Betaspan Depo suspension for injection 7mg/ml 1ml ampoules, 5pcs

Composition

1 ml: betamethasone dipropionate 6.43 mg, which corresponds to the content of betamethasone 5 mg; betamethasone sodium phosphate 2.63 mg, which corresponds to the content of betamethasone 2 mg. Auxiliary substances: methyl parahydroxybenzoate (E 218) – 1.3 mg parahydroxybenzoate (E 216) – 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.

Pharmacological action

Anti-inflammatory, anti-allergic, immunosuppressive, glucocorticoid.

Indications

Treatment of conditions and diseases in which corticosteroid therapy can achieve an adequate clinical effect (please note that in some diseases, corticosteroid therapy is additional and does not replace 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 (hay fever), allergic bronchitis, seasonal or year-round rhinitis, drug allergies, serum sickness, reactions to insect bites. * Dermatological diseases, including atopic dermatitis, coin-shaped eczema, neurodermatitis, contact dermatitis, severe photodermatitis, urticaria, lichen planus, alopecia areata, discoid lupus erythematosus, psoriasis, keloid scars, pemphigus vulgaris, cystic acne. * Systemic connective tissue diseases, including systemic lupus erythematosus, scleroderma, dermatomyositis, and periarteritis nodosa. * Hemoblastosis (palliative therapy of leukemia and lymphoma 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 that require systemic corticosteroid therapy (adrenogenital syndrome, regional ileitis, abnormal blood changes when corticosteroid therapy is required).

Contraindications

* Hypersensitivity to betamethasone or other components of the drug, or other corticosteroids• * systemic mycoses;• intravenous, subcutaneous, epidural, and intrathecal use;• injection directly into muscle tendons• * intra-articular injection: unstable joint, infectious arthritis• * injection into infected surfaces and intervertebral space;• children under 3 years of age (the presence of gasoline alcohol in the composition•; * coagulation disorders (including treatment with anticoagulants);• thrombocytopenic purpura (intramuscular injection); * breast-feeding period;• concomitant use of immunosuppressive doses of the drug with live or weakened vaccines.

With caution

Parasitic and infectious diseases of a viral, fungal or bacterial nature (currently or recently transmitted, including recent contact with the patient) — herpes simplex, herpes zoster (viremic phase), chickenpox, measles; amoebiasis, strongyloidosis (established or suspected); active or latent tuberculosis. Use in severe infectious diseases is permissible only against the background of specific antimicrobial therapy.

Vaccination period (with inactivated vaccines) 8 weeks before and 2 weeks after vaccination, lymphadenitis after BCG vaccination. Immunodeficiency conditions (including AIDS or HIV infection).

Gastrointestinal diseases: peptic ulcer of the stomach and duodenum, esophagitis, gastritis, acute or latent peptic ulcer, newly created intestinal anastomosis, ulcerative colitis with the threat of perforation or abscessing, diverticulitis, abscess or other purulent infections.

Diseases of the cardiovascular system, including recent myocardial infarction (in patients with acute and subacute myocardial infarction, the spread of necrosis may occur, the formation of scar tissue may slow down and the resulting rupture of the heart muscle); decompensated chronic heart failure; arterial hypertension; hyperlipidemia.

Endocrine diseases — diabetes mellitus, decreased glucose tolerance, thyrotoxicosis, hypothyroidism, Itsenko-Cushing’s disease, grade III-IV obesity.

Severe chronic renal and / or hepatic insufficiency, nephrourolithiasis, cirrhosis of the liver. Hypoalbuminemia and conditions predisposing to its occurrence.

Acute psychosis, severe affective disorders (including in the anamnesis, especially “steroid” psychosis).

Systemic osteoporosis, myasthenia gravis, polio (except for the tabloid form of encephalitis).

Open-and closed-angle glaucoma, eye diseases caused by Herpes simplex (due to the risk of corneal perforation).

Pregnancy.

For intra-articular use: general serious condition of the patient, ineffectiveness (or short duration) of the previous two injections (taking into account the individual properties of the corticosteroids used).

Precautions should be taken in elderly patients due to hypersensitivity to corticosteroids, especially in postmenopausal women (high risk of osteoporosis); in convulsive syndrome.

Side effects

The frequency and severity of side effects, as with other corticosteroids, depend on the amount of dose used and the duration of use of the drug. These phenomena are usually reversible and can be eliminated or reduced by reducing the dose. Immune system disorders: anaphylactic reactions, angioedema, anaphylactic shock. Endocrine system disorders: secondary adrenal insufficiency (especially during periods of stress due to illness, trauma, or surgery), Itsenko-Cushing syndrome, decreased glucose tolerance, “steroid” diabetes mellitus or latent diabetes mellitus, increased need for insulin or oral hypoglycemic drugs, impaired intrauterine development, delayed growth and sexual development in children, hirsutism, hypertrichosis, thinning hair on the head, inhibition of pituitary function. 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 pronounced psychotic reactions), personality disorders, increased irritability, insomnia. Nervous system disorders: convulsions, increased intracranial pressure with edema of the optic disc (more often at the end of therapy), dizziness, headache, neuritis, neuropathy, paresthesia, with intecal use — arachnoiditis, meningitis, paresis/paralysis, sensory disorders. Visual disorders: posterior subcapsular cataract, increased intraocular pressure, glaucoma, exophthalmos, worsening of corneal ulcer symptoms, corneal perforation with existing keratitis (especially herpetic), ptosis, mydriasis, chemosis; in rare cases — blindness (when the drug is administered in the face and head). Cardiac disorders: chronic heart failure (in predisposed patients), cardiac arrhythmias, bradycardia, tachycardia, syncope, pulmonary edema, dilated cardiomyopathy, hypertrophic myopathy in premature infants, myocardial rupture after a recent myocardial infarction. Vascular disorders: decreased blood pressure, increased 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). Skin and subcutaneous tissue disorders: impaired wound healing, atrophy and thinning of the skin, petechiae, ecchymosis, increased sweating, dermatitis, “steroid acne”, striae, tendency to develop pyoderma and candidiasis, decreased 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 pseudoparalytic myasthenia gravis, osteoporosis, compression fracture of the spine, aseptic necrosis of the femoral or humeral head, pathological fractures of the tubular bones, tendon tears, joint instability (with repeated intra-articular injections), neurogenic arthropathy. Disorders of the genitals and breast: violation of the menstrual cycle, increase or decrease in motility and sperm count. General disorders and disorders at the injection site: hyperpigmentation, hypopigmentation, subcutaneous and cutaneous atrophy, aseptic abscess, “hot flashes” of blood to the face after injection (or intra-articular use).

Interaction

When used concomitantly with phenobarbital, rifampicin, carbamazepine, primidone, phenytoin or ephedrine, corticosteroid metabolism may be accelerated with a decrease in their therapeutic activity. With the combined use of corticosteroids and potassium-withdrawing diuretics, the likelihood of hypokalemia increases. CORTICOSTEROIDS may increase the excretion of potassium caused by amphotericin B. Concomitant use of corticosteroids and cardiac glycosides increases the risk of arrhythmia or digitalis intoxication (due to hypokalemia). With the combined use of corticosteroids and indirect anticoagulants, changes in blood clotting may occur, requiring dose adjustment of anticoagulants.The combined use of corticosteroids with nonsteroidal anti-inflammatory drugs, salicylates, ethanol and ethanol-containing drugs may increase the frequency or intensity of erosive and ulcerative lesions of the gastrointestinal tract, increase the risk of gastrointestinal bleeding. When used together, corticosteroids can reduce the concentration of salicylates in the blood plasma. Concomitant use of corticosteroids and somatropin may slow down the absorption of the latter (doses of betamethasone exceeding 0.3-0.45 mg/m2 of body surface area per day should be avoided). Aminoglutetimide may cause a decrease in corticosteroid-induced suppression of adrenal function. Concomitant use of corticosteroids and ketoconazole or itraconazole may increase the systemic side effects of corticosteroids. Estrogens, including oestrogen-containing oral contraceptives, can reduce the metabolism of corticosteroids in the liver, thereby increasing their effect. CORTICOSTEROIDS can reduce the effect of cholinesterase inhibitors, which can lead to severe weakness in patients with myasthenia gravis. If possible, cholinesterase inhibitors should be discontinued at least 24 hours before starting corticosteroid therapy. With the simultaneous use of corticosteroids and angiotensin-converting enzyme (ACE) inhibitors, a change in the blood picture may occur. When used concomitantly with the anti-tuberculosis drug isoniazid, a decrease in the concentration of isoniazid in blood plasma was noted. Patients taking isoniazid should be carefully monitored. Concomitant use of cyclosporine and corticosteroids may lead to an increase in the concentration of cyclosporine and an increase in the effect of corticosteroids. There is a high risk of developing seizures. Concomitant use of corticosteroids with macrolide antibiotics may significantly reduce the excretion of corticosteroids. When used concomitantly with colestyramine, it is possible to increase the excretion of corticosteroids. Hypokalemia caused by corticosteroids may increase the severity and duration of muscle block while taking muscle relaxants. With the simultaneous use of betamethasone and atropine or other cholinolytic agents, an additional increase in intraocular pressure may occur. When using corticosteroids and antimalarial drugs of the quinoline group (chloroquine, hydroxychloroquine, mefloquine) at the same time, there is an increased risk of developing myopathy and cardiomyopathy. With the simultaneous use of corticosteroids and praziquantel, its concentration in the blood may decrease. With the simultaneous use of corticosteroids and protirelin, it is possible to reduce the release of thyroid-stimulating hormone stimulated by protirelin. Against the background of the use of corticosteroids, a false negative result can be obtained when conducting a nitrogen blue tetrazole test to detect bacterial infection.

How to take, course of use and dosage

IV, intra-articular, periarticular, intrabursal, IV, interstitial and intraocular use.

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

You can not enter I / o and p/K.

Strict compliance with the rules of asepsis is mandatory when using the drug.

The syringe should be shaken before use of the drug.

The dosage regimen and method of use are set individually, depending on the indications, the severity of the disease and the patient’s reaction.

With systemic therapy, the initial dose of Betaspan Depot in most cases is 1-2 ml. The use is repeated as needed, depending on the patient’s condition.

Intramuscular use Intramuscular use of Betaspan Depot should be carried out deep into the muscle, while choosing large muscles and avoiding contact with other tissues (to prevent tissue atrophy).

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

For various dermatological diseases, as a rule, use of 1 ml of the drug is sufficient.

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

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

In acute and chronic bursitis, the initial dose for intravenous use is 1-2 ml of the drug. If necessary, several repeated injections are performed.

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

Local introduction

When administered topically, concomitant use of a local anesthetic is necessary only in rare cases. If it is desirable, then use 1 or 2% solutions of procaine hydrochloride or lidocaine that do not contain methylparaben, propylparaben, phenol and other similar substances. In this case, mixing is performed in a syringe, first collecting the required dose of Betaspan Depot from the vial into the syringe. Then, in the same syringe, the required amount of local anesthetic is taken from the ampoule and shaken for a short period of time.

In acute bursitis (subdeltoid, subscapular, ulnar and pre-patellar), the introduction of 1-2 ml of the drug into the synovial sac relieves pain and restores joint mobility within a few hours. After relief of exacerbation in chronic bursitis, smaller doses of the drug are used.

In acute tendosynovitis, tendinitis and peritendinitis, one injection of the drug improves the patient’s condition; in chronic cases, the injection is repeated depending on the patient’s reaction. Avoid injecting the drug directly into the tendon.

Intra-articular use of the drug in a dose of 0.5-2 ml relieves pain, joint mobility restriction in rheumatoid arthritis and osteoarthritis within 2-4 hours after use. The duration of therapeutic action varies significantly and can be 4 or more weeks.

Recommended doses of the drug when administered in large joints are from 1 to 2 ml; in medium joints — 0.5–1 ml; in small joints-0.25-0.5 ml.

In some dermatological diseases, intravenous use of the drug directly into the lesion is effective, the dose is 0.2 ml/cm2. The lesion is evenly punctured using a tuberculin syringe and a needle with a diameter of about 0.9 mm. The total amount of the drug administered at all sites should not exceed 1 ml for 1 week. It is recommended to use a tuberculin syringe with a 26-gauge needle for injection into the lesion.

Recommended single doses of the drug (with an interval between injections of 1 week) for bursitis: with omozolelost-0.25-0.5 ml (usually 2 injections are effective), with spur-0.5 ml, with limited mobility of the big toe-0.5 ml, with synovial cyst-0.25-0.5 ml, with tendosynovitis-0.5 ml, with acute gouty arthritis-0.5-1 ml. A tuberculin syringe with a 25-gauge needle is suitable for most injections.

After the therapeutic effect is achieved, the maintenance dose is selected by gradually reducing the dose of Betaspan Depot, administered at appropriate intervals. The reduction is continued until the minimum effective dose is reached.

If a stressful situation (not related to the disease) occurs or threatens to occur, it may be necessary to increase the dose of the drug. Discontinuation of the drug after prolonged therapy is carried out by gradually reducing the dose. Monitoring of the patient’s condition is carried out at least for a year after the end of long-term therapy or use in high doses.

Overdose

Symptoms: acute overdose of betamethasone does not lead to life-threatening situations. use of corticosteroids in high doses for several days does not lead to undesirable consequences (except in cases of very high doses or when used in diabetes mellitus, glaucoma, exacerbation of erosive and ulcerative lesions of the gastrointestinal tract, or with simultaneous use of cardiac glycosides, indirect anticoagulants or potassium-withdrawing diuretics). Treatment: careful medical monitoring of the patient’s condition is necessary; optimal fluid intake should be maintained and the content of electrolytes in plasma and urine (especially the ratio of Na+ and K+ions) should be monitored. If necessary, appropriate therapy should be performed.

Special instructions

Severe nervous system complications (up to fatal) have been reported with epidural and intrathecal use of corticosteroids (with or without X-ray control), including spinal cord infarction, paraplegia, quadriplegia, cortical blindness, and stroke. Since the safety and efficacy of epidural corticosteroids have not been established, this method of use is not indicated for this group of drugs. Recommended methods of use are listed in the section “Dosage and use”. It is necessary to avoid intravascular ingestion of the drug. Due to the lack of data on the risk of calcification, the introduction of the drug into the intervertebral space is contraindicated.

The dosage regimen and method of use are set individually, depending on the indications, the severity of the disease and the patient’s reaction.

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. If there is no effect from the therapy or if it is used for a long time, the drug is also canceled, gradually reducing the dose.

Gradual withdrawal of corticosteroids reduces the risk of developing secondary adrenal insufficiency.

If a stressful situation (not related to the disease) occurs or threatens to occur, it may be necessary to increase the dose of Betaspan Depot, the drugs of choice as a supplement should be hydrocortisone and cortisone.

The development of secondary adrenal cortical insufficiency due to too rapid withdrawal of corticosteroids is possible within a few months after the end of therapy. If a stressful situation occurs or threatens to occur during this period, therapy with Betaspan Depot should be resumed and a mineralocorticoid drug should be prescribed simultaneously (due to a possible violation of mineralocorticoid secretion).

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 into soft tissues, into the lesion site and intra-articularly can simultaneously lead to a systemic effect with a pronounced local effect.

Given the likelihood of developing anaphylactoid reactions with parenteral use of corticosteroids, the necessary precautions should be taken before use of the drug, especially if the patient has a history of allergic reactions to drugs.

Betaspan Depot contains two active substances-betamethasone derivatives, 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 may occur (especially in patients with emotional lability or a tendency to psychosis).

The effect of corticosteroids is enhanced in patients with cirrhosis of the liver or hypothyroidism.

When using Betaspan Depot in patients with diabetes mellitus, correction of hypoglycemic therapy may be required.

Patients receiving corticosteroids should not be vaccinated against smallpox. Other immunizations should not be performed in patients receiving corticosteroids (especially in high doses), due to the possibility of neurological complications and a low immune response (lack of antibody formation). Betaspan Depot should not be used 8 weeks before and 2 weeks after vaccination with killed or inactivated viral and antibacterial vaccines. However, immunization is possible with replacement therapy (for example, with primary adrenal insufficiency).

Patients receiving Betaspan Depot in immune-suppressing doses should be warned to avoid contact with patients with chickenpox and measles (especially important when using the drug in children).

Against the background of the use of corticosteroids, it is possible to suppress the reaction during skin tests.

When using the drug, it should be borne in mind that corticosteroids can mask the signs of an infectious disease, as well as reduce the body’s resistance to infections. The immunosuppressive effect of corticosteroids can lead to activation of 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 corticosteroids in patients with confirmed or suspected Strongyloides infection. In such patients, GCS-induced immunosuppression can lead to hyperinfection of Strongyloides and spread of infection due to larval migration, which is often accompanied by severe enterocolitis and septicemia caused by gram-negative microorganisms, possibly with a fatal outcome.

Since corticosteroids can worsen the course of latent amoebiasis, all patients with unexplained diarrhea or patients arriving from tropical countries should be evaluated to exclude amoebiasis before starting corticosteroid therapy. It is necessary to carefully observe the rules of asepsis and antiseptics when administering the drug.

Caution should be exercised when using the drug in patients with a high risk of infection (on hemodialysis or with dentures). The use of the drug in active tuberculosis is possible only in cases of lightning-fast or disseminated tuberculosis in combination with adequate antitubercular therapy. When using the drug in patients with latent tuberculosis or during the turn of the tuberculin test, the dose selection of Betaspan® Depot should be very careful (due to the risk of reactivation of tuberculosis), and with prolonged use, antitubercular chemoprophylaxis is necessary. When using rifampicin prophylactically, the acceleration of hepatic clearance of betamethasone should be taken into account (dose adjustment of betamethasone may be required).

If there is fluid in the joint cavity, the septic process should be excluded. A marked increase in soreness, swelling, increased temperature of the surrounding tissues and further restriction of joint mobility indicate septic arthritis. It is necessary to conduct a study of aspirated joint fluid. If the diagnosis is confirmed, appropriate antibacterial therapy should be prescribed. The use of Betaspan Depot in septic arthritis is contraindicated. Repeated injections into the joint for osteoarthritis can increase the risk of joint destruction. The introduction of corticosteroids into the tendon tissue gradually leads to tendon rupture. After successful intra-articular therapy, the patient should avoid overloading the joints.

Long-term use of corticosteroids can lead to posterior subcapsular cataracts (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). An eye examination should be performed periodically, especially in patients receiving Betaspan Depot for more than 6 weeks. Special care should be taken when considering the possibility of systemic use of corticosteroids in patients with active herpetic eye damage (keratitis caused by the herpes simplex virus).

The use of medium and high doses of corticosteroids can lead to increased blood pressure, sodium and fluid retention in the body and increased excretion of potassium from the body (these phenomena are less likely in the case of taking synthetic corticosteroids, unless they are used in high doses). With prolonged use of high doses of Betaspan Depot, the risk of arrhythmia and hypokalemia should be considered the need to prescribe potassium-containing drugs and a diet with a restriction of table salt. All corticosteroids enhance the excretion of calcium.

When Betaspan Depot is co-administered with cardiac glycosides or drugs that affect the electrolyte composition of plasma, monitoring of the water-electrolyte balance is required.

Acetylsalicylic acid is used with caution in combination with Betaspan Depot in patients with hypoprothrombinemia. Caution should be exercised when using corticosteroids in elderly patients; in patients with renal or hepatic insufficiency, diverticulitis, active or latent peptic ulcer of the stomach and/or intestines, or with the presence of recently created intestinal anastomoses, osteoporosis, confirmed or suspected parasitic infections (for example, strongyloidosis).

Symptoms of peritoneal irritation or reduced pain associated with perforation of the stomach or intestinal walls may be minimal or absent in patients receiving corticosteroids.

Corticosteroids should be used with caution in patients with hypothyroidism or myasthenia gravis.

Cases of Kaposi’s sarcoma have been reported in patients receiving corticosteroids, and discontinuation of this therapy may lead to remission of the disease.

Against the background of the use of corticosteroids, it is possible to change the motility and number of spermatozoa.

With long-term corticosteroid therapy, it is advisable to consider switching from parenteral to oral corticosteroid use, taking into account the assessment of the benefit/risk ratio.

Application in pediatrics

Children undergoing therapy with the drug (especially long-term ones) should be under close medical supervision for possible growth retardation and the development of secondary adrenal insufficiency.

Use in athletes

Patients participating in competitions under the supervision of the World Anti-Doping Agency (WADA) should read the WADA rules before starting treatment, as taking Betaspan Depot may affect the results of doping control.

Influence on the ability to drive vehicles and mechanisms

During treatment with Betaspan Depot, caution should be exercised when driving vehicles and engaging in other potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions.

Form of production

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

Active ingredient

Betamethasone

Conditions of release from pharmacies

By prescription

Dosage form

suspension for injection

Purpose

Children as prescribed by a doctor, Adults as prescribed by a doctor, Children over 3 years of age, Pregnant women as prescribed by a doctor

Indications

Bronchial Asthma, Urticaria, Allergies, Dermatitis, Eczema, Pollinosis, Psoriasis, Rheumatoid Arthritis, Neurodermatitis, Dermatosis, Bursitis, Insect Bites