Dipropan, 2mg+5mg/ml suspension 1 ml

Dipropan is anti-allergic, anti-inflammatory.

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

Pharmacokinetics

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

Indications

Treatment of conditions and diseases in which GCS therapy can achieve adequate clinical effect (please note that in some diseases GCS therapy is additional and does not replace standard therapy):

Musculoskeletal and soft tissue diseases, including. rheumatoid arthritis, osteoarthritis, bursitis, ankylosing spondylitis, epicondylitis, radiculitis, coccygodynia, sciatica, lumbago, torticollis, ganglion cyst, exostosis, fasciitis, foot disorders;

Allergic diseases, including

Bronchial asthma, hay fever (pollinosis), allergic bronchitis, seasonal or year-round rhinitis, drug allergies, serum sickness, insect bite reactions;

Dermatological conditions including Atopic dermatitis, pontine eczema, neurodermatitis, contact dermatitis, severe photodermatitis, urticaria, lichen planus, insulin lipodystrophy, alopecia angiosis, lupus erythematosus, psoriasis, keloid scars, common vesicular disease, herpes dermatitis, cystic acne;

Systemic connective tissue diseases, including systemic lupus erythematosus, scleroderma, dermatomyositis, periarteritis nodosa;

Hemoblastosis (palliative therapy for leukemia and lymphoma 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 systemic GKS therapy (adrenogenital syndrome, ulcerative colitis, regional ileitis, malabsorption syndrome, ocular mucosal lesions if injection into conjunctival sac is necessary, abnormal blood changes if GKS is necessary, nephritis, nephrotic syndrome).

Active ingredient

Composition

1 ml of the suspension contains:

Active substances:

Betamethasone dipropionate 6.43 mg;

Betamethasone sodium phosphate 2.63 mg;

Associates:

Anhydrous disodium phosphate;

Sodium chloride; Trilon B;

Polysorbate 80;

Benzyl alcohol;

/p>

Carboxymethylcellulose sodium salt;

Polyethylene glycol 4000;

Nipagin;

Nipazole;

Water for injection.

How to take, the dosage

Dipropan® is used for intramural, intraarticular, periarticular, intrabursal, intradermal, intratissue and intrafocal administration.

The small size of betamethasone dipropionate crystals allows for small needle diameters (up to 26 gauge) for intradermal injection and administration directly to the lesion.

The drug is not intended for intravenous and percutaneous administration.

Dipropan® injections should be performed in strict compliance with the rules of asepsis.

Dosing regimen and method of administration are determined individually depending on indications, severity of the disease and patient’s reaction.

In systemic use the initial dose of Dipropan® in most cases is 1-2 ml. The administration is repeated as necessary depending on the patient’s condition.

Introduction

Dipropan® should be injected deeply intravenously, selecting large muscles and avoiding contact with other tissues (to prevent tissue atrophy).

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

In various dermatological diseases, as a rule, administration of 1 ml of Dipropan suspension is enough.

In diseases of the respiratory system the beginning of the drug action occurs within a few hours after the intravenous injection of the suspension. In bronchial asthma, hay fever, allergic bronchitis and allergic rhinitis significant improvement is achieved after 1-2 ml of Dipropan.

In acute and chronic bursitis the initial dose for I/m injection is 1-2 ml of suspension. If necessary, several repeated injections are given.

If a satisfactory clinical response does not occur after a certain period of time, Dipropan® should be withdrawn and other therapy should be prescribed.

Topical administration

When administered topically, concomitant use of a local anesthetic agent is only rarely necessary. If it is required, a 1% or 2% solution of procaine hydrochloride or lidocaine without methylparaben, propylparaben, phenol and other similar substances is used. In this case the mixing is done in the syringe, first filling the syringe from the bottle with the required dose of Dipropan® suspension. Then in the same syringe the required amount of local anesthetic is taken from the ampoule and shaken for a short time.

In acute bursitis (subdeltoid, scapula, elbow and patellofemoral) the injection of 1-2 ml of suspension into the synovial bag relieves pain and restores mobility of the joint within several hours. After acute exacerbation in chronic bursitis, smaller doses of the drug are used.

In acute tenosynovitis, tendinitis and peritendinitis one injection of Dipropan® improves the condition of the patient; in chronic ones the injection is repeated depending on the patient’s reaction.

Intra-articular injection of Dipropan® in a dose of 0.5-2 ml relieves pain, restriction of joint mobility in rheumatoid arthritis and osteoarthritis within 2-4 hours after injection. Duration of therapeutic effect varies considerably and can be 4 or more weeks.

Recommended doses of the drug when injected into large joints are 1 to 2 ml; into medium joints – 0 ml.

In some dermatological diseases intradermal injection of Dipropan® directly to the lesion is efficient and the dose is 0.2 ml/cm2. The lesion is evenly pricked using a tuberculin syringe and a needle with a diameter of about 0.9 mm. The total amount of drug injected at all sites should not exceed 1 ml for 1 week. It is recommended to use tuberculin syringe with 26-gauge needle for injection into the lesion site.

Recommended single doses of the drug (with 1 week interval between injections) for bursitis: for omosoles 025-0.5 ml (2 injections are usually effective), for spurs – 0.5 ml, for restriction of big toe mobility – 0.5 ml, for synovial cysts – 0.25-0.5 ml, for tenosynovitis – 0.5 ml, for acute gouty arthritis – 0.5-1 ml. For most injections a tuberculin syringe with a 25-gauge needle is suitable.

After therapeutic effect is achieved, the maintenance dose is adjusted by gradual reduction of the dose of Dipropan®, which is carried out at intervals. The reduction continues until the minimum effective dose is achieved.

If a stressful situation (unrelated to the disease) occurs or is threatened, the Dipropan® dose may need to be increased.

Discontinuation of the drug after long-term therapy is done by gradual dose reduction.

The patient is monitored for at least one year at the end of long-term therapy or high-dose use.

Interaction

When Dipropan® is concomitantly administered with phenobarbital, rifampin, phenytoin or ephedrine, metabolism of betamethasone may be accelerated while reducing its therapeutic activity.

When Dipropan® and indirect anticoagulants are used together, blood clotting changes may occur requiring dose adjustments.

When Dipropan® is coadministered with potassium-eluting diuretics, the possibility of hypokalemia increases.

Dipropan® may increase potassium excretion caused by amphotericin B.

Simultaneous use of GCS and estrogens may require dosage adjustment of the drugs (due to the risk of overdose).

Simultaneous use of GCS and cardiac glycosides increases the risk of arrhythmia or digitalis intoxication (due to hypokalemia).

When combined use of GCS with NSAIDs, with ethanol or ethanol-containing drugs the frequency or intensity of gastrointestinal erosive ulcers may increase.

Simultaneous use of GCS may decrease plasma concentration of salicylates.

Simultaneous administration of GCS and somatotropin may cause delayed absorption of the latter (betamethasone in doses greater than 03-0.45 mg/m2 body surface per day).

GCS may affect the nitrogen blue tetrazole test for bacterial infection and cause a false negative result.

Special Instructions

Contraindications

Systemic mycoses;

I/V or p/u administration;

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

Injection into infected surfaces and intervertebral space;

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

Hypersensitivity to the components of the drug;

Hypersensitivity to other GKS.

With caution:

Parasitic and infectious diseases of viral, fungal or bacterial nature (current or recent, including recent exposure) – herpes simplex, herpes zoster (viremic phase), chickenpox, measles; amebiasis, strongyloidiasis (established or suspected); systemic mycosis; active and latent tuberculosis. Use in severe infectious diseases is allowed only against a background of specific therapy.

Postvaccination period (period of 8 weeks before and 2 weeks after vaccination), lymphadenitis after BCG vaccination. Immunodeficiency conditions (including AIDS or HIV infection).

Gastrointestinal diseases: gastric and duodenal ulcer, esophagitis, gastritis, acute or latent peptic ulcer, newly created intestinal anastomosis, ulcerative colitis with threat of perforation or abscess, diverticulitis, abscess or other purulent infections.

Cardiovascular disease, including. Recent myocardial infarction (patients with acute and subacute myocardial infarction may have disseminated necrosis, delayed scar tissue formation and thereby rupture of the heart muscle), decompensated chronic heart failure, arterial hypertension, hyperlipidemia.)

Endocrine diseases – diabetes mellitus (including impaired carbohydrate tolerance), thyrotoxicosis, hypothyroidism, Icenko-Cushing’s disease.

Severe chronic renal and/or hepatic failure, nephrourolithiasis, liver cirrhosis.

Thrombocytopenic purpura (w/injection).

Hypoalbuminemia and conditions predisposing to its occurrence.

Systemic osteoporosis, myasthenia gravis, acute psychosis, grade III-IV obesity, polio (except for the bulbar encephalitis form), open- and closed-angle glaucoma, eye diseases caused by Herpes simplex (because of risk of corneal perforation), pregnancy, lactation period.

Intraarticular injection: generalized grave condition of patient and ineffectiveness (or short duration) of 2 previous injections (taking into account individual characteristics of GCS used).

Side effects

CNS side:sleep disorders, agitation, depression, anxiety syndrome, polyphagia, neurosis.

From the metabolic side: increased body weight, osteoporosis, growth retardation in children.

Others: accession of secondary infection.

Overdose

Symptoms: An acute overdose of betamethasone does not result in life-threatening situations. Administration of GCS in high doses over several days does not lead to undesirable effects, except in cases of very high doses or when used in diabetes mellitus, glaucoma, exacerbation of erosive-ulcerative lesions of the GI tract or when concurrent use of digitalis, indirect anticoagulants or potassium-eluting diuretics.

Treatment: Careful medical monitoring of the patient is required. Optimal fluid intake should be maintained and the plasma and urine electrolyte content, especially the sodium-potassium ion ratio, should be monitored. Appropriate therapy should be given if necessary.

Pregnancy use

Dipropan is not used during pregnancy.

If it is necessary to use Dipropan during lactation, it is recommended to stop breastfeeding.

Similarities