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Warnings

Betamethasone can weaken your immune system, making it easier for you to get an infection. Steroids can also worsen an infection you already have, or reactivate an infection you recently had. Tell your doctor about any illness or infection you have had within the past several weeks.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

It is not known whether betamethasone will harm an unborn baby. Tell your doctor if you are pregnant.

Interactions

Fingolimod: Immunosuppressants may enhance the immunosuppressive effect of Fingolimod. Management: Avoid the concomitant use of fingolimod and other immunosuppressants when possible. If combined, monitor patients closely for additive immunosuppressant effects (eg, infections). Consider therapy modification

Indium 111 Capromab Pendetide: Corticosteroids (Systemic) may diminish the diagnostic effect of Indium 111 Capromab Pendetide. Avoid combination

Urea Cycle Disorder Agents: Corticosteroids (Systemic) may diminish the therapeutic effect of Urea Cycle Disorder Agents. More specifically, Corticosteroids (Systemic) may increase protein catabolism and plasma ammonia concentrations, thereby increasing the doses of Urea Cycle Disorder Agents needed to maintain these concentrations in the target range. Monitor therapy

Food interaction

Take with food to reduce irritation.

Pregnancy

• Pregnancy is an absolute contraindication to be evaluated or admitted to the study and is grounds for removal from the study.
• Birth defects in child of male recipient of kidney transplant.
• Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Overview

Betamethasone interacts with specific receptors in the cytoplasm of the cell, the resulting complex passes into the cell nucleus, where it binds to DNA and enhances the synthesis of mRNA, which promotes the synthesis of proteins, including lipocortin. In some cells (in lymphocytes, for example), mRNA is inhibited. Lipocortin has a depressing effect on phospholipase A2, thereby blocking the release of arachidonic acid and the synthesis of prostaglandins, endoperoxides, leukotrienes (which contribute to the development of allergies, inflammation and other pathological processes). It affects all phases of inflammation. Anti-inflammatory effect is possible due to many factors. The main one is the inhibition of phospholipase A2 with further inhibition of the synthesis of such pro-inflammatory mediators as leukotrienes and prostaglandins. Betamethasone also stabilizes cell membranes, including lysosome membranes, which prevents the release of their enzymes, reducing the concentration in the focus of inflammation. It reduces the migration of macrophages and neutrophils to the site of inflammation and their phagocytic activity. Reduces vascular permeability, leads to vasoconstriction of capillaries, reduces fluid exudation, improves microcirculation. The antiallergic effect of betamethasone is possible as a result of a decrease in the release and formation of allergic mediators, blocking the release of histamine and other biologically active substances from basophils and sensitized mast cells, a decrease in the number of circulating basophils, inhibition of proliferation of connective and lymphoid tissue, a decrease in the number of mast cells, B and T cells lymphocytes, reducing the sensitivity of effector cells to allergic mediators, inhibiting the formation of antibodies, changing immune ETA body. The immunosuppressive effect is associated with a decrease in the activity of B- and T-lymphocytes, as well as inhibition of the release of cytokines (interferon-gamma, interleukin-2, interleukin-1) from macrophages and leukocytes. Antitoxic and antishock effects are associated with an increase in blood pressure (the number of circulating catecholamines increases, the sensitivity of adrenoreceptors to them and vasoconstriction is restored), activation of hepatic enzymes that are involved in the metabolism of xeno - and endobiotics. Betamethasone affects all types of metabolism. It enhances gluconeogenesis in the liver, in the blood it increases the level of glucose (up to glucosuria). Accelerates protein catabolism, especially in muscles. Redistributes fats: increases lipolysis in the limbs, but contributes to the accumulation of fat in the shoulder girdle, neck, face (moon face). It retains water and Na +, enhances the excretion of K +, Ca +. With prolonged use, it suppresses the work of the hypothalamus-pituitary-adrenal gland system. After enteral and parenteral (intramuscular) administration, it is absorbed rapidly - when administered orally, the maximum effect will develop in 1-2 hours. When using a combination of salts in one preparation, betamethasone disodium phosphate from the injection site is well absorbed and acts quickly, betamethasone dipropionate is absorbed more slowly, but provides a long-lasting effect. It passes into the intraocular fluid, iris, cornea, choroid, retina, ciliary body when instilled into the conjunctival sac. Systemic absorption can only become significant if high doses are used or used continuously in children. When applied topically to the skin, the intensity of absorption depends on a number of factors: the state of the skin barrier (skin diseases and inflammation increase absorption), the solvent (improve the penetration of polypropylene components). Betamethasone binds to plasma proteins. It easily penetrates the histohematological barriers, including the placental, excreted in breast milk. In the liver, it is biotransformed with the formation of inactive metabolites. Excreted by the kidneys. To assess the effect on fertility and the Becotide carcinogenicity of betamethasone for local use in animals, no lengthy studies have been conducted. In vitro in tests of chromosomal aberrations on human lymphocytes (during metabolic activation) and in vivo in a micronucleus test in the bone marrow of mice, betamethasone was genotoxic.

Indications

Suspensions for injection, solutions for injection: shock (traumatic, burn, operational, blood transfusion, cardiogenic, toxic, anaphylactic); anaphylactoid and allergic reactions; asthmatic status; cerebral edema (including those associated with radiation therapy, surgery, therapy head injury, a brain tumor); bronchial asthma (severe form); systemic diseases of the connective tissue: rheumatoid arthritis, lupus erythematosus; acute adrenal insufficiency; thyrotoxic crisis; hepatic coma; acute hepatitis; poisoning with cauterizing fluids (to reduce inflammation and prevent scarring).
Intra-articular use of betamethasone: rheumatoid arthritis; ankylosing spondylitis; psoriatic arthritis; Reiter's disease; osteoarthrosis (with severe signs of synovitis, joint inflammation).
Inside: systemic diseases of the connective tissue: scleroderma, systemic lupus erythematosus, periarteritis nodosa, rheumatoid arthritis, dermatomyositis; acute and chronic inflammation of the joints: psoriatic and gouty arthritis, osteoarthritis (including post-traumatic), juvenile arthritis, polyarthritis, ankylosing spondylitis, shoulder-shoulder periarteritis, bursitis, Check syndrome in adults, nonspecific tendosynitis, epicondylitis and synovitis; rheumatic heart disease; bronchial asthma; acute rheumatism; chorea; chronic and acute allergic diseases: allergic reactions to food products and medicines, drug exanthema, urticaria, serum sickness, allergic rhinitis, Quincke's edema, hay fever; skin diseases: psoriasis, pemphigus, eczema, contact dermatitis, atopic dermatitis, toxidermy, exfoliative dermatitis, seborrheic dermatitis, toxic epidermal necrolysis, malignant exudative erythema, bullous herpetiform dermatitis; cerebral edema (postoperative, traumatic, metastatic) after parenteral use; allergic eye diseases: allergic corneal ulcers and conjunctivitis forms; inflammatory eye diseases: severe sluggish back and front uveitis, sympathetic ophthalmia, optic neuritis; congenital adrenal hyperplasia; secondary or primary adrenal insufficiency (including conditions after removal of the adrenal glands); nephrotic syndrome; autoimmune kidney disease (including acute glomerulonephritis); subacute thyroiditis; hematopoietic diseases: panmyelopathy, agranulocytosis, hemolytic autoimmune anemia, acute lymph and myeloid leukemia, congenital hypoplastic anemia, lymphogranulomatosis, secondary thrombocytopenia in adults, thrombocytopenic purpura, erythroblastopenia; interstitial lung diseases: pulmonary fibrosis, acute alveolitis, sarcoidosis 2 and 3 degrees; pulmonary tuberculosis; tuberculous meningitis; aspiration pneumonia (together with specific chemotherapy); Leffler's syndrome (which is not amenable to other treatment); digestive system diseases: Crohn's disease, ulcerative colitis, hepatitis, local enteritis; myeloma hypoglycemic conditions; hypercalcemia due to malignant neoplasms; prevention of transplant rejection; vomiting and nausea with cytostatic therapy.
Using betamethasone topically on the skin (ointment): dermatitis (exfoliative, simple, solar, radiation, seborrheic, herpetiform, atopic, contact and others); eczema (coin-shaped, children’s and others); Hyde's knobby pruritus; psoriasis; lichen planus; discoid lupus erythematosus; itchy skin; hives; exudative erythema multiforme; generalized erythroderma; mushroom mycosis; pemphigus.
Ear and eye drops: inflammatory and allergic eye diseases, including conjunctivitis, allergic blepharitis, keratoconjunctivitis, uveitis, scleritis, sympathetic iridocyclitis, chorioretinitis, central retinitis; optic neuritis; otitis externa; retrobulbar neuritis.

Contraindications

Hypersensitivity (exception short-term systemic use for health reasons). For systemic use (by mouth and parenterally): herpetic diseases, systemic mycoses, chickenpox, measles (including recent and recent contact with the patient), strongyloidosis (including if it is suspected), tuberculosis (with an active form and the absence of specific therapy), the state of immunodeficiency (including HIV infection or AIDS), diseases of the gastrointestinal tract (including peptic ulcer, peptic ulcer, diverticulitis, gastritis, esophagitis, recently created intestinal anastomosis), blood system pathology treatment (including congestive heart failure, recent myocardial infarction, arterial hypertension), myastenia gravis, diabetes (also with impaired glucose tolerance), renal / hepatic failure, acute psychosis, during the vaccination.
For the introduction of betamethasone into the joint cavity and the lesion: previous arthroplasty, unstable joints, pathological bleeding, intraarticular bone fracture, infected lesions of the periarticular soft tissues, joints and intervertebral spaces, osteoporosis in the joints.
When used on the skin: skin tuberculosis, syphilis, bacterial, fungal, viral skin diseases, trophic ulcers of the leg, skin cancer, atheroma, nevus, melanoma, xanthoma, hemangioma, sarcoma, acne vulgaris and rosacea, post-vaccination skin reactions, in children under 1 years - rash with diaper rash.
Ear and eye drops: fungal diseases of the ear or eyes, acute viral diseases of the ear or eyes, tuberculosis of the eyes or ear (including a history), bacterial infections of the ear or eyes, glaucoma, defect or thinning of the corneal and scleral epithelium, perforation of the tympanic membranechronic or transferred otitis media.
Limit the use of betamethasone (parenterally and orally) for open-angle glaucoma, hyperlipidemia, hypoalbuminemia, viral and bacterial infections, syphilis, Itsenko-Cushing's disease, systemic osteoporosis, thrombophlebitis, obesity of 3-4 degrees; (intra-articular administration) the general serious condition of the patient, inefficiency or short duration of action of 2 past injections; (application to the skin) when applied to large areas or prolonged use - diabetes, cataracts, tuberculosis, glaucoma. For children during the growth period, take only by absolute indications.

Dosage

Betamethasone is used parenterally, orally, topically. Doses and route of administration depend on the disease and are selected individually. Inside, betamethasone is taken after a meal: the daily dose for children is 0.017-0.25 mg / kg, for adults 0.25-8 mg. After prolonged treatment, the dose is gradually reduced under the supervision of a doctor, every 3 days by 250 mcg. Parenteral, betamethasone disodium phosphate: - slowly, intravenously, by stream or by drop, in adults: single dose of 4–8 mg (up to 20 mg if necessary), followed by a maintenance dose of 2–4 mg. Betamethasone dipropionate - intramuscularly, deeply, for adults - 4-6 mg (up to 9 mg) per day. For children - intramuscularly, from 1 year to 5 years old - an initial dose of 2 mg, 6-12 years old - 4 mg. Periarticular and intraarticular (for adults): in large joints - 2–4 mg (up to 9 mg), small ones - 0.8–2 mg not more often than 1 time Becotide 3 weeks; tendon sheaths - 0.4–1 mg, in a synovial bag - 2-3 mg; soft tissues - 2-6 mg; intradermally into the lesion - not more than 0.1 mg / cm2 and not therapy than 2 mg per week; if necessary, it can be mixed with local anesthetics (1% solution of lidocaine, procaine). In ophthalmology, subconjunctival: if necessary, 2 mg is administered as a solution for injection. Topically: apply a thin layer and gently rub (cream, ointment) on the affected skin 2 to 6 times a day until clinical improvement, then 1-2 times a day; it is better to apply the cream on wet or moist areas, ointment - with dry scaly or lichen lesions. The course of therapy for children and patients with facial lesions is not more than 5 days. Ear and eye drops: for eye pathology, in the conjunctival sac - 1-2 drops of 0.1% solution every 1-2 hours at the beginning of therapy, for diseases of the ear, in the external auditory canal - 2-3 drops of 0.1% solution every 2-3 hours, then, depending on the therapeutic effect, the frequency of administration is reduced.
If you skip the next dose of betamethasone, you should do this, as you recall, take it next time after the set time from the last time.
Mental disorders are likely in patients who have chronic diseases, are prone to the appearance of mental disorders and use large doses of the drug; such symptoms can occur up to 2 weeks after starting treatment. Betamethasone preparations are used with caution with herpes simplex, diabetes mellitus, systemic lupus erythematosus (the risk of aseptic necrosis increases), in patients with a risk of thrombosis, osteoporosis, in the elderly (risk of hypertension, osteoporosis, especially in the postmenopausal period in women), only with appropriate antibiotic therapy - with purulent infections, abscesses, tuberculosis. It is necessary to take into account the increased effect of cirrhosis of the liver, hypothyroidism, the possibility of developing relative adrenal insufficiency (within a few months after stopping the drug). With prolonged therapy, careful monitoring of the dynamics of development and growth of children is necessary, periodically examining the eyes (to detect cataracts, glaucoma and other pathologies), regularly monitoring the functioning of the hypothalamus-pituitary-adrenal system, glucose levels in urine and blood, serum electrolytes, the presence of latent blood in the stool. With systemic use, electroencephalography is recommended. Avoid contact with mucous membranes and eyes of dosage forms that are intended for skin. Avoid immunization and vaccination during treatment. It is not recommended to drink alcohol during treatment with betamethasone.

Side effects

The severity and frequency of development of adverse reactions depend on the size of the dose and the duration of treatment. Long-term therapy or high doses of glucocorticoids can lead to severe manifestations of mineral - and glucocorticoid effects, which are considered as side effects.
Systemic reactions: sensory organs and nervous system: delirium (agitation, confusion, anxiety), euphoria, disorientation, hallucinations, depression, paranoia, manic / depressive episode, increased intracranial pressure and swelling of the optic nerve head, sleep disturbance, vertigo, dizziness, sudden loss of visionheadache, formation of subcapsular posterior cataract, increased intraocular pressure with possible damage to the optic nerve, steroid exophthalmos, glaucoma, the development of secondary viral treatment for fungal infections second eye; blood and circulatory system: hypertension, chronic heart failure, hypercoagulation, myocardial dystrophy, thrombosis, ECG changes that are characteristic of hypokalemia; digestive system: vomiting, erosive and ulcerative lesions, pancreatitis, nausea, erosive esophagitis, changes in appetite, hiccups; metabolism: water retention and Na +, negative nitrogen balance due to protein catabolism, hypokalemia, weight gain; endocrine system: decreased adrenal cortex function, steroid diabetes, decreased glucose tolerance, Itsenko-Cushing's syndrome, manifestation of latent diabetes mellitus, growth retardation in children, hirsutism; support and movement system: muscle weakness, decreased muscle mass, spontaneous bone fractures, steroid myopathy, osteoporosis, tendon ruptures, aseptic necrosis of the femoral head; skin: steroid acne, thinning of the skin, striae, hypo- or hyperpigmentation, petechiae, delayed wound healing, ecchymosis, excessive sweating; allergic reactions: swelling of the face, stridor, urticaria, shortness of breath, rash, anaphylactic shock; other: decreased immunity, activation of infectious diseases, withdrawal syndrome (nausea, anorexia, lethargy, joint pain, back pain, muscle pain, abdominal pain, general weakness, and others), irregular menstruation.
With the introduction of betamethasone intravenously: arrhythmias, cramps, flushing.
When injected into the joints : increased pain. Local effects when administered parenterally: burning, pain, numbness, infection and paresthesia at the injection site, atrophy of the subcutaneous tissue and skin, scar formation at the injection site.
When using betamethasone on the skin: itching, dryness and burning of the skin, hyperemia, erythema, striae, steroid acne, folliculitis, prickly heat, hypertrichosis, secondary infections, with prolonged use - local hirsutism, skin atrophy, telangiectasia, hypopigmentation, purpura, systemic manifestations are possible on large surfaces.
Ear and eye drops: increased intraocular pressure, the formation of a subcapsular posterior cataract, glaucoma, perforation or thinning Becotide the sclera and cornea, tingling or burning in the ear, pain, irritation, burning and itching of the skin, the development of secondary infection, dermatitis, with prolonged use of large doses, systemic reactions are possible.

Interaction

Toxic and therapeutic effects reduce the inducers of liver enzymes, and increase oral contraceptives and estrogens, the possibility of hypokalemia and arrhythmias increase diuretics, digitalis glycosides, amphotericin B, carbonic anhydrase inhibitors; the possibility of ulcerative-erosive lesions or bleeding in the gastrointestinal tract is increased by non-steroidal anti-inflammatory drugs and alcohol; the risk of developing lymphomas and other lymphoproliferative diseases and the appearance of infections is enhanced by immunosuppressants, the possibility of developing pulmonary edema in pregnant women increases erythrocytes. Reduces hypoglycemic activity of insulin and antidiabetic drugs, diuretic and natriuretic activity of diuretics, activity of vaccines; reduces anticoagulant activity of coumarin and indandion derivatives, streptokinase and urokinase, heparin. Enhances hepatotoxicity of paracetamol. Reduces blood levels of mexiletine and salicylates.

special instructions

Pregnancy and lactation

During pregnancy, betamethasone can be used if the expected benefit to the mother is higher than the possible risk to the fetus. With eclampsia, preeclampsia, symptoms of placental damage, it is contraindicated to use betamethasone. It is not recommended to be taken in large doses and often over a long period of time. Breastfeeding should be discontinued during betamethasone therapy.

Overdose

With an overdose of betamethasone, nausea, sleep disturbances, vomiting, euphoria, agitation occur. With prolonged use of high doses, osteoporosis, hypertension, fluid retention in the body and other symptoms of hypercorticism, including Itsenko-Cushing's syndrome and secondary adrenal insufficiency, appear. Treatment: gradual discontinuation of the drug, correction of electrolyte balance, maintenance of vital functions, taking antacids, phenothiazines, lithium preparations; with Itsenko-Cushing's syndrome - aminoglutethimide.