Diprometa suspension for injection 7mg/ml 1ml syringes, complete with sterile needle, 1pc

Composition

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1 ml (one pre-filled syringe) contains:

active ingredients:

betamethasone dipropionate-6.43 mg in terms of betamethasone-5.00 mg;

betamethasone sodium phosphate-2.63 mg in terms of betamethasone-2.00 mg;

excipients:  methyl parahydroxybenzoate – 1.30 mg; propyl parahydroxybenzoate – 0.20 mg; benzyl alcohol – 9.00 mg; macrogol-4000 – 20.00 mg; carmellose sodium – 5.00 mg; sodium hydrophosphate dodecahydrate – 5.04 mg; disodium edetate – 0.10 mg; sodium chloride – 5.00 mg; polysorbate 80 – 0.625 mg; hydrochloric acid solution of 1 M – up to pH = 7.4 ± 0.1; water for injection – up to 1.00 ml (1.0127 g).

Pharmacological action

Pharmacotherapy group: Glucocorticosteroid (corticosteroid)

ATX code: H02AB01

Pharmacological properties

Pharmacodynamics

Betamethasone is a synthetic corticosteroid that has high glucocorticoid and minor mineralocorticoid activity. Betamethasone has an anti-inflammatory, anti-allergic and immunosuppressive effect, and also has a pronounced and diverse effect on various types of metabolism.

It interacts with specific cytoplasmic receptors to form a complex that penetrates the cell nucleus and stimulates the synthesis of matrix ribonucleic acid, the latter induces the formation of proteins, including lipocortin, mediating cellular effects. Lipocortin inhibits phospholipase A2, inhibits the release of arachidonic acid, and suppresses the synthesis of endoperoxides, prostaglandins, and leukotrienes, which contribute to the processes of inflammation, allergies, and others. Protein metabolism: reduces the amount of protein in the blood plasma (due to globulins) with an increase in the albumin / globulin ratio, increases the synthesis of albumins in the liver and kidneys, increases protein catabolism in muscle tissue.

Lipid metabolism: increases the synthesis of higher fatty acids and triglycerides, redistributes fat (accumulation of fat mainly in the shoulder girdle, face, abdomen), leads to the development of hypercholesterolemia.

Carbohydrate metabolism: increases the absorption of carbohydrates from the gastrointestinal tract (GIT), increases the activity of glucose-6-phosphatase, leading to increased glucose intake from the liver into the blood, increases the activity of phosphoenolpyruvate carboxylase and the synthesis of aminotransferases, leading to activation of gluconeogenesis.

Water-electrolyte metabolism: detains sodium ions and water in the body, stimulates the excretion of potassium ions (mineralocorticoid activity), reduces the absorption of calcium from the gastrointestinal tract, “washes” calcium ions from the bones and increases their excretion by the kidneys.

The anti-inflammatory effect is associated with inhibition of the release of inflammatory mediators by eosinophils; inducing the formation of lipocortin and reducing the number of mast cells that produce hyaluronic acid; reducing capillary permeability; and stabilizing cell membranes and organelle membranes (especially lysosomal ones).

The anti-allergic effect develops as a result of suppressing the synthesis and secretion of allergy mediators, inhibiting the release of histamine and other biologically active substances from sensitized mast cells and basophils, inhibiting maturation and differentiation  T-and B-lymphocytes and mast cells, reducing the sensitivity of effector cells to allergy mediators, inhibiting antibody formation, and changing the body’s immune response.

Increases the sensitivity of small and medium-sized bronchial beta-adrenergic receptors to endogenous catecholamines and exogenous sympathomimetics, reduces the viscosity of bronchial mucosal secretions by inhibiting or reducing its production.

The immunosuppressive effect is caused by inhibition of the release of cytokines (interleukin-1, interleukin-2, gamma interferon) from lymphocytes and macrophages. Inhibits the synthesis and secretion of ACTH and, secondarily, the synthesis of endogenous corticosteroids.

It inhibits the secretion of thyroid-stimulating hormone (TSH) and follicle-stimulating hormone (FSH).

It suppresses the release of beta-lipotropin, but does not reduce the content of circulating beta-endorphin.

It inhibits connective tissue reactions during the inflammatory process and reduces the possibility of scar tissue formation.

Betamethasone sodium phosphate is an easily soluble compound that is well absorbed after parenteral use into tissues and provides a quick effect. Betamethasone dipropionate has a slower absorption rate. By combining these betamethasone salts, it is possible to create a drug with both short-term (but fast) and long-term effects. Depending on the method of application (intramuscularly (iv), intraarticularly, periarticularly, intradermally (iv)) a general or local effect is achieved.

Pharmacokinetics

Betamethasone sodium phosphate is highly soluble in water and after intramuscular use is rapidly hydrolyzed and almost immediately absorbed from the injection site, which ensures a rapid onset of therapeutic action. It is almost completely eliminated within one day after use.

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

Betamethasone binds well to plasma proteins (62.5%). It is metabolized in the liver to form mainly inactive metabolites. It is mainly excreted by the kidneys.

Indications

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

• Diseases of the musculoskeletal system and soft tissues, including rheumatoid arthritis, osteoarthritis, bursitis, ankylosing spondylitis, epicondylitis, coccygodynia, torticollis, ganglion cyst, fasciitis.
• Allergic diseases, including bronchial asthma, hay fever (hay fever), allergic bronchitis, seasonal or year-round rhinitis, drug allergies, serum sickness, reactions to insect bites.
• Dermatological diseases, including atopic dermatitis, coin-shaped eczema, neurodermatitis, contact dermatitis, severe photodermatitis, urticaria, lichen planus, alopecia areata, discoid lupus erythematosus, psoriasis, keloid scars, pemphigus vulgaris, cystic acne.
• Systemic connective tissue diseases, including systemic lupus erythematosus, scleroderma, dermatomyositis, and periarteritis nodosa.
• Hemoblastosis (palliative therapy of 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 that require systemic corticosteroid therapy (adrenogenital syndrome, regional ileitis, abnormal blood changes when corticosteroid therapy is necessary).

Use during pregnancy and lactation

Pregnancy

Due to the lack of controlled studies on the safety of using betamethasone during pregnancy, the use of Diprometa during pregnancy or in women with preserved reproductive potential is indicated only if the expected therapeutic effect for the mother exceeds the risk of possible negative effects of the drug on the fetus.

The condition of patients with fluid retention or gestosis in the second half of pregnancy (especially severe – preeclampsia, eclampsia) should be carefully monitored.

CORTICOSTEROIDS penetrate the placental barrier and can reach high concentrations in the fetus. Newborns whose mothers received therapeutic doses of corticosteroids during pregnancy should be under medical supervision (for early detection of signs of adrenal insufficiency).

The use of corticosteroids in pregnant animals can cause fetal malformations, including cleft palate (“cleft palate”), delayed fetal development, and affect brain growth and development. There are no data on an increase in cases of congenital malformations, such as cleft palate/lip, associated with the use of corticosteroids in humans. However, with prolonged or repeated use during pregnancy, the use of corticosteroids may increase the risk of delayed fetal development. Theoretically, after prenatal use of corticosteroids, it is possible to develop adrenal hypofunction in newborns, which, as a rule, spontaneously passes after birth and in rare cases is clinically significant. When using betamethasone during pregnancy in newborns, cases of myocardial hypertrophy and gastroesophageal reflux have been reported.

When used systemically in pregnant women, betamethasone can lead to a transient decrease in the heart rate (HR) and inhibition of fetal biophysical activity, which are widely used to assess the condition of the fetus. These characteristics may include a decrease in the number of respiratory movements, fetal motor activity, and fetal heart rate.

Breast-feeding period

If it is necessary to use betamethasone during breastfeeding, taking into account the importance of corticosteroid therapy for the mother and the possibility of undesirable effects in the child, breastfeeding should be discontinued.

Contraindications

• hypersensitivity to betamethasone or any of the excipients of the drug, or other corticosteroids;
• systemic mycoses;
• intravenous, subcutaneous, epidural, intrathecal use;
• injection directly into muscle tendons;
• with intraarticular injection: an unstable joint, infectious arthritis;
• introduction to the infected cavity and into the intervertebral space;
• children’s age up to 3 years (the presence of benzyl alcohol);
• coagulation disorders (incl. treatment with anticoagulants);
• breastfeeding;
• simultaneous use of immunosuppressive doses of live and attenuated vaccines;
• thrombocytopenic purpura (intramuscular injection);
• swelling of the brain due to traumatic brain injury.

With caution

• Parasitic and infectious diseases of a viral, fungal or bacterial nature (currently or recently transmitted, including recent contact with the patient) – herpes simplex, herpes zoster (viremic phase), chickenpox, measles; amoebiasis, strongyloidosis (established or suspected); active and latent tuberculosis. Use in severe infectious diseases is permissible only against the background of specific antimicrobial therapy.
• Post-vaccination period (a period lasting 8 weeks before and 2 weeks after vaccination), lymphadenitis after BCG vaccination.
• Immunodeficiency conditions (including AIDS or HIV infection).
• Diseases of the gastrointestinal tract (GIT): peptic ulcer of the stomach and duodenum, esophagitis, gastritis, acute or latent peptic ulcer, newly created intestinal anastomosis, ulcerative colitis with the threat of perforation or abscessing, diverticulitis, abscess or other purulent infections.
• Diseases of the cardiovascular system, including recent myocardial infarction (in patients with acute and subacute myocardial infarction, the spread of necrosis may occur, the formation of scar tissue may slow down and the resulting rupture of the heart muscle); decompensated chronic heart failure; arterial hypertension, hyperlipidemia.
• Endocrine diseases – diabetes mellitus (including decreased glucose tolerance), thyrotoxicosis, hypothyroidism, Itsenko-Cushing’s disease.
• Chronic renal and / or hepatic insufficiency, nephrourolithiasis, cirrhosis of the liver.
• Hypoalbuminemia and conditions predisposing to its occurrence.
• Systemic osteoporosis, grade III-IV obesity, myasthenia gravis, acute psychosis, polio (except for bulbar encephalitis), open-and closed-angle glaucoma, eye diseases caused by Herpes simplex (due to the risk of corneal perforation), pregnancy.
• In elderly patients due to hypersensitivity to corticosteroids, especially in postmenopausal women (high risk of osteoporosis).
• In case of convulsive syndrome.
• For intra-articular use: general serious condition of the patient, ineffectiveness (or short duration) of the previous 2 injections (taking into account the individual properties of the corticosteroids used).

Precautions should be taken in elderly patients due to hypersensitivity to corticosteroids, especially in postmenopausal women (high risk of osteoporosis); in convulsive syndrome.

Side effects

The frequency and severity of adverse reactions, as with other corticosteroids, depend on the amount of the dose used and the duration of use of the drug. These reactions are usually reversible and can be eliminated or reduced by reducing the dose.

Immune system disorders: allergic or anaphylactic reactions, including anaphylactic shock, angioedema.

From the nervous system: convulsions, increased intracranial pressure with edema of the optic disc (usually at the end of therapy), dizziness, headache, neuritis, neuropathy, paresthesia, with intrathecal use – arachnoiditis, meningitis, paresis/paralysis, sensory disorders.

From the side of the psyche: euphoria, mood changes, depression (with pronounced psychotic reactions), personality disorders, increased irritability, insomnia.

Visual disorders: posterior subcapsular cataract, increased intraocular pressure, glaucoma, exophthalmos; blurred vision; in rare cases – blindness (when the drug is administered in the face and head).

Cardiac disorders: chronic heart failure (in predisposed patients), cardiac arrhythmias, bradycardia, tachycardia, hypertrophic myopathy in premature infants, myocardial rupture after a recent myocardial infarction.

Vascular disorders: decreased blood pressure, increased blood pressure, thromboembolic complications, vasculitis.

From the endocrine system: secondary adrenal insufficiency (especially during periods of stress during illness, trauma, or surgery); Itsenko-Cushing syndrome; decreased glucose tolerance; “steroid” diabetes mellitus or latent diabetes mellitus; increased need for insulin or oral hypoglycemic drugs; when used during pregnancy – violation of intrauterine development of the fetus; growth retardation and sexual development in children; hirsutism; hypertrichosis; suppression of the function of the adrenal glands and pituitary gland.

Metabolic and nutritional 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, increased appetite.

Gastrointestinal disorders: erosive and ulcerative lesions of the gastrointestinal tract with possible subsequent perforation and bleeding, pancreatitis, flatulence, hiccups, nausea.

Liver and biliary tract disorders: hepatomegaly, increased activity of “liver” enzymes (usually reversible).

Musculoskeletal and connective tissue disorders: 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 or humeral head, pathological fractures of the tubular bones, tendon tears, joint instability (with repeated intra-articular injections).

Skin and subcutaneous tissue disorders: impaired wound healing, atrophy and thinning of the skin, petechiae, ecchymosis, increased sweating, dermatitis, “steroid” acne, striae, tendency to develop pyoderma and candidiasis, decreased reaction during skin tests, urticaria, rash, thinning of the scalp, allergic dermatitis, erythema.

Disorders of the genitals and breast: violation of the menstrual cycle, changes in motility and sperm count.

General disorders and disorders at the injection site: rarely-hyper-or hypopigmentation, subcutaneous and cutaneous atrophy, aseptic abscesses, ” rush ” of blood to the face after injection (or intra-articular injection), neurogenic arthropathy.

Interaction

CORTICOSTEROIDS (including betamethasone) are metabolized by the enzyme CYP3A4.

Concomitant use with strong CYP3A4 inhibitors (for example, ketoconazole, itraconazole, clarithromycin, ritonavir, or drugs containing cobicistat) may lead to increased exposure to corticosteroids and, consequently, to an increased risk of developing systemic HP. Concomitant use of betamethasone and strong CYP3A4 inhibitors should be avoided if the expected benefit of corticosteroid therapy does not exceed the risk of developing systemic HP. If concomitant use of betamethasone with strong CYP3A4 inhibitors is necessary, patients should be carefully monitored for the risk of developing systemic HP.

Simultaneous use of phenobarbital, rifampicin, phenytoin or ephedrine may accelerate the metabolism of betamethasone with a decrease in its therapeutic activity.

When concomitant use of betamethasone and estrogens may require adjustment of the dose of betamethasone (due to the risk of overdose).

With the combined use of betamethasone and potassium-withdrawing diuretics, the likelihood of hypokalemia increases.

Concomitant use of corticosteroids and cardiac glycosides increases the risk of arrhythmia or digitalis intoxication (due to hypokalemia). Betamethasone may increase the excretion of potassium caused by amphotericin B.

With the combined use of betamethasone and oral anticoagulants, changes in blood clotting may occur, requiring dose adjustment of anticoagulants.

Combined use of corticosteroids with nonsteroidal anti-inflammatory drugs (NSAIDs) or with ethanol (or ethanol-containing drugs) may increase the frequency or intensity of erosive and ulcerative lesions of the gastrointestinal tract.

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

Concomitant use of corticosteroids and somatropin may slow down the absorption of the latter (doses of betamethasone exceeding 0.3-0.45 mg/m of body surface area per day should be avoided).

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

Aminoglutetimide may cause increased or decreased adrenal cortical suppression caused by corticosteroids. Aminoglutetimide causes a decrease in the secretion of cortisol by the adrenal glands, followed by an increase in the secretion of pituitary adrenocorticotropic hormone (ACTH), which can neutralize the blockade of the synthesis of adrenocortical steroids by aminoglutetimide, leading to increased adrenal function. Therefore, doctors should be advised to read information about the concomitant use of Diprometa with aminoglutetimide.

CORTICOSTEROIDS may reduce the effect of cholinesterase inhibitors, which may lead to severe muscle weakness in patients with myasthenia gravis. If possible, cholinesterase inhibitors should be discontinued at least 24 hours before starting corticosteroid therapy.

With the simultaneous use of corticosteroids and isoniazid, a decrease in the concentration of isoniazid in blood plasma is possible. Patients taking isoniazid should be carefully monitored.

Concomitant use of cyclosporine and corticosteroids may lead to an increase in the concentration of cyclosporine and an increase in the effect of corticosteroids. There is a high risk of developing seizures.

Concomitant use of corticosteroids with macrolide antibiotics may significantly reduce the excretion of corticosteroids.

When used concomitantly with colesteramine, it is possible to increase the excretion of corticosteroids.

When using betamethasone in patients with diabetes mellitus, correction of hypoglycemic therapy may be required.

How to take, course of use and dosage

Intramuscular, intra-articular, periarticular, intrabursal, intradermal, interstitial and intra-focal injections.

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

DO NOT INJECT INTRAVENOUSLY! DO NOT INJECT SUBCUTANEOUSLY!

Strict compliance with the rules of asepsis is mandatory when using the drug Diprometa.

The syringe should be shaken before use.

The dosage regimen and method of use are set individually depending on the indications, the severity of the disease and the patient’s reaction.

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

Intramuscular (i/m) use of the drug should be carried out deep into the muscle, while choosing large muscles and avoiding contact with other tissues (to prevent atrophic tissue changes).

The drug is administered intravenously:

• in severe conditions that require emergency measures, the initial dose is 2 ml;
• in various dermatological diseases, as a rule, the introduction of 1 ml of Dipromet is sufficient;
• in diseases of the respiratory system. The onset of action of the drug occurs within a few hours after intravenous use of the drug. In bronchial asthma, hay fever, allergic bronchitis and allergic rhinitis, a significant improvement in the condition is achieved after use of 1-2 ml of Dipromet;
• in the treatment of acute and chronic bursitis,1 ml or 2 ml of Dipromet is administered intravenously. If necessary, the drug can be administered again.

If a satisfactory clinical response does not occur after a sufficient period of time, the drug Diprometa should be discontinued and another therapy should be prescribed.

When administered topically, concomitant use of a local anesthetic is necessary only in rare cases. If it is desired, Diprometa can be mixed in a syringe with a 1% or 2% procaine or lidocaine solution that does not contain methylparaben, propylparaben, phenol and other similar substances. A local anesthetic is taken from the ampoule into the Diprometa syringe and shaken for a short period of time.

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

In acute tendosynovitis, tendinitis and peritendinitis, one injection of Dipromet improves the patient’s condition; in chronic cases, the injection is repeated depending on the patient’s reaction. Avoid injecting the drug directly into the tendon.

Intra-articular use of Diprometa in a dose of 0.5-2 ml relieves pain, reduces the restriction of joint mobility in rheumatoid arthritis and osteoarthritis within 2-4 hours after use. The duration of therapeutic action varies significantly and can be 4 or more weeks.

Recommended doses of the drug when administered in large joints (for example, knee or hip) make from 1 to 2 ml; in the middle (for example, ulnar) – 0.5-1 ml; in small (for example, joints of the hands) – 0.25-0.5 ml.

For dermatological diseases: Diprometa should be administered intradermally directly into the lesion site. If the drug is not administered directly into the affected tissue, then a mild systemic effect of the drug may develop in response to therapy. Diprometa is administered intradermally (not subcutaneously) at the rate of 0.2 ml / cm2. The total amount of Diprometa administered at all sites during each week should not exceed 1 ml. For injection into the lesion, it is recommended to use a tuberculin syringe with a 26 G needle.

Recommended single doses (with an interval between injections of 1 week): bursitis under the petrifaction – 0.25-0.5 ml (usually 2 injections are effective); bursitis under the heel spur-0.5 ml; bursitis with limited mobility of the big toe-0.5 ml; synovial cyst-0.25-0.5 ml; tendosynovitis-0.5 ml; acute gouty arthritis-0.5-1 ml.

A tuberculin syringe with a 25 G needle is suitable for most injections.

After the therapeutic effect is achieved, the maintenance dose of the drug is selected by gradually reducing the dose administered at appropriate time intervals. The reduction is continued until the minimum effective dose is reached.

If a stressful situation occurs (or threatens to occur) that is not related to an existing disease, it may be necessary to increase the dose of Diprometa.

Discontinuation of the drug after prolonged therapy is carried out by gradually reducing the dose.

Monitoring of the patient’s condition is carried out for at least one year after the end of long-term therapy or the use of Diprometa in high doses.

Overdose

Symptoms

Acute overdose of betamethasone does not lead to life-threatening situations. use of high doses of corticosteroids for several days does not lead to undesirable consequences (except in cases of very high doses or if the patient has diabetes mellitus, glaucoma, exacerbation of erosive and ulcerative lesions of the gastrointestinal tract, or with simultaneous use of cardiac glycosides, indirect anticoagulants or potassium-withdrawing diuretics).

Treatment

Careful medical monitoring of the patient’s condition is necessary; optimal fluid intake should be maintained and the content of electrolytes in plasma and urine (especially the ratio of sodium and potassium ions) should be monitored. If necessary, appropriate therapy should be performed.

Description

Suspension containing white or almost white particles, easily resuspended, without agglomerate formation. It does not contain extraneous inclusions. When lightly shaken, a white or slightly yellowish suspension is obtained.

Special instructions

Severe nervous system complications (up to fatal) have been reported with epidural and intrathecal use of corticosteroids (with or without X-ray control), including but not limited to spinal cord infarction, paraplegia, quadriplegia, cortical blindness, and stroke. Since the safety and efficacy of epidural corticosteroids have not been established, this method of use is not indicated for this group of drugs.

Recommended methods of use are listed in the section “Dosage and use”.

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.

Rare cases of anaphylactoid/anaphylactic reactions (up to the development of anaphylactic shock) have been reported with parenteral use of corticosteroids. Necessary precautions should be taken before use of the drug, especially if the patient has a history of allergic reactions to corticosteroids.

The dosage regimen and method of use are set individually, depending on the indications, the severity of the disease and the patient’s reaction.

The dose should be as small as possible, and the period of use as short as possible. The initial dose is selected until the desired therapeutic effect is achieved. Then gradually reduce the dose of Dipromet to the minimum effective maintenance dose. If there is no effect from the therapy or if it is used for a long time, the drug is also canceled, gradually reducing the dose.

If a stressful situation (not related to the disease) occurs or threatens to occur, it may be necessary to increase the dose of Diprometa.

Monitoring of the patient’s condition is carried out for at least one year after the end of long-term therapy or use in high doses.

The introduction of the drug into soft tissues, into the lesion site and intra-articularly can simultaneously lead to a systemic effect with a pronounced local effect.

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

Against the background of the use of Diprometa, the patient may experience increased emotional instability or a tendency to psychosis.

When using Diprometa in patients with diabetes mellitus, correction of hypoglycemic therapy may be required.

Patients receiving corticosteroids should not be vaccinated against smallpox.Other immunizations should not be performed in patients receiving corticosteroids (especially in high doses), due to the possibility of neurological complications and a low immune response (lack of antibody formation). . However, immunization is possible with replacement therapy (for example, with primary adrenal insufficiency). Patients receiving Diprometa in immune-suppressing doses should be warned to avoid contact with patients with chickenpox and measles (especially important when using the drug in children).

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

When using Diprometa, it should be taken into account that corticosteroids can mask the signs of an infectious disease, as well as reduce the body’s resistance to infections.

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

Caution should be exercised when using the drug in patients with a high risk of infection (on hemodialysis or with dentures).

The use of Diprometa in active tuberculosis is possible only in cases of lightning-fast or disseminated tuberculosis in combination with adequate antitubercular therapy. When using Diprometa in patients with latent tuberculosis or a positive reaction to tuberculin, careful medical supervision is necessary due to the risk of reactivation of tuberculosis. With prolonged use of corticosteroids, such patients should receive specific chemotherapy. When using rifampicin prophylactically, the acceleration of hepatic clearance of betamethasone should be taken into account (it may be necessary to adjust its dose).

If there is fluid in the joint cavity, the septic process should be excluded. A marked increase in soreness, swelling, increased temperature of the surrounding tissues and further restriction of joint mobility indicate septic arthritis. It is necessary to conduct a study of aspirated joint fluid. If the diagnosis is confirmed, appropriate antibacterial therapy should be prescribed. The use of Diprometa in septic arthritis is contraindicated.

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

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

Long-term use of corticosteroids can lead to posterior subcapsular cataracts (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 ophthalmological examination, especially in patients receiving Diprometa for more than 6 months.

The use of medium and high doses of corticosteroids can lead to increased blood pressure, sodium and fluid retention in the body and 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). In this case, the need to prescribe potassium-containing drugs and a diet with a restriction of table salt should be considered. All corticosteroids enhance the excretion of calcium.

When Diprometa is used concomitantly with cardiac glycosides or drugs that affect the electrolyte composition of plasma, monitoring of the water-electrolyte balance is required.

With caution, acetylsalicylic acid is used in combination with betamethasone for hypoprothrombinemia.

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

The development of secondary adrenal cortical insufficiency due to too rapid withdrawal of corticosteroids is possible within a few months after the end of therapy. If a stressful situation occurs or threatens to occur during this period, therapy with Diprometa should be resumed and a mineralocorticoid should be prescribed simultaneously (due to a possible violation of mineralocorticoid secretion). Gradual withdrawal of corticosteroids reduces 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 corticosteroid therapy, it is advisable to consider switching from parenteral to oral corticosteroid use, taking into account the assessment of the benefit/risk ratio.

Caution should be exercised when using CORTICOSTEROIDS in elderly patients; in patients with ulcerative colitis at risk of perforation, with abscess or other purulent infections, diverticulitis, with the presence of recently created intestinal anastomoses, active or latent peptic ulcer of the stomach and/or intestines, renal or hepatic insufficiency, arterial hypertension, osteoporosis, myasthenia gravis, confirmed or suspected parasitic infections (for example, strongyloidosis).

With systemic and local (including intranasal, inhaled and intraocular) use of corticosteroids, visual impairment may occur. If the patient has symptoms such as blurred vision or other visual disturbances, then it should be decided to refer him to an ophthalmologist to identify possible causes, including cataracts, glaucoma, or rare diseases, such as central serous chorioretinopathy (CSC), which have been observed in some cases with systemic or topical corticosteroids.

Application in pediatrics

Children undergoing Diprometa therapy (especially long-term ones) should be closely monitored for possible growth retardation and secondary adrenal insufficiency.

Use in athletes

Patients participating in competitions under the supervision of the World Anti-Doping Agency (WADA) should read the WADA rules before starting treatment with the drug, since the use of betamethasone may affect the results of doping control.

Influence on the ability to drive vehicles and mechanisms

There are no data on the effect of betamethasone on the ability to drive vehicles and mechanisms. However, if adverse reactions (blurred vision, dizziness, insomnia) occur during long-term treatment, you should refrain from driving vehicles and mechanisms.

Form of production

Suspension for injection 7 mg / ml.

1.0 ml of the drug in a pre-filled syringe with a capacity of 2.25 ml made of colorless glass, equipped with a piston, piston rod and a control flange.

A label is placed on the syringe.

One syringe is placed in a contour cell package made of PVC, sealed with unmarked aluminum foil or PET/PE foil. One blister together with a needle (size 0.8 x 40 mm) and instructions for use are placed in a cardboard pack.

Storage conditions

At a temperature not exceeding 25 °C, in the original packaging (in a pack). Keep out of reach of children.

Shelf

life is 2 years. Do not use after the expiration date!

Active ingredient

Betamethasone

Conditions of release from pharmacies

By prescription

Dosage form

suspension for injection