Betaspan

General characteristics. Structure:

Active ingredient: betamethasone;

1 ml of solution contains betamethasone of sodium of phosphate 5,3 mg in terms of betamethasone of 100% substance of 4 mg;

excipients: dinatrium phosphate a dihydrate, dinatrium эдетат, sodium metabisulphite (Е 223), the phenol liquefied sodium hydroxide, water for injections.

Pharmacological properties:

Pharmacodynamics. Betamethasone - synthetic glucocorticoid drug for system use. Has the expressed antiinflammatory, antirheumatic and antiallergic action at treatment of diseases which answer corticosteroid therapy. Betamethasone has high glucocorticosteroid activity and weak mineralokortikoidny action. Modifies immune responses of an organism and causes considerable changes of a metabolism.

Pharmacokinetics. Betamethasone:
it is quickly absorbed from the place of an injection;
it is almost completely removed for days;
the maximum concentration in plasma is reached in 1 hour;
it biotransformirutsya in a liver;
the elimination half-life makes 300 min. and more;

Patients with diseases of a liver have a clearance of betamethasone slower. Linkng with proteins of plasma high. Researches showed that clinical performance depends on the level of untied fraction of corticosteroids more, than on the general plasma concentration. There is no interrelation between the level of corticosteroids in a blood plasma and duration of therapeutic effect. Easily overcomes placental, hematoencephalic and other gistogematichesky barriers, it is allocated in breast milk. It is removed by kidneys.

Pharmaceutical characteristics

Main physical and chemical properties: transparent, colourless liquid without mechanical inclusions, with a characteristic smell.

Indications to use:

As the accompanying therapy of the diseases and syndromes demanding bystry and the expressed therapeutic effect.

Endocrine diseases:
acute adrenal insufficiency, insufficiency of bark of adrenal glands (primary and secondary), a preoperative maintenance therapy at the known adrenal insufficiency (or at suspicion on it), considering injuries and associated diseases, a bilateral adrenalectomy, an inborn adrenal hyperplasia;
shock (anaphylactic, endotoxic, hemodynamic, burn, operational, traumatic), with suspicion on adrenocortical insufficiency;
not purulent thyroiditis (acute, chronic) and thyrocardiac crisis, a hypercalcemia owing to malignant new growths.

Musculoskeletal system diseases (for short-term treatment):
inflammatory damages of joints and soft tissues, including circumarticular (arthritis: rhematoid, psoriasis, acute gouty, the osteoarthritis ankylosing a spondylarthritis; the acute and subacute bursitis, acute rheumatic fever, a fibrositis, acute nonspecific tendosinoviit, an epicondylitis, cysts of aponeuroses and сухожильев, a miositis and callosities).

Collagenoses: system lupus erythematosus, acute rheumatic carditis, scleroderma, dermatomyositis.

Dermatological diseases: pempigus, herpetiform violent dermatitis, heavy multiformny erythema (Stephens-Johnson's syndrome), dermatitis (simple, exfoliative), psoriasis (severe form), dermatomycosis, allergic eczema (chronic dermatitis), heavy chronic seborrheal dermatitis. It is shown for use in places of defeat at: colloids, limited sites of a hypertrophy, flat herpes (infiltration and an inflammation), a psoriasis plaque, a ring-shaped granuloma, chronic flat herpes (neurodermatitis), at a diskoidny lupus erythematosus, an insulin lipodystrophy, a nested alopecia.

Respiratory diseases: a symptomatic sarcoidosis, a berylliosis, Lefler's syndrome (not stopped syndrome), aspiration pneumonia, a pulmonary tuberculosis (dessiminirovanny, fulminantny against the background of antitubercular therapy).

The allergic zabolevaniya of a state which are not giving in to traditional treatment (bronchial asthma, the asthmatic status, seasonal or year-round rhinitises, nose polyps, a medicamentous allergy, a Quincke's edema, a serum disease, atopic dermatitis (neurodermatitis)).

Hematologic diseases: autoimmune hemolitic thrombocytopenia, an eritroblastopeniya (RBC anemia), hypoplastic erythroidal anemia, idiopathic and secondary thrombocytopenia at adults, transfusion reactions.

Ophthalmologic diseases: heavy course of inflammatory and allergic diseases of eyes: iritis, iridocyclitis, chorioretinitis, keratitis, diffusion back uveitis and choroiditis, helcomas (allergic, marginal), herpetic damages of eyes, allergic conjunctivitis, optic neuritis, simpatooftalmiya, inflammation of a front segment.

Other diseases: wet brain, at reaction of rejection of renal allotransplant; prenatal prevention a distress syndrome at premature newborns;
gastrointestinal diseases: nonspecific ulcer colitis;
oncological diseases: palliative therapy of leukemia and lymphoma at adults, acute leukemia at children;
hypostases: for increase in a diuresis or remission of a proteinuria at a nephrotic syndrome of idiopathic type without uraemia or at a system lupus erythematosus;
tubercular meningitis with subarachnoidal blockade or its threat against the background of specific antitubercular therapy, a trichinosis (with neurologic and myocardial defeat).

Route of administration and doses:

Betaspan is recommended to enter intramusculary or intravenously (struyno slowly, kapelno), into the defeat center, and also into soft tissues.

The way of introduction and the mode of dosing are set individually depending on weight and the nature of a disease.

The initial dose needs to be adjusted individually before obtaining satisfactory clinical effect then the dose is gradually reduced through certain intervals before achievement of the smallest dose allowing to support necessary clinical result. During the forecasting or emergence of a stressful situation the dose of drug should be raised to, in time and after the end of this period. If the clinical result is not achieved through a certain period, drug it is necessary to cancel and reconsider the appointed therapy.

The initial dose for adults makes 8 mg of betamethasone a day.

The average initial intramuscular dose of betamethasone for children makes 20-125 mkg/kg of body weight a day.

Betaspan enter intravenously kapelno with isotonic solution of sodium of chloride, glucose and add Betaspan to infusion solution at the time of introduction. Unused solution can remain in the refrigerator for days.

To children at intravenous administration apply such doses of betamethasone: the newborn (aged till 1 year) - 1 mg; to children at the age of 1-5 years – 2 mg; 6-12 years – 4 mg (1 ml) within a day enter 3-4 times depending on a state and reaction of the patient.

At brain hypostasis: enter 2 - 4 mg of betamethasone.

In coma the average single dose makes 0,5-1 ml of solution (2-4 mg) 4 times a day.

At reaction of rejection of renal allotransplant the drug is administered intravenously kapelno, the initial dose of Betaspan makes 60 mg for the first 24 hours. Little individual changes of a dose are possible.

For prevention of transfusion complications enter 1-2 ml of drug (4-8 mg) intravenously (just before hemotransfusion); it is impossible to add drug to blood which is transfused. At repeated hemotransfusions the total dose of drug can reach 4 single doses which enter for 24 hours.

Prenatal prevention respiratory distress syndrome. At stimulation of patrimonial activity up to 32 weeks of pregnancy or at inevitability of premature births up to 32 weeks of pregnancy owing to obstetric complications it is recommended for 24 – 48 hours till the expected moment of childbirth to enter intramusculary 1 - 1,5 ml (4 – 6 mg) of drug each 12 hours (2 – 4 doses). Treatment needs to be begun in 24 hours (and it is even better - in 48 - 72 hours) prior to childbirth.

Drug can be used also with the preventive purpose if in amniotic waters the ratio lecithin/sphingomyelin is lowered. When determining a dose in similar cases it is necessary to be guided by the recommendations stated above, including, concerning the period of administration of drug before childbirth.

At musculoskeletal defeats, diseases of soft tissues the drug is administered depending on localization in the following doses:

 Place of defeat                      Betaspan's Solution, ml

                                                   (betamethasone, mg)

large joints

(hip joint)               of 0,5-1 ml (2,0 - 4,0 mg)

small joints                           of 0,2-0,5 ml (0,8 - 2,0 mg)

synovial bag                   of 0,5-0,75 ml (2,0 - 3,0 mg)

tendinous vagina              of 0,1-0,25 ml (0,4 - 1,0 mg)

make callous                                       0,1-0,25 ml (0,4 - 1,0 mg)

soft tissues                               of 0,5-1,5 ml (2,0 - 6,0 mg)

Subkonjyunktivalno enter at ophthalmologic diseases, as a rule, 0,5 ml of Betaspan (2 mg of betamethasone).

Features of use:

Use during pregnancy and feeding by a breast

Safety of use of drug during pregnancy is not established therefore Betaspan it is necessary to apply during this period when the expected advantage for mother exceeds possible risk for a fruit.

The question of expediency of prenatal prevention a distress syndrome after 32 weeks of pregnancy is finally not studied. Therefore doctors need to estimate a ratio advantage/risk for mother and a fruit at use of corticosteroids after 32 weeks of pregnancy. Corticosteroids do not appoint for treatment a distress syndrome after the child's birth.

Women who have defeat of a placenta, and also to women with a preeclampsia or an eclampsia cannot administer the drug.

Drug gets into breast milk therefore during treatment by Betaspan feeding by a breast needs to be stopped.

Newborns whose mothers received considerable doses of corticosteroids during pregnancy have to be inspected for identification of signs of adrenocortical insufficiency and (that is observed very seldom) an inborn cataract.

The women accepting corticosteroids during pregnancy have to be under special observation in time and after the delivery in connection with possibility of adrenocortical insufficiency (owing to a stress at the time of delivery).

Children. At prolonged treatment of children it is necessary to watch their growth and development (considering a possibility of oppression of growth and endogenous products of corticosteroids).

Special security measures. At administration of drug it is necessary to adhere to sterile conditions strictly.

Injections need to be entered deeply only into large muscles for the prevention of a local atrophy of fabric.

Drug incorporates sodium bisulphate which can cause development of allergic reactions in persons with hypersensitivity.

At introduction to soft tissues, to places of defeat and vnutrisustavno emergence of both local, and system effects of corticosteroids is possible.

It is necessary to avoid injections in the infected joint (for an exception of septic process investigate intra joint liquid).

Corticosteroids should not be entered into unstable joints, sites of an inflammation and intervertebral spaces, directly into sinews. Repeated injections in joints at an osteoarthritis can increase destruction of a joint.

With care appoint to the persons having allergic reactions to medicines in the anamnesis.

Betaspan for injections it is necessary to appoint carefully intramusculary the patient suffering from an idiopathic Werlhof's disease.

At prolonged use of corticosteroid therapy before transition with parenteral to oral administration it is necessary to consider all potential advantages and risk.

Changes of the mode of dosing are possible it agrees with the course of a disease (remission or an aggravation), reactions of the patient to therapy, negative changes of an emotional and physical condition of the patient (a heavy infection, surgical intervention, an injury).

After the termination of a long or intensive course of treatment glucocorticosteroids constant control behind a condition of the patient for a year is necessary.

It is impossible to use drug for treatment of a hyaline and membrane disease of newborns, to enter into the unstable joints infected zones and intervertebral spaces.

Corticosteroids can mask symptoms of infections, besides, resistance of an organism and ability to localize an infection decreases.

Use of averages and high doses of corticosteroids can cause increase in arterial pressure, a delay of sodium of chloride and water, and also increase in excretion of potassium from an organism that can be shown by hypostases and deviations in cardiac performance. In such cases the diet with the limited use of kitchen salt and in addition administration of drugs, containing potassium is recommended. These effects are less probable at use of synthetic derivatives (but not in high doses).

With caution it is necessary to take acetylsalicylic acid in a combination with Betaspan at a prothrombinopenia in connection with a possibility of increase in bleeding.

Prolonged use of Betaspan can lead to development of a cataract (especially at children), glaucomas with possible damage of an optic nerve and can promote development of consecutive infection of eyes (fungal or virus).

The patients receiving corticosteroids (preferential high doses) are not subject to vaccination (danger of development of neurologic complications and decrease in an immune response). However immunization is possible at the patients receiving corticosteroids as replacement therapy (Addison's disease).

The patients receiving immunosuppressive doses of corticosteroids have to avoid contact with patients with chicken pox and measles (it is especially important for children).

At active tuberculosis drug is used only along with antitubercular therapy. The patients with latent tuberculosis receiving corticosteroids have to be under observation of the doctor and receive chemoprophylaxis.

Effect of drug amplifies at persons with a hypothyroidism and cirrhosis.

During the forecasting or emergence of a stressful situation the dose of drug has to be raised to, in time and after the end of this period. Against the background of corticosteroid therapy emergence of mental disturbances is possible: an agravation of the existing emotional instability, psychotic tendencies.

Because of possible perforation of a cornea, with care it is necessary to appoint at eye herpes.

Drug should be used with care at nonspecific ulcer colitis with perforation threat, abscesses or other purulent infections, a diverticulitis, recently created intestinal anastomosis, a round ulcer (active or latent) a renal nedostatanost, arterial hypertension, osteoporosis, a myasthenia гравис. In certain cases corticosteroids can reduce quantity and mobility of spermatozoa.
Ability to influence speed of response at control of motor transport or work with other mechanisms

It is necessary to refrain from control of vehicles and work with potentially dangerous mechanisms as at use of drug decrease in concentration of attention, dizziness and psychoemotional instability is possible.

Side effects:

Frequency of development and expressiveness of by-effects (as well as at all glucocorticoids) depends on a dose and duration of therapy. Usually these phenomena are reversible or are minimized by reduction of a dose that has advantage before drug withdrawal.

From a nervous system and mental disturbances: dizziness, a headache, psychoemotional instability, euphoria, a depression, psychotic reactions, changes of the personality, irritability, insomnia, spasms, increase in intracranial pressure with hypostasis of disks of optic nerves.

Ophthalmologic: at long use – a subkapsulyarny back cataract, glaucoma, an exophthalmos.

From endocrine system: secondary adrenocortical and pituitary insufficiency (especially during a stress – injuries, surgical intervention, diseases), the lowered tolerance to carbohydrates, manifestation of latent diabetes, the increased need for insulin and peroral hypoglycemic means, disturbance of a menstrual cycle, development of a cushingoid state, oppression of growth of a fruit or growth of children.

From a metabolism: negative nitrogenous balance (in connection with a proteinaceous catabolism), hypostases, a hypernatremia.

From cardiovascular system: arterial hypertension, development (at inclined patients) or strengthening of expressiveness of chronic heart failure, a hypopotassemia.

From a musculoskeletal system: muscular weakness, a corticosteroid myopathy, reduction of muscle bulk, strengthening of symptoms of a myasthenia, osteoporosis (it is very rare - compression fractures of vertebras, an aseptic necrosis of heads of femoral and humeral bones, pathological fractures of long bones), ruptures of sinews, joint instability (owing to repeated intra joint injections); in isolated cases - an arthropathy as Sharko.

From the alimentary system: a hiccups, "steroid" stomach ulcer and a duodenum with possible subsequent perforation and bleeding, pancreatitis, a meteorism, an ulcer esophagitis.

Skin reactions: the slowed-down healing of wounds, petechias and ecchymomas, an atrophy, an erythema of the person, the increased perspiration, oppressed reactions to skin tests, hyper - or hypopigmentation.

Local reactions: atrophy of skin and hypodermic cellulose; in isolated cases - a post-injection inflammation (after intra joint introduction).

Allergic reactions: anaphylactic or hyper sensitive reaction to administration of drug, allergic dermatitis, small tortoiseshell, Quincke's disease.

Others: in isolated cases – the vision disorder (connected with introduction to places of defeat: area of the person and head), sterile abscesses.

Interaction with other medicines:

Simultaneous use of phenobarbital, rifampicin, Phenytoinum or ephedrine can accelerate metabolism of corticosteroids that will lead to easing of therapeutic effect.

The overshot effect from use of a corticosteroid can be observed at the patients receiving corticosteroids and estrogen.

Simultaneous use of the corticosteroids and diuretics removing potassium ions can cause a hypopotassemia.

The combined use of corticosteroids with cardiac glycosides can increase probability of developing of arrhythmias or increase toxicity of glycosides.

Corticosteroids can strengthen the removal of potassium ions caused by Amphotericinum B. Simultaneous use of corticosteroids with anticoagulants of indirect action can lead to strengthening or weakening of effect of anticoagulants that, perhaps, will demand dose adjustment.

Combined action of non-steroidal anti-inflammatory drugs or alcohol with glucocorticosteroids can lead to increase in frequency of manifestations or weight of a course of ulcers of digestive tract.

At use of corticosteroids concentration of salicylates in blood can decrease.

At introduction of corticosteroids a sick diabetes mellitus correction of doses of hypoglycemic means can be necessary.

Treatment by glucocorticosteroids can reduce reaction to Somatotropinum.

Also such drugs increase risk of development of by-effects: androgens, are oestrogenic, oral contraceptives, steroid anabolic steroids (a hirsutism, acne rash); antipsychotic means, immunodepressants (increase in probability of development of infections, and also lymphoma and other limfoproliferativny diseases), букарбан, Azathioprinum (cataract); M-holinoblokatory, antihistamines, tricyclic antidepressants, nitrates (increase in intraocular pressure); ритордин (a possibility of edematization of lungs at pregnant women).

Increases metabolism of an isoniazid, mekseliten that leads to decrease in their plasma concentration.

Miotan and other inhibitors of function of bark of adrenal glands can cause need of increase in a dose of Betaspan.

Betamethasone, as well as other corticosteroids, increases calcium removal.

Contraindications:

Hypersensitivity to betamethasone and/or to other components of drug, including to other glucocorticoids. System mycoses.

Overdose:

The acute overdose of corticosteroids, including betamethasone, does not provide development of vitally dangerous states. Excessive use of corticosteroids does not lead to emergence of side effects on condition of lack of such states as diabetes, glaucoma, an active round ulcer and also if the patient does not accept digitalis drugs, coumarinic anticoagulants and kaliyvyvodyashchy diuretics.

Treatment. Symptomatic therapy.

Storage conditions:

Term godnosti.2 years. To store in the unavailable to children, protected from light place at a temperature not above 25 °C. Not to freeze.

Issue conditions:

According to the recipe

Packaging:

On 1 ml in an ampoule. On 1 or 5 ampoules in a pack. On 5 ampoules in the blister, on 1 blister in a pack.