Cloveit cream 0.05%, 25 g

- Psoriasis (excluding pustular and extensive plaque psoriasis)

- Eczema (various forms)

- Lichen planus

- Discoid lupus erythematosus

- Skin diseases resistant to therapy with less active glucocorticosteroids for topical use.

Outwardly. The cream is applied in a thin layer to the affected skin 1-2 times a day. The duration of the continuous course of treatment is limited to 34 weeks.

In particularly resistant cases, especially in the presence of hyperkeratosis, the anti-inflammatory effect of Cloveit can be enhanced by applying a plastic film bandage to the area of ??application of the drug at night, which is usually accompanied by a positive effect. When changing the occlusive dressing, the skin must be cleaned. In the future, the achieved effect can be maintained without the use of an occlusive dressing.

1 g of cream contains:

Active ingredient: clobetasol propionate 0.5 mg

Excipients: propylene glycol, disodium edetate, chlorocresol, liquid paraffin, white petrolatum, glyceryl monostearate, cetostearyl alcohol (cetyl alcohol 60%, stearyl alcohol 40%), polysorbate 40, triglycerides of decanoic acid decanoic acid and octanoic acid acid, flavoring Hemoderm 841, purified water.

- Rosacea

- Acne vulgaris

- Skin cancer

- Hyde's nodular pruritus

- Perioral dermatitis

- Perianal and genital itching

- Skin manifestations of syphilis, diaper rash

- Bacterial, viral and fungal skin diseases (including herpes simplex, chickenpox, skin tuberculosis, actinomycosis)

- Common plaque and pustular psoriasis

- Hypersensitivity to the active and auxiliary substances of the drug

- Age up to 1 year

- Lactation period

- Pregnancy

Trade name of the drug: CloveitЃ

International non-proprietary name:

Clobetasol

Dosage form:

Cream for external use

Composition:

1 g of cream contains:

Active ingredient: clobetasol propionate 0.5 mg

Excipients: propylene glycol, disodium edetate, chlorocresol, liquid paraffin, white petrolatum, glyceryl monostearate, cetostearyl alcohol (cetyl alcohol 60%, stearyl alcohol 40%), polysorbate 40, triglycerides of decanoic acid decanoic acid and octanoic acid acid, flavoring Hemoderm 841, purified water.

Description:

White homogeneous mass.

Pharmacotherapeutic group:

Topical glucocorticosteroid.

Pharmacological properties
Pharmacodynamics
Glucocorticosteroid for external use. Prevents marginal accumulation of neutrophils, reduces inflammatory exudation and production of lymphokines, inhibits the migration of macrophages, reduces the intensity of infiltration and granulation processes, has local anti-inflammatory, antipruritic, anti-allergic and anti-exudative effects.

Pharmacokinetics
The average maximum concentration of clobetasol propionate is reached in plasma 13 hours after the first application and 8 hours after repeated application to healthy skin of 30 g of clobetasol propionate in the form of 0.05% ointment and is 0.63 Iig / ml. 10 hours after the application of the second dose (30 g) of clobetasol propionate in the form of a cream, its average maximum plasma concentration slightly exceeds that of the ointment. 3 hours after a single application of 25 g of 0.05% clobetasol propionate ointment in patients with psoriasis and eczema, the average maximum plasma concentration of the drug is 2.3 ng / ml and 4.6 ng / ml, respectively.

When applied to large areas of the skin, absorption is possible (damage to the integrity or inflammation of the skin increases absorption) and the manifestation of a systemic effect. It is metabolized mainly in the liver, a small part - in the kidneys. It is excreted by the kidneys.

Indications

- Psoriasis (excluding pustular and extensive plaque psoriasis)

- Eczema (various forms)

- Lichen planus

- Discoid lupus erythematosus

- Skin diseases resistant to therapy with less active glucocorticosteroids for topical use.

Contraindications

- Rosacea

- Acne vulgaris

- Skin cancer

- Hyde's nodular pruritus

- Perioral dermatitis

- Perianal and genital itching

- Skin manifestations of syphilis, diaper rash

- Bacterial, viral and fungal skin diseases (including herpes simplex, chickenpox, skin tuberculosis, actinomycosis)

- Common plaque and pustular psoriasis

- Hypersensitivity to the active and auxiliary substances of the drug

- Age up to 1 year

- Lactation period

- Pregnancy

Pregnancy and lactation
Topical glucocorticosteroids should not be used during pregnancy for a long time in high doses.

The safety of using clobetasol during lactation has not been established.

Method of administration and dosage
Outwardly. The cream is applied in a thin layer to the affected skin 1-2 times a day. The duration of the continuous course of treatment is limited to 34 weeks.

In particularly resistant cases, especially in the presence of hyperkeratosis, the anti-inflammatory effect of Cloveit can be enhanced by applying a plastic film bandage to the area of ??application of the drug at night, which is usually accompanied by a positive effect. When changing the occlusive dressing, the skin must be cleaned. In the future, the achieved effect can be maintained without the use of an occlusive dressing.

Side effect
Burning, itching, steroid acne, dry skin.

With prolonged use: weakening of the barrier function of the skin. When applied to large surfaces, systemic side effects may develop (gastritis, ulceration of the gastrointestinal mucosa, increased intraocular pressure, symptoms of hypercortisolism).

Long-term administration of glucocorticosteroids for topical use in large doses or their application to large areas of the skin may be accompanied by systemic absorption with the subsequent development of symptoms of hypercortisolism. The risk of developing this complication is increased in children, especially when using an occlusive dressing, while the diaper can act as such a dressing.

Provided that the drug Cloveit is prescribed to adult patients at a dosage of no more than 50 g per week, the suppression of the function of the pituitary and adrenal glands has a transient character with their rapid recovery immediately after the end of the course of treatment.

Long-term treatment with highly active glucocorticosteroids for topical application in large doses can cause atrophic changes in the skin, in particular, its thinning, the appearance of atrophic streaks (striae), expansion of superficial blood vessels, especially when applying occlusive dressings and when applying the drug to areas of skin with folds. Skin pigmentation and hypertrichosis may develop. In rare cases, treatment of psoriasis with topical glucocorticosteroids (or their withdrawal) provokes the development of pustular psoriasis.

Rarely, the drug Cloveit can exacerbate the symptoms of the disease.

Interaction with other medicinal products
No data available.

Overdose
Development of acute overdose is unlikely. However, in the case of chronic overdose or improper use, symptoms of hypercortisolism may develop, which requires a gradual withdrawal of the drug under the supervision of a physician.

Special instructions
Cloveit cream is recommended for the treatment of acute inflammatory skin diseases, including those accompanied by the development of wetness, as well as for the treatment of inflammation of the scalp.

The drug is recommended for short-term use.

Avoid the appointment of glucocorticosteroids for topical use for a long time, especially when treating young children, as this can lead to suppression of adrenal function. The use of the drug in children requires medical supervision at least once a week.

On the face more often than on other parts of the body, atrophic skin changes may appear as a result of prolonged use of local glucocorticosteroids.

Do not apply the drug in the eye area, as glaucoma may develop if it is used in the periorbital area.

Treatment of psoriasis with glucocorticosteroids for local use may be accompanied by the development of relapses of the disease, tolerance to the drug, generalized pustular form of the disease, local or systemic toxic reactions due to a violation of the barrier function of the skin, therefore, careful monitoring of the patient is especially important.

When a secondary infection is attached, appropriate antibiotic therapy should be carried out. For any signs of generalization of the infection, it is necessary to stop the local use of glucocorticosteroids and conduct appropriate treatment with antibacterial drugs.

The warm, humid conditions created by applying an occlusive dressing are conducive to bacterial infection, so be sure to cleanse the skin before applying a new dressing.

It is not recommended to dilute the cream.

Influence on the ability to drive vehicles and mechanisms
Does not affect.

Release form
Cream for external use 0.05%.
25 g of cream in lithographed aluminum tubes with lacquered inner surface. The tube is placed in a lithographed cardboard box with instructions for use.

Shelf life is
3 years.
Do not use after the expiration date.

Storage
conditions Store at a temperature not exceeding 25 ? —. Do not freeze.
Keep out of the reach of children.

Terms of dispensing from pharmacies
List B. By prescription.