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Pharmacological properties

aurobin is a combined preparation, the composition of which in the optimal ratio includes active substances effective in the treatment of inflammatory processes and pain localized in the perianal region. prednisolone capronate is a non-halogenated glucocorticoid with a local anti-inflammatory effect. reduces vascular permeability, increases vascular wall tone, reduces the severity of inflammation symptoms. lidocaine eliminates pain and burning sensation in a short time. dexpanthenol promotes the regeneration of the affected epithelium and mucous membranes.

Pharmacokinetics Pharmacokinetic studies with ointment have not been conducted. The active substances of the drug have mainly local effects. When applied topically, prednisone can be absorbed and cause a systemic effect. Prednisolone is rapidly distributed in all body tissues. It is firmly bound to plasma proteins. It is excreted in the urine in the form of conjugates. Prednisolone quickly penetrates the placenta, passes into breast milk.

Lidocaine is well absorbed from the mucous membrane and affected skin. It is firmly bound to plasma proteins. T½ plasma lidocaine - 1-2 hours. Metabolized in the liver. Impaired renal function does not affect the excretion of the starting substance, but can lead to the accumulation of its active metabolite. It penetrates the placenta, the BBB and into breast milk.

Indications

Processes accompanied by inflammation of the perianal region: itching, eczema and dermatitis of the perianal region, hemorrhoids, anal fissures.

Application

For external use only.

Avoid the use of ointments for a long time and on a large surface of the skin, regardless of the age of the patient.

Use under an occlusive dressing is not recommended.

Adults and elderly patients. A thin layer of ointment is applied to the affected area 2–4 ​​times a day. With a decrease in the severity of symptoms, the ointment is used less often. The duration of therapy should not exceed 5-7 days.

Children. Children from the age of 1 year can use the drug only in exceptional cases and in the minimum dose that ensures the achievement of the therapeutic effect, and not more than 2 times a day. The duration of treatment of children should not exceed 5 days.

Contraindications

Hypersensitivity (allergy) to one of the active or any of the excipients of the drug. hypersensitivity to other local amide type anesthetics (e.g. bupivacaine, ethidocaine, mepivacaine and prilocaine). treatment of the eyes or periocular region. primary bacterial, viral, or fungal skin lesions, including herpes simplex. acne rosacea, acne vulgaris, perioral dermatitis or diaper rash, tuberculosis of the skin, skin manifestations of syphilis, dryness, peeling of the skin. simultaneous treatment with lidocaine for other indications. skin tumors. cushing syndrome. vaccination period. children under the age of 1 year. i trimester of pregnancy.

Side effects

Topical glucocorticoid treatment can cause local side effects.

With prolonged topical application or application to large surfaces of the skin, suppression of adrenal cortex function is possible. This is especially often noted when using ointments in children or under occlusive dressings. Protein catabolism can lead to a negative nitrogen balance.

Absorption of a large amount of lidocaine after topical administration can lead to stimulation and / or inhibition of central nervous system function.

Depending on the amount of glucocorticoid and lidocaine absorbed, side effects may occur, which are listed below.

Infections and infestations: activation of subclinical infections, masking the manifestations of infections, opportunistic infections;

from the immune system: hypersensitivity reactions;

from the endocrine system: inhibition of the function of the adrenal cortex, hypercorticism (as a manifestation of the resorptive effect of prednisolone);

disorders of nutrition and metabolism: hypokalemic alkalosis, sodium and fluid retention in the body, hypokalemia;

mental disorders: insomnia, mental disorders;

from the central nervous system: convulsions, dizziness, headache, increased intracranial pressure;

on the part of the organ of vision: cataract (the likelihood of developing cataracts is higher in children), subcapsular cataract, exophthalmos, glaucoma, edema of the optic disc, corneal ulcer.

from the cardiovascular system: heart failure, impaired cardiac conduction, hypertension, peripheral vasodilation;

from the digestive system: gastric bleeding, gastrointestinal bleeding, perforation of the digestive tract, esophagitis, pancreatitis, peptic ulcer;

on the part of the skin and subcutaneous tissue: dermatitis, folliculitis at the site of application, rashes of the type of acne (steroid acne), contact dermatitis, dryness, thinning and tenderness of the skin; erythema, rash, urticaria, hirsutism, hyperhidrosis, diaper rash, itching, skin atrophy, hypopigmentation, skin irritation, striae, telangiectasia, skin burning, purple;

from the musculoskeletal system: growth retardation, steroid myopathy, osteonecrosis, osteoporosis;

systemic disorders: slow wound healing;

laboratory parameters: increased intraocular pressure, negative nitrogen balance, slowing down reactions during skin tests.

special instructions

If skin irritation or allergic reactions occur, the use of the drug should be stopped immediately and appropriate symptomatic therapy should be started. to avoid local or general toxicity of the drug, the drug should not be used on large affected skin surfaces, in skin folds, under an occlusive dressing and / or for a long time.

With prolonged use on the same skin surface, the drug can cause skin atrophy, especially in young patients.

With extreme caution, the drug is used in the presence of cataracts, diabetes mellitus, glaucoma, tuberculosis or anemia, as well as in the presence of inhibition of the hypothalamic-pituitary system caused by glucocorticoids.

Use with caution in patients with severe heart failure, renal and hepatic insufficiency.

Caution is required when treating patients with a weakened or potentially weakened immune system (including AIDS or HIV infection).

Use during pregnancy and lactation. The drug is contraindicated in the first trimester of pregnancy. When prescribing the drug in the II and III trimester of pregnancy, it is necessary to carefully assess the benefit / risk ratio.

Glucocorticoids and lidocaine pass into breast milk. Thus, glucocorticoids can affect the function of the adrenal cortex of the newborn and cause dysplasia. A small amount of lidocaine is detected in breast milk. Despite the fact that in practice this does not pose any risk to the baby, increased caution is necessary when using the drug during lactation.

Children. In children under the age of 1 year, the use of ointment is contraindicated.

The ability to influence the reaction rate when driving vehicles or working with other mechanisms. The potential impact on the ability to drive vehicles or work with other mechanisms has not been studied, but the possibility of developing adverse reactions from the central nervous system and organ of vision should be considered.

Interactions

Interaction studies with the use of aurobin ointment have not been conducted.

The drug should not be used simultaneously with lidocaine in connection with other indications.

The simultaneous use with other antiarrhythmic drugs requires caution.

MAO inhibitors enhance the local analgesic effect of lidocaine.

Overdose

May manifest local or systemic symptoms depending on the amount of glucocorticoid and lidocaine absorbed. there is no specific antidote. supportive therapy should be given.

Storage conditions

At a temperature of 8-15 ° C.

Tags: Aurobin