Betaspan Depot

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Betaspan Depot: instructions for use and reviews

1. Release form and composition
2. Pharmacological properties
3. Indications for use
4. Contraindications
5. Method of application and dosage
6. Side effects
7. Overdose
8. Special instructions
9. Application during pregnancy and lactation
10. Use in childhood
11. In case of impaired renal function
12. For violations of liver function
13. Use in the elderly
14. Application in athletes
15. Drug interactions
16. Analogs
17. Terms and conditions of storage
18. Terms of dispensing from pharmacies
19. Reviews
20. Price in pharmacies

Latin name: Betaspan Depo

ATX code: H02AB01

Active ingredient: betamethasone disodium phosphate (Betamethasone sodium phosphate), betamethasone dipropionate (Betamethasone dipropionate)

Producer: Farmak, PJSC (Ukraine)

Description and photo update: 2019-11-07

Prices in pharmacies: from 227 rubles.

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Betaspan Depo is a drug for injection with glucocorticoid, immunosuppressive, anti-allergic and anti-inflammatory effects.

Release form and composition

Dosage form - suspension for injection: slightly viscous transparent yellowish liquid (or colorless), contains easily suspended white or almost white particles; when shaking, an almost white or white suspension forms (in a cardboard box 1 blister containing 1 or 5 ampoules of 1 ml each, and instructions for the use of Betaspan Depot).

Composition of 1 ml of suspension:

active substances: betamethasone dipropionate - 6.43 mg (betamethasone - 5 mg), betamethasone sodium phosphate - 2.63 mg (betamethasone - 2 mg);
auxiliary components: sodium carmellose - 5.2 mg; edetate disodium dihydrate - 0.1 mg; propyl parahydroxybenzoate (E 216) - 0.2 mg; methyl parahydroxybenzoate (E 218) - 1.3 mg; sodium hydrogen phosphate - 0.6 mg; benzyl alcohol - 9 mg; sodium chloride - 5.5 mg; macrogol-4000 - 25 mg; polysorbate-80 - 0.5 mg; water for injection - up to 1 ml.

Pharmacological properties

Pharmacodynamics

Betaspan Depo is a synthetic corticosteroid (glucocorticosteroid), has a high glucocorticosteroid and insignificant mineralocorticosteroid activity. The drug has an immunosuppressive, antiallergic and anti-inflammatory effect, as well as a pronounced and varied effect on different types of metabolism.

The active substances of Betaspan Depo interact with specific cytoplasmic receptors, thus forming a complex that penetrates the cell nucleus and stimulates the biosynthesis of matrix ribonucleic acid. Thanks to the latter, the formation of proteins that mediate cellular effects, including lipocortin, is induced. Lipocortin suppresses phospholipase A2, inhibits the release of arachidonic acid and suppresses the biosynthesis of prostaglandins, endoperoxides, leukotrienes, which contribute to inflammation, allergies, etc.

Effects of Betaspan Depot on different types of metabolic processes:

protein: due to globulins, a decrease in the amount of protein in the blood plasma is noted, while the globulin / albumin ratio increases; there is also an increase in the synthesis of albumin in the kidneys and liver, an increase in protein catabolism in muscle tissue;
lipid: there is an increase in the biosynthesis of higher fatty acids and triglycerides, redistribution of fat (accumulation of fat mainly in the face, shoulder girdle and abdomen); hypercholesterolemia may occur;
carbohydrate: there is an increase in the absorption of carbohydrates from the gastrointestinal tract, an increase in the activity of glucose-6-phosphatase, leading to an increase in the flow of glucose into the blood from the liver, an increase in the activity of phosphoenolpyruvate carboxylase and biosynthesis of aminotransferases, which lead to the activation of gluconeogenesis;
water-electrolyte: there is a delay in the body of sodium (Na ⁺) and water ions, stimulation of the excretion of potassium ions (K ⁺) (mineralocorticosteroid activity), a decrease in the absorption of calcium (Ca ²⁺) from the gastrointestinal tract, leaching of Ca ² ions from the bones ⁺, increasing their excretion by the kidneys.

The antiallergic effect is associated with suppression of the synthesis and secretion of allergy mediators, inhibition of the release of histamine and other biologically active substances from sensitized mast cells and basophils, a decrease in the number of T- and B-lymphocytes, mast cells, a decrease in the sensitivity of effector cells to allergy mediators, inhibition of antibody production, a change in the body's immune response.

The anti-inflammatory effect is based on inhibition of the release of inflammatory mediators by eosinophils, inducing the formation of lipocortin and a decrease in the number of mast cells producing hyaluronic acid, reducing capillary permeability, stabilizing cell membranes and organelle membranes (especially lysosomal membranes).

The use of the drug promotes an increase in the sensitivity of beta-adrenergic receptors of the bronchi of medium and small caliber to exogenous sympathomimetics and endogenous catecholamines, a decrease in the viscosity of the secretion of the bronchial mucosa (due to the reduction or inhibition of its production).

The immunosuppressive effect of Betaspan Depo is due to inhibition of the release of cytokines from macrophages and lymphocytes (interleukin 1, interleukin 2, interferon gamma).

Other effects of Betaspan Depot:

suppression of the biosynthesis and secretion of adrenocorticotropic hormone and secondary - endogenous GCS;
inhibition of the secretion of TSH and FSH (thyroid-stimulating and follicle-stimulating hormones);
suppression of the release of beta-lipotropin (while the content of circulating beta-endorphin does not decrease);
inhibition of connective tissue reactions during the inflammatory process and reducing the possibility of scar tissue formation.

Betamethasone sodium phosphate is an easily soluble compound, after parenteral administration it is well absorbed into tissues and provides a rapid development of therapeutic action. Betamethasone dipropionate is absorbed more slowly. Thanks to the combination of these salts of betamethasone, it is possible to ensure the development of both a quick (but short-lived) and long-term effect.

To achieve a general or local effect, different methods of administration can be used: intramuscularly, intravenously, periarticular, intraarticular, intradermal.

Pharmacokinetics

Betamethasone sodium phosphate dissolves well, after intramuscular injection it is rapidly hydrolyzed and almost immediately absorbed from the injection site. This ensures a quick onset of the therapeutic effect. Betamethasone dipropionate is absorbed slowly from the depot. Betamethasone binds to plasma proteins at 62.5%.

Metabolism occurs in the liver, with predominantly inactive metabolites being formed. The metabolic process of betamethasone dipropionate is gradual, which causes a long-term effect of the drug, the duration of excretion is more than 10 days.

Phosphate of betamethasone sodium is excreted almost completely within one day after administration. Excretion of betamethasone occurs mainly by the kidneys.

Indications for use

Betaspan Depo is prescribed for the treatment of diseases / conditions in which, thanks to the use of GCS, an adequate clinical effect can be obtained (it should be borne in mind that in some diseases GCS are used as an addition to standard therapy):

allergic diseases, including bronchial asthma, drug allergies, reactions to insect bites, hay fever (pollinosis), allergic bronchitis, serum sickness, perennial / seasonal rhinitis;
diseases of the musculoskeletal system and soft tissues, including ankylosing spondylitis, rheumatoid arthritis, bursitis, osteoarthritis, epicondylitis, coccygodynia, ganglion cyst, torticollis, fasciitis, exostosis;
systemic connective tissue diseases, including periarteritis nodosa, dermatomyositis, systemic lupus erythematosus, scleroderma;
dermatological diseases, including atopic dermatitis, severe photodermatitis, coin-like eczema, contact dermatitis, neurodermatitis, urticaria, lichen planus, alopecia areata, psoriasis, discoid lupus erythematosus, keloid scars, cystic acne, pemphigus vulgaris;
primary / secondary adrenal cortex insufficiency (necessarily in combination with mineralocorticosteroids);
hemoblastosis (in adults - palliative therapy of lymphomas and leukemia; in children - acute leukemia);
other pathological conditions / diseases in which systemic therapy of corticosteroids is required (regional ileitis, adrenogenital syndrome, pathological changes in the blood if corticosteroids are needed)

Contraindications

Absolute:

systemic mycoses;
violation of coagulation (including the use of anticoagulants);
thrombocytopenic purpura (with intramuscular injection);
infectious arthritis, unstable joint (with intra-articular administration);
simultaneous use of Betaspan Depo in immunosuppressive doses with attenuated / live vaccines;
lactation period;
age up to 3 years (due to the presence of benzyl alcohol in the composition);
individual intolerance to the components of Betaspan Depot, as well as other GCS.

When using the drug, intrathecal, epidural, intravenous and subcutaneous administration is not allowed, as well as administration directly into the muscle tendon, intervertebral space and infected surfaces.

Relative contraindications (Betaspan Depot is prescribed under medical supervision):

severe chronic hepatic and / or renal failure, liver cirrhosis, nephrourolithiasis;
diseases of the cardiovascular system, including a recent myocardial infarction (against the background of acute and subacute myocardial infarction, it is possible to develop consequences in the form of the spread of the focus of necrosis, slowing down the formation of scar tissue, which can cause rupture of the heart muscle), decompensated chronic heart failure, hyperlipidemia, arterial hypertension;
infectious / parasitic diseases of viral, bacterial or fungal etiology (including those transferred recently, as well as recent contact with a patient) - active / latent tuberculosis, amebiasis, herpes zoster (in the viremic phase), herpes simplex, measles, chickenpox, established / suspected strongyloidosis; in case of severe infectious diseases, the use of Betaspan Depo is possible only against the background of specific antimicrobial treatment;
a period of 8 weeks before and within 2 weeks after vaccination (with the use of inactivated vaccines), lymphadenitis after BCG vaccination;
immunodeficiency states (including HIV infection or AIDS);
endocrine diseases, including decreased glucose tolerance, diabetes mellitus, hypothyroidism, thyrotoxicosis, grade III – IV obesity, Itsenko-Cushing's disease;
diseases of the gastrointestinal tract: gastritis, esophagitis, gastric ulcer and duodenal ulcer, latent / acute peptic ulcer, recently created intestinal anastomosis, diverticulitis, ulcerative colitis, in which there is a threat of abscess formation or perforation, abscess or other purulent infections;
acute psychosis, affective disorders in severe course (including aggravated history, in particular steroid psychosis);
hypoalbuminemia and conditions that predispose to its development;
eye diseases caused by Herpes simplex, closed and open-angle glaucoma;
myasthenia gravis, systemic osteoporosis, poliomyelitis (except bulbar encephalitis);
the general serious condition of the patient, the short duration / ineffectiveness of the action of the two previous injections, while the individual properties of the GCS used (for intra-articular administration) should be taken into account;
convulsive syndrome;
pregnancy;
age 3-18 years;
advanced age, especially in postmenopausal women.

Betaspan Depot, instructions for use: method and dosage

Betaspan Depot injections can be administered intramuscularly, intraarticularly, periarticularly, intrabursally, intradermally, interstitially and intralesionally. Intravenous and subcutaneous administration of the drug is prohibited.

Due to the small size of betamethasone dipropionate crystals, small-diameter needles (up to 26 gauge) can be used for direct injection into the lesion and intradermal injection.

When using Betaspan Depot, strict adherence to the rules of asepsis is mandatory.

The syringe must be shaken before the suspension is injected.

The route of administration and dosage regimen are set individually, taking into account the indications, the patient's response and the severity of the disease.

In most cases, the initial dose for systemic therapy is 1–2 ml. The need for repeated administration is determined by the patient's condition.

Intramuscular injection

Betaspan Depot injections are injected deep into the muscle, preferably into large muscles, while avoiding contact with other tissues (this is the prevention of atrophic changes).

The initial dose for severe conditions in which emergency measures are required is 2 ml. For various dermatological diseases, the drug is most often used in a dose of 1 ml.

The onset of action of Betaspan Depot in diseases of the respiratory system after injection is noted within several hours.

For a significant improvement in the condition of hay fever, bronchial asthma, allergic rhinitis and allergic bronchitis, administration of 1-2 ml of suspension is usually sufficient.

The initial dose for acute / chronic bursitis is 1–2 ml. Several repeated injections are performed if necessary.

If after a certain period of time a satisfactory clinical response is not observed, Betaspan Depot should be canceled and another treatment should be prescribed.

Local introduction

The combined use of a drug with a local anesthetic effect is required only in rare cases. If necessary, a 1 or 2% solution of procaine or lidocaine hydrochloride is used, which does not contain propylparaben, methylparaben, phenol and other similar substances. Mixing Betaspan Depot with such a drug is carried out in a syringe, while first drawing the required dose of Betaspan Depot from the vial into the syringe. After withdrawing the correct amount of local anesthetic, shake the syringe for a short period of time.

In patients with acute bursitis (subscapularis, subdeltoid, pre-patellar and ulnar), when Betaspan Depot is injected into the synovial bag at a dose of 1-2 ml for several hours, pain relief and restoration of joint mobility are noted.

In chronic bursitis after relieving an exacerbation, the use of the drug in lower doses is indicated.

In acute tendosynovitis, peritendinitis and tendinitis, the patient's condition improves after a single injection; in the chronic course of these pathologies, the drug is used repeatedly, depending on the patient's reaction. Direct injection of Betaspan Depot into the tendon should be avoided.

Intra-articular administration of 0.5–2 ml of the drug for osteoarthritis and rheumatoid arthritis can relieve pain, limiting joint mobility 2–4 hours after application. The duration of the therapeutic effect has significant variability and can be 4 or more weeks.

Recommended doses of Betaspan Depot when injected into joints:

small joints - 0.25–0.5 ml;
middle joints - 0.5-1 ml;
large joints - 1–2 ml.

In the treatment of certain dermatological diseases, the administration of Betaspan Depo intradermally directly into the lesion at a dose of 0.2 ml / cm is effective. The lesion must be evenly pricked, for which a tuberculin syringe and a needle with a diameter of about 0.9 mm are used. The total volume of the injected drug in all areas should not exceed 1 ml for 1 week. For introduction into the lesion, it is possible to use a tuberculin syringe with a 25-gauge needle.

Recommended single doses of Betaspan Depo (interval between injections - 1 week):

acute gouty arthritis - 0.5-1 ml;
callousness - 0.25–0.5 ml (usually 2 injections are effective);
synovial cyst - 0.25–0.5 ml;
spur, tendosynovitis and limited mobility of the big toe - 0.5 ml.

In most cases, a tuberculin syringe with a 25 gauge needle is suitable for injection.

The maintenance dose of Betaspan Depo after reaching the therapeutic effect is selected by gradually decreasing the dose administered at appropriate intervals. The decrease is continued until the minimum effective dose is reached.

In case of occurrence / threat of occurrence of a stressful situation (which is not related to illness), there may be a need to increase the dose of Betaspan Depo. After prolonged therapy, withdrawal should be carried out with a gradual dose reduction. At the end of long-term therapy or use in high doses, the patient's condition should be monitored for at least a year.

Side effects

The severity and frequency of development of adverse events during therapy with Betaspan Depo, as with the use of other GCS, depend on the dose and duration of the drug. Usually these disorders are reversible and can be reduced or eliminated with dose reduction.

Possible side reactions:

endocrine system: secondary adrenal insufficiency (especially during periods of stress during illness, surgery, trauma), decreased glucose tolerance, Itsenko-Cushing syndrome, manifestation of latent diabetes mellitus or steroid diabetes mellitus, increased need for oral hypoglycemic drugs or insulin, delay growth and sexual development in children, impaired intrauterine development, hypertrichosis, hirsutism, inhibition of the function of the pituitary gland, thinning of the hair on the head;
immune system: angioedema, anaphylactic reactions, anaphylactic shock;
psyche: mood changes, euphoria, personality disorders, depression (possibly in combination with severe psychotic reactions), insomnia, increased irritability;
nutrition and metabolism: increased excretion of calcium and potassium, hypernatremia, hypokalemic alkalosis, retention in fluid tissues, negative nitrogen balance (associated with protein catabolism), lipomatosis (including epidural and mediastinal lipomatosis, which can lead to neurological complications), increased appetite, weight gain, hypertriglyceridemia, hypercholesterolemia;
organ of vision: exophthalmos, increased intraocular pressure, posterior subcapsular cataract, glaucoma, worsening symptoms of corneal ulcers, chemosis, corneal perforation with existing keratitis (especially herpetic), mydriasis, ptosis; in rare cases - blindness (in cases of administration of Betaspan Depo in the head and face);
nervous system: neuritis, convulsions, headache, neuropathy, increased intracranial pressure with edema of the optic nerve head (more often after the end of therapy), dizziness, paresthesia; with intrathecal administration - sensory disturbances, meningitis, arachnoiditis, paralysis / paresis;
digestive system: hepatomegaly, erosive and ulcerative lesions of the gastrointestinal tract (possible subsequent perforation and bleeding), flatulence, acute pancreatitis, nausea, hiccups, increased activity of liver enzymes (usually reversible);
vessels: vasculitis, decrease / increase in blood pressure, thromboembolic complications;
heart: chronic heart failure (if there is a predisposition), cardiomyopathy, pulmonary edema, heart rhythm disturbances, bradycardia, fainting, tachycardia, myocardial rupture in patients who have recently had myocardial infarction, dilated hypertrophic myopathy in premature infants;
genitals and mammary gland: violation of the menstrual cycle, decrease / increase in the number and mobility of sperm;
musculoskeletal and connective tissue: steroid myopathy, muscle weakness, compression fracture of the spine, loss of muscle mass, osteoporosis, increased myasthenic symptoms in severe pseudoparalytic myasthenia gravis, pathological fractures of tubular bones, aseptic necrosis of the head of the humerus or femur, ruptured arthroplasty instability of the joints (with repeated intra-articular injections);
skin and subcutaneous tissues: increased sweating, thinning and atrophy of the skin, impaired wound healing, ecchymosis, dermatitis, striae, steroid acne, petechiae, a tendency to candidiasis and pyoderma, decreased reaction during skin tests, skin rash, rosacea, allergic dermatitis, telangiectasia, erythema;
disorders at the injection site and general disorders: cutaneous and subcutaneous atrophy, aseptic abscess, hypopigmentation, hyperpigmentation, flushing of the face after injection (or intra-articular injection).

Overdose

Main symptoms: an acute overdose of betamethasone does not lead to life-threatening situations. The introduction of high doses of GCS for several days does not cause undesirable consequences (except for the use of very high doses of Betaspan Depo, therapy in patients with diabetes mellitus, glaucoma, exacerbation of erosive and ulcerative lesions of the gastrointestinal tract, or when used in combination with cardiac glycosides, indirect anticoagulants or potassium-excreting diuretics).

Therapy: the patient's condition should be carefully monitored, optimal fluid intake should be maintained and the electrolyte levels in urine and plasma should be monitored (in particular the ratio of sodium and potassium ions). Appropriate treatment is provided if necessary.

special instructions

There is information about cases of severe complications from the nervous system (sometimes up to death) with intrathecal and epidural administration of GCS (with / without fluoroscopic control). These include spinal cord infarction, paraplegia, quadriplegia, stroke, and cortical blindness. Since the efficacy and safety of GCS have not been established with epidural administration, this method of administration for this group of drugs is not shown.

Intravascular ingestion of Betaspan Depot should be avoided. The introduction of the suspension into the intervertebral space is contraindicated due to the lack of information regarding the risk of calcification.

The route of administration and dosage regimen are set individually. It is recommended to use the smallest possible dose in the shortest possible course.

The initial dose is adjusted until the desired therapeutic effect is achieved. Then the dose of Betaspan Depot is gradually reduced to the minimum effective maintenance dose. When carrying out a long course, or there is no effect of therapy, the drug should be canceled with a gradual dose reduction.

The gradual cancellation of Betaspan Depot provides a decrease in the likelihood of secondary adrenal insufficiency.

If a stressful situation arises / threatens (which is not associated with a disease), an increase in the dose of corticosteroids may be required; as an addition, the drugs of choice are drugs containing cortisone and hydrocortisone.

For several months after the end of therapy, secondary adrenal cortex insufficiency may develop (due to too rapid withdrawal of GCS). During this period, if a stressful situation arises / threatens, the use of Betaspan Depo must be resumed with the simultaneous administration of a mineralocorticosteroid drug (associated with a possible violation of the secretion of mineralocorticosteroids).

If Betaspan Depot is injected into soft tissues, intra-articularly and into the lesion, this can lead to a pronounced local effect and, at the same time, to systemic action.

With parenteral administration of GCS, the risk of developing anaphylactoid reactions should be taken into account, and therefore, precautions should be taken before the administration of Betaspan Depo, especially if the patient has a history of allergic reactions to drugs.

Betamethasone sodium phosphate, one of the active components of Betaspan Depot, is characterized by rapid penetration into the systemic circulation, so its possible systemic action must be taken into account.

In patients with hypothyroidism or liver cirrhosis, the effect of Betaspan Depot is enhanced.

Against the background of therapy, mental disorders may occur (this is especially true for patients with emotional lability or with a tendency to psychosis).

In case of diabetes mellitus, during the period of Betaspan Depo use, correction of hypoglycemic therapy may be required.

Patients receiving corticosteroids should not be vaccinated against smallpox. It is not recommended to carry out other immunizations (especially in high doses), since there is a possibility of neurological complications and a low immune response (there is no formation of antibodies).

During the period of application of Betaspan Depo in immunosuppressive doses, patients should avoid contact with patients with measles and chickenpox (this warning is especially important when used in pediatrics).

When conducting skin tests, it is necessary to consider the possibility of suppressing the reaction.

Betaspan Depot can mask the signs of infectious diseases, as well as reduce the body's resistance to infections.

The immunosuppressive effect of GCS can promote the activation of latent infections or exacerbation of intercurrent infections, including infections caused by Mycobacterium, Candida, Toxoplasma, Cryptococcus, Pneumocystis, Strongyloides, Ameba or Nocardia.

When using Betaspan Depo in patients with confirmed / suspected Strongyloides infection (intestinal acne), special care must be taken, since GCS-induced immunosuppression can cause Strongyloides hyperinfection and lead to the spread of infection (due to the migration of larvae, which is often accompanied by enterocolitis in severe course and septicemia associated with gram-negative microorganisms), death is possible.

Betaspan Depo can aggravate latent amoebiasis, therefore, the condition of all patients with unexplained diarrhea or patients who came from countries with a tropical climate should be controlled. Before starting GCS therapy, to exclude amebiasis, it is necessary to conduct an examination. When administering the drug, the rules of antisepsis and asepsis must be carefully followed.

Against the background of a high risk of infection (in patients on hemodialysis or with dentures), the use of Betaspan Depo requires caution.

With active tuberculosis, therapy can be carried out only with fulminant or disseminated tuberculosis simultaneously with adequate anti-tuberculosis therapy. The selection of the dose of Betaspan Depo for latent tuberculosis or during the bend of the tuberculin test should be very careful (due to the danger of tuberculosis reactivation), and in case of prolonged use, anti-tuberculosis chemoprophylaxis is required.

When using rifampicin for prophylactic purposes, it is necessary to take into account the acceleration of hepatic clearance of betamethasone (while the dose of betamethasone may be adjusted).

If there is fluid in the articular cavity, the septic process must be excluded. Symptoms such as a noticeable increase in swelling, soreness, further limitation of joint mobility and an increase in the temperature of the surrounding tissues may indicate septic arthritis. A study of the aspirated joint fluid is recommended. If the diagnosis is confirmed, appropriate antibiotic treatment should be prescribed. In case of septic arthritis, Betaspan Depo is contraindicated.

In osteoarthritis, repeated injections of the drug into the joint may increase the risk of joint destruction. The introduction of glucocorticosteroids into the tendon tissue leads to a gradual rupture of the tendon. After the end of successful intra-articular therapy, the patient is advised to avoid overloading the joints.

Long-term use of Betaspan Depo can lead to posterior subcapsular cataract (especially in children), glaucoma (possibly in combination with damage to the optic nerve) and can contribute to the occurrence of a secondary ocular infection of viral or fungal etiology. Ophthalmologic examinations should be performed periodically, especially when using the drug for more than 6 weeks.

Particular care must be taken when considering the possibility of systemic use of GCS in patients with active herpetic lesions of the eyes (keratitis caused by the herpes simplex virus).

The use of Betaspan Depo in medium and high doses can lead to an increase in blood pressure, fluid and sodium retention, and increased excretion of potassium from the body (these disorders are less likely to develop in the case of synthetic GCS, unless these drugs are used in high doses). With prolonged use of high doses of Betaspan Depo, the risk of hypokalemia and arrhythmia, the need for a diet with limited salt and potassium-containing drugs should be considered. Against the background of the use of GCS, the excretion of calcium increases.

When combined with cardiac glycosides or drugs that affect the electrolyte composition of plasma, it is necessary to monitor the water-electrolyte balance.

In case of hypoprothrombinemia, Betaspan Depo should be used in combination with acetylsalicylic acid with caution.

In patients receiving corticosteroids, pain relief from perforation of the intestinal / stomach walls or signs of peritoneal irritation may be minimal or absent.

There is evidence of cases of Kaposi's sarcoma in patients receiving corticosteroids, the cancellation of therapy can lead to remission of the disease.

During the use of Betaspan Depot, it is possible to change the number and mobility of sperm.

With prolonged therapy with glucocorticosteroids, it is advisable to consider the possibility of transferring the patient from parenteral administration of GCS to oral administration, taking into account the assessment of the ratio of benefits and risks.

Influence on the ability to drive vehicles and complex mechanisms

When using Betaspan Depot, care must be taken when driving.

Application during pregnancy and lactation

Controlled studies of the efficacy / safety of betamethasone in pregnant women have not been conducted. The use of Betaspan Depo, especially during the first trimester, is indicated only in cases where the expected therapeutic effect is higher than the possible harm. It is necessary to carefully monitor the condition of patients with gestosis in the second half of pregnancy (especially with preeclampsia).

When conducting studies on animals against the background of the use of GCS during pregnancy, cases of malformations and violations (delay) of fetal development were recorded.

During pregnancy, repeated or prolonged use of GCS may increase the risk of intrauterine growth retardation. Cases of gastroesophageal reflux and myocardial hypertrophy have been reported in newborns whose mothers used betamethasone during pregnancy. The condition of such children should be under strict medical control in order to timely detect adrenal insufficiency.

Betamethasone passes into breast milk. Given the importance of therapy for the mother and the likelihood of possible adverse events in children, breastfeeding is recommended to be interrupted.

Pediatric use

up to 3 years: the appointment of Betaspan Depot is contraindicated (due to the presence of benzyl alcohol in the composition);
from 3 to 18 years: during the period of therapy, especially long-term, the condition of pediatric patients must be carefully monitored in order to identify growth retardation and the occurrence of secondary adrenal cortex insufficiency.

With impaired renal function

In severe chronic renal failure and nephrourolithiasis, therapy is carried out under medical supervision.

For violations of liver function

In severe chronic liver failure and liver cirrhosis, therapy is carried out under medical supervision.

Use in the elderly

In old age, especially in postmenopausal women, Betaspan Depot is used with caution.

Application in athletes

Patients participating in competitions under the control of WADA (World Anti-Doping Agency), before starting treatment with Betaspan Depo, should familiarize themselves with the WADA rules, since the use of the drug may affect the results of doping control.

Drug interactions

primidone, phenobarbital, carbamazepine, rifampicin, ephedrine, phenytoin: with combined use, the metabolism of GCS can be accelerated with a simultaneous decrease in their therapeutic activity;
potassium-excreting diuretics: the risk of hypokalemia increases;
amphotericin B: GCS enhance the excretion of potassium;
cardiac glycosides: against the background of combination therapy, the likelihood of developing digitalis intoxication or arrhythmia (associated with hypokalemia) increases;
indirect anticoagulants: there may be changes in blood clotting, in which it is necessary to adjust the doses of anticoagulants;
nonsteroidal anti-inflammatory drugs, salicylates, ethanol and ethanol-containing drugs: simultaneous use with corticosteroids can cause an increase in the intensity or frequency of erosive and ulcerative lesions of the gastrointestinal tract, the likelihood of gastrointestinal bleeding;
salicylates: combined therapy can lead to a decrease in their plasma concentration;
somatropin: its absorption rate may slow down (it is necessary to avoid the introduction of daily doses of betamethasone above 0.3-0.45 mg / m ² of body surface);
aminoglutethimide: simultaneous use helps to reduce corticosteroid-induced adrenal suppression;
ketoconazole, itraconazole: combined use can lead to an increase in systemic adverse events of GCS;
estrogens, including oral contraceptive drugs containing estrogen: GCS metabolism in the liver may decrease, which enhances their effect;
cholinesterase inhibitors: with combined use, the effect of GCS decreases, which in patients with myasthenia gravis can cause the development of severe weakness; it is advisable to cancel cholinesterase inhibitors at least one day before starting Betaspan Depo use;
angiotensin-converting enzyme inhibitors: combined therapy leads to a change in the blood picture;
isoniazid: its plasma concentration in the blood decreases; against the background of combination therapy, the patient's condition should be carefully monitored;
cyclosporine: its concentration increases, which enhances the effect of Betaspan Depot; there is a high likelihood of seizures;
antibiotics of the macrolide group: combined use can lead to a significant decrease in the excretion of GCS;
cholestyramine: there may be an increase in the excretion of GCS;
muscle relaxants: against the background of hypokalemia caused by GCS, an increase in the duration and severity of muscle blockade is possible;
atropine or other anticholinergics: there may be an additional increase in intraocular pressure;
antimalarial drugs of the quinoline group (hydroxychloroquine, chloroquine, mefloquine): when used together, there is an increase in the likelihood of undesirable disorders such as myopathy and cardiomyopathy;
praziquantel: there is a risk of a decrease in its concentration in the blood;
protireline: likely to decrease the release of thyroid-stimulating hormone stimulated by protireline.

During the period of application of Betaspan Depo, when carrying out a nitrogen blue tetrazole test to detect a bacterial infection, a false negative result may be obtained.

Analogs

The analogues of Betaspan Depot are Flosteron, Diprospan, Celeston.

Terms and conditions of storage

Store in a place protected from light at temperatures up to 25 ° C. Keep out of the reach of children.

Shelf life is 2 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Betaspan Depot

Reviews about Betaspan Depot are mostly positive. The drug is used for various indications, while usually indicating a rapid development of therapeutic action.

The price of Betaspan Depot in pharmacies

The approximate price for Betaspan Depot (5 ampoules of 1 ml) is 492 rubles.

Betaspan Depot: prices in online pharmacies

Drug name

Price

Pharmacy

Betaspan Depo suspension for injection 7mg / ml 1ml 1 ampoule

227 r

Buy

Betaspan Depot 7 mg / ml suspension for injection 1 ml 5 pcs.

231 RUB

Buy

Maria Kulkes Medical journalist About the author

Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!