Diprospan suspension for injection. 2mg + 5mg / ml, 1ml

Treatment of conditions and diseases in which GCS therapy allows an adequate clinical effect to be achieved (it should be borne in mind that for some diseases GCS therapy is additional and does not replace standard therapy):

• diseases of the musculoskeletal system and soft tissues, incl. rheumatoid arthritis, osteoarthritis, bursitis, ankylosing spondylitis, epicondylitis, radiculitis, coccygodynia, sciatica, lumbago, torticollis, ganglion cyst, exostosis, fasciitis, foot diseases;

• allergic diseases, incl. bronchial asthma, hay fever (pollinosis), allergic bronchitis, seasonal or perennial rhinitis, drug allergies, serum sickness, insect bite reactions;

• dermatological diseases, incl. atopic dermatitis, coin-like eczema, neurodermatitis, contact dermatitis, severe photodermatitis, urticaria, lichen planus, insulin lipodystrophy, alopecia areata, discoid lupus erythematosus, psoriasis, keloid scars, pemphigus vulgaris, herpetic dermatitis;

• systemic connective tissue diseases, 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 the obligatory simultaneous use of mineralocorticoids);

• other diseases and pathological conditions requiring therapy with systemic corticosteroids (adrenogenital syndrome, ulcerative colitis, regional ileitis, malabsorption syndrome, lesions of the mucous membrane of the eye if it is necessary to inject the drug into the conjunctival sac, pathological changes in the blood if it is necessary to use corticosteroids, nephritis, nephrotic syndrome).

DiprospanЃ is recommended to be administered intramuscularly, if necessary, systemic intake of glucocorticoids into the body; directly into the affected soft tissue or in the form of intra-articular and periarticular injections for arthritis, in the form of intra-articular injections for various dermatological diseases and in the form of injections into the lesion in certain diseases of the foot.

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

With systemic therapy, the initial dose of Diprospan in most cases is 1-2 ml. The introduction is repeated as needed, depending on the patient's condition.

The drug is administered intramuscularly, deeply:

- in severe conditions requiring emergency measures, the initial dose is 2 ml;

- for various dermatological diseases, as a rule, it is sufficient to administer 1 ml of DiprospanЃ suspension;

- with diseases of the respiratory system; the onset of action of the drug occurs within a few hours after i / m injection of the suspension; with bronchial asthma, hay fever, allergic bronchitis and allergic rhinitis, a significant improvement in the condition is achieved after the introduction of 1Ц2 ml of DiprospanЃ;

- for acute and chronic bursitis, the initial dose for intramuscular injection is 1Ц2 ml of suspension. Several repeated injections are performed if necessary.

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

With local administration, the simultaneous use of a local anesthetic drug is necessary only in rare cases. If desired, use 1 or 2% solutions of procaine hydrochloride or lidocaine, which do not contain methylparaben, propylparaben, phenol and other similar substances. In this case, mixing is carried out in a syringe, first drawing the required dose of the DiprospanЃ suspension into the syringe from the vial. Then, the required amount of local anesthetic is taken from the ampoule into the same syringe and shaken for a short period of time.

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

In acute tenosynovitis, tendinitis and peritendinitis, 1 injection of DiprospanЃ improves the patient's condition; for chronic - the injection is repeated depending on the patient's response. Avoid injecting the drug directly into the tendon.

Intra-articular administration of Diprospan in a dose of 0.5Ц2 ml relieves pain, restriction of joint mobility in rheumatoid arthritis and osteoarthritis within 2Ц4 hours after administration. The duration of the therapeutic effect varies greatly and can be 4 weeks or more.

The recommended doses of the drug when injected into large joints are from 1 to 2 ml, in medium - 0.5Ц2 ml, in small - 0.25Ц0.5 ml.

In some dermatological diseases, intravenous administration of DiprospanЃ directly into the lesion is effective, the dose is 0.2 ml / cm2. The lesion is evenly injected using a tuberculin syringe and a needle with a diameter of about 0.9 mm. The total amount of the injected drug in all areas should not exceed 1 ml for 1 week.

Recommended single doses of the drug (with an interval between injections of 1 week) for bursitis: with callus 0.25-0.5 ml (as a rule, 2 injections are effective), with a spur - 0.5 ml, with limited mobility of the big toe - 0 , 5 ml, with synovial cyst - 0.25-0.5 ml, with tenosynovitis - 0.5 ml, with acute gouty arthritis - 0.5-1.0 ml. For the introduction, it is recommended to use a tuberculin syringe with a needle about 1 mm in diameter.

After reaching the therapeutic effect, the maintenance dose is selected by gradually decreasing the initial dose by decreasing the concentration of betamethasone in the solution administered at appropriate intervals. The decrease is continued until the minimum effective dose is reached.

If a stressful situation arises or is threatened (not related to the disease), it may be necessary to increase the dose of DiprospanЃ.

Cancellation of the drug after prolonged therapy is 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 use in high doses.

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

1 ml

betamethasone sodium phosphate 2.63 mg,

which corresponds to the content of betamethasone 2 mg

betamethasone dipropionate 6.43 mg,

which corresponds to the content of betamethasone 5 mg

Excipients: sodium hydrogen phosphate dihydrate - 2.51 mg, sodium chloride - 5 mg, disodium edetate - 0.1 mg, polyoxyethylene sorbitan monooleate (polysorbate 80) - 0.5 mg, benzyl alcohol - 9 mg, methyl parahydroxybenzoate - 1.3 mg, propyl parahydroxybenzoate - sodium 0.2 mg - 5 mg, macrogol (polyethylene glycol) - 20 mg, hydrochloric acid - qs, water d / i - qs up to 1 ml.

• Systemic mycoses;

• intravenous or subcutaneous administration;

• for intra-articular administration: unstable joint, infectious arthritis;

• introduction into infected surfaces and into the intervertebral space;

• hypersensitivity to betamethasone, drug components or other corticosteroids.

  With caution, the drug should be prescribed for hypothyroidism; cirrhosis of the liver; eye diseases caused by Herpes simplex (due to the risk of corneal perforation); ulcerative colitis; the threat of perforation; abscess or other purulent infections; diverticulitis; the presence of recently created intestinal anastomoses; active or latent gastric ulcer and duodenal ulcer; kidney failure; arterial hypertension; osteoporosis; severe myasthenia gravis; thrombocytopenic purpura (intramuscular injection).

pharmachologic effect

GKS. It has high glucocorticoid and low mineralocorticoid activity. The drug has anti-inflammatory, anti-allergic and immunosuppressive effects, and also has a pronounced and varied effect on various types of metabolism.

Pharmacokinetics

Absorption and distribution

Betamethasone sodium phosphate is highly soluble, after i / m administration, it quickly undergoes hydrolysis and is almost immediately absorbed from the injection site, which provides a rapid onset of therapeutic action. It is almost completely excreted within one day after administration.

Betamethasone dipropionate is slowly absorbed from the depot, metabolized gradually, which causes a long-term effect of the drug, and is excreted over more than 10 days.

The binding of betamateson with plasma proteins is 62.5%.

Metabolism and excretion

It is metabolized in the liver with the formation of mainly inactive metabolites. It is excreted mainly by the kidneys.

Side effect

The frequency of development and the severity of side effects, as with the use of other GCS, depend on the size of the dose used and the duration of the drug. These effects are usually reversible and can be eliminated or reduced with dose reduction.

Metabolic disorders: hypernatremia, increased potassium excretion, increased calcium excretion, hypokalemic alkalosis, fluid retention in tissues, negative nitrogen balance (due to protein catabolism), lipomatosis (including mediastinal and epidural lipomatosis, which can cause neurological complications), weight gain.

From the side of the cardiovascular system: chronic heart failure (in predisposed patients), increased blood pressure.

From the musculoskeletal system: muscle weakness, steroid myopathy, loss of muscle mass, increased myasthenic symptoms in severe pseudoparalytic myasthenia gravis, osteoporosis, compression fracture of the spine, aseptic necrosis of the femoral head or humerus, pathological fractures of tubular bones, tendon ruptures, with repeated intra-articular 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, a tendency to develop pyoderma and candidiasis, decreased reaction during skin tests.

From the side of the central nervous system and peripheral nervous system: convulsions, increased intracranial pressure with edema of the optic nerve head (more often at the end of therapy), dizziness, headache, euphoria, mood changes, depression (with severe psychotic reactions), personality disorders, increased irritability, insomnia ...

From the endocrine system: menstrual irregularities, secondary adrenal insufficiency (especially during stressful periods of illness, injury, surgery), Itsenko-Cushing's syndrome, decreased carbohydrate tolerance, steroid diabetes mellitus or manifestation of latent diabetes mellitus, increased need for insulin or oral hypoglycemic drugs, impaired intrauterine growth, growth retardation and sexual development in children.

From the side of the organ of vision: posterior 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 cutaneous atrophy, aseptic abscesses.

Others: flushing of the face after injection (or intra-articular injection), neurogenic arthropathy.

Application during pregnancy and lactation

Due to the lack of controlled studies of the safety of using the drug DiprospanЃ during pregnancy, if it is necessary to prescribe the drug to pregnant women or women of childbearing age , a preliminary assessment of the expected benefits of therapy for the mother and the potential risk to the fetus is required.

Newborns whose mothers received therapeutic doses of GCS during pregnancy should be under medical supervision (for early detection of signs of adrenal insufficiency).

If it is necessary to prescribe the drug DiprospanЃ during lactation, the issue of stopping breastfeeding should be decided, taking into account the importance of therapy for the mother (due to possible side effects in children).

Application for violations of liver function

Use with caution in liver cirrhosis.

Application for impaired renal function

Use with caution in renal impairment.

Application in children

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

special instructions

Severe complications from the nervous system (up to death) have been reported with epidural and intrathecal administration of GCS (with or without fluoroscopic guidance), including spinal cord infarction, paraplegia, quadriplegia, cortical blindness and stroke. Because the safety and efficacy of corticosteroids for epidural administration have not been established, this route of administration is not indicated for this group of drugs.

It is necessary to avoid intravascular ingestion of the drug.

Due to the lack of data on the risk of calcification, the introduction of the drug into the intervertebral space is contraindicated.

The dosage regimen and the route 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. Then the dose of DiprospanЃ is gradually reduced to the minimum effective maintenance dose. In the absence of the effect of the therapy or with its prolonged use, the drug is also canceled, gradually reducing the dose.

If a stressful situation arises or is threatened (not related to the disease), it may be necessary to increase the dose of DiprospanЃ.

The patient's condition is monitored for at least a year after the end of long-term therapy or use in high doses.

The introduction of the drug into soft tissues, into the lesion focus and into the joint can, with pronounced local action, simultaneously lead to systemic action.

Given the likelihood of developing anaphylactoid reactions with parenteral administration of GCS, the necessary precautions should be taken before administering the drug, especially if there is a history of indications of allergic reactions to drugs.

DiprospanЃ contains two active substances - betamethasone compounds, one of which, betamethasone sodium phosphate, is a rapidly dissolving fraction and therefore quickly enters the systemic circulation. The possible systemic effect of the drug should be taken into account.

Against the background of the use of the drug DiprospanЃ, mental disorders are possible, especially in patients with emotional instability or a tendency to psychosis.

When the drug DiprospanЃ is prescribed to patients with diabetes mellitus, correction of hypoglycemic therapy may be required.

Patients receiving GCS should not be vaccinated against smallpox. Other immunization should not be carried out in patients receiving GCS (especially in high doses), due to the possibility of developing neurological complications and a low immune response (lack of antibody formation). However, immunization is possible when carrying out replacement therapy (for example, with primary adrenal insufficiency).

Patients receiving DiprospanЃ in doses that suppress immunity should be warned about the need to avoid contact with patients with chickenpox and measles (especially important when prescribing the drug to children).

It is possible to suppress the reaction when conducting skin tests against the background of the use of corticosteroids.

When using the drug DiprospanЃ, 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.

It is necessary to carefully follow the rules of asepsis and antiseptics when administering the drug.

Care must be taken when using the drug in patients with a high risk of infection (on hemodialysis or with dentures).

The use of the drug DiprospanЃ in active tuberculosis is possible only in cases of fulminant or disseminated tuberculosis in combination with adequate anti-tuberculosis therapy. When prescribing DiprospanЃ to patients with latent tuberculosis or during the bend of a tuberculin test, the dose of DiprospanЃ should be selected very carefully (due to the danger of tuberculosis reactivation), and with prolonged use, anti-tuberculosis chemoprophylaxis is necessary. With the prophylactic use of rifampicin, the acceleration of hepatic clearance of betamethasone should be taken into account (a dose adjustment of betamethasone may be required).

In the presence of fluid in the articular cavity, a septic process should be excluded.

A noticeable increase in pain, swelling, an increase in the temperature of the surrounding tissues and a further limitation of joint mobility indicate infectious arthritis. It is necessary to conduct a study of aspirated joint fluid. When confirming the diagnosis, it is necessary to prescribe appropriate antibiotic therapy. The use of the drug DiprospanЃ for septic arthritis is contraindicated.

Repeated injections into a joint for osteoarthritis can increase the risk of joint destruction. The introduction of GCS into the tendon tissue gradually leads to rupture of the tendon.

After successful therapy with intra-articular injections of DiprospanЃ, the patient should avoid overloading the joint.

Long-term use of GCS can lead to posterior subcapsular cataract (especially in children), glaucoma with possible damage to the optic nerve and can contribute to the development of secondary ocular infection (fungal or viral). It is necessary to periodically conduct an ophthalmological examination, especially in patients receiving DiprospanЃ for more than 6 months.

The use of medium and high doses of corticosteroids can lead to an increase in blood pressure, sodium and fluid retention in the body and an increased excretion of potassium from the body (these phenomena are less likely in the case of taking synthetic corticosteroids, unless they are used in high doses). With long-term use of the drug DiprospanЃ in high doses, the risk of arrhythmia and hypokalemia, the need to prescribe potassium-containing drugs and a diet with limited sodium chloride should be considered.

All corticosteroids enhance calcium excretion.

With the simultaneous use of the drug DiprospanЃ and cardiac glycosides or drugs that affect the electrolyte composition of the plasma, control of the water-electrolyte balance is required.

Acetylsalicylic acid is prescribed with caution in combination with DiprospanЃ for hypoprothrombinemia.

The effect of GCS is enhanced in patients with hypothyroidism and liver cirrhosis.

Care must be taken when using GCS in elderly patients; in patients with renal or hepatic insufficiency, diverticulitis, active or latent gastric ulcer and / or intestinal ulcer, or with recent intestinal anastomoses, osteoporosis, myasthenia gravis, confirmed or suspected parasitic infections (eg, strongyloidosis).

–азвитие вторичной недостаточности коры надпочечников в св¤зи со слишком быстрой отменой v — возможно в течение нескольких мес¤цев после окончани¤ терапии. ѕри возникновении или угрозе стрессовой ситуации в течение этого периода терапию препаратом ?ипроспанЃ следует возобновить и одновременно назначить минералокортикоидный препарат (из-за возможного нарушени¤ секреции минералокортикоидов). ѕостепенна¤ отмена v — позвол¤ет уменьшить риск развити¤ вторичной надпочечниковой недостаточности.

Ќа фоне применени¤ v — возможно изменение подвижности и числа сперматозоидов.

ѕри длительной терапии v — целесообразно рассмотреть возможность перехода с парентеральных на пероральные v —, с учетом оценки соотношени¤ польза/риск.

ѕациентам, участвующим в соревновани¤х под контролем ¬семирного антидопингового агентства (WADA), перед началом лечени¤ препаратом следует ознакомитьс¤ с правилами WADA, поскольку применение препарата ?ипроспанЃ может повли¤ть на результаты допингового контрол¤.

»спользование в педиатрии

?ети, у которых проводитс¤ терапи¤ препаратом ?ипроспанЃ (особенно длительна¤), должны находитьс¤ под тщательным медицинским наблюдением на предмет возможного отставани¤ в росте и развити¤ вторичной недостаточности коры надпочечников.

¬ли¤ние на способность к управлению транспортными средствами и механизмами

?анные о том, что применение препарата ?ипроспанЃ вли¤ет на способность управл¤ть транспортными средствами и работать с механизмами, отсутствуют.

ѕередозировка

—имптомы: остра¤ передозировка бетаметазона не приводит к угрожающим жизни ситуаци¤м. ¬ведение в течение нескольких дней v — в высоких дозах не приводит к нежелательным последстви¤м, за исключением случаев применени¤ очень высоких доз или при применении при сахарном диабете, глаукоме, обострении эрозивно-¤звенных поражений ? “ или при одновременном применении препаратов дигиталиса, непр¤мых антикоагул¤нтов или калийвывод¤щих диуретиков.

Ћечение: требуетс¤ тщательный медицинский контроль состо¤ни¤ пациента. —ледует поддерживать оптимальное потребление жидкости и контролировать содержание электролитов в плазме и в моче, особенно соотношение ионов натри¤ и кали¤. ѕри необходимости следует провести соответствующую терапию.

Ћекарственное взаимодействие

ѕри одновременном назначении препарата ?ипроспанЃ с фенобарбиталом, рифампином, фенитоином или эфедрином возможно ускорение метаболизма бетаметазона при снижении его терапевтической активности.

ѕри совместном применении препарата ?ипроспанЃ и непр¤мых антикоагул¤нтов возможны изменени¤ свертываемости крови, требующие коррекции дозы.

ѕри совместном применении препарата ?ипроспанЃ и калийвывод¤щих диуретиков повышаетс¤ веро¤тность развити¤ гипокалиемии.

?ипроспанЃ может усиливать выведение кали¤, вызванное амфотерицином ¬.

ѕри одновременном применении v — и эстрогенов может потребоватьс¤ коррекци¤ дозы препаратов (из-за опасности их передозировки).

ќдновременное применение v — и сердечных гликозидов повышает риск возникновени¤ аритмии или дигиталисной интоксикации (из-за гипокалиемии).

With the combined use of GCS with NSAIDs, with ethanol or ethanol-containing drugs, an increase in the frequency of occurrence or intensity of erosive and ulcerative lesions of the gastrointestinal tract is possible.

When used together, GCS can reduce the concentration of salicylates in the blood plasma.

The simultaneous administration of corticosteroids and somatotropin can lead to a slowdown in the absorption of the latter (the administration of betamethasone in doses exceeding 0.3-0.45 mg / m2 of body surface / day should be avoided).

GCS can interfere with the nitrogen blue tetrazole test for bacterial infection and cause a false negative result.