"Diclofenac" (tablets): instructions for use. Diclofenac tablets - a reliable "ambulance" in the first aid kit Diclofenac tablets 100 mg instructions for use

Diclofenac retard: instructions for use and reviews

Diclofenac retard is a non-steroidal anti-inflammatory drug (NSAID); a derivative of phenylacetic acid.

Release form and composition

Diclofenac retard is produced in the form of long-acting enteric-coated tablets: biconvex, round, almost white or white color, with the possible presence of a rough surface (10 or 20 pcs. in a cell contour package, 1–8, 10, 20, 40, 60, 80 or 100 packages in a carton pack; 10, 20, 30, 40, 50 or 100 pcs. in a polymer container, 1, 5, 10 or 20 containers in a carton pack).

1 tablet contains:

active ingredient: diclofenac sodium - 100 mg;
additional components: microcrystalline cellulose, lactose monohydrate (milk sugar), povidone (polyvinylpyrrolidone), magnesium stearate, talc, hypromellose;
enteric coating: polysorbate-80, cellacephate, titanium dioxide.

Pharmacological properties

Pharmacodynamics

Diclofenac sodium is an NSAID that has analgesic, anti-inflammatory, antipyretic and antiplatelet effects. Indiscriminately inhibiting the activity of cyclooxygenase-1 and cyclooxygenase-2, the active substance of the drug leads to a violation of the metabolism of arachidonic acid and a decrease in the amount of prostaglandins in the inflammation focus. The remedy demonstrates the greatest effectiveness against the background of inflammatory pains.

Pharmacokinetics

Due to the delayed release, the maximum concentration (C max) of the active substance in plasma is lower than the concentration created when using a short-acting drug, however, it remains high for a long period after taking Diclofenac retard. With oral administration of a prolonged-release drug at a dose of 100 mg, the time required to reach C max (TC max) is 5 hours, C max is 0.5–1 μg / ml.

The concentration of a substance in plasma depends linearly on the size of the dose taken. Changes in the pharmacokinetic parameters of diclofenac with repeated administration are not observed. If the recommended dosing regimen is observed, the substance does not accumulate. Bioavailability is 50%, communication with proteins (mostly with albumins) exceeds 99%.

The drug penetrates into the synovial fluid and breast milk. In synovial fluid, Cmax is reached 2–4 hours later than in plasma, and the half-life (T ½) from articular exudate can vary from 3 to 6 hours. The level of diclofenac in the synovial fluid 4-6 hours after its administration is higher than in plasma, and remains higher for another 12 hours.

Metabolism is 50% of the drug during the first passage through the liver. After oral administration, the area under the concentration-time curve is 2 times less than after parenteral administration of the drug at the same dose. Biotransformation of diclofenac is carried out by single or multiple hydroxylation and conjugation with glucuronic acid. The CYP2C9 isoenzyme also takes part in metabolic transformation. Metabolites are less pharmacologically active when compared with diclofenac.

The total clearance of Diclofenac retard is 260 ml / min, T ½ from plasma is 1-2 hours. Through the kidneys in the form of metabolites, 60% of the dose taken is excreted, unchanged - 1%, in the form of metabolites, the remaining part of the dose is excreted in the bile.

In the presence of severe renal failure [creatinine clearance (CC) less than 10 ml / min], the excretion of metabolites in the bile increases, but their concentration in the blood does not increase.

Against the background of compensated liver cirrhosis or chronic hepatitis, the pharmacokinetic parameters of Diclofenac retard do not change.

Indications for use

degenerative and inflammatory diseases musculoskeletal system: ankylosing spondylitis (Bekhterev's disease), rheumatoid arthritis, psoriatic arthritis, osteochondrosis, gouty arthritis, deforming osteoarthritis of the spine and peripheral joints, including with radicular syndrome, bursitis, tendovaginitis;
algomenorrhea, inflammatory processes occurring in the small pelvis, including adnexitis;
pain syndrome: headache (including migraine) and toothache, sciatica, arthralgia, neuralgia, sciatica, myalgia, ossalgia, lumbago, post-traumatic and postoperative pain syndrome, accompanied by an inflammatory process, pain against the background of oncological diseases;
diseases of the throat, ear, nose of an infectious-inflammatory nature with severe pain syndrome: tonsillitis, pharyngitis, otitis media (as part of combination therapy).

According to the instructions, Diclofenac retard is intended for symptomatic treatment, reducing the severity of pain and inflammation at the time of use. The drug does not affect the progression of the disease.

Contraindications

Absolute:

partial or complete combination of bronchial asthma, recurrent polyposis rhinosinusitis and intolerance to acetylsalicylic acid or any other NSAIDs (including indications in history);
active gastrointestinal bleeding, erosive and ulcerative defects of the gastrointestinal tract and duodenum 12;
inflammatory bowel disease (ulcerative colitis, Crohn's disease);
the period after coronary artery bypass surgery;
severe heart failure;
diagnosed hyperkalemia;
progressive kidney damage, severe renal failure (CC below 30 ml / min);
active liver disease or severe liver failure;
age up to 18 years;
malabsorption of glucose-galactose, lactase deficiency, hereditary lactose intolerance;
III trimester of pregnancy;
hypersensitivity to any of their constituents or other NSAIDs.

chronic heart failure, ischemic disease hearts;
arterial hypertension;
lesions of peripheral arteries;
chronic renal failure (CC 30-60 ml / min);
history of liver damage, hepatic porphyria;
diabetes;
dyslipidemia/hyperlipidemia;
cerebrovascular diseases;
bronchial asthma;
history of gastrointestinal ulcer, infection Helicobacter pylori;
a pronounced decrease in the volume of circulating blood (BCC) (including the condition after extensive surgery);
smoking and/or alcoholism;
severe somatic pathologies;
long-term use of NSAIDs;
elderly age(including patients with low body weight, debilitated, receiving diuretics);
I-II trimesters of pregnancy;
combined use of the following medicines: antiplatelet agents ( acetylsalicylic acid, clopidogrel and others), anticoagulants (including warfarin), selective serotonin reuptake inhibitors (SSRIs) (for example, fluoxetine, citalopram, sertraline, paroxetine), oral glucocorticosteroids (GCS) (including prednisolone).

Instructions for use Diclofenac retard: method and dosage

Diclofenac retard 100 mg tablets are taken orally, swallowed whole, without chewing or breaking, drinking plenty of water.

Take the drug 1 time per day for 100 mg (1 tablet). Upon reaching the desired therapeutic effect, switching to maintenance therapy, the dose is gradually reduced to 50 mg (½ tablet) per day. The maximum daily dose should not exceed 150 mg.

If it is necessary to increase the daily dose to the maximum, it is allowed to take 1 regular short-acting diclofenac tablet (50 mg) in addition to 1 tablet of Diclofenac retard (100 mg).

Side effects

nervous system: often - dizziness, headache; rarely - drowsiness; extremely rarely - insomnia, irritability, nightmares, anxiety, memory disorders, mental disorders, depression, sensitivity disorders, including paresthesia, convulsions, tremors, cerebrovascular disorders, disorientation, aseptic meningitis;
cardiovascular system: extremely rarely - chest pain, palpitations, increased blood pressure, heart failure, vasculitis, myocardial infarction;
hematopoietic organs: extremely rarely - leukopenia, thrombocytopenia, aplastic and hemolytic anemia, agranulocytosis;
digestive system: often - nausea, epigastric pain, anorexia, vomiting, flatulence, dyspepsia, diarrhea, increased activity of aminotransferases; rarely - proctitis, gastritis, bloody diarrhea, melena, vomiting with blood, gastrointestinal ulcers (with or without bleeding or perforation), jaundice, abnormal liver function, hepatitis; extremely rarely - glossitis, stomatitis, esophagitis, constipation, exacerbation of Crohn's disease or ulcerative colitis, nonspecific hemorrhagic colitis, fulminant hepatitis, pancreatitis;
urinary system: extremely rarely - proteinuria, hematuria, acute renal failure, nephrotic syndrome, interstitial nephritis, papillary necrosis;
respiratory system: rarely - bronchial asthma (including shortness of breath); extremely rarely - pneumonitis;
sense organs: often - vertigo; extremely rarely - a violation of taste sensations, visual impairment (diplopia, blurred vision), tinnitus, hearing impairment;
allergic reactions: anaphylactic / anaphylactoid reactions, including a pronounced decrease in blood pressure and shock; extremely rarely - angioedema (including swelling of the face);
skin: often - skin rash; rarely - urticaria; extremely rarely - photosensitivity, hair loss, itching, bullous rashes, purpura, including allergic, exfoliative dermatitis, eczema, including multiforme and Stevens-Johnson syndrome, Lyell's syndrome;
others: rarely - edema.

Overdose

Symptoms of an overdose of Diclofenac retard include: epigastric pain, vomiting, diarrhea, bleeding from the gastrointestinal tract, tinnitus, dizziness, convulsions, lethargy; rarely - increased blood pressure, hepatotoxic effects, acute renal failure, respiratory depression, coma.

If this condition is suspected, gastric lavage is prescribed, activated carbon, symptomatic treatment aimed at eliminating the increase in blood pressure, seizures, functional disorders of the kidneys, irritation of the gastrointestinal tract, respiratory depression. In view of Diclofenac's inherent intensive metabolism and significant protein binding, the appointment of hemodialysis or forced diuresis is ineffective.

special instructions

To reduce the risk of adverse reactions from the gastrointestinal tract, it is necessary to take Diclofenac retard in the minimum effective dose, as short as possible.

In patients with heart or renal insufficiency, in elderly people receiving diuretics, as well as in patients with a marked decrease in BCC (including due to extensive surgery), when prescribing diclofenac, renal function should be monitored as a precautionary measure (since prostaglandins play important role in maintaining renal blood flow).

Against the background of long-term use of Diclofenac retard, it is required to monitor liver function parameters, peripheral blood patterns, and fecal occult blood tests.

For the relief of an acute attack of gout, it is advisable to use fast-acting dosage forms.

Diclofenac can affect the levels of serum transaminases, in the case when this effect is prolonged or complications occur, it is necessary to stop taking the drug. Also, taking Diclofenac retard can increase the level of potassium.

Influence on the ability to drive vehicles and complex mechanisms

During therapy, you should refrain from driving vehicles and any other complex mechanisms due to a possible decrease in the speed of motor and mental reactions.

Use during pregnancy and lactation

In the III trimester of pregnancy, the drug is contraindicated, in the I-II trimesters it should be taken with caution.

If you need to take Diclofenac retard during lactation, you need to stop breast-feeding.

It is not recommended to use the drug for women planning pregnancy, as it adversely affects fertility. Patients with infertility (including those undergoing examination) should also discontinue Diclofenac retard.

Application in childhood

Diclofenac retard is contraindicated for children and adolescents under 18 years of age.

For impaired renal function

The use of Diclofenac retard is contraindicated against the background of progressive kidney disease or severe renal failure (CC below 30 ml / min). In chronic renal failure (CC from 30 to 60 ml / min), the drug should be used with caution.

For impaired liver function

Diclofenac retard is contraindicated in the presence of active liver disease or severe liver failure. With a history of liver damage or hepatic porphyria, the drug is prescribed with caution.

Use in the elderly

drug interaction

lithium preparations, methotrexate, digoxin, cyclosporine - the plasma concentration of these substances increases;
diuretics - their effect is reduced;
acetylsalicylic acid - the level of diclofenac in the blood decreases;
potassium-sparing diuretics - the threat of hyperkalemia is aggravated;
cyclosporine - its nephrotoxicity increases;
thrombolytic agents (urokinase, streptokinase, alteplase), anticoagulants, corticosteroids, other NSAIDs - the risk of bleeding increases (mainly from the gastrointestinal tract);
methotrexate - its toxicity increases;
hypnotics and antihypertensives - their effect is weakened;
paracetamol - the likelihood of a nephrotoxic effect of diclofenac increases;
hypoglycemic medicines- their effect is reduced;
valproic acid, cefotetan, cefoperazone, cefamandol, plicamycin - the incidence of hypoprothrombinemia increases;
gold preparations, cyclosporine - the effect of diclofenac on the production of prostaglandins in the kidneys increases, which contributes to an increase in its nephrotoxicity;

Terms and conditions of storage

Keep out of the reach of children, protected from moisture and light, at a temperature not exceeding 25 °C.

Shelf life - 3 years.

Active substance

Diclofenac sodium (diclofenac)

Release form, composition and packaging

10 pieces. - cellular contour packings (1) - packs of cardboard.
10 pieces. - cellular contour packings (2) - packs of cardboard.
10 pieces. - cellular contour packings (3) - packs of cardboard.
10 pieces. - cellular contour packings (5) - packs of cardboard.
10 pieces. - cellular contour packings (10) - packs of cardboard.
20 pcs. - cellular contour packings (1) - packs of cardboard.
20 pcs. - cellular contour packings (2) - packs of cardboard.
20 pcs. - cellular contour packings (3) - packs of cardboard.
30 pcs. - jars of dark glass (1) - packs of cardboard.
30 pcs. - polymer cans (1) - packs of cardboard.

pharmachologic effect

Diclofenac has anti-inflammatory, analgesic and antipyretic effects. Indiscriminately inhibiting cyclooxygenase 1 and 2, disrupts the metabolism of arachidonic acid, reduces the amount of prostaglandins in the focus of inflammation. In rheumatic diseases, the anti-inflammatory and analgesic effect of diclofenac contributes to a significant decrease in the severity of pain, morning stiffness, swelling of the joints, which improves the functional state of the joint. With injuries, in the postoperative period, diclofenac reduces pain and inflammatory edema.

Pharmacokinetics

Absorption is fast and complete, food slows down the absorption rate by 1-4 hours and reduces Cmax by 40%. After oral administration of 25 mg C max 1.0 μg / ml is achieved after 2-3 hours. The concentration in is linearly dependent on the size of the administered dose.

Changes in the pharmacokinetics of diclofenac against the background of repeated administration are not observed, do not cumulate.

Bioavailability - 50%. Communication with plasma proteins - more than 99% (most associated with). Penetrates into the synovial fluid: C max in the synovial fluid is observed 2-4 hours later than in plasma. T1 / 2 from the synovial fluid 3-6 hours (the concentration of the active substance in the synovial fluid 4-6 hours after the administration of the drug is higher than in plasma, and remains higher for another 12 hours). The relationship between the concentration of the drug in the synovial fluid and the clinical efficacy of the drug has not been elucidated.

Metabolism 50% of the active substance is metabolized during the "first pass" through the liver. Metabolism occurs as a result of multiple or single hydroxylation and conjugation with glucuronic acid. The enzyme system P450 CYP2C9 takes part in the metabolism of the drug. The pharmacological activity of metabolites is lower than that of diclofenac.

Systemic clearance is 350 ml / min, the volume of distribution is 550 ml / kg, T 1/2 from plasma is 2 hours. 65% of the administered dose is excreted as metabolites by the kidneys; less than 1% is excreted unchanged, the rest of the dose is excreted as metabolites in the bile.

In patients with severe renal insufficiency (creatinine clearance less than 10 ml / min), the excretion of metabolites in the bile increases, while an increase in their concentration in the blood is not observed.

In patients with chronic hepatitis or compensated liver cirrhosis, the pharmacokinetic parameters of diclofenac do not change. Diclofenac passes into breast milk.

Indications

- diseases of the musculoskeletal system (rheumatoid arthritis, psoriatic, juvenile chronic arthritis, ankylosing spondylitis; gouty arthritis, rheumatic soft tissue lesions, osteoarthritis of the peripheral joints and spine, including with radicular syndrome, tendovaginitis, bursitis);

- pain syndrome of mild or moderate severity: neuralgia, myalgia, lumboischialgia, post-traumatic pain syndrome, accompanied by inflammation, postoperative pain, headache, migraine, algomenorrhea, adnexitis, proctitis, toothache;

- as part of the complex therapy of infectious and inflammatory diseases of the ear, throat, nose with severe pain syndrome (pharyngitis, tonsillitis, otitis media);

- febrile syndrome.

Contraindications

- erosive and ulcerative lesions of the gastrointestinal tract (in the acute phase);

- bleeding from the gastrointestinal tract;

- "aspirin" asthma;

- violations of hematopoiesis;

- violations of hemostasis (including hemophilia);

- pregnancy;

— childhood(up to 6 years);

- lactation period;

- hypersensitivity (including to other NSAIDs).

Carefully: anemia, bronchial asthma, congestive insufficiency, arterial hypertension, edematous syndrome, liver or kidney failure, alcoholism, inflammatory bowel disease, erosive and ulcerative diseases of the gastrointestinal tract without exacerbation, diabetes mellitus, condition after major surgical interventions, induced porphyria, old age, diverticulitis, systemic diseases connective tissue.

Dosage

Inside, without chewing, during or after a meal, drinking a small amount of water. Adults and adolescents from 15 years old - 25-50 mg 2-3 times / day. Upon reaching the optimal therapeutic effect, 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 old) daily dose up to 2 mg/kg of body weight, divided into 2-3 doses.

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

The approximate mode of application of the drug is presented in the table:

Side effects

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 than 1% - vomiting, jaundice, melena, blood in the feces, damage to the esophagus, aphthous stomatitis, dry mucous membranes (including the mouth), hepatitis (possibly fulminant), liver necrosis, cirrhosis, hepatorenal syndrome, change in appetite, pancreatitis , cholecystopancreatitis, colitis.

Nervous system:

more often 1% - headache, dizziness;

less than 1% - sleep disturbance, drowsiness, depression, irritability, aseptic meningitis (more often in patients with systemic lupus erythematosus and other systemic diseases of the connective tissue), convulsions, general weakness, disorientation, nightmares, feeling of fear.

Sense organs:

more than 1% - tinnitus,

less than 1% - blurred vision, diplopia, taste disturbance, reversible or irreversible hearing loss, scotoma.

Skin covers:

more often than 1% - skin itching, skin rash;

less often 1% - alopecia, urticaria, eczema, toxic dermatitis, erythema multiforme exudative (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), increased photosensitivity, punctate hemorrhages.

Urogenital system:

more than 1% - fluid retention,

less than 1% - nephrotic syndrome, proteinuria, oliguria, hematuria, interstitial nephritis, papillary necrosis, acute renal failure, azotemia

Organs of hematopoiesis and immune system:

less often 1% - anemia (including hemolytic and aplastic anemia), leukopenia, thrombocytopenia, eosinophilia, agranulocytosis, thrombocytopenic purpura, worsening of the course of infectious processes (including the development of necrotizing fasciitis).

Respiratory system:

less than 1% - cough, bronchospasm, laryngeal edema, pneumonitis.

The cardiovascular system:

less than 1% - increased blood pressure; congestive heart failure, extrasystole, chest pain.

Allergic reactions:

less often 1% - anaphylactoid reactions, anaphylactic shock (usually develops rapidly), swelling of the lips and tongue, allergic vasculitis.

Overdose

Symptoms: vomiting, dizziness, headache, shortness of breath, clouding of consciousness, in children - myoclonic convulsions, nausea, abdominal pain, bleeding, impaired liver and kidney function.

Treatment: gastric lavage, administration of activated charcoal, symptomatic therapy, forced diuresis. Hemodialysis is ineffective.

drug interaction

Increases plasma concentration of digoxin,. lithium and cyclosporine.

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

Reduces the effects of antihypertensive and hypnotic drugs.

Increases the likelihood of side effects other NSAIDs and glucocorticosteroids (GI bleeding), methotrexate toxicity and ciclosporin nephrotoxicity.

Reduces the concentration of diclofenac in the blood.

Simultaneous use with paracetamol increases the risk of developing nephrotoxic effects of diclofenac.

Reduces the effect of hypoglycemic agents.

Cefamandol, cefoperazone, cefotetan, and plicamycin increase the incidence of hypoprothrombinemia.

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

Simultaneous administration with ethanol, colchicine, corticotropin and St. John's wort increases the risk of bleeding in the gastrointestinal tract.

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

Active substance

diclofenac

Dosage form

long-acting tablets

Manufacturer

Ozon, Russia

Compound

Composition: for 1 long-acting tablet of Diclofenac retard, enteric-coated:
- active substance: diclofenac sodium 100 mg;
- excipients: [hypromellose (hydroxypropylmethylcellulose), hyetellose (hydroxyethylcellulose), kollidone SR [polyvinyl acetate 80%, povidone 19%, sodium lauryl sulfate 0.8%, silicon dioxide 0.2%], sodium alginate, microcrystalline cellulose, magnesium stearate] .

pharmachologic effect

Farmgroup: NSAIDs.
Pharmaceutical action: Diclofenac retard is a non-steroidal anti-inflammatory drug (NSAID), a derivative of phenylacetic acid; has anti-inflammatory, analgesic and antipyretic effect.
Indiscriminately inhibiting cyclooxygenase 1 and 2 (COX1 and COX2), disrupts the metabolism of arachidonic acid, reduces the amount of prostaglandins in the focus of inflammation. Most effective for inflammatory pain. Like all NSAIDs, the drug has an antiplatelet effect. In rheumatic diseases, the anti-inflammatory and analgesic effect of diclofenac contributes to a significant decrease in the severity of pain, morning stiffness, swelling of the joints, which improves the functional state of the joint. With injuries, in the postoperative period, diclofenac reduces pain and inflammatory edema.
Pharmacokinetics: Absorption is fast and complete. Food slows down the absorption rate by 1-4 hours and reduces the maximum concentration (Cmax) by 40%.
As a result of the delayed release of the drug, Cmax in plasma is lower than that created by the administration of short-acting drugs (LS); however, it remains high for a long time after ingestion. Cmax - 0.5-1.0 μg / ml, the time to reach maximum plasma concentration (TCmax) - 5 hours after taking 100 mg of prolonged-release tablets.
Changes in the pharmacokinetics of diclofenac against the background of repeated administration are not observed. Does not accumulate if the recommended interval between meals is observed.
Bioavailability - 50%. Communication with plasma proteins - more than 99% (most of it binds to albumin). Penetrates into breast milk, synovial fluid; Cmax in synovial fluid is observed 2-4 hours later than in plasma. The half-life (T1 / 2) from the synovial fluid is 3-6 hours (the concentration of the drug in the synovial fluid 4-6 hours after its administration is higher than in plasma, and remains higher for another 12 hours).
50% of the active substance is metabolized during the "first pass" through the liver. Metabolism occurs as a result of multiple or single hydroxylation and conjugation with glucuronic acid. The enzyme system of cytochrome P 450 CYP2C9 takes part in the metabolism of the drug. The pharmacological activity of metabolites is less than that of diclofenac.
Systemic clearance is 206 ml/min. T1 / 2 from plasma - 1-2 hours. 60% of the administered dose is excreted as metabolites through the kidneys; less than 1% is excreted unchanged, the rest of the dose is excreted as metabolites in the bile.
In patients with severe renal insufficiency (creatinine clearance (CC) less than 10 ml / min), the excretion of metabolites in the bile increases, while an increase in their concentration in the blood is not observed.
In patients with chronic hepatitis or compensated liver cirrhosis, pharmacokinetic parameters do not change.
Diclofenac passes into breast milk.

Indications

Diseases of the musculoskeletal system (rheumatoid arthritis, psoriatic, juvenile chronic arthritis, ankylosing spondylitis (Bekhterev's disease); gouty arthritis; rheumatic soft tissue lesions; osteoarthritis of the peripheral joints and spine, including with radicular syndrome; tendovaginitis; bursitis).
Pain syndrome of mild or moderate severity: neuralgia, myalgia, lumboischialgia, post-traumatic pain syndrome, accompanied by inflammation, postoperative pain, headache, migraine, algomenorrhea, adnexitis, proctitis, toothache.
As part of the complex therapy of infectious and inflammatory diseases of the ear, throat, nose with severe pain syndrome (pharyngitis, tonsillitis, otitis media).
The drug Diclofenac retard is intended for symptomatic therapy, reducing pain and inflammation at the time of use, does not affect the progression of the disease.

Contraindications

Erosive and ulcerative lesions of the gastrointestinal tract in the acute phase, the "aspirin triad", hematopoietic disorders of unknown etiology, hypersensitivity to diclofenac and the components of the dosage form used, or other NSAIDs.

Side effects

On the part of the digestive system: nausea, vomiting, epigastric pain, anorexia, flatulence, constipation, gastritis up to erosive with bleeding, increased activity of transaminases, drug-induced hepatitis, pancreatitis.

From the urinary system: interstitial nephritis.

From the side of the central nervous system: headache, dizziness, disorientation, agitation, insomnia, irritability, fatigue, aseptic meningitis.

From the respiratory system: bronchospasm.

From the hemopoietic system: anemia, thrombocytopenia, leukopenia, agranulocytosis.

Dermatological reactions: exanthema, erythema, eczema, hyperemia, erythroderma, photosensitivity.

Allergic reactions: erythema multiforme, Lyell's syndrome, Stevens-Johnson syndrome, anaphylactic reactions, including shock.

Local reactions: at the injection site, burning, infiltrate formation, necrosis of adipose tissue are possible.

Others: fluid retention in the body, edema, increased blood pressure.

Interaction

With the simultaneous use of the drug Diclofenac with digoxin, phenytoin or lithium preparations, an increase in plasma concentrations of these drugs is possible; with diuretics and antihypertensive drugs - it is possible to reduce the effect of these drugs; with potassium-sparing diuretics - the development of hyperkalemia is possible; with acetysalicylic acid - a decrease in the concentration of diclofenac in the blood plasma and an increased risk of side effects.
Diclofenac may enhance the toxic effect of cyclosporine on the kidneys.
Diclofenc can cause hypo- or hyperglycemia, therefore, when used simultaneously with hypoglycemic agents, it is necessary to control the concentration of glucose in the blood.
When using methotrexate within 24 hours before or after taking Diclofenac, it is possible to increase the concentration of methotrexate and increase its toxic effect.
With simultaneous use with anticoagulants, regular monitoring of blood coagulation parameters is necessary.

How to take, course of administration and dosage

For children over the age of 6 years, diclofenac is prescribed at a dose of 2 mg / kg of body weight, and the daily dose is also divided into several doses.

Overdose

Symptoms: dizziness, headache, hyperventilation of the lungs, clouding of consciousness, vomiting, bleeding from the gastrointestinal tract, diarrhea, tinnitus, convulsions, with a significant overdose - acute renal failure, hepatotoxic effect.
Treatment: gastric lavage, activated charcoal. Symptomatic therapy is aimed at eliminating the increase in blood pressure, impaired renal function, convulsions, irritation of the gastrointestinal tract, and respiratory depression. Forced diuresis, hemodialysis are ineffective (due to a significant connection with proteins and intensive metabolism).

Diclofenac 100 mg, 20 tablets

International non-proprietary name

prolonged-release tablets, film-coated.

active ingredient: diclofenac sodium 100.0000 mg; excipients: sucrose - 94.7880 mg, cetyl alcohol - 54.8200 mg, colloidal silicon dioxide - 0.7900 mg, talc - 3.9500 mg, povidone K-25 - 1.0530 mg, magnesium stearate - 7.8990 mg; shell: hypromelose - 3.4355 mg, titanium dioxide E 171 CI 77891 - 0.8649 mg, talc - 2.4178 mg, polysorbate 80 - 0.3826 mg, macrogol 6000 - 0.6894 mg, crimson dye [Ponceau 4R] - 0.0441 mg, brown dye [sunset yellow dye + azorubine dye + brilliant black dye] - 0.0147 mg, aluminum varnish based on sunset yellow dye - 0.0500 mg.

Non-steroidal anti-inflammatory drug (NSAID)

In rheumatic diseases, the anti-inflammatory and analgesic effect of diclofenac contributes to a significant decrease in the severity of pain, morning stiffness, swelling of the joints, which improves the functional state of the joint. With injuries, in the postoperative period, diclofenac reduces pain and inflammatory edema.

Changes in the pharmacokinetics of diclofenac against the background of repeated administration are not observed. Does not accumulate if the recommended interval between doses is observed.

Bioavailability - 50%. Communication with plasma proteins - more than 99% (most of it binds to albumin). Penetrates into the synovial fluid; Cmax in synovial fluid is observed 2-4 hours later than in plasma. The half-life (T½) from the synovial fluid is 3-6 hours (the concentration of the active substance in the synovial fluid 4-6 hours after the administration of the drug is higher than in plasma, and remains higher for another 12 hours). The relationship between the concentration of the drug in the synovial fluid and the clinical efficacy of the drug has not been elucidated.

The systemic clearance is about 260±50 ml/min, the volume of distribution is 550 ml/kg. T½ from plasma averages about 2.5 hours. 65% of the administered dose is excreted as metabolites by the kidneys; less than 1% is excreted unchanged, the rest of the dose is excreted as metabolites in the bile.

In patients with severe renal insufficiency (creatinine clearance (CC) less than 10 ml / min), the excretion of metabolites in the bile increases, while an increase in their concentration in the blood is not observed.

In patients with chronic hepatitis or compensated liver cirrhosis, the pharmacokinetic parameters of diclofenac do not change.

Diclofenac passes into breast milk.

Symptomatic treatment of diseases of the musculoskeletal system (rheumatoid arthritis, psoriatic arthritis, juvenile chronic arthritis, ankylosing spondylitis (Bekhterev's disease); gouty arthritis, rheumatic soft tissue lesions, osteoarthritis of the peripheral joints and spine, including those with radicular syndrome, tendovaginitis, bursitis) .

The drug relieves or reduces pain and inflammation during the treatment period, while not affecting the progression of the disease.

As part of the complex therapy of infectious and inflammatory diseases of the ear, throat, nose with severe pain syndrome (pharyngitis, tonsillitis, otitis media).

Erosive and ulcerative changes in the mucous membrane of the stomach or duodenum, active gastrointestinal bleeding;
Cardiac ischemia;
severe liver failure or active liver disease;
Severe renal failure (creatinine clearance less than 30 ml / min); progressive kidney disease;
Confirmed hyperkalemia;
Sucrase/isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption (the product contains sucrose).
Children's age up to 18 years.

Anemia, bronchial asthma, confirmed chronic heart failure I functional class according to the NYHA classification, arterial hypertension, edematous syndrome, liver or kidney failure (creatinine clearance 30-60 ml / min), dyslipidemia, hyperlipoproteinemia, diabetes mellitus, smoking, inflammatory bowel disease, condition after major surgical interventions, induced porphyria, diverticulitis, systemic connective tissue diseases, pregnancy I-II trimester.

Simultaneous therapy with anticoagulants (eg, warfarin), antiplatelet agents (eg, acetylsalicylic acid, clopidogrel), oral glucocorticosteroids (eg, prednisolone), selective serotonin reuptake inhibitors (eg, citalopram, fluoxetine, paroxetine, sertraline).

In all patients receiving diclofenac, it should be used at the lowest effective dose for the shortest possible time required to reduce symptoms.

Inside, without chewing, during or after a meal, drinking plenty of water.

1 tablet 1 time per day. If necessary, additional administration of the drug is used in tablets of 50 mg. The maximum daily dose is 150 mg.

Criteria for assessing the frequency of adverse reactions: very often (> 1/10), often (≥ 1/100,

www.stada.ru

Diclofenac instructions for use tablets 100 mg

Diclofenac 100 mg tablets is a non-steroidal anti-inflammatory drug. It has anti-inflammatory, analgesic, antiplatelet and antipyretic effects. Most effective for inflammatory pain. It is used for symptomatic treatment of diseases of the musculoskeletal system, reduction different kind pain syndromes.

Registration number: P N011648/02

Brand name: Diclofenac

International non-proprietary name: diclofenac

Dosage form: prolonged-release tablets, film-coated

Photo of diclofenac tablets on which the composition is indicated

One extended-release film-coated tablet contains:

active ingredient: diclofenac sodium 100.0000 mg;

excipients: sucrose - 94.7880 mg, cetyl alcohol - 54.8200 mg, colloidal silicon dioxide - 0.7900 mg, talc - 3.9500 mg, povidone K-25 - 1.0530 mg, magnesium stearate - 7.8990 mg;

shell: hypromelose - 3.4355 mg, titanium dioxide E 171 CI 77891 - 0.8649 mg, talc - 2.4178 mg, polysorbate 80 - 0.3826 mg, macrogol 6000 - 0.6894 mg, crimson dye [Ponceau 4R] [E124] - 0.0441 mg, brown dye [sunset yellow dye + azorubine dye [E122] + brilliant black dye [E151]] - 0.0147 mg, aluminum varnish based on sunset yellow dye [E110] - 0, 0500 mg.

Description

Round, biconvex, pink film-coated tablets; in cross section, the nucleus is white to almost white.

Pharmacotherapeutic group: non-steroidal anti-inflammatory drug (NSAID)

ATX code: M01AB05

Pharmacological properties

Pharmacodynamics

Non-steroidal anti-inflammatory drug (NSAID), a derivative of phenylacetic acid. Diclofenac has anti-inflammatory, analgesic, antiplatelet and antipyretic effects. Indiscriminately inhibiting cyclooxygenase 1 and 2 (COX1 and COX2), disrupts the metabolism of arachidonic acid, reduces the amount of prostaglandins in the focus of inflammation. Most effective for inflammatory pain. In rheumatic diseases, the anti-inflammatory and analgesic effect of diclofenac contributes to a significant decrease in the severity of pain, morning stiffness, swelling of the joints, which improves the functional state of the joint. With injuries, in the postoperative period, diclofenac reduces pain and inflammatory edema.

Pharmacokinetics

Absorption is fast and complete, food slows down the absorption rate by 1-4 hours and reduces the maximum concentration (Cmax) by 40%. After oral administration of 100 mg tablets, Stakh - 0.5 μg / ml is reached after - 4-5 hours. Plasma concentration is linearly dependent on the size of the administered dose. Changes in the pharmacokinetics of diclofenac against the background of repeated administration are not observed. Does not accumulate if the recommended interval between doses is observed.

Bioavailability: 50%. Communication with plasma proteins - more than 99% (most of it binds to albumin). Penetrates into the synovial fluid; Stach in the synovial fluid is observed 2-4 hours later than in plasma. The half-life (PM) from the synovial fluid is 3-6 hours (the concentration of the active substance in the synovial fluid 4-6 hours after the administration of the drug is higher than in plasma, and remains higher for another 12 hours). The relationship between the concentration of the drug in the synovial fluid and the clinical efficacy of the drug has not been elucidated.

Metabolism: 50% of the active substance is metabolized during the "first pass" through the liver. Metabolism occurs as a result of multiple or single hydroxylation and conjugation with glucuronic acid. In the metabolism of the drug takes part in the CYP2C9 isoenzyme. The pharmacological activity of metabolites is lower than that of diclofenac. Systemic clearance is about 260 + 50 ml / min, the volume of distribution is 550 ml / kg. PM from plasma averages about 2.5 hours. 65% of the administered dose is excreted as metabolites by the kidneys; less than 1% is excreted unchanged, the rest of the dose is excreted as metabolites in the bile. In patients with severe renal insufficiency (creatinine clearance (CC) less than 10 ml / min), the excretion of metabolites in the bile increases, while an increase in their concentration in the blood is not observed. In patients with chronic hepatitis or compensated liver cirrhosis, the pharmacokinetic parameters of diclofenac do not change. Diclofenac passes into breast milk.

Diclofenac indications for use

Pain syndrome of mild or moderate severity: neuralgia, myalgia, lumboischialgia, post-traumatic pain syndrome, accompanied by inflammation, postoperative pain, headache, migraine, algomenorrhea, adnexitis, proctitis, toothache. As part of the complex therapy of infectious and inflammatory diseases of the ear, throat, nose with severe pain syndrome (pharyngitis, tonsillitis, otitis media).

Diclofenac contraindications

Hypersensitivity to the active substance (including other NSAIDs) or auxiliary components;
Complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses and intolerance to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (including history);
Erosive and ulcerative changes in the mucous membrane of the stomach or duodenum, active gastrointestinal bleeding;
Inflammatory bowel disease (ulcerative colitis, Crohn's disease) in the acute phase;
The period after coronary artery bypass grafting;
III trimester of pregnancy, breastfeeding period;
Confirmed chronic heart failure (II-IV functional class according to NYHA classification);
Cardiac ischemia;
Peripheral arterial disease or cerebrovascular disorders;
Hematopoietic disorders, hemostasis disorders (including hemophilia);
severe liver failure or active liver disease;
Severe renal failure (creatinine clearance less than 30 ml / min);
Progressive g; kidney disease;
Confirmed hyperkalemia;
Sucrase/isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption (preparation 1 contains sucrose);
Children's age up to 18 years.

Carefully

Anemia, bronchial asthma, confirmed NYHA functional class chronic heart failure, arterial hypertension, edematous syndrome, hepatic or renal insufficiency (creatinine clearance 30-60 ml/min), dyslipidemia, hyperlipoproteinemia, diabetes mellitus, smoking, inflammatory bowel disease, after extensive surgical interventions, induced porphyria, diverticulitis, systemic connective tissue diseases, pregnancy I-II trimester.

Anamnestic data on the development of peptic ulcer of the gastrointestinal tract, the presence of Helicobacter pylori infection, old age, long-term use of NSAIDs, frequent alcohol consumption, severe symptomatic diseases. Simultaneous therapy with anticoagulants (eg, warfarin), antiplatelet agents (eg, acetylsalicylic acid, clopidogrel), oral glucocorticosteroids (eg, prednisolone), selective serotonin reuptake inhibitors (eg, citalopram, fluoxetine, paroxetine, rertraline).

In patients with seasonal allergic rhinitis, swelling of the nasal mucosa (including those with nasal polyps), chronic obstructive pulmonary disease, chronic respiratory infections (especially those associated with allergic rhinitis-like symptoms), allergies to other medications, in patients with a significant decrease in circulating blood volume, diclofenac should be used with caution.

Use during pregnancy and during breastfeeding

There is insufficient data on the safety of diclofenac in pregnant women. Therefore, diclofenac should be prescribed in the I and II trimesters of pregnancy only in cases where the expected benefit to the mother outweighs the potential risk to the fetus. Diclofenac, like other prostaglandin synthesis inhibitors, is contraindicated in the last 3 months of pregnancy (possible suppression of uterine contractility and premature closure of the ductus arteriosus in the fetus).

Diclofenac passes in small amounts into breast milk. To prevent unwanted effects on the child, the drug should not be administered to lactating women. If necessary, the use of the drug breastfeeding should be discontinued.

Diclofenac tablets: analogues are cheaper

Diclofenac tablets dosage and method of administration

In all patients receiving diclofenac, it should be used at the lowest effective dose for the shortest possible time required to reduce symptoms. Inside, without chewing, during or after a meal, drinking plenty of water. 1 tablet 1 time per day. If necessary, additional administration of the drug is used in tablets of 50 mg. The maximum daily dose is 150 mg.

diclofenac side effects

Criteria for assessing the frequency of adverse reactions: very often (> 1/10), often (> 17100,

pro-tablets.ru

Instructions for use of the drug Diclofenac Retard

Diclofenac is a domestic drug that eliminates the inflammatory process, relieves fever, and has an analgesic effect. Indications: joint pain, gout attacks, arthritis, neuritis and neuralgia, tissue swelling.

After the course of application, such improvements were noticed as the removal of stiffness of movements in the affected areas, the restoration of the patient's range of motion, the elimination of swelling, swelling and pain in the inflamed areas.

Description of the drug

This is a non-steroidal drug aimed at relieving inflammation, eliminating pain. Mechanism of action: inhibition of cyclooxygenases, deterioration of the metabolism of arachidonic acid, elimination of prostaglandins.

Reduces pain, swelling, stiffness of joints in rheumatic diseases. Helps during the recovery period after operations and injuries. The drug relieves pain and swelling of injured tissues.

Absorption is complete, with food absorption slows down. It does not accumulate between doses of the drug. The maximum plasma concentration is reached 5 hours after ingestion, in the synovial fluid the concentration is reached two to four hours later than in plasma.

Excreted through the kidneys, liver.

Manufacturer

The drug is produced by three pharmaceutical companies: Ozon (Samara Region, Zhigulevsk), Obolenskoye Pharmaceutical Enterprise JSC (Obolensk, Moscow Region), AKRIKHIN Company (Moscow).

Forms of release and composition

Tablets of the company "Ozone"

Release form: enteric-coated tablets. Types of packaging: cellular contour packaging or polymer container. Packing of 10, 20, 30, 40, 50, 60, 80, 100, 120, 150, 160, 200, 250, 300, 400, 500, 600, 800, 1000, 1200, 1600 or 2 thousand tablets. Packed in a cardboard box.

Composition: active substance diclofenac sodium (100 mg), additional components (milk sugar, microcrystalline cellulose, povidone, talc, etc.). Sheath: polysorbate, titanium dioxide, cellacephate.

The average cost of 20 tablets: 28 rubles.

Diclofenac Retard Obolenskoe

Release form: round tablets in an enteric cover. Diclofenac Retard Obolenskoye are red-brown tablets.

Composition: active substance diclofenac sodium (100 mg); additional substances: microcrystalline cellulose, talc, magnesium stearate, milk sugar, refined sugar, etc. Shell: talc, dyes (red and yellow), titanium dioxide.

Diclofenac Retard Obolenskoye is packed in 10 tablets per blister pack. Each carton contains 1,2,3, 5 or 10 blisters.

The price of diclofenac Retard Obolenskoye varies from 35 rubles to 51 rubles.

Diclofenac Retard Akrikhin

Release form: light brown (pink-brown) coated tablets. They are rough to the touch, the shape of the tablet is round. Packaging in blisters; 10, 20, 30 tablets are packed in a cardboard box.

Composition: active substance (diclofenac sodium) 100 mg; additional components: povidone, lactose monohydrate, microcrystalline cellulose, silicon dioxin, stearic acid. The shell consists of macrogol, glycerin, talc, dye, etc.

The average price for 20 tablets: from 45 rubles.

The difference between Retard tablets and diclofenac

The active ingredient in drugs is one, but diclofenac itself has more forms of release. These are eye drops, and solutions for intramuscular injection, and rectal suppositories, and forms for external use, and tablets. While diclofenac Retard is produced only in the form of tablets.

There is also a difference in the concentration of the active ingredient. For example, in various forms of diclofenac, manufacturers prefer to produce a drug with a concentration of a substance from 25 mg to 100 mg. When using a product with a concentration of 25 to 50 mg, it should be noted that its effect will be shorter. Retard tablets are produced with a concentration of 100 mg, which makes the effect of taking them longer. But they are not recommended for the treatment of children less than 6 years old. But the concentration of the substance allows you to reduce the number of pills, because Retard is often taken only once a day.

Diclofenac is produced by domestic and foreign pharmaceutical companies, which allows the consumer and doctors to choose the right drug in terms of the form of release and price. While Diclofenac Retard is produced in our country only by 3 companies.

The difference between diclofenac Akos and diclofenac Retard

Differences of drugs can be divided into several areas:

According to the release form: Akos can be administered intramuscularly, and Retard has only an oral form. In this regard, Akos quickly enters the bloodstream and can be used as an ambulance for pain. At the time when Retard reaches its maximum concentration in the blood longer. In addition, diclofenac Akos has a form for external use.
Course of treatment: Retard can be used for a long period of time for the treatment of diseases of the joints and the musculoskeletal system. And the recommended course of injections: from 24 hours to 5 days.
The concentration of a substance. Akos in the form of injections is administered in doses of 75 mg, the maximum dosage is 150 mg. In fact, injections with this agent are used in severe cases of the disease or after surgery, when the main goal is to quickly achieve the concentration of the active substance. While Retard is slowly absorbed and intended for a long course of treatment.

Differences between Diclofenac Retard and Diclofenac Akrikhin

The Akrikhin company produces three forms with the active substance diclofenac:

Diclofenac-Akrikhin (ointment)
Diclofenac-Akrikhin (gel)
Diclofenac Retard - Akrikhin (tablets).

What are the differences between these drugs?

Release form. Akrikhin's Diclofenac Retard is available only in tablets and is taken orally, while other forms of this manufacturer are intended for external use.
The concentration of a substance. In external forms, the amount of diclofenac is 1 g, and in Retard tablets 100 mg.
Akrikhin ointment and gel are allowed for children from the age of 6, while Retard tablets can only be used from the age of 18. Topical application of a cream or gel does not allow high concentrations to be absorbed into the bloodstream and is less harmful to the body.

Dosages, scheme of application

Tablets of the company "Ozone" and "Obolenskoye"

A single dosage of diclofenac Retard "Obolenskoe", according to the instructions for use, for an adult will be from 25 to 50 mg 2-3 times a day. The frequency of administration varies with the degree of the disease. Orally, it is one to three times a day, and rectal use is no more than once a day. In order to relieve an acute attack or exacerbation of a chronic disease, an intramuscular injection is prescribed with a dosage of 75 mg. For adolescents and children over the age of 6 years, the recommended dosage is 2 mg per 1 kg of body weight.

External use of diclofenac forms is used in a dosage of 2-4 g (depending on the area of the lesion). The drug is applied 3-4 times in 24 hours.

For the treatment of eye diseases, the doctor makes a decision on the dosage based on the course of the disease and the individual characteristics of the patient.

Tablets "Akrikhin"

The drug is taken orally during a meal or after it. Akrikhin diclofenac Retard tablets are not chewed, but swallowed. It is recommended to drink them with water or juice. Optimal dosage: 1 tablet per day.

With severe headache or algomenorrhea, it is allowed to increase the dosage of diclofenac Retard Akrikhin to 200 mg per day for 24-48 hours.

When using this drug, you can increase the dose of the drug up to 150 mg. To do this, take another additional 50 mg tablet.

Indications for use

It is used to eliminate pain in arthritis, spondylitis, gout attacks. Can be used to treat tendinitis, bursitis, tendovaginitis, periarthritis.

Diclofenac Retard treats pain after injuries, sprains, sprains of muscles and ligaments. It is used to treat pain in the lumbar region, toothache.

It is used as a medicine during the recovery period after operations.

Contraindications

It can not be taken with individual intolerance to the components, stomach ulcers and erosions of the gastrointestinal tract. Contraindicated in patients who have internal bleeding or gastrointestinal perforation, or who have had previous gastrointestinal ulcers, perforations, or bleeding.

It is not recommended to take pills to reduce pain before coronary artery bypass surgery. It is forbidden to take it to patients with bronchial asthma, taking the medicine can provoke the disease. Contraindicated in people with urticaria, rhinitis in acute form after taking acetylsalicylic acid. Do not take with kidney or liver failure, problems with blood clotting and blood diseases. Contraindicated in the III trimester of pregnancy. Do not use during feeding and children under 18 years of age.

It is used under the supervision of a physician and with caution in case of gastrointestinal ulcers, colitis, liver diseases. It is recommended to be careful when taking pills with renal and hepatic insufficiency and with a decrease in blood volume in the body (after severe abdominal operations).

Under the supervision of a physician, treatment of elderly patients (over 65 years of age) should be carried out; people with bronchial asthma; patients taking simultaneously with tablets glucocorticoids, anticoagulants, antiaggregants.

special instructions

For a quick effect, take half an hour before meals. Eating inhibits absorption. The rest of the time the tablets are taken orally. They are not chewed, but swallowed with water.

The mechanism of action is based on the inhibition of prostaglandins. They are important in ensuring a full blood supply to the liver, so the treatment of people at risk should be carried out under the supervision of a doctor. It includes: patients with renal and heart failure; older people who take diuretics; patients who have lost a lot of blood after major surgery. When prescribing tablets in these cases, the functioning of the kidneys is necessarily monitored.

The drug does not have a special effect on people with liver diseases, but it is recommended to monitor liver function for patients with liver failure.

During therapy, it is necessary to abandon potentially dangerous processes that require quick response and increased concentration.

Pregnancy and lactation

The drug is contraindicated in nursing mothers and in the third trimester of pregnancy.

Reception by children

Admission to elderly patients

Elderly people should take Diclofenac Retard with caution and only under medical supervision. They have an increased risk of developing gastrointestinal diseases, the occurrence of internal bleeding.

Particular vigilance should be exercised in the treatment of elderly patients over 65 years of age treated with diuretics; who are underweight or have kidney disease.

Overdose and side effects

If side effects occur, patients complain of nausea, vomiting, increased education, and impaired stool. Anorexia, internal bleeding (manifested by vomiting or bloody feces), gastric ulcer, gastrointestinal perforation may occur. The patient develops stomatitis, glossitis, pancreatitis, etc.

Side effects are manifested in the form of migraines, patients feel dizzy, they quickly get tired, drowsiness appears less often, hearing and vision impairments occur. The patient may have insomnia, pursue nightly "nightmares", and have tinnitus. In especially severe cases, mental disorders and neuritis of the optic nerve occur.

In rare cases, swelling of the kidneys, nephritis, hematuria, renal failure, etc. begin. The transient activity of transaminases in the blood increases, hepatitis or liver necrosis occurs.

The work of the hematopoietic system is disrupted, the result of this is leukopia, neutropenia, blood clotting decreases, anemia of various genesis develops, etc.

The patient may complain of chest pain, increased heart rate, vasculitis, or heart failure. In very rare cases, side effects occur, which manifest themselves in the form of myocardial infarction.

Side effects can be manifested in the form of shortness of breath, asthma, and occasionally pneumonitis begins. In rare cases, patients report the appearance of impotence.

In rare cases, a rash occurs on the patient's skin, even more rarely hives, eczema, erythroderma or asthma attacks. It is possible to lower blood pressure or anaphylactic shock, swelling of the skin.

In overdose, the patient complains of migraine. Dizziness, confusion, convulsions, bouts of nausea, and vomiting may occur. On the part of the nervous system, there is increased excitability. Pain in the abdomen, internal bleeding, impaired kidney and liver function are possible.

Symptomatic therapy is performed aimed at reducing high blood pressure, relieving convulsions, relieving irritation of the gastrointestinal tract and other manifestations of overdose.

Drug toxicity

More than ten years ago, scientists started talking about the serious toxicity of diclofenac. In their conclusions, they were guided by scientific studies, the conclusion of which is disappointing: the drug in high dosage (75 mg 2 times a day) increases the risk of strokes and heart attacks by 2 times. A patient treated with such dosages for several years, according to scientists, becomes cardio ill. In addition, another scientific study found that people who already have heart disease have a 40% increased risk of heart attacks.

It negatively affects the stomach and duodenum, destroying the mucous membrane. This can lead to stomach ulcers, erosions, perforations and other diseases of the gastrointestinal tract.

Interaction with other drugs

Increases the plasma concentration of drugs based on lithium, cyclosporine, digoxin. When taken with other non-steroids and glucocorticosteroids, the risk of side effects increases. It enhances the toxic damage to the organs of methotrexate, enhances the effect on the kidneys of cyclosporine and gold preparations.

If the tablets are used with paracetamol or tacrolimus, then the negative effect of diclofenac on the kidneys increases.

The drug reduces the effectiveness of diuretics, for example, after taking it, indafon Retard acts worse, the instructions for use confirm this fact.

Tablets reduce the effectiveness of ACE inhibitors, beta-blockers. Simultaneous administration of diclofenac and antihypertensive drugs should be carried out under the strict supervision of a physician, especially for patients over 65 years of age.

When taking diclofenac with anticoagulants or thrombolytic agents, the patient has an increased risk of bleeding. Taking acetylsalicylic acid, colestipol, cholestyramine reduces the absorption of diclofenac or increases the time to reach maximum concentration.

Tablets reduce the effectiveness of mifepristone. Therefore, they should be taken only two weeks after the end of treatment with mifepristone.

An increased risk of internal bleeding occurs when taking ethanol, drugs based on St. John's wort, colchicine or corticotropin with the drug.

When taken simultaneously with drugs from the quinolone class, the risk of seizures increases. The drug reduces the effectiveness of sleeping pills. If you take tablets with drugs against diabetes, then the patient may develop hyper- or hypoglycemia. When taken simultaneously with anticoagulants, strict monitoring of the patient's condition by the attending physician is required.

Interaction with alcohol

It is strictly forbidden to take the drug with alcoholic beverages. Otherwise, the patient will get a hepatoxic effect on the liver. The body may not be able to withstand the load of the drug and alcohol. This will lead to the death of hepatocytes (liver cells), intoxication of the body and liver failure.

Storage, dispensing from pharmacies

The drug is released only by prescription. It should be stored in a dark, dry place at a temperature of 15 to 25 degrees.

The place should not be accessible to children.

Analogues

The pharmaceutical industry produces many products with the active substance diclofenac. They differ from each other in cost, manufacturer and form of release:

Diklak. This is a German drug, available in 4 forms: gel for external use 1%, 5%; rectal suppositories; tablets 100 mg and 75 mg, solution for injection. The cost varies from 44 to 375 rubles (depending on the chosen form of medicine and the markup of the pharmacy chain).
Diclofenac Bufus. Domestic drug, release form: solution for intramuscular injection. It is used after operations, with neuritis, neuralgia, diseases of the joints. The average price is 100-130 rubles.
Ortofen. Release form: ointment and gel for external use, tablets. It is used for pain in the ligaments, soft tissue and joint injuries, rheumatism, etc. The cost varies from 29 to 116 rubles (depending on the form of the medicine).
Sanfinak. Release form: tablets 25 mg, 50 mg. Indications for use: arthritis, acute attacks of gout, neuralgia, myalgia, rheumatism, pain during fractures, etc. The average price for these tablets starts from 110 rubles.
Diklovit. Release form: suppositories and gel for external use. It is used for myalgia, neuralgia, trauma, arthritis, etc. Average cost: from 93 to 314 rubles, depending on the chosen form of medication.