Diprospan injection solution ampoules 1 ml 1 pc
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Active ingredients
Release form
Composition
on 1 ml:
Active substances:
- betamethasone sodium phosphate 2.63 mg,
- betamethasone dipropionate 6.43 mg.
Excipients: sodium hydrophosphate dihydrate, sodium chloride, disodium edetate, polysorbate 80 (polyoxyethylene sorbitan monooleate), benzyl alcohol, methyl parahydroxybenzoate, propyl parahydroxybenzoate, carmellose sodium, macrogol (polyethylene glycol), a hydrogen chloride, macrogol (polyethylene glycol), and a hydrochloric benzoate, propyl parahydroxybenzoate, sodium hydrochloride, macrogol (polyethylene glycol), hydrochloride benzoate, propyl parahydroxybenzoate;
Pharmacological effect
Pharmacokinetics
Absorption and distribution:
Betamethasone sodium phosphate is highly soluble and, after i / m administration, is rapidly hydrolyzed and absorbed almost immediately from the site of administration, which ensures a rapid onset of therapeutic action. Almost completely eliminated within one day after administration.
Betamethasone dipropionate is slowly absorbed from the depot, is gradually metabolized, which causes a long-lasting effect of the drug, and is eliminated for more than 10 days.
Binding of betamaton with plasma proteins is 62.5%.
Metabolism and excretion:
Metabolized in the liver to form mainly inactive metabolites. Excreted mainly by the kidneys.
Indications
Treatment of conditions and diseases in which GCS therapy allows to achieve an adequate clinical effect (it must be taken into account that in some diseases GCS therapy is additional and does not replace the standard therapy):
- - diseases of the musculoskeletal system and soft tissues, incl. rheumatoid arthritis, osteoarthritis, bursitis, ankylosing spondylitis, epicondylitis, sciatica, coccygodynia, sciatica, lumbago, torticollis, ganglion cyst, exostosis, fasciitis, foot diseases;
- - allergic diseases, incl. bronchial asthma, hay fever (pollinosis), allergic bronchitis, seasonal or year-round rhinitis, drug allergy, serum sickness, reactions to insect bites;
- - dermatological diseases, incl.atopic dermatitis, monet-like eczema, neurodermatitis, contact dermatitis, pronounced photodermatitis, urticaria, lichen planus, insulin lipodystrophy, alopecia alopecia, discoid lupus erythematosus, psoriasis, keloid scars, rhythmic heart disease, herpetic dermatitis, herpes lupus erythematosus, psoriasis, celloid scars, rhythmic heart disease, herpes lupus erythematosus, psoriasis
- - Systemic diseases of the connective tissue, including systemic lupus erythematosus, scleroderma, dermatomyositis, periarteritis nodosa;
- - hemoblastosis (palliative therapy of leukemia and lymphomas in adults, acute leukemia in children);
- - primary or secondary insufficiency of the adrenal cortex (with mandatory simultaneous use of mineralocorticoids);
- - other diseases and pathological conditions requiring treatment with systemic corticosteroids (adrenogenital syndrome, ulcerative colitis, regional ileitis, malabsorption syndrome, lesions of the eye mucosa, if necessary, injecting the drug into the conjunctival sac, pathological changes in the blood when using GCS, nephritis, nephrotic syndrome).
Contraindications
- - systemic mycoses;
- - in / in or p / to the introduction;
- - for intraarticular injection: unstable joint, infectious arthritis;
- - introduction to infected surfaces and intervertebral space;
- - children's age up to 3 years (the presence of benzyl alcohol in the composition);
- - hypersensitivity to the drug;
- - hypersensitivity to other corticosteroids.
Carefully:
- Parasitic and infectious diseases of a viral, fungal or bacterial nature (currently or recently transferred, including recent contact with a patient) - herpes simplex, herpes zoster (viremic phase), chicken pox, measles; amebiasis, strongyloidiasis (established or suspected);
- systemic mycosis;
- active and latent tuberculosis.
- Use in severe infectious diseases is permissible only against the background of specific therapy.
- Post-vaccination period (a period of 8 weeks before and 2 weeks after vaccination), lymphadenitis after BCG vaccination. Immunodeficiency states (including AIDS or HIV infection).
- Diseases of the digestive tract:
- gastric ulcer and duodenal ulcer,
- esophagitis,
- gastritis,
- acute or latent peptic ulcer,
- newly created intestinal anastomosis,
- ulcerative colitis with the threat of perforation or abscess formation
- diverticulitis,
- abscess or other purulent infections.
- Diseases of the cardiovascular system, incl. recent myocardial infarction (in patients with acute and subacute myocardial infarction, the focus of necrosis may spread, slowing the formation of scar tissue and consequently the rupture of the heart muscle),
- decompensated chronic heart failure,
- arterial hypertension, hyperlipidemia).
- Endocrine diseases - diabetes mellitus (including impaired carbohydrate tolerance), thyrotoxicosis, hypothyroidism, Itsenko-Cushing's disease.
- Severe chronic renal and / or liver failure, nephroluritiasis, cirrhosis of the liver.
- Thrombocytopenic purpura (intramuscular injection).
- Hypoalbuminemia and conditions predisposing to its occurrence.
- Systemic osteoporosis
- myasthenia
- acute psychosis
- obesity III-IV degree
- poliomyelitis (with the exception of the form of bulbar encephalitis),
- open and closed angle glaucoma,
- eye diseases caused by herpes simplex (due to the risk of corneal perforation),
- pregnancy,
- lactation period.
For intraarticular administration:
- the overall serious condition of the patient
- inefficiency (or short duration) of the action of 2 previous introductions (taking into account the individual properties of the applied GCS).
Use during pregnancy and lactation
Due to the lack of controlled studies of the safety of the drug Diprospan: during pregnancy, if necessary, the prescription of the drug to pregnant women or women of childbearing age requires a preliminary assessment of the intended use of therapy for the mother and the potential risk to the fetus.
Newborns whose mothers received therapeutic doses of GCS during pregnancy should be under medical supervision (for early detection of signs of adrenal insufficiency).
If necessary, the appointment of the drug Diprospan; during lactation, the issue of discontinuing breastfeeding should be resolved, taking into account the importance of therapy for the mother (due to possible side effects in children).
Dosage and administration
Diprospan is applied for
- intramuscular
- intra-articular,
- periarticular,
- Intrabursalnogo
- intracutaneous,
- interstitial
- and intrafocal introduction.
The insignificant size of betamethasone dipropionate crystals allows the use of needles of small diameter (up to 26 gauge) for intracutaneous administration and administration directly into the lesion.
The drug is not intended for intravenous and subcutaneous administration.
Diprospan drug injections should be carried out in strict compliance with the rules of asepsis.
The dosage regimen and method of administration are set individually, depending on the indications, the severity of the disease and the patient's response.
With systemic use, the initial dose of Diprospan in most cases is 1-2 ml. The introduction is repeated as necessary, depending on the condition of the patient.
Intramuscular administration: Diprospan should be administered deep intramuscularly, while choosing large muscles and avoiding contact with other tissues (to prevent tissue atrophy).
In severe conditions requiring emergency treatment, the initial dose is 2 ml.
In case of various dermatological diseases, as a rule, the administration of 1 ml of Diprospan suspension is sufficient.
In diseases of the respiratory system, the onset of action of the drug occurs within a few hours after the intramuscular injection of the suspension.
In case of bronchial asthma, hay fever, allergic bronchitis and allergic rhinitis, a significant improvement is achieved after the administration of 1-2 ml of Diprospan.
In acute and chronic bursitis, the initial dose for intramuscular injection is 1-2 ml of suspension. If necessary, carry out several repeated injections.
If a satisfactory clinical response does not occur after a certain period of time, Diprospan should be canceled and another therapy prescribed.
Topical administration: For topical administration, the simultaneous use of a local anesthetic preparation is necessary only in rare cases. If it is required, then use 1% or 2% solutions of procain hydrochloride or lidocaine, which do not contain methyl paraben, propyl paraben, phenol and other similar substances. In this case, mixing is carried out in a syringe, first dialing the required dose of Diprospan suspension into a syringe from a vial. Then, in the same syringe, the required amount of local anesthetic is collected from the ampoule and shaken for a short time.
In case of acute bursitis (subdeltoid, subscapularis, elbow, and pre-knee), the introduction of 1-2 ml of suspension into the synovial bag relieves pain and restores joint mobility for several hours. After relief of exacerbation in chronic bursitis, use smaller doses of the drug.
In acute tenosynovitis, tendinitis, and perienendinitis, a single injection of Diprospan improves the patient's condition; in chronic cases, the injection is repeated depending on the response of the patient. The introduction of the drug directly into the tendon should be avoided.
Intra-articular administration of the drug Diprospan; at a dose of 0.5-2 ml relieves pain, limiting the mobility of joints in rheumatoid arthritis and osteoarthritis within 2-4 hours after administration. The duration of the therapeutic effect varies considerably and can be 4 weeks or more.
Recommended doses of the drug when administered in large joints range from 1 to 2 ml; in the middle joints - 0.5-1 ml; in small joints - 0.25-0.5 ml.
In some dermatological diseases, intradermal administration of the drug Diprospan is effective; directly to the lesion, the dose is 0.2 ml / cm2. The lesion is evenly cut off using a tuberculin syringe and needle with a diameter of about 0.9 mm. The total amount of the administered drug in all areas should not exceed 1 ml for 1 week. A tuberculin syringe with a 26 gauge needle is recommended for insertion into the lesion.
Recommended single doses of the drug (with an interval of 1 week)
- in case of bursitis: in the presence of an antiglomeration of 0.25-0.5 ml (usually 2 injections are effective),
- with a spur - 0.5 ml,
- with limited mobility of the big toe - 0.5 ml,
- with a synovial cyst - 0.25-0.5 ml,
- with tendosynovit - 0.5 ml,
- in acute gouty arthritis - 0.5-1 ml.
For most injections, a tuberculin syringe with a 25 gauge needle is suitable.
After reaching the therapeutic effect, the maintenance dose is selected by gradually reducing the dose of the drug Diprospan, which is carried out at intervals. The reduction is continued until the minimum effective dose is reached.
If a stressful situation (not related to the disease) arises or is threatened, it may be necessary to increase the dose of Diprospan.
The abolition of the drug after long-term 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.
Side effects
Metabolism:
- hypernatremia,
- increased excretion of potassium,
- 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.
Since the cardiovascular system:
- chronic heart failure (in predisposed patients),
- increase in blood pressure.
From the musculoskeletal system:
- muscle weakness
- steroid myopathy
- loss of muscle mass
- increased myasthenic symptoms in severe pseudo-paralytic myasthenia,
- osteoporosis,
- spinal compression fracture,
- aseptic necrosis of the femoral head or humerus,
- pathological fractures of tubular bones, tendon ruptures,
- joint instability (with repeated intraarticular injections).
From the digestive system:
- erosive and ulcerative lesions of the gastrointestinal tract with possible subsequent perforation and bleeding,
- pancreatitis,
- flatulence,
- hiccups
Dermatological reactions:
- impaired wound healing
- atrophy and thinning of the skin,
- petechiae
- ecchymosis,
- excessive sweating
- dermatitis,
- steroid acne,
- striae
- propensity to develop pyoderma and candidiasis,
- decrease in reaction during skin tests.
From the side of the central nervous system and peripheral nervous system:
- convulsions
- increase in intracranial pressure with swelling of the optic nerve head (usually at the end of therapy) dizziness
- headache,
- euphoria,
- mood changes
- depression (with severe psychotic reactions),
- personality disorders
- irritability,
- insomnia.
On the part of the endocrine system:
- violation of the menstrual cycle,
- secondary adrenal insufficiency (especially in the period of stress in case of illness, injury, surgery),
- Itsenko-Cushing syndrome
- reduction of carbohydrate tolerance,
- steroid diabetes mellitus or manifestation of latent diabetes mellitus,
- increased need for insulin or oral hypoglycemic drugs,
- violation of intrauterine development,
- growth retardation and sexual development in children.
On the part of the organ of vision:
- rear subcapsular cataract,
- increased intraocular pressure
- glaucoma,
- exophthalmos;
- in rare cases - blindness (with the introduction of the drug in the face and head).
Allergic reactions:
- anaphylactic reactions,
- shock,
- angioedema,
- arterial hypotension.
Local reactions:
- rarely hyper or hypopigmentation,
- subcutaneous and skin atrophy,
- aseptic abscesses.
Other:
- blood rush to the face after injection (or intraarticular injection),
- neurogenic arthropathy.
The frequency of development and severity of side effects, as with the use of other GCS, depend on the size of the applied dose and the duration of the drug. These phenomena are usually reversible and can be eliminated or reduced by lowering the dose.
Overdose
Symptoms: acute overdose of betamethasone does not lead to life-threatening situations. The administration of GCS in high doses over several days does not lead to undesirable consequences, except for cases when very high doses are used or when used for diabetes mellitus, glaucoma, exacerbation of erosive-ulcerative lesions of the gastrointestinal tract or with simultaneous use of digitalis, indirect anticoagulants or potassium-releasing diuretics.
Treatment: careful medical monitoring of the patient’s condition is required. Optimum fluid intake should be maintained and the electrolyte content in plasma and urine should be controlled, especially the ratio of sodium and potassium ions. If necessary, appropriate therapy should be carried out.
Interaction with other drugs
With the simultaneous appointment of the drug Diprospan with phenobarbital, rifampin, phenytoin or ephedrine, it is possible to accelerate the metabolism of betamethasone while reducing its therapeutic activity.
When combined use of the drug Diprospan and indirect anticoagulants may change blood clotting, requiring dose adjustment.
With the joint use of the drug Diprospan; and potassium-diuretic increases the likelihood of hypokalemia.
Diprospan can increase the excretion of potassium caused by amphotericin B.
With the simultaneous use of corticosteroids and estrogens, it may be necessary to adjust the dose of drugs (due to the risk of overdose).
The simultaneous use of GCS and cardiac glycosides increases the risk of arrhythmias or digitalis intoxication (due to hypokalemia).
With the combined use of GCS with NSAIDs, with ethanol or ethanol-containing drugs, it is possible to increase the frequency of appearance or intensity of erosive and ulcerative lesions of the gastrointestinal tract.
When combined use of GCS can reduce the concentration of salicylates in the blood plasma.
Simultaneous administration of GCS and somatotropin may slow down the absorption of the latter (administration of betamethasone in doses exceeding 0.3-0.45 mg / m2 of body surface / day should be avoided).
GCS can affect the nitric blue tetrazole test for bacterial infection and cause a false negative result.
special instructions
The dosage regimen and method of administration are set individually, depending on the indications, the severity of the disease and the patient's response.
The drug should be used in the minimum effective dose, the period of use should be as short as possible.
The initial dose is selected until the desired therapeutic effect is achieved. If after a sufficient period of time the therapeutic effect is not observed, the drug is discontinued by gradually lowering the dose of the drug and another appropriate treatment method is selected.
After reaching the therapeutic effect, the maintenance dose is selected by gradually reducing the dose of betamethasone, which is administered at appropriate intervals. The reduction is continued until the minimum effective dose is reached.
If a stressful situation (not related to the disease) arises or is threatened, it may be necessary to increase the dose of Diprospan.
The abolition of the drug after long-term 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.
The introduction of the drug in the soft tissue, in the lesion and in the joint can, with pronounced local action, simultaneously lead to systemic action.
Given the likelihood of anaphylactoid reactions when parenteral GCS, the necessary precautions should be taken before the introduction of the drug, especially if there are indications in the history of allergic reactions to drugs.
Diprospan contains two active substances - betamethasone compounds, one of which, betamethasone sodium phosphate, is an instant soluble fraction and therefore quickly penetrates the systemic circulation. Should take into account the possible systemic effects of the drug.
Against the background of the use of the drug Diprospan, mental disorders are possible, especially in patients with emotional instability or a tendency to psychosis.
When prescribing Diprospan to patients with diabetes mellitus, correction of hypoglycemic therapy may be required.
Patients receiving diprospan; in doses that suppress immunity, should be warned about the need to avoid contact with patients with chickenpox and measles (it is especially important when prescribing the drug to children).
When using the drug Diprospan it should be borne in mind that GCS can mask the signs of an infectious disease, as well as reduce the body's resistance to infections.
Appointment of Diprospan with active tuberculosis is possible only in cases of fulminant or disseminated tuberculosis in combination with adequate anti-tuberculosis therapy. When prescribing Diprospana to patients with latent tuberculosis or with a positive reaction to tuberculin, the issue of prophylactic anti-tuberculosis therapy should be resolved. With prophylactic use of rifampin, an increase in hepatic clearance of betamethasone should be considered (dose adjustment may be required).
In the presence of fluid in the articular cavity, a septic process should be excluded.
A marked increase in soreness, swelling, increased temperature of the surrounding tissues and a further restriction of joint mobility indicate infectious arthritis. When confirming the diagnosis, it is necessary to prescribe antibiotic therapy.
Repeated injections into a joint with osteoarthritis may increase the risk of joint destruction. The introduction of GCS into the tendon tissue gradually leads to a tendon rupture.
After successful therapy with intra-articular injections of Diprospan, the patient should avoid overloading the joint.
Prolonged use of corticosteroids can lead to a posterior subcapsular cataract (especially in children), glaucoma with possible damage to the optic nerve, and may contribute to the development of a secondary eye infection (fungal or viral).
It is necessary to periodically conduct an ophthalmologic examination, especially in patients receiving Diprospan for more than 6 months.
With an increase in blood pressure, fluid retention and sodium chloride in the tissues and an increase in potassium excretion from the body (less likely than with the use of other GCS), patients are recommended a diet with salt restriction and potassium supplements are prescribed. All GKS increase calcium excretion.
With the simultaneous use of Diprospana and cardiac glycosides or drugs that affect the electrolyte composition of the plasma, control of the water-electrolyte balance is required.
With caution prescribed acetylsalicylic acid in combination with the drug Diprospan with hypoprothrombinemia.
The development of secondary insufficiency of the adrenal cortex due to the too rapid removal of the GCS is possible within a few months after the end of therapy. If a stressful situation arises or is threatened during this period, Diprospan therapy should be resumed and a mineralocorticoid drug should be prescribed at the same time (due to a possible violation of mineralocorticoid secretion). The gradual abolition of GCS reduces the risk of secondary adrenal insufficiency.
Against the background of the use of GCS, it is possible to change the motility and number of spermatozoa.
With long-term treatment of GCS, it is advisable to consider the possibility of switching from parenteral to oral GCS, taking into account the assessment of the benefit / risk ratio.
Patients receiving GCS should not be vaccinated against smallpox, as well as other immunization, especially against the background of treatment of GCS in high doses, due to the possibility of the development of neurological complications and low immune response (lack of antibodies). Immunization is possible during replacement therapy (for example, in case of primary insufficiency of the adrenal cortex).
Use in pediatrics:
Children undergoing therapy with Diprospan (especially long-lasting) should be under close medical supervision for possible growth retardation and development of secondary insufficiency of the adrenal cortex.