Betamethasone Calcipotriol

Brand Leo Pharmaceutical

In stock 531 Items

Available since: 2019-09-19

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Clinical Pharmacology

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

Betamethasone - glucocorticosteroid (GCS) for external use; has a local anti-inflammatory, antipruritic, vasoconstrictor and immunosuppressive effects, however, the exact mechanisms of the anti-inflammatory action of steroids for external use are not completely clear. The use of occlusive dressings enhances the effect of corticosteroids, as this increases their penetration into the skin.

Pharmacokinetics

When using XAMIOL®, the absorption of calcipotriol and betamethasone through intact skin is less than 1%. When applying the drug to psoriatic plaques and under occlusive dressings, the absorption of external GCS increases. Since a depot of the drug is created in the skin, it is eliminated from the skin within a few days. Betamethasone is metabolized in the liver and in the kidney to form glucuronides and sulfoesters, excreted through the intestines and kidneys.

Indications

Psoriasis of the scalp. Psoriasis mild and moderate severity of other parts of the body.

Composition

1 g of gel contains:

Active substances: betamethasone dipropionate, 0.643 mg (equivalent to betamethasone, 0.5 mg), calcipotriol monohydrate, 0.052 mg (equivalent to calcipotriol, 0.05 mg).

Excipients: liquid paraffin (contains about 10 ppm alpha-tocopherol) 820 mg, polypropylene glycol stearate (PPG - 15) (contains 0.1% butylhydroxytoluene) 160 mg, castor oil hydrogenated 20 mg.

Betamethasone Calcipotriol is marketed under different brands and generic names, and comes in different dosage forms:

Brand name	Manufacturer	Country	Dosage form
Xamiol	Leo Pharmaceutical	Denmark	gel
Daivobet	Leo Pharmaceutical	Denmark	ointment

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Dosage and Administration

Topically.

Use in adults

Shake the vial before using it. The gel is applied with a thin layer to the affected areas of the scalp or to the psoriatic plaques of other parts of the body 1 time per day. The maximum daily dose of not more than 15 g; The maximum weekly dose should not exceed 100 g. The recommended duration of treatment is 4 weeks for psoriasis of the scalp and 8 weeks for damage to the skin of other parts of the body. The area of application of the drug should not exceed 30% of the body surface. The drug should remain on the skin overnight or day to achieve the optimal therapeutic effect. Perhaps repeated use of the drug Xamiol® under the supervision of a physician.

Adverse reactions

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.

Eye disorders: infrequent - eye irritation.

From the skin and skin appendages: frequent - itching; infrequent - rash, burning sensation, pain, irritation, dermatitis, exacerbation of psoriasis, folliculitis, dry skin, acne, pustular psoriasis. Calcipotriol can cause local skin irritation, itching, burning and tingling, dry skin, erythema, rash, dermatitis, eczema, exacerbation of psoriasis, hyper and photosensitivity reactions, including very rare cases of angioedema and edema of the face. The development of skin atrophy, telangiectasia, stretch marks, folliculitis, hypertrichosis, perioral dermatitis, allergic contact dermatitis, depigmentation, colloid degeneration of the skin, as well as an increased risk of generalized pustular psoriasis are associated with prolonged external use of betamethasone (dipropionate)

Systemic reactions: associated with the use of calcipotriol (very rare) - hypercalcemia or hypercalciuria; associated with the use of betamethasone (rare, but sometimes heavy, especially with prolonged use, on large surfaces and with the use of occlusive dressings) - suppression of the function of the adrenal cortex, cataracts, infections, increased intraocular pressure. Systemic reactions occur more frequently when applying the drug under occlusive dressings and when applied to thin skin and skin folds, as well as during prolonged treatment when applied to large areas of skin.

Contraindications

Hypersensitivity to any of the components of the drug;
diseases associated with impaired calcium metabolism;
severe renal and hepatic impairment;
viral (herpes, shingles), fungal, bacterial and parasitic infections of the skin, rosacea, rosacea, common acne, perioral dermatitis, skin manifestations of tuberculosis and syphilis, skin atrophy, ulcers, wounds, itching in the perianal and genital areas, increased fragility of skin vessels, ichthyosis, striae;
psoriatic erythroderma, teardrop-shaped, exfoliative, pustular psoriasis;
age up to 18 years.

Drug interactions

Not known.

Pregnancy and Lactation

In pregnancy, XAMIOL® is used only if the intended benefit to the mother outweighs the potential risk to the fetus.

If necessary, the use of the drug during lactation is recommended to refuse breastfeeding.

Special instructions

Do not use the drug on mucous membranes.

To use the drug with caution when applied to the skin of the face and genitals.

In case of accidental eye contact, unwanted adverse reactions are possible in the form of eye and skin irritation, conjunctivitis. In case of accidental contact with eyes, rinse with running water.

After applying the drug you need to wash your hands.

With the development of secondary infections, antimicrobial therapy should be prescribed.Termination of psoriasis treatment with local corticosteroids with drugs may be associated with the risk of developing generalized pustular psoriasis and the effect of withdrawal. Therefore, after discontinuation of such treatment, it is necessary to continue clinical observation of the patient.

During the period of treatment with KSAMIOL®, the patient is advised to limit or avoid excessive exposure to natural or artificial sunlight. Calcipotriol (and preparations containing it) are allowed to be used topically in combination with ultraviolet radiation only when the attending physician considers the risk of undesirable side effects associated with such treatment justified.

KSAMIOL® contains butylhydroxytoluene (E321), which can cause local skin reactions (for example, contact dermatitis) or irritation of the eyes and mucous membranes.

To achieve an optimal therapeutic effect, it is not recommended to take a shower / bath or wash hair (in case of treatment of lesions of the scalp) immediately after applying the drug.

Influence on the ability to drive vehicles and mechanisms requiring high concentration of attention

Does not affect.

Overdosage

Symptoms: increased calcium in the blood, with the termination of the drug is quickly restored; suppression of the function of the pituitary-adrenal system with the development of reversible secondary adrenal insufficiency.

Treatment: cancel the drug and conduct symptomatic therapy. In cases of chronic toxicity, GCS should be phased out.