Cloveit, 0.05% ointment 25 g

Cloveit is a GKS for external use.

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

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

Pharmacokinetics:

Intake

The average Cmax of clobetasol propionate is 0.63 ng/mL and is reached in plasma 13 h after the first application and 8 h after reapplication to healthy skin of 30 g clobetasol propionate as 0.05% ointment.

Ten hours after application of the second dose (30 g) of clobetasol propionate in the form of cream its average Cmax in plasma is slightly higher than that after application of the ointment. In 3 hours after a single application of 25 g of 0.05% clobetasol 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 skin, absorption is possible (damage to the integrity or inflammation of the skin increases absorption) and a systemic effect may occur.

Metabolism and excretion

Metabolized mainly in the liver, a small part in the kidneys. It is excreted with the urine.

Indications

– psoriasis (except pustular and extensive plaque psoriasis);
– eczema (various forms);
– lichen planus;
– discoid lupus;
– skin diseases resistant to therapy with less active local GCS.

Active ingredient

Composition

1 g:

– clobetasol propionate 500 mcg

Supplementary substances:

Propylene glycol – 50 mg,

sorbitan sesquiolate – 5 mg,

Vaseline white – up to 1 g.

How to take, the dosage

It is used externally. Cloveit cream or ointment is applied in a thin layer on the affected areas of the skin 1-2 times a day.

The duration of the 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 Cloveit® can be enhanced by applying a polyethylene film dressing overnight to the area of application of the drug, which is usually accompanied by a positive effect.

The skin should be cleaned when the occlusive dressing is changed. Thereafter, the effect achieved can be maintained without the use of an occlusive dressing.

Special Instructions

Cloveit® ointment is recommended for use in skin lesions accompanied by dryness, hyperkeratosis, thickening.

Cloveit® cream is recommended for the treatment of acute inflammatory skin conditions, including those accompanied by mucous membrane development, as well as for the treatment of inflammation of the scalp.

The product is recommended for short-term use.

Application of external GCS should be avoided, especially in young children, because of the potential for adrenal dysfunction. The use of Cloveit® in children requires monitoring by a physician at least once a week.

Atrophic skin changes may occur on the face more often than on other parts of the body as a result of long-term use of external forms of GCS.

To avoid applying Cloveit to the eye area, use in the periorbital area may cause glaucoma.

The external treatment of psoriasis with GKS may be accompanied by the development of relapses, tolerance to the drug, generalized pustular form of the disease, local or systemic toxic reactions due to violation of skin barrier function, so close monitoring of the patient is especially important.
If secondary infection has occurred, appropriate antibiotic therapy should be performed.

If there are any signs of a generalized infection, the external use of GCS should be discontinued and appropriate antibacterial treatment should be given. Warm moist conditions created by the application of an occlusive dressing promote bacterial infection, so be sure to clean the skin before a new dressing is applied.

Cloveit Cream is not recommended to dilute.

Impact on driving and operating ability

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

Contraindications

– pink acne;
– vulgar acne;
– skin cancer;
– Hyde’s nodular psoriasis;
– perioral dermatitis;
– Perianal and genital itching;
– Syphilis skin manifestations;
– Diaper rash;
– Bacterial, viral and fungal skin diseases (incl.Herpes simplex, varicella, skin tuberculosis, actinomycosis);
– widespread plaque and pustular psoriasis;
– age less than 1 year;
– pregnancy;
– lactation;
– hypersensitivity to components of the preparation Cloveit.

Side effects

Dermatological reactions: burning, skin itching, steroid acne, dry skin; with prolonged use, weakening of the skin barrier function; with prolonged use at high doses, atrophic skin changes, particularly thinning, appearance of atrophic stripes (stretch marks), dilation of surface blood vessels, especially when occlusive dressings are applied and when the drug is applied to skin areas with folds; skin pigmentation and hypertrichosis may develop. In rare cases, treatment of psoriasis with topical GCS (or their abolition) may provoke pustular psoriasis.

When applied to large surfaces, systemic side effects may develop: gastritis, gastrointestinal mucosal ulceration, increased intraocular pressure, and hypercorticism symptoms.

Long-term use of GCS for external use in large doses or application to large areas of skin may be accompanied by systemic absorption with subsequent development of symptoms of hypercorticism. The risk of this complication is higher in children, especially if an occlusive dressing is used, and a diaper may serve as such a dressing.

As long as Cloveit® is prescribed to adult patients at a dosage of no more than 50 g per week, the suppression of pituitary and adrenal function is transient with rapid recovery immediately after completion of treatment.

In rare cases, Cloveit® may cause exacerbation of symptoms.

Overdose

The development of an acute overdose is unlikely.

However, in chronic overdose or improper use, symptoms of hypercorticism may develop, requiring gradual withdrawal of the drug under medical supervision.

Similarities