Ksamiol gel naruzhn.prim th 15g

Description

Composition
Active substance:
betamethasone dipropionate 0.643 mg (equivalent to 0.5 mg of betamethasone)
calcipotriol monohydrate 0.052 mg (equivalent to 0.05 mg Calcipotriol)
Excipients:
paraffin liquid (containing about 10 ppm alpha-tocopherol) 820 mg, polypropylene glycol stearate (PPG-15) (containing 0.1% BHT) 160 mg hydrogenated castor oil 20 mg.
Description:
Almost transparent, colorless to almost white gel. On thin oily film may be observed surface.
Product form:
Gel for external application. 15 g of gel in a vial of high density polyethylene, low density nozzle equipped with a screw cap and high density polyethylene, polyethylene; per vial is glued two-page self-adhesive label. 1 bottle together with instructions for use in a cardboard box.
Contraindications
Hypersensitivity to betamethasone, calcipotriol, any excipient the formulation.
Ksamiol® The drug is contraindicated in erythrodermic psoriasis, exfoliative and pustular psoriasis.
Due to the presence of the drug calcipotriol Ksamiol® contraindicated in patients with impaired calcium metabolism.
Due to the presence of the drug glucocorticosteroid betamethasone, Ksamiol®
contraindicated in the following conditions: viral, fungal, bacterial and parasitic infections of the skin, skin manifestations of tuberculosis, perioral dermatitis, skin atrophy, striae, increased fragility of the saphenous veins, ichthyosis, acne vulgaris, rosacea (acne rosacea), ulcers, wounds,
Children up to age 18 years.
Indications
Psoriasis of the scalp. Psoriasis mild to moderate severity of other body parts.
Interaction with other drugs
Studies on the interaction with other drugs has not been conducted.
Overdose
Use of the drug in doses exceeding the recommended may cause hypercalcemia (increased blood calcium); at the termination of the treatment condition normalized.
Symptoms of hypercalcemia include polyuria (increased urine formation), constipation,
muscle weakness, confusion and coma.
Excessively long-term use of corticosteroids for topical application can inhibit the function of the pituitary-adrenal system with the development of a reversible secondary adrenal insufficiency. Symptomatic treatment is given in such cases. In cases of chronic toxicity of corticosteroids should be withdrawn gradually.
pharmachologic effect
Pharmacological group:
treatment for psoriasis
Pharmacodynamics:
Calcipotriol – a synthetic analogue of the active metabolite of vitamin D. It is inhibition of keratinocyte proliferation and accelerates their morphological differentiation.
Betamethasone – glucocorticosteroid (GCS) for external use; has a local anti-inflammatory, antipruritic, vasoconstrictive and immunosuppressive effect, however, the exact mechanisms of action of anti-inflammatory corticosteroids for topical use are not entirely clear.
Pharmacokinetics:
In applying the drug Ksamiol® calcipotriol and betamethasone absorption through intact skin is less than 1%. When applying the drug on psoriatic plaques and under occlusive dressings increases the absorption of corticosteroids. Since the skin creates a depot of the active ingredients, its elimination from the skin occurs within a few days. Betamethasone is metabolized in the liver and in the kidneys to form glucuronides and ethersulfates, excretion via the kidneys and intestine
Pregnancy and breast-feeding
Pregnancy
Adequate and well-controlled studies have not been conducted in pregnant women. Clinical data on the use of the drug in pregnant women is limited. In experimental animal studies, it was found the presence of reproductive toxicity, including teratogenicity. Risk to the fetus or the child is not completely excluded. The question of the appropriateness of the drug during pregnancy should be decided individually after consulting a doctor, if the potential benefit to the mother outweighs the potential risk to the fetus.
Breastfeeding
Animal studies suggest that betamethasone crosses the placental barrier and is excreted in breast milk. For information about the penetration of calcipotriol in breast milk is not available. If necessary, use during breastfeeding should not cause the drug to the mammary gland.
fertility
Studies of oral doses of calcipotriol and betamethasone in animals have not revealed impaired fertility in male and female rats.
Conditions of supply of pharmacies
Without a prescription.
side effects
Classification side reactions organs and systems indicating the frequency of occurrence: very often (> 1/10), often (> 1/100
special instructions
To avoid application of the drug to the area exceeding 30% of the body surface, and to use more than 15 g of the drug per day, or 100 g per week.
It is not recommended to apply the preparation by bathing cap, cast bandage, dressing, since it increases the absorption of corticosteroids.
Should not be applied on large areas of damaged skin, mucous membranes, skin folds (groin area, armpit under the breast), since this leads to an increase in absorption of corticosteroids.
Avoid applying the product to the face and the skin of the genitals (sex organs) as they are very sensitive to corticosteroids. In case of accidental contact with eyes, undesirable reactions such as irritation of the eyes and skin, conjunctivitis. In case of eye contact with the drug they must be rinsed with running water.
During drug treatment Ksamiol® patient is advised to limit or avoid excessive exposure natural or artificial sunlight. Calcipotriol (and products containing it) is allowed to be used topically in combination with UV radiation only in those cases where the physician deems warranted coupled with the risks of the treatment.
Preparation Ksamiol® comprises butylhydroxytoluene (E321) which may cause local skin reactions (e.g., contact dermatitis) or irritation to the eyes and mucous membranes.
Consultation with a doctor in the following cases:
– if you are taking other medicines that contain corticosteroids, due to an increased risk of side effects;
– if you have used more than 15 grams per day or 100 grams per week;
– cessation of treatment of psoriasis topical preparations containing steroids may be associated with the risk of generalized pustular psoriasis and cancel the effect. Therefore, discontinuation of therapy is recommended under medical supervision;
– if you have diabetes, because steroids affect the level of sugar (glucose) in the blood;
– when the skin infection, as it may require antimicrobial therapy. In the case of aggravation of infection, treatment with Ksamiol® should be discontinued;
– with guttate psoriasis as treatment experience guttate psoriasis drug Ksamiol®
is absent.
Effect on the ability to drive mechanisms and
Does not affect.
Storage conditions
At temperatures above 25 ° C. Do not store in the refrigerator. Store in a carton box to protect from light.
Keep out of the reach of children.
After opening the bottle store 6 months.
Dosing and Administration
Outwardly.
Use in adults.
Before use, the vial should be shaken drug. The gel is applied a thin layer to the affected areas of the scalp or other parts of the psoriatic plaque body 1 once a day, after forcing a small amount of gel on a clean finger or directly to the affected portion of psoriasis.
Gel coated areas should not close tightly fitting cloth bandages and occlusion.
After applying the gel Ksamiol® hands must be washed, if the gel is in contact with the fingers. This prevents the accidental ingress of gel on other areas of the body (especially on the face,
the mouth and eyes).
Excess gel accidentally trapped on healthy skin when applied to the affected area,
removed.
Wash your hair before applying the gel Ksamiol® on the scalp is not necessary.
For optimum effect it is not recommended immediately after application of the gel to take a shower or bath. The drug should remain on the skin during the night or day.
The dose and duration of treatment
If you use other products containing calcipotriol, the total amount of drug should not exceed 15 grams per day and 100 g per week. The maximum daily dose of 15 grams per day. 4 g of the gel corresponding to 1 teaspoon.
Typically, the treatment of the scalp a sufficient amount of 1 g to 4 g of gel per day.
course recommended duration of treatment is 4 weeks for psoriasis of the scalp, and 8 weeks for psoriasis to other body parts. In most cases, a visible improvement occurs after 2 weeks of treatment, although by this time complete disappearance of psoriasis has not yet been observed.
The total area of ​​drug applied should not exceed 30% of the body surface (including both the scalp and other body parts). In order to achieve the optimal therapeutic effect of the drug should remain on the skin throughout the night or day.
If the recommended period of treatment was insufficient, consult your doctor.
Continued treatment or re-treatment are possible only under medical supervision!
The use of the drug Ksamiol®
in higher doses and / or longer period may cause an increase in calcium levels in the blood, adrenal gland malfunction.
If you missed taking the drug, you can not apply a double dose on the next application,
to compensate for the missed dose.
Discontinue use of the gel Ksamiol® should be gradually, especially if used for a long time.
Before the termination of treatment, consult your physician.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist