Lekhim

Lekhim

23, Shota Rustaveli St., 01033 Kyiv, Ukraine

Bemedozone

Bemedozone

(BETAMETHSONE)

Storage:

active substance: betamethasone;

1 ml of the solution contains 5.3 mg of betamethasone sodium phosphate, calculated at 100%, which is equivalent to 4.0 mg of betamethasone;

excipients: disodium edetate, disodium phosphate dihydrate, concentrated phosphoric acid, water for injections.

Medicinal form. Solution for injections.

Main physicochemical properties: transparent colorless solution.

Pharmacotherapeutic group. Corticosteroids for systemic use. Glucocorticoids. Betamethasone. ATX code H02A B01.

Pharmacological properties.

Pharmacodynamics.

Betamethasone is a synthetic glucocorticoid drug for systemic use. It has a pronounced anti-inflammatory, anti-rheumatic and anti-allergic effect in the treatment of diseases that respond to corticosteroid therapy. Modifies the body's immune reactions. Betamethasone has a high glucocorticosteroid activity and a weak mineralocorticoid effect.

Pharmacokinetics.

Betamethasone is quickly absorbed from the injection site. The maximum concentration in blood plasma is reached after 1 hour. Betamethasone is almost completely eliminated within 1 day. Biotransformed in the liver. The half-life is 300 minutes or more. Betamethasone clearance is slower in patients with liver disease. Binding to blood plasma proteins is high. It has been studied that the clinical effectiveness depends more on the level of the unbound fraction of the corticosteroid than on the total plasma concentration. There is no relationship between the level of corticosteroid in the blood plasma and the duration of the therapeutic effect. It easily overcomes the placental, hematoencephalic and other histogematic barriers, penetrates into breast milk. It is excreted by the kidneys.

Clinical characteristics.

Indication.

In the treatment of various endocrine, rheumatic diseases, collagenoses, dermatological, allergic, ophthalmological, gastrointestinal, respiratory, hematological and other diseases that respond to corticosteroid therapy. Corticosteroid hormone therapy is complementary to traditional therapy and is not a substitute. This drug is indicated when a rapid, intense effect of a corticosteroid is needed or desired. Betamethasone is intended for a rapid and powerful therapeutic effect.

Endocrine diseases:первинна та вторинна недостатність кори надниркових залоз (у комбінації з мінералокортикостероїдами, за можливості); гостра адреналова недостатність; передопераційна підтримуюча терапія (а також у випадках травм та супутніх захворювань) при відомій адреналовій недостатності або при підозрі на неї; шок, нечутливість до традиційної терапії, коли підозрюється адренокортикальна недостатність; двобічна адреналектомія; вроджена адреналова гіперплазія; гострий тиреоїдит, негнійний тиреоїдит та тиреоїдний криз; гіперкальціємія, асоційована з раком.

Cerebral edema (increased intracranial pressure): The clinical benefit of concomitant corticosteroid therapy in cerebral edema is likely to be achieved by suppression of cerebral inflammation. Corticosteroids should not be considered a substitute for neurosurgery. They help reduce or prevent brain edema associated with surgical and other brain trauma, cerebrovascular events, and primary or metastatic brain tumors.

Cases of renal allograft rejection: the drug has been shown to be effective in the treatment of acute primary rejection and classic delayed rejection in combination with conventional therapy in the prevention of renal transplant rejection.

Prenatal use to prevent respiratory distress syndrome in premature newborns: the drug is intended for the prophylactic treatment of hyaline membrane disease in premature infants when administered to mothers (up to the 32nd week of pregnancy) before delivery.

Lesions of the muscles and skeleton: as adjunctive therapy for short-term use(to overcome acute conditions or exacerbation) in rheumatoid arthritis; osteoarthritis (post-traumatic or with synovitis); psoriatic arthritis; ankylosing spondylitis; acute gouty arthritis; acute and subacute bursitis; acute rheumatic fever; fibrositis; epicondylitis; acute nonspecific tendosynovitis; myositis; corns Treatment of cystic tumors of aponeurosis or tendon (ganglia).

Collagenoses: during exacerbations or as supportive therapy in individual cases of systemic lupus erythematosus, acute rheumatic carditis, scleroderma, and dermatomyositis.

Dermatological diseases:pemphigus; bullous dermatitis herpetiformis; severe erythema multiforme (Stevens-Johnson syndrome); exfoliative dermatitis; fungal mycosis; severe psoriasis, allergic eczema (chronic dermatitis), severe seborrheic dermatitis. Use in the affected areas is indicated for keloids; on limited areas of hypertrophy, with infiltration and inflammation in lichen planus, psoriatic plaques, ring-shaped granuloma and chronic lichen planus (neurodermatitis); with discoid lupus erythematosus; diabetic lipoid necrosis; with focal alopecia.

Allergic diseases : control of severe allergic conditions that are not controlled by adequate means of traditional treatment, such as seasonal or year-round allergic rhinitis, nasal polyps, bronchial asthma (including status asthmaticus), contact dermatitis, atopic dermatitis (neurodermatitis), allergic reactions to drugs and Blood Transfusion; acute non-infectious swelling of the larynx.

Ophthalmological diseases:severe, acute and chronic allergic and inflammatory processes in the eyes and adjacent tissues, such as allergic conjunctivitis, keratitis, allergic marginal corneal ulcers, ocular herpes zoster, iritis and iridocyclitis, chorioretinitis, anterior segment inflammation, diffuse posterior uveitis and choroiditis, neuritis optic nerve; sympathophthalmia.

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