Orthofen, 25 mg 20 pcs.

Phenylacetic acid derivative NSAID. It has a pronounced anti-inflammatory, analgesic and moderate antipyretic effect. The mechanism of action is associated with inhibition of COX activity – the main enzyme of arachidonic acid metabolism, which is a precursor of prostaglandins that play an important role in the pathogenesis of inflammation, pain and fever. Analgesic effect is caused by two mechanisms: peripheral (indirectly, through inhibition of prostaglandin synthesis) and central (due to inhibition of prostaglandin synthesis in central and peripheral nervous system).

In vitro at concentrations equivalent to those achieved in the treatment of patients, it does not inhibit cartilage proteoglycan biosynthesis.

In rheumatic diseases, it reduces joint pain at rest and on movement, as well as morning stiffness and joint swelling, and helps increase range of motion. It reduces post-traumatic and post-operative pain, as well as inflammatory swelling.

In case of post-traumatic and post-operative inflammatory phenomena it quickly relieves pain (occurring both at rest and during movement), reduces inflammatory swelling and edema of the postoperative wound.

Inhibits platelet aggregation. With long-term use has a desensitizing effect.

Pharmacokinetics .

Indications

Inflammatory and degenerative diseases of the musculoskeletal system, including rheumatoid, psoriatic, juvenile chronic arthritis, ankylosing spondylitis (Behterev’s disease), osteoarthritis, gouty arthritis, bursitis, tendovaginitis. The drug is intended for symptomatic therapy, to reduce pain and inflammation at the time of use, does not affect the progression of the disease.

Pain syndrome: headache (including migraine) and toothache, lumbago, ischialgia, ossalgia, neuralgia, myalgia, arthralgia, radiculitis, with cancer, post-traumatic and postoperative pain syndrome accompanied by inflammation.

Algodysmenorrhea: pelvic inflammatory processes, including adnexitis.

Infectious inflammatory diseases of the ENT-organ with a pronounced pain syndrome (in the treatment): pharyngitis, tonsillitis, otitis.

Active ingredient

Composition

1 tablet contains:

The active ingredients:

diclofenac sodium 25 mg

How to take, the dosage

Ingestion.

To achieve the desired rapid therapeutic effect, take 30 min before a meal. In other cases it is taken before, during or after a meal, in a non-chewed form, with plenty of water. For adults and adolescents from 15 years of age, 25-50 mg 2-3 times a day.

If optimal therapeutic effect is achieved, the dose is gradually reduced and maintenance treatment is initiated at a dose of 50 mg/day. The maximum daily dose is 150 mg.

In juvenile rheumatoid arthritis the daily dose may be increased to 3 mg/kg body weight.

The indicative regimen of the drug is shown in the table:

Interaction

Increases the plasma concentration of digoxin, methotrexate, lithium drugs and cyclosporine.

Decreases the effect of diuretics, against potassium-saving diuretics the risk of hyperkalemia increases; against anticoagulants, thrombolytic agents (alteplase, streptokinase, urokinase) – risk of bleeding (often from the gastrointestinal tract).

Limits the effects of hypotensive and sleeping pills.

Induces side effects of other NSAIDs and glucocorticosteroids (gastrointestinal bleeding), methotrexate toxicity and cyclosporine nephrotoxicity.

Acetylsalicylic acid reduces the blood concentration of diclofenac. Concomitant use with paracetamol increases the risk of nephrotoxic effects of diclofenac.

Limits the effect of hypoglycemic agents.

Cefamandole, cefoperazone, cefotetan, valproic acid and plikamycin increase the incidence of hypoprothrombinemia.

Cyclosporine and gold drugs increase the effect of diclofenac on prostaglandin synthesis in the kidneys, which increases nephrotoxicity.

Concomitant use with ethanol, colchicine, corticotropin and St John’s wort preparations increases the risk of gastrointestinal bleeding.

Diclofenac increases the effect of drugs that cause photosensitization. Drugs that block tubular secretion increase the plasma concentration of diclofenac, thereby increasing its toxicity.

Antibacterial drugs from quinolone group – risk of seizures.

Special Instructions

In patients with hepatic insufficiency (chronic hepatitis, compensated cirrhosis) kinetics and metabolism do not differ from those in patients with normal liver function.

When long-term therapy it is necessary to monitor liver function, peripheral blood count, fecal occult blood test.

During the treatment period mental and motor reactions can decrease, therefore it is necessary to refrain from driving motor transport and carrying out other potentially dangerous activities, which require high concentration and quick psychomotor reactions.

Contraindications

Hypersensitivity (including to other NSAIDs), complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose and sinuses and intolerance to acetylsalicylic acid (ASA) or other NSAIDs (including history), erosive ulcerative lesions of the stomach and duodenum, active gastrointestinal bleeding, inflammatory bowel disease, severe liver and heart failure; period after coronary artery bypass grafting; severe renal insufficiency (creatinine clearance (CK) less than 30 ml/min), advanced renal disease, active liver disease, confirmed hyperkalemia, pregnancy (III trimester), lactation, children age (under 6 years for tablets coated with 25 mg).

Hereditary lactose intolerance, impaired glucose-galactose absorption, lactase deficiency.

With caution. Gastric and 12 duodenal ulcer, ulcerative colitis, Crohn’s disease, liver disease in anamnesis, hepatic porphyria, chronic heart failure, arterial hypertension, significant decrease in circulating blood volume (DCV) (including after major surgery), elderly patients (including those treated with diuretics, patients with debility and patients with low body weight), bronchial asthma, concomitant use of GCS (including prednisolone), anticoagulants (including warfarin), antiplatelet agents (including ASA, clopidogrel), selective serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxetine, sertraline), CHD, cerebrovascular disease, dyslipidemia/hyperlipidemia, diabetes mellitus, peripheral arterial disease, smoking, chronic renal failure (CK 30-60 ml/min), presence of Helicobacter pylori infection, long-term use of NSAIDs, alcoholism, severe somatic diseases.

Side effects

Gastrointestinal tract disorders: more often 1% – abdominal pain or cramping, feeling of bloating, diarrhea, nausea, constipation, flatulence, increased activity of “liver” tranaminases, peptic ulcer with possible complications (bleeding, perforation), gastrointestinal bleeding without ulceration; less frequently 1% – vomiting, jaundice, melena, blood in stool, esophageal damage, aphthous stomatitis, dry mucous membranes (including oral cavity), hepatitis (possible lightning course), liver necrosis, cirrhosis, hepatorenal syndrome, change of appetite, pancreatitis (including with concomitant hepatitis), cholecystopancreatitis, colitis.

Nervous system disorders: more than 1% – headache, dizziness; less frequently 1% – sleep disturbance, somnolence, depression, irritability, aseptic meningitis (more common in patients with systemic lupus erythematosus and other systemic connective tissue diseases), seizures, general weakness, disorientation, nightmares, feeling of fear.

Sensory organs: more often 1% – tinnitus; less often 1% – blurred vision, diplopia, taste disturbance, reversible or irreversible hearing loss, scotoma.

Skin disorders: more than 1% – skin itching, skin rash, less than 1% – alopecia, urticaria, eczema, toxic dermatitis, erythema multiforme (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell’s syndrome), photosensitivity, fine-point hemorrhage.

Urinary system disorders: more often 1% – fluid retention; less often 1% – nephrotic syndrome, proteinuria, oliguria, hematuria, interstitial nephritis, papillary necrosis, acute renal failure, azotemia.

Hematopoietic and immune system disorders: less frequently 1% – anemia (including hemolytic and aplastic anemia), leukopenia, thrombocytopenia, eosinophilia, agranulocytosis, thrombocytopenic purpura, worsening of the course of infection processes (including development of necrotic fasciitis).

Respiratory system disorders: less frequently 1% – cough, bronchospasm, laryngeal edema, pneumonitis.

Cardiovascular system disorders: rarely 1% – increase in blood pressure; congestive heart failure, extrasystole, pain in the chest.

Allergic reactions: less than 1% – anaphylactoid reactions, anaphylactic shock (usually develops rapidly), edema of the lips and tongue, allergic vasculitis.

Overdose

Symptoms: vomiting, dizziness, headache, shortness of breath, confusion, in children – myoclonic convulsions, nausea, vomiting, abdominal pain, bleeding, liver and kidney function disorders.

Treatment: gastric lavage, administration of activated charcoal, symptomatic therapy aimed at eliminating increased blood pressure, impaired renal function, convulsions, gastrointestinal tract irritation, respiratory depression. Forced diuresis, hemodialysis are ineffective.

Similarities