Etrivex shampoo 0.05% 60ml

User manual for Etrivex

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Release form, composition and packaging

Shampoo 0.05% in the form of a viscous translucent from colorless to slightly yellow color of the liquid with the smell of ethanol.
1 ml
clobetasol propionate 500 mcg
Excipients: ethanol 96% - 100 mg, cocobetaine (30% solution) - 60 mg, sodium lauryl sulfate (70% solution) - 170 mg, polyquaternium-10 - 20 mg, sodium citrate - 26 mg, citric acid monohydrate - 2.4 mg , purified water - 621.1 mg.

pharmachologic effect

Like other corticosteroids for topical administration, clobetasol has anti-inflammatory, antipruritic and vasoconstrictive properties. The mechanism of anti-inflammatory activity of corticosteroids for external use is not fully understood. However, it is believed that GCS act by induction of lipocortins, proteins, which in turn are inhibitors of phospholipase A2. Inhibition of phospholipase A2, in turn, leads to the suppression of the release of arachidonic acid, which is a precursor of such powerful inflammatory mediators as prostaglandins and leukotrienes. Thus, clobetasol due to the induction of lipocortins leads to a decrease in the biosynthesis of the main mediators of inflammation, and, therefore, has an anti-inflammatory effect.

Pharmacokinetics

Suction

GCS for external use can undergo systemic absorption from intact healthy skin. The degree of percutaneous absorption of GCS for external use is determined by a number of factors, including the scope, skin condition (integrity of the skin), the basis of the medicinal product, the method and duration of use. Occlusion, inflammation and / or other pathological processes of the skin can also increase percutaneous absorption. When using clobetasol in accordance with therapeutic recommendations (15 minutes, then wash off), absorption is very low and systemic exposure is negligible. Available clinical data show that only one of 126 patients has a plasma clobetasol propionate concentration that reaches a concentration that can be quantified (0.43 ng / ml).

Distribution

The use of pharmacodynamic endpoints to assess the systemic exposure of GCS for external use is necessary due to the fact that the concentration of Etrivex circulating in the blood is well below the detection limit.
Clobetasol does not accumulate.

Metabolism

After absorption through the skin, GCS is metabolized for external use mainly in the liver.

Removal

GCS for external use are excreted by the kidneys.

Indications

Treatment and prevention of recurrent psoriasis of the scalp in adults (with the exception of pustular and extensive plaque psoriasis).

Contraindications

- hypersensitivity to the active substance or to any of the excipients;
- skin areas affected by bacterial, viral, fungal or parasitic infections and specific skin diseases (skin tuberculosis, skin diseases caused by syphilis), as well as ulcerated skin areas;
- applying the drug to the eyes and eyelids (risk of developing glaucoma, cataracts);
- children's age up to 18 years;
- breastfeeding period.
With care: severe abnormal liver function and severe diabetes mellitus.

Dosage

For external use only.
Apply only to the skin of the scalp.
The main course of treatment with daily use of shampoo
Etrivex shampoo should be applied 1 time / day on dry scalp, rubbing thoroughly into the affected areas. For one application on the entire skin of the scalp about 7.5 ml (half a tablespoon) of the preparation is sufficient.
Wash thoroughly after applying hand. Etrivex applied shampoo should be left on the scalp, not covering it for 15 minutes, then rinse with water and / or, if necessary, wash the hair with regular shampoo.
The course of treatment with daily application of Etrivex should not exceed 4 weeks. In this case, the dose of the drug should not exceed 50 ml per week.
Upon reaching the desired result, drug treatment should be discontinued.
If there is no improvement after 4 weeks of treatment, the diagnosis and therapy should be reconsidered.
Supportive therapy with shampoo 2 times a week
After cleansing the lesions, as well as in the case when after 4 weeks of the main course the patient has a small amount of psoriatic flakes, Etrivex shampoo should be applied 2 times a week to maintain the therapeutic effect and prevent relapse. Such supportive therapy is effective for 6 months.

Patients with impaired liver function

Patients with severely impaired liver function and severe diabetes mellitus should be prescribed Etrivex with extreme caution and carefully monitor possible side effects.

Side effects of Etrivex

When using the drug Etrivex, undesirable reactions can occur as indicated in the table below, which are divided into classes of organ systems and frequency of occurrence: very often (≥1 / 10), often (from ≥1 / 100 to <1/10), infrequently ( ≥1 / 1000 to <1/100), rarely (≥1 / 10 000 to <1/1000), very rarely (<1/10 000), the frequency is unknown (the frequency of occurrence cannot be determined based on the available data, including post-registration application data).
The frequency of occurrence of undesirable drug reaction
From the endocrine system
infrequent suppression of adrenal function *
Cushing's syndrome *
On the part of the organ of vision
rarely stinging / burning eyes
eye irritation
feeling of tension in the eyes
glaucoma*
The immune system
infrequently hypersensitivity *
The nervous system
infrequently headache
Skin and Subcutaneous Tissues
often burning sensation of the skin
folliculitis
rarely sore skin
skin discomfort
itch
acne
skin swelling
telangiectasia
psoriasis (aggravation)
alopecia
dry skin
hives
skin atrophy
skin irritation
skin tightness
allergic contact dermatitis *
erythema*
rash*
Clobetasol belongs to the class of potent GCS drugs for external use, prolonged daily use and / or intensive application of which can cause atrophic skin changes, such as striae, purpura, and generalized pustular psoriasis. With the cessation of treatment may cause withdrawal.
When exposed to the skin, very potent SCS can cause perioral dermatitis or exacerbation of rosacea.
There were cases of changes in pigmentation, hair growth, pustular rashes and hypertrichosis with external use of GCS.
A cataract was observed in case of GCS in the eyes or on the eyelids.
In rare cases with prolonged use of potent corticosteroids for external use, immunosuppression and opportunistic infections have been noted.
When absorption of external corticosteroids into the systemic circulation, growth retardation may be observed in children.
If any of these side effects worsen or any other side effects occur, you should immediately inform your doctor.

Overdose

Acute overdose is very unlikely, however, in case of chronic overdose or improper use, signs of hypercorticism may appear. In this situation, treatment should be gradually canceled. However, due to the risk of acute suppression of adrenal function, this should be done under medical supervision.

Drug interaction

Drug interaction is not known.

special instructions for Etrivex

Hypersensitivity to GKS can be observed. It is not recommended to apply clobetasol in patients with hypersensitivity to other corticosteroids, as well as in patients with acne, rosacea or perioral dermatitis.
GCS for external use should be used with caution because of the possibility of recurrence of the disease and withdrawal after stopping treatment, as well as the development of resistance (tachyphylaxis) and local or systemic toxicity, such as skin atrophy (thinning of the skin), infections (including isolated cases of systemic infections), telangiectasia of the skin (local expansion of small skin vessels, as a result of which they become more noticeable) or suppression of the hypothalamic-pituitary-adrenal system (disorders with Endocrine s).
Atrophic changes with prolonged use of potent corticosteroids for external use are most susceptible to the face, compared to other parts of the body.
Prolonged continuous therapy with daily application of corticosteroids, especially in the treatment of large areas of lesions, and the use of occlusive dressings can increase absorption and, consequently, lead to an increased risk of systemic effects. In such cases, it is necessary to strengthen medical supervision and regularly examine the patient for suppression of the hypothalamic-pituitary-adrenal system. In some cases, the absorption of GCS for external use into the systemic circulation leads to a reversible suppression of the adrenal glands with the possible development of glucocorticoid insufficiency, manifestations of Cushing syndrome, hyperglycemia and glucosuria. After cessation of treatment, such systemic effects disappear. However, abrupt cessation of treatment can lead to the development of acute adrenal insufficiency, especially in children.
Etrivex shampoo is indicated only for the treatment of psoriasis of the scalp and is not intended for application to other parts of the body and areas of the skin prone to chafing (axillary cavities, genital and anal areas) and erosive areas of the skin, because This increases the risk of local adverse reactions, such as atrophic skin changes, telangiectasia, or dermatitis caused by GCS.
In case of contact with eyes, rinse immediately with plenty of water.
In order to avoid contact with products intended for hair coloring, Etrivex shampoo should be thoroughly rinsed off after use.

Influence on ability to drive vehicles and mechanisms

Studies on the effect of clobetasol for external use on the ability to drive vehicles and mechanisms was not conducted. Patients should be warned about the possibility of a cramping / burning sensation in the eyes, eye irritation, feelings of tension in the eyes. At the occurrence of the described adverse events should refrain from performing the specified activities.

Pregnancy and lactation

External use of GCS in pregnant animals can cause fetal development disorders. The value of this data for humans has not been established, since adequate and strictly controlled studies in pregnant women have not been conducted. The use of clobetasol during pregnancy should be considered only if the expected benefit to the mother exceeds the risk to the fetus.
You should apply the minimum amount of Etrivex in a small area and for a minimum time.
Systematically applied GCS penetrate into breast milk. There are no data on the possible secretion of clobetasol in breast milk when applied externally, therefore, if you need to use the drug during lactation, it is recommended to stop breastfeeding.

Pharmacy sales terms

You can buy Etrivex without a prescription.

Terms and conditions of storage

Etrivex should be stored out of the reach of children at a temperature not higher than 25 ° C. Shelf life - 3 years. Do not use after expiration date.