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Release form, composition and packaging
Tablets, enteric coated tablets 1 tab.
diclofenac sodium 50 mg Pharmacological action
Diclofenac has anti-inflammatory, analgesic and antipyretic action. Non-selectively inhibiting cyclooxygenase 1 and 2 violates the arachidonic acid metabolism, reduces the amount of prostaglandins in inflammation. In rheumatic diseases anti-inflammatory and analgesic effect of diclofenac contributes to a significant reduction in the severity of pain, morning stiffness, swelling of joints, improve the functional status of the joint. Trauma, postoperative diclofenac reduces pain, and inflammatory edema.
Absorption is rapid and complete, food slows the absorption rate on a 1-4 hour and reduces Cmax by 40%. After oral administration of 25 mg Cmax 1.0 µg/ml is reached after 2-3 hours Plasma concentrations are in linear dependence on the input doses.
Changes in the pharmacokinetics of diclofenac on the background of repeated injection is not marked, it does not cumulate.
Bioavailability of 50%. Relationship to plasma proteins - more than 99% (most of the associated with albumin). Penetrates into synovial fluid: Cmax in synovial fluid is observed at 2-4 h later than in plasma. T1/2 of synovial fluid is 3-6 h (concentration of active substance in the synovial fluid after 4-6 h after injection of the drug is higher than in plasma, and remains higher for 12 hours). The relationship of drug concentration in sinoville fluid with clinical efficacy of the drug has not been elucidated.
The metabolism of 50% of the active substance is metabolized during the first passage "through the liver. Metabolism occurs as a result of multiple or single hydroxylation and conjugation with glucuronic acid. In the metabolism of the drug involved enzyme system P450 CYP2C9. The pharmacological activity of metabolites is lower than that of diclofenac.
Systemic clearance is 350 ml/min, volume of distribution - 550 ml/kg, T1/2 from plasma is -2 hours 65% of the administered dose is excreted as metabolites by the kidneys; less than 1% excreted unchanged, the rest of the dose is excreted as metabolites in the bile.
In patients with severe renal insufficiency (creatinine clearance less than 10 ml/min) increases the excretion of metabolites in bile, thus increasing their concentration in the blood is not observed.
In patients with chronic hepatitis or compensated cirrhosis, the pharmacokinetic parameters of diclofenac will not change. Diclofenac passes into breast milk.
The inside is not liquid, during or after eating, squeezed small amounts of water. Adults and adolescents 15 years - 25-50 mg 2-3 times/day. In achieving optimal therapeutic effect dose gradually and go to maintenance treatment at a dose of 50 mg/day. The maximum daily dose of 150 mg. For children (over 6 years) daily dose of 2 mg/kg of body weight, divided into 2-3 doses. In juvenile rheumatoid arthritis the daily dose may be increased to 3 mg/kg of body weight.
The indicative mode of the drug presented in the table:
Age (body weight, kg) Single dose (number of tablets, [mg]) Daily dose (number of tablets, [mg])
6-7 years(20-24) 1  1 
8-11 years(25-37) 1  2-3 [50-75]
12-14 years(38-50) 1-2 [25-50] 3-4 [75-100]
Over 15 and adults 1-2 [25-50] 2-6 [50-150]
Symptoms: vomiting, dizziness, headache, shortness of breath, dizziness in children - myoclonic seizures, nausea, abdominal pain, bleeding, liver and kidney.
Treatment: gastric lavage, introduction of activated carbon, symptomatic therapy, forced diuresis. Hemodialysis is ineffective.
Increases plasma concentration of digoxin, methotrexate. drugs lithium and cyclosporine.
Reduces the effect of diuretics on the background of potassium-sparing diuretics increases the risk of hyperkalemia; on the background of anticoagulants, thrombolytic agents (alteplase, streptokinase, urokinase), the risk of bleeding (usually from the gastrointestinal tract).
Reduces the hypotensive effects and hypnotics.
Increases the likelihood of side effects of other NSAIDs and glucocorticosteroid (bleeding in the digestive tract), methotrexate toxicity and nephrotoxicity of cyclosporine.
Acetylsalicylic acid reduces the concentration of diclofenac in the blood.
Simultaneous use of paracetamol increases the risk of nephrotoxic effects of diclofenac.
Reduces the effect of hypoglycemic agents.
Cefamandole, cefoperazone, cefotetan, valproic acid and plicamycin increase the incidence of hypoprothrombinemia.
Cyclosporine and gold drugs increase the effect of diclofenac on the synthesis of prostaglandins in the kidneys, which increases the nephrotoxicity.
Coadministration with ethanol, colchicine, and corticotropin preparations St. John's wort increases the risk of bleeding in the gastrointestinal tract.
Diclofenac increases the effects of drugs that cause photosensitivity Drugs that block tubular secretion, increase the plasma concentration of diclofenac, thereby increasing its toxicity.
Pregnancy and lactation
Contraindicated in pregnancy. If necessary, the use of the drug during lactation should decide on the termination of breastfeeding.
more than 1% - abdominal pain, sensation of bloating, diarrhea, nausea, constipation, flatulence, increased levels of "liver" enzymes, peptic ulcer with possible complications (bleeding, perforation), gastrointestinal bleeding;
less than 1% - vomiting, jaundice, melena, blood in the stool, esophageal lesions, aphthous stomatitis, dry mucous membranes (including the mouth), hepatitis a (possibly fulminant) hepatic necrosis, cirrhosis, hepatorenal syndrome, change of appetite, pancreatitis, cholecystoenteric, colitis.
more than 1% - headache, dizziness;
less than 1% - sleep disturbance, drowsiness, depression, irritability, aseptic meningitis (more common in patients with systemic lupus erythematosus and other systemic diseases of connective tissue), muscle cramps, weakness, disorientation, nightmares, a feeling of fear.
more than 1% noise in the ears,
less than 1% - blurred vision, diplopia, dysgeusia, reversible or irreversible hearing loss, scotoma.
more than 1% - itching, skin rash;
less than 1% - alopecia, urticaria, eczema, toxic dermatitis, erythema multiforme (including syndrome Stevens-Johnson), toxic epidermal necrolysis (Lyell's syndrome), increased photosensitivity, punctate hemorrhages.
more than 1% fluid retention,
less than 1% of nephrotic syndrome, proteinuria, oliguria, hematuria, interstitial nephritis, papillary necrosis, acute renal failure, azotemia
The organs of hematopoiesis and immune system:
less than 1% - anemia (including hemolytic and aplastic anemia), leukopenia, thrombocytopenia, eosinophilia, agranulocytosis, thrombocytopenic purpura, deteriorating course of infectious processes (including the development of necrotizing fasciitis).
less than 1% - cough, bronchospasm, laryngeal edema, pneumonitis.
less than 1% - increase in blood pressure; congestive heart failure, extrasystoles, chest pain.
less than 1% - anaphylactoid reactions, anaphylactic shock (usually develops rapidly), swelling of the lips and tongue, allergic vasculitis.
The terms and conditions of storage
the temperature is not above 25°C. keep In a dry, protected from light place out of reach of children. Shelf life - 3 years.
— diseases of the musculoskeletal system (rheumatoid arthritis, psoriasis, juvenile chronic arthritis, ankylosing spondylitis; gouty arthritis; rheumatic soft tissue, osteoarthritis of peripheral joints and spine, including radicular syndrome, tenosynovitis, bursitis);
— pain syndrome mild or moderate symptoms: neuralgia, myalgia, sciatica, post-traumatic pain, accompanied by inflammation, postoperative pain, headache, migraine, algomenorrhea, adnexitis, proctitis, toothache;
— in the complex therapy of infectious and inflammatory diseases of the ear, nose and throat, with severe pain (pharyngitis, tonsillitis, otitis media);
— febrile syndrome.
— erosive-ulcerative lesions of the gastrointestinal tract (in acute phase);
— bleeding from the digestive tract;
— "aspirin" asthma;
— disorders of hematopoiesis;
— hemostasis disorders (including hemophilia);
— children's age (up to 6 years);
— hypersensitivity (including to other NSAIDs).
Caution: anemia, asthma, congestive heart failure, arterial hypertension, edema syndrome, hepatic or renal failure, alcoholism, inflammatory bowel disease, erosive-ulcerative gastrointestinal disease without exacerbation, diabetes mellitus, condition after extensive surgery, induced porphyria, elderly age, diverticulitis, systemic diseases of connective tissue.
During the period of drug treatment should be systematic monitoring of peripheral blood, liver, kidneys, examination of feces for the presence of blood.
Patients receiving the drug should refrain from activities requiring increased attention and rapid mental and motor reactions, alcohol consumption.
When kidney functions
Caution: renal failure.
When human liver
Caution: hepatic failure.