1 ml of suspension contains
- active ingredients: betamethasone dipropionate 6.43 mg (equivalent to 5.00 mg betamethasone), betamethasone sodium phosphate 2.63 mg (equivalent to 2.00 mg betamethasone)
- excipients: sodium hydrogen phosphate dihydrate, sodium chloride, disodium edetate, polysorbate 80, benzyl alcohol, methyl parahydroxybenzoate, propyl parahydroxybenzoate, sodium carboxymethylcellulose, macrogol, hydrochloric acid, water for injection
Betamethasone sodium phosphate is a highly soluble component that is rapidly absorbed from the injection site, providing a rapid onset of therapeutic action. Betamethasone dipropionate is a poorly soluble component that is slowly absorbed from the depot that forms at the injection site and determines the long-lasting effect of the drug.
Plasma protein binding – 62.5%. Metabolized in the liver. It is excreted mainly by the kidneys, a small part – with bile.
Diprospan® has high glucocorticosteroid activity and insignificant mineralocorticosteroid activity.
In addition, the drug regulates carbon homeostasis and water-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 injections directly into the lesion.
Indications for use
˗ rheumatoid arthritis, osteoarthritis, bursitis, tenosynovitis, ankylosing spondylitis, radiculitis, coccydynia, sciatica, lumbago, torticollis, ganglion cyst, exostosis, fasciitis, severe gout
˗ bronchial asthma (including in complex therapy of status asthmaticus), hay fever, angioedema, allergic bronchitis, seasonal or year-round allergic rhinitis, drug allergies, serum sickness, reactions to insect bites
˗ atopic dermatitis (coin-shaped eczema), neurodermatitis, contact dermatitis, severe solar dermatitis, lichen planus, insulin lipodystrophy, alopecia areata, discoid erythematous lupus, psoriasis, keloid scars, pemphigus vulgaris, herpetic dermatitis, cystic acne
˗ systemic lupus erythematosus, scleroderma, dermatomyositis, periarteritis nodosa
˗ palliative therapy of leukemia and lymphomas in adults, acute leukemia in children
˗ adrenogenital syndrome, hemorrhagic proctocolitis, Crohn’s disease, sprue, corticosteroid-dependent blood diseases, nephritis, nephrotic syndrome
˗ primary and secondary insufficiency of the adrenal cortex (with mandatory simultaneous administration of mineralocorticosteroids)
Directions for use and doses
Diprospan® is recommended to be administered intramuscularly if there is a need for systemic intake of a glucocorticosteroid into the body or directly into the affected soft tissue, in the form of intra-articular and periarticular injections for arthritis, in the form of intradermal injections for a variety of skin diseases, in the form of local injections into the lesion for some foot diseases.
The dosage regimen and route of administration are set individually, depending on the indications, severity of the disease and the patient’s response to treatment. The dose should be minimal, the period of use should be as short as possible.
The dose should be adjusted to obtain a satisfactory clinical effect. If there is no satisfactory clinical effect, Diprospan® should be discontinued and alternative therapeutic tactics should be chosen.
For systemic therapy, the initial dose of Diprospan® in most cases is 1-2 ml. The administration is repeated if necessary, depending on the patient’s condition. The drug is administered deeply intramuscularly into the gluteal region. Dosages and frequency of administration are selected individually, taking into account the severity of the patient’s condition and therapeutic response:
˗ in severe conditions (lupus erythematosus and status asthmaticus) requiring emergency measures, the initial dose of the drug can be 2 ml
˗ for dermatological diseases , as a rule, 1 ml of the drug is sufficient
˗ for diseases of the respiratory system, the effect of Diprospan® begins within several hours after intramuscular injection of the drug. For bronchial asthma, hay fever, allergic bronchitis and allergic rhinitis, a significant improvement in the condition is achieved after administration of 1-2 ml of the drug
˗ for acute and chronic bursitis, the initial dose for intramuscular administration is 1-2 ml of the drug. If necessary, carry out several repeated injections.
When administered locally, simultaneous use of a local anesthetic drug is necessary only in isolated cases. When administering an anesthetic at the same time, Diprospan® can be mixed with a 1% or 2% solution of procaine hydrochloride or lidocaine (in a syringe, not in a bottle), using dosage forms that do not contain parabens. Similar local anesthetics may also be used. The use of anesthetics that contain methylparaben, propylparaben, phenol and other similar substances is not permitted. When using an anesthetic in combination with the drug Diprospan®, first draw the required dose of the drug into a syringe from the bottle, then draw the required amount of local anesthetic from the ampoule into the same syringe and shake for a short period of time.
For acute bursitis (subdeltoid, subscapular, ulnar and prepatellar), injection of 1-2 ml of Diprospan® into the synovial bursa can relieve pain and completely restore mobility within 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 tenosynovitis, tendinitis and peritendinitis, one injection of Diprospan® alleviates the patient’s condition; in chronic cases , the injection of the drug should be repeated depending on the reaction. It is necessary to avoid injecting the drug directly into the tendon.
Intra-articular administration of the drug in a dose of 0.5-2.0 ml reduces pain, tenderness and stiffness of joints in rheumatoid arthritis and osteoarthritis within 2-4 hours after administration. The duration of the therapeutic effect of the drug varies significantly and can be 4 or more weeks.
Recommended doses of the drug when administered to large joints (knee, hip, shoulder) are 1-2 ml; in the middle (elbow, wrist, ankle) – 0.5-1 ml; in small areas (foot, hand, chest) – 0.25-0.5 ml.
For some skin diseases , intradermal injection of the drug directly into the lesion is effective , the dose is 0.2 ml/cm2. The affected area is evenly pricked using a tuberculin syringe and needle. The total dose of the drug administered to all injection sites within 1 week should not exceed 1 ml.
Recommended single doses of Diprospan® (once a week):
˗ for hard calluses – 0.25-0.5 ml (as a rule, 2 injections are effective)
˗ for spur – 0.5 ml
˗ for stiffness of the big toe – 0.5 ml
˗ for synovial cyst – from 0.25 to 0.5 ml; for tenosynovitis – 0.5 ml
˗ for acute gouty arthritis – from 0.5 to 1 ml.
For administration, it is recommended to use a tuberculin syringe with a needle.
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 certain intervals. The dose reduction is continued until the minimum effective dose is reached.
If a stressful situation occurs or threatens to occur (which is not related to the disease), it may be necessary to increase the dose of the drug.
Discontinuation of the drug after long-term therapy should be carried out by gradually reducing the dose. The patient’s condition is monitored for at least a year after the end of long-term therapy or after using the drug in high doses.
Adverse events, as with the use of other glucocorticosteroids, are determined by the dose and duration of use of the drug. These reactions are usually reversible and can be reduced by reducing the dose:
– natremia, increased potassium excretion, hypokalemic alkalosis, fluid retention in tissues, congestive heart failure in patients predisposed to this disease, arterial hypertension
– muscle weakness, myopathy, loss of muscle mass, worsening of myasthenic symptoms in pseudoparalytic myasthenia gravis, osteoporosis, vertebral compression fracture, aseptic necrosis of the femoral or humeral head, pathological fractures of long bones, tendon ruptures, joint instability (after multiple injections)
– hiccups, peptic ulcer with possible subsequent perforation and bleeding, pancreatitis, flatulence, ulcerative esophagitis
– impaired wound healing, skin atrophy, skin thinning, petechiae and ecchymoses, facial erythema, increased sweating, decreased sensitivity of skin tests, dermatitis, rash, angioedema
– convulsions, increased intracranial pressure with papilledema (usually at the end of treatment), dizziness, headache
– menstrual irregularities, Cushing’s syndrome, delayed fetal development or child growth, secondary adrenocortical and pituitary immunological tolerance (especially during stress due to injury, surgery, illness), impaired glucose tolerance, manifestations of latent diabetes mellitus, increased need for injections insulin or oral antidiabetic agents
– posterior subcapsular cataract, increased intraocular pressure, glaucoma, exophthalmos
– negative nitrogen balance (due to protein catabolism)
– euphoria, mood changes, severe depression up to its open manifestations (psychosis), personality changes, insomnia
– anaphylactic, hypersensitive, hypotensive or shock-like reactions to drug administration
– isolated cases of visual impairment, including blindness, which accompany local application in the face and head, hyper- or hypopigmentation, subcutaneous and cutaneous atrophy, aseptic abscesses, post-injection inflammatory hyperemia (after intra-articular administration) and neurogenic arthropathy, similar to Charcot’s disease
˗ hypersensitivity to betamethasone, other components of the drug or other glucocorticosteroids
˗ systemic mycoses
˗ lactation period
˗ children under 3 years of age
˗ with intra-articular injection: unstable joint, infectious arthritis
˗ Diprospan® is not administered intramuscularly to patients with idiopathic or thrombocytopenic purpura
Concomitant use of phenobarbital, rifampicin, phenytoin or ephedrine may increase the metabolism of the drug, thereby reducing its therapeutic activity.
With the simultaneous use of glucocorticosteroids and estrogens, dose adjustment of the drug may be necessary (due to the risk of overdose).
Concomitant use of corticosteroids with diuretics can lead to hypokalemia. The simultaneous use of glucocorticosteroids and cardiac glycosides increases the risk of arrhythmia or digitalis intoxication due to hypokalemia. Corticosteroids may increase potassium loss caused by amphotericin B. Serum electrolyte levels, especially potassium, should be carefully monitored in all patients taking any of these drug combinations.
Concomitant use of corticosteroids and coumarin anticoagulants may increase or decrease the anticoagulant effects, which may require dose adjustment.
With the combined use of glucocorticosteroids with non-steroidal anti-inflammatory drugs or alcohol, an increase in the incidence or intensity of erosive and ulcerative lesions of the gastrointestinal tract (GIT) is possible.
Concomitant use of glucocorticosteroids may reduce the concentration of salicylates in the blood plasma. Acetylsalicylic acid should be administered with caution in combination with corticosteroids for hypoprothrombinemia.
Dose adjustment of the antidiabetic drug may be required when corticosteroids are prescribed to patients with diabetes mellitus.
Concomitant administration of glucocorticosteroids may suppress the response to growth hormone.
Corticosteroids may interfere with the nitroblue tetrazolium test for bacterial infections and cause false negative results.
Diprospan® suspension is not intended for intravenous or subcutaneous administration.
Strict adherence to aseptic rules is mandatory when using the drug.
Intramuscular corticosteroid injections must be administered deep into the muscle to prevent local soft tissue atrophy.
Any administration of the drug (soft tissue, lesion, intra-articular, etc.) can lead to systemic action with simultaneous pronounced local action.
Intra-articular injections should only be performed by qualified medical personnel. Analysis should be carried out
intra-articular fluid to exclude a septic process. Do not administer the drug if there is an intra-articular infection. A noticeable increase in pain, swelling, increased temperature of the surrounding tissues and further limitation of joint mobility indicate septic arthritis. Once the diagnosis is confirmed, antibacterial therapy must be prescribed.
Corticosteroids should not be injected into unstable joints, infected areas, or 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.
Since rare cases of anaphylactoid reactions have occurred in patients receiving corticosteroid therapy, appropriate precautions should be taken before administering the drug, especially if the patient has a history of allergic reactions to drug administration.
When prescribing a long course of corticosteroid therapy, the potential benefit and risk of drug administration should be weighed and the possibility of switching from parenteral to oral administration should be considered.
Dosage adjustments may be necessary if the disease process improves or worsens, the patient’s individual response to therapy, or the patient’s exposure to emotional or physical stress such as serious infection, surgery, or trauma. After stopping long-term or high-dose corticosteroid therapy, medical supervision may be required for 1 year after completion of therapy.
When using the drug, it should be taken into account that corticosteroids can mask the signs of an infectious disease and also reduce the body’s resistance.
Long-term use of corticosteroids 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 secondary eye infections (fungal or viral). It is necessary to periodically undergo an ophthalmological examination, especially for patients receiving Diprospan® for more than 6 weeks.
Medium and high doses of corticosteroids can increase blood pressure, promote fluid and sodium chloride retention in tissues and increase potassium excretion from the body (which can be manifested by edema, cardiac dysfunction); A diet with limited dietary salt and additional intake of medications containing potassium are recommended. The occurrence of such manifestations is unlikely/less likely with the use of synthetic derivatives, unless they are used in high doses. All corticosteroids increase calcium excretion.
Patients receiving corticosteroids should not receive the smallpox vaccine. Other immunizations should not be performed during treatment with corticosteroids (especially in high doses), given the risk of neurological complications and the low immune response (lack of antibody formation). When carrying out replacement therapy (for example, with primary adrenal insufficiency), immunization is possible.
Patients who receive Diprospan® in doses that suppress the immune system should avoid contact with patients with chickenpox and measles (this is especially important when prescribing the drug to children).
Prescribing the drug for active tuberculosis is possible only in cases of fulminant or disseminated tuberculosis in combination with adequate anti-tuberculosis therapy. For patients with latent tuberculosis or with a positive reaction to tuberculin, it is necessary to decide on preventive anti-tuberculosis therapy before starting treatment with Diprospan®. It should be taken into account that rifampin increases the metabolism of hepatic clearance of corticosteroids and dosage adjustment of corticosteroids may be required.
The lowest possible dose of the drug should be prescribed. If necessary, it is possible to reduce the dose of the drug, which should be gradual.
Stopping corticosteroids too quickly may result in drug-induced secondary adrenocortical insufficiency, which can be minimized by gradual dosage reduction. It is also necessary to remember about the possibility of developing secondary adrenal insufficiency within several months after the end of therapy. If a stressful situation occurs or threatens to occur during this period, treatment with Diprospan® should be resumed. If the patient has already been prescribed therapy, the dose of drugs can be increased. The secretion of mineralocorticosteroids may deteriorate, so salt and/or mineralocorticosteroids should be prescribed simultaneously.
Use the drug with caution in patients with hypothyroidism or cirrhosis of the liver, in patients with herpetic eye lesions (due to the risk of corneal perforation).
When treated with the drug, patients with diabetes mellitus may require adjustment of their glucose-lowering therapy.
While using the drug Diprospan®, mental disorders are possible (especially in patients with emotional instability or a tendency to psychosis).
Corticosteroids should be prescribed with caution in case of nonspecific ulcerative colitis, threat of perforation, abscess or other pustular infections, as well as diverticulitis, fresh intestinal anastomoses, active or latent gastric and duodenal ulcers, renal failure, arterial hypertension, osteoporosis, myasthenia gravis, glaucoma , acute psychosis, viral and bacterial infections, growth retardation, tuberculosis, Cushing’s syndrome, diabetes mellitus, heart failure, intractable epilepsy, tendency to thromboembolism or thrombophlebitis and pregnancy.
With the use of glucocorticosteroids, changes in sperm motility and number are possible.
Since the complications of glucocorticosteroid therapy depend on the dose, course and duration of therapy, the assessment of the benefit/risk ratio is decided individually for each patient.
Serious neurological reactions (sometimes fatal) have been reported with epidural corticosteroid injections. Specific reactions have also been reported and include (but are not limited to): spinal cord infarction, paraplegia, quadriplegia, cortical blindness, and stroke. These serious neurological reactions have been reported regardless of fluoroscopic examination. The safety and effectiveness of epidural corticosteroids have not been established and such use of corticosteroids is not recommended.
Application in pediatric practice
Because corticosteroids can slow growth in neonates and children and inhibit endogenous corticosteroid production, careful monitoring of growth and development is necessary if treatment is prolonged.
Pregnancy and lactation
Due to the lack of controlled studies on the safety of the drug in pregnant women, it should be prescribed only when absolutely necessary, after a careful assessment of the benefit/risk ratio for the mother and for the fetus/child. Children born to mothers who received significant doses of corticosteroids during pregnancy require careful medical monitoring (for early detection of signs of adrenal insufficiency).
If it is necessary to prescribe the drug Diprospan during lactation, the issue of stopping breastfeeding should be decided, taking into account the importance of therapy for the mother (due to possible unwanted side effects in children).
Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms
As a rule, Diprospan® does not affect the speed of reaction when driving vehicles or working with complex mechanisms. However, in isolated cases, muscle weakness, convulsions, visual disturbances, dizziness, headache, mood changes, depression (with severe psychotic reactions), increased irritability may occur, therefore it is recommended to refrain from driving vehicles or working with complex mechanisms during treatment with the drug.
Symptoms: acute overdose of betamethasone does not create life-threatening situations. Administration of high doses of glucocorticosteroids for several days does not lead to undesirable consequences (except for cases of very high doses or in the case of diabetes mellitus, glaucoma, exacerbation of erosive and ulcerative lesions of the gastrointestinal tract or in patients who are simultaneously undergoing therapy with digitalis, indirect anticoagulants or diuretics).
Treatment: careful medical monitoring of the patient’s condition is necessary. It is necessary to maintain optimal fluid intake and monitor the electrolyte composition of blood plasma and urine (especially the balance of sodium and potassium in the body). If an imbalance of these ions is detected, appropriate therapy must be carried out.
Store at temperatures between 2 °C and 25 °C, protected from light.
Do not freeze.
Keep out of the reach of children.
Shelf life – 2 years
Do not use after the expiration date