Expiration date: 04/2026

The composition and form of issue:

Cream for external use. 1 g contains active substance: 

of clobetasol propionate 0.5 mg

excipients: propylene glycol — 100 mg of disodium edetate 0.2 mg chlorocresol 1 mg liquid paraffin — 23 mg white vaseline — 252 mg glyceryl monostearate — 31 mg cetostearyl alcohol (cetyl alcohol 60%, stearyl alcohol 40%) — 69 mg Polysorbate 40 — 53 mg triglycerides dekanova and octanoic acid — 15 mg colloidal silicon dioxide 1 mg sodium citrate and 0.5 mg of citric acid — 0.5 mg flavour of geoderm 841 — 0.3 mg purified water to 1 g 

tube aluminum with polished inner surface 25 g in cartons lithographed 1 tube.

Description pharmaceutical form:

A homogeneous mass of white color.

Pharmacokinetics:

The average Cmax of clobetasol propionate in plasma is reached after 13 h after the first application and 8 hours after repeated application on healthy skin 30 g clobetasol propionate as a 0.05% ointment and 0.63 ng/ml 10 h after application of the second dose (30 g) of clobetasol propionate in a cream its average Cmax in plasma is slightly higher than that of the ointment. After 3 h after a single application of 25 g 0.05% ointment and clobetasol propionate in patients with psoriasis and eczema average Cmax of the drug in plasma is 2.3 ng/ml and 4.6 ng/ml, respectively.

When applied to large areas of skin aspiration (damage to the integrity or inflammation of the skin enhances absorption) and systemic effect. Metabolized mainly in the liver, a small part in the kidneys. Excreted by the kidneys.

Description pharmacological action:

GKS for external use. Warns boundary accumulation of neutrophils, reduces inflammatory exudation and production of lymphokines, inhibits the migration of macrophages, reduces the intensity of the processes of infiltration and granulation tissue, providing local anti-inflammatory, pruritic, anti-allergic and antiexudative effects.

Indications:

• psoriasis (excluding pustular and extensive plaque psoriasis)
  
• eczema (various forms)
  
• lichen planus
  
• diskoidna lupus erythematosus
  
• skin disease resistant to therapy less active corticosteroids for local use.
  

Contraindications:

• acne rosacea
  
• acne vulgaris
  
• skin cancer
  
• nodular pruritus Hyde
  
• okolorotova dermatitis
  
• perianal and genital itching
  
• cutaneous manifestations of syphilis and diaper rash
  
• bacterial, viral and fungal diseases of the skin (including herpes simplex, varicella, tuberculosis skin, actinomycosis)
  
• common plaque and pustular psoriasis
  
• hypersensitivity to the active and auxiliary substances of the drug
  
• the age of 1 year
  
• lactation
  
• pregnancy.
  

Application of pregnancy and breast-feeding:

Corticosteroids for topical use should not be used during pregnancy for a long time in large doses.

The safe use of clobetasol during lactation is not established.

Side effects:

Burning, itching, steroid acne, dry skin.

With prolonged use: the weakening of the barrier function of the skin.

When applied to large surfaces may develop systemic side effects (gastritis, ulceration of gastrointestinal mucosa, increased intraocular pressure, symptoms of Cushing).

Long appointment corticosteroids for local application in high doses or applying them to large areas of skin may be accompanied by systemic absorption with subsequent development of symptoms gipercortitizma. The risk of developing this complication increased in children, especially when using occlusive dressings, the diaper can perform the role of dressings.

On the appointment of the drug Clovate adult patients in a dosage of not more than 50 g per week, a suppression of the pituitary and adrenal glands is transient with a rapid recovery immediately after the end of treatment.

Prolonged treatment with highly active corticosteroids for local application in high doses may cause atrophic changes in the skin, particularly thinning, the appearance of atrophic streaks (striae), dilation of superficial blood vessels, particularly when occlusive dressing should overlap when applying the product on areas of the skin with folds. May develop skin pigmentation and hypertrichosis. In rare cases psoriasis treatment corticosteroids for local application (or cancel) provokes the development of pustular psoriasis.

Rarely the drug Clovate can cause worsening of symptoms.

Drug interactions:

There is no data.

Method of application and dose:

Externally.

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

In particularly resistant cases, especially in the presence of hyperkeratosis, inflammatory effect of the drug Clovate can be enhanced using overlay for the night on the field of application of the drug bandage made of PE film, which is usually accompanied by a positive effect. When changing an occlusive bandage the skin should be cleaned. In the future, the achieved effect it is possible to maintain without the use of occlusive dressings.

Overdose:

The development of acute overdose is unlikely. However, in the case of chronic overdose or misuse can develop symptoms of hypercortisolism, which requires the gradual withdrawal of the drug under medical supervision.

Precautions:

Clovate cream is recommended for the treatment of acute inflammatory diseases of the skin including accompanied by the development of soak, and also for the treatment of inflammation of the skin of the scalp.

The drug is recommended for short-term use. Should be avoided corticosteroids for local use for a long time, especially when treating younger children, because this can cause suppression of adrenal function. The use of the drug in children requires supervision at least once a week.

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

Do not use this product in the eye area, because when it is used in the periorbital area may develop glaucoma.

Psoriasis treatment corticosteroids for local use may be followed by recurrence of the disease, tolerance to the drug, generalized pustular form of the disease, local or systemic toxicity due to impairment of barrier function of the skin, it is particularly important, careful observation of the patient.

When you join secondary infection should be the appropriate antibiotic therapy. At any sign of generalization of infection it is necessary to stop local use of corticosteroids and for the treatment with antibacterial drugs.

Warm, moist conditions created when applying occlusive dressings, contribute to the emergence of bacterial infection, so be sure to clean the skin before applying new bandages.

The cream is not recommended to breed.

Effects on ability to drive or to perform work requiring high speed physical and mental reactions