Pharmacological properties
Pharmacodynamics. Diklak sodium is a nonsteroidal compound with pronounced anti-inflammatory and analgesic properties. The main mechanism of action of this substance is considered to be the inhibition of the biosynthesis of prostaglandins, which play an important role in the occurrence of inflammation and pain.
The use of diclofenac helps increase the range of motion in the affected joints.
In in vitro experiments at concentrations equivalent to those achieved in patients, diclofenac does not inhibit the biosynthesis of cartilage proteoglycans.
Diclac also has a positive effect in the case of migraine attacks.
In post-traumatic and postoperative conditions with inflammation, Diklak relieves pain during movement and reduces swelling caused by inflammation and wounds.
If diclofenac sodium is used simultaneously with opioid analgesics to eliminate postoperative pain, the need for them is significantly reduced.
Diclac is especially necessary at the beginning of treatment for inflammatory and degenerative rheumatic diseases and pain due to inflammation of non-rheumatic origin.
Pharmacokinetics
Absorption. Diclac, enteric-coated tablets. Although absorption is complete, the onset of action may be delayed as a result of gastric transit, which may be affected by food, which slows gastric emptying. The mean C max of 1.48 ± 0.65 μg/ml (1.5 μg/ml = 5 μmol/l) is achieved approximately 2 hours after administration of a 50 mg tablet.
Diclac, solution for injection. After administration of 75 mg of diclofenac sodium by i.m. injection, absorption begins immediately, and the average C max in blood plasma, which is about 2.5 μg/ml (8 μmol/l), is reached in about 20 minutes. The extent of absorption is linearly dependent on the dose. In the case of administration of 75 mg of diclofenac sodium by i.v. infusion over 2 hours, the average C max in blood plasma is about 1.9 μg/ml (5.9 μmol/l). AUC after i.m. or i.v. administration is almost twice as high as after oral or rectal administration, since in the latter case approximately half of the active substance is metabolized during the first pass through the liver. Pharmacokinetic properties do not change after repeated administration. When the recommended dosing intervals are observed, the drug does not accumulate.
Diklak ID, modified-release tablets, are two-layer tablets with a combination of rapid (1/6 of the total amount) and gradual release (5/6 of the total amount) of diclofenac sodium. This combination of effects in one tablet allows for both a rapid onset of action and long-term circulation of the active substance in the systemic bloodstream and a therapeutic effect throughout the day.
After oral administration of the drug, diclofenac is completely absorbed and, depending on the duration of passage through the stomach, C max in blood plasma is reached after 1-16 hours, on average after 2-3 hours. The amount of absorbed active substance linearly depends on the dose of the drug.
Distribution. 99.7% of diclofenac binds to plasma proteins, mainly albumin. The volume of distribution is 0.12-0.17 l/kg body weight. Diclofenac penetrates into the synovial fluid, where it reaches C max after 2-4 h. T ½ from the synovial fluid is from 3 to 6 h. 2 hours after reaching C max in the blood plasma, the concentration of diclofenac in the synovial fluid becomes higher than in the blood plasma, and remains higher for up to 12 h.
Biotransformation. The biotransformation of diclofenac occurs partly by glucuronidation of the parent molecule, but mainly by hydro- and methoxylation, leading to the formation of several phenolic metabolites, two of which are biologically active, but to a lesser extent than diclofenac.
Elimination. The total systemic clearance of diclofenac from blood plasma is 263 ± 56 ml/min, T ½ - 1-2 h. About 60% of the dose is excreted in the urine as metabolites.
About 70% is excreted by the kidneys in the form of inactive metabolites. Less than 1% is excreted as unchanged compound, the rest - in the form of metabolites with bile.
Certain patient groups. No age-related differences in absorption, metabolism, or excretion of the drug were observed. However, in some elderly patients, plasma concentrations of diclofenac after a 15-minute intravenous infusion were 50% higher than those observed in healthy younger subjects.
In individuals with impaired renal function, when following the usual dosing regimen, accumulation of the active substance did not occur.
In patients with chronic hepatitis or cirrhosis, the kinetics and metabolism of diclofenac are the same as in patients without liver disease.
Indication
According to general therapeutic principles, the underlying disease requires treatment with basic therapy. Fever in itself is not an indication for the use of the drug.
Diklak, solution for injection
Intramuscular administration:
inflammatory and degenerative forms of rheumatism (rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, spondyloarthritis, vertebral pain syndrome, extra-articular rheumatism); acute attacks of gout; renal and biliary colic; post-traumatic and postoperative pain syndrome; severe migraine attacks.
In / in infusion:
treatment or prevention of postoperative pain.
Diclac ID, modified-release tablets:
Pain relief and reduction of inflammation of varying degrees in various conditions, including:
Joint pathology: rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, acute attacks of gout; acute musculoskeletal diseases such as periarthritis (e.g., shoulder scapular periarthritis), tendonitis, tendovaginitis, bursitis; other pathological conditions caused by trauma, including fractures, low back pain, sprains, dislocations, orthopedic, dental, and other minor surgical interventions.
Application
In general, it is recommended to select the dose individually, as well as to use the minimum effective dose for the shortest possible time, taking into account the treatment objectives of each individual patient.
Diclac, enteric-coated tablets. For oral use.
The drug should be used in the most effective doses for the shortest period of time, taking into account the treatment objectives of each individual patient.
The use of the drug should begin after the first pain symptoms appear and continue for several days, depending on the dynamics of symptom regression.
It is advisable to take the tablets before meals, without chewing, with water.
The dose of the drug and the duration of use are determined by the doctor depending on the nature and course of the disease, the patient's response and the therapeutic effect.
The initial dose for adults is usually 100-150 mg/day. With mild symptoms, as well as with long-term therapy, a dose of 75-100 mg/day is sufficient. The daily dose should be divided into 2-3 doses. If a dose of 75 mg is necessary, use the drug with the appropriate dosage. The maximum daily dose of the drug is 150 mg.
In primary dysmenorrhea, the daily dose is selected individually, usually it is 50-150 mg. The initial dose can be 50-100 mg, if necessary, it can be increased over several menstrual cycles to a maximum of 200 mg/day. The drug should be started as early as possible after the appearance of the first pain symptoms; the duration of treatment, depending on the symptoms, is several days.
Diclac, solution for injection. The drug should be used in the lowest effective doses for the shortest period, taking into account the treatment objectives of each individual patient.
Adults. The drug should not be used for longer than 2 days; if necessary, treatment can be continued with Diclac tablets.
Intramuscular injection. To prevent damage to the nerve and other tissues at the site of intramuscular injection, the following rules should be followed.
The daily dose is usually 75 mg (1 ampoule), which is administered by deep injection into the upper outer sector of the gluteus maximus muscle. In severe cases (e.g. colic), the daily dose can be increased to 2 injections of 75 mg, the interval between which should be several hours (1 injection in each buttock). As an alternative, the administration of 1 ampoule of diclofenac sodium 75 mg can be combined with other dosage forms of the drug Diclac (e.g. tablets) up to a total maximum daily dose of 150 mg of diclofenac sodium.
In the setting of a migraine attack, according to clinical experience, 75 mg of diclofenac sodium should be administered intramuscularly as early as possible and, if necessary, 100 mg suppositories should be used on the same day. The total daily dose should not exceed 175 mg on the first day. There are no data available on the use of Diclofenac for the treatment of migraine attacks for more than one day. If necessary, suppositories can be continued on subsequent days of treatment up to a maximum daily dose of 150 mg.
In / in infusion. Immediately before the start of the in / in infusion, depending on its required duration, the contents of the ampoule should be diluted in 100-500 ml of 0.9% sodium chloride solution or 5% glucose solution, buffered with sodium bicarbonate solution for injection (0.5 ml of 8.4% solution or 1 ml of 4.2% solution). Only clear solutions can be used.
Diclac, solution for injection, should not be administered as an intravenous bolus injection.
Two alternative infusion dosing regimens are recommended:
for the treatment of moderate to severe postoperative pain, 75 mg of diclofenac sodium should be administered continuously for 30 minutes to 2 hours. If necessary, the therapy can be repeated after 4-6 hours, but the dose should not exceed 150 mg/day; for the prevention of postoperative pain, a loading dose of 25-50 mg should be administered 15 minutes to 1 hour after surgery, followed by a continuous infusion of about 5 mg/h to a maximum daily dose of 150 mg
.
The recommended initial dose for adults is 75-150 mg/day, depending on the severity of the symptoms. For long-term therapy, 1 tablet (75 mg) per day is usually sufficient. If the symptoms of the disease are most pronounced during the night or in the morning, Diclac ID should be taken in the evening.
The maximum daily dose is 150 mg and should not be exceeded. Diclac ID is intended for short-term use (maximum 2 weeks). The duration of treatment is determined by the doctor.
The tablets should be swallowed whole, without chewing, with sufficient liquid, preferably during or after a meal.
Children: Diclac is not recommended for use in children.
Elderly patients. Although the pharmacokinetics of Diclofenac are not altered to any clinically significant extent in the elderly, NSAIDs should be used with caution in these patients, who are generally more susceptible to adverse reactions. In particular, the lowest effective dose is recommended for debilitated elderly patients or those with low body mass, and patients should be monitored for gastrointestinal bleeding when taking NSAIDs. The recommended maximum dose of Diclofenac is 150 mg/day.
Patients with severe cardiovascular disease and significant risk of developing it. The use of diclofenac is not recommended in patients with severe cardiovascular disease or uncontrolled hypertension. Patients with severe cardiovascular disease, uncontrolled hypertension or significant risk factors for cardiovascular disease should use diclofenac at a dose of 100 mg/day with particular caution if treatment lasts more than 4 weeks.
Patients with renal impairment. Diclofenac is contraindicated in renal insufficiency. Specific studies of the drug in patients with renal impairment have not been conducted, therefore it is not possible to provide specific recommendations for dose adjustment. Diclofenac should be used with particular caution in patients with mild to moderate renal insufficiency.
Patients with hepatic impairment. Diclofenac is contraindicated in hepatic insufficiency. Specific studies of the drug in patients with hepatic impairment have not been conducted, therefore specific recommendations for dose adjustment cannot be given. Diclofenac should be used with extreme caution in patients with mild to moderate hepatic insufficiency.
Contraindication
Hypersensitivity to the active substance or to any of the excipients. History of gastrointestinal bleeding or perforation related to previous NSAID treatment. Active ulcer/bleeding or history of recurrent ulcer/bleeding (≥2 separate episodes of established ulceration or bleeding). 3rd trimester of pregnancy. Like other NSAIDs, diclofenac is also contraindicated in patients in whom the use of ibuprofen, acetylsalicylic acid or other NSAIDs provokes attacks of BA, angioedema, urticaria or acute rhinitis. Inflammatory bowel disease (e.g. Crohn's disease or ulcerative colitis). Hepatic failure. Renal failure (<15 ml/min/1.73 m2). Congestive heart failure (NYHA II-IV). high risk of postoperative bleeding, decreased blood clotting, hemostasis disorders, hematopoietic disorders or cerebrovascular bleeding. treatment of perioperative pain in coronary artery bypass grafting (or use of an artificial blood circulation device). coronary artery disease in patients with angina pectoris, myocardial infarction. cerebrovascular disease in people who have had a stroke or have episodes of transient ischemic attacks. peripheral artery disease. in the form of a solution for injection, the drug is contraindicated in children.
Only for IV administration: concomitant use of NSAIDs or anticoagulants (including low-dose heparin). History of hemorrhagic diathesis, confirmed or suspected cerebrovascular bleeding in history. Operations associated with a high risk of bleeding. History of asthma. Moderate or severe renal impairment (plasma creatinine 160 μmol/l). Hypovolemia or dehydration from any cause.
Side effects
Classification of side effects by organ system and frequency of occurrence: very common (≥1/10); common (≥1/100, 1/10); uncommon (≥1/1000, 1/100); rare (≥1/10,000, 1/1000); very rare (1/10,000), including isolated reports.
The following undesirable effects include phenomena associated with the use of the solution for injection and/or other dosage forms of diclofenac sodium in conditions of short-term and long-term administration.
Infections and infestations: very rarely - abscess at the injection site.
From the blood system: very rarely - thrombocytopenia, leukopenia, anemia (including hemolytic and aplastic anemia), agranulocytosis.
Immune system disorders: rarely - hypersensitivity, anaphylactic and pseudoanaphylactic reactions (including hypotension and shock); very rarely - angioedema (including facial swelling).
From the nervous system: often - headache, dizziness; rarely - drowsiness; very rarely - paresthesia, memory impairment, convulsions, anxiety, tremor, aseptic meningitis, taste disturbance, stroke, touch disturbance; frequency unknown - confusion, hallucinations, sensory disturbances, general malaise, fatigue.
On the part of the organ of vision: very rarely - visual impairment, blurred vision, diplopia; frequency unknown - optic neuritis.
From the side of the organs of hearing and labyrinth: often - vertigo; very rarely - tinnitus, hearing impairment.
Cardiac disorders: very rarely - palpitations, chest pain, heart failure, myocardial infarction, acute coronary syndrome
From the vascular system: very rarely - arterial hypertension, arterial hypotension, vasculitis.
From the respiratory system: rarely - asthma (including dyspnea), bronchospasm, very rarely - pneumonitis.
On the part of the digestive system: often - nausea, vomiting, diarrhea, dyspepsia, abdominal pain, flatulence; rarely - gastritis, intestinal bleeding, vomiting with blood, hemorrhagic diarrhea, melena, gastric or intestinal ulcer (with or without bleeding, with or without perforation); very rarely - colitis (including hemorrhagic colitis, ischemic colitis and exacerbation of ulcerative colitis or Crohn's disease), constipation, stomatitis, glossitis, diseases of the esophagus, intestinal stricture, pancreatitis.
On the part of the liver: sometimes - increased transaminase levels; rarely - hepatitis, jaundice, impaired liver function; very rarely - fulminant hepatitis, hepatonecrosis, liver failure.
Skin and subcutaneous tissue disorders: common: rash; rare: urticaria; very rare: bullous eruptions, eczema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), exfoliative dermatitis, hair loss, photosensitivity reaction, purpura, allergic purpura, pruritus, erythema.
From the kidneys and urinary tract: very rarely - acute renal failure, hematuria, proteinuria, nephrotic syndrome, interstitial nephritis, renal papillary necrosis.
General disorders and administration site conditions: Common: injection site reactions, including injection site induration, injection site pain; injection site edema, injection site necrosis. In isolated cases, symptoms of aseptic meningitis may occur, including neck stiffness, fever, or confusion. Patients with autoimmune diseases (systemic lupus erythematosus, mixed collagen diseases) are more likely to experience these reactions.
From the reproductive system and mammary glands: very rarely - impotence.
Clinical trial data and epidemiological data suggest an increased risk of thrombotic complications (e.g. myocardial infarction or stroke) associated with the use of diclofenac, particularly at high therapeutic doses (150 mg/day) and with long-term use.
Visual disturbances. Visual disturbances such as visual disturbances, blurred vision and diplopia are class effects of NSAIDs and are usually reversible upon discontinuation of the drug. The most likely mechanism of visual disturbances is inhibition of the synthesis of prostaglandins and other related compounds, which disrupt the regulation of retinal blood flow and contribute to the development of visual disturbances. If such symptoms occur during the use of diclofenac, an ophthalmological examination should be performed to exclude other possible causes.
Special instructions
Gastrointestinal bleeding, ulceration or perforation, with or without warning symptoms, without a previous history of serious gastrointestinal events, may occur with all NSAIDs at any time during treatment and may be fatal. The risk of these events is increased in the elderly. If gastrointestinal bleeding occurs, diclofenac sodium should be discontinued.
Very rarely, allergic reactions, including anaphylactic/anaphylactoid and skin reactions, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in association with the use of nonsteroidal anti-inflammatory drugs, including Diclofenac.
The highest risk of such reactions occurs at the beginning of therapy, in the first month of treatment. The use of the drug Diclac should be discontinued at the first appearance of skin rashes, mucosal lesions or any other signs of hypersensitivity.
NSAIDs may increase the risk of serious cardiovascular thrombotic events, myocardial infarction and stroke, which can be fatal, and therefore Diclac is not recommended for use in postoperative pain during coronary artery bypass grafting surgery.
Like other nonsteroidal anti-inflammatory drugs, Diclac, due to its pharmacodynamic properties, may mask the signs and symptoms of infection.
General precautions: The use of Diclac concomitantly with systemic NSAIDs, including selective COX-2 inhibitors, should be avoided due to the lack of any synergistic effect and the possibility of additional side effects.
History of asthma. Patients with bronchial asthma, seasonal allergic rhinitis, nasal mucosal edema (i.e. polyps), COPD, or chronic respiratory tract infections have an increased incidence of adverse reactions to NSAIDs. These reactions include: exacerbation of asthma (analgesic asthma), angioedema, urticaria. Special measures are recommended for such patients (emergency preparedness). This also applies to patients with allergies, for example, with skin reactions, itching, or urticaria.
Special precautions are recommended for patients with asthma when Diclac is administered parenterally, as symptoms may be exacerbated.
Gastrointestinal effects: Gastrointestinal bleeding (hemorrhage, melena), ulceration or perforation, which can be fatal, have been reported with all NSAIDs, including diclofenac, and may occur at any time during treatment, with or without warning symptoms, or with a history of serious gastrointestinal events. These events are usually more severe in the elderly. If gastrointestinal bleeding or ulceration occurs in patients taking diclofenac, the drug should be discontinued.
As with other nonsteroidal anti-inflammatory drugs, when prescribing Diklak to patients with symptoms indicating gastrointestinal disorders, medical supervision and special caution are mandatory. The risk of gastrointestinal bleeding, ulceration or perforation increases with increasing dose of NSAIDs in patients with a history of ulcer, especially with complications such as hemorrhage or perforation, and in the elderly, so they should be treated using the lowest effective dose for the shortest possible time.
Such patients, as well as those requiring concomitant low-dose acetylsalicylic acid, should be treated with combination therapy with protective drugs (e.g. misoprostol or proton pump inhibitors).
Caution is also required in patients receiving concomitant medications that may increase the risk of ulceration or bleeding, such as systemic corticosteroids, anticoagulants (e.g. warfarin), antithrombotic agents (e.g. acetylsalicylic acid) or selective serotonin reuptake inhibitors.
Diclac should be prescribed with caution to patients with a history of inflammatory bowel diseases, such as Crohn's disease or ulcerative colitis, and careful medical supervision of their health should be established due to the possibility of exacerbation.
Effects on the liver. Careful medical supervision is necessary when prescribing Diclac to patients with impaired liver function, as their condition may worsen.
Treatment with diclofenac sodium, as with other NSAIDs, may lead to an increase in the level of one or more liver enzymes, therefore, when using the drug Diklak, regular monitoring of liver function is necessary as a precautionary measure. If during treatment liver function deteriorates or other manifestations are observed (e.g. eosinophilia, rash), the drug should be discontinued. When treating with diclofenac sodium, the course of hepatitis may occur without prodromal symptoms.
Caution is required when prescribing Diclac to patients with hepatic porphyria due to the possibility of provoking an attack.
Renal effects: Since fluid retention and edema have been reported with NSAIDs, special care should be taken in patients with impaired cardiac or renal function (including functional renal failure due to hypovolemia, nephrotic syndrome, lupus nephropathy, and decompensated cirrhosis), a history of hypertension, the elderly, patients receiving diuretic therapy or drugs that significantly affect renal function, and patients with significant volume depletion from any cause, such as before or after major surgery. In such cases, monitoring of renal function is recommended. Discontinuation of therapy usually results in a return to pre-treatment status.
Skin effects. Serious skin reactions (some of which were fatal) have been reported very rarely in association with the use of NSAIDs, including Diclac, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis. The risk of these reactions is apparently highest at the beginning of therapy, in most cases within the first month of treatment. Diclac should be discontinued at the first appearance of skin rash, mucosal lesions or any other sign of hypersensitivity.
Systemic lupus erythematosus and mixed connective tissue diseases: Patients with systemic lupus erythematosus and mixed connective tissue diseases may be at increased risk of developing aseptic meningitis.
Cardiovascular effects. Diclofenac should only be prescribed to patients with significant risk factors for cardiovascular events (e.g. hypertension, hyperlipidemia, diabetes mellitus, smokers) after careful clinical evaluation. Since the cardiovascular risks of diclofenac may increase with increasing dose and duration of treatment, it should be used for the shortest possible period and at the lowest effective dose. The patient's need for diclofenac should be periodically reviewed to assess the patient's symptoms and response to therapy. Use with caution in patients over 65 years of age.
For patients with a history of hypertension and/or mild to moderate congestive heart failure, appropriate monitoring and advice are necessary, as cases of fluid retention and edema have been reported in association with the use of NSAIDs, including diclofenac.
The risk of serious cardiovascular thrombotic events (myocardial infarction and stroke) may be increased in connection with the use of NSAIDs, including diclofenac, especially in high doses and for a long time.
Diclofenac is not recommended for use in patients with uncontrolled hypertension, congestive heart failure, stable coronary artery disease, peripheral arterial disease and/or cerebrovascular disease, and should only be used after careful risk/benefit assessment at doses not exceeding 100 mg/day. A similar assessment should be made before initiating long-term treatment in patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidemia, diabetes mellitus and smoking).
Patients should be informed about the possibility of serious events (chest pain, shortness of breath, weakness, speech disorders) that may occur at any time. In this case, a doctor should be consulted immediately.
History of asthma. Patients with bronchial asthma, seasonal allergic rhinitis, patients with swelling of the nasal mucosa (nasal polyps), COPD or chronic respiratory infections (especially those associated with allergic rhinitis-like symptoms) are more likely than others to experience reactions to NSAIDs that resemble exacerbations of asthma (so-called analgesic intolerance / analgesic asthma), angioedema, urticaria. In this regard, special measures are recommended for such patients (readiness to provide emergency care). This also applies to patients with allergies to other substances, which manifest themselves as skin reactions, itching or urticaria.
Like other drugs that inhibit prostaglandin synthetase activity, diclofenac sodium and other nonsteroidal anti-inflammatory drugs can provoke the development of bronchospasm in patients with existing asthma or a history of asthma.
Fertility in women: The use of the drug may impair fertility in women and is not recommended in women attempting to conceive. In women who may have difficulty conceiving or are undergoing investigation for infertility, discontinuation of Diclac should be considered.
Use during pregnancy and breastfeeding. Pregnancy. In the I and II trimesters of pregnancy, Diclac can be prescribed only if the expected benefit to the mother outweighs the potential risk to the fetus, only in the minimum effective dose, the duration of treatment should be as short as possible. Like other nonsteroidal anti-inflammatory drugs, the drug is contraindicated in the III trimester of pregnancy (possible inhibition of uterine contractility and premature closure of the ductus arteriosus in the fetus).
Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryo/foetal development. Epidemiological studies have shown an increased risk of miscarriage and/or heart defects and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk of cardiovascular defects increased from less than 1% to 1.5%.
It is possible that the risk increases with increasing dose and duration of treatment. In animals, administration of a prostaglandin synthesis inhibitor has been shown to result in increased pre- and post-implantation losses and embryo/fetal lethality.
In addition, in animals treated with a prostaglandin synthesis inhibitor during organogenesis, an increased incidence of various malformations, including those of the cardiovascular system, has been reported. If Diclac is used in women attempting to conceive or in the first trimester of pregnancy, the dose should be as low as possible and the duration of treatment as short as possible.
In the third trimester of pregnancy, all prostaglandin synthesis inhibitors can affect the fetus in the following ways:
Cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension); renal dysfunction, which may progress to renal failure with oligohydramnios.
For the mother and newborn, as well as at the end of pregnancy:
Possible prolongation of bleeding time, antiplatelet effect, which can be observed even at very low doses; inhibition of uterine contractions, leading to delayed or prolonged labor.
Breastfeeding. Like other nonsteroidal anti-inflammatory drugs, diclofenac passes into breast milk in small amounts. Therefore, to avoid undesirable effects on the infant, Diclofenac should not be used during breastfeeding.
Fertility. Like other nonsteroidal anti-inflammatory drugs, Diclac may affect female fertility. The drug is not recommended for women planning to become pregnant. Women who have difficulty conceiving or who have undergone infertility testing should discontinue use of Diclac.
Children. The drug Diclac in the form of tablets and injections is not used in children.
Ability to influence the reaction rate when driving vehicles or operating other mechanisms. Patients who experience visual disturbances, dizziness, drowsiness or other central nervous system disorders while using diclofenac sodium should refrain from driving vehicles and operating mechanisms.
Interactions
Below are the interactions that have been observed with the use of the drug Diclac, solution for injection and / or other dosage forms of diclofenac.
Lithium: Diclofenac may increase plasma lithium concentrations when used concomitantly. Monitoring of plasma lithium levels is recommended.
Digoxin: Diclofenac may increase the plasma concentration of digoxin when used concomitantly. Monitoring of digoxin plasma levels is recommended.
Diuretics and antihypertensives: Concomitant use of diclofenac sodium and other NSAIDs with diuretics or antihypertensives (e.g. β-blockers, ACE inhibitors) may lead to a reduction in their antihypertensive effect. Therefore, such a combination should be used with caution and patients, especially the elderly, should be closely monitored for blood pressure. Patients should be adequately hydrated and renal function should be monitored after initiation of concomitant therapy and regularly thereafter, especially with diuretics and ACE inhibitors due to the increased risk of nephrotoxicity.
Potassium supplements are known to cause hyperkalemia. Concomitant treatment with potassium-sparing diuretics, cyclosporine, tacrolimus, or trimethoprim may be associated with increases in plasma potassium levels, and patients should be monitored more frequently.
Other NSAIDs and corticosteroids: Concomitant administration of diclofenac and other systemic NSAIDs or corticosteroids may increase the incidence of gastrointestinal adverse reactions. The simultaneous use of two or more NSAIDs should be avoided.
Anticoagulants and antithrombotic agents: Caution is advised as concomitant administration may increase the risk of bleeding. Although clinical studies have not shown an effect of diclofenac on the activity of anticoagulants, there is some evidence of an increased risk of bleeding in patients receiving diclofenac and these drugs concomitantly. Therefore, close monitoring of such patients is recommended.
Therefore, careful monitoring of these patients is recommended to ensure that any changes in anticoagulant dosage are not necessary. Like other NSAIDs, diclofenac in high doses inhibits platelet aggregation.
Selective serotonin reuptake inhibitors: Concomitant administration of systemic NSAIDs and selective serotonin reuptake inhibitors may increase the risk of gastrointestinal bleeding.
Antidiabetic drugs: clinical studies have shown that diclofenac can be used together with oral hypoglycemic agents without affecting their clinical effect. However, isolated cases of both hypoglycemic and hyperglycemic reactions have been reported.
