Ksamiol

General characteristics. Structure:

Active ingredients: betamethasone Dipropionas of 0,643 mg (it is equivalent to betamethasone of 0,5 mg) a kaltsipotriola monohydrate of 0,052 mg (it is equivalent to a kaltsipotriol of 0,05 mg)
Excipients: liquid paraffin (contains about 10 ррт alpha tocopherol) 820 mg, polypropylene glycol stearate (PPG - 15) (contains 0,1% of butyl hydroxytoluene) 160 mg, castor oil the hydrogenated 20 mg.

Description
Almost transparent, from colourless till almost white color gel. On a surface the thin fat film can be observed.

Pharmacological properties:

Kaltsipotriol - a synthetic analog of an active metabolite of vitamin D. Causes braking of proliferation of keratinotsit and accelerates their morphological differentiation. Betamethasone - a glucocorticosteroid (GKS) for external use; renders local antiinflammatory, antipruritic, vasopressor and immunosuppressive action, however, exact mechanisms of antiinflammatory action of steroids are up to the end not clear for external use. Use of occlusive bandages strengthens effect of GKS as at the same time their penetration into skin increases.

Pharmacokinetics. At drug KSAMIOL® use absorption of a kaltsipotriol and betamethasone through the unimpaired skin makes less than 1%. When putting drug on psoriasis plaques and under okklyuzioyny bandages absorption of outside GKS increases. As in skin the depot of drug is created, its elimination comes from skin within several days. Betamethasone is metabolized in a liver and in kidneys with formation of glucuronides and sulfoethers, removal is carried out through intestines and kidneys.

Indications to use:

Psoriasis of a pilar part of the head. Psoriasis easy and moderate severity of other parts of a body.

Route of administration and doses:

Outwardly.
Use for adults. Before drug use the bottle needs to be stirred up. Gel is applied with a thin layer on affected areas of a pilar part of the head or on psoriasis plaques of other parts of a body of 1 times a day. Maximum day dose no more than 15 g; the maximum week dose should not exceed 100 g. The recommended duration of a course of treatment 4 weeks at psoriasis of a pilar part of the head and 8 weeks at damage of skin of other parts of a body. The area of putting drug should not exceed 30% of a body surface. Drug has to remain on skin during the night or day for achievement of optimum therapeutic effect. Perhaps repeated use of drug Ksamiol under observation of the doctor.

Features of use:

Not to use drug on mucous membranes.
With care to use drug when drawing on face skin and generative organs.
At accidental hit in eyes undesirable side reactions in a look irritation of eyes and face skin, conjunctivitis are possible. At accidental hit in eyes they need to be washed out flowing water.
After putting drug it is necessary to wash hands.
At development of consecutive infections it is necessary to appoint antimicrobic therapy.
The termination of treatment of psoriasis local GKS can be accompanied by drugs by risk of development of generalized pustular psoriasis and effect of cancellation. Therefore after the termination of such treatment it is necessary to continue clinical observation of the patient.
During treatment by the drug KSAMIOL® the patient is recommended to limit or avoid excessive radiation by a natural or artificial sunlight. Kaltsipotriol (and the drugs supporting him) it is authorized to use locally in a combination with ultra-violet radiation only when the attending physician considers justified the risk of undesirable side effects interfaced to such treatment.
The drug KSAMIOL® contains butyl hydroxytoluene (E321) which can cause local skin reactions (for example, contact dermatitis) or irritation of eyes and mucous membranes.
For achievement of optimum therapeutic effect it is not recommended to accept souls/bathtub or to wash hair (in case of processing of defeats of a pilar part of the head) right after drug use.

Influence on ability to manage vehicles and mechanisms
Does not influence.

Side effects:

Side effects are classified depending on occurrence frequency:
the most frequent> 1/10
frequent> 1/100i <1/10
infrequent> 1/1000 and <1/100
rare> 1/10000 and <1/1000
very rare <1/10000

Disturbances about hundred-ions of eyes:
Infrequent: irritation of eyes.

From integuments and appendages of skin:
Frequent: itch.
Infrequent: rash, burning sensation, pain, irritation, dermatitis, exacerbation of psoriasis, folliculitis, xeroderma, acne, pustular psoriasis.

Kaltsipotriol can cause local irritation of skin, an itch, burning sensation and tinglings, a xeroderma, an erythema, rash, dermatitis, eczema, an exacerbation of psoriasis, reaction hyper - and photosensitivity, the including very exceptional cases of a Quincke's disease and a face edema.

Connect development of an atrophy of skin, teleangiectasias, striya, a folliculitis, hypertrichosis, perioral dermatitis, allergic contact dermatitis, a depigmentation, colloid degeneration of skin, and also increase in risk of development of generalized pustular psoriasis with prolonged external use of betamethasone (Dipropionas).

System reactions
(Very rare) connected using a kaltsipotriol: hypercalcemia or hypercalcuria.

Connected using betamethasone (rare, but sometimes heavy, especially at prolonged use, on big surfaces and when using occlusive bandages): suppression of function of bark of adrenal glands, cataract, infections, increase in intraocular pressure.

System reactions arise more often when putting drug under occlusive bandages and when drawing on thin skin and on skin folds, and also during prolonged treatment when drawing on big sites of skin.

Interaction with other medicines:

It is not known.

Contraindications:

The diseases which are followed by calcium metabolism disturbance.
Hypersensitivity to any of drug components.
The expressed renal and liver failure.
Virus (herpes, shingles), fungal, bacterial and parasitic infections of skin, a rozatse, pink eels, ordinary eels, perioral dermatitis, skin displays of tuberculosis and syphilis, an atrophy of skin, an ulcer, wound, an itch in perianal area and in genitals, the increased fragility of vessels of skin, an ichthyosis, striya.
Psoriasis erythrosis, tear-shaped, exfoliative, pustular psoriasis.
Age up to 18 years.

Use at pregnancy and a lactation
At pregnancy КСАМИОЛ® apply only if the estimated advantage for mother exceeds potential risk for a fruit. If necessary use of drug in the period of a lactation it is recommended to refuse breastfeeding.

Overdose:

Symptoms: increase in content of calcium in blood, at phase-out of drug is quickly recovered; suppression of function of pituitary and adrenal system with development of reversible secondary adrenal insufficiency.
Treatment: to cancel drug and to carry out symptomatic therapy. In cases of chronic toxicity of GKS it is necessary to cancel gradually.

Storage conditions:

At a temperature not above 25 °C. To store in the place, unavailable to children. A period of validity 2 years, after opening of a bottle - 3 months. Not to use after expiry date.

Issue conditions:

Without recipe

Packaging:

Gel for external use. On 15, 30 or 60 g of gel in the bottle from polyethylene of high density equipped with a nozzle from polyethylene of low density and the screw-on cover from polyethylene of high density; on 1 bottle together with the application instruction in a cardboard pack.