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Flosteron - instructions for use, reviews, analogs and forms of release (injections in ampoules for injections in the form of a suspension, including intra-articular) drug for the treatment of arthrosis, allergies in adults, children and pregnancy. Composition

Flosteron - instructions for use, reviews, analogs and forms of release (injections in ampoules for injections in the form of a suspension, including intra-articular) drug for the treatment of arthrosis, allergies in adults, children and pregnancy. Composition

In this article, you can read the instructions for using the drug Flosteron. Presented are reviews of visitors to the site - consumers of this medication, as well as opinions of doctors specialists on the use of Flosteron in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues of Flosteron in the presence of existing structural analogues.Use for the treatment of arthrosis, allergies, inflammation in adults, children, as well as during pregnancy and lactation. Composition of the hormonal drug.

 

Flosteron - synthetic glucocorticosteroid (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 release of ACTH and beta-lipotropin, but does not reduce the level of circulating beta-endorphin. Oppressing the secretion of thyroid-stimulating hormone (TSH) and follicle-stimulating hormone (FSH).

 

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

 

Interacts with specific cytoplasmic receptors and forms a complex penetrating into the nucleus of the cell, and stimulates the synthesis of matrix RNA; the latter induces the formation of proteins, incl. lipocortin, mediating cellular effects. Lipocortin depresses phospholipase A2, inhibits the release of arachidonic acid and suppresses the synthesis of endoperoxides,prostaglandin (Pg), leukotrienes, contributing to the processes of inflammation, allergies, etc.

 

Protein metabolism: reduces the amount of protein in the 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 thyroid-stimulating hormone (TG), redistributes fat (accumulation of fat mainly in the shoulder region, face of the abdomen), leads to the development of hypercholesterolemia.

 

Carbohydrate metabolism: increases the absorption of carbohydrates from the digestive tract; 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 the activation of gluconeogenesis.

 

Water-electrolyte exchange: delays Na and water in the body, stimulates the excretion of K (mineralocorticosteroid activity), reduces absorption of Ca from the digestive tract, "flushes" Ca from the bones, increases the excretion of Ca by the kidneys. The anti-inflammatory effect is associated with the inhibition of eosinophil release by inflammatory mediators; inducing the formation of lipocortin and reducing the number of mast cells,producing hyaluronic acid; with a decrease in the permeability of capillaries; stabilization of cell membranes and membranes of organelles (especially lysosomal).

 

Antiallergic effect develops by inhibiting synthesis and secretion of mediators of allergy, inhibition of release from sensitized mast cells and basophils, histamine, and others. Bioactive substances, T and B lymphocytes, mast cells, effector cells, reducing sensitivity to the mediators of allergy, inhibition of antibody production, changes immune response of the body.

 

In COPD action it is based primarily on the inhibition of inflammation, inhibition or prevention of development of mucosal edema, inhibition of eosinophil infiltration bronchial epithelium submucosal layer deposition in the bronchial mucosa of circulating immune complexes, and the braking erozirovaniya and mucosal desquamation. Sensitizing bronchial β-adrenoceptors small and medium caliber to endogenous catecholamines and exogenously sympathomimetics, reduces the viscosity of mucus due to inhibition or reduction of its production.

 

Antishock and toxic effect associated with increased blood pressure (by increasing the concentration of circulating catecholamines and restore sensitivity thereto adrenoceptors and vazokonsggoihtsii), decreased vascular permeability, membrane-protective properties, activation of liver enzymes involved in the metabolism of endo- and xenobiotics. Immunosuppressive effect is due to inhibition of the release of cytokines (interleukin-1, interleukin-2; interferon-gamma) from lymphocytes and macrophages. It inhibits the synthesis and secretion of adrenocorticotropic hormone (ACTH), and a second synthesis of endogenous corticosteroids. It inhibits connective tissue reactions during the inflammatory process and reduces the possibility of scar tissue formation. Betamethasone sodium phosphate is highly soluble compound, which is well absorbed after parenteral administration into the tissue, 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 application (intramuscularly, intraarticularly, periarticularly, intradermally), a general or local effect is achieved.

 

Composition

 

Betamethasone disodium phosphate + Betamethasone dipropionate + auxiliary substances.

 

Pharmacokinetics

 

After intra-articular injection, Cmax in plasma is reached after 30 minutes. Plasma binds to proteins. Easily passes gistogematicheskie barriers, including placental. Metabolized in the liver with the formation of predominantly inactive metabolites. It is excreted by the kidneys, a small amount - by bile, in part - with breast milk.

 

Indications

 

Local treatment:

  • intraarticular and periarticular administration of inflammatory rheumatic diseases (rheumatoid arthritis, seronegative spondylitis, arthritis in systemic connective tissue diseases), posttraumatic arthritis, psoriatic arthritis with multiple joint damage and tenosynovitis, with crystalline arthritis;
  • intraarticular administration with degenerative rheumatic diseases, especially in the presence of synovitis (not applicable for arthrosis of the hip joint);
  • inflammatory lesions of periarticular tissues (bursitis, tendinitis, tenosynovitis, epicondylitis, plantar fasciitis);
  • introduction to the lesion for the treatment of skin diseases in rare cases (if there is no reaction to other methods of local therapy): sclerosing folliculitis, keloids, ring-shaped granuloma, sarcoidosis of the skin, diabetic lipodystrophy (liponecrosis), psoriasis, alopecia areata, flat red lichen, neurodermatitis, coin-like eczema, discoid lupus erythematosus.

 

Systemic treatment:

  • the systemic effect of Flosteron is used in certain severe allergic diseases: allergic rhinitis, asthmatic status, Quincke's edema, allergic reactions to medicines and serums, insect bites.

 

Forms of release

 

Suspension for injection (injections in ampoules).

 

Other dosage forms, be it tablets, ointment or cream for external use at the time of publication of the drug in the Directory did not exist.

 

Instructions for use and how to use them

 

The route of administration is parenteral (intraarticular, periarticular, intradermal, introduction to the affected tissue and, in exceptional situations, intramuscular injection).

 

The dose for adults and children should be determined individually, depending on the size of the joint, the severity, the nature of the disease and the patient's reaction.

 

Intraarticular and periarticular administration

  • very large joints (hip) - 1-2 ml;
  • large joints (knee, shoulder, ankle) - 1 ml;
  • joints of medium size (elbow, wrist) - 0.5-1 ml;
  • small joints (sternoclavicular, metacarpophalangeal, interphalangeal) - 0.25-0.5 ml. In acute gouty arthritis, 0.5 to 1 ml is used.

 

Injections into large joints - no more often 3-4 times a year in one joint.

 

Introduction to the lesion (intradermally, but not subcutaneously)

 

A single dose should not exceed 0.2 ml / cm2, and the total weekly dose administered to all affected areas should not exceed 1 ml / week.

 

Local infiltration:

  • bursitis - 0.25-1 ml (in the acute stage to 2 ml),
  • tenosynovitis, tendonitis - 0.5 ml,
  • fibrositis - 0.5-1 ml.

 

The preparation is repeated every 1-2 weeks.

 

If necessary, the drug can be mixed in one syringe with a local anesthetic.

 

Systemic administration in severe allergic diseases

 

Only a single dose of 1 to 2 ml can be used (intramuscularly, but not intravenously)

 

The drug should be injected deep into the muscle in the gluteal region.

 

Children aged 3 to 5 years the initial dose of 2 mg, which corresponds to 0.3 ml of the drug, 6-12 years - 4 mg, which corresponds to 0.5-0.6 ml of the drug.

 

Side effect

  • decreased glucose tolerance;
  • Steroid diabetes mellitus or manifestation of latent diabetes mellitus;
  • oppression of adrenal function;
  • Isenko-Cushing syndrome (moonlike face, pituitary-type obesity, bovine hump, hirsutism, increased blood pressure, dysmenorrhea, amenorrhea, muscle weakness, striae);
  • delay in sexual development in children;
  • nausea, vomiting;
  • pancreatitis;
  • erosive esophagitis;
  • steroid ulcer of 12 duodenum;
  • bleeding and perforation of the gastrointestinal tract (black stool, vomiting "coffee grounds");
  • increased or decreased appetite;
  • flatulence;
  • hiccough;
  • increased activity of hepatic transaminases and alkaline phosphatase;
  • oropharyngeal candidiasis;
  • abdominal pain;
  • arrhythmias;
  • bradycardia (up to cardiac arrest);
  • development (in predisposed patients) or increased manifestation of heart failure;
  • changes in ECG, characteristic of hypokalemia;
  • increased blood pressure;
  • hypercoagulation;
  • vein thrombosis;
  • affective insanity;
  • depression;
  • disorientation;
  • euphoria;
  • hallucinations;
  • paranoia;
  • nervousness or anxiety;
  • insomnia;
  • dizziness;
  • pseudotumor of the cerebellum;
  • headache;
  • increased intracranial pressure;
  • convulsions;
  • sudden loss of vision (possibly the deposition of drug crystals in the chambers of the eye);
  • posterior subcapsular cataract;
  • increased intraocular pressure with possible damage to the optic nerve;
  • propensity to develop secondary bacterial, fungal or viral infections of the eyes;
  • trophic changes of the cornea;
  • weight gain;
  • fluid retention and sodium (peripheral edema);
  • hypokalemic syndrome (arrhythmia, myalgia or muscle spasm, unusual weakness and fatigue);
  • slowing growth and ossification processes in children (premature closure of epiphyseal growth zones);
  • osteoporosis (very rarely pathological bone fractures, aseptic necrosis of the head of the humerus and femur);
  • rupture of muscle tendons;
  • steroid myopathy;
  • decrease in muscle mass (atrophy);
  • weakness of the proximal muscles, especially in the hands and feet;
  • petechiae;
  • ecchymosis;
  • hyper or hypopigmentation;
  • propensity to develop pyoderma and candidiasis;
  • delayed healing of wounds;
  • skin atrophy;
  • thinning of the skin;
  • steroid acne or acne;
  • stria;
  • skin rash;
  • itching;
  • anaphylactic shock;
  • local allergic reactions;
  • bronchospasm (in patients with bronchial asthma due to the content of metabisulphites);
  • eosinophilia;
  • backache;
  • development of opportunistic infections (this side effect is promoted by jointly used immunosuppressants and vaccination);
  • leukocyturia;
  • leukocytosis;
  • withdrawal syndrome after abrupt discontinuation of drug use;
  • burning, numbness, pain, tingling at the injection site;
  • infection at the injection site;
  • necrosis of surrounding tissues;
  • scar formation at the injection site;
  • atrophy of the skin and subcutaneous tissue with intramuscular injection (especially dangerous is the introduction to the deltoid muscle).

 

Contraindications

  • peptic ulcer of the stomach or duodenum, newly created intestinal anastomosis, diverticulitis;
  • osteoporosis;
  • tuberculosis;
  • glaucoma;
  • diabetes;
  • thrombophlebitis;
  • acute viral, bacterial, fungal, systemic infections (in cases when appropriate therapy is not performed);
  • the Itenko-Cushing syndrome;
  • condition after surgery and serious injuries;
  • post-vaccination period (8 weeks before and within 2 weeks after vaccination);
  • idiopathic thrombocytopenic purpura (i / m administration);
  • infectious (septic) inflammatory process in the joint and periarticular infections (including in the anamnesis);
  • absence of signs of inflammation in the joint (so-called, "dry" joint, for example, with osteoarthritis without synovitis);
  • previous arthroplasty;
  • over-joint fracture of bone;
  • severe bone destruction and joint deformity (a sharp narrowing of the joint space, ankylosis);
  • joint instability as the outcome of arthritis;
  • Introduction to the Achilles tendon;
  • aseptic necrosis of the joints forming the epiphyses of bones;
  • pathological hemorrhage (endogenous or caused by the use of anticoagulants);
  • lactation period;
  • Flosteron contains benzyl alcohol, so the drug is contraindicated in newborns and children up to 3 years;
  • hypersensitivity to betamethasone or any other ingredient in the drug.

 

Application in pregnancy and lactation

 

Use Flosteron only when the potential benefit from their use for the mother exceeds the potential risk of therapy for the fetus.When pregnancy is usually recommended the use of the smallest doses of glucocorticosteroids, providing control of a disease. Children born to mothers who received SCS during pregnancy should be carefully screened to identify possible signs of adrenal insufficiency. SCs penetrate the placental barrier and can reach high concentrations in the fetus.

 

In small amounts, GCS penetrates into breast milk. Therefore, breast-feeding during therapy with GCS drugs is not recommended.

 

Use in children

 

Carefully.

 

Flosteron contains benzyl alcohol, so the drug is contraindicated in newborns and children up to 3 years.

 

Application in elderly patients

 

Carefully.

 

special instructions

 

The suspension of Flosteronum can not be administered intravenously.

 

Intraarticular and periarticular administration should be carried out by a specially trained specialist.

 

With topical application of the drug in all cases, it is necessary to assess its compatibility with concurrently administered local anesthetics. Mixing with an equal volume of solutions of local anesthetics (1% solution of procaine hydrochloride or 1% solution of Lidocaine hydrochloride) is allowed in a syringe, but not in an ampoule.

 

It can not be used for the treatment of hyaline-membrane disease of newborns, enter into infected areas and intervertebral spaces.

 

With local (intra-articular) introduction of GCS, both local and systemic effects are possible.

 

Before and during the steroid therapy, it is necessary to monitor the general blood test, glycemia and glucosuria, and the electrolyte content in the blood plasma.

 

An appropriate study of the synovial fluid in each joint is necessary to exclude the septic process. A significant increase in pain, accompanied by local edema, further restriction of joint mobility, fever and malaise, suggests septic arthritis. If the diagnosis of sepsis is confirmed, appropriate antimicrobial therapy is necessary. With therapy during intercurrent infections, septic conditions, tuberculosis - concomitantly treated with antibiotics.

 

Do not enter into the "unstable" joints, in the Achilles tendon area due to the risk of rupture of this tendon.

 

Vaccination with live viral vaccines is contraindicated during SCS therapy.Immunization with killed viral or bacterial vaccines against the background of SCS does not provide the expected increase in the number of antibodies and does not give the expected protective effect. Therefore, these drugs should not be prescribed 8 weeks before and within 2 weeks after vaccination.

 

In patients who have not had chicken pox and are receiving treatment with GCS, the risk of chickenpox or herpetic infection increases with accidental contact with infected individuals. In such cases, passive immunization is recommended.

 

Caution is necessary in patients after operations and fractures of the bones, as SCS can slow the healing of wounds and fractures.

 

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

 

In the application of Flosteron against arterial hypertension, heart failure, diabetes mellitus, epilepsy, thromboembolism, myasthenia, glaucoma, hypothyroidism and severe liver damage, the risk of hypokalemia increases.

 

The use of Flosteron may alter the indices of hypersensitivity tests.

 

In children during the growth period, SCS should be used only in absolute indications and under the strictest supervision of the attending physician.

 

In patients with acute and subacute myocardial infarction, a foci of necrosis may spread, a delay in the formation of scar tissue and, as a result, a rupture of the heart muscle.

 

Metabisulfites in patients with bronchial asthma or in the presence of an allergy in an anamnesis can cause reactions of an allergic type, including anaphylaxis and bronchospasm.

 

0.6 mg of betamethasone is equivalent to 0.75 mg of dexamethasone, 4 mg of triamcinolone, 4 mg of methylprednisolone and 20 mg of Hydrocortisone (according to AMA, 1994).

 

Impact on the ability to drive vehicles and manage mechanisms

 

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

 

Drug Interactions

 

Combined use with non-steroidal anti-inflammatory drugs (NSAIDs) and ethanol (alcohol) increases the risk of gastrointestinal bleeding and ulceration.

 

Increases the risk of hepatotoxic effects of paracetamol.

 

The effectiveness of betamethasone decreases if it is administered simultaneously with rifampicin, carbamazepine, phenobarbital, phenytoin (diphenylhydantoin), primidon, Ephedrine and aminoglutethimide.

 

Increased risk: antipsychotic drugs, immunosuppressants (increasing the likelihood of infection, as well as lymphomas and other lymphoproliferative diseases.), Carbutamide, azathioprine (cataract), M-holinoblokatory, antihistamine drugs, tricyclic antidepressants, nitrates (increase in intraocular pressure) glycosides digitalis (arrhythmias associated with hypokalemia).

 

GCS reduces the therapeutic effect of antidiabetic drugs, antihypertensive agents, anticoagulants (coumarin and indanedione derivatives) and sodium nurets.

 

Flosteron reduces the effectiveness of anticoagulants (including heparin, streptokinase and urokinase), albendazole and potassium -uretic drugs.

 

With the simultaneous use of GCS in high doses and beta2-adrenomimetics, the risk of hypokalemia increases.

 

SCS increases the renal clearance of salicylates, and therefore, against the background of their action, it is sometimes difficult to achieve a therapeutic concentration of salicylates in the blood serum.

 

When simultaneous administration with androgens, estrogens, anabolic steroid, oral contraceptives, corticosteroids half-life can be extended, their effect is enhanced, and frequency of side effects (hirsutism, acne) increase.

 

The combined use of ritodrine and GCS is contraindicated, since with such a combination, the development of pulmonary edema is possible.

 

With simultaneous use with live antiviral vaccines and against the background of other types of immunization, the risk of virus activation and the development of infections increases.

 

Reduces the concentration of praziquantel in the blood serum.

 

Amphotericin B and carbonic anhydrase inhibitors increase the risk of osteoporosis.

 

It increases the toxicity of asparaginase (possibly increasing its hypoglycemic action and the risk of developing neuropathy and disturbing erythropoiesis).

 

Reduces the metabolism of cyclosporine, increase its toxicity.

 

Increases (with prolonged use) the content of folic acid. Increases the metabolism of isoniazid, mexiletine (especially in "fast acetylators"), which leads to a decrease in their plasma concentrations.

 

Mitotane and other inhibitors of the function of the adrenal cortex may necessitate increased doses of GCS.

 

Hypokalemia caused by SCS can increase the severity and duration of muscle blockade against the background of muscle relaxants.

 

Reduces the effect of growth hormone.

 

Increases the severity of hyperglycemic action of streptozocin.

 

Analogues of the drug Flosteron

 

Structural analogs for the active substance:

  • Acriderm;
  • Beloderm;
  • Beloderm Express;
  • Betazon;
  • Betamethasone sodium phosphate;
  • Betamethasone valerate;
  • Betamethasone dipropionate;
  • Betaspan Depot;
  • Betliben;
  • Betnoveit;
  • Diprospan;
  • Kuterid;
  • Celestoderm B;
  • Celeston.

 

Analogues on the curative effect (agents for the treatment of arthrosis):

  • Actasulide;
  • Alflutop;
  • Apranaks;
  • Arthra;
  • Arthrotheca;
  • Brufen;
  • Burana;
  • Voltaren Emulgel;
  • Glucosamine sulfate;
  • Dexaven;
  • Dexazone;
  • Dexamethasone phosphate;
  • Diklobene;
  • Dicluberl;
  • Dicloran;
  • Diclofenac;
  • Dimexide;
  • Diprospan;
  • Donalgin;
  • Don;
  • Ibuprofen;
  • Indomethacin;
  • Kenalog;
  • Clynoril;
  • Mesulide;
  • Miolastane;
  • Movasin;
  • Mukosat;
  • Naproxen;
  • Nimesulide;
  • Nimulid;
  • Nikofleks;
  • Niflugel;
  • Nifluryl;
  • Orthophene;
  • Piroxicam;
  • Polcortolone 40;
  • Rheumatic Gel;
  • Remoxicam;
  • Ronidase;
  • Rumalon;
  • Sanaprox;
  • Structum;
  • Tilcotyl;
  • Triamsinolone;
  • Fastum gel;
  • Feloran;
  • Feloran retard;
  • Floiled;
  • Chondrolon;
  • Cefecon H;
  • Cigapan;
  • The Unium.

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