Universal reference book for medicines
Product name: DAIVOBET ® (DAIVOBET ® )

Active substance: betamethasone, calcipotriol

Type: The drug with antiproliferative and anti-inflammatory action for the treatment of psoriasis

Manufacturer: LEO Pharmaceutical Products Ltd.
A / S (LEO Pharma A / S) (Denmark) manufactured by LEO Laboratories (Ireland)
Composition, form of production and packaging
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Ointment for external use is uniform, from almost white to pale yellow.
1 g

betamethasone dipropionate 643 μg,

equivalent to betamethasone 500 μg

Calcipotriol monohydrate 52 μg,

is equivalent to calcipotriol 50 μg

Auxiliary substances: paraffin liquid (contains about 10 ppm alpha-tocopherol) - 30 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) up to 1.0 g.

15 g - aluminum tubes (1) - cardboard packs.

30 g - aluminum tubes (1) - cardboard packs.

60 g - aluminum tubes (1) - packs of cardboard.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2014.

PHARMACHOLOGIC EFFECT

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

Betamethasone - 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 the drug Daivobet ® absorption of calcipotriol and betamethasone through intact skin is less than 1%.

When applying the drug to psoriatic plaques and under occlusive dressings, absorption of betamethasone increases.
Since the depot is created in the skin, its elimination from the skin occurs within a few days. Betamethasone is metabolized in the liver and in the kidneys with the formation of glucuronides and sulfoesters, excretion is carried out through the intestine and kidneys.
INDICATIONS

- chronic vulgar plaque psoriasis.

DOSING MODE

Outwardly.
In adults, the ointment is applied a thin layer on the affected areas of the skin 1 time / day.
The maximum daily dose is not more than 15 g;
the maximum weekly dose should not exceed 100 g. The recommended duration of the course of treatment 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 EFFECT

Side effects are classified according to the frequency of occurrence: the 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 skin appendages: frequent - itching, rash, 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 the long topical application of betamethasone (dipropionate), the development of skin atrophy, telangiectasia, striae, folliculitis, hypertrichosis, perioral dermatitis, allergic contact dermatitis, depigmentation, colloidal skin degeneration is associated with an increased risk of generalized pustular psoriasis, hyper- and photosensitivity reactions, including extremely rare cases of angioedema and edema of the face.

Systemic reactions: associated with the use of calcipotriol (very rare): hypercalcemia or hypercalciuria.
With prolonged use of local GCS in high doses, suppression of adrenal function with the development of secondary adrenal insufficiency and symptoms of hypercorticism, including Itenko-Cushing syndrome, is possible.
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.

CONTRAINDICATIONS

- diseases accompanied by a violation of calcium metabolism;

- hypersensitivity to any of the components of the drug;

- severe hepatic impairment;

- severe renal failure;

- viral (including herpes or chicken pox), fungal, bacterial and parasitic skin infections;

- rosacea;

- rosacea;

- 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 Daivobet ® in children under the age of 18 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 child.

APPLICATION FOR FUNCTIONS OF THE LIVER

Contraindication: severe renal failure;

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

Contraindication: severe hepatic impairment;

APPLICATION FOR CHILDREN

The experience of using Daivobet ® in children under the age of 18 is absent.

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, with the use of Daivobet ® in doses exceeding the recommended maximum weekly dose (100 g), the development of hypercalcemia, rapidly passing with a decrease in its dose or cancellation, is possible.
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 bandage, to be applied to the folds of the skin, as this increases the likelihood of systemic absorption of SCS 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 systemic administration of GCS may also occur with prolonged use of local SCS, due to systemic absorption.
In case of complication of psoriasis secondary infection, antibiotic therapy should be carried out, and with aggravation of infection, cancel Daybobet ® .
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.
Impact on the ability to drive vehicles and manage mechanisms

Does not affect.

OVERDOSE

Symptoms: increased calcium levels in the blood;
suppression of the function of the pituitary-adrenal system with the development of reversible secondary adrenal insufficiency.
Treatment: cancel the drug and carry out symptomatic therapy.
In cases of chronic toxicity, GCS should be discontinued gradually.
DRUG INTERACTION

It is not known.

TERMS OF RELEASE FROM PHARMACY

The drug is dispensed without a prescription.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored out of reach of children at a temperature of no higher than 25 ° C.

Shelf life - 2 years, after autopsy - 6 months.
Do not use after the expiration date.
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