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

Pharmacological effect

Cloveit – GCS for external use.

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

It has local anti-inflammatory, antipruritic, antiallergic and antiexudative effects.

Pharmacokinetics:

Suction

The 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 a 0.05% ointment.

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

Metabolism and excretion

Metabolized mainly in the liver, a small part in the kidneys. Excreted in urine.

Special instructions

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

Cloveit® cream is recommended for the treatment of acute inflammatory skin diseases, incl. accompanied by the development of weeping, as well as for the treatment of inflammation of the scalp.

The drug is recommended for short-term use.

Prescription of corticosteroids for external use for a long time should be avoided, especially when treating young children, as this may suppress adrenal function. The use of Cloveit® in children requires medical supervision at least once a week.

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

Do not apply Cloveit in the eye area, because use of the drug in the periorbital area may cause the development of glaucoma.

Treatment of psoriasis with GCS for external use may be accompanied by the development of relapses of the disease, tolerance to the drug, a generalized pustular form of the disease, local or systemic toxic reactions due to impaired barrier function of the skin, therefore careful monitoring of the patient is especially important.
If a secondary infection occurs, appropriate antibacterial therapy should be carried out.

If there are any signs of generalization of the infection, it is necessary to stop the external use of GCS and carry out appropriate treatment with antibacterial drugs. The warm, moist conditions created by applying an occlusive dressing promote bacterial infection, so be sure to clean the skin before applying a new dressing.

Cloveit cream is not recommended to be diluted.

Impact on the ability to drive vehicles and operate machinery

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

Active ingredient

Clobetasol

Composition

1 g:

– clobetasol propionate 500 mcg

Excipients:

propylene glycol – 50 mg,

sorbitan sesquioleate – 5 mg,

white petroleum jelly – up to 1 g.

Contraindications

— rosacea;
— acne vulgaris;
– skin cancer;
– nodular prurigo Hyde;
— perioral dermatitis;
– perianal and genital itching;
– skin manifestations of syphilis;
– diaper rash;
– bacterial, viral and fungal skin diseases (including herpes simplex, chicken pox, skin tuberculosis, actinomycosis);
– widespread plaque and pustular psoriasis;
– age up to 1 year;
— pregnancy;
– lactation period;
– hypersensitivity to the components of the drug Cloveit.

Side Effects

Dermatological reactions: burning, itching, steroid acne, dry skin; with long-term use – weakening of the skin barrier function; with long-term use in high doses – atrophic changes in the skin, in particular, its thinning, the appearance of atrophic stripes (striae), 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 with 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 hypercortisolism.

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

Provided that the drug Cloveit® is prescribed to adult patients in a dosage of no more than 50 g per week, the suppression of the function of the pituitary gland and adrenal glands is transient in nature with their rapid recovery immediately after the end of the course of treatment.

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

Overdose

The development of an acute overdose is unlikely.

However, in case of chronic overdose or improper use, symptoms of hypercortisolism may develop, which requires gradual withdrawal of the drug under medical supervision.

Storage conditions

At a temperature not exceeding 25 °C

Shelf life

3 years

Manufacturer

Pharmaceutical plant Elfa A.O., Poland