Betaspan depot 7mg/ml ampoule 1 ml №1

Release form

Suspension for injection transparent, colorless or yellowish, slightly viscous, containing easily suspended particles of white or almost white color; when agitating, a suspension of white or almost white color is formed.

Mechanism of action

Anti-inflammatory, antiallergic, immunosuppressive, glucocorticoid.

Indications and usage

Treatment of conditions and diseases in which GCS therapy allows to achieve an adequate clinical effect (it must be taken into account that in some diseases GCS therapy is additional and does not replace the standard therapy):
• Diseases of the musculoskeletal system and soft tissues, including rheumatoid arthritis, osteoarthritis, bursitis, ankylosing spondylitis, epicondylitis, coccygodynia, torticollis, ganglion cyst, exostosis, fasciitis.
• Allergic diseases, including bronchial asthma, hay fever (pollinosis), allergic bronchitis, seasonal or year-round rhinitis, drug allergies, serum sickness, reactions to insect bites.
• Dermatological diseases, r. H. Atopic dermatitis, nummular eczema, neurodermatitis, contact dermatitis, photodermatitis expressed, urticaria, lichen planus, alopecia areata, discoid lupus erythematosus, psoriasis, keloid scarring, pemphigus vulgaris, cystic acne forms.
• Systemic diseases of the connective tissue, including systemic lupus erythematosus, scleroderma, dermatomyositis, periarteritis nodosa.
• Hemoblastosis (palliative therapy of leukemia and lymphomas in adults; acute leukemia in children).
• Primary or secondary insufficiency of the adrenal cortex (with mandatory simultaneous use of mineralocorticosteroids).
• Other diseases and pathological conditions requiring systemic corticosteroids therapy (adrenogenital syndrome, regional ileitis, pathological changes in the blood, if necessary, use of corticosteroids).

Contraindications

• Hypersensitivity to betamethasone or other components of the drug, or other corticosteroids;
• systemic mycoses;
• intravenous, subcutaneous, epidural, intrathecal administration;
• introduction directly into the tendons of the muscles;
• with intraarticular injection: unstable joint, infectious arthritis;
• introduction to infected surfaces and intervertebral space;
• children's age up to 3 years (presence in the composition of gasoline alcohol);
• violation of coagulation (including treatment with anticoagulants);
• thrombocytopenic purpura (intramuscular administration);
• breastfeeding period;

• simultaneous administration of immunosuppressive doses of the drug with live or attenuated vaccines.

Parasitic and infectious diseases of a viral, fungal or bacterial nature (currently or recently transferred, including recent contact with the patient) - herpes simplex, herpes zoster (viremic phase), chicken pox, measles; amebiasis, strongyloidiasis (established or suspected); active or latent tuberculosis. Use in severe infectious diseases is permissible only against the background of specific antimicrobial therapy.
Vaccination period (inactivated vaccines) 8 weeks before and 2 weeks after vaccination, lymphadenitis after BCG vaccination. immunodeficiency states (including AIDS or HIV infection).
Diseases of the gastrointestinal tract: gastric ulcer and duodenal ulcer, esophagitis, gastritis, acute or latent peptic ulcer, a newly created intestinal anastomosis, ulcerative colitis with the threat of perforation or abscess formation, diverticulitis, abscess or other purulent infections.
Diseases of the cardiovascular system, incl. recent myocardial infarction (in patients with acute and subacute myocardial infarction, the focus of necrosis may spread, slowing the formation of scar tissue and consequently the rupture of the heart muscle); decompensated chronic heart failure; arterial hypertension; hyperlipidemia.
Endocrine diseases - diabetes mellitus, reduced glucose tolerance, thyrotoxicosis, hypothyroidism, Itsenko-Cushing disease, grade III-IV obesity.
Severe chronic renal and / or liver failure, nephroluritiasis, cirrhosis of the liver.
Hypoalbuminemia and conditions predisposing to its occurrence.
Acute psychosis, severe affective disorders (including a history, especially "steroid" psychosis).
Systemic osteoporosis, myasthenia gravis, poliomyelitis (with the exception of tabloid encephalitis).
Open-and closed-angle glaucoma, eye diseases caused by Herpes simplex (due to the risk of perforation of the cornea).
Pregnancy.
For intra-articular administration: the patient’s overall serious condition, the ineffectiveness (or short duration) of the actions of the two previous injections (taking into account the individual properties of the applied GCS).
It is necessary to observe precautionary measures in patients in old age due to hypersensitivity to GCS, especially in postmenopausal women (high risk of osteoporosis); with convulsive syndrome.

Pregnancy and Breastfeeding

Controlled studies of the safety of betamethasone in pregnancy have not been conducted. Use of the drug Betaspan Depot during pregnancy, especially in the first 3 months, is shown only in case of exceeding the expected therapeutic effect for the mother over the possible negative effect on the fetus. The condition of patients with preeclampsia in the second half of pregnancy (especially with pre-eclampsia) should be carefully monitored.
In animal studies, defects and abnormalities (delay) of fetal development were recorded during the use of GCS during pregnancy.
With prolonged or repeated use of GCS during pregnancy may increase the risk of intrauterine growth retardation. When betamethasone was used during pregnancy, myocardial hypertrophy and gastroesophageal reflux were reported in newborns.
Newborns whose mothers received therapeutic doses of GCS during pregnancy should be under medical supervision (for early detection of adrenal insufficiency).
GKS get into breast milk. If necessary, the use of the drug Betaspan® Depot during breastfeeding, breastfeeding should be stopped (due to possible side effects in children), taking into account the importance of therapy for the mother.

Severe complications of the nervous system (up to death) were reported with epidural and intrathecal administration of GCS (with or without fluoroscopic control), including spinal cord infarction, paraplegia, quadriplegia, cortical blindness and stroke. Since the safety and efficacy of epidural corticosteroids have not been established, this route of administration is not indicated for this group of drugs. The recommended route of administration is indicated in the section "Route of administration and dosage". It is necessary to avoid intravascular ingestion of the drug. Due to the lack of data regarding the risk of calcification, the introduction of the drug into the intervertebral spacecontraindicated.
The dosage regimen and method of administration are set individually, depending on the indications, the severity of the disease and the patient's response.
The dose should be as small as possible, and the period of use as short as possible.
The initial dose is selected until the desired therapeutic effect is achieved. Then gradually reduce the dose of Betaspan® Depot to the minimum effective maintenance dose. In the absence of the effect of therapy or with its long-term use, the drug is also canceled, gradually reducing the dose.
The gradual abolition of GCS reduces the risk of secondary adrenal insufficiency.
If a stressful situation (not associated with a disease) arises or is threatened, it may be necessary to increase the dose of Betaspan® Depo, Hydrocortisone and Cortisone should be the drugs of choice as a supplement.
The development of secondary insufficiency of the adrenal cortex due to the too rapid removal of the GCS is possible within a few months after the end of therapy. If a stressful situation arises or is threatened during this period, treatment with Betaspan® Depo should be resumed and at the same time be prescribed a mineralocorticosteroid preparation (due to a possible violation of the secretion of mineralocorticosteroids).
Monitoring of the patient's condition is carried out for at least one year after the end of long-term therapy or use in high doses.
The introduction of the drug in the soft tissue, in the lesion and intra-articular can, with a pronounced local effect, simultaneously lead to systemic action.
Given the likelihood of anaphylactoid reactions when parenteral GCS, the necessary precautions should be taken before the introduction of the drug, especially if the patient has indications in history, allergic reactions to drugs.
The drug Betaspan Depot contains two active substances - derivatives of betamethasone, one of which - betamethasone sodium phosphate - quickly penetrates the systemic circulation, and therefore, its possible systemic effect should be taken into account.
Against the background of the use of the drug, mental disorders are possible (especially in patients with emotional lability or a tendency to psychosis).
The action of GCS is enhanced in patients with cirrhosis or hypothyroidism.
When using the drug Betaspan® Depot in patients with diabetes mellitus, correction of hypoglycemic therapy may be required.
Patients receiving GCS should not be vaccinated against smallpox. No other immunization should be carried out in patients receiving GCS (especially in high doses), due to the possibility of the development of neurological complications and a low immune response (lack of antibody formation). Betaspan® Depot should not be used 8 weeks before and within 2 weeks after vaccination with killed or inactivated viral and antibacterial vaccines.However, immunization is possible during replacement therapy (for example, in case of primary insufficiency of the adrenal cortex).
Patients receiving the drug Betaspan® Depot in doses that suppress immunity should be warned about the need to avoid contact with patients with chickenpox and measles (it is especially important when using the drug in children).
Against the background of the use of corticosteroids, it is possible to suppress the reaction when conducting skin tests.
When using the drug should take into account that the corticosteroids can mask the signs of an infectious disease, as well as reduce the body's resistance to infections. The immunosuppressive action of corticosteroids can lead to activation of a latent infection or exacerbation of intercurrent infections, including infections caused by microorganisms: Candida, Mycobacterium, Toxoplasma, Strongyloides, Pneumocystis, Cryptococcus, Nocardia or Ameba. Special care should be taken when using GCS in patients with confirmed or suspected infection Strongyloides (intestinal acne). In such patients, GCS-induced immunosuppression can lead to hyperinfection of Strongyloides and the spread of infection through the migration of larvae, which is often accompanied by severe enterocolitis and septicemia caused by Gram-negative microorganisms, possibly fatal.
Since GCS can aggravate the course of latently flowing amebiasis, all patients with unexplained diarrhea or patients arriving from countries with a tropical climate should be examined to exclude amebiasis before GCS therapy begins.
You must carefully follow the rules of asepsis and antiseptics with the introduction of the drug.
Care must be taken when using the drug in patients with a high risk of infection (on hemodialysis or with dentures). Use of the drug with active tuberculosis is possible only in cases of fulminant or disseminated tuberculosis in combination with adequate anti-tuberculosis therapy. When using the drug in patients with latent tuberculosis or during a tuberculin bend test, the dose of Betaspan® Depot should be very carefully selected (because of the danger of reactivating tuberculosis), and for long-term use, anti-tuberculosis Chemotherapy is necessary. With the prophylactic use of rifampicin, the acceleration of hepatic clearance of betamethasone should be considered (a dose adjustment of betamethasone may be required).
In the presence of fluid in the articular cavity, a septic process should be excluded. A marked increase in soreness, swelling, increased temperature of the surrounding tissues and a further restriction of joint mobility indicate septic arthritis. It is necessary to conduct a study of the aspirated articular fluid. When confirming the diagnosis, it is necessary to prescribe the appropriate antibiotic therapy. Use of the drug Betaspan® Depot in septic arthritis is contraindicated.
Repeated injections into a joint with osteoarthritis may increase the risk of joint destruction.The introduction of GCS into the tendon tissue gradually leads to a tendon rupture. After successful intra-articular therapy, the patient should avoid overloading the joints.
Prolonged use of corticosteroids can lead to a posterior subcapsular cataract (especially in children), glaucoma with possible damage to the optic nerve, and may contribute to the development of a secondary eye infection (fungal or viral). It is necessary to periodically conduct an ophthalmologic examination, especially in patients receiving Betaspan® Depot for more than 6 weeks.
Special care must be taken when considering the possibility of systemic use of GCS in patients with active herpetic eye disease (keratitis caused by the herpes simplex virus).
The use of medium and high doses of GCS can lead to an increase in blood pressure, sodium retention and fluid in the body and increased removal of potassium from the body (these phenomena are less likely in the case of taking synthetic GCS, unless they are used in high doses). With long-term use of high doses of Betaspan® Depot, the risk of arrhythmias and hypokalemia should be considered if it is necessary to prescribe potassium-containing drugs and a diet with salt restriction. All GKS increase Calcium excretion.
With the simultaneous use of the drug Betaspan® Depot and cardiac glycosides or drugs that affect the electrolyte composition of the plasma, control of the water-electrolyte balance is required.
With caution apply Acetylsalicylic acid in combination with the drug Betaspan® Depot with hypoprothrombinemia.
Care must be taken when using GCS in elderly patients; in patients with renal or hepatic insufficiency, diverticulitis, active or latent gastric and / or intestinal ulcers, or with newly created intestinal anastomoses, osteoporosis, confirmed or suspected parasitic infections (eg, strongyloidosis).
Symptoms of peritoneal irritation or reduction of pain during perforation of the walls of the stomach or intestines may be minimal or absent in patients receiving GCS.
GCS should be used with caution in patients with hypothyroidism or myasthenia gravis.
Reported on the registration of cases of Kaposi's sarcoma in patients receiving GCS, the cancellation of this therapy can lead to remission of the disease.
Against the background of the use of GCS, a change in motility and sperm count is possible.
With long-term treatment of GCS, it is advisable to consider the possibility of switching from parenteral to oral administration of GCS, taking into account the assessment of the "benefit / risk" ratio.
Pediatric use
Children who receive drug therapy (especially long-term) should be carefully monitored for possible growth retardation and the development of secondary adrenal insufficiency.
Use of athletes
Patients participating in competitions under the control of the World Anti-Doping Agency (WADA) should be familiarized with the WADA rules before starting treatment with the drug, since taking Betaspan® Depo may affect the results of doping control.

Influence on ability to drive vehicles and mechanisms

During the period of treatment with Betaspan® Depot, care must be taken when driving and engaging in other potentially hazardous activities that require an increased concentration of attention and speed of psychomotor reactions.

1 ml:
betamethasone dipropionate 6.43 mg, which corresponds to the content betamethasone 5 mg;
betamethasone sodium phosphate 2.63 mg, which corresponds to the content betamethasone 2 mg.

Excipients: methyl parahydroxybenzoate (E218) - 1.3 mg, propyl parahydroxybenzoate (E216) - 0.2 mg, benzyl alcohol - 9 mg, sodium chloride - 5.5 mg, sodium hydrogen phosphate - 0.6 mg, disodium edetate dihydrate - 0.1 mg, carmellose sodium - 5.2 mg, Polysorbate 80 - 0.5 mg, macrogol 4000 - 25 mg, water d / and - up to 1 ml. f

V / m, intraarticular, periarticular, intrabursal, iv, interstitial and intrafocal introduction.

The insignificant size of betamethasone dipropionate crystals allows the use of needles of small diameter (up to 26 gauge) for intravenous injection and injection directly into the lesion.

It is impossible to enter in / in and p / to.

Strict adherence to the rules of asepsis is mandatory when using the drug.

Shake the syringe before administering the drug.

The dosage regimen and method of administration are set individually, depending on the indications, the severity of the disease and the patient's response.

With systemic therapy, the initial dose of the drug Betaspan^® Depot in most cases is 1-2 ml. The introduction is repeated as necessary, depending on the condition of the patient.

V / m introduction

V / m injection of the drug Betaspan^® Depot should be carried deep into the muscle, while choosing large muscles and avoiding contact with other tissues (to prevent tissue atrophy).

In severe conditions requiring emergency measures, the initial dose is 2 ml of the drug.

In various dermatological diseases, as a rule, 1 ml of the preparation is sufficient.

In diseases of the respiratory system, the onset of action of the drug occurs within a few hours after the i / m injection.

In case of bronchial asthma, hay fever, allergic bronchitis and allergic rhinitis, a significant improvement is achieved after the administration of 1-2 ml of the drug.

In acute and chronic bursitis, the initial dose for intramuscular administration is 1-2 ml of the preparation. If necessary, carry out several repeated injections.

If a satisfactory clinical response does not occur after a certain period of time, the drug should be withdrawn and another therapy prescribed.

Local introduction

With local administration, the simultaneous use of a local anesthetic preparation is necessary only in rare cases. If it is desired, then use 1 or 2% solutions of procain hydrochloride or Lidocaine , which do not contain methyl paraben, propyl paraben, phenol and other similar substances. In this case, mixing is carried out in a syringe, first dialing the required dose of Betaspan into a syringe from a vial.^® Depot Then, in the same syringe, take the required amount of local anesthetic from the ampoule and shake it for a short period of time.

In acute bursitis (subdeltoid, subscapularis, elbow and pre-knee), the introduction of 1-2 ml of the drug in the synovial bag relieves pain and restores mobility of the joint for several hours. After arresting the exacerbation of chronic bursitis, lower doses of the drug are used.

In acute tenosynovitis, tendinitis and perienendinitis one injection of the drug improves the patient's condition; in chronic injections, repeat depending on the response of the patient. The introduction of the drug directly into the tendon should be avoided.

Intra-articular administration of the drug in a dose of 0.5-2 ml relieves pain, limiting the mobility of the joints in rheumatoid arthritis and osteoarthritis within 2-4 hours after administration. The duration of the therapeutic effect varies considerably and can be 4 weeks or more.

Recommended doses of the drug when administered in large joints range from 1 to 2 ml; in the middle - 0.5-1 ml; in small - 0.25-0.5 ml.

In some dermatological diseases, it is effective to administer the drug directly into the lesion, the dose is 0.2 ml / cm². The lesion is evenly cut off using a tuberculin syringe and needle with a diameter of about 0.9 mm. The total amount of the administered drug in all areas should not exceed 1 ml for 1 week. A tuberculin syringe with a 26 gauge needle is recommended for insertion into the lesion.

Recommended single doses of the drug (with an interval of 1 week between injections) in case of bursitis: when the cornflow is 0.25-0.5 ml (usually 2 injections are effective), with a spur 0.5 ml, while limiting the mobility of the big toe 0.5 ml, with synovial cysts - 0.25-0.5 ml, with tendosynovitis - 0.5 ml, with acute gouty arthritis - 0.5-1 ml. For most injections, a tuberculin syringe with a 25 gauge needle is suitable.

After reaching a therapeutic effect, the maintenance dose is selected by gradually reducing the dose of Betaspan.^® Depot entered at appropriate intervals. The reduction is continued until the minimum effective dose is reached.

If a stress situation (not related to the disease) arises or is threatened, it may be necessary to increase the dose of the drug. The abolition of the drug after long-term therapy is carried out by gradually reducing the dose. The patient’s condition is monitored for at least one year after the end of long-term therapy or high-dose administration.

The frequency of development and severity of side effects, as with the use of other corticosteroids, depend on the size of the dose used and the duration of use of the drug. These phenomena are usually reversible and can be eliminated or reduced by lowering the dose.
Immune system disorders: Anaphylactic reactions , angioedema, anaphylactic shock.
Endocrine disruption: secondary adrenal insufficiency (especially during stressful illness, trauma, surgery), Itsenko-Cushing's syndrome, decreased glucose tolerance, steroid diabetes, or manifestation of latent diabetes, increased insulin or oral need hypoglycemic drugs, impaired intrauterine development, growth retardation and sexual development in children, hirsutism, hypertrichosis, thinning of hair on the head, suppression of the function of the hypothalamus Fiza.
Metabolic and nutritional disorders: hypernatremia, increased potassium excretion, increased calcium excretion, hypokalemic alkalosis, fluid retention in tissues, negative nitrogen balance (due to protein catabolism), lipomatosis (including mediastinal and epidural lipomatosis, which can cause neurological complications), weight gain, increased appetite, hypercholesterolemia, hypertriglyceridemia.
Mental disorders: euphoria, mood changes, depression (with severe psychotic reactions), personality disorders, irritability, insomnia.
Nervous system disorders: convulsions, increased intracranial pressure with edema of the optic nerve head (usually at the end of therapy), dizziness, headache, neuritis, neuropathy, paresthesia, with intecal injection - arachnoiditis, meningitis, paralysis / paralysis, sensory disturbances.
Violations on the part of the organ of vision: posterior subcapsular cataract, increased intraocular pressure, glaucoma, exophthalmos, worsening of symptoms of a corneal ulcer, perforation of the cornea with existing keratitis (especially herpetic), ptosis, mydriasis, chemosis; in rare cases - blindness (with the introduction of the drug in the face and head).
Cardiac disorders: chronic heart failure (in susceptible patients), cardiac arrhythmias, bradycardia, tachycardia, syncope, pulmonary edema, dilated cardiomyopathy, hypertrophic myopathy in premature babies, myocardial rupture after a recent myocardial infarction.
Vascular disorders: decrease in blood pressure, increase in blood pressure, vasculitis, thromboembolic complications.
Gastrointestinal disorders: erosive and ulcerative lesions of the gastrointestinal tract with possible subsequent perforation and bleeding, acute pancreatitis, flatulence, hiccups, nausea, hepatomegaly, increased activity of liver enzymes (usually reversible).
Violations of the skin and subcutaneous tissues: impaired wound healing, atrophy and thinning of the skin, petechiae, ecchymosis,increased sweating, dermatitis, "steroid acne", striae, a tendency to the development of pyoderma and candidiasis, a decrease in the reaction during skin tests, skin rash, allergic dermatitis, erythema, telangiectasia, rosacea.
Musculoskeletal and connective tissue disorders: muscle weakness, steroid myopathy, loss of muscle mass, increased myasthenic symptoms in severe pseudo-paralytic myasthenia, osteoporosis, compression fracture of the spine, aseptic necrosis of the head of the femoral or humerus, pathological fractures of the tubular cysts. tendons, joint instability (with repeated intraarticular injections), neurogenic arthropathy.
Violations of the genital organs and breast cancer: menstrual disorders, increased or decreased mobility and sperm count.
General disorders and disorders at the injection site: hyperpigmentation, hypopigmentation, subcutaneous and skin atrophy, aseptic abscess, “flushing” of the blood to the face after injection (or intraarticular injection).

With simultaneous use with phenobarbital, rifampicin, Carbamazepine , primidone, phenytoin or ephedrine, acceleration of GCS metabolism is possible with a decrease in their therapeutic activity.
With the combined use of GCS and potassium diuretics increases the likelihood of hypokalemia.
GCS can enhance the excretion of potassium caused by amphotericin B.
The simultaneous use of GCS and cardiac glycosides increases the risk of arrhythmias or digitalis intoxication (due to hypokalemia).
When combined use of GCS and indirect