Hydrocortisone Richter (Hydrocortison-Richter)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceHydrocortisone + LidocaineHydrocortisone + Lidocaine
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  • Hydrocortisone Richter
    suspension in / Sust. 
    GEDEON RICHTER, OJSC     Hungary
    • Dosage form: & nbsp

    suspension for intraarticular and periarticular administration

    Composition:

    One bottle (5 ml) contains:

    Active substances: hydrocortisone acetate - 125 mg, lidocaine hydrochloride monohydrate - 26.66 mg (equivalent to lidocaine hydrochloride 25 mg).

    Excipients: propyl parahydroxybenzoate; methylparahydroxybenzoate; sodium chloride; sodium phosphate; sodium dihydrogen phosphate; povidone; polysorbate 80; N, Ndimethylacetamide; water for injections.

    Description:White or almost white suspension with a characteristic odor.
    Pharmacotherapeutic group:Glucocorticosteroid
    ATX: & nbsp

    H.02.A.B.09   Hydrocortisone

    Pharmacodynamics:

    Hydrocortisone acetate is a glucocorticosteroid. Has anti-inflammatory effect. Hydrocortisone inhibits the release of cytokines (interleukins and interferon) from lymphocytes and macrophages, inhibits the release of eosinophils mediators of inflammation, reduces the intensity of arachidonic acid metabolism and synthesis prostaglandins. Activates steroid receptors, induces the formation of lipocortins, which have anti-edema activity.Reduces inflammatory cell infiltration, prevents the migration of leukocytes and lymphocytes to the sites of inflammation. In large doses inhibits the development of lymphoid and connective tissue. By reducing the number of mast cells, reduces the formation of hyaluronic acid; suppresses hyaluronidase, helps reduce the permeability of capillaries. Intended for intramuscular, intra- and periarticular administration, with the aim of providing systemic or local anti-inflammatory action. With intraarticular administration, the therapeutic effect occurs within 6-24 hours and lasts for several days or weeks.|

    Lidocaine - a local anesthetic with a membrane-stabilizing effect, has an analgesic effect in a short time.

    Pharmacokinetics:

    With intraarticular and periarticular injection hydrocortisone penetrates into the systemic circulation. The connection with proteins is more than 90%. Metabolised in the liver in tetrahydrocortisone and tetrahydrocortisol, which are excreted by the kidneys in conjugated form. Penetrates through the placental barrier.

    Lidocaine is well absorbed, has a high affinity with plasma proteins.Metabolized mainly in the liver: Half-life - 1-2 hours. Lidocaine penetrates into breast milk, through the placental and blood-brain barrier.

    Indications:

    Rheumatic diseases accompanied by arthritis, including osteoarthritis in the presence of synovitis (except for tuberculosis, gonorrhea, purulent and other infectious arthritis); rheumatoid arthritis, humeroscapular periarthritis, bursitis, epicondylitis, tenosynovitis.

    Contraindications:

    Hypersensitivity to any of the components of the drug; an infected joint; the Itenko-Cushing syndrome; tendency to thrombosis; I trimester of pregnancy; systemic infection without specific treatment; Achilles tendon disease.

    Intra-articular administration is contraindicated in patients with arthroplasty, pathological bleeding (endogenous or induced by anticoagulants), intraarticular bone fracture, infectious (septic) arthritis and periarticular infection (including history), general infectious disease, expressed near-joint osteoporosis, osteoarthritis without synovitis called a "dry" joint), an unstable joint,aseptic necrosis forming the joint of the bones epiphyses, severe bone destruction and joint deformity (significant narrowing of the joint gap, ankylosis).

    Carefully:

    Peptic ulcer of the stomach and duodenum; simple herpes, including the eye (the possibility of perforation of the cornea of ​​the eye); arterial hypertension; diabetes mellitus, including in family history; osteoporosis (in the postmenopause the risk of osteoporosis increases); chronic psychotic reactions; a tuberculosis in the anamnesis; glaucoma; steroid myopathy; epilepsy; measles; chronic heart failure; elderly age (more than 65 years), pregnancy (II-III trimesters), lactation period.

    Pregnancy and lactation:
    Pregnant in the first trimester appointment Hydrocortisone-Richter is contraindicated because of the lack of sufficient data on the safety of the drug in this group. In the second and third trimesters of pregnancy and lactating women, Hydrocortisone-Richter is possible when the intended benefit to the mother exceeds the potential risk to the fetus or child.

    The use of hydrocortisone-Richter during lactation can lead to a disruption of adrenal function and a delay in the development of infants, hydrocortisone and lidocaine penetrate into breast milk.

    Dosing and Administration:

    Intra - and periarticular. One day Hydrocortisone-Richter can be injected into no more than 3 joints. Repeated injection is possible if a 3-week interval is observed. Introduction Hydrocortisone-Richter directly into the joint can have an adverse effect on hyaline cartilage, so the same joint can be treated no more than 3 times a year.

    With tendinitis, the injection should be done in the vagina of the tendon - you can not inject it directly into the tendon.

    Adults: at depending on the size of the joint and the severity of the disease, 5-50 mg intra-and periarticular.

    Children: 5-30 mg / day, divided into several doses. Single dose for periarticular administration for children aged 3 months. up to 1 year: 25 mg; from 1 year to 6 years: 25-50 mg; from 6 to 14 years: 50-75 mg.

    Side effects:
    From the endocrine system: a decrease in glucose tolerance and an increase in the need for a hypoglycemic drug; manifestation of latent diabetes mellitus; steroid diabetes mellitus. With long-term treatment - oppression of the adrenal glands; the Itenko-Cushing syndrome; growth retardation in children and adolescents.

    From the gastrointestinal tract: nausea; vomiting; pancreatitis; peptic ulcer; esophagitis; bleeding and perforation of the gastrointestinal tract; increased appetite; flatulence; hiccough; in rare cases - increased activity of liver transaminases and alkaline phosphatase.

    From the side of the cardiovascular system: lidocaine can cause conduction disruption (at doses exceeding therapeutic), peripheral vasodilation; at high doses of hydrocortisone: an increase in blood pressure; Hypokalemia and its characteristic ECG changes; thromboembolism; heart failure.

    From the nervous system: insomnia, irritability, anxiety, agitation, euphoria, epileptiform convulsions; mental disorders; delirium; disorientation; hallucinations; exacerbation of manic-depressive psychosis on the background of taking the drug; depression; paranoia; increased intracranial pressure with papilledema of the optic nerve, dizziness; pseudotumor of the cerebellum; headache.

    From the side of metabolism: increase in body weight, negative nitrogen balance, increased sweating.

    Co hand organ of vision: corneal ulceration; posterior capsular cataract (more likely in children); increased intraocular pressure with possible damage to the optic nerve; secondary bacterial, fungal, viral infections of the eyes; trophic changes of the cornea; exophthalmos, glaucoma.

    From the side of the musculoskeletal system: 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; decreased muscle mass; arthralgia.

    Effects due to mineralocorticoid activity of the drug: fluid and sodium retention with the formation of peripheral edema; hypernatremia; hypokalemia, arrhythmia, myalgia, muscle spasm, increased weakness, fatigue.

    From the immune system: opportunistic infections, exacerbation of latent tuberculosis, hypersensitivity reactions; local and generalized: skin rash, itching; anaphylactic shock; delayed healing of wounds; propensity to develop pyoderma and candidiasis, exacerbate infections,especially during vaccination and simultaneous treatment with immunosuppressive agents.

    From the skin and mucous membranes: petechiae; ecchymosis; hyper - or hypopigmentation; steroid acne; stria; folliculitis, hirsutism, telangiectasia.

    Local Reactions: edema of the tissues and pain at the injection site, which spontaneously disappear after a few hours, increased pain in the joint when the drug is injected into the joint, burning, numbness, paresthesia at the site of injection, atrophy of the skin and subcutaneous tissue at the site of injection (when accidentally introduced into the deltoid muscle ), rarely - necrosis of surrounding tissues, scar formation at the injection site.

    Other: malaise, withdrawal syndrome (high body temperature, myalgia, arthralgia, adrenal insufficiency); leukocyturia, leukocytosis.

    In elderly patients, the risk of adverse reactions is higher.

    With long-term treatment and the use of large doses of hydrocortisone and lidocaine, systemic side effects may develop.

    Overdose:

    Exceeding the dose or prolonged administration of Hydrocortisone-Richter can lead to suppression of the own production of glucocorticoids, an increase in blood pressure,ulcerous bleeding of the digestive tract, exacerbation of chronic infections, arthralgia, development of the Itenko-Cushing syndrome. There is no specific antidote. Treatment is symptomatic.

    Interaction:
    Hydrocortisone increases the toxicity of cardiac glycosides (because of the resulting hypokalemia, the risk of arrhythmias increases).

    Accelerates the removal of acetylsalicylic acid, reduces the content of its metabolites in the blood (when it is abolished, the concentration of salicylates in the blood increases and the risk of side effects increases).

    When used simultaneously with live (attenuated) vaccines and against other types of immunizations, increases the risk of virus activation and the development of infections.

    Increases the metabolism of isoniazid, mexiletine (especially in "fast acetylators"), which leads to a decrease in their plasma concentrations. Increases the risk of hepatotoxic effects of paracetamol (induction "hepatic" enzymes and the formation of a toxic metabolite of paracetamol).

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

    In high doses reduces the effect of somatropin.

    Hydrocortisone reduces the effect of oral hypoglycemic drugs.

    Enhances the anticoagulant effect of coumarin derivatives.

    Weaken the influence of vitamin D on the absorption of calcium in the lumen of the intestine. Ketoconazole (reduces clearance) increases the toxicity of hydrocortisone.

    Thiazide diuretics, carbonic anhydrase inhibitors, other glucocorticoids and amphotericin B increase the risk of hypokalemia, sodium-containing drugs - edema and increased blood pressure. Nonsteroidal anti-inflammatory drugs and ethanol increase the risk of ulceration of the gastrointestinal mucosa (GI tract) and bleeding. In combination with non-steroidal anti-inflammatory agents for the treatment of arthritis, a decrease in the dose of hydrocortisone is possible because of the summation of the therapeutic effect.

    Indomethacin, displacing hydrocortisone from its association with albumin, increases the risk of developing its side effects.

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

    The therapeutic effect of hydrocortisone is reduced under the influence of phenytoin, barbiturates, ephedrine, theophylline,rifampicin and other inducers of "hepatic" microsomal enzymes (increased metabolic rate). Mitotane and other inhibitors of the synthesis of steroids may necessitate an increase in the dose of hydrocortisone.

    The clearance of hydrocortisone rises on the background of drugs of thyroid hormones.

    Immunosuppressants increase the risk of infection and lymphoma or other lymphoproliferative disorders associated with the Epstein-Barr virus.

    Estrogens (including oral estrogen-containing contraceptives) reduce hydrocortisone clearance, prolong T1 / 2 and their therapeutic and toxic effects.

    The emergence of hirsutism and acne is facilitated by the simultaneous use of hydrocortisone and steroid hormonal drugs - androgens, estrogens, anabolic steroids, oral contraceptives. Tricyclic antidepressants can increase the severity of depression caused by hydrocortisone (not shown for the therapy of these side effects).

    The risk of developing cataracts increases with other glucocorticoids, antipsychotic drugs (neuroleptics), carbutamide and azathioprine.

    Simultaneous administration with nitrates, m-holinoblokatorami (including antihistamines, tricyclic antidepressants), promotes increased intraocular pressure.

    Special instructions:

    Injection is administered by observing the rules of antiseptic and-aseptic in order to avoid the development of bacterial infection.

    During treatment with Hydrocortisone-Richter, especially in large doses, any vaccination is contraindicated, since there may be insufficient synthesis of antibodies.

    During treatment with hydrocortisone-Richter, a diet with sodium restriction and high potassium content is recommended, providing sufficient protein in the food.

    It is necessary to regularly monitor blood pressure, blood glucose concentration, blood coagulability, diuresis and body weight of the patient. Relative adrenal insufficiency can continue for several months after the abolition of hydrocortisone, therefore, in conditions of increased stress, hormone therapy should be resumed with the simultaneous administration of mineralocorticosteroids and salts.

    Children whose mothers received hydrocortisone during pregnancy, should be carefully monitored in order to identify signs of adrenal insufficiency.

    With the latent form of tuberculosis and during the period of the tubular test, careful monitoring of the patient's condition and, if necessary, chemoprophylaxis, is necessary.

    Hydrocortisone-Richter slows the growth and development of children and adolescents. It is recommended to prescribe the drug in the least therapeutic doses and, if possible, for a short period of time.

    Effect on the ability to drive transp. cf. and fur:Not described.
    Form release / dosage:

    Suspension for intraarticular and periarticular administration, 25 mg + 5 mg / ml.

    Packaging:5 ml of the drug in a colorless glass vial. 1 bottle with instructions for use in a cardboard box.
    Storage conditions:

    Store at a temperature of 15 ° C to 30 ° C in a dark place. Keep out of the reach of children!

    Shelf life:

    2 years.

    Do not use the drug after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:П N011969 / 01
    Date of registration:21.06.2010
    Expiration Date:Unlimited
    The owner of the registration certificate:GEDEON RICHTER, OJSC GEDEON RICHTER, OJSC Hungary
    Manufacturer: & nbsp
    Representation: & nbspGEDEON RICHTER OJSC GEDEON RICHTER OJSC Hungary
    Information update date: & nbsp07.04.2017
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