Description
Release form
Ointment for external use.
Packaging
25 g.
Pharmacological action
Cloveit – GCS for external use.
Prevents marginal accumulation of neutrophils, reduces inflammatory exudation and cytokine production, inhibits macrophage migration, reduces the intensity of the processes of infiltration and granulation.
Provides local anti-inflammatory, antipruritic, anti-allergic and anti-exudative effects.
Pharmacokinetics: Absorption
Average Cmax of clobetasol propionate is 0.63 ng / ml and is achieved in plasma 13 hours after the first application and 8 hours after repeated application of 30 g of clobetasol propionate to healthy skin in the form of 0.05% ointment. 10 hours after the application of a second dose (30 g) of clobetasol propionate in the form of a cream, its average plasma Cmax slightly exceeds that after application of the ointment. 3 hours after a single application of 25 g of 0.05% ointment of clobetasol propionate 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 (integrity damage or inflammation of the skin enhances absorption) and a systemic effect.
Metabolism and excretion
Metabolized mainly in the liver, a small part in the kidneys. It is excreted in the urine.
Indications
– psoriasis (with the exception of pustular and extensive plaque psoriasis)
– eczema (various forms)
– lichen planus
– discoid lupus erythematosus
– skin diseases, resistant to therapy with less active GCS for topical use.
Contraindications
– rosacea
– acne vulgaris
– skin cancer
– nodular pruritus guida
– perioral dermatitis
– perianal and genital pruritus
skin infections – skin infections including herpes simplex, chickenpox, skin tuberculosis, actinomycosis)
– common plaque and pustular psoriasis
– under 1 year of age
– pregnancy
– lactation period
– hypersensitivity to drug components and Cloveit.
Special instructions
The drug Cloveit ® ointment is recommended for skin lesions accompanied by dryness, hyperkeratosis, and thickening.
Cloveit ® cream is recommended for the treatment of acute inflammatory skin diseases, including accompanied by the development of weeping, as well as for the treatment of inflammation of the skin of the scalp.
The drug is recommended for short-term use.
The administration of corticosteroids for external use for a long time should be avoided, especially in the treatment of young children, as this may suppress adrenal function. The use of Cloveit ® in children requires medical supervision at least 1 time per week.
On the face more often than on other parts of the body, atrophic skin changes may occur as a result of prolonged use of external forms of corticosteroids.
Do not apply Cloveit in the eye area, as the use of the drug in the periorbital region can cause the development of glaucoma.
Treatment of psoriasis of corticosteroids for external use may be accompanied by the development of relapses of the disease, drug tolerance, generalized pustular form of the disease, local or systemic toxic reactions due to impaired skin barrier function, therefore careful monitoring of the patient is especially important.
When attaching a secondary infection, appropriate antibiotic therapy should be given. With any signs of generalization of the infection, it is necessary to stop the external use of GCS and conduct appropriate treatment with antibacterial drugs. Warm humid conditions created when applying an occlusive dressing, contribute to the occurrence of a bacterial infection, therefore, it is necessary to clean the skin before applying a new dressing.
Cloveit cream is not recommended to breed.
Effect on the ability to drive vehicles and control 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.
Dosage and administration
Applied externally. Cloveit cream or ointment is applied in a thin layer to the affected areas of the skin 1-2 times / day. The duration of a continuous course of treatment is limited to 3-4 weeks.
In especially resistant cases, especially in the presence of hyperkeratosis, the anti-inflammatory effect of Cloveit® can be enhanced by applying a bandage from a plastic film overnight to the area of ??application of the drug, 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 effects
Dermatological reactions: burning, skin itching, steroid acne, dry skin with prolonged use – weakening of the skin’s barrier function with prolonged use in high doses – atrophic changes in the skin, in particular, thinning, the appearance of atrophic bands (stria), dilation 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 of corticosteroids for external use (or their cancellation) provokes the development of pustular psoriasis.
When applied to large surfaces, systemic side effects may develop: gastritis, ulceration of the gastrointestinal mucosa, increased intraocular pressure, symptoms of hypercorticism.
Long-term administration of corticosteroids for external use in large doses or applying them to large areas of the skin may be accompanied by systemic absorption with the subsequent development of symptoms of hypercorticism. The risk of developing this complication is increased in children, especially when using an occlusive dressing, while the diaper can play the role of such a dressing. Subject to the administration of the drug Cloveit ® to adult patients at a dosage of not more than 50 g per week, the suppression of the pituitary and adrenal gland functions is transient in nature with their rapid recovery immediately after the course of treatment.
In rare cases, Cloveit ® may exacerbate the symptoms of the disease.
Overdose
The development of an acute overdose is unlikely. However, in case of chronic overdose or improper use, symptoms of hypercorticism may develop, which requires the gradual discontinuation of the drug under the supervision of a doctor.
active substance
Clobetasol
Terms and conditions
prescription
Dosage form
ointment
Elf Farmzavod, Poland
