Clovate, 0.05% ointment, 25g

Composition

1 g:

– clobetazole propionate 500 mcg

Auxiliary substances:

propylene glycol-50 mg,

sorbitan sesquioleate-5 mg,

white vaseline-up to 1 g

Pharmacological action

Kloveyt-corticosteroids for external use.

It prevents marginal accumulation of neutrophils, reduces inflammatory exudation and cytokine production, inhibits macrophage migration, and reduces the intensity of infiltration and granulation processes.

It has local anti-inflammatory, antipruritic, anti-allergic and anti-exudative effects.

Pharmacokinetics:  

Suction

The average Cmax of clobetasol propionate is 0.63 ng / ml and 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.

10 hours after applying the second dose (30 g) of clobetasol propionate as a cream, its average plasma Cmax slightly exceeds that after applying the ointment. 3 h after a single use of 25 g of 0.05% clobetazole propionate ointment in patients with psoriasis and eczema, the average Cmax of the drug in 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 increases absorption) and the manifestation of a systemic effect.

Metabolism and elimination

It is mainly metabolized in the liver, a small part – in the kidneys. It is excreted in the urine.

Indications

-psoriasis (except for pustular and extensive plaque psoriasis);- eczema (various forms);- lichen planus erythematosus;- discoid lupus erythematosus; – skin diseases resistant to therapy with less active topical corticosteroids.

Contraindications

-rosacea; – vulgar acne;— skin cancer— – nodular pruritus of the Guide;- perioral dermatitis;- perianal and genital pruritus;- skin manifestations of syphilis;- diaper rash;- bacterial, viral and fungal skin diseases (including herpes simplex, chickenpox, skin tuberculosis, actinomycosis);- common plaque and pustular psoriasis;— age up to 1 year;— pregnancy— – lactation period;- hypersensitivity to the components of the drug Kloveyt.

Side effects

Dermatological reactions: burning, pruritus, steroid acne, dry skin; with prolonged use-weakening of the skin barrier function; with prolonged use in high doses – atrophic changes in the skin, in particular, its thinning, the appearance of atrophic strips (striae), 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, the treatment of psoriasis with corticosteroids for external use (or their cancellation) provokes the development of pustular psoriasis.

When applied on large surfaces, systemic side effects may develop: gastritis, ulceration of the gastrointestinal mucosa, increased intraocular pressure, symptoms of hypercorticism.

Long-term use of corticosteroids for external use in large doses or their application to large areas of the skin may be accompanied by systemic absorption, followed by the development of symptoms of hypercorticism. The risk of developing this complication is increased in children, especially when using an occlusive dressing, and the diaper can serve as such a dressing.

If Clovate® is prescribed to adult patients at a dosage of no more than 50 g per week, suppression of pituitary and adrenal function is transient with rapid recovery immediately after the end of the course of treatment.

In rare cases, the drug Clovate® can cause an exacerbation of the symptoms of the disease.

How to take, course of use and dosage

Apply externally. Cream or ointment Kloveyt is applied in 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 Clovate® can be enhanced by applying a plastic wrap dressing to the area of application at night, which is usually accompanied by a positive effect.

When changing the occlusal dressing, the skin should be cleaned. In the future, the achieved effect can be maintained without the use of an occlusive dressing.

Overdose

The development of an acute overdose is unlikely.

However, in the case of chronic overdose or improper use, symptoms of hypercorticism may develop, which requires gradual discontinuation of the drug under the supervision of a doctor.

Special instructions

The preparation Kloveyt ® ointment is recommended for use in skin lesions accompanied by its dryness, hyperkeratosis, thickening.

Kloveyt ® 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.

External corticosteroids should be avoided for extended periods of time, especially in the treatment of young children, as this may lead to suppression of adrenal function. The use of Clovate® 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 external forms of corticosteroids.

Do not apply Clovate in the eye area, as the use of the drug in the periorbital area may cause glaucoma.

Treatment of psoriasis with corticosteroids for external 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 violation of the skin barrier function, so careful monitoring of the patient is especially important. When a secondary infection is added, appropriate antibacterial therapy should be carried out.

If there are any signs of generalization of infection, it is necessary to stop external use of corticosteroids and conduct appropriate treatment with antibacterial drugs. The warm, humid conditions created when applying an occlusal dressing contribute to the occurrence of bacterial infection, so you should always clean the skin before applying a new dressing.

Kloveyt cream is not recommended to be diluted.

Influence on the ability to drive motor vehicles and manage mechanisms

The use of the drug does not affect the patient’s ability to perform work that requires increased attention and speed of psychomotor reactions.

Form of production

Ointment for external use.

Storage conditions

At a temperature not exceeding 25 °C

Shelf life

3 years

Active ingredient

Clobetazol

Conditions of release from pharmacies

By prescription

Dosage form

ointment