Active substanceDiclofenacDiclofenac
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  • Dosage form: & nbspSolution for intramuscular injection.
    Composition:1 ml of the solution contains: sodium diclofenac - 0.025 g. Excipients: propylene glycol, mannitol, benzyl alcohol, sodium pyrosulfite technical, sodium hydroxide 1 M solution, water for injection.
    Description:Transparent, colorless or slightly colored liquid with a faint smell of benzyl alcohol
    Pharmacotherapeutic group:Non-steroidal anti-inflammatory drug (NSAID).
    ATX: & nbsp

    S.01.B.C.03   Diclofenac

    M.01.A.B.05   Diclofenac

    Pharmacodynamics:It has anti-inflammatory, analgesic and antipyretic effect, inhibits cyclooxygenase in the cascade of arachidonic acid metabolism and disrupts the biosynthesis of prostaglandins.
    Pharmacokinetics:With intramuscular injection, the peak concentration in plasma is achieved after 10-20 minutes. 99% of the injected drug binds to blood proteins. Diclofenac well penetrates into the tissues and synovial fluid, the peak concentration of diclofenac in which observed 4 hours after administration.35% of diclofenac is excreted with feces, 65% is metabolized in the liver and is excreted as inactive derivatives through the kidneys. The half-life of plasma is 2 hours, of synovial fluid - 4-6 hours.
    Indications:The drug is indicated for the removal of acute pain syndrome: rheumatoid arthritis; ankylosing spondylitis (Bekhterov's disease); arthrosis; spondyloarthrosis; neuralgia; myalgia; post-traumatic and post-operative pain; renal or hepatic colic.
    Contraindications:Increased individual sensitivity to diclofenac and the components of the drug, acetylsalicylic acid or other NSAIDs ("aspirin asthma"); disorders of hematopoiesis; stomach ulcer and duodenal ulcer; destructive-inflammatory bowel disease in the phase of exacerbation; III trimester of pregnancy; lactation period (breastfeeding should be avoided); in childhood and adolescence (up to 18 years).
    Carefully:Induced acute liver porphyria, severe violations of the liver and kidneys, heart failure.
    Dosing and Administration:The drug is usually used at the beginning of treatment, the injection solution is injected deep in the / m for no more than 2 days. If necessary, the continuation of therapy goes to taking tablets, capsules or suppositories.Intramuscular injections can be combined with the use of the drug inside or rectally, and the maximum daily dose should not exceed 150 mg.
    Side effects:
    The resulting side effects depend on individual sensitivity, the magnitude of the dose used and the duration of treatment.

    From the digestive tract: nausea, vomiting, epigastric pain, anorexia flatulence, constipation, diarrhea, gastritis up to erosive with bleeding; increased activity of "hepatic" transaminases, drug-induced hepatitis, pancreatitis.

    From the digestive system: gastrointestinal bleeding (hematemesis, melena), fulminant hepatitis, nonspecific colitis with bleeding, exacerbation of ulcerative colitis or Crohn's disease, aphthous stomatitis, glossitis, erosive esophagitis, constipation.

    From the side of the central nervous systemheadache, dizziness, disorientation, agitation, insomnia, irritability, fatigue, swelling, aseptic meningitis, impaired perception, paresthesia, memory loss, decreased visual acuity, diplopia, hearing loss, tinnitus, convulsions, depression, anxiety, "nightmarish "dreams, tremors, psychotic reactions, a violation of taste sensations.

    Allergic: from the skin (exanthema, purpura, erythema, eczema, hyperemia, erythema multiforme, Lyell syndrome, Stevens-Johnson syndrome, erythroderma, photosensitivity, respiratory system: bronchospasm, systemic anaphylactic reactions including shock.

    From the urinary system: acute renal failure, hematuria, proteinuria, interstitial nephritis, nephrotic syndrome, papillary necrosis.

    On the part of the organs of hematopoiesis: anemia, thrombocytopenia, leukopenia, agranulocytosis, hemolytic anemia, aplastic anemia. Systemic anaphylactic reactions (including shock).

    Local: burning at the injection site, the formation of infiltration, necrosis of adipose tissue.

    Other: fluid retention, edema, increased blood pressure, impotence, heart palpitations, chest pain. In the place of / m introduction - aseptic abscess.


    Overdose:
    Symptoms:

    Disorders from the central nervous system (headache, dizziness, increased excitability, hyperventilation with increased convulsive readiness, in children - myoclonic cramps) and gastrointestinal disorders (abdominal pain, nausea, vomiting).There may be bleeding in the gastrointestinal tract and / or impaired liver and / or kidney function.

    Treatment:

    Forced diuresis, hemodialysis are ineffective. There is no specific antidote. In case of an overdose, intensive medical care and symptomatic treatment are necessary.
    Interaction:
    With the simultaneous use of the drug and:

    - digoxin, phenytoin, or lithium preparations - the level of plasma levels of these drugs may increase;

    - diuretics, hypotensive and hypnotics - can weaken the effect of these drugs;

    - potassium-sparing diuretics - can cause hyperkalemia;

    - other NSAIDs or glucocorticoids - there is an increased risk of side effects from the gastrointestinal tract;

    - Acetylsalicylic acid - reduces the concentration of diclofenac in the blood serum and increases the likelihood of side effects;

    - cyclosporine - may increase the toxic effect of the latter on the kidneys;

    - antidiabetic drugs - can cause hypo or hyperglycemia. With this combination of funds, blood sugar levels need to be monitored;

    - methotrexate within 24 hours before or after its administration - may lead to an increase in the concentration of methotrexate and to an increase in its toxic effect;

    - anticoagulants - regular blood clotting is necessary.
    Special instructions:Due to the fact that with the use of the drug in high dosages, the occurrence of side effects such as dizziness and fatigue can occur, in some cases, the ability to drive a car or other driving objects is impaired. These phenomena increase with the simultaneous intake of alcohol. Because of the important role of Pg in maintaining renal blood flow, caution should be exercised in appointing patients with cardiac or renal insufficiency, as well as in the treatment of elderly people taking diuretics and patients who for any reason have a decrease in the volume of circulating fluid for example, after extensive surgical intervention). If in such cases appoint diclofenac, recommend as a precautionary measure to monitor kidney function.

    In patients with hepatic insufficiency (chronic hepatitis, compensated cirrhosis), the kinetics and metabolism do not differ from similar processes in patients with normal liver function.When performing long-term therapy, it is necessary to monitor liver function, the picture of peripheral blood, the analysis of feces for latent blood. During the treatment period, the speed of mental and motor reactions may decrease.
    Form release / dosage:Solution for intramuscular injection 2.5%.
    Packaging:2.5% injection for 3 ml in ampoules. 5 ampoules in the outline of the cell, 1 or 2 contiguous cell packs in the bundle.
    Storage conditions:
    In a place protected from light and inaccessible to children.
    Shelf life:2 years. Do not use after the time specified on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:P N002288 / 03
    Date of registration:18.07.2008
    The owner of the registration certificate:BRYNTSALOV-A, CJSC BRYNTSALOV-A, CJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp28.02.2016
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