Gel, injections, tablets and ointment Ortofen: instructions for use, price, reviews. Analogues and indications for use

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.

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.

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 25 mg 20 pcs. enteric-coated tablets

pharmachologic effect

NSAID, phenylacetic acid derivative.
It has a pronounced anti-inflammatory, analgesic and moderate antipyretic effect. The mechanism of action is associated with inhibition of the activity of COX, the main enzyme in the metabolism of arachidonic acid, which is a precursor of prostaglandins, which play an important role in the pathogenesis of inflammation, pain and fever. The analgesic effect is due to two mechanisms: peripheral (indirectly, through suppression of prostaglandin synthesis) and central (due to inhibition of prostaglandin synthesis in the central and peripheral nervous system). In vitro, at concentrations equivalent to those achieved when treating patients, it does not inhibit the biosynthesis of cartilage tissue proteoglycans.

For rheumatic diseases, it reduces pain in the joints at rest and during movement, as well as morning stiffness and swelling of the joints, and helps to increase range of motion. Reduces post-traumatic and postoperative pain, as well as inflammatory swelling.

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

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

Composition and release form Ortofen 25 mg 20 pcs. enteric-coated tablets

Tablets - 1 tablet: diclofenac sodium 25 mg.

10 pieces. — contour cell packaging (2) — cardboard packs.

Description of the dosage form

Enteric-coated tablets.

Directions for use and doses

The dose is selected individually; it is recommended to use the drug in the minimum effective dose, with the shortest possible treatment period.

For oral and rectal use

Adults

When taken orally in the form of tablets of regular duration or rectally in the form of suppositories, the recommended initial dose is 100-150 mg/day. In relatively mild cases of the disease, as well as for long-term therapy, 75-100 mg/day is sufficient. The daily dose should be divided into several doses.

When taken in the form of extended-release tablets, the recommended initial dose is 100 mg 1 time / day. The same daily dose is used for moderately severe symptoms, as well as for long-term therapy. In cases where the symptoms of the disease are most pronounced at night or in the morning, it is advisable to take extended-release tablets at night.

To relieve night pain or morning stiffness; in addition to taking the drug during the day, prescribe diclofenac in the form of rectal suppositories before bedtime; in this case, the total daily dose should not exceed 150 mg.

For primary dysmenorrhea, the daily dose is selected individually; usually it is 50-150 mg. The initial dose should be 50-100 mg; if necessary, over several menstrual cycles it can be increased to 150 mg/day. The drug should be started when the first symptoms appear. Depending on the dynamics of clinical symptoms, treatment can be continued for several days.

In elderly patients (65 years and older), no adjustment of the initial dose is required.

In weakened patients and patients with low body weight, it is recommended to adhere to the minimum dose.

The drug should be used with extreme caution in patients with diseases of the cardiovascular system (including uncontrolled arterial hypertension) or a high risk of developing cardiovascular diseases. If long-term therapy (more than 4 weeks) is necessary in such patients, the drug should be used in a daily dose not exceeding 100 mg.

Children aged 1 year and older

The drug is prescribed in a dose of 0.5-2 mg/kg body weight/day (in 2-3 doses, depending on the severity of the disease). For the treatment of rheumatoid arthritis, the daily dose can be increased to a maximum of 3 mg/kg (in several doses). The maximum daily dose is 150 mg.

The drug in the form of extended-release tablets should not be used in children and adolescents under the age of 18 years.

For parenteral use

Adults

Injected deep into the / m. Single dose - 75 mg. If necessary, repeated administration is possible, but not earlier than after 12 hours.

Duration of use is no more than 2 days, if necessary, then switch to oral or rectal use of diclofenac.

In severe cases (for example, with colic), as an exception, 2 injections of 75 mg each can be given, with an interval of several hours (the second injection should be carried out in the opposite gluteal region). Alternatively, IM administration once a day (75 mg) can be combined with diclofenac in other dosage forms (tablets, rectal suppositories), and the total daily dose should not exceed 150 mg.

For migraine attacks, diclofenac is recommended to be administered as soon as possible after the onset of an attack, IM at a dose of 75 mg, followed by the use of suppositories at a dose of up to 100 mg on the same day, if required. The total daily dose should not exceed 175 mg on the first day.

In elderly patients (65 years and older), no adjustment of the initial dose is required. In weakened patients and patients with low body weight, it is recommended to adhere to the minimum dose.

Children and teenagers under 18 years of age

Diclofenac should not be used intramuscularly in children and adolescents under 18 years of age due to the difficulty of dosing the drug.

Pharmacokinetics

After oral administration, it is absorbed from the gastrointestinal tract. Eating slows down the rate of absorption, but the degree of absorption does not change. About 50% of the active substance is metabolized during the “first pass” through the liver. When administered rectally, absorption occurs more slowly. The time to reach Cmax in plasma after oral administration is 2-4 hours depending on the dosage form used, after rectal administration - 1 hour, intramuscular administration - 20 minutes. The concentration of the active substance in plasma is linearly dependent on the dose applied.

Does not accumulate. Plasma protein binding is 99.7% (mainly with albumin). Penetrates into synovial fluid, Cmax is achieved 2-4 hours later than in plasma.

It is extensively metabolized to form several metabolites, of which two are pharmacologically active, but to a lesser extent than diclofenac.

Systemic clearance of the active substance is approximately 263 ml/min. T1/2; from plasma is 1-2 hours, from synovial fluid - 3-6 hours. Approximately 60% of the dose is excreted in the form of metabolites by the kidneys, less than 1% is excreted unchanged in the urine, the rest is excreted in the form of metabolites in bile.

Indications for use Ortofen 25 mg 20 pcs. enteric-coated tablets

Inflammatory and degenerative diseases of the musculoskeletal system, incl. rheumatoid, juvenile, chronic arthritis; ankylosing spondylitis and other spondyloarthropathy; osteoarthritis; gouty arthritis; bursitis, tendovaginitis; pain syndrome from the spine (lumbago, sciatica, ossalgia, neuralgia, myalgia, arthralgia, radiculitis); post-traumatic postoperative pain syndrome accompanied by inflammation (for example, in dentistry and orthopedics); algodismenorrhea; inflammatory processes in the pelvis (including adnexitis); infectious and inflammatory diseases of the ENT organs with severe pain syndrome (as part of complex therapy): pharyngitis, tonsillitis, otitis media.

Isolated fever is not an indication for the use of the drug.

The drug is intended for symptomatic therapy, reducing pain and inflammation at the time of use, and does not affect the progression of the disease.

Contraindications

Hypersensitivity to diclofenac and excipients of the drug used; “aspirin triad” (attacks of bronchial asthma, urticaria and acute rhinitis when taking acetylsalicylic acid or other NSAIDs); erosive and ulcerative lesions of the gastrointestinal tract in the acute phase; proctitis (only for suppositories); pregnancy (for intramuscular administration); III trimester of pregnancy (for oral and rectal administration); children and adolescents up to 18 years of age (for intramuscular administration and for long-acting dosage forms).

With caution: ;suspicion of gastrointestinal disease; indications in the anamnesis of bleeding from the gastrointestinal tract and perforation of the ulcer (especially in elderly patients), Helicobacter pylori infections, ulcerative colitis, Crohn's disease, dysfunction; mild to moderate liver dysfunction, hepatic porphyria (diclofenac can provoke attacks of porphyria); in patients with bronchial asthma, seasonal allergic rhinitis, swelling of the nasal mucosa (including polyps in the nasal cavity), COPD, chronic infectious diseases of the respiratory tract (especially those associated with allergic rhinitis-like symptoms); cardiovascular diseases (including coronary artery disease, cerebrovascular diseases, compensated heart failure, peripheral vascular diseases); impaired renal function, including chronic renal failure (creatinine clearance 30-60 ml/min); dyslipidemia/hyperlipilemia; diabetes; arterial hypertension; a significant decrease in blood volume of any etiology (for example, in the periods before and after major surgical interventions); violation of the hemostasis system; risk of developing thrombosis (including myocardial infarction and stroke); elderly patients, especially those who are weakened or have low body weight (diclofenac should be used in the minimum effective dose); in patients receiving drugs that increase the risk of gastrointestinal bleeding, including systemic corticosteroids (including prednisolone), anticoagulants (including warfarin), antiplatelet agents (including clopidogrel, acetylsalicylic acid), selective inhibitors serotonin reuptake (including citalopram, fluoxetine, paroxetine, sertraline); simultaneous treatment with diuretics or other drugs that can impair renal function; when treating smoking patients or patients who abuse alcohol; when administered intramuscularly to patients with bronchial asthma due to the risk of exacerbation of the disease (since sodium bisulfite, which is contained in some dosage forms for injection, can cause severe hypersensitivity reactions).

Application Ortofen 25 mg 20 pcs. Enteric-coated tablets during pregnancy and breastfeeding

There is insufficient data on the safety of diclofenac in pregnant women. Therefore, administration in the first and second trimesters of pregnancy is possible only in cases where the expected benefit to the mother outweighs the potential risk to the fetus. Diclofenac (like other inhibitors of prostaglandin synthesis) is contraindicated in the third trimester of pregnancy (possible suppression of uterine contractility and premature closure of the ductus arteriosus in the fetus).

Despite the fact that diclofenac is excreted in breast milk in small quantities, use during lactation (breastfeeding) is not recommended. If use is necessary during lactation, breastfeeding should be discontinued.

Since diclofenac (like other NSAIDs) may have a negative effect on fertility, use in women planning pregnancy is not recommended.

For patients undergoing examination and treatment for infertility, the drug should be discontinued.

Use in children

Not recommended for use in children under 6 years of age.

special instructions

Use with extreme caution in patients with a history of liver, kidney, gastrointestinal diseases, dyspeptic symptoms, bronchial asthma, arterial hypertension, heart failure, immediately after major surgical interventions, as well as in elderly patients.

If there is a history of allergic reactions to NSAIDs and sulfites, diclofenac is used only in emergency cases. During treatment, systematic monitoring of liver and kidney function and peripheral blood patterns is necessary.

Rectal use is not recommended in patients with diseases of the anorectal region or a history of anorectal bleeding. It should be used externally only on undamaged areas of the skin.

Avoid contact of diclofenac with the eyes (except for eye drops) or mucous membranes. Patients using contact lenses should use eye drops no earlier than 5 minutes after removing the lenses.

Not recommended for use in children under 6 years of age.

During treatment with dosage forms for systemic use, alcohol consumption is not recommended.

Impact on the ability to drive vehicles and machinery

During the treatment period, the speed of psychomotor reactions may decrease. If your vision becomes blurred after using eye drops, you should not drive a car or engage in other potentially hazardous activities.

Side effects Ortofen 25 mg 20 pcs. enteric-coated tablets

Determination of the frequency of adverse reactions: very often (≥1/10), often (≥1/100,

From the digestive system: often - abdominal pain, nausea, vomiting, diarrhea, dyspepsia, flatulence, loss of appetite, anorexia, increased activity of aminotransferases in the blood serum; rarely - gastritis, gastrointestinal bleeding, vomiting blood, melena, diarrhea mixed with blood, stomach and intestinal ulcers (with or without bleeding or perforation), hepatitis, jaundice, liver dysfunction; very rarely - stomatitis, glossitis, damage to the esophagus, the occurrence of diaphragm-like strictures in the intestine, colitis (nonspecific hemorrhagic colitis, exacerbation of ulcerative colitis or Crohn's disease), constipation, pancreatitis, fulminant hepatitis, liver necrosis, liver failure.

From the nervous system: often - headache, dizziness; rarely - drowsiness; very rarely - sensory disturbances, including paresthesia, memory disorders, tremors, convulsions, anxiety, acute cerebrovascular accidents, aseptic meningitis; very rarely - disorientation, depression, insomnia, nightmares, irritability, mental disorders.

From the senses: ;often - vertigo; very rarely - visual impairment (blurred vision), diplopia, hearing impairment, tinnitus, dysgeusia.

Dermatological reactions: often - skin rash; rarely - urticaria; very rarely - bullous rashes, eczema, erythema, erythema multiforme, Stevens-Johnson syndrome, Lyell's syndrome (toxic epidermal necrolysis), exfoliative dermatitis, itching, hair loss, photosensitivity reactions; purpura, Henoch-Schönlein purpura.

From the genitourinary system: very rarely - acute renal failure, hematuria, proteinuria, tubulointerstitial nephritis, nephrotic syndrome, papillary necrosis.

From the hematopoietic system: very rarely - thrombocytopenia, leukopenia, hemolytic anemia, aplastic anemia, agranulocytosis.

Allergic reactions: rarely - hypersensitivity, anaphylactic/anaphylactoid reactions, including decreased blood pressure and shock; very rarely - angioedema (including facial swelling).

From the cardiovascular system: very rarely - palpitations, chest pain, increased blood pressure, vasculitis, heart failure, myocardial infarction. There is evidence of a slight increase in the risk of developing cardiovascular thrombotic complications (for example, myocardial infarction), especially with long-term use of diclofenac in high doses (daily dose more than 150 mg).

From the respiratory system: rarely - asthma (including shortness of breath); very rarely - pneumonitis.

General reactions: rarely - swelling.

Drug interactions

Potent CYP2C9 inhibitors - when diclofenac is co-administered with strong CYP2C9 inhibitors (such as voriconazole), it is possible to increase the concentration of diclofenac in the blood serum and enhance the systemic effect caused by inhibition of the metabolism of diclofenac.

Lithium, digoxin - an increase in the concentration of lithium and digoxin in plasma is possible. It is recommended to monitor the concentration of lithium and digoxin in the blood serum.

Diuretics and antihypertensive drugs - when used simultaneously with diuretics and antihypertensive drugs (for example, beta-blockers, ACE inhibitors), diclofenac may reduce their hypotensive effect.

Cyclosporine - The effect of diclofenac on the activity of prostate glandins in the kidneys may increase the nephrotoxicity of cyclosporine.

Drugs that can cause hyperkalemia - Concomitant use of diclofenac with potassium-sparing diuretics, cyclosporine, tacrolimus and trimethoprim may lead to an increase in plasma potassium levels (in the case of such a combination, this indicator should be monitored frequently).

Antibacterial agents quinolone derivatives - there are isolated reports of the development of seizures in patients receiving quinolone derivatives and diclofec at the same time.

NSAIDs and GCS - with simultaneous systemic use of diclofenac and other systemic NSAIDs or GCS may increase the incidence of adverse events (in particular, from the gastrointestinal tract).

Anticoagulants and antiplatelet agents; - an increased risk of bleeding cannot be excluded when diclofenac is used simultaneously with drugs from these groups.

Selective serotonin reuptake inhibitors may increase the risk of gastrointestinal bleeding.

Hypoglycemic drugs - cases of both hypoglycemia and hyperglycemia cannot be excluded, which necessitated the need to change the dose of hypoglycemic drugs during the use of diclofenac.

Methotrexate - when using diclofenac within 24 hours before or within 24 hours after taking methotrexate, the concentration of methotrexate in the blood may increase and its toxic effect may increase.

Phenytoin - may increase the effect of phenytoin.

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.

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
Ortofen gel (tube 5% 30g)Vertex
126 rub. order
Ortofen (table enteric dissolved.p.pl.vol. 25 mg No. 20) TCPP JSC
26 RUR order
Ortofen (tablet p/o 25 mg No. 20) TCPP
30 rub. order

Pharmacy24

Ortofen 0.025 g No. 30 tablets PAT "Vitamin" Ukraine
8 UAH order

PaniPharmacy

Ortofen forte tablets Ortofen forte tablets. 50mg No. 30 Ukraine, Health LLC
12 UAH order
Ortofen tablets Ortofen tablets. p/o 0.025g No. 30 Ukraine, Vitamins PJSC
11 UAH order
Ortofen tablets Ortofen tablets. p/o 0.025g No. 30 Ukraine, Tekhnolog ChAO
9 UAH order
Ortofen forte tablets Ortofen forte tablets. 50 mg No. 10 Ukraine, Health LLC
4 UAH order
Ortofen tablets Ortofen tablets. p/o 0.025g No. 30 Ukraine, Health LLC
11 UAH order