Cloveit - instructions for use, dose, side effects, contraindications

Excipients: propylene glycol 100.0 mg, disodium edetate 0.2 mg, chlorocresol 1.0 mg, paraffin liquid 23.0 mg, petrolatum white 252.0 mg, glyceryl monostearate 31.0 mg, cetostearyl alcohol (cetyl alcohol 60%, stearyl alcohol 40%) 69.0 mg, polysorbate-40 53.0 mg, triglycerides of decanoic and octanoic acids 15.0 mg, silicon dioxide colloid 1.0 mg, sodium citrate 0.5 mg, citric acid 0.5 mg, purified water up to 1.0 g.

Description:

White homogeneous mass.

Pharmacotherapeutic group:Glucocorticosteroid for topical application

ATX: & nbsp

D.07.A.D.01 Clobetasol

Pharmacodynamics:

Glucocorticosteroid for external use. It prevents the accumulation of neutrophils, reduces inflammatory exudation and production of lymphokines, inhibits the migration of macrophages, reduces the intensity of infiltration and granulation processes, exerts local anti-inflammatory,antipruritic, anti-allergic and anti-exsudative effects.

Pharmacokinetics:

The average maximum concentration of clobetasol propionate is reached in the plasma 13 hours after the first application and 8 hours after repeated application to the healthy skin of 30 g clobetasol propionate in the form of 0.05% ointment and is 0.63 ng / ml. 10 hours after the application of the second dose (30 g) of clobetasol propionate in the form of a cream, its average maximum concentration in the plasma slightly exceeds that of the ointment. After 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 in the plasma 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 builds up absorption) and the manifestation of a systemic effect. Metabolized mainly in the liver, a small part - in the kidneys. It is excreted by the kidneys.

Indications:

- Psoriasis (with the exception of pustular and extensive plaque psoriasis);

- eczema (various forms);

- red flat lichen;

- discoid lupus erythematosus;

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

Contraindications:

- Pink acne;

- Acne vulgaris;

- skin cancer;

- nodular pruritus of Gaida;

- perioral dermatitis;

- perianal and genital itching;

- cutaneous manifestations of syphilis, diaper rash;

- bacterial, viral and fungal skin diseases (including herpes simplex, chicken pox, 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:

Glucocorticosteroids for topical application should not be used during pregnancy for a long time in large doses.

The safety of the use of clobetasol during lactation is not established.

Dosing and Administration:

Outwardly.

The cream is applied a thin layer on the affected skin 1-2 times a day. The duration of a continuous course of treatment is limited to 3-4 weeks.

In particularly resistant cases, especially in the presence of hyperkeratosis, the anti-inflammatory effect of the drug Kloveit® can be strengthened by applying overnight the area of application of the drug bandages made of polyethylene film, which is usually accompanied by a positive effect. When changing the occlusive dressing, the skin should be cleaned. In the future, the achieved effect can be maintained without the use of an occlusive dressing.

Side effects:

Burning, itching, steroid acne, dry skin.

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

Long-term administration of glucocorticosteroids for topical application in large doses or applying them to large areas of the skin can be accompanied by systemic absorption with the subsequent development of symptoms of hypercorticoidism. The risk of developing this complication is increased in children, especially with the use of an occlusive dressing, while the diaper can serve as a bandage.

Subject to the appointment of the drug Cloveit® adult patients in a dosage of not more than 50 g per week suppression of the function of the pituitary and adrenal glands is transient in nature with their rapid recovery immediately after the end of the course of treatment.

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

Rarely the drug Cloveit® can cause an exacerbation of the symptoms of the disease.

Overdose:

The development of acute overdose is unlikely. However, in case of chronic overdose or misuse, symptoms of hypercorticism may develop, which requires a gradual discontinuation of the drug under the supervision of a physician.

Interaction:

No data.

Special instructions:

Cloveit® the 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 skin inflammation of the scalp.

The drug is recommended for short-term use.

Should be avoided glucocorticosteroids for topical administration for a long time, especially in the treatment of young children, as this can happen adrenal suppression. The use of the drug in children requires observation of the doctor at least once a week.

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

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

Treatment of psoriasis topical corticosteroids may be accompanied by the development of recurrence of the disease, tolerance to the drug, generalized pustular forms of the disease, local or systemic toxic reactions due to violation of the skin barrier function, so it is particularly important close observation of the patient.

When attaching a secondary infection, appropriate antibiotic therapy should be carried out. If any signs of generalized infection should stop the topical application of glucocorticosteroids and conduct appropriate treatment with antibacterial drugs.

Warm moist conditions created with the application of an occlusive dressing, contribute to the emergence of a bacterial "infection, so it is necessary to cleanse the skin before applying a new dressing.

The cream is not recommended to plant.

Form release / dosage:

Cream for external use, 0.05%.

Packaging:

25 grams of cream in lithographed aluminum tubes with a lacquered inner surface.

The tube is placed in a lithographed cardboard box with instructions for use.

Storage conditions:

Store at a temperature not exceeding 25 ° C. Do not freeze.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LSR-000837/10

Date of registration:09.02.2010 / 15.10.2014

Expiration Date:Unlimited

The owner of the registration certificate:VALEANT, LLC VALEANT, LLC Russia

Manufacturer: & nbsp

JELFA PHARMACEUTICAL WORKS, S.A. Poland

Representation: & nbspVALEANT LLC VALEANT LLC Russia

Information update date: & nbsp29.01.2018

Illustrated instructions

Instructions

Cloveit® (Clovate®)