Diprospan - instructions for use, doses, side effects, contraindications

active ingredients: betamethasone dipropionate 6.43 mg (equivalent to 5.0 mg betamethasone), betamethasone sodium phosphate 2.63 mg (equivalent to 2.0 mg betamethasone);

Excipients: sodium hydrophosphate dihydrate 2.51 mg, sodium chloride 5.0 mg, edetate disodium 0.1 mg, polyoxyethylene sorbitan monooleate (polysorbate 80) 0.5 mg, benzyl alcohol 9.0 mg, methyl parahydroxybenzoate 1.3 mg, propyl parahydroxybenzoate 0.2 mg, carmellose sodium 5.0 mg, macrogol (polyethylene glycol) 20.0 mg, hydrochloric acid q.s., water for injections q.s. up to 1 ml.

Description:

Transparent, colorless or yellowish color, slightly viscous liquid, containing easily suspended particles of white or almost white color, free from foreign matter. When shaken, a stable suspension of white or yellowish color is formed.

Pharmacotherapeutic group:glucocorticosteroid

ATX: & nbsp

H.02.A.B.01 Betamethasone

Pharmacodynamics:

Diprospan - glucocorticosteroid (GCS) drug, has a high glucocorticoid and minor mineralocorticoid activity. The drug has anti-inflammatory, antiallergic and immunosuppressive effect, and also has a pronounced and diverse effect on various types of metabolism.

Pharmacokinetics:

Betamethasone sodium phosphate is readily soluble and after intramuscular injection it is rapidly hydrolyzed and almost immediately absorbed from the injection site, which provides a rapid onset of therapeutic action. Virtually completely eliminated within one day after administration.Betamethasone dipropionate is absorbed slowly from the depot, it is metabolized slowly, which leads to long-term effect of the drug, and is displayed for more than 10 days.

Betamethasone well bound to plasma proteins (62.5%). Metabolized in the liver with the formation of predominantly inactive metabolites. It is excreted mainly by the kidneys.

Indications:

Treatment in adult conditions and diseases in which GCS therapy allows to achieve the necessary clinical effect (it must be taken into account that in some diseases SCS therapy is complementary and does not replace standard therapy):

- зabolevaniya musculoskeletal system and soft tissueIn t h rheumatoid arthritis, osteoarthritis, bursitis, ankylosing spondylitis, epicondylitis, sciatica, coccyalgia, sciatica, lumbago, torticollis, ganglion cyst, exostoses, fasciitis, stop disease..;

- aallergic diseases, in t h bronchial asthma, hay fever (pollinosis), allergic bronchitis, seasonal or perennial rhinitis, drug allergy, serum sickness, reactions to insect bites..;

- dDermatological diseases, Including.atopic dermatitis, coin-like eczema, neurodermatitis, contact dermatitis, severe photodermatitis, urticaria, lichen planus, insulinic lipodystrophy, alopecia areata, discoid lupus erythematosus, psoriasis, keloid scars, pemphigus vulgaris, herpetic dermatitis, cystic acne;

- fromsystemic connective tissue diseases, including systemic lupus erythematosus, scleroderma, dermatomyositis, nodular periarteritis;

- gsememelastosis (palliative therapy of leukemia and lymphomas in adults, acute leukemia in children);

- PPrimary or secondary insufficiency of the adrenal cortex (with the obligatory simultaneous application of mineralocorticoids);

- dOther diseases and pathological conditions requiring systemic GCS therapy (adrenogenital syndrome, ulcerative colitis, regional ileitis, malabsorption syndrome, lesions of the eye mucosa when it is necessary to administer the drug into the conjunctival sac, pathological changes in blood if necessary, use of GCS, nephritis, nephrotic syndrome).

Contraindications:

- Pincreased sensitivity to betamethasone or other components of the drug, or other SCS;

- systemic fungal infections;

- intravenous or subcutaneous administration;

- with intra-articular injection: unstable joint, infectious arthritis;

- introduction into infected surfaces and into the intervertebral space.

Carefully:

Hypothyroidism, liver cirrhosis, eye diseases caused by Herpes simplex (due to the risk of corneal perforation), ulcerative colitis, perforation threat, abscess or other purulent infections, diverticulitis, recent intestinal anastomoses, active or latent stomach and duodenal ulcer, renal failure, arterial hypertension, osteoporosis, myasthenia gravis, thrombocytopenic purpura (intramuscular injection).

Pregnancy and lactation:

Due to the lack of controlled studies of the safety of the use of Diprospana® during pregnancy, the use of the drug in pregnant women or in women of childbearing age requires a preliminary assessment of the intended benefit and potential risk to the mother and 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 it is necessary to appoint Diprospan® During the lactation period, the question of stopping breastfeeding should be addressed, taking into account the importance of therapy for the mother (due to possible side effects in children).

Dosing and Administration:

Intramuscular, intraarticular, periarticular, intra-abdominal, intradermal, interstitial and intraluminal injections.

The small dimensions of the crystals of betamethasone dipropionate allow the use of needles of small diameter (up to 26 calibers) for intradermal administration and administration directly to the lesion site.

DO NOT INSERT INSIDE! DO NOT INSERT!

Strict compliance with asepsis rules is mandatory when applying Diprospan®.

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

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

Intramuscular (IM) administration SCS should be carried deep into the muscle, while choosing large muscles and avoiding entering other tissues (to prevent tissue atrophy).

The drug is given in / m:

- at heavy states, requiring emergency measures, the initial dose is 2 ml;

- at various dermatological diseases, as a rule, it is sufficient to introduce 1 ml of a suspension of Diprospan®;

- at diseases of the respiratory system. The onset of the drug occurs within a few hours after an intravenous injection of the suspension. When bronchial asthma, hay fever, allergic bronchitis and allergic rhinitis a significant improvement is achieved after the introduction of 1-2 ml of Diprospan®;

- at acute and chronic bursitis the initial dose for the / m administration is 1-2 ml of the suspension. If necessary, several repeated injections are carried out.

If a satisfactory clinical response does not occur after a certain period of time, Diprospan® it is necessary to cancel and prescribe another therapy.

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

When acute bursitis (sub-deltoid, subscapular, elbow and prednadolennikovym) the introduction of 1-2 ml of the suspension into the synovial bag facilitates the pain and restores the mobility of the joint for several hours. After relieving the exacerbation of chronic bursitis, smaller doses of the drug are used.

When acute tenosynovitis, tendinitis and peritendinitis one injection of Diprospan® improves the condition of the patient; at chronic - The injection is repeated depending on the patient's reaction. It is necessary to avoid the introduction of the drug directly into the tendon.

Intra-articular administration Diprospana® in a dose of 0.5-2 ml relieves pain, limiting the mobility of joints with rheumatoid arthritis and osteoarthritis for 2-4 hours after administration. The duration of the therapeutic effect varies considerably and can be 4 or more weeks.

Recommended doses of the drug when introduced in large joints make upt from 1 to 2 ml; at medium - 0.5-1 ml; at small - 0.25-0.5 ml.

For some dermatological diseases effectively intradermal administration Diprospana® directly into the lesion, the dose is 0.2 ml / cm². The hearth is evenly chipped, using a tuberculin syringe and a needle with a diameter of about 0.9 mm. The total amount of the drug administered on all sites should not exceed 1 ml for 1 week. For introduction into the lesion it is recommended to use a tuberculin syringe with a 26 gauge needle.

Recommended single doses of the drug (with an interval between administrations 1 week) with bursitis: with omozolelosti 0.25-0.5 ml (usually 2 injections are effective), with spur - 0.5 ml, with restriction of 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 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 betamethasone administered at appropriate intervals. The reduction is continued until the minimum effective dose is reached.

If there is a risk of a stressful situation (not related to the disease), it may be necessary to increase the dose of Diprospan®.

The cancellation of the drug after prolonged therapy is carried out by a gradual dose reduction.

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

Side effects:

The frequency of development and severity of side effects, as in the application of other GCS, depend on the magnitude of the dose used and the duration of the drug. These phenomena are usually reversible and can be eliminated or reduced by lowering the dose.

From the side of the water-electrolyte balance: hypernatremia, increased potassium release, increased excretion of calcium, hypokalemic alkalosis, fluid retention in tissues.

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 pseudo-paralytic myasthenia gravis,osteoporosis, compression fracture of the spine, aseptic necrosis of the head of the femoral or humerus, pathological fractures of the tubular bones, ruptures of the tendons, instability of the joints (with repeated intraarticular injections).

From the digestive system: erosive and ulcerative lesions of the gastrointestinal tract with possible subsequent perforation and bleeding, pancreatitis, flatulence, hiccough.

From the skin and mucous membranes: impaired wound healing, atrophy and thinning of the skin, petechiae, ecchymosis, increased sweating, dermatitis, steroid acne, striae, a tendency to develop pyoderma and candidiasis, a decrease in the 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 disc (more often at the end of therapy) dizziness, headache; euphoria, mood changes, depression (with pronounced psychotic reactions), personality disorders, increased irritability, insomnia.

From the endocrine system: violation of the menstrual cycle,secondary adrenal insufficiency (especially during stress period in case of illness, trauma, surgical intervention), Itenko-Cushing syndrome, decrease in carbohydrate tolerance, steroid diabetes mellitus or manifestation of latent diabetes mellitus, increased need for insulin or oral hypoglycemic drugs, intrauterine growth disorder, 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).

From the side of metabolism: negative nitrogen balance (due to protein catabolism), lipomatosis (including mediastinal and epidural lipomatosis, which can cause neurological complications), weight gain.

Allergic reactions: anaphylactic reactions, shock, angioedema, lowering of blood pressure.

Other reactions associated with parenteral administration of the drug: rarely - hyper- or hypopigmentation, subcutaneous and dermal atrophy, aseptic abscesses, rush of blood to the face after injection (or intra-articular injection), neurogenic arthropathy.

Overdose:

Symptoms. Acute overdose of betamethasone does not lead to life-threatening situations. The introduction of high doses of SCS within a few days does not lead to undesirable consequences (except in cases of very high doses or when used in diabetes mellitus, glaucoma, exacerbation of erosive-ulcerative gastrointestinal lesions, or simultaneous use of digitalis preparations, indirect anticoagulants or potassium-releasing diuretics ).

Treatment. Careful medical monitoring of the patient's condition is necessary; should maintain optimal fluid intake and control the electrolyte content in plasma and in urine (especially the ratio of sodium and potassium ions). If necessary, appropriate therapy should be provided.

Interaction:

With the simultaneous administration of phenobarbital, rifampin, phenytoin or ephedrine, it is possible to accelerate the metabolism of the drug with a decrease in its therapeutic activity.

With the simultaneous use of GCS and estrogens, dosage adjustment may be required (because of the risk of overdose).

With the combined use of diprospan® and potassium-eliminating diuretics, the likelihood of developing hypokalemia increases.

Simultaneous use of GCS and cardiac glycosides increases the risk of arrhythmia or digitalis intoxication (due to hypokalemia). Diprospan® can enhance the excretion of potassium caused by amphotericin-B.

With the joint application of Diprospan® and indirect anticoagulants, blood coagulability changes that require dose adjustment are possible.

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

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

Simultaneous administration of GCS and somatotropin can lead to a slower absorption of the latter (avoidance of doses of betamethasone exceeding 0.3-0.45 mg / m² body surface area per day).

SCS can affect the nitrogen blue tetrazole test for bacterial infection and cause a false-negative result.

Special instructions:

Severe complications of the nervous system (up to a lethal outcome) have been reported with epidural and intrathecal administration of SCS (under fluoroscopic control or without it), including spinal cord infarction, paraplegia, quadriplegia, cortical blindness and stroke.Since safety and efficacy in epidural administration of corticosteroids have not been established, this mode of administration is not indicated for this group of drugs. Recommended methods of administration are indicated in the section "Method of administration and dose"

Avoid intravascular drug ingestion.

Because of 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 mode of administration are set individually, depending on the indications, the severity of the disease and the patient's response.

The dose should be as small as possible, and the period of application as short as possible. The initial dose is selected until the necessary therapeutic effect is achieved. Then gradually reduce the dose of Diprospan® to a minimally effective maintenance dose. In the absence of effect from the therapy or with its long-term use, the drug is canceled in the same way, gradually reducing the dose.

If there is a risk of a stressful situation (not related to the disease), you may need to increase the dose of Diprospan®.

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

The introduction of the drug into soft tissues, into the lesion lesion and intraarticular 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 the patient has history of allergic reactions to medicines.

The drug Diprospan® contains two active substances - betamethasone derivatives, one of which - betamethasone sodium phosphate - quickly penetrates into the systemic bloodstream, and therefore its possible systemic action should be taken into account.

Against the background of the use of the drug Diprospan®, mental disorders are possible (especially in patients with emotional instability or susceptibility to psychosis).

When using Diprospan ® in patients with diabetes mellitus, it may be necessary to correct hypoglycemic therapy.

Patients receiving SCS should not be vaccinated against smallpox.Do not perform other immunizations in patients receiving SCS (especially in high doses). Due to the possibility of developing neurological complications and low response immune response (absence of antibody formation). However, immunization is possible with replacement therapy (for example, with primary adrenal insufficiency).

Patients receiving Diprospan® at doses suppressing immunity should be warned about the need to avoid contact with patients with chickenpox and measles (especially when taking the drug in children).

It is possible to suppress the reaction when carrying out skin tests on the background of the use of GCS.

When using Diprospan®, it should be taken into account that SCS can mask the signs of an infectious disease, and also reduce the body's resistance to infections. It is necessary to carefully observe the rules of aseptic and antiseptic treatment with the administration of the drug.

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

The use of the drug Diprospan® with active tuberculosis is possible only in cases of lightningor disseminated tuberculosis in combination with adequate antituberculous therapy. When using Diprospan® in patients with latent tuberculosis or during the tubular test, the dose of the Diprospan® preparation should be very careful (due to the danger of reactivation of tuberculosis), and with prolonged use, antituberculous chemoprophylaxis is necessary. In the preventive use of rifampicin, acceleration of hepatic clearance of betamethasone should be considered (correction of the dose of betamethasone may be required).

In the presence of fluid in the joint cavity, the septic process should be excluded. A marked increase in soreness, swelling, an increase in the temperature of surrounding tissues, and a further limitation of joint mobility indicate septic arthritis. It is necessary to conduct a study of aspirated joint fluid. When confirming the diagnosis, appropriate antibiotic therapy should be prescribed. The use of Diprospan® for septic arthritis is contraindicated.

Repeated injections into the joint with osteoarthritis may increase the risk of joint destruction.The introduction of SCS into the tendon tissue gradually leads to rupture of the tendon.

After successful intra-articular therapy, the patient should avoid overloading the joint.

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

The use of medium and high doses of GCS can lead to increased blood pressure, sodium and liquid retention in the body, and increased excretion of potassium from the body (these phenomena are less likely in the case of taking synthetic GCS, unless they are used in high doses). With long-term use of high doses of the drug Diprospan®, the risk of arrhythmia and hypokalemia should consider the need to prescribe potassium-containing drugs and sharosa with restriction of table salt. All GCSs increase the excretion of calcium.

With the simultaneous use of the preparation Diprospan® and cardiac glycosides or preparations affecting the electrolyte composition of the plasma, control of the water-electrolyte balance is required.

Caution is prescribed acetylsalicylic acid in combination with the preparation Diprospan ® with hypoprothrombinemia.

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

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

The development of secondary adrenocortical insufficiency due to too rapid cancellation of SCS is possible within a few months after the end of therapy. In case of occurrence or threat of occurrence of a stressful situation during this period, therapy with Diprospan® should be resumed and at the same time a mineralocorticosteroid (due to a possible violation of secretion of mineralocorticosteroids) should be started. The gradual elimination of GCS can reduce the risk of developing secondary adrenal insufficiency.

Against the background of the use of GCS, a change in the mobility and the number of spermatozoa is possible.

With prolonged therapy with GCS, it is advisable to consider the possibility of switching from parenteral to oral administration of GCS, taking into account the evaluation of the "benefit / risk" ratio.

Pediatric Use

Children who are being treated with Diprospan® (especially long-term) should be carefully monitored for possible lag in the growth and development of secondary adrenal insufficiency.

Application in athletes

Patients participating in competitions under the supervision of the World Anti-Doping Agency (WADA) should read the WADA rules before starting treatment, as taking Diprospan® may affect the results of doping control.

Effect on the ability to drive transp. cf. and fur:

Data that the use of the drug Diprospan® affects the ability to drive vehicles and work with mechanisms are absent.

Form release / dosage:

Suspension for injection, 2 mg + 5 mg / ml.

Packaging:

1 ml per ampoule of glass of hydrolytic class 1.

For 1 or 5 ampoules in a plastic contour pack together with instructions for use in a cardboard bundle.

Storage conditions:In a place inaccessible to children and protected from light, at a temperature of no higher than 25 ° C. Do not freeze.

Shelf life:

2 years.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:П N013528 / 01

Date of registration:04.07.2008

The owner of the registration certificate:Schering-Plau N. Labo.Schering-Plau N. Labo. USA

Manufacturer: & nbsp

SCHERING-PLOUGH LABO, N.V. Belgium

Representation: & nbspMSD Pharmaceuticals Ltd.MSD Pharmaceuticals Ltd.

Information update date: & nbsp16.11.2015

Illustrated instructions

Instructions

Diprospan® (Diprospan®)