Ortofen, 20 pcs., 25 mg, enteric-coated tablets
From the gastrointestinal tract:
More often than 1% - abdominal pain, a feeling of bloating, diarrhea, nausea, constipation, flatulence, increased levels of liver enzymes, peptic ulcer with possible complications (bleeding, perforation), gastrointestinal bleeding;
Less often than 1% - vomiting, jaundice, melena, blood in the stool, damage to the esophagus, aphthous stomatitis, dry mucous membranes (including the mouth), hepatitis (possibly fulminant), liver necrosis, cirrhosis, hepatorenal syndrome, changes in appetite - anorexia , pancreatitis, cholecystopancreatitis, colitis;
Very rarely - glossitis, diaphragm-like intestinal strictures (nonspecific hemorrhagic colitis, exacerbation of ulcerative colitis or Crohn's disease).
From the central nervous system:
More often 1% - headache, dizziness;
Less often than 1% - sleep disturbance, drowsiness, depression, irritability, aseptic meningitis (more often in patients with systemic lupus erythematosus and other systemic connective tissue diseases), convulsions, general weakness, disorientation, nightmares, a feeling of fear;
Very rarely - sensory disturbance, incl. paresthesia, memory disorders, tremor, anxiety, cerebrovascular disorders, mental disorders.
From the cardiovascular system:
Less often than 1% - increased blood pressure; congestive heart failure, extrasystole, chest pain;
Very rarely - palpitations, myocardial infarction.
From the hematopoietic and immune system:
Less often than 1% - anemia (including hemolytic and aplastic anemia), leukopenia, thrombocytopenia, eosinophilia, agranulocytosis, thrombocytopenic purpura, worsening of infectious processes (including the development of necrotizing fasciitis).
From the respiratory system:
Less often than 1% - cough, bronchospasm, laryngeal edema, pneumonitis.
From the urinary system:
More often 1% - fluid retention;
Less often than 1% - nephrotic syndrome, proteinuria, oliguria, hematuria, interstitial nephritis, papillary necrosis, acute renal failure, azotemia.
Sense organs:
More often 1% - tinnitus;
Less often than 1% - blurred vision, diplopia, taste disturbance, reversible or irreversible hearing loss, scotoma.
Skin:
More often 1% - skin itching, skin rash;
Less commonly 1% - alopecia, urticaria, eczema, toxic dermatitis, exudative erythema multiforme (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), increased photosensitivity, pinpoint hemorrhages.
Allergic reactions:
Less often than 1% - anaphylactoid reactions, anaphylactic shock (usually develops rapidly), swelling of the lips and tongue, allergic vasculitis.
Ortofen ampoules
Pharmachologic effect:
NSAID, phenylacetic acid derivative; has anti-inflammatory, analgesic and antipyretic effects. By indiscriminately inhibiting COX1 and COX2, it disrupts the metabolism of arachidonic acid and reduces the amount of Pg at the site of inflammation. Most effective for inflammatory pain. Like all NSAIDs, the drug has antiplatelet activity.
Indications:
Inflammatory and degenerative diseases of the musculoskeletal system: rheumatoid, psoriatic, juvenile chronic arthritis, ankylosing spondylitis (ankylosing spondylitis), neuralgic amyotrophy (Personage-Turner disease), osteoarthritis, rheumatism, gouty arthritis (in case of an acute attack of gout, fast-acting dosage forms are preferred), arthritis due to Reiter's disease. Pain syndrome: headache (including migraine) and toothache, bursitis, tendinitis, lumbago, sciatica, ossalgia, neuralgia, myalgia, arthralgia, radiculitis, in cancer, post-traumatic and postoperative pain syndrome accompanied by inflammation. Algodismenorrhea; inflammatory processes in the pelvis, incl. adnexitis; childbirth (as an analgesic and tocolytic agent). Infectious and inflammatory diseases of the ENT organs with severe pain syndrome (as part of complex therapy): pharyngitis, tonsillitis, otitis media. Feverish syndrome with “colds” and infectious diseases.
Contraindications:
Hypersensitivity (including to other NSAIDs), “aspirin” triad (a combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses and intolerance to ASA and pyrazolone-type drugs), hematopoietic disorders (leukopenia and anemia), various blood clotting disorders (including hemophilia, prolongation of bleeding time, tendency to bleed), erosive and ulcerative lesions of the gastrointestinal tract in the acute phase, bleeding from the gastrointestinal tract, pregnancy, lactation, young children (up to 6 years). For rectal use: rectal bleeding, hemorrhoids, injury or inflammation of the rectum (including the anus). Caution. Anemia, bronchial asthma, decompensated CHF, arterial hypertension, edema syndrome, liver and/or renal failure, alcoholism, diverticulitis, erosive and ulcerative diseases of the gastrointestinal tract without exacerbation, diabetes mellitus, old age, postoperative period, inducible acute hepatic porphyria.
Side effects:
From the digestive organs. More often than 1% - abdominal pain or spasm, bloating, diarrhea, dyspepsia, nausea, constipation, flatulence, increased activity of liver transaminases, peptic ulcer, incl. with complications (perforation, bleeding), gastrointestinal bleeding without ulcer. Less often than 1% - vomiting, jaundice, melena, blood in the stool, damage to the esophagus, aphthous stomatitis, dry mucous membranes (including the oral cavity), hepatitis, hepatonecrosis, cirrhosis, hepatorenal syndrome, changes in appetite, pancreatitis (including .ch. with concomitant hepatitis), colitis. From the nervous system. More often than 1% - headache, dizziness. Less often than 1% - sleep disturbance, drowsiness, depression, diplopia, anxiety, irritability, aseptic meningitis, convulsions, weakness. From the senses. More often than 1% - tinnitus. Less often than 1% - blurred visual perception, taste disturbance, hearing loss (including irreversible), scotoma. From the side of the skin. More often than 1% - skin rash, itchy skin. Less commonly 1% - alopecia, urticaria, eczema, toxic dermatitis, exudative erythema multiforme (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), photosensitivity. From the genitourinary system. More often than 1% is fluid retention. Less often than 1% - nephrotic syndrome, proteinuria, oliguria, interstitial nephritis, papillary necrosis, acute renal failure, azotemia. From the hematopoietic organs. Less often than 1% - anemia (including hemolytic and aplastic), leukopenia, thrombocytopenia, eosinophilia, agranulocytosis, thrombocytopenic purpura. From the respiratory system. Less often than 1% - cough, bronchospasm, laryngeal edema. From the SSS side. Less often than 1% - increased blood pressure, congestive heart failure. Allergic reactions. Less often than 1% - swelling of the lips and tongue, anaphylactoid reactions, anaphylactic shock (usually develops rapidly). Overdose. Symptoms: dizziness, headache, hyperventilation, clouding of consciousness, in children - myoclonic convulsions, nausea, vomiting, abdominal pain, bleeding, impaired liver and kidney function. Treatment: gastric lavage, activated charcoal, symptomatic therapy aimed at eliminating increased blood pressure, renal dysfunction, convulsions, gastrointestinal irritation, respiratory depression. Forced diuresis and hemodialysis are ineffective.
Directions for use and dosage:
Orally, without chewing, during or after meals, adults - 25-50 mg 2-3 times a day. When the optimal therapeutic effect is achieved, the dose is gradually reduced and switched to maintenance treatment at a dose of 50 mg/day. The maximum daily dose is 150 mg. For children over 6 years of age and adolescents, only tablets with a regular duration of action of 25 mg are used; daily dose - 2 mg/kg child. For juvenile rheumatoid arthritis, the daily dose can be increased to 3 mg/kg. The tablets should be taken whole, without chewing, on an empty stomach, with a small amount of liquid. Long-acting diclofenac is prescribed 100 mg once a day (for dysmenorrhea and migraine attacks - up to 200 mg/day). When taking 100 mg retard, if it is necessary to increase the daily dose to 150 mg, you can additionally take 1 regular tablet (50 mg). IV drip. The maximum daily dose is 150 mg. Immediately before intravenous administration, diclofenac (contents of 1 ampoule - 75 mg) should be diluted in 100-500 ml of 0.9% NaCl solution or 5% dextrose solution (after adding sodium bicarbonate solution to the infusion solutions - 0.5 ml 8.4% or 1 ml 4.2% solution). Depending on the severity of the pain syndrome, the infusion is carried out for 30-180 minutes. In order to prevent postoperative pain, an infusion is carried out with a “shock” dose of the drug (25-50 mg over 15-60 minutes). Subsequently, the infusion is continued at a rate of 5 mg/hour (until the maximum daily dose of 150 mg is reached). For the treatment of acute conditions or relief of exacerbation of a chronic disease, intramuscular (single) administration is also possible; further treatment is continued with oral diclofenac, taking into account the maximum daily dose of 150 mg (including on the day of injection). The injection solution is injected deep intramuscularly for no more than 2 weeks. Rectally, 50 mg 2 times a day or 100 mg 1 time a day. Migraine attack - rectal suppositories in a dose of 100 mg at the first signs of an attack. If necessary, repeat 100 mg.
Special instructions:
In order to quickly achieve the desired therapeutic effect, take 30 minutes before meals. In other cases, take before, during or after meals, unchewed, with a sufficient amount of water. Because of the important role of Pg in maintaining renal blood flow, special caution should be exercised when prescribing to patients with heart or renal failure, as well as when treating elderly patients taking diuretics, and patients who, for any reason, have a decrease in blood volume (for example, after a major surgical intervention). If diclofenac is prescribed in such cases, monitoring of renal function is recommended as a precaution. In patients with renal failure with CC less than 10 ml/min, the Css of metabolites in plasma should theoretically be significantly higher than in patients with normal renal function, but this is not actually observed, since in this situation the excretion of metabolites in the bile is enhanced. In patients with liver failure (chronic hepatitis, compensated cirrhosis of the liver), the kinetics and metabolism do not differ from similar processes in patients with normal liver function. When carrying out long-term therapy, it is necessary to monitor liver function, peripheral blood patterns, and stool analysis for occult blood. During the treatment period, the speed of mental and motor reactions may decrease, so it is necessary to refrain from driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.
Interaction:
Increases plasma concentrations of digoxin, methotrexate, Li+ drugs and cyclosporine. Reduces the effect of diuretics; against the background of potassium-sparing diuretics, the risk of developing hyperkalemia increases; against the background of anticoagulants, antiplatelet and thrombolytic drugs (alteplase, streptokinase, urokinase), the risk of bleeding increases (usually the gastrointestinal tract). Reduces the effect of antihypertensive and hypnotic drugs. Increases the likelihood of side effects of other NSAIDs and corticosteroids (bleeding in the gastrointestinal tract), the toxicity of methotrexate and the nephrotoxicity of cyclosporine. ASA reduces the concentration of diclofenac in the blood. Concomitant use with paracetamol increases the risk of developing nephrotoxic effects of diclofenac. Reduces the effect of hypoglycemic drugs. Cefamandole, cefoperazone, cefotetan, valproic acid and plicamycin increase the incidence of hypoprothrombinemia. QT Cyclosporine and Au preparations increase the effect of diclofenac on Pg synthesis in the kidneys, which is manifested by increased nephrotoxicity. Simultaneous administration with ethanol, colchicine, corticotropin and St. John's wort preparations increases the risk of bleeding in the gastrointestinal tract. Drugs that cause photosensitivity increase the sensitizing effect of diclofenac to UV irradiation. Drugs that block tubular secretion increase the plasma concentration of diclofenac, thereby increasing its effectiveness and toxicity.
