Betaspan Depo

General characteristics. Structure:

Active ingredient: betamethasone;

1 ml of suspension contains betamethasone of Dipropionas 6,43 mg in terms of 100% dry matter (that is equivalent to 5 mg of betamethasone), betamethasone of sodium of phosphate of 2,63 mg in terms of 100% anhydrous substance (that is equivalent to 2 mg of betamethasone);

excipients: methylparaben (Е 218), propylparaben    (Е 216), benzyl alcohol, sodium chloride, sodium hydrophosphate anhydrous, dinatrium эдетат, sodium carboxymethylcellulose, polysorbate 80, polyethyleneglycol 4000, water for injections.

Pharmacological properties:

Pharmacodynamics. Betaspan Depo is a combination of soluble and slightly soluble ethers of betamethasone for intramuscular, intra joint, circumarticular, intra synovial and intradermal injections, and also for introduction directly to the defeat center. Betaspan Depo has high glucocorticosteroid activity and insignificant mineralokortikosteroidny activity.

Besides, drug regulates a carbohydrate homeostasis and water and electrolytic balance.

The insignificant sizes of crystals of betamethasone of Dipropionas allow to apply needles of small diameter (to 0,9 mm) to intradermal introductions and introduction directly to the defeat center.

Pharmacokinetics. Sodium betamethasone phosphate – a readily soluble component which is quickly absorbed from an injection site that provides quick start of therapeutic action. Betamethasone Dipropionas – the slightly soluble component which is slowly absorbed from the depot which is formed in the place of an injection and causes long effect of drug.

Linkng with proteins of plasma – 62,5%. It is metabolized in a liver. Elimination is carried out preferential by kidneys, an insignificant part is removed with bile.

Pharmaceutical characteristics

Main physical and chemical properties: the transparent colourless or yellowish, slightly viscous liquid containing parts of white or almost white color which easily suspend.

Incompatibility. Drug can be mixed in one syringe with local anesthetics (see the section "Route of Administration and Doses"); however, compatibility always needs to be controlled.

Indications to use:

– A pseudorheumatism, osteoarthrites, a bursitis, tendosinoviita, tendinites, peritendinites, an ankylosing spondylitis, an epicondylitis, radiculitis, a koktsidiniya, a sciatica, a lumbago, a wryneck, a ganglionic cyst, an exostosis, a fasciitis, diseases of feet, a bursitis against the background of a firm callosity, a spur, rigidity of a thumb of foot.

– Bronchial asthma, asthmatic status, hay fever, allergic bronchitis, allergic rhinitis, medicamentous allergy, serum disease, reactions to stings of insects.

– Atopic dermatitis (monetopodobny eczema), neurodermatitis, contact dermatitis, the expressed solar dermatitis, a small tortoiseshell, red flat deprive, an insulin lipodystrophy, a nested alopecia, a diskoidny erythematic lupus, psoriasis, keloid cicatrixes, a usual pemphigus, herpetic dermatitis, cystous eels.

– System erythematic lupus, scleroderma, dermatomyositis, nodular periarteritis.

– Palliative therapy of a leukosis and lymphoma at adults; an acute leukosis at children.

– Adrenogenital syndrome. Intestines diseases (ulcer colitis, regional ileitis, spra). The pathological changes of blood demanding performing corticosteroid therapy. Nephrite, nephrotic syndrome.

– Primary and secondary insufficiency of bark of adrenal glands (at obligatory simultaneous introduction of mineralokortikoid).

Route of administration and doses:

Betaspan Depo is recommended to enter intramusculary in need of system receipt of a glucocorticosteroid into an organism; directly in the struck soft tissue or in the form of intra joint and periartikulyarny injections at arthritises; in the form of intradermal injections at various diseases of skin; in the form of local injections in the defeat center at some diseases of foot.

The mode of dosing and way of introduction establish individually, depending on indications, disease severity and reaction of the patient to treatment. The dose has to be minimum, and the use period – the shortest.

If through a certain period the satisfactory clinical effect is not reached, treatment it is necessary to stop and carry out by drug other corresponding therapy.

System therapy. The initial dose of drug in most cases makes 1-2 ml. Introduction is repeated if necessary, depending on a condition of the patient. The drug is administered deeply intramusculary in a buttock:

– at the tyazhelykhsostoyaniye (red volchanka the asthmatic status) demanding emergency measures, the initial dose of drug can make 2 ml;

– at various dermatological diseases 1 ml of drug, as a rule, there is enough;

– at diseases of respiratory system effect of drug begins within several hours after an intramuscular injection. At bronchial asthma, hay fever, allergic allergic rhinitis of a bronkhitea significant improvement of a state is reached after introduction of 1-2 ml of drug;

– at an acute and chronic bursitis the dose for intramuscular introduction makes 1-2 ml of drug. If necessary carry out several repeated introductions.

Local introduction. Simultaneous use of mestnoanesteziruyushchy drug is necessary only in isolated cases. If simultaneous administration of the anesthetizing substance is desirable, then solution of Procainum of a hydrochloride or lidocaine and the dosage forms which are not containing parabens use 1% or 2%. It is not allowed to apply the anesthetics containing methylparaben, propylparaben, phenol and other similar substances. At use of anesthetic in a combination with drug Betaspan Depo at first gather in the syringe from a bottle a necessary dose of drug, then in the same syringe gain necessary amount of local anesthetic from an ampoule and stir up during a short span. Before use of lidocaine conducting skin test on hypersensitivity is necessary.

At an acute bursitis (subdeltoid, infrascapular, elbow and perednenadkolenny) introduction of 1-2 ml of drug Betaspan Depo in a synovial bag can relieve pain and completely recover mobility at several o'clock. Treatment of a chronic bursitis is carried out by smaller doses of drug after stopping of a bad attack of a disease.

At acute tendosinoviita, tendinites and peritendinites one injection of drug Betaspan Depo facilitates a condition of the patient, at chronic - it is necessary to repeat a drug injection depending on reaction. It is necessary to avoid administration of drug directly in sinews. Intra joint administration of drug in a dose of 0,5-2 ml reduces pain, morbidity and rigidity of joints at a rhematoid osteoarthritis of an artritea within 2-4 hours after introduction. Duration of therapeutic effect of drug considerably varies and can make 4 and more weeks.

The recommended drug doses at introduction to big joints – 1-2 ml; in averages – 0,5-1 ml; in small – 0,25-0,5 ml.

At some zabolevaniyakhkozh intradermal administration of drug directly in ochagporazheniye is effective, the dose makes 0,2 ml/cm2. The place of defeat is evenly cut away by means of the tuberkulinovy syringe and a needle with a diameter about 0,9 mm. The total dose of the administered drug in all injection sites within 1 week should not exceed 1 ml.

The recommended single doses of drug Betaspan Depo ( 1 week, bucketed between introductions): at a firm callosity – 0,25-0,5 ml (as a rule, 2 injections are effective); at a spur – 0,5 ml; at rigidity of a thumb of foot – 0,5 ml; at a synovial cyst –  from 0,25 to 0,5 ml; at a tendosinoviita – 0,5 ml; at acute gouty arthritis –    from 0,5 to 1 ml. For introduction recommend to use the tuberkulinovy syringe with a needle with a diameter about 1 mm.

After achievement of therapeutic effect the maintenance dose is selected by gradual decrease in an initial dose due to reduction of concentration of betamethasone in solution which is entered through the corresponding intervals of time. Continue to reduce a dose to achievement of a minimal effective dose.

At emergence or threat of emergence of the stressful situation (which is not connected with a disease) there can be necessary an increase in a dose of drug.

Drug withdrawal after long therapy should be carried out by a gradual dose decline. Observation of a condition of the patient is continued, at least, within a year after the end of long therapy or after use of drug in high doses.

Features of use:

Use during pregnancy or feeding by a breast

Due to the lack of controlled researches on safety of use of drug to pregnant women, it is necessary to appoint it after careful assessment of a ratio of advantage for mother and potential risk for the fruit/child. The children who were born at mothers to whom entered therapeutic doses of corticosteroids during pregnancy have to be under medical control (for early identification of signs of insufficiency of bark of adrenal glands).

In need of purpose of drug Betaspan Depo in the period of a lactation it is necessary to resolve an issue of the feeding termination by a breast, in view of importance of therapy for mother (in connection with possible undesirable side effects at children).
Children

Not enough clinical data on drug use to children therefore it is undesirable to patients of this age category to apply it (possibly lag in growth and development of secondary insufficiency of bark of adrenal glands).
Appropriate security measures

 

Suspension Betaspan Depo is not intended for intravenous or hypodermic administration.

Strict observance of rules of an asepsis is obligatory at drug use.

Any administration of drug (in soft tissues, the defeat center, vnutrisustavno, etc.) can lead to systemic action at the simultaneous expressed local action.

At a Werlhof's disease intramusculary Betaspan Depo it is necessary to enter with extra care.

Intramuscular injections of glucocorticosteroids need to be entered deeply into a muscle for prevention of a local atrophy of fabrics.

Intra joint injections have to be carried out only by medical personnel. It is necessary to carry out the analysis of intra joint liquid for an exception of septic process. Not to administer the drug in the presence of an intra joint infection. Noticeable strengthening of morbidity, hypostasis, temperature increase of surrounding fabrics and further restriction of mobility of a joint testifies to septic arthritis. At confirmation of the diagnosis it is necessary to appoint antibacterial therapy.

It is not necessary to enter the glucocorticosteroids in an unstable joint infected zones and intervertebral spaces. Repeated injections in a joint at an osteoarthritis can increase risk of destruction of a joint. After successful intra joint therapy the patient should avoid joint overloads.

With care patients need to use drug with a hypothyroidism or cirrhosis, with herpetic damage of eyes (in connection with a possibility of perforation of a cornea); at nonspecific ulcer colitis, at perforation threat, at abscess or other pustulous infections, and also at a diverticulitis, recently formed intestinal anastomosis, an active or latent peptic ulcer of a stomach and a duodenum, a renal failure, arterial hypertension, osteoporosis, a heavy myasthenia.

Against the background of use of drug disturbances of mentality are possible (especially at patients with emotional instability or tendency to psychoses).

At treatment by drug a sick diabetes mellitus correction of antihyperglycemic therapy can be necessary.

The patients receiving glucocorticosteroids should not do smallpox inoculations. It is not necessary to carry out other immunization by the patient which receive corticosteroids (especially in high doses), in connection with risk of development of neurologic complications and a low immune response in the answer (lack of antibody formation). When performing replacement therapy (for example, at primary insufficiency of bark of adrenal glands) carrying out immunization is possible.

The patients receiving Betaspan Depo in the doses oppressing immunity need to avoid contact with patients with chicken pox and measles. At use of drug it is necessary to consider that glucocorticosteroids can mask symptoms of an infectious disease, and also reduce body resistance.

Purpose of drug at active tuberculosis is possible only in cases of the rapid or disseminated tuberkulyoz in a combination with adequate antitubercular therapy. Patients with latent tuberculosis or with positive reaction to tuberculine have to resolve first of all with the doctor an issue of preventive antitubercular therapy.

Prolonged use of glucocorticosteroids 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). It is necessary to undergo periodically ophthalmologic inspection, especially to patients who receive Betaspan Depo over 6 months.

At increase in arterial pressure, a delay of liquid and sodium of chloride in fabrics and increase in removal of potassium from an organism (that can be shown by hypostases, deviations in cardiac performance) the diet with restriction of kitchen salt and additional administration of drugs, containing potassium is recommended.

With caution it is necessary to take acetylsalicylic acid in a combination with drug at a prothrombinopenia in connection with possible increase in bleeding.

It is necessary to remember also a possibility of development of secondary insufficiency of bark of adrenal glands within several months after the end of therapy. At emergence or threat of emergence of a stressful situation during this period treatment by drug Betaspan Depo needs to be resumed.

At use of glucocorticosteroids change of mobility and quantity of spermatozoa is possible.
Ability to influence speed of response at control of motor transport or work with other mechanisms

Usually Betaspan Depo does not influence the speed of response of the patient at control of motor transport or work with other mechanisms.

However in isolated cases there can be muscular weakness, spasms, vision disorders, dizziness, a headache, change of mood, a depression (with the expressed psychotic reactions), an acrimony therefore it is recommended to abstain from control of motor transport or work with other mechanisms at treatment as drug.

Side effects:

The undesirable phenomena, as well as at use of other glucocorticosteroids, are caused by a dose and duration of use of drug. These reactions are, as a rule, reversible and can be reduced by a dose decline.

Water and electrolytic balance: a natriyemiya, the increased release of potassium, a gipokaliyemichesky alkalosis, increase in removal of calcium, a liquid delay in fabrics.

From cardiovascular system: congestive heart failure at the patients inclined to this disease; arterial hypertension.

Musculoskeletal system: muscular weakness, a myopathy, loss of muscle bulk, aggravation of myasthenic symptoms at a heavy pseudoparalytic myasthenia, osteoporosis, an aseptic necrosis of heads of a femoral or humeral bone, pathological fractures of tubular bones, ruptures of sinews, instability of joints (after repeated injections).

From the alimentary system: a hiccups, GIT erosive cankers with possible subsequent perforation and bleeding, gullet ulcers, pancreatitis, a meteorism.

From skin: deterioration in healing of wounds, a skin atrophy, thinning of skin, a petechia and ecchymomas, an erythema of the person, the increased perspiration, skin reactions, such as dermatitis, rash, a Quincke's disease.

From a nervous system: spasms, increase in intracranial pressure with a papilledema (usually after completion of treatment), dizziness, a headache; euphoria, change of mood, a depression (with the expressed psychotic reactions), an acrimony, sleeplessness.

From endocrine system: disturbance of a menstrual cycle, Cushing's syndrome, an arrest of development of a fruit or growth of the child, disturbance of tolerance to glucose, manifestations of a latent diabetes mellitus, increase in need for injections of insulin or in use of peroral anti-diabetic means.

From organs of sight: back subkapsulyarny cataract, increase in intraocular pressure, glaucoma, exophthalmos.

From a metabolism: negative balance of nitrogen owing to a protein catabolism; липоматоз, including mediastinal and epidural липоматоз which can lead to neurologic complications; increase in body weight.

From immune system: anaphylactic reaction or reaction of hypersensitivity to administration of drug and hypotensive reaction.

Other side reactions connected with parenteral administration of drug: the isolated cases of a vision disorder accompanying topical administration in a face zone and the heads hyper - or hypopigmentation, a hypodermic or skin atrophy, aseptic abscesses, rushes of blood to the person after an injection (intra joint introduction) and a neurogenic arthropathy.

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.

At simultaneous use of glucocorticosteroids and estrogen drug dose adjustment can be necessary (in connection with overdose threat).

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. Betaspan Depo and indirect anticoagulants can lead a concomitant use of drug to change of speed of a blood coagulation that demands 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.

Simultaneous introduction of glucocorticosteroids and Somatotropinum can lead to delay of absorption of the last.

Contraindications:

Hypersensitivity to betamethasone, other components of drug or to other glucocorticosteroids. System mycoses. Intramuscular introduction to patients with an idiopathic Werlhof's disease.

Overdose:

The acute overdose of betamethasone does not create the situations menacing for life. Introduction within several days of high doses of glucocorticosteroids does not lead to undesirable effects (except for cases of use of very high doses or in case of use at a diabetes mellitus, glaucoma, an aggravation of erosive cankers of a GIT, or to patients who at the same time undergo therapy by digitalis drugs, indirect anticoagulants or diuretics which remove potassium).

Treatment. Careful medical control of a condition of the patient is necessary. It is necessary to support optimum consumption of liquid and to control the content of electrolytes in plasma and urine (especially balance in an organism of sodium and potassium). At identification of an imbalance of these ions it is necessary to carry out the corresponding therapy.

Storage conditions:

Period of validity. 2 years. Not to use drug after the expiry date specified on packaging. To store in original packaging at a temperature not above 25 °C. Not to freeze. To store in the place, unavailable to children.

Issue conditions:

According to the recipe

Packaging:

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