Instructions for Cloveit cream tube 25 g
Composition
active ingredient: clobetasol;
1 g of cream contains clobetasol propionate 0.5 mg;
Excipients: propylene glycol; disodium edetate; chlorocresol; mineral oil; white soft paraffin; glycerol monostearate; cetostearyl alcohol; polysorbate 40; medium chain triglycerides; sodium citrate; citric acid, monohydrate; colloidal anhydrous silicon dioxide; purified water.
Dosage form
Cream.
Main physicochemical properties: white, homogeneous mass with a faint characteristic odor.
Pharmacotherapeutic group
Corticosteroids for topical use. ATX code D07A D01.
Pharmacological properties
Pharmacodynamics
The main effect of clobetasol propionate on the skin is a nonspecific anti-inflammatory effect due to vasoconstriction and reduced collagen synthesis.
Pharmacokinetics
The penetration of clobetasol propionate through the skin varies between individuals and may be increased by the use of occlusive dressings or by inflammation or skin damage. In individuals with healthy skin, mean peak plasma concentrations of clobetasol propionate of 0.63 ng/mL may be observed 8 hours after the second application (13 hours after the first application) of 30 g of 0.05% clobetasol propionate ointment. Following the application of a second dose of 30 g of 0.05% clobetasol propionate cream, mean peak plasma concentrations may be slightly higher than with the ointment and may be observed 10 hours later. Other peak concentrations (approximately 2.3 ng/mL and 4.6 ng/mL) may be observed in psoriasis and eczema patients, respectively, 3 hours after a single application of 25 g of 0.05% clobetasol propionate ointment. After absorption through the skin, the drug most likely undergoes the same metabolic pathway as corticosteroids after systemic administration. However, the systemic metabolism of clobetasol has not been fully established.
Indication
Psoriasis (except widespread plaque psoriasis), persistent eczema, lichen planus, discoid lupus erythematosus and other skin diseases that are not amenable to treatment with less active corticosteroids.
Contraindication
Untreated skin infections.
Pink acne.
Common acne.
Itching without inflammation.
Perianal and genital itching.
Perioral dermatitis.
Hypersensitivity to the components of the drug.
Clobetasol is not indicated for the treatment of primary infected skin lesions caused by fungi (e.g., candidiasis, lichen) or bacterial microorganisms (e.g., impetigo), dermatitis, diaper rash.
Interaction with other medicinal products and other types of interactions
Concomitant use with drugs that may inhibit CYP3A4 (e.g. ritonavir, itraconazole) has been shown to inhibit the metabolism of corticosteroids, which may result in systemic effects. The extent to which this interaction is clinically significant depends on the dose of the drug, the route of administration of the corticosteroid, and the potency of the CYP3A4 inhibitor.
Application features
The drug should be used with caution in patients with a history of local hypersensitivity reactions to corticosteroids or any of the excipients. Local hypersensitivity reactions (see section "Adverse reactions") may resemble the symptoms of the disease being treated. Manifestations of hypercorticism (Cushing's syndrome) and reverse suppression of the hypothalamic-pituitary-adrenal axis with suppression of adrenal function in some individuals may result from increased systemic absorption of topical steroids. If any of the above symptoms occur, the drug should be gradually discontinued by reducing the frequency of application or replacing it with a less potent corticosteroid. Abrupt discontinuation of treatment may cause glucocorticosteroid insufficiency (see section "Adverse reactions").
Cloveit, cream, contains:
propylene glycol, which may cause skin irritation; cetostearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis); chlorocresol, which may cause allergic reactions.
Risk factors for systemic effects include:
potency and composition of the topical steroid; duration of application; application to a large area of skin; application to skin surfaces that touch each other, such as in diaper areas, or where an occlusive dressing is applied (in infants, diapers can act as an occlusive dressing); increased hydration of the stratum corneum; application to areas with thin skin, such as the face; application to areas of damaged skin or other conditions where the skin barrier is compromised.
Children may absorb proportionally greater amounts of topical corticosteroids than adults and are therefore more susceptible to systemic side effects. This is because children have an underdeveloped skin barrier and a larger skin surface area relative to body weight than adults.
Children
Children are more susceptible to the development of atrophic changes when using topical corticosteroids. If Cloveite is necessary for the treatment of children, it is recommended that the treatment be continued for several days and reviewed weekly.
Risk of infection when applying an occlusive dressing.
The risk of bacterial infections increases in the warm and humid conditions that can occur under occlusive dressings, so the skin should be thoroughly cleaned before applying a new dressing.
Psoriasis treatment.
Topical corticosteroids should be used with caution in the treatment of psoriasis, as in some cases relapses, development of tolerance, risk of generalization of pustular psoriasis and development of symptoms of local or systemic toxicity due to impaired skin barrier function have been reported. When used for the treatment of psoriasis, the patient should be under close medical supervision.
Concomitant infections.
Whenever treating inflammatory lesions that are infected, appropriate antibacterial agents should be prescribed. In the event of widespread infection, topical corticosteroids should be discontinued and appropriate antibacterial therapy should be prescribed.
Chronic leg ulcers.
Topical corticosteroids can sometimes be used to treat dermatitis around chronic leg ulcers, but this use is associated with an increased incidence of local hypersensitivity reactions and an increased risk of local infections.
Applying cream to the face.
Applying the cream to the skin of the face is undesirable, as atrophic changes occur more often in this area. If necessary, use should be limited to a few days.
Application to the eyelids.
When applying the cream to the eyelids, avoid getting the drug in the eyes, as repeated use may cause cataracts and glaucoma.
Vision disorders.
Visual impairment may occur with systemic and topical corticosteroids. If a patient experiences symptoms such as blurred vision or other visual disturbances, an ophthalmologist should be consulted to rule out possible causes, which may include cataracts, glaucoma, or rare conditions such as central serous chorioretinopathy (CSCR), which have been reported following systemic and topical corticosteroid use.
Ability to influence reaction speed when driving vehicles or other mechanisms
No studies have been conducted to study this effect. Given the adverse reaction profile, no effect on the reaction speed when driving or using other mechanisms is expected.
Use during pregnancy or breastfeeding
Pregnancy.
Data on the use of the drug Cloveite in pregnant women are limited.
Topical corticosteroids have been shown to cause fetal harm when administered to pregnant animals. The relevance of these data to humans has not been established. Cloveyt should be used during pregnancy only if the expected benefit to the mother outweighs the potential risk to the fetus. Use the minimum amount of the drug for the shortest duration of treatment.
Breast-feeding.
The safety of clobetasol propionate during breastfeeding has not been established. It is not known whether topical corticosteroids can result in systemic absorption that would result in measurable amounts of the drug in breast milk. Clobetasol propionate should be used during breastfeeding only if the expected benefit to the mother outweighs the potential risk to the infant. If used during breastfeeding, the ointment should not be applied to the breasts to avoid accidental ingestion of the cream by the infant.
Method of administration and doses
The cream is especially suitable for treating moist or weeping areas of skin.
The cream should be applied in a thin layer to the affected areas of the skin 1–2 times a day until the condition improves. As with other highly active corticosteroids, treatment should be discontinued after the disease is controlled. Improvement from treatment occurs individually: in patients who tolerate treatment well, the result may appear within a few days. It is recommended to continue treatment for no more than 4 weeks; if the condition does not improve, it is necessary to clarify or revise the diagnosis.
To prevent exacerbation of the disease, repeated short courses of treatment with Cloveit can be carried out. If long-term continuous treatment with steroids is necessary, other, less potent drugs should be used.
In very persistent lesions, especially in areas of hyperkeratosis, the anti-inflammatory effect of Cloveit can be enhanced if necessary by covering the affected area with plastic wrap. To achieve a positive result, apply an airtight bandage overnight. The effect already achieved can be maintained by simply applying the drug to the skin without covering it with a wrap.
Children
The drug is contraindicated for the treatment of dermatoses, including dermatitis, in children under 1 year of age.
Overdose
With normal use, Cloveite can be absorbed in quantities sufficient to produce a systemic effect. The likelihood of an acute overdose is very small, but in case of chronic overdose or improper use, signs of hypercortisolism may occur.
Treatment.
In case of overdose, Cloveite should be gradually discontinued by reducing the frequency of cream application or replacing it with a less potent corticosteroid due to the risk of glucocorticosteroid insufficiency.
Further treatment is carried out according to the clinical condition of the patient or according to national guidelines for the treatment of poisonings, if available.
Adverse reactions
Infections and invasions: opportunistic infections.
On the part of the immune system: local hypersensitivity.
On the part of the endocrine system: suppression of the hypothalamic-pituitary-adrenal system: Cushingoid features (e.g., moon face, central obesity), delayed weight gain/growth in children, osteoporosis, glaucoma, hyperglycemia/glucosuria, cataracts, arterial hypertension, weight gain/obesity, decreased endogenous cortisol levels, alopecia, hair fragility.
Skin and subcutaneous tissue disorders: itching, local burning sensation/skin pain, local skin atrophy*, atrophic skin streaks*, telangiectasia*, skin thinning*, skin wrinkling*, skin dryness*, pigmentation changes*, hypertrichosis, exacerbation of main symptoms, allergic contact dermatitis/dermatitis, pustular psoriasis, erythema, rash, urticaria.
Visual disturbances: blurred vision (see section "Special instructions"). If topical application involves use on the skin of the eyelids, glaucoma or cataracts may occur.
General disorders and administration site conditions: irritation/pain at the application site.
* Skin disorders secondary to local and/or systemic hypothalamic-pituitary-adrenal suppression.
Expiration date
3 years.
Storage conditions
Store at a temperature not exceeding 25 ° C. Do not freeze.
Packaging
25 g of cream in a tube.
Vacation category
According to the recipe.
Producer
Pharmaceutical factory Elfa A.T.
Location of the manufacturer and its business address
58-500 m. Jelenia Góra, 21 Vincentiego Pola Street, Poland.
