Lorinden® [Clioquinol, Flumetazone Pivalate]

Pharmacological properties

the properties of the ointment lorinden with due to the combined action of flumetasone pivalate and clioquinol. flumethasone pivalate is a synthetic corticosteroids with moderate anti-inflammatory effect. if applied in the form of an ointment, it has a local effect of medium intensity. possesses lipophilic properties, easily penetrates the stratum corneum of the skin and exhibits a long anti-inflammatory, antipruritic and anti-allergic effect. with external use of flumethasone, pivalate inhibits the formation of prostaglandins and leukotrienes in the skin due to inhibition of phospholipase a2 activity and a decrease in the release of arachidonic acid from phospholipids of cell membranes. inhibits phagocytosis, the release of interleukins and other cytokines, the release of histamine and the manifestation of local allergic reactions, reduces proliferative processes. due to local vasoconstrictor action reduces the severity of exudative reaction. reduces protein synthesis and collagen deposition.

Clioquinol has an antibacterial effect against gram-positive and gram-negative bacteria, as well as a weak antifungal effect.

Pharmacokinetics Flumethasone pivalate easily penetrates the stratum corneum, where it accumulates. It is not metabolized in the skin. When applied externally, a small amount can penetrate the body and in this case has a systemic effect. After penetration through the skin, the drug is metabolized mainly in the liver, excreted in the urine and in small quantities with bile in the form of glucuronide conjugates, as well as unchanged. The absorption of flumethasone pivalate is increased when applied to areas with delicate skin - in the area of ​​folds or face, on skin with damaged epidermis or inflammatory skin. The use of an occlusive dressing, which helps to increase the temperature and humidity of the skin, also increases the absorption of flumetasone pivalate. In addition, absorption increases with frequent use of the drug or when applied to large areas of the skin. Absorption through the skin in young people is more intense than in older people.

Clioquinol has a local effect and is practically not absorbed into the blood.

Indications

Local treatment of skin lesions without exudation complicated by a bacterial infection accompanied by itching and hyperkeratosis: seborrheic dermatitis, atopic dermatitis, allergic contact dermatitis, erythema multiforme, systemic lupus erythematosus, psoriasis, lichen planus.

Application

The drug is intended for topical use. the ointment is applied in a thin layer to the affected area of ​​the skin 1-2 times a day. treatment should not be carried out continuously for more than 2 weeks. can not be used on face skin for more than 1 week. within a week, it is recommended to use no more than 1 tube.

With increased lichenization or excessive hyperkeratosis, an occlusive dressing is allowed, which should be changed every 24 hours.

Contraindications

Hypersensitivity to flumetasone pivalate, other corticosteroids, clioquinol or other components of the ointment. viral (e.g. chickenpox, herpes simplex), fungal or bacterial (e.g. tuberculosis) skin infections, skin neoplasms, common and pink acne, perioral and diaper dermatitis, anal itching, pruritus in the vulva, inflammation or ulcers of varicose nodes.

Do not use on large areas of the skin, especially if there is a violation of the integrity of the skin, such as burns.

Side effects

On the part of the skin and subcutaneous tissue: acne, poststeroidal purpura, inhibition of epidermal growth, atrophy of the subcutaneous tissue, dry skin, burning sensation, irritation, itching, excessive hair growth on the body or alopecia, discoloration or hyperpigmentation of the skin, atrophy and impaired skin integrity, telangiectasia , perioral dermatitis, inflammation of the hair follicles, secondary infections. in some cases, there may appear: urticaria, maculopapular rash or exacerbation of existing changes.

From the side of the organ of vision: with external use on the skin of the eyelids, cataracts or glaucoma can sometimes develop.

Others: the absorption of the active substance in the blood can cause systemic side effects inherent in flumethasone pivalate. This occurs mainly in the case of prolonged use of the drug, when applied to large areas of the skin, under an occlusive dressing, or when used in children.

Systemic side effects of flumetasone pivalate, typical for corticosteroids, including dysfunction of the hypothalamic-pituitary-adrenal system, Cushings syndrome, inhibition of growth and development in children, hyperglycemia, glucosuria, edema, hypertension, increased sensitivity to infections, decreased immunity; a neurotoxic effect is possible with topical use of clioquinol, especially in cases of prolonged use or use under an occlusive dressing.

In individuals with individual intolerance to the components of the drug, hypersensitivity reactions are possible.

special instructions

Do not use without a break for more than 2 weeks. with prolonged use on large areas of the skin, the incidence of side effects increases. the use of the drug should be stopped immediately if its use leads to itching, dryness or allergic skin reactions.

During the external use of flumethasone pivalate, the secretion of ACTH by the pituitary gland due to inhibition of the pituitary-adrenal gland may decrease, the level of cortisol in the blood may decrease, and iatrogenic Cushings syndrome may develop, which disappears after treatment is stopped. In the case of an increase in the severity of infection at the place of use of the drug, additional use of antibacterial, antifungal drugs is necessary. If the symptoms of the infection do not disappear, the use of the drug must be discontinued.

Avoid applying the drug to the eyelids or the skin around the eyes in patients with angle-closure and open-angle glaucoma, as well as cataracts, given the possibility of increasing the severity of the symptoms of the disease.

Avoid contact with eyes and mucous membranes.

On the skin of the face, inguinal and axillary areas, use only if absolutely necessary, since it is possible to increase absorption and a high risk of side effects (telangiectasia, perioral dermatitis), even after a short application.

The use of ointment under an occlusive dressing should be limited to exceptional situations due to the possibility of atrophy and epidermal defects, superinfection.

Use the drug with caution in the presence of atrophy of the subcutaneous tissue, mainly in the elderly.

During the treatment of chronic conditions, such as psoriasis or chronic eczema, the drug should not be abruptly discontinued. It should be used with caution in patients with psoriasis, since topical application of GCS in this case can lead to relapse of the disease due to the development of tolerance, the risk of spreading pustular psoriasis and systemic toxicity due to skin dysfunction.

Use during pregnancy and lactation. In studies conducted on animals, it was confirmed that GCS have a teratogenic effect even when administered orally in low doses. Teratogenic effect is also confirmed with the external use of corticosteroids. No controlled studies of the reliability of teratogenic effects with the external use of flumethasone pivalate during pregnancy.

Lorinden C ointment can be used during pregnancy only for a short time, in small areas of the skin and only if, according to the doctor, the benefit exceeds the risk of use. The use of the drug in the first trimester of pregnancy is contraindicated.

The degree of excretion of flumetasone pivalate in breast milk with external use is unknown.When using corticosteroids inside, a significant amount of the hormone, which could have an effect on the body of a newborn, was not detected in breast milk. However, it is recommended that caution be used with Lorinden C ointment during lactation. In some cases, you can use the drug for a short time on small areas of the skin. Do not apply Lorinden C ointment to the skin of the mammary glands.

Children. The drug is not used in children under the age of 12 years. For children over the age of 12 years, the drug is prescribed with caution. It is allowed to apply the ointment in some cases on small areas of the skin. Do not apply the drug to the skin of the face.

In children, a proportionally greater amount of topical corticosteroid can be absorbed, so they are more susceptible to systemic side effects. This is due to the fact that children have an underdeveloped skin barrier and a large surface of the skin relative to body weight compared to adults.

The ability to influence the reaction rate when driving vehicles or working with other mechanisms. The drug does not limit mental and motor ability, as well as the ability to drive vehicles or other mechanisms.

Interactions

With external use of corticosteroids, interactions with other drugs have not been identified.

During treatment, it is not recommended to vaccinate against smallpox, as well as other types of immunization, especially with prolonged use on large areas of the skin, given the possibility of an insufficient immune response.

Lorinden C ointment can enhance the effect of immunosuppressive and inhibit the effect of immunostimulating drugs.

Overdose

With prolonged use of the drug in large areas of the skin, overdose symptoms may occur, which are manifested by an increase in the severity of side effects, including swelling, burning sensation, irritation, itching, ag, hyperglycemia, decreased resistance to infections), and in severe cases, the development of cushing syndrome. it is necessary to gradually stop the use of the drug in a timely manner or switch to the use of weak-acting corticosteroids. symptomatic therapy.

Storage conditions

At a temperature not exceeding 25 ° C.