1 ml suspension contains
- Active Ingredients – Betamethasone dipropionate 6.43 mg in terms of 100% dry matter (equivalent to 5 mg of betamethasone), betamethasone sodium phosphate 2.63 mg in terms of 100% anhydrous substance (equivalent to 2 mg of betamethasone),
- Excipients: methyl parahydroxybenzoate, propyl parahydroxybenzoate, benzyl alcohol, sodium chloride, sodium hydrogen phosphate anhydrous, disodium edetate, sodium carboxymethylcellulose, polysorbate 80, polyethylene glycol 4000, water for injection
Betamethasone sodium phosphate is a highly soluble component that is rapidly absorbed from the injection site, which ensures a rapid onset of therapeutic action. Betamethasone dipropionate is a poorly soluble component that is slowly absorbed from the depot formed at the injection site and causes a long-term effect of the drug.
Plasma protein binding – 62.5%. Metabolized in the liver. Elimination is carried out mainly by the kidneys, a small part is excreted in the bile.
Betaspan® Depot is a combination of soluble and slightly soluble betamethasone esters for intramuscular, intraarticular, periarticular and intradermal injections, as well as for injection directly into the lesion. Betaspan® Depot has a high glucocorticosteroid activity and a slight mineralocorticosteroid activity, in addition, the drug regulates carbohydrate metabolism and water and electrolyte balance.
The small size of betamethasone dipropionate crystals allows the use of small-diameter needles (up to 0.9 mm) for intradermal injections and injection directly into the lesion.
Indications for use
– rheumatoid arthritis, osteoarthritis, bursitis, tendosynovitis, tendonitis, peritendinitis, ankylosing spondylitis, epicondylitis, sciatica, coccydynia, sciatica, lumbago, torticollis, ganglion cyst, exostosis, fasciitis, foot disease, bursitis against the background of hard callus, spurs, thumb stiffness feet
– bronchial asthma, status asthmaticus, hay fever, allergic bronchitis, allergic rhinitis, drug allergy, serum sickness, insect sting reactions
– atopic dermatitis (coin-like eczema), neurodermatitis, contact dermatitis, severe solar dermatitis, urticaria, lichen planus, insulin lipodystrophy, alopecia areata, discoid lupus erythematosus, psoriasis, keloid scars, pemphigus vulgaris, dermatitis herpes, cystic acne
– systemic lupus erythematosus, scleroderma, dermatomyositis, periarteritis nodosa
– palliative therapy for leukemia and lymphomas in adults
– adrenogenital syndrome
– intestinal diseases (ulcerative colitis, regional ileitis, sprue)
– pathological changes in the blood, requiring corticosteroid therapy
– nephritis, nephrotic syndrome
– primary and secondary insufficiency of the adrenal cortex (with the mandatory simultaneous administration of mineralocorticoids).
Dosage and administration
Betaspan® Depot is recommended to be administered intramuscularly if systemic intake of a glucocorticosteroid into the body is necessary; directly into the affected soft tissue or in the form of intra-articular and peri-articular injections for arthritis; in the form of intradermal injections for various skin diseases; in the form of local injections into the lesion for certain diseases of the foot.
The dosage regimen and method of administration are set individually, depending on the indications, the severity of the disease and the patient’s response to treatment. The dose should be minimal and the period of application should be as short as possible.
If after a certain period of time a satisfactory clinical effect is not achieved, treatment with the drug should be discontinued and other appropriate therapy should be carried out.
Systemic therapy. The initial dose of the drug in most cases is 1-2 ml. The introduction is repeated if necessary, depending on the condition of the patient. The drug is administered deep intramuscularly into the buttock:
– in severe conditions (lupus erythematosus and status asthmaticus), requiring emergency measures, the initial dose of the drug may be 2 ml;
– for various dermatological diseases, as a rule, 1 ml of the drug is sufficient;
– in diseases of the respiratory system, the effect of the drug begins within a few hours after intramuscular injection. With bronchial asthma, hay fever, allergic bronchitis and allergic rhinitis, a significant improvement in the condition is achieved after the introduction of 1-2 ml of the drug;
– in acute and chronic bursitis, the dose for intramuscular injection is 1-2 ml of the drug. If necessary, carry out several repeated injections.
local introduction. The simultaneous use of a local anesthetic drug is necessary only in isolated cases. If simultaneous administration of an anesthetic agent is desirable, then a 1% or 2% solution of procaine hydrochloride or lidocaine and paraben-free dosage forms are used. It is not allowed to use anesthetics containing methylparaben, propylparaben, phenol and other similar substances. When using an anesthetic in combination with Betaspan® Depot, the necessary dose of the drug is first drawn into the syringe from the vial, then the required amount of local anesthetic is drawn into the same syringe from the ampoule and shaken for a short period of time. Before using lidocaine, a skin test for hypersensitivity is necessary.
In acute bursitis (subdeltoid, subscapular, ulnar and anteropatellar), the introduction of 1-2 ml of Betaspan® Depot into the synovial bag can relieve pain and fully restore mobility for several hours. Treatment of chronic bursitis is carried out with smaller doses of the drug after stopping an acute attack of the disease.
In acute tendosynovitis, tendonitis and peritendinitis, one injection of Betaspan® Depot relieves the patient’s condition, in chronic cases, the injection of the drug should be repeated depending on the reaction. It is necessary to avoid the introduction of the drug directly into the tendons. Intra-articular administration of the drug at a dose of 0.5-2 ml reduces pain, tenderness and stiffness of the joints in rheumatoid arthritis and osteoarthritis within 2-4 hours after administration. The duration of the therapeutic effect of the drug varies greatly and can be 4 or more weeks.
Recommended doses of the drug when injected into large joints – 1-2 ml; in the middle – 0.5-1 ml; in small ones – 0.25-0.5 ml.
In some skin diseases, intradermal administration of the drug directly into the lesion is effective, the dose is 0.2 ml / cm2. The site of the lesion is evenly pricked with a tuberculin syringe and a needle with a diameter of approximately 0.9 mm. The total dose of the drug administered to all injection sites within 1 week should not exceed 1 ml.
Recommended single doses of Betaspan® Depot (with intervals between injections of 1 week): with hard callus – 0.25-0.5 ml (usually 2 injections are effective); with a spur – 0.5 ml; with stiffness of the big toe – 0.5 ml; with a synovial cyst – from 0.25 to 0.5 ml; with tendosynovitis – 0.5 ml; in acute gouty arthritis – from 0.5 to 1 ml. For administration, it is recommended to use a tuberculin syringe with a needle of approximately 1 mm in diameter.
After achieving a therapeutic effect, the maintenance dose is selected by gradually reducing the initial dose by reducing the concentration of betamethasone in the solution, which is administered at appropriate intervals. Continue to reduce the dose until the minimum effective dose is reached.
If a stressful situation (not associated with a disease) occurs or is threatened, it may be necessary to increase the dose of the drug.
Cancellation of the drug after prolonged therapy should be carried out by gradually reducing the dose. Monitoring of the patient’s condition is continued for at least a year after the end of long-term therapy or after the use of the drug in high doses.
Possible side effects
Adverse events, as with the use of other glucocorticosteroids, are due to the dose and duration of the drug. These reactions are usually reversible and can be reduced by dose reduction:
– natremia, increased excretion of potassium, hypokalemic alkalosis, increased excretion of calcium, fluid retention in tissues
– congestive heart failure in patients prone to this disease, arterial hypertension
– muscle weakness, myopathy, loss of muscle mass, aggravation of myasthenic symptoms in severe pseudoparalytic myasthenia gravis, osteoporosis, aseptic necrosis of the femoral head or humerus, pathological fractures of tubular bones, tendon ruptures, joint instability (after multiple injections)
– hiccups, erosive and ulcerative lesions of the gastrointestinal tract with possible subsequent perforation and bleeding, esophageal ulcers, pancreatitis, flatulence
– deterioration of wound healing, skin atrophy, thinning of the skin, petechiae and ecchymosis, facial erythema, excessive sweating, skin reactions such as dermatitis, rash, angioedema
– convulsions, increased intracranial pressure with papilledema (usually after completion of treatment), dizziness, headache, euphoria, mood changes, depression (with severe psychotic reactions), irritability, insomnia
– menstrual irregularities, Cushing’s syndrome, fetal or child growth retardation, impaired glucose tolerance, manifestations of latent diabetes mellitus, increased need for insulin injections or oral antidiabetic agents
– posterior subcapsular cataract, increased intraocular pressure, glaucoma, exophthalmos
– negative nitrogen balance due to protein catabolism, lipomatosis (including mediastinal and epidural lipomatosis, which can lead to neurological complications), weight gain
– anaphylactic reaction or hypersensitivity reaction to the administration of the drug and hypotensive reaction
– visual disturbances accompanying topical application in the area of the face and head, hyper- or hypopigmentation, subcutaneous or cutaneous atrophy, aseptic abscesses, flushing of the face after injection (intra-articular injection) and neurogenic arthropathy
– hypersensitivity to betamethasone, other components of the drug or other glucocorticosteroids
– systemic mycoses
– intramuscular injection in patients with idiopathic thrombocytopenic purpura
– infectious arthritis, unstable joint, injection into the infected skin surface and intervertebral space
– lactation period
The simultaneous use of phenobarbital, rifampicin, phenytoin or ephedrine may accelerate the metabolism of corticosteroids, which will lead to a weakening of the therapeutic effect.
With the simultaneous use of glucocorticosteroids and estrogen, dose adjustment may be necessary (due to the risk of overdose).
The simultaneous use of corticosteroids and diuretics that remove potassium ions can cause hypokalemia.
The combined use of corticosteroids with cardiac glycosides may increase the likelihood of arrhythmias or increase the toxicity of glycosides.
Corticosteroids may increase the excretion of potassium ions caused by amphotericin B. Simultaneous administration of Betaspan® Depot and indirect anticoagulants may lead to a change in the rate of blood clotting, which requires dose adjustment.
The combined action of non-steroidal anti-inflammatory drugs or alcohol with glucocorticosteroids can lead to an increase in the frequency of manifestations or the severity of the course of ulcers of the gastrointestinal tract.
When using corticosteroids, the concentration of salicylates in the blood may decrease.
The simultaneous administration of glucocorticosteroids and somatotropin can lead to a slowdown in the absorption of the latter.
Suspension Betaspan® Depot is not intended for intravenous or subcutaneous administration.
Strict observance of asepsis rules is mandatory when using the drug.
Any administration of the drug (into soft tissues, lesion, intra-articular, etc.) can lead to a systemic effect with a simultaneous pronounced local effect.
With thrombocytopenic purpura intramuscularly, Betaspan® Depot should be administered with extreme caution.
Intramuscular injections of glucocorticosteroids must be injected deep into the muscle to prevent local tissue atrophy.
Intra-articular injections should only be carried out by medical personnel. An analysis of the intra-articular fluid should be carried out to exclude a septic process. Do not administer the drug in the presence of an intra-articular infection. A noticeable increase in pain, swelling, an increase in the temperature of the surrounding tissues and a further restriction of joint mobility indicate septic arthritis. When confirming the diagnosis, it is necessary to prescribe antibiotic therapy.
Glucocorticosteroids should not be injected into an unstable joint, infected areas and intervertebral spaces. Repeated injections into a joint for osteoarthritis may increase the risk of joint destruction. After successful intra-articular therapy, the patient should avoid overloading the joint.
With caution, the drug should be used in patients with hypothyroidism or cirrhosis of the liver, with herpetic eye damage (due to the possibility of corneal perforation); with nonspecific ulcerative colitis, with the threat of perforation, with an abscess or other pustular infections, as well as with diverticulitis, recently formed intestinal anastomoses, active or latent gastric and duodenal ulcers, renal failure, arterial hypertension, osteoporosis, myasthenia gravis.
Against the background of the use of the drug, mental disorders are possible (especially in patients with emotional instability or a tendency to psychosis).
In the treatment of patients with diabetes mellitus, correction of hypoglycemic therapy may be necessary.
Patients receiving glucocorticosteroids should not be vaccinated against smallpox. Other immunizations should not be performed in patients who receive corticosteroids (especially in high doses), due to the risk of developing neurological complications and a low immune response (lack of antibody formation). When carrying out replacement therapy (for example, with primary insufficiency of the adrenal cortex), immunization is possible.
Patients receiving Betaspan® Depot at doses that depress the immune system should avoid contact with patients with chickenpox and measles. When using the drug, it must be taken into account that glucocorticosteroids can mask the signs of an infectious disease, as well as reduce the body’s resistance.
The appointment of the drug in active tuberculosis is possible only in cases of transient or disseminated tuberculosis in combination with adequate anti-tuberculosis therapy. Patients with latent TB or those who test positive for tuberculin should first discuss prophylactic anti-TB therapy with their doctor.
Long-term use of glucocorticosteroids can lead to the development of 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). It is necessary to periodically undergo an ophthalmological examination, especially for patients who receive Betaspan® Depot for more than 6 months.
With an increase in blood pressure, fluid retention and sodium chloride in the tissues and an increase in the excretion of potassium from the body (which may be manifested by edema, abnormalities in the work of the heart), a diet with restriction of kitchen salt and additional intake of preparations containing potassium are recommended.
With caution, acetylsalicylic acid should be taken in combination with the drug for hypoprothrombinemia due to a possible increase in bleeding.
It is also necessary to remember the possibility of developing secondary adrenal insufficiency within a few months after the end of therapy. If a stressful situation occurs or threatens to occur during this period, treatment with Betaspan® Depot should be resumed.
When using glucocorticosteroids, changes in motility and sperm count are possible.
Incompatibility. The drug can be mixed in one syringe with local anesthetics (see section “Method of application and doses”); however, compatibility must always be monitored.
Application in pediatrics
There is not enough clinical data on the use of the drug in children, so it is undesirable to use it in patients of this age group (growth retardation and the development of secondary adrenal insufficiency are possible).
Use during pregnancy or lactation
Due to the lack of controlled studies on the safety of the drug in pregnant women, it should be prescribed after a thorough assessment of the ratio of benefits to the mother and the potential risk to the fetus / child. Children born to mothers who received therapeutic doses of corticosteroids during pregnancy should be under medical supervision (for early detection of signs of adrenal insufficiency).
If it is necessary to prescribe Betaspan® Depot during lactation, the issue of stopping breastfeeding should be considered, taking into account the importance of therapy for the mother (due to possible undesirable side effects in children).
Features of the effect of the drug on the ability to drive vehicles and potentially dangerous mechanisms
Usually Betaspan® Depot does not affect the patient’s reaction rate when driving vehicles or working with other mechanisms.
However, in isolated cases, muscle weakness, convulsions, visual disturbances, dizziness, headache, mood changes, depression (with severe psychotic reactions), irritability may occur, so it is recommended to refrain from driving vehicles or working with other mechanisms during drug treatment.
Acute overdose of betamethasone does not create life-threatening situations. The introduction of high doses of glucocorticosteroids over several days does not lead to undesirable consequences (with the exception of cases of very high doses or in case of use in diabetes mellitus, glaucoma, exacerbation of erosive and ulcerative lesions of the gastrointestinal tract, or patients who simultaneously receive therapy with digitalis preparations, indirect anticoagulants or diuretics, which remove potassium).
Treatment. Careful medical monitoring of the patient’s condition is necessary. It is necessary to maintain optimal fluid intake and control the content of electrolytes in plasma and urine (especially the balance in the body of sodium and potassium). If an imbalance of these ions is detected, appropriate therapy should be carried out.
Store in original packaging at a temperature not exceeding 25 °C. Do not freeze.
Keep out of the reach of children!
Shelf life – 2 years
Do not use the drug after the expiration date.