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Depot Betaspan 1 ml 5’s suspension for injection in ampoules




The instruction for medical use

of BETASPAN® medicine of DEPOT

the Trade name
of Betaspan® of Depot

the International unlicensed

name Betamethasone Dosage Form Suspension for injections of 1 ml

of 1 ml of suspension contains
active agents – betamethasone Dipropionas of 6.43 mg in terms of 100% dry matter (5 mg of betamethasone are equivalent), sodium betamethasone phosphate of 2.63 mg in terms of 100% anhydrous substance (2 mg of betamethasone are equivalent),
excipients: methylparahydroxybenzoate, propilparagidroksibenzoat, benzyl alcohol, sodium chloride, sodium hydrophosphate anhydrous, dinatrium edetat, sodium carboxymethylcellulose, polysorbate 80, polyethyleneglycol 4000, water for injections

the Description
the Transparent colourless or yellowish, a little viscous liquid containing particles of white or almost white color which easily suspend

Pharmacotherapeutic group
Corticosteroids for system use. Glucocorticosteroids. Betamethasone.
The ATX H02A B01 code

the Pharmacological

Betamethasone Pharmacokinetics properties of sodium phosphate – a readily soluble component which is quickly absorbed from the 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.
Linking with proteins of plasma – 62.5%. It is metabolized in a liver. Elimination is carried out mainly by kidneys, an insignificant part is removed with bile.
The pharmacodynamics
of Betaspan® of Depot is a combination of soluble and slightly soluble ethers of betamethasone for intramuscular, intra articulate, circumarticular and intracutaneous injections and also for introduction directly to the defeat center. Бетаспан® the Depot has high glucocorticosteroid activity and insignificant mineralokortikosteroidny activity, besides, drug regulates carbohydrate metabolism 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 intracutaneous introductions and introduction directly to the defeat center.

– a pseudorheumatism, osteoarthrites, a bursitis, tendosinoviita, tendinites, peritendinites, an ankylosing spondylitis, an epicondylitis, sciatica, 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, the asthmatic status, hay fever, an allergic bronchitis, allergic rhinitis, a medicamentous allergy, a serum disease, reactions to stings of insects
– atopic dermatitis (monetopodobny eczema), neurodermatitis, contact dermatitis, the profound solar dermatitis, urticaria, red flat deprive, an insulin lipodystrophy, a nested alopecia, a diskoidny erythematic lupus, psoriasis, keloid cicatrixes, a usual bladderwort, herpetic dermatitis, cystous eels
– a system erythematic lupus, a scleroderma, a dermatomyositis, a nodular periarteritis
– palliative therapy of a leukosis and lymphoma at adults
– an adrenogenital syndrome
– intestines diseases (ulcer colitis, a regional ileitis, a spra)
– the pathological changes of blood demanding performing corticosteroid therapy
– nephrite, a nephrotic syndrome
– primary and secondary insufficiency of bark of adrenal glands (at obligatory simultaneous introduction of mineralokortikoid).

The route of administration and doses
of Betaspan® of Depot is recommended to be entered intramusculary in need of system receipt of a glucocorticosteroid into an organism, directly into the struck soft tissue or in the form of intra articulate and periartikulyarny injections in arthritises, in the form of intracutaneous injections in various diseases of skin, in the form of local injections in the defeat center in some diseases of foot.
The mode of dosing and a method of administration 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, drug treatment it is necessary to stop and carry out 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 serious conditions (lupus erythematosus and the asthmatic status) demanding emergency measures, the initial dose of drug can make 2 ml,
– in various dermatological diseases, as a rule, there is enough 1 ml of drug,
– in diseases of a respiratory system the effect of drug begins within several hours after an intramuscular injection. In bronchial asthma, hay fever, an allergic bronchitis and allergic rhinitis the significant improvement of a state is reached after introduction of 1-2 ml of drug,
– in 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 the drug Betaspan® of Depot 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 the short span. Before use of lidocaine conducting skin test on hypersensitivity is necessary.
In an acute bursitis (subdeltoid, subscapular, elbow and perednenadkolenny) introduction of 1-2 ml of the drug Betaspan® of Depot to a synovial bag can relieve pain and completely restore 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 sharp tendosinoviita, tendinites and peritendinites one injection of the drug Betaspan® of Depot 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 articulate administration of drug in a dose of 0.5-2 ml reduces pain, morbidity and rigidity of joints in a pseudorheumatism and an osteoarthritis within 2-4 hours after introduction. Duration of therapeutic effect of drug considerably varies and can be 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.
In some diseases of skin the intracutaneous administration of drug directly in the defeat center 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 to all injection sites within 1 week should not exceed 1 ml.
The recommended single doses of the drug Betaspan® of Depot (with intervals between introductions of 1 week): 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, in a synovial cyst – from 0.25 to 0.5 ml, at a tendosinoviita – 0.5 ml, in 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.

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, as a rule, are reversible and can be reduced by a dose decline:
– a natriyemiya, the raised potassium discharge, a gipokaliyemichesky alkalosis, increase in removal of calcium, a liquid delay in fabrics
– stagnant heart failure at the patients inclined to this disease, arterial hypertension
– muscle weakness, a myopathy, loss of muscle bulk, aggravation of myasthenic symptoms at a heavy pseudoparalytic myasthenia, osteoporosis, aseptic necrosis of a head of a femoral or humeral bone, pathological fractures of tubular bones, ruptures of sinews, instability of joints (after repeated injections)
– a hiccups, digestive tract erosive cankers with possible subsequent perforation and bleeding, gullet ulcers, pancreatitis, a meteorism
– 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
– spasms, increase in intracranial pressure with a papilledema (usually after completion of treatment), dizziness, a headache, euphoria, change of mood, a depression (with the significant psychotic reactions), acrimony, insomnia
– 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 latent diabetes, increase in need for injections of insulin or in use of oral anti-diabetic means
– a back subkapsulyarny cataract, increase in intraocular pressure, glaucoma, an exophthalmos
– negative balance of nitrogen owing to protein catabolism, lipomatoz (including mediastinal and epidural lipomatoz which can lead to neurologic complications), increase in body weight
– anaphylactic reaction or reaction of hypersensitivity to administration of drug and hypotensive reaction
– the disorders of vision accompanying topical administration in a zone of face and head hyper – or hypopigmentation, a hypodermic or skin atrophy, aseptic abscesses, rushes of blood to the person after an injection (intra articulate introduction) and a neurogenetic arthropathy

of the Contraindication
– hypersensitivity to betamethasone, other components of drug or to other glucocorticosteroids
– system mycoses
– intramuscular introduction to patients with an idiopathic Werlhof’s disease
– infectious arthritis, an unstable joint, introduction to the infected surface of skin and intervertebral space
– the lactation period

Medicinal interaction
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 the 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 the probability of developing of arrhythmias or enhance toxicity of glycosides.
Corticosteroids can strengthen the removal of potassium ions caused by Amphotericinum B. The concomitant use of the drug Betaspan® of Depot and indirect anticoagulants can lead to change of speed of fibrillation that demands dose adjustment.
Joint effect 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 the concentration of salicylates in blood can decrease.
Simultaneous introduction of glucocorticosteroids and Somatotropinum can lead to delay of absorption of the last.

The special
instructions Betaspan® Suspension of Depot it 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 significant local action.
At a Werlhof’s disease intramusculary Betaspan® of Depot should be entered with extra care.
Intramuscular injections of glucocorticosteroids need to be entered deeply into a muscle for prevention of a local atrophy of fabrics.
Intra articulate injections have to be carried out only by medical personnel. It is necessary to carry out the analysis of intra articulate liquid for an exception of septic process. It is not necessary to administer the drug in the presence of an intra articulate 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 in an osteoarthritis can increase risk of destruction of a joint. After successful intra articulate 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), in nonspecific ulcer colitis, at perforation threat, in abscess or other pustulous infections and also in 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 drug treatment by sick diabetes 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 reply (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® of Depot 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.
Prescribing of drug in active tuberculosis is possible only in cases of rapid or disseminate tuberculosis 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 contribute to the development of consecutive infection of eyes (fungal or virus). It is necessary to undergo periodically ophthalmologic inspection, especially to patients who receive Betaspan® of Depot over 6 months.
At increase in arterial blood 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 in 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 the Betaspan® drug treatment of Depot needs to be resumed.
At use of glucocorticosteroids the change of mobility and quantity of spermatozoa is possible.
Incompatibility. Drug can be mixed in one syringe with local anesthetics (see the section “Route of Administration and Doses”), however, the compatibility always needs to be controlled.
Use in pediatrics
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).
Use during pregnancy or a lactation
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 prescribing of the drug Betaspan® of Depot 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).
Features of influence of drug on ability to run transport and potentially dangerous mechanisms
Usually Betaspan® of Depot 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 muscle weakness, spasms, disorders of vision, dizziness, a headache, change of mood, a depression (with the significant psychotic reactions), acrimony therefore it is recommended to abstain from control of motor transport or work with other mechanisms at drug treatment.

The overdose
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 consequences (except for cases of use of very high doses or in case of use in diabetes, glaucoma, exacerbation of erosive cankers of a GIT, or to patients who at the same time receive 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.

The form of release and packing
On 1 ml of drug spill in ampoules glass with a break ring (or a break point). On 1 or 5 ampoules put in blister strip packaging from a film polymeric.
On 1 planimetric packing with ampoules together with the instruction for medical use in the state and Russian languages place in a pack from cardboard.

To Store storage conditions in original packing at a temperature not above 25 °C. Not to freeze.
To store out of children’s reach!

A period of storage
2 years
not to use drug after expiry date.

Prescription status
According to the prescription

PJSC Pharmak Producer, Ukraine, 04080, Kiev, st. of Frunze, 63.
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