the development of secondary adrenal insufficiency and symptoms of hypercorticism, including Itenko-Cushing syndrome.

If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, tell your doctor.

Overdose:

Symptoms: increase of calcium in the blood; suppression of the function of the pituitary-adrenal system with the development of reversible secondary adrenal insufficiency.

Treatment: abolish the drug and carry out symptomatic therapy. In cases of chronic toxicity, GCS should be discontinued gradually.

Interaction:

Unknown.

Special instructions:

It is not recommended to apply the drug on the face, mucous membranes and scalp.

Do not apply the drug to the periorbital area due to the possible development of cataracts and increased intraocular pressure.

After applying the ointment, you should thoroughly wash your hands.

The risk of developing hypercalcemia while observing the recommended dosing regimen is minimal. However, when using Daivobet® in doses exceeding the recommended maximum weekly dose (100 g), hypercalcemia may develop, rapidly passing with a decrease in its dose or cancellation.

Daivobet® contains a potent corticosteroids, therefore it is not recommended to perform concomitant treatment with other GCS.

It is recommended to avoid the use of the drug on large areas of the skin that make up more than 30% of the body surface, as well as under the occlusive dressing,apply to the folds of the skin, as this increases the likelihood of systemic absorption of GCS and the development of systemic adverse reactions.

Adverse events, such as suppression of the hypothalamic-pituitary-adrenal system with the development of reversible secondary adrenal insufficiency or exacerbation of diabetes mellitus, associated with the systemic administration of GCS, can also be observed with long-term use of local SCS due to systemic absorption.

In case of complication of psoriasis by secondary infection, antibacterial therapy should be carried out, and with aggravation of infection, canceling Dayvobet®.

During treatment with Daivobet®, doctors recommend that patients limit or avoid excessive exposure to natural or artificial sunlight.

Calcipotriol for topical use should be used with UV light only if the doctor and patient feel that the potential benefit outweighs the potential risks.

Effect on the ability to drive transp. cf. and fur:

Does not affect.

Form release / dosage:

Ointment for external use.

Packaging:

For 15, 30 and 60 g of the drug in an aluminum tube, lacquered inside with a screwed polyethylene lid.

1 tube with instructions for use in cardboard pack.

Storage conditions:

At a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years; after autopsy - 6 months.

Do not use after the expiration date.

Terms of leave from pharmacies:Without recipe
Registration number:П N015586 / 01
Date of registration:07.04.2009 / 07.05.2013
Expiration Date:Unlimited
The owner of the registration certificate:Leo Pharmaceutical Products Co., Ltd. A / S (Leo Pharma A / S) Leo Pharmaceutical Products Co., Ltd. A / S (Leo Pharma A / S) Denmark
Manufacturer: & nbsp
Representation: & nbspLEO Pharmaceutical Products Ltd.LEO Pharmaceutical Products Ltd.
Information update date: & nbsp17.03.2017
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