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Betamethasonum

From the endocrine system:

decreased glucose tolerance, steroid diabetes mellitus or manifestation of latent diabetes mellitus, suppression of adrenal function, Itsenko-Cushing syndrome (including moon face, pituitary type obesity, hirsutism, increased blood pressure, dysmenorrhea, amenorrhea, myasthenia gravis, striae), delayed puberty development in children.

From the side of metabolism:

increased excretion of calcium ions, hypocalcemia, weight gain, negative nitrogen balance (increased protein breakdown), increased sweating, fluid and sodium ion retention (peripheral edema), hypernatremia, hypokalemic syndrome (including hypokalemia, arrhythmia, myalgia or muscle spasm, unusual weakness and fatigue).

From the side of the central nervous system:

delirium, disorientation, euphoria, hallucinations, manic-depressive psychosis, depression, paranoia, increased intracranial pressure, nervousness or anxiety, insomnia, dizziness, vertigo, pseudotumor of the cerebellum, headache, convulsions.

From the cardiovascular system:

arrhythmias, bradycardia (up to cardiac arrest); development (in predisposed patients) or increased severity of chronic heart failure, ECG changes characteristic of hypokalemia, increased blood pressure, hypercoagulation, thrombosis. In patients with acute and subacute myocardial infarction - the spread of necrosis, slowing down the formation of scar tissue, which can lead to rupture of the heart muscle; with intracranial administration - nosebleeds.

From the digestive system:

nausea, vomiting, pancreatitis, steroid ulcer of the stomach and duodenum, erosive esophagitis, bleeding and perforation of the gastrointestinal tract, increased or decreased appetite, flatulence, hiccups. In rare cases, increased activity of liver transaminases and alkaline phosphatase.

From the senses:

sudden loss of vision (with parenteral administration in the head, neck, nasal turbinates, scalp, deposition of drug crystals in the vessels of the eye is possible), posterior subcapsular cataract, increased intraocular pressure with possible damage to the optic nerve, a tendency to develop secondary bacterial, fungal or viral infections eye, trophic changes in the cornea, exophthalmos.

From the musculoskeletal system:

slower growth and ossification processes in children (premature closure of epiphyseal growth zones), osteoporosis (very rarely - pathological bone fractures, aseptic necrosis of the head of the humerus and femur), rupture of muscle tendons, steroid myopathy, decreased muscle mass (atrophy); with intra-articular administration - increased pain in the joint.

Dermatological reactions:

delayed wound healing, petechiae, ecchymosis, skin thinning, hyper- or hypopigmentation, steroid acne, stretch marks, tendency to develop pyoderma and candidiasis.

Allergic reactions:

generalized (skin rash, skin itching, anaphylactic shock), local allergic reactions.

Local reactions:

with parenteral administration - burning, numbness, pain, paresthesia and infection at the injection site, rarely - necrosis of surrounding tissues, scar formation at the injection site; with intramuscular injection (especially into the deltoid muscle) - atrophy of the skin and subcutaneous tissue.

Other:

development or exacerbation of infections (the appearance of this side effect is facilitated by jointly used immunosuppressants and vaccination), leukocyturia, withdrawal syndrome.

When administered intravenously

- blood to the face, convulsions.

For external use:

rarely - itching, hyperemia, burning, dryness, folliculitis, acne, hypopigmentation, perioral dermatitis, allergic dermatitis, skin maceration, secondary infection, skin atrophy, stretch marks, prickly heat. With prolonged use or application to large areas of the skin, systemic side effects characteristic of glucocorticosteroids may develop.

Contraindications

- hypersensitivity to betamethasone or to any other components of the drug;

- bacterial skin diseases (skin tuberculosis, skin manifestations of syphilis);

- fungal skin diseases;

— viral skin diseases (chickenpox, herpes simplex);

— skin post-vaccination reactions;

- open wounds;

- trophic ulcers of the leg;

- rosacea, acne vulgaris;

- skin cancer, nevus, atheroma, melanoma, hemangioma, xanthoma, sarcoma;

- period of breastfeeding;

- children under 1 year of age.

Carefully

Cataracts, diabetes mellitus, glaucoma, tuberculosis (with long-term use or application to large areas of the body).

Use during pregnancy and breastfeeding

Pregnancy

The safety of external use of glucocorticosteroids in pregnant women has not been established. The prescription of drugs in this group during pregnancy is justified only if the expected benefit to the mother outweighs the possible risk to the fetus. In such cases, the use of the drug should be short-term and limited to small areas of the skin. Before using Betamethasone, if you are pregnant, or think you might be pregnant, or are planning to become pregnant, you should consult your doctor.

Breastfeeding period

When using the drug, breastfeeding should be stopped.

special instructions

Long-term external use of the drug on the skin of the face is not recommended, since the development of rosacea, perioral dermatitis and acne is possible.

The course of treatment should not exceed 5 days. The drug should not be used in the eye area due to the likelihood of the drug getting into the mucous membrane, which can contribute to the development of cataracts, glaucoma, fungal infections of the eye and exacerbation of herpetic infections. With prolonged treatment, when applying the drug to a large surface of the body, as well as in the armpits and inguinal folds, when using occlusive dressings, diapers, systemic absorption of glucocorticosteroids is possible.

For children over 1 year of age, the drug is prescribed only according to strict indications and under medical supervision, as systemic side effects associated with betamethasone may develop.

When using the drug in children aged 1 year and older, it is necessary to limit the total duration of treatment and exclude measures that lead to increased resorption and absorption (warming, fixing and occlusive dressings, diapers). When using the drug on large areas of the body and/or under an occlusive dressing, suppression of the function of the hypothalamic-pituitary-adrenal system and the development of symptoms of hypercorgycism may occur; a decrease in the excretion of growth hormone and an increase in intracranial pressure may be observed.

Impact on the ability to drive vehicles and machinery

The drug does not affect the ability to drive vehicles and machinery, or the ability to engage in potentially hazardous activities that require rapid psychomotor reactions.

Betamethasone 0.05% cream for external use, 30g

Registration Certificate Holder

VERTEX (Russia)

Dosage form

Medicine - Betamethasone (Betamethasone-Vertex)

Description

Cream for external use

white or almost white, uniform.

1 g

betamethasone dipropionate 0.643 mg, which corresponds to the content of betamethasone 0.5 mg

Excipients

: white soft paraffin - 150 mg, cetostearyl alcohol - 72 mg, liquid paraffin - 60 mg, macrogol 20 cetostearyl ether - 22.5 mg, sodium dihydrogen phosphate dihydrate - 3.39 mg, methyl parahydroxybenzoate (methylparaben) - 1 mg, propyl parahydroxybenzoate (propylparaben) - 0.5 mg , sodium hydroxide - in the amount necessary to establish the pH, concentrated phosphoric acid - in the amount necessary to establish the pH, purified water - up to 1 g.

15 g - aluminum tubes (1) - cardboard packs. 30 g - aluminum tubes (1) - cardboard packs. 50 g - aluminum tubes (1) - cardboard packs.

Indications

Skin diseases amenable to GCS therapy: atopic dermatitis/neurodermatitis, allergic contact dermatitis, eczema (various forms), contact dermatitis (including occupational) and other non-allergic dermatitis (including sun and radiation dermatitis), reactions to insect bites, psoriasis , bullous dermatoses, discoid lupus erythematosus, lichen planus, exudative erythema multiforme, skin itching of various etiologies, erythroderma.

Contraindications for use

Hypersensitivity, bacterial (skin tuberculosis, skin manifestations of syphilis), fungal, viral (varicella, herpes simplex) skin diseases, skin post-vaccination reactions, open wounds, trophic leg ulcers, rosacea, acne vulgaris, skin cancer, nevus, atheroma, melanoma , hemangioma, xanthoma, sarcoma, children up to 1 year (cream and ointment) and up to 2 years (spray), breastfeeding period.
With caution
Cataracts, diabetes mellitus, glaucoma, tuberculosis (with long-term use or application to large areas of the body), children aged 2 to 12 years (spray).

pharmachologic effect

Betamethasone dipropionate is a synthetic corticosteroid. It has anti-inflammatory, antipruritic, antiallergic, vasoconstrictive, antiexudative and antiproliferative effects. When applied to the surface of the skin, it constricts blood vessels, relieves itching, reduces the release of inflammatory mediators (from eosinophils and mast cells), interleukins 1 and 2, interferon gamma (from lymphocytes and macrophages), inhibits activity and reduces the permeability of the vascular wall. Interacts with specific receptors in the cytoplasm of the cell, stimulates the synthesis of matrix ribonucleic acid, inducing the formation of proteins, including lipocortin, mediating cellular effects. Lipocortin inhibits phospholipase A2, blocks the release of arachidonic acid and the biosynthesis of endoperoxides, prostaglandins, leukoproteins (contributing to the development of inflammation, allergies and other pathological processes).

Dosage regimen

External use. The dosage regimen is individual, depending on the indications, the patient’s age and the clinical situation.

Side effect

For the skin and subcutaneous tissues:

skin itching, burning, irritation, dry skin, folliculitis, hypertrichosis, striae, acne-like rashes (“steroid” acne), hypopigmentation, perioral dermatitis, allergic contact dermatitis, skin maceration, secondary infection, skin atrophy, local hirsutism, telangiectasia, miliaria, purpura.

From the laboratory parameters:

hyperglycemia, glucosuria.
On the part of the organ of vision:
blurred vision.

Other:

reversible inhibition of adrenal cortex function, manifestation of Itsenko-Cushing syndrome.

special instructions

Long-term use of the drug on the skin of the face is not recommended, as the development of rosacea, perioral dermatitis and acne is possible. The course of treatment should not exceed 5 days.

The drug is not intended for use in ophthalmology. Avoid getting the drug into your eyes. If the drug gets on the mucous membranes of the eye, it is possible to develop cataracts, glaucoma, fungal infections of the eye and exacerbation of herpes infection.

With prolonged treatment, when applied to large surfaces of the skin, as well as in the armpits and inguinal folds, when using occlusive dressings, diapers, systemic absorption of GCS is possible.

When used on large surfaces and/or under an occlusive dressing, suppression of the function of the hypothalamic-pituitary-adrenal system and the development of symptoms of hypercortisolism may occur; a decrease in the excretion of growth hormone and an increase in intracranial pressure may be observed.

The spray form is preferable for use in acute forms of dermatosis, including those accompanied by exudation (formation of weeping surfaces).
Use in pediatrics
Use in children aged 1-2 years is possible only under medical supervision. Children are more at risk of suppressing the function of the hypothalamic-pituitary-adrenal system due to the use of corticosteroids for external use than adults, due to their greater ratio of body surface area to body weight and, accordingly, increased absorption of this drug. In children, this is accompanied by low plasma cortisol levels and lack of response to ACTH stimulation. Itsenko-Cushing syndrome may occur, impaired growth and development, slower weight gain, increased intracranial pressure, manifested by protrusion of the fontanelle, headaches, and bilateral papilledema.

Use during pregnancy and breastfeeding

Restrictions during pregnancy - Contraindicated. Restrictions when breastfeeding - Contraindicated. Contraindicated during pregnancy and lactation (breastfeeding).

Use in children

Restrictions for children - Contraindicated.

The drug is contraindicated for use in children under 1 year (ointment and cream) and under 2 years (spray).
Use caution when using the spray form in children aged 2 to 12 years.

pharmachologic effect

Betamethasone is a glucocorticosteroid for external use. It has anti-inflammatory, antipruritic, antiallergic, vasoconstrictive, antiexudative and antiproliferative effects. Inhibits the accumulation of leukocytes, the release of lysosomal enzymes and pro-inflammatory mediators at the site of inflammation, inhibits phagocytosis, reduces vascular tissue permeability, and prevents the formation of inflammatory edema. When applied to the surface of the skin, it has a quick and strong effect at the site of inflammation, reducing the severity of objective symptoms (erythema, swelling, lichenification) and subjective sensations (itching, irritation, pain).