Kenalog® 40 (Kenalog® 40)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceTriamcinoloneTriamcinolone
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    • Dosage form: & nbspSuspension for injection.
    Composition:

    1 ml of suspension for injection contains:

    Active substance:

    Triamcinolone acetonide 40.00 mg

    Excipients:

    Carmellose sodium 6.30 mg

    Sodium chloride 6.60 mg

    Benzyl alcohol 9.90 mg

    Polysorbate-80 0.40 mg

    Water for injections up to 1.00 ml

    Description:
    A white suspension with a faint smell of benzyl alcohol may contain easily resuspended white or almost white particles free from foreign inclusions.
    Pharmacotherapeutic group:Glucocorticosteroid.
    ATX: & nbsp

    H.02.A.B.08   Triamcinolone

    Pharmacodynamics:
    Glucocorticosteroid (GCS) inhibits the release of interleukin-1, 2, gamma-interferon from lymphocytes and macrophages. Has anti-inflammatory, antiallergic, desensitizing, anti-shock, antitoxic and immunosuppressive action.
    Suppresses the release of pituitary adrenocorticotropic hormone and beta-lipotropin, but does not reduce the level of circulating beta-endorphin. Oppressing the secretion of thyroid-stimulating hormone and follicle-stimulating hormone. 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).
    Interacts with specific cytoplasmic receptors, forming a complex that penetrates into the nucleus of the cell. Synthesized mRNA induces the formation of proteins, (including lipocortin), mediating cellular effects. Lipocortin depresses phospholipase A2, inhibits the release of arachidonic acid and inhibits the synthesis of endoperoxides, prostaglandins, leukotrienes, contributing to the process of inflammation.
    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, which leads 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: detains sodium ions and water in the body, stimulates the excretion of potassium ions (mineralocorticosteroid activity), reduces the absorption of calcium ions from the digestive tract, increases their renal excretion.
    The anti-inflammatory effect is associated with the inhibition of eosinophil release by inflammatory mediators; inducing the formation of lipocortins 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 of histamine and other biologically active substances, a decrease in the number of circulating basophils,inhibition of lymphoid and connective tissue development, decrease in the number of T- and B-lymphocytes, mast cells, reduction of the sensitivity of effector cells to mediators of allergy, inhibition of antibody formation. The anti-shock and antitoxic effect is associated with increased blood pressure (by increasing the concentration of circulating catecholamines and restoring the sensitivity of adrenoreceptors to them, as well as vasoconstriction), reducing the permeability of the vascular wall, membrane-protective properties, activation of liver enzymes involved in the metabolism of endo- and xenobiotics. Immunodepressive effect is due to inhibition of the release of cytokines (interleukin-1,2, gamma-interferon) from lymphocytes and macrophages. It inhibits connective tissue reactions during the inflammatory process and reduces the possibility of scar tissue formation.
    For anti-inflammatory activity triamcinolone is close to hydrocortisone; triamcinolone 6 times more active. Mineralocorticosteroid activity is low.
    Pharmacokinetics:
    With intramuscular injection, slowly but completely absorbed. Connection with plasma proteins - 40%.Metabolised in the liver by 6-beta-hydroxylation to inactive metabolites; partial metabolism is carried out in the kidneys. It is excreted by the kidneys in the form of inactive products of transformation.
    After intramuscular injection, the maximum effect is observed after 24-28 hours, the duration of action with intramuscular injection is 1-6 weeks, in the joint cavity - several weeks.
    Indications:
    Locally
    - intraarticular and periarticular administration with inflammatory rheumatic diseases (rheumatoid arthritis, seronegative spondylitis, arthritis in systemic connective tissue diseases);
    - intraarticular administration with osteoarthritis in the presence of synovitis (not applicable for osteoarthrosis of the hip joint);
    - inflammatory lesions of the periarticular tissues (bursitis, tendinitis, tendosinovitis, epicondylitis, generalized fibromyalgia);
    - introduction to the lesion for the treatment of skin diseases in rare cases (if there is no reaction to other methods of local therapy): psoriasis, alopecia areata, lichen planus, neurodermatitis, coin-like eczema, discoid lupus erythematosus;
    Systemic treatment
    The systemic effect of triamcinolone is used in some severe allergic diseases: allergic rhinitis, Quincke's edema, allergic reactions to medicines and serums, insect bites, and severe bronchial asthma.
    Contraindications:
    For short-term use according to vital indications, the only contraindication is hypersensitivity.
    Peptic ulcer of the stomach or duodenum, osteoporosis, tuberculosis, newly created anastomosis, diverticulitis, glaucoma, diabetes mellitus, thrombophlebitis, acute viral, bacterial, fungal systemic infections (when no appropriate therapy is provided), infectious (septic) inflammatory process in the joint and periarticular (including in the anamnesis), absence of signs of inflammation in the joint (so-called "dry" joint, for example, with osteoarthritis without synovitis), Itenko-Cushing syndrome, condition after the surgeon iCal interventions and serious injuries, previous arthroplasty, abnormal bleeding (endogenous or caused by the use of anticoagulants), chrezsustavnoy bone fracture,pronounced bone destruction and joint deformation (sharp narrowing of the joint gap, ankylosis), joint instability as the outcome of arthritis, aseptic necrosis of the joints forming the epiphyses of the bones, idiopathic thrombocytopenic purpura (intramuscular injection), children under 12 years of age (intramuscular injection).
    Carefully:Chronic renal failure, cirrhosis of the liver or chronic hepatitis, hypothyroidism, hyperthyroidism, esophagitis, gastritis, ulcerative colitis, psychosis or psychoneurosis, immunodeficiency conditions (including AIDS or HIV infection), diseases of the cardiovascular system, including . the recently transferred myocardial infarction (in patients with acute and subacute myocardial infarction it is possible to spread the focus of necrosis, slow the formation of scar tissue and, as a result, break the heart muscle), hyperlipidemia, nephrourolythiasis, hypoalbuminemia and conditions predisposing to its onset (nephrotic syndrome), systemic osteoporosis, obesity (III - IV degree), poliomyelitis (except for the form of bulbar encephalitis), pregnancy, lactation, elderly age.
    Pregnancy and lactation:
    Preparation Kenalog® 40 should be used with caution in pregnancy, as animal studies indicate a teratogenic effect of triamcinolone (in the first 3 months of use), and data on the safety of the drug during pregnancy in humans are absent.
    With prolonged use of the preparation Kenalog® 40, it is impossible to exclude the violation of intrauterine development. When triamcinolone is used in the last trimester of pregnancy, there is a risk of developing fetal adrenal atrophy. Glucocorticosteroids (GCS) penetrate into breast milk, so during the period of breastfeeding during the treatment with Kenalog® 40 it is necessary to evaluate the benefit / risk ratio.
    Dosing and Administration:
    Before use, shake the contents of the ampoule.
    The preparation Kenalog® 40 is a suspension, therefore it should not be administered intravenously.
    Unintentional intravascular administration should be avoided.
    1. Systemic application (intramuscular)
    The dosage of GCS is determined individually; it depends on the nature of the disease and should be consistent with the goals of the therapy.
    When systemic treatment of adults and adolescents older than 12 years (see.Section Contraindications) the drug is administered by intramuscular injection slowly and deeply (1 ml = 40 mg triamcinolone) (do not inject intravenously and subcutaneously!!).
    In severe cases, the dose of the drug may be up to 80 mg. After the injection should be for 1-2 minutes. tightly press a sterile napkin to the place of injection. For the treatment of seasonal allergic diseases, usually one injection of Kenalog® 40 per year during the pollen season is sufficient.
    If several injections are necessary, the interval between injections should be at least 4 weeks.
    2. Local application
    a) With intraarticular administration The dose of Kenalog® 40 is determined by the size of the joint and the severity of the symptoms. Usually for adults and children over 12 years (see Contraindications) the following doses of the drug are used:

    Small joints (for example, phalanges of fingers and legs)

    up to 10 mg

    Joints of medium size (for example, brachial, elbow)

    20 mg

    Large joints (for example, hip, knee)

    20-40 mg

    If several joints are affected, the total dose of the drug can be up to 80 mg. To ensure faster relief of symptoms, Kenalog® 40 can be administered in combination with a local anesthetic (not containing a vasoconstrictor).Injections should be carried out so as to avoid creating a drug depot in the subcutaneous fat tissue. Injections should comply with aseptic conditions. Before the intra-articular injection, the skin area is prepared, as before the surgical operations.

    Repeat the drug should not be earlier than 2 weeks.

    b) When intramuscular introduction with small lesions: with inflammation of the articular bag (bursitis), periostitis, adults and children over the age of 12 years, depending on the magnitude and location of the lesions to be treated, up to 10 mg of the drug is administered and, with large lesions, 10 to 40 mg of the Kenalog® 40 preparation.

    The preparation Kenalog® 40 can be mixed with an anesthetic for topical application.

    at) When introducing into the area of ​​skin lesions 1 ml of the drug at a concentration of 40 mg / ml is diluted with an anesthetic for topical use that does not contain a vasoconstrictor and is mixed in a syringe. Injection is carried out horizontally into the area between the skin and the subcutaneous layer to ensure anesthesia of the infiltrate. As an indicative dose, 1 mg of drug per 1 square meter is recommended. see the surface of skin lesions.In the treatment of several lesions (one-time use), the daily dose of the drug should not exceed 30 mg.

    With keloid scars, the preparation Kenalog® 40 can be directly introduced into the tissue of the rumen without dilution. Do not administer subcutaneously!

    Repeated use of the drug is possible not earlier than in 2 weeks.

    Elderly patients

    Therapy of elderly people, especially long-term, should be planned taking into account more serious consequences and more frequent side effects against the background of glucocorticosteroids in the elderly, such as osteoporosis, diabetes, hypertension, susceptibility to infections and thinning of the skin. To avoid the development of life-threatening reactions, patients should / are under clinical observation.

    Removal of triamcinolone

    In patients receiving the preparation Kenalog® 40 at doses exceeding physiological (more than one injection for 4 weeks), the drug can not be abruptly abolished. First, you need to reduce the dose of the drug or increase the interval of administration to achieve a dose of 40 mg with an interval of more than 4 weeks. Clinical evaluation of disease activity may be required.

    Rapid cancellation of a short course of systemic glucocorticosteroids is permissible if there is no threat of exacerbation of the disease. A single dose, not repeated for three weeks, is unlikely to lead to clinically significant suppression of the hypothalamic-pituitary-adrenal system in most patients. Nevertheless, in some groups of patients it is recommended to always abolish glucocorticosteroids gradually:

    - patients taking repeated courses of systemic glucocorticosteroids;

    - if the course of the preparation Kenalog® 40 is prescribed within a year after the abolition of long-term therapy with glucocorticosteroids (months or years);

    - patients who have adrenal insufficiency may be due to other causes not associated with therapy with exogenous glucocorticosteroids.

    Side effects:

    Classification of incidence of adverse events (World Organization

    Health):

    very often> 1/10

    often from> 1/100 to <1/10

    infrequently from> 1/1000 to <1/100

    rarely from> 1/10000 to <1/1000

    very rarely from <1/10000, including individual messages.

    Undesirable effects are classified by organs and systems:

    From the cardiovascular system:

    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, thrombosis. In patients with acute and subacute myocardial infarction - the spread of the focus of necrosis, slowing the formation of scar tissue, which can lead to rupture of the heart muscle (with systemic use of the drug).

    On the part of the hematopoiesis system:

    Granulocytosis, lymphopenia, monocytopenia. From the nervous system:

    Manic-depressive psychosis, depression, disorientation, euphoria, hallucinations, paranoia, nervousness or anxiety, insomnia, dizziness, pseudotumor of the cerebellum, headache, increased intracranial pressure, convulsions.

    From the sense organs:

    Posterior subcapsular cataract, increased intraocular pressure (ophthalmic hypertension, glaucoma1) with possible damage to the optic nerve, a tendency to develop secondary bacterial, fungal or viral infections of the eyes, trophic changes in the cornea, exophthalmos, sudden loss of vision (possibly the deposition of triamcinolone crystals in the eye chambers).

    On the part of the respiratory system:

    Reducing the timbre of the voice, irritation and dryness of the mucous membrane of the mouth and pharynx.

    From the digestive system:

    Nausea, vomiting, pancreatitis, erosive esophagitis, steroid ulcer of the stomach 12 duodenal ulcer, bleeding and perforation of the gastrointestinal tract, increase or decrease in appetite, flatulence, hiccough, increased activity of "liver" transaminases and alkaline phosphatase.

    From the skin:

    Steroid acne, subcutaneous hemorrhage, dermatitis, ecchymosis, facial erythema, skin atrophy, delayed wound healing, excessive sweating, striae, telangiectasia and thinning of the skin, hyper or hypopigmentation, oropharyngeal candidiasis, septic necrosis (especially in patients with systemic lupus erythematosus or rheumatoid arthritis), avascular necrosis.

    From the musculoskeletal system:

    Steroid myopathy, osteonecrosis, osteoporosis2 (the maximum loss of bone tissue occurs at the beginning of therapy and mainly affects the spongy (trabecular) bone tissue), slowing growth and ossification processes in children (premature closure of epiphyseal growth zones), muscle loss (atrophy).

    From the endocrine system:

    The delay of sodium (as a result of fluid retention and compensatory increase in the excretion of potassium by the kidneys, leading to hypokalemia), delayed growth and sexual development in children (with prolonged therapy), decreased glucose tolerance, steroid diabetes mellitus or manifestation of latent diabetes mellitus, oppression of function adrenal gland syndrome, Itenko-Cushing syndrome (lunar face, obesity of the pituitary type, hirsutism, increased blood pressure, dysmenorrhea, amenorrhea, myasthenia, stria).

    Laboratory indicators:

    Leukocytosis (more than 20000 / mm3), without signs of inflammation or neoplastic process.

    From the side of metabolism:

    Porphyria, increased total cholesterol, low-density lipoprotein (LDL) and triglycerides, hypocalcemia, weight gain, negative nitrogen balance, fluid retention and Na+ (peripheral edema), hypernatremia, hypokalemic syndrome (hypokalemia, arrhythmia, myalgia or muscle spasm, unusual weakness and fatigue).

    Allergic reactions:

    Skin rash, itching, hives, angioedema, bronchospasm, respiratory arrest, anaphylactic shock.

    From the genitourinary system:

    Violations of the menstrual cycle.

    1The effect of systemic glucocorticosteroids on an existing glaucoma is usually weak; "Steroid" glaucoma often develops after a year or more against the background of systemic use of glucocorticosteroids.

    2For the prevention of osteoporosis, the lowest effective doses of glucocorticosteroids should be used, and if possible, forms for external use.

    Overdose:
    Symptoms: nausea, vomiting, sleep disorders, euphoria, agitation, depression, Itenko-Cushing syndrome, hyperglycemia, glucosuria.
    Treatment: symptomatic, amid a gradual withdrawal of the drug.
    There is no specific antidote.
    Hemodialysis is not effective.
    Interaction:
    Triamcinolone povppaet.toktichnost cardiac glycosides (because of the emerging hypokalemia increases the risk of arrhythmias).
    Accelerates the excretion of acetylsalicylic acid (ASA), reduces its concentration in the blood (with the elimination of triamcinolone, the concentration of salicylates in the blood increases and the risk of side effects increases).
    With simultaneous use of triamcinolone with live viral vaccines and against the background of other types of immunization, the risk of virus activation and infection development increases.
    Increases the metabolism of isoniazid, mexiletine (especially in fast acetyls), which leads to a decrease in their plasma concentrations.
    Increases the risk of hepatotoxic reactions of paracetamol (induction of "hepatic" enzymes and the formation of a toxic metabolite of paracetamol). Popvpayet (with prolonged therapy) the concentration of folic acid. In high doses reduces the effect of somatropin.
    Triamcinolone reduces the effect of hypoglycemic drugs; enhances the anticoagulant effect of coumarin derivatives.
    Weaken the influence of vitamin D on the absorption of Ca2 + in the lumen of the intestine. Cyclosporin (inhibits metabolism) and ketoconazole (reduces clearance) increase the toxicity of triamcinolone.
    Indomethacin, displacing triamcinolone from association with albumin, increases the risk of developing its side effects.
    The simultaneous use of triamcinolone with m-holinoblokatorami (including antihistamine JIC, tricyclic antidepressants), nitrates contributes to the development of increased intraocular pressure.
    Special instructions:
    The preparation Kenalog® 40 can not be administered intravenously and subcutaneously!
    Before and during GCS therapy, it is necessary to monitor the total blood test, the sugar level, and the electrolyte content in the blood plasma.
    It is necessary to study the synovial fluid in each joint to exclude the septic process. Significant pain intensification, accompanied by local edema, further restriction of joint mobility, fever and malaise, suggests the development of septic arthritis. If sepsis is confirmed, appropriate antimicrobial therapy is necessary. During therapy during intercurrent infections, septic conditions, tuberculosis, they are simultaneously treated with antibiotics.
    Do not enter into "unstable" joints, in the Achilles tendon area (risk of rupture).
    Vaccination with live viral vaccines is contraindicated during SCS therapy. Immunization with inactivated 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 used 8 weeks before and within 2 weeks after vaccination.
    Care should be taken in case of contact of the patient receiving SCS treatment with sick chickenpox, measles and other contagious diseases, because the risk of the above-mentioned pathology increases with accidental contact with infected persons. In such cases, passive immunization is recommended. Caution is necessary in patients after operations and bone fractures, as glucocorticosteroids can slow the healing of wounds and fractures. The effect of GCS is enhanced in patients with cirrhosis or hypothyroidism.
    The use of the preparation Kenalog® 40 can change the parameters of skin allergic tests for hypersensitivity.
    In children during the period of growth, GCS should be used only in absolute indications and under the close supervision of the attending physician.
    Effect on the ability to drive transp. cf. and fur:Therapy with Kenalog® 40 has an insignificant or moderate effect on the management of motor vehicles and working with technical devices. The undesirable effects of the central nervous system that occur during the first or second week of therapy include: retardation, disorientation, depression, headache, convulsions, personality changes, mania, hallucinations and psychoses.When such symptoms appear, patients should refuse to drive vehicles and work with technical devices until these symptoms disappear completely.
    Form release / dosage:
    Suspension for injection 40 mg / ml.
    Packaging:
    1 ml of the drug in an ampoule of transparent colorless glass (type I, Ph.Eur.). On the ampoule, a colored ring is placed on the site of the ampoule fracture and a color coding ring.
    5 ampoules per blister. 1 blister is placed in a pack of cardboard along with instructions for use.
    Storage conditions:
    At a temperature of 8 ° C to 25 ° C. Do not freeze. 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 N012379 / 01
    Date of registration:25.10.2010
    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: & nbsp23.09.2015
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