Betametazon (When ATH A07EA04)

When ATH:
A07EA04

Characteristic.

Hormonal agents (glucocorticoid for systemic and topical).

In clinical practice using betamethasone valerate, betamethasone dipropionate, betamethasone disodium phosphate. Betamethasone valerate and betamethasone dipropionate are the current top ointments and creams, betamethasone disodium phosphate in solution is introduced into / in and subkonyunktivalno.

Betamethasone valerate - white or almost white, crystalline powder;, practically insoluble in water, freely soluble in acetone and chloroform, soluble in ethanol, slightly soluble in benzene and ether. Molecular weight 476,58.

Betamethasone dipropionate - white or creamy white, crystalline powder;, insoluble in water. Molecular weight 504,6.

Betamethasone disodium phosphate - a white or almost white odorless powder, hygroscopic, freely soluble in water and methanol, practically insoluble in acetone and chloroform. Molecular weight 516,41.

Betamethasone disodium phosphate / dipropionate (Combined PM) - Suspension of fine crystals; injected i / m, vnutrisustavno, peryartykulyarno (you can not enter in /).

Pharmacological action.
Glucocorticoid, anti-inflammatory, antiallergic, protivozudnoe.

Application.

Solution for injection, suspension for injection. Shock (ambustial, traumatic, operating, toxic, cardiogenic, transfusion, anaphylactic); Allergic (sharp, severe) and anaphylactoid reactions; swelling of the brain (incl. amid brain tumor or associated with surgery, radiotherapy or head injury); bronchial asthma (severe form), asthmatic status; systemic connective tissue disease: systemic lupus erythematosus, rheumatoid arthritis; acute adrenal insufficiency; thyrotoxic crisis; acute hepatitis, pechenochnaya coma; poisoning cauterizing liquids (decrease inflammation and prevent scarring restrictions).

Intra: rheumatoid arthritis, psoriaticheskiy arthritis, ankiloziruyushtiy spondylitis, Reiter's disease, osteoarthritis (when there are significant signs of joint inflammation, synovitis).

Pills. Systemic diseases of connective tissue: systemic lupus erythematosus, scleroderma, periarteritis nodosa, dermatomyositis, rheumatoid arthritis; acute and chronic inflammatory diseases of the joints: podagricheskiy and psoriaticheskiy arthritis, yuvenilynыy arthritis, osteoarthritis (incl. posttraumatic), polyarthritis, humeroscapular nodosa, ankylosing spondylitis (ankylosing spondylitis), Still's syndrome in adults, ʙursit, nonspecific tenosynovitis, synovitis and epicondylitis; rheumatic fever, revmokardit, chorea; bronchial asthma; acute and chronic allergic diseases: allergies to drugs and food, drug rash, serum sickness, hives, nasal allergy, pollen disease, angioedema; skin diseases: pemphigus, psoriasis, eczema, atopic dermatitis, contact dermatitis (with damage to a large area of ​​the skin), drug reaction, seborrheic dermatitis, exfoliative dermatitis, toxic epidermal necrolysis (Lyell's syndrome), bullous dermatitis herpetiformis, malignant exudative erythema (Stevens-Johnson syndrome); swelling of the brain (traumatic, postoperative, metastatic) after pre parenteral administration; ocular allergy: allergic corneal ulcers, allergic conjunctivitis form; inflammatory diseases of the eye: transferred ophtalmia, heavy sluggish front and posterior uveitis, optic neuritis; congenital adrenal hyperplasia; primary or secondary adrenal insufficiency (incl. condition after the removal of the adrenal glands); kidney disease of autoimmune origin (incl. acute glomerulonephritis), nephrotic syndrome; subacute thyroiditis; diseases of the blood: agranulocytosis, panmyelopathy, autoimmunnaya gemoliticheskaya anemia, Congenital (erythroid) gipoplasticheskaya anemia, acute lymphatic- and myeloid leukemias, limfogranulematoz, trombotsitopenicheskaya purpura, secondary thrombocytopenia in adults, erythroblastopenia (эritrotsitarnaya anemia); interstitial lung disease: Acute alveolitis, fibrosis lyegkikh, sarcoidosis II-III st.; tuberculous meningitis, pulmonary tuberculosis, inhalation pneumonia (in combination with a specific chemotherapy), berylliosis, Loffler's syndrome (not amenable to other therapy), lung cancer (in combination with cytostatics); multiple sclerosis; gastrointestinal diseases: yazvennыy colitis, Crohn's disease, Local enteritis; hepatitis, hypoglycemic states; prevention of graft rejection; hypercalcemia due to malignancies, nausea and vomiting during cytostatic therapy; multiple myeloma.

When applied to the skin: dermatitis (simple, exfoliative, sunny, seborrheal, radiation, herpetiform, contact, atopic et al.), eczema (nursery, and other coin-like.), psoriasis, uzlovataya pochesuha Gaida, Lichen planus, itching, discoid lupus erythematosus, hives, erythema multiforme exudative, generalized erythroderma (in the complex therapy), pemphigus, mycosis fungoides and other skin disorders.

Eye drops and ear: allergic and inflammatory diseases of the eye, incl. Allergic blepharitis, conjunctivitis, keratokonъyunktyvyt, scleritis, uveitis, chorioretinitis, sympathetic iridotsyklit, central retinitis; optic neuritis, optic neuritis, otitis externa.

Contraindications.

Hypersensitivity (for short-term use of the system for health is the only contraindication).

For systemic use (parenterally and inwardly): systemic mycosis, herpetic disease, incl. enable vetryanaya, and measles (currently or recently transferred, including the recent contact with a patient), strongiloidoz (or suspected), tuberculosis (active form in the absence of specific treatment, latent), immunodeficiency states (incl. AIDS or HIV infection), gastrointestinal diseases (incl. pepticheskaya ulcer, gastric ulcer and duodenal ulcer in the acute phase, diverticulitis, esophagitis, gastritis, recently established intestinal anastomosis), diseases of the cardiovascular system (incl. recent myocardial infarction, congestive heart failure, arterial hypertension), diabetes (incl. impaired glucose tolerance), myastenia gravis, acute psychosis, renal / hepatic insufficiency, during vaccination.

For intraarticular administration, intralesional: unstable joints, previous arthroplasty, abnormal bleeding (endogenous or caused by the use of anticoagulants), chressustavnoy fracture, infected lesions of the joints, periarticular soft tissue intervertebral spaces, marked periarticular osteoporosis.

When applied to the skin: cutaneous manifestations of syphilis, lupus; Bacterial, Viral, fungal skin diseases (incl. enable vetryanaya, herpes); leg sores, associated with varicose veins; skin cancer, nevus, atheroma, melanoma, gemangioma, ksantoma, sarkoma; rosacea and acne vulgaris (possible worsening of the disease), post-vaccination skin reactions, in children under 1 year - rashes (against the backdrop of diaper rash).

Eye drops and ear: fungal eye or ear, acute viral diseases of the eye (incl. Acute superficial keratitis, caused Herpes simplex) or ear, ocular tuberculosis (incl. history) or ear, bacterial infections of the eye or ear, thinning, or a defect of corneal epithelial, sclera; glaucoma, or the presence of chronic otitis media previously transferred, perforated eardrum (possible development of ototoxicity).

Restrictions apply.

For systemic use (parenterally and inwardly): otkrыtougolynaya glaucoma, hyperlipidemia, hypoalbuminemia, viral and bacterial infections, syphilis, pituitary basophilia, systemic osteoporosis, tromboflebit, Obesity grade III-IV.

For intraarticular administration: general grave condition of the patient, inefficiency or short-acting 2 predыduschyh introduced (taking into account the individual properties used GC).

When applied to the skin: long-term use, or applied to large surfaces - cataracts, diabetes, glaucoma, tuberculosis.

Childhood: children in the growth period is used only on absolute grounds.

Pregnancy and breast-feeding.

When pregnancy is possible, if the effect of therapy outweighs the potential risk to the fetus (adequate and well-controlled studies of the safety of not performed); contraindicated - in preeclampsia, eclampsia, symptomatic lesions of the placenta. Do not use often, large doses, over a long period of time.

The potential teratogenicity of betamethasone dipropionate in the dermal application was not evaluated. Betamethasone dipropionate shown to be teratogenic in rabbits when i / m administration at doses 0,05 mg / kg. Reported violations included umbilical hernia, tsefalotsele, cleft palate.

Category actions result in FDA - C. (The study of reproduction in animals has revealed adverse effects on the fetus, and adequate and well-controlled studies in pregnant women have not held, However, the potential benefits, associated with drugs in pregnant, may justify its use, in spite of the possible risk.)

Nursing women should stop any breastfeeding, or the use of betamethasone (especially in high doses).

Side effects.

The frequency and severity of side effects depend on the duration of use and magnitude of the dose used. High doses or prolonged use can cause GC pronounced manifestation of mineralogy- and glucocorticoid effects, considered as side.

Systemic effects

From the nervous system and sensory organs: delirium (confusion, excitation, anxiety), disorientation, euphoria, hallucinations, manic / depressive episode, depression or paranoia, increased intracranial pressure with papilledema (pseudotumor cerebellum) - Usually after treatment, sleep disturbance, dizziness, vertigo, headache, sudden loss of vision (by parenteral administration in the head, Neck, turbinates, possibly due to the scalp fat crystals substance in vessels of the eye), posterior subcapsular cataract formation, increased intraocular pressure with possible damage to the optic nerve, glaucoma, steroid exophthalmos, the development of secondary fungal or viral eye infections.

Cardio-vascular system and blood (hematopoiesis, hemostasis): arterial hypertension, the development of chronic heart failure (in predisposed patients), miokardiodistrofija, hypercoagulation, thrombosis, ECG changes, typical of hypokalemia.

From the digestive tract: nausea, vomiting, erosive and ulcerative lesions of the gastrointestinal tract, pancreatitis, erosive esophagitis, Ikotech, increase / decrease of appetite.

Metabolism: delay Na⁺ and water, kaliopenia, negative nitrogen balance due to protein catabolism, weight gain.

On the part of the endocrine system: inhibition of the function of the adrenal cortex, reduced glucose tolerance, steroid diabetes or a manifestation of latent diabetes mellitus, Cushing's syndrome, girsutizm, growth retardation in children.

On the part of the musculoskeletal system: muscular weakness, steroidnaya myopathy, reduced muscle mass, osteoporosis (incl. spontaneous bone fractures, quiet hip disease), tendon rupture.

For the skin: steroid acne, striae, thinning of the skin, Hyper- or hypopigmentation, petechiae and ecchymosis, delayed wound healing, increased sweating.

Allergic reactions: skin rash, hives, swelling of the face, wheezing or shortness of breath, anaphylactic shock.

Other: decreased immunity and activation of infectious diseases, violation of the regularity of menstruation, withdrawal (anorexia, nausea, lethargy, pain in the muscles or joints, back, abdominal pain, general weakness, and others.).

The on / in the introduction: arrhythmia, flushing, convulsions.

With intraarticular injection: strengthening joint pain.

Local reactions when administered parenterally: burning, numbness, pain, paresthesia, and infection at the injection site, scarring at the injection site; atrophy of the skin and subcutaneous tissue (when i / m administration).

When applied to the skin: itch, hyperemia, burning and dryness of the skin, эritema, steroid acne, striae, folliculitis, hypertryhoz, jerseys, secondary infections of the skin and mucous membranes; long-term use - skin atrophy, Local hirsutism, teleangiэktaziya, purpura, gipopigmentatsiya; when applied to large surfaces are possible systemic manifestations (gastritis, ulceration of the gastrointestinal mucosa).

Eye drops and ear: increased intraocular pressure, glaucoma, posterior subcapsular cataract formation, thinning or perforation of the cornea, sclera; tingling and burning sensation in the ear; irritation, pain, itching and burning of the skin; dermatitis, secondary infection, long-term use at high doses - the development of systemic effects of the Civil Code.

Cooperation.

Therapeutic, toxic effects reduce inductors of liver enzymes, strengthen - estrogens, oral contraceptives, the likelihood of arrhythmias and hypokalaemia digitalis glycosides increase, Diuretic (causing potassium deficiency), amphotericin B, carbonic anhydrase inhibitors; the risk of ulcerative erosive lesions or bleeding in the digestive tract - alcohol and NSAIDs; the likelihood of infection and the development of lymphomas and other lymphoproliferative diseases - immunosuppressants, the possibility of pulmonary edema in pregnant women - ritodrine. Weakens hypoglycemic activity of antidiabetic drugs and insulin, natriuretic and diuretic - diuretic, Activity vaccines (due to lower production of antibodies); Anticoagulation - coumarin derivatives and indandiona, geparina, streptokinase and urokinase. Increases gepatotoksičnostʹ paracetamol. It reduces blood levels of salicylates, mexiletine.

Overdose.

Symptoms: nausea, vomiting, sleep disorders, euphoria, excitation. With prolonged use at high doses - an osteoporosis, fluid retention, increased blood pressure and other signs of Cushing, including Cushing's syndrome, Secondary adrenal insufficiency.

Treatment: against the background of the gradual withdrawal of the drug to maintain vital functions, correction of electrolyte imbalance, antacids, fenotiazinы, lithium preparations; the syndrome of Cushing - aminoglutethimide.

Dosing and Administration.

Inside, parenterally, locally. The route of administration and dosage regimen are selected individually depending on the nature and severity of the disease, patient's condition and response to therapy.

Inside: daily dose for adults - 0,25-8 mg, Children - 0,017-0,25 mg / kg. After prolonged treatment, reduce the dose gradually.

Parenteral. Betamethasone disodium phosphate: - In / jet, slow drip, adult: a single dose of 4-8 mg (if necessary - 20 mg), followed by a maintenance dose - 2-4 mg. Betamethasone dipropionate - a / m, deep, adults - 4-6 mg (to 9 mg) per day. Children - / m, aged 1 Year to 5 years - starting dose 2 mg, 6-12 years - 4 mg. Intra-articular and periarticular (adult): in large joints - 2-4 mg (to 9 mg), small - no more than 0.8-2 mg 1 times a 3 Sun; in the bursa - 2-3 mg, tendon sheath - 0.4-1 mg; soft tissues - 2-6 mg; w / c in the lesion - 0,1 mg / cm² (not more), no more 2 mg per week; if appropriate mixed with local anesthetics (1% lidocaine, prokayna).

Subkonъyunktyvalno, in ophthalmology: If necessary, enter 2 mg as a solution for injection.

Locally: the affected skin is applied thinly and gently rub (ointment, cream) from 2 to 6 once daily until clinical improvement, then - 1-2 times per day; Cream is recommended to apply on damp or moist surfaces, ointment - if you have dry or scaly lesions lishaynyh. The course of treatment in children and patients with lesions of the face - no more 5 days.

Eye drops and ear: eye diseases, in the conjunctival sac - 1-2 drops 0,1% solution every 1-2 h in the beginning of therapy, in diseases of the ear, in the external auditory canal - 2-3 drops 0,1% solution every 2-3 hours, subsequently, depending on the therapeutic effect reduces the multiplicity of application.

Precautions.

Mental disorders are more likely in patients with chronic diseases, predisposing to the development of these disorders, and high doses; Symptoms may appear within several days before 2 weeks after start of therapy.

To use caution in diabetes, herpes simplex corneal, systemic lupus erythematosus (It increases the risk of avascular necrosis), osteoporosis, in patients with risk of thrombosis (administered on a background of anticoagulants), in elderly (increased risk of hypertension, osteoporosis, particularly in postmenopausal women), Only against the background of appropriate antibiotic therapy - abscesses, purulent infections, tuberculosis. It is necessary to take into account the strengthening of actions in hypothyroidism, cirrhosis, chance of developing (especially with prolonged use) Relative adrenal insufficiency (for months after drug withdrawal).

Long-term treatment should be carefully monitored for the dynamics of growth and development in children, periodic eye examination (to detect glaucoma, cataract etc..), regularly monitor the function of the hypothalamic-pituitary-adrenal system, glucose in blood and urine (especially in patients with diabetes), serum electrolytes, of occult blood in faeces. When the system is recommended to control the use of EEG.

Avoid contact with eyes and mucous membrane dosage forms for application to the skin.

During therapy, avoid Vaccines and Immunization. Do not drink alcohol.

Cooperation