Diprospan suspension for injection 1 ml x 5 ampoules — Made in Belgium — Free Delivery

(Diprospan )
Diprospan suspension for injection 1 ml x 5 ampoules — Made in Belgium — Free Delivery
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Schering-Plough Labo N.V. Brand: Schering-Plough Labo N.V.

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Description Diprospan suspension for injection 1 ml x 5 ampoules — Made in Belgium — Free Delivery

Pharmachologic effect

Diprospan - anti-allergic, anti-inflammatory.

Inhibits the release of interleukins 1 and 2, gamma-interferon from lymphocytes and macrophages, inflammatory mediators (eosinophils); induces the formation of lipocortins; reduces the metabolism of arachidonic acid.

Pharmacokinetics

Betamethasone disodium phosphate (an easily soluble component) is rapidly absorbed and provides a quick onset of effect. Betamethasone dipropionate, which has a slower absorption, provides a prolonged action.

Indications

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, preparation 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 necessary, injecting the preparation into the conjunctival sac, pathological changes in the blood, if necessary, using corticosteroids, nephritis, nephrotic syndrome).

Application during pregnancy and lactation

Diprospan is not used during pregnancy.

If necessary, the use of Diprospan during lactation is recommended to stop breastfeeding.

Contraindications

Systemic mycoses;

In / in or n / a introduction;

For intra-articular administration: unstable joint, infectious arthritis;

Introduction into infected surfaces and into the intervertebral space;

Children under 3 years of age (presence of benzyl alcohol in the composition);

Hypersensitivity to the components of the preparation;

Hypersensitivity to other GCS.

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), chickenpox, measles; amebiasis, strongyloidosis (established or suspected); systemic mycosis; active and latent tuberculosis. Application for severe infectious diseases is permissible only against the background of specific therapy.

Post-vaccination period (a period lasting 8 weeks before and 2 weeks after vaccination), lymphadenitis after BCG vaccination. Immunodeficiency states (including AIDS or HIV infection).

Diseases of the gastrointestinal tract: gastric ulcer and duodenal ulcer, esophagitis, gastritis, acute or latent peptic ulcer, recently 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, it is possible to spread the focus of necrosis, slow down the formation of scar tissue and, as a result, 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 hepatic failure, nephrourolithiasis, liver cirrhosis.

Thrombocytopenic purpura (IM injection).

Hypoalbuminemia and conditions predisposing to its occurrence.

Systemic osteoporosis, myasthenia gravis, acute psychosis, grade III-IV obesity, poliomyelitis (except for 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 intra-articular administration: general serious condition of the patient, ineffectiveness (or short duration) of the action of 2 previous injections (taking into account the individual properties of the GCS used).

Side effects

From the side of the central nervous system: sleep disorders, agitation, depression, anxiety syndrome, polyphagia, neuroses.

From the side of metabolism: weight gain, osteoporosis, growth retardation in children.

Others: accession of a secondary infection.

Interaction

With the simultaneous administration of the preparation Diprospan® with phenobarbital, rifampin, phenytoin or ephedrine, it is possible to accelerate the metabolism of betamethasone while reducing its therapeutic activity.

With the combined use of the preparation Diprospan® and indirect anticoagulants, changes in blood clotting are possible, requiring dose adjustment.

With the combined use of the preparation Diprospan® and potassium-excreting diuretics, the likelihood of developing hypokalemia increases.

Diprospan® can enhance the excretion of potassium caused by amphotericin B.

With the simultaneous use of corticosteroids and estrogens, a dose adjustment of the preparationsmay be required (due to the danger of their overdose).

The simultaneous use of corticosteroids and cardiac glycosides increases the risk of arrhythmia or digitalis intoxication (due to hypokalemia).

With the combined use of GCS with NSAIDs, with ethanol or ethanol-containing preparations, 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 per day should be avoided).

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

How to take, course and dosage

Diprospan® is used for intra-articular, intraarticular, periarticular, intrabursal, intradermal, interstitial and intralesional administration.

The small size of the crystals of betamethasone dipropionate allows the use of needles of small diameter (up to 26 gauge) for intradermal injection and injection directly into the lesion.

The preparation is not intended for intravenous and subcutaneous administration.

Injections of the preparation Diprospan® should be carried out with strict adherence to the rules of asepsis.

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

IM introduction

Diprospan® should be injected deep intramuscularly, while selecting large muscles and avoiding contact with other tissues (to prevent tissue atrophy).

In severe conditions requiring urgent therapy, the initial dose is 2 ml.

For various dermatological diseases, as a rule, it is sufficient to administer 1 ml of Diprospan suspension.

In diseases of the respiratory system, the onset of action of the preparation occurs within a few hours after the 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 1-2 ml of Diprospan.

In acute and chronic bursitis, the initial dose for intramuscular administration is 1-2 ml of suspension. Several repeated injections are performed if necessary.

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

Local introduction

With local 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 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 suspension of the Diprospan® preparation 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 time.

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

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

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

The recommended doses of the preparation when injected into large joints are from 1 to 2 ml; in the middle joints - 0.5-1 ml; small joints - 0.25-0.5 ml.

In some dermatological diseases, intradermal administration of the preparation Diprospan® 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 preparation in all areas should not exceed 1 ml for 1 week. For injection into the lesion, it is recommended to use a tuberculin syringe with a 26-gauge needle.

Recommended single doses of the preparation (with an interval between injections of 1 week) at 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 a synovial cyst - 0.25-0.5 ml, with tendosynovitis - 0.5 ml, with acute gouty arthritis - 0.5-1 ml. For most injections, a tuberculin syringe with a 25-gauge needle is suitable.

After the therapeutic effect is achieved, the maintenance dose is selected by gradually reducing the dose of Diprospan®, which is carried out at 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), an increase in the dose of Diprospan® may be required.

Cancellation of the preparation 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 use in high doses.

Overdose

Symptoms: Acute overdose of betamethasone does not lead to life-threatening situations. Administration of high doses of GCS for several days does not lead to undesirable consequences, except for cases of very high doses or when used in diabetes mellitus, glaucoma, exacerbation of erosive and ulcerative lesions of the gastrointestinal tract, or with the simultaneous use of digitalis preparations, indirect anticoagulants or potassium-excreting diuretics.

Treatment: requires careful medical monitoring of the patient's condition. Optimal fluid intake should be maintained and plasma and urine electrolytes monitored, especially the ratio of sodium to potassium ions. If necessary, appropriate therapy should be carried out.

Special instructions

The introduction of the preparation 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 preparation, especially if there is a history of indications of allergic reactions to preparations.

Diprospan® 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 preparation should be taken into account.

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

When Diprospan is prescribed 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 (especially important when prescribing the preparation to children).

When using the preparation 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 in active tuberculosis is possible only in cases of fulminant or disseminated tuberculosis in combination with adequate anti-tuberculosis therapy. When prescribing Diprospan to patients with latent tuberculosis or with a positive reaction to tuberculin, the issue of prophylactic anti-tuberculosis therapy should be decided. 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 noticeable increase in pain, swelling, an increase in the temperature of the surrounding tissues and a further limitation of joint mobility indicate infectious arthritis. When confirming the diagnosis, it is necessary to prescribe antibiotic therapy.

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 Diprospan®, 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 Diprospan® 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 (less likely than with the use of other GCS), patients are recommended a diet with a restriction of sodium chloride and additionally prescribed potassium-containing preparations. All corticosteroids enhance calcium excretion.

With the simultaneous use of Diprospan and cardiac glycosides or preparations 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 Diprospan® for hypoprothrombinemia.

The development of secondary adrenal cortex insufficiency due to too rapid withdrawal of GCS is possible within several months after the end of therapy. If a stressful situation arises or is threatened during this period, therapy with Diprospan® should be resumed and a mineralocorticoid preparation should be prescribed at the same time (due to a possible violation of mineralocorticoid secretion). The gradual cancellation of GCS can reduce the risk of developing secondary adrenal insufficiency.

Against the background of the use of corticosteroids, it is possible to change the motility and number of spermatozoa.

With long-term therapy with 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 corticosteroids should not be vaccinated against smallpox, as well as other immunizations, especially during treatment with corticosteroids in high doses, due to the possibility of neurological complications and a low immune response (lack of antibody formation). Immunization is possible when carrying out replacement therapy (for example, with primary adrenal cortex insufficiency).

Use in pediatrics

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

Storage conditions

In a dark place at a temperature of 2-25 ° C.

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