Pharmacodynamics and pharmacokinetics
The active substance is diclofenac . The drug has antipyretic, analgesic and anti-inflammatory effects. The main component of the drug is a derivative of phenylacetic acid. The main mechanism of action is aimed at non-selective inhibition of cyclooxygenases-1,2, a decrease in the concentration of prostaglandins in the inflammatory focus, and disruption of the metabolic process of arachidonic acid . The drug has additional antiplatelet activity.
Composition and dosage forms
Ortofen contains one active substance - diclofenac, which has a pronounced analgesic, anti-inflammatory and moderate antipyretic effect. The drug has several forms of release for systemic and local use:
- tablets: white, flat-cylindrical, with a dosage of 25 mg, auxiliary components: povidone, starch, magnesium stearate and others;
- gel: a clear, slightly viscous liquid containing 5% diclofenac, packaged in 100 ml bottles, containing water, ethyl alcohol, propylene glycol and other binders;
- Ortofen ointment: 20% preparation in the form of a homogeneous viscous mass, available in tubes of 30 and 50 ml;
- water-based injection solution: liquid in 3 ml ampoules containing 25 mg. diclofenac in 1 ml.
Indications for use of Ortofen
What do tablets and ointment help with? Let's consider the indications for the use of this medication.
The drug is prescribed for the treatment of diseases of the musculoskeletal system of degenerative and inflammatory origin: Personage-Turner disease amyotrophy ), ankylosing spondylitis (ankylosing spondylitis), chronic juvenile arthritis, rheumatism, arthritis in Reiter's disease , psoriatic arthritis, rheumatoid arthritis, osteoarthritis.
The drug is effective for relieving pain after surgery, trauma, cancer, neuralgia, sciatica , bursitis, myalgia, radiculitis, arthralgia, toothache, migraine, headache, tendinitis , ossalgia, lumbago.
The medication is used for adnexitis, inflammatory diseases of the pelvic organs, algodismenorrhea , otitis, pharyngitis, tonsillitis and other diseases of the ENT organs.
The drug is prescribed for the relief of febrile syndrome, which accompanies the course of many infectious and “cold” diseases.
Contraindications
Ortofen is not used for “aspirin” asthma , with intolerance to diclofenac, with various disorders of the blood coagulation system, with hematopoiesis disorders, with the “aspirin” triad (recurrent polyposis of the nose, paranasal sinuses combined with bronchial asthma and intolerance to acetylsalicylic acid , pyrazolone-type medications), during pregnancy, erosive and ulcerative lesions in the digestive tract, hemophilia , breastfeeding, anemia, leukopenia, tendency to bleeding, prolongation of the bleeding period, children under 6 years of age.
For swelling, alcoholism, renal and liver failure, arterial hypertension, erosive and ulcerative lesions of the digestive system, for decompensated forms of chronic heart failure, for anemia, bronchial asthma, diabetes mellitus , in the postoperative period, for acute inducible hepatic porphyrias and elderly patients Ortofen prescribed with caution.
Contraindications and side effects
The drug is not applicable for cases of high sensitivity to salicylates, inflammatory and erosive lesions of the digestive tract mucosa, severe liver and urinary tract diseases. Contraindications also include:
- tendency to internal bleeding, decreased blood clotting;
- Iron-deficiency anemia;
- pregnancy at all stages;
- breastfeeding period.
Ortofen is also prohibited for the treatment of children under 6 years of age. An extensive list of contraindications is explained by high toxicity. Various undesirable reactions are possible against the background of its use:
- loss of appetite, change in taste, pain in the epigastrium, abdominal cavity, exacerbation of gastritis and gastrointestinal pathologies, diarrhea;
- kidney inflammation, impaired diuresis;
- dizziness, asthenic syndrome, insomnia;
- drug hepatosis.
Ortofen should be used with caution in diseases of the heart and blood vessels, bronchial asthma, and diabetes mellitus. Possible signs of a drug overdose: severe headache, vomiting, loss of coordination of movements, deterioration of hearing and vision.
Side effects
Gastrointestinal tract: peptic ulcers, flatulence, constipation, dyspeptic disorders, diarrhea syndrome, cramps, abdominal pain, increased liver enzymes, gastrointestinal bleeding, perforation , dry mouth, aphthous stomatitis , esophageal damage, blood in the stool, melena , jaundice, hepatorenal syndrome , hepatitis, liver cirrhosis, hepatonecrosis, colitis, pancreatitis, perversion of taste perception.
Nervous system: anxiety, headache, weakness throughout the body, diplopia, depression, drowsiness, sleep disturbances, convulsions, aseptic meningitis .
Sense organs: scotoma , possible irreversible decrease in auditory perception, blurred visual perception, taste disturbances.
Skin: itching, rash, eczema , urticaria , alopecia, Lyell's syndrome, Stevens-Johnson syndrome , toxic dermatitis, photosensitivity.
Genitourinary system: proteinuria , nephrotic syndrome , fluid retention in the body, azotemia, papillary necrosis, acute renal failure, interstitial nephritis , oliguria. Hematopoietic organs: the development of anemia, eosinophilia, leukopenia, thrombocytopenic purpura, and agranulocytosis is rarely observed.
Respiratory system: laryngeal edema, cough, development of bronchospasm. Cardiovascular system: congestive heart failure, increased blood pressure.
Allergic responses: swelling of the tongue and lips, anaphylactic shock, anaphylactoid reactions.
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.
Instructions for use of Ortofen (Method and dosage)
Ortofen tablets, instructions for use
The tablets are not chewed, taken orally after meals.
The dosage for adults is 25-50 mg 2-3 times a day. The amount of the drug is gradually reduced when the required therapeutic result is achieved, after which they switch to a maintenance dose of 50 mg/day.
When treating rheumatoid juvenile arthritis, the daily amount of the drug can be increased to 3 mg/kg.
Ortofen injections, instructions for use
A single intramuscular injection of the drug is acceptable to relieve exacerbations of chronic diseases, and subsequently switch to taking oral forms. The medicine is injected intramuscularly at a dose of 75 mg.
Ortofen ointment, instructions for use
Apply about 3 g of ointment to the sore spot in a thin layer. A maximum of 8 g of the product should be applied externally per day.
Application: instructions
Ortofen tablets are taken in one or several doses per day:
- 1 tablet once and up to 3-4 times a day, after eating food or simultaneously with it, the maximum amount of the product is 150 mg;
- in case of severe pain, from the second day of therapy it is recommended to reduce the number of tablets to 2-3 pieces in order to avoid undesirable consequences for the body;
- It is not recommended to take tablets for more than 5 days in a row.
Ortofen injections are indicated intramuscularly. They are administered once, in a dose of no more than 75 mg. active substance. After a single injection, therapy should be continued by taking the drug in tablets.
Gel and ointment are used externally, treating the surface of the skin in the area of damage or inflammation of the joint. The product in an amount of 2–3 g is applied to clean surfaces, rubbing until the medicine is completely absorbed. If necessary, wrap part of the body in warmth. It is recommended to use Ortofen ointment at night or at rest. It is allowed to use up to 8 g of a topical drug per day without health consequences.
Important: when using both systemic and external forms of the medication, you must take into account its total amount when discussing it with your doctor.
When using injections and tablets, you must avoid other NSAIDs and carefully check the dosage of anticoagulants and glucocorticoids, as they increase the toxicity of Ortofen.
Overdose
Manifested by myoclonic convulsions , epigastric pain, disturbances in the liver and kidneys, bleeding, clouding of consciousness, hyperventilation of the pulmonary system, headaches and dizziness.
Gastric lavage, emergency administration of enterosorbents , and syndromic therapy are required. Forced diuresis and hemodialysis have not proven their effectiveness and are not used.
How does Ortofen work?
The mechanism of action of all forms of the drug is determined by the non-steroidal anti-inflammatory active component they contain. The injection solution and tablets have a systemic effect, relieve symptoms of fever and acute pain. Diclofenac indiscriminately inhibits the activity of pain and inflammatory prostaglandins, has an antiplatelet property - it increases blood flow. After administration intramuscularly or orally, the medicine is distributed in all fluids and tissues of the body. The liver and kidneys take part in the transformation and filtration of drug metabolites.
Topical preparations: Ortofen ointment and gel have moderate analgesic properties and are used to reduce pain in muscles and joints. Part of the drug is absorbed orally through the skin. With prolonged use, the active substance may accumulate in the blood and affect the tissues of internal organs.
Interaction
Ortofen is able to increase the level of cyclosporine , digoxin, lithium preparations, methotrexate in the blood. The drug reduces the severity of the effect of diuretics, increases the likelihood of bleeding when taking alteplase, urokinase, streptokinase, antiplatelet and anticoagulant drugs. There is a decrease in the effectiveness of sleeping pills and antihypertensive drugs.
The medication increases the nephrotoxicity of cyclosporine, enhances the toxic effect of methotrexate, and increases the severity of side effects of glucocorticosteroids and other NSAID medications. It is not recommended to prescribe simultaneously with paracetamol.
The drug reduces the effectiveness of hypoglycemic agents . Valproic acid , cefotetan, cefamandole, plicamycin, cefoperazone increase the likelihood of developing hypoprothrombinemia .
St. John's wort, corticotropin, ethanol and colchicine significantly increase the risk of gastrointestinal bleeding .
Medicines that, by their mechanism of action, cause blocking of tubular secretion, can increase the level of the main substance in the blood, which increases the toxicity and effectiveness of the drug Ortofen.
Ortofen-ZT 25 mg No. 30 tablet p.o. solution/intestinal.
Instructions for medical use of the drug ORTOFEN-HEALTH Trade name Ortofen-Zdorovye International nonproprietary name Diclofenac Dosage form Enteric-coated tablets, 25 mg Composition One tablet contains the active substance - diclofenac sodium (in terms of 100% substance) 25 mg, excipients : lactose monohydrate, microcrystalline cellulose, crospovidone, croscarmellose sodium, magnesium stearate, colloidal anhydrous silicon dioxide; shell: dry mixture “Acryl-eze white” (talc, titanium dioxide (E 171), methacrylate copolymer (type C), sodium lauryl sulfate, sodium bicarbonate, colloidal anhydrous silicon dioxide), macrogol 6000, bright red dye 4R “Ponceau 4R” » E 124, sunset yellow dye FCF E 110. Description Film-coated tablets, orange-pink to pink-orange in color. Slight marbling is allowed on the surface of the tablets. The cross section shows two layers. Pharmacotherapeutic group Anti-inflammatory and antirheumatic drugs. Non-steroidal anti-inflammatory drugs. Acetic acid derivatives. Diclofenac Code ATC M01AB05 Pharmacological properties Pharmacokinetics Absorption. When taken orally, diclofenac is quickly and completely absorbed. Simultaneous food intake reduces the rate of absorption without changing the amount of absorbed active substance. The maximum concentration in the blood (Cmax) after a single oral administration of diclofenac at a dose of 50 mg is reached after approximately 2 hours and is 1.5 μg/ml (5 μmol/l). The amount of active substance absorbed is proportional to the dose. Approximately half the dose of diclofenac is metabolized during the first passage through the liver (first-pass effect). If the recommended dosing interval is observed, drug accumulation is not observed. Distribution. Communication with plasma proteins is more than 99%. The expressed volume of distribution ranges from 0.12 to 0.17 l/kg. Diclofenac penetrates into the synovial fluid, where it reaches maximum concentrations after 3-6 hours. 2 hours after peak plasma concentrations are reached, levels of the active substance in the synovial fluid are already higher than in the plasma and remain higher for up to 12 hours. Biotransformation. Metabolized in the liver partly by glucuronidation of the parent molecule, but mainly through single and multiple hydroxylation and methoxylation, which leads to the formation of several phenolic metabolites, most of which are converted to glucuronide conjugates. Two of these phenolic metabolites are biologically active, but to a lesser extent than diclofenac. Elimination. The total systemic clearance of diclofenac from plasma is 263 ml/min. The half-life (T½) from plasma is approximately 2 hours, from synovial fluid – 3-6 hours. Excreted by the kidneys (40-65%), with bile and feces (35%). Pharmacokinetics in various groups of patients. There are no significant differences in absorption, metabolism or excretion of the drug depending on the age of the patients. In patients with renal failure, accumulation of unchanged active substance is not allowed. In patients with chronic hepatitis or uncompensated liver cirrhosis, the pharmacokinetic parameters of diclofenac are the same as in patients without liver disease. Pharmacodynamics Anti-inflammatory, analgesic, antipyretic agent. The mechanism of action of diclofenac is due to the inhibition of cyclooxygenases (COX-1 and COX-2), as a result of which the reactions of the arachidonic cascade are blocked and the synthesis of prostaglandins (PGE2 and PGF2alpha), thromboxane A2, prostacyclin, leukotrienes and the release of lysosomal enzymes is disrupted, as well as the suppression of platelet aggregation. Diclofenac eliminates or significantly reduces the severity of symptoms of inflammation; reduces prostaglandin-induced increased sensitivity of nerve endings to biologically active substances that are formed at the site of inflammation; lowers body temperature (preventing the effect of prostaglandins on the hypothalamic link of thermoregulation); reduces the concentration of prostaglandins in menstrual blood and the intensity of pain during primary dysmenorrhea. In rheumatic diseases, the anti-inflammatory and analgesic properties of diclofenac provide a significant reduction in the severity of symptoms and complaints such as pain at rest and during movement, morning stiffness, swelling of the joints, and also improves joint function. In case of post-traumatic and postoperative inflammatory phenomena, diclofenac quickly relieves both spontaneous pain and pain during movement, reduces inflammatory swelling and swelling of the postoperative wound. In cell culture studies, diclofenac sodium at concentrations equivalent to those achieved in patient treatment does not inhibit the biosynthesis of cartilage proteoglycans. Diclofenac exhibits a pronounced analgesic effect for moderate and severe pain of non-rheumatic origin (including migraine attacks); is able to eliminate pain and reduce the severity of blood loss during primary dysmenorrhea. Indications for use: inflammatory and degenerative forms of rheumatic diseases (rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, spondyloarthritis), pain syndromes localized in the spine; non-articular rheumatism - acute attacks of gout - post-traumatic and postoperative pain syndromes accompanied by inflammation and swelling, for example after dental and orthopedic interventions - gynecological diseases accompanied by pain and inflammation, for example primary dysmenorrhea or adnexitis - in combination therapy of ENT organs for severe inflammatory diseases accompanied by pain (pharyngotonsillitis, otitis and others) Method of administration and dosage: Prescribed to adults orally during or immediately after meals, without chewing, with a sufficient amount of water. It is recommended that the dose be individualized and that the lowest effective dose be taken for the shortest possible time. For adults, the recommended initial daily dose is 100-150 mg. In mild cases, as with long-term therapy, 75-100 mg is usually sufficient. The total daily dose for adults is usually divided into 2-3 doses. The daily dose of the drug should not exceed 150 mg. For primary dysmenorrhea, the daily dose is selected individually, and is usually 50-150 mg. The initial dose can be 50-100 mg, but if necessary, it can be increased over several menstrual cycles, but not higher than 200 mg/day. The use of the drug should be started as soon as possible after the first pain symptoms appear; The duration, depending on the symptoms, is up to several days. Single and daily doses, as well as the duration of treatment, are determined individually by the doctor. Side effects Often (from >1/100 to <1/10) - headache, dizziness - vertigo - nausea, vomiting, diarrhea, dyspepsia, abdominal pain, flatulence, anorexia - increased transaminase levels - rash Rarely (from >1/10000 up to <1/1000) - hypersensitivity reactions, anaphylactic/anaphylactoid reactions, including hypotension and shock - drowsiness - asthma (including dyspnea) - gastritis, gastrointestinal bleeding (hematemesis, melena, bloody diarrhea), stomach and intestinal ulcers , accompanied or not accompanied by bleeding or perforation - hepatitis, jaundice, liver dysfunction - urticaria, skin irritations Very rare (<1/10000) - thrombocytopenia, leukopenia, hemolytic anemia, aplastic anemia, agranulocytosis - angioedema - disorientation, depression, insomnia , nightmares, irritability, psychotic disorders - paresthesia, memory impairment, convulsions, anxiety, tremor, aseptic meningitis, dysgeusia, acute cerebrovascular accident - visual impairment, blurred vision, diplopia - ringing in the ears, hearing impairment - rapid heartbeat, pain in breast, heart failure, myocardial infarction - hypertension, vasculitis - pneumonia - colitis (including hemorrhagic colitis and exacerbation of ulcerative colitis or Crohn's disease), constipation, stomatitis, glossitis, esophageal disorder, diaphragm-like intestinal strictures, pancreatitis - fulminant hepatitis, necrotizing hepatitis , liver failure - bullous dermatitis, eczema, erythema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), exfoliative dermatitis, alopecia, photosensitivity reaction, purpura, Henoch-Schönlein purpura, itching - acute renal failure, hematuria, proteinuria, nephrotic syndrome, interstitial nephritis, papillary necrosis Contraindications - hypersensitivity to diclofenac and any other ingredients of the drug - gastric or intestinal ulcers, bleeding or perforation - hereditary fructose intolerance, Lapp-lactase enzyme deficiency, malabsorption of glucose - galactose - pregnancy and period lactation - severe dysfunction of the liver, kidneys and heart - a history of asthma attacks, urticaria, acute rhinitis when taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs - diseases of the hematopoietic system - treatment of postoperative pain after coronary bypass surgery or the use of a heart-lung machine - children's age up to 18 years of age (due to the presence of dyes) Drug interactions Diclofenac may increase the concentrations of lithium and digoxin in the blood plasma. Monitoring of the latter in blood plasma is recommended. Diclofenac, like other non-steroidal anti-inflammatory drugs (NSAIDs), when used together with diuretics or antihypertensive drugs (for example, beta-blockers, ACE inhibitors) may reduce their antihypertensive effect. Therefore, a combination of such drugs should be prescribed with caution, and patients (especially elderly) should periodically monitor blood pressure. Patients should drink sufficient amounts of water, and renal function should be periodically monitored after initiation and termination of concomitant therapy, particularly when using diuretics and ACE inhibitors, due to the increased risk of nephrotoxicity. Concomitant use of potassium-sparing diuretics may lead to an increase in serum potassium levels (in the case of such a combination of drugs, this indicator should be monitored frequently). Concomitant use of diclofenac, like other systemic non-steroidal anti-inflammatory drugs or corticosteroids, may increase the incidence of adverse events from the digestive tract. In patients using diclofenac, anticoagulants and antithrombotic drugs simultaneously, there may be an increased risk of bleeding. Therefore, in the case of such a combination of drugs, careful and regular monitoring of patients is recommended. Concomitant use of systemic non-steroidal anti-inflammatory drugs and selective serotonin reuptake inhibitors may increase the risk of gastrointestinal bleeding. The simultaneous use of diclofenac and antidiabetic drugs is possible, but the effectiveness of the latter does not change. However, in such cases, it is very rare that both hypoglycemia and hyperglycemia may develop, which necessitates the need to change the dose of glucose-lowering drugs during use of the drug. For this reason, it is recommended to monitor blood glucose levels during therapy. Caution should be exercised when using diclofenac less than 24 hours before or after taking methotrexate, since in such cases the concentration of methotrexate in the blood may increase and its toxic effect may increase. Concomitant use of diclofenac, colestipol or cholestyramine reduces the absorption of diclofenac by approximately 30% and 60%, respectively. The drugs should be taken at intervals of several hours. Drugs that stimulate microsomal liver enzymes, such as rifampicin, carbamazepine, phenytoin, St. John's wort (Hypericum perforatum), are theoretically capable of reducing diclofenac plasma concentrations. The effect of diclofenac on the synthesis of prostaglandins in the kidneys may enhance the nephrotoxicity of cyclosporine. Therefore, the drug should be prescribed in lower doses than those that would be prescribed to patients not taking cyclosporine. Patients using quinolone derivatives and diclofenac antibacterial agents at the same time rarely develop seizures. Special instructions Effects on the gastrointestinal tract All NSAIDs, including diclofenac, are known to cause gastrointestinal bleeding, ulceration or perforation, which can be fatal and occur at any time in patients with or without previous symptoms, serious gastrointestinal history of diseases. The risk of gastrointestinal bleeding is increased with increasing doses of NSAIDs, in patients with a history of ulcers, especially those complicated by bleeding or perforation, and in elderly patients. To reduce the risk of gastrointestinal toxicity in patients with a history of gastrointestinal disease, gastric ulcers, ulcerative colitis or Crohn's disease, as well as in elderly patients, treatment should be carried out using the minimum effective dose of the drug and under close medical supervision. Particular caution is recommended in patients receiving concomitant medications that increase the risk of ulceration or bleeding, such as systemic corticosteroids, anticoagulants, antiplatelet agents, or selective serotonin reuptake inhibitors. For patients at increased risk of developing gastrointestinal complications, as well as for patients receiving therapy with low doses of acetylsalicylic acid, it is necessary to consider the use of combination therapy of diclofenac, for example, with proton pump inhibitors or misoprostol. If patients develop gastrointestinal bleeding or ulceration, Ortofen-Zdorovye should be discontinued. Patients with a history of gastrointestinal disorders, especially elderly patients, should report any abdominal symptoms (especially gastrointestinal bleeding). Patients with respiratory tract diseases In patients with asthma, seasonal allergic rhinitis, swelling of the nasal mucosa, chronic obstructive pulmonary diseases or chronic respiratory tract infections (especially if associated with symptoms similar to allergic rhinitis), Quincke's edema or urticaria is more common compared with other patients. These patients, as well as patients with allergies to other drugs (rash, itching or urticaria), should be especially careful when prescribing Ortofen-Zdorovye. Skin reactions Very rarely, serious skin reactions, including fatal ones (exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis), may occur with the use of NSAIDs, including diclofenac. The risk of developing such reactions in patients, in most cases, is increased during the first month of treatment. It is necessary to stop using the drug Ortofen-Zdorovye if a skin rash, damage to the mucous membrane or other signs of hypersensitivity appears. As with other NSAIDs, when using Ortofen-Zdorovye, allergic reactions, including anaphylactic/anaphylactoid reactions, may develop in rare cases in patients who have not previously experienced allergic reactions to diclofenac. Effects on the liver Careful medical supervision is necessary when prescribing Ortofen-Zdorovye to patients with impaired liver function, as their condition may worsen. During long-term treatment with Ortofen-Zdorovye, as a precautionary measure, regular monitoring of liver function is recommended. Like other NSAIDs, diclofenac may cause an increase in liver enzyme activity. If the activity of liver enzymes persists or further increases, the development of clinical symptoms of impaired liver function, or the appearance of other symptoms (for example, eosinophilia, rash), the drug should be discontinued. It should be borne in mind that hepatitis during the use of diclofenac can develop without previous symptoms. Caution must be exercised when prescribing Ortofen-Zdorovye to patients with hepatic porphyria, since the drug can provoke an attack of porphyria. Effects on the kidneys Because fluid retention and edema have been reported during treatment with NSAIDs, including diclofenac, special caution should be exercised in patients with impaired cardiac or renal function, with a history of hypertension, in elderly patients, in patients receiving concomitant treatment with diuretics or drugs that may have a significant effect on renal function, and also in patients with a significant decrease in extracellular fluid volume for any reason before or after major surgery. When using the drug Ortofen-Zdorovye in such cases, as a precautionary measure, it is recommended to monitor renal function. Discontinuation of the drug usually results in renal function returning to baseline levels. The impact on the cardiovascular system treatment for NSAIDs, including diclofenac, especially in high doses and for a long time can be associated with a slight increase in the risk of serious cardiovascular thrombotic phenomena (including myocardial infarction and stroke). In order to minimize the potential risk of unwanted cardiovascular phenomena in patients taking NSAIDs, especially in the case of cardially risk factors, the smallest effective dose for the most short possible period of time should be used. Hematological effects in the course of prolonged treatment with diclofenac, like other NSAIDs, are recommended to monitor a general clinical blood test. Like other NSAIDs, Diclofenac can temporarily reduce platelet aggregation. Patients with hemostasis disorders need to establish thorough observation, and a systematic monitoring of the picture of peripheral blood is necessary. Geriatrics must be careful when prescribing the drug to elderly patients. In particular, it is recommended to prescribe the lowest effective dose of weakened elderly patients or patients with a low body weight. Diclofenac, due to its pharmacodynamic properties, can mask complaints and symptoms characteristic of infectious and inflammatory diseases. Pregnancy and lactation period. The use of diclofenac in pregnant women was not studied. Therefore, orthophen-stones should not be prescribed for the first two trimesters of pregnancy, unless the benefits of its use do not exceed the risks for the fetus. As for other NSAIDs, the use of the drug during the third trimester of pregnancy is contraindicated due to the risk of the development of the weakness of the generic activity of the uterus and/or premature closure of the arterial duct. Like other NSAIDs, diclofenac is excreted in small quantities into breast milk. Thus, orthophen-health should not be used during breastfeeding in order to prevent undesirable reactions in the child. Like other NSAIDs, Diclofenac can negatively affect female fertility, so it is not recommended to prescribe the drug to women planning pregnancy. In women who have problems with conception or undergoing a study for infertility, the appropriateness of the cancellation of the drug Ortophen-Stostering should be considered. Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms to patients experiencing dizziness or other unpleasant sensations from the central nervous system during the intake of orthophen-stones, including visual impairment, the car should not be driven or mechanisms. Overdose symptoms: vomiting, gastrointestinal bleeding, diarrhea, dizziness, ringing in the ears or cramps. In the case of severe poisoning, the development of acute renal failure and liver damage is possible. Treatment: gastric lavage, adsorbent. If necessary, supporting and symptomatic therapy, which is indicated for complications such as arterial hypotension, renal failure, convulsions, disturbances by the digestive tract and respiratory depression. It is unlikely that forced diuresis, hemodialysis or hemoperfusion will turn out to be useful for the excretion of diclofenac, since the active substances of non -steroidal anti -inflammatory drugs are largely associated with blood plasma proteins and are subjected to intensive metabolism. The release form and packaging of 10 or 30 tablets in the contour cell package from the polyvinyl chloride film and aluminum foil. 1 contour cell packaging of 30 tablets or 3 contour cell packages for 10 tablets along with instructions for medical use in a cardboard box. Storage conditions are stored in original packaging at a temperature of not higher than 25 ºС. Keep out of the reach of children! The shelf life of 3 years does not use the drug after the expiration date indicated on the package! Conditions of vacation from pharmacies according to the recipe manufacturer of LLC Pharmaceutical Company Health. Ukraine, 61013, Kharkov, st. Shevchenko, 22. The owner of the registration certificate of LLC Pharmaceutical Company Health, Ukraine. The address of the organization receiving in the territory of the Republic of Kazakhstan claims from consumers on the quality of the product (goods) of Pharma-Europe LLP 050039, Almaty, Mailin St., 72, apt. 34 tel. Fax e-mail
special instructions
Ortofen can be taken half an hour before meals to achieve a faster therapeutic effect. In other cases, the drug is recommended to be taken before, during, or after meals. Tablet dosage forms are not chewed and washed down with the required amount of liquid.
an important role in maintaining renal blood flow , which requires the doctor to have a special attitude towards patients with pathologies of the renal and cardiac systems, as well as persons taking diuretics with a reduced volume of circulating blood. Long-term therapy requires periodic monitoring of liver function and the state of peripheral blood ; it is recommended to conduct regular stool tests for occult blood.
Ortofen affects the course of certain motor and mental reactions, therefore it is recommended to refrain from driving vehicles and performing complex work during the period of treatment with diclofenac.
Ortofen's analogs
Level 4 ATC code matches:
Voltaren
Rapten
Zerodol
Dickloberl Retard
Dikloberl N 75
Dicloberl
Ketanov
Dolak
Panoxen
Ketorolac
Naklofen Duo
Naklofen
Olfen-100
Olfen-75
Neurodiclovit
Nizilat
Fanigan
Aertal
Methindol retard
Analogs are the following drugs: Almiral , Argett , Bioran , Voltaren , Diklak , Dicloberl , Diclovit , Dicloran , Diclorapid , Dicloreum , Diclofenac , Diclofenac Sodium , Naklofen , Nergez , Olfen , Feloran , Evinopon .
Reviews about Ortofen
The tablets quickly and effectively help relieve pain and inflammation and reduce fever. The drug is effective for otitis, bursitis, inflammation of the joints, and is a good pain reliever for arthritis.
The downside is that it has a bad effect on the stomach, which can lead to ulcers. The medicine also has a large number of contraindications.
Reviews of Ortofen ointment also testify in favor of this remedy. The medicine instantly relieves pain and relieves inflammation in problem areas.
Ortofen price, where to buy
The price of Ortofen in tablets is approximately 40 rubles.
The price of Ortofen injections starts from 40 rubles per pack of 10 ampoules of 3 ml.
The price of Ortofen ointment is 30-60 rubles per 30 g.
- Online pharmacies in RussiaRussia
- Online pharmacies in UkraineUkraine
- Online pharmacies in KazakhstanKazakhstan
ZdravCity
- Ortofen gel for external use.
approx. 5% 50g Vertex AO RUB 224 order - Ortofen ointment 2% 50gVertex AO
129 RUR order
- Ortofen ointment 2% 30gVertex AO
108 RUR order
- Ortofen gel for external use. approx. 5% 30gVertex JSC
RUB 141 order
- Ortofen gel d/nar. approx. 5% 100g Vertex JSC
RUB 286 order
Pharmacy Dialogue
- Ortofen ointment (tube 2% 30g)Vertex
85 rub. order
- Ortofen ointment (tube 2% 50g)Vertex
115 rub. order
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