Flosteron - instructions for use, dose, side effects, contraindications

Excipients: disodium phosphate dihydrate 2.50 mg, sodium chloride 5.00 mg, disodium edetate 0.10 mg, polysorbate 80 0.50 mg, benzyl alcohol 9.00 mg, methylparahydroxybenzoate 1.30 mg, propyl parahydroxybenzoate 0.20 mg, croscarmellose sodium 5.00 mg, macrogol (polyethylene glycol) 20.00 mg, hydrochloric acid, concentrated q.s.. water for injection up to 1.00 ml

Description:

The suspension is white, without visible mechanical impurities.

Pharmacotherapeutic group:glucocorticosteroid

ATX: & nbsp

H.02.A.B.01 Betamethasone

Pharmacodynamics:

Betamethasone - a synthetic GCS, inhibits the release of interleukin-1, interleukin-2, gamma-interferon from lymphocytes and macrophages. Has anti-inflammatory, antiallergic, desensitizing, anti-shock, antitoxic and immunosuppressive action. Suppresses pituitary adrenocorticotropic hormone release (ACTH) and beta-lipotropin, but does not reduce the concentration of circulating beta-endorphin in blood plasma. Oppressing the secretion of thyroid-stimulating hormone (TSH) and follicle-stimulating hormone (FSH).

Increases the excitability of the central nervous system (CNS), reduces the number of lymphocytes and eosinophils. Increases the number of erythrocytes (by increasing the production of erythropoietins).

It interacts with specific cytoplasmic receptors and forms a complex penetrating into the nucleus of the cell, and stimulates the synthesis of matrix ribonucleic acid (RNA), the latter induces the formation of proteins, including linocortin, which mediate cellular effects. Linocortin oppresses phospholipase A2, inhibits the release of arachidonic acid, and suppresses the synthesis of endoperoxides, prostaglandins (Pg), leukotrienes, contributing to the processes of inflammation, allergies, etc.

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, enhances protein catabolism in muscle tissue.

Lipid metabolism: increases the synthesis of higher fatty acids and triglycerides, redistributes fat (accumulation of fat mainly in the area of 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 an increase in the intake of glucose from the liver into the blood, increases the activity of phosphoenolpyruvate carboxylase and the synthesis of aminotransferases leading to activation of gluconeogenesis.

In one-electrolyte exchange: retards Na ions⁺ and water in the body, stimulates the elimination of ions K⁺(mineralocorticosteroid activity), reduces absorption of Ca²⁺ from the gastrointestinal tract, "wash out" the ions of Ca²⁺ from bones, increases the excretion of Ca²⁺ kidneys.

The anti-inflammatory effect is associated with the inhibition of eosinophil release by inflammatory mediators; inducing the formation of linocortin and reducing the number of mast cells that produce hyaluronic acid; with a decrease in the permeability of capillaries; stabilization of cell membranes and membranes of organelles (especially lysosomal).

The antiallergic effect develops as a result of suppression of synthesis and secretion of mediators of allergy, inhibition of release from sensitized mast cells and basophils histamine and other biologically active substances, T- and B-lymphocytes, mast cells, reducing the sensitivity of effector cells to mediators of allergy, inhibition of antibody formation, changes in the immune response of the body. In chronic obstructive pulmonary disease (COPD), the action is based primarily on inhibition of inflammatory processes, oppression of development or prevention of edema of the mucous membranes,inhibition of eosinophilic infiltration of the submucosal layer of bronchial epithelium, deposition of circulating immune complexes in the mucous membrane of the bronchi, as well as inhibition of erosion and desquamation of the mucosa. Increases the sensitivity of beta-adrenergic receptors of small and medium-sized bronchial tubes to endogenous catecholamines and exogenous sympathomimetics, reduces the viscosity of mucus due to oppression or reduction of its production.

The anti-shock and antitoxic effect is associated with an increase in blood pressure (BP) (due to an increase in the concentration of catecholamines circulating in the blood plasma and restoration of the sensitivity of adrenoreceptors to them, as well as vasoconstriction), a decrease in the permeability of the vascular wall, membrane-protective properties, activation of liver enzymes involved in endometrial metabolism - and xenobiotics.

Immunodepressive effect is due to inhibition of the release of cytokines (interleukin1, interleukin2, interferon gamma) from lymphocytes and macrophages. Suppresses the synthesis and secretion of ACTH and, again, the synthesis of endogenous GCS. 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 administration to tissues and provides a quick effect. Betamethasone dipropionate has a slower absorption. By combining these salts may create the drug with both short (but fast) and duration of action.

Depending on the method of administration (intravenously (intravenously), intramuscularly (in / m), intraarticularly, periarticularly, intradermally (in / to), a general or local effect is achieved.

Pharmacokinetics:

Betamethasone sodium phosphate is readily soluble in water and, after im injection, rapidly undergoes hydrolysis and is absorbed almost immediately from the injection site, which provides a rapid onset of therapeutic action. Virtually completely eliminated within one day after administration. Betamethasone dipropionate is slowly absorbed from the depot, metabolized gradually, which causes a prolonged effect of the drug and is withdrawn for more than 10 days.

Betamethasone binds well to blood 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 patients with a condition and diseases in which GCS therapy allows to achieve the necessary clinical effect (it must be taken into account that in some diseases GCS therapy is complementary and does not replace standard therapy):

- diseases of the musculoskeletal system and soft tissues, including rheumatoid arthritis, osteoarthrosis, bursitis, ankylosing spondylitis, epicondylitis, coccidia, torticollis, ganglionic cyst, fasciitis;

- allergic diseases, incl. bronchial asthma, hay fever (hay fever), allergic bronchitis, seasonal or all-the-year-round rhinitis, drug allergy, serum sickness, reactions to insect bites;

- dermatological diseases, including atopic dermatitis, coin-like 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, nodular periarteritis;

- hemoblastoses (palliative therapy of leukemia and lymphomas in adult patients, acute leukemia in children);

- primary or secondary insufficiency of the adrenal cortex (with simultaneous simultaneous application of mineralocorticosteroids);

- other diseases and pathological conditions requiring systemic corticosteroids therapy (adrenogenital syndrome, regional ileitis, the pathological changes of blood when necessary use of GCS therapy).

Contraindications:

- Hypersensitivity 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 cavities and into the intervertebral space;

- epidural, intrathecal administration and administration of the drug directly into the muscle tendons;

- violations of coagulation (including treatment with anticoagulants);

- simultaneous administration of immunosuppressive doses of the drug with live or weakened vaccines;

- cerebral edema due to craniocerebral trauma;

- the period of breastfeeding;

- children's age to 3 years (the presence of a gasoline alcohol).

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, strongyloidiasis (established or suspected), active and latent tuberculosis. The use in severe infectious diseases is permissible only against the background of specific therapy;

- postvaccination period (8 weeks before and 2 weeks after vaccination), lymphadenitis after BCG vaccination;

- immunodeficiency states (including acquired immune deficiency syndrome (AIDS) or human immunodeficiency virus (HIV) - infection);

- diseases of the gastrointestinal tract: peptic ulcer of stomach and duodenum, esophagitis, gastritis, acute or latent peptic ulcer, newly created intestinal anastomosis, ulcerative colitis with perforation or abscessing, diverticulitis, abscess or other purulent infections;

- diseases of the cardiovascular system, including the recently transferred myocardial infarction (in patients with acute and subacute myocardial infarction it is possible to spread a foci of necrosis,slowing the formation of scar tissue and, as a result, rupture of the heart muscle), uncompensated chronic heart failure (CHF), hypertension, hyperlipidemia;

- endocrine diseases - diabetes mellitus (including a decrease in glucose tolerance), thyrotoxicosis, hypothyroidism, Itenko-Cushing's disease;

- severe chronic renal and / or liver failure, nephrourolythiasis, liver cirrhosis;

- thrombocytopenic purpura (intramuscular injection);

- hypoalbuminemia and conditions predisposing to its occurrence;

- systemic osteoporosis, myasthenia gravis gravis, acute psychosis, obesity (III-IV degrees), 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;

- for intra-articular administration: the general severe condition of the patient, the ineffectiveness (or short-term) of the action of the previous two administrations (taking into account the individual properties used by the GCS);

- use in elderly patients due to increased sensitivity to GCS, especially in postmenopausal women (high risk of osteoporosis);

- with convulsive syndrome.

Pregnancy and lactation:

Due to the lack of controlled studies on the safety of the use of betamethasone in pregnancy, the use of Flosteron® during pregnancy or in women with preserved reproductive potential is only indicated if the expected therapeutic effect for the mother exceeds the risk of possible adverse effects of the drug on the fetus. Newborns, whose mothers received therapeutic doses of GCS during pregnancy, should be under medical supervision (for early detection of signs of adrenal insufficiency). SCs penetrate the placental barrier and can reach high concentrations in the fetus.

The use of GCS in pregnant animals can cause intrauterine malformations of the fetus, including the cleft palate ("cleft palate"), the retardation of intrauterine fetal development, and affect the growth and development of the brain. There are no indications that the use of GCS in humans leads to an increase in the occurrence of congenital malformations, such as cleft palate / lips. However, with prolonged or repeated use during pregnancy, the use of GCS may increase the risk of delaying intrauterine development of the fetus.Theoretically, after perinatal application of GCS, hypofunction of the adrenal glands in newborns is possible, which, as a rule, spontaneously passes after birth and in rare cases is clinically significant. Cases of myocardial hypertrophy and gastroesophageal reflux have been reported in newborns with betamethasone during pregnancy.

Like all drugs, SCS should be administered during pregnancy only if the potential benefit to the mother is significantly greater than the potential risk to the fetus. However, if you need to use SCS women with a normal pregnancy can receive SCS therapy, as if they were not pregnant. Careful monitoring of patients with gestosis of the second half of pregnancy or fluid retention (especially preeclampsia) should be carefully monitored.

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

Breastfeeding period

If you need to use Flosteron® during breastfeeding, given the importance of GCS treatment for the mother and the possibility of developing unwanted effects in the baby, breastfeeding should be discontinued.

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 with the use of the preparation Flosteron®.

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

Intramuscular injection of SCS should be performed deep in the muscle, choosing the large muscles and avoiding entering other tissues (to prevent atrophic changes).

The drug is given in / m:

- with heavy states, requiring emergency measures. The initial dose is 2 ml;

- with of various dermatological diseases, as a rule, it is sufficient to administer 1 ml of a suspension of the preparation Flosteron®;

- with diseases of the respiratory system the onset of action of the drug occurs within a few hours after intramuscular injection of the drug. When bronchial asthma, hay fever, allergic bronchitis and allergic rhinitis a significant improvement is achieved after the introduction of 1-2 ml of Flosteron^®;

- with acute and chronic bursitis. The initial dose for intramuscular injection 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, the Flosteron drug^® it is necessary to cancel and prescribe another therapy.

With local administration, simultaneous application of a local anesthetic is necessary only in rare cases. If desired, 1% or 2% solutions of procaine hydrochloride or lidocaine without methyl paraben, propylparaben, phenol and other similar substances are used. 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 the Flosteron® preparation. Then, in the same syringe, the required amount of local anesthetic is taken from the ampoule and shaken for a short period of time.

In acute bursitis (sub-deltoid, subscapular, elbow and prednadolenikovym) 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 peritendintah one injection of Flosteron® improves the patient's condition; 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 injection of Flosteron^® in a dose of 0.5-2 ml relieves pain, limiting the mobility of joints with 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.

Recommended doses of the Flosterone preparation when administered in large joints are from 1 to 2 ml, in medium - 0.5-1 ml, into small - 0.25-0.5 ml.

For some dermatological diseases effectively in / to the introduction of the drug Flosteron ® directly into the lesion, the dose is 0.2 ml / cm. The lesion is uniformly 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 the tuberculin width with a 25 gauge needle.

Recommended single doses of the preparation Flosteron® (with the interval between administrations 1 week) with bursitis: with homosexuality 0.25-0.5 ml (as a rule, 2 injections are effective), with a spur - 0.5 ml, with restriction of mobility of the thumb feet - 0,5 ml, with synovial cyst - 0,25-0,5 ml, with tendosinovitis - 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 achieving the therapeutic effect, the maintenance dose is selected by gradually reducing the dose of betamethasone administered at appropriate intervals. Reduction in the dose of Flosteron® 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 Flosteron®. 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 size of the dose and the duration of the drug. These phenomena are usually reversible and can be eliminated or reduced by lowering the dose.

Immune system disorders: anaphylactic reactions, anaphylactic shock, angioedema.

Disorders from the endocrine system: Suppression of function of adrenal and pituitary, secondary adrenal insufficiency (especially during stress at disease, trauma, surgery), Cushing's syndrome, decreased glucose tolerance, "steroid" diabetes or manifestation of latent diabetes mellitus, increase insulin requirements, or oral hypoglycemic drugs, delayed growth and sexual development in children, hirsutism, hypertrichosis.

Disorders from the metabolism and nutrition: Negative nitrogen balance (due to protein catabolism), lipomatosis (including mediastinal and epidural lipomatosis, which can cause neurological complications..), Weight gain, increased appetite, hypernatremia, increased excretion of potassium ions, an increase in excretion of calcium ions, hypokalemic alkalosis, fluid retention in tissues.

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

Impaired nervous system: convulsions, increased intracranial pressure with papilledema (usually by the end of treatment), dizziness, headache, neuritis, neuropathy, paresthesia,when intrathecal administration - arachnoiditis, meningitis, paresis / paralysis. sensory disturbances.

Disorders 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).

Heart Disease: CHF (in predisposed patients), heart rhythm disturbances, bradycardia, tachycardia, hypertrophic myopathy in premature infants, myocardial rupture after a recent myocardial infarction.

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

Disorders from the gastrointestinal tract: erosive and ulcerative lesions of the gastrointestinal tract with possible subsequent perforation and bleeding, flatulence, hiccups, nausea.

Disturbances from the liver and bile ducts: pancreatitis, hepatomegaly, increased activity of "liver" enzymes (usually reversible).

Disturbances from the skin and subcutaneous tissues: disruption of wound healing, atrophy and thinning of the skin, petechiae, ecchymosis, increased sweating,dermatitis, steroid acne, striae, a tendency to develop pyoderma and candidiasis, decrease reaction in skin tests, urticaria, skin rash, thinning of hair on the head, allergic dermatitis, erythema.

Disturbances from musculoskeletal and connective tissue: 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, tendon ruptures, joint instability (with repeated intraarticular injections ).

Violations of the genitals and mammary gland: violation of the menstrual cycle.

Pregnancy, postpartum and perinatal conditions: violation of intrauterine development.

General disorders and disorders at the site of administration (associated with parenteral administration of the drug): rarely - hyper- or hypopigmentation, subcutaneous and cutaneous atrophy, aseptic abscesses, blood flush to the skin of 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 for several days does not lead to undesirable consequences (with the exception of cases of very high doses or when used in diabetes mellitus, glaucoma, exacerbation of erosive-ulcerative lesions of the gastrointestinal tract, or simultaneous application of cardiac glycosides, indirect anticoagulants or potassium-withdrawing diuretics).

Treatment

A careful medical control of the patient's condition is necessary, optimal fluid intake should be maintained and the electrolyte content in the blood plasma and in the urine should be controlled (especially the ratio of sodium and potassium ions). If necessary, appropriate therapy should be provided.

Interaction:

With the simultaneous use of phenobarbital, rifampicin, phenytoin, aminoglutethimide 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, a dose adjustment of Flosteron may be required^® (because of the risk of overdose).

With the simultaneous use of the drug Flosteron® and potassium-releasing 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).

The drug Flosterone® can enhance the excretion of potassium ions caused by amphotericin B.

With the simultaneous use of the drug Flosteron^® and indirect anticoagulants are possible changes in blood clotting, requiring correction of the dose of anticoagulants.

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

With simultaneous application of 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 / m²body surface area per day).

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

When using Flosteron®, patients with diabetes mellitus may need to correct hypoglycemic therapy.

SCS can reduce the effects of cholinesterase inhibitors.

With simultaneous use with prednisolone, there was a decrease in the concentration of isoniazid in the blood plasma. Careful monitoring of the condition of patients taking isoniazid.

Simultaneous use of cyclosporine and GCS may lead to an increase in the effects of both drugs. There is a high risk of epileptic seizures.

At the same time, the use of certain GCS with isoenzyme inhibitors CYP3A4 (for example, macrolide antibiotics, ketoconazole) can reduce the excretion of GCS.

With simultaneous application with colestyramine, an increase in excretion of GCS is possible.

Special instructions:

The dosage regimen and the mode of administration 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 application as short as possible. The initial dose is selected until the necessary therapeutic effect is achieved.If after a sufficient period of time the therapeutic effect is not observed, the drug is canceled by gradually reducing the dose of Flosteron® and selecting another appropriate method of treatment.

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

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.

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

Given the likelihood of developing anaphylactoid reactions with parenteral administration of GCS,should take the necessary precautions before the introduction of the drug, especially if the patient has anamnestic indications of allergic reactions to medicines.

The drug Flosteron^®contains two active substances - derivatives of betamethasone, one of which - betamethasone sodium phosphate - quickly penetrates into the systemic bloodstream. When using the drug Flosterone^®should take into account the possible systemic action of the rapidly dissolving fraction of the drug.

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

The effect of SCS is enhanced in patients with cirrhosis or hypothyroidism.

When using Flosteron®, patients with diabetes mellitus may need to correct hypoglycemic therapy.

Patients receiving SCS should not be vaccinated against smallpox. Do not conduct and another immunizations for patients receiving SCS therapy (especially in high doses), due to the possibility of developing neurological complications and low response immune reaction (absence of antibody formation). The drug Flosteron^® should not be prescribed 8 weeks before and within 2 weeks after vaccination with killed or inactivated viral and antibacterial vaccines. However, immunization is possible with replacement therapy (for example, with primary adrenal insufficiency).

Patients who use the drug Flosteron^® in doses suppressing immunity, should be warned about the need to avoid contact with patients with chicken pox and measles (especially important when applying the drug to children).

When using Flosteron®, it should be borne in mind that SCS can mask the signs of an infectious disease, as well as reduce the body's resistance to infections. Application of the drug Flosteron^® with active tuberculosis is possible only in cases of fulminant or disseminated tuberculosis in combination with adequate antituberculous therapy. When using the drug Flosterone^® patients with latent tuberculosis or with a positive reaction to tuberculin should consider the issue of preventive antituberculous therapy. In the preventive use of rifampicin, acceleration of hepatic clearance of betamethasonecorrection of the dose is 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 are indicative of infectious arthritis. When confirming the diagnosis, antibacterial therapy should be prescribed.

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 corticosteroids may result in posterior subcapsular cataract (especially in children), glaucoma with possible lesion of the optic nerve and can promote the development of secondary ocular infections (fungal or viral). It is necessary to conduct an ophthalmological examination periodically, especially in patients using the Flosteron® preparation for more than 6 months.

When the increase in blood pressure, fluid retention and hypernatremia and increase excretion of potassium ions from the body (less probable,than with the use of other GCS), patients are recommended a diet with restriction of table salt and additionally prescribed potassium-containing drugs. All GCSs increase the excretion of calcium ions.

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

Caution is used acetylsalicylic acid concurrently with the preparation Flosteron^® with gipoprotrombinemii.

Development of secondary insufficiency of the adrenal cortex in communication with too rapid cancellation of GCS therapy 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 Flosteron® should be resumed and a mineralocorticosteroid drug should be given at the same time (due to a possible violation of the secretion of mineralocorticosteroids). The gradual elimination of GCS therapy reduces the risk of developing a secondary adrenal insufficiency.

It is possible to suppress the reaction when carrying out skin tests on the background of the use of GCS. Caution should be used in patients with hypothyroidism or myasthenia gravis gravis.

Special care must be taken when considering the possibility of systemic use of GCS in patients with active herpetic eye damage (keratitis caused by the herpes simplex virus).

Reported on the registration of cases of Kaposi's sarcoma in patients receiving SCS, the cancellation of this therapy can lead to remission of the disease.

Symptoms of irritation of the peritoneum or a reduction in pain syndrome with perforation of the walls of the stomach or intestine may be minimal or absent in patients receiving SCS.

The immunosuppressive effect of GCS can lead to activation of a latent infection or exacerbation of intercurrent infections, including infections caused by microorganisms: Candida, Mycobacterium, Toxoplasma, Strongyloides, Pneumocystis, Cryptococcus, Nocardia or Ameba. Special care should be taken when using GCS in patients with confirmed or suspected infection Strongyloides (eel intestinal). In such patients, GCS-induced immunosuppression may lead to hyperinfection Strongyloides and the spread of infection through migration of larvae, which is often accompanied by severe enterocolitis and septicemia caused by Gram-negative microorganisms, possibly with a fatal outcome.

Because GCS may exacerbate the course of latent amoebiasis, all patients with unexplained diarrhea or patients arriving from countries with tropical climates should be examined to exclude amoebiasis prior to GCS therapy.

If a stressful situation (not related to the disease) occurs or is threatened, it may be necessary to increase the dose of Flosteron®, and the preparations of hydrocortisone and cortisone should be the drugs of choice.

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

Pediatric Use

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

Fertility

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

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

During the treatment period it is necessary to refrain from driving motor vehicles and practicing potentially dangerous activities,requiring increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:

Suspension for injection, 7 mg / ml.

Packaging:

1 ml per ampoule of clear glass (ISO 9187-2-OPC-B-1-c1) with a colored dot at the fracture site of the ampoule.

5 ampoules are placed in a contour mesh box made of PVC / aluminum foil, which is placed together with the instructions for use in a cardboard pack.

Storage conditions:

In the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use the drug after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:П N015404 / 01

Date of registration:26.12.2008

The owner of the registration certificate:KRKA, dd, Novo mesto, AOKRKA, dd, Novo mesto, AO

Manufacturer: & nbsp

KRKA, d.d. Slovenia

Representation: & nbspKRKA, dd, Novo mesto, AOKRKA, dd, Novo mesto, AO

Information update date: & nbsp16.11.2015

Illustrated instructions

Instructions

Flosteron® (Flosteron® )