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HEALTH CARE
Dicloberl 50, 50mg 10 suppositories — Made in Germany — Free Delivery
Dicloberl 50, 50mg 10 suppositories — Made in Germany — Free Delivery
Brand:
Berlin-Chemie
Product Code:
Dicloberl 50
Availability:
In Stock
$20.26
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Description
Pharmacological properties
Pharmacodynamics. Dicloberl contains diclofenac sodium, a non-steroidal substance that has a pronounced analgesic and anti-inflammatory effect. is an inhibitor of prostaglandin synthetase (cog).
Pharmacokinetics. Suction. Absorption is fast, but slower than with enteric-coated tablets. After the use of Dicloberl suppositories at a dose of 50 mg, Cmax in blood plasma is achieved after 1 hour, but Cmax per dose unit is about ⅔ of the concentration achieved after using enteric coated tablets (1.95 ± 0.8 μg / ml (1, 9 μg / ml = 5.9 μmol / L)).
Bioavailability. As in the case of oral dosage forms of the preparation, the AUC is approximately half the value obtained with parenteral dose administration. After repeated use of the preparation, its pharmacokinetics does not change. Cumulation of the preparation is not noted, provided that the recommended doses are observed.
Distribution. The binding of diclofenac to blood plasma proteins is 99.7%, mainly with albumin - 99.4%.
Diclofenac penetrates into the synovial fluid, where its Cmax is reached 2–4 hours later than in blood plasma. The apparent T½ from the synovial fluid is 3–6 hours. 2 hours after reaching Cmax in the blood plasma, the concentration of diclofenac in the synovial fluid remains higher than in the blood plasma; this phenomenon is observed for 12 hours.
Diclofenac was detected at a low concentration (100 ng / ml) in breast milk in one lactating woman. The estimated amount of the preparation that enters the infant's body with breast milk is equivalent to a dose of 0.03 mg / kg / day.
Metabolism. Diclofenac is metabolized in part by glucuronidation of an unchanged molecule, but mainly by single and repeated hydroxylation and methoxylation, which leads to the formation of several phenolic metabolites, most of which form conjugates with glucuronic acid. Two of these phenolic metabolites are biologically active, but significantly less than diclofenac.
Excretion. The total systemic clearance of diclofenac from blood plasma is 263 ± 56 ml / min (mean ± mean deviation). The final half-life in blood plasma is 1–2 hours. The half-life in blood plasma of four metabolites, including two pharmacologically active ones, is also short and amounts to 1–3 hours. About 60% of the preparation dose is excreted in the urine as a glucuronide conjugate of an intact molecule and as metabolites, most of which are also converted to glucuronide conjugates. Less than 1% of diclofenac is excreted unchanged. The rest is excreted in the form of metabolites in the feces.
Pharmacokinetics in certain groups of patients. The effect of the patient's age on the absorption, metabolism and excretion of the preparation was not noted, in addition to the fact that in 5 elderly patients, a 15-minute intravenous infusion led to a 50% increase in plasma concentration than was expected in healthy young volunteers.
In patients with impaired renal function who received therapeutic doses, accumulation of unchanged active substance can not be expected, based on the kinetics of the preparation after a single use. In patients with creatinine clearance of 10 ml / min, the calculated equilibrium plasma concentrations of hydroxylated metabolites were approximately 4 times higher than in healthy volunteers. Ultimately, however, all metabolites were excreted in the bile.
Patients with impaired liver function. In patients with chronic hepatitis or compensated liver cirrhosis, the pharmacokinetics and metabolism of diclofenac are similar to those in patients without liver disease.
Indications
Inflammatory and degenerative forms of rheumatism: rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, including spondyloarthritis; pain syndromes from the spine; rheumatic diseases of extra-articular soft tissues; post-traumatic and postoperative pain syndromes accompanied by inflammation and edema, especially after dental and orthopedic operations; gynecological diseases accompanied by pain and inflammation, for example, primary dysmenorrhea and adnexitis; migraine attacks; acute attacks of gout; as an adjuvant in severe inflammatory diseases of ENT organs, accompanied by painful sensations, for example, with pharyngotonsillitis, otitis media.
In accordance with general therapeutic principles, treatment for the underlying disease should be carried out with basic therapy. Fever in itself is not an indication for the use of the preparation.
Application
In order to minimize side effects, the lowest effective dose should be used for a short period.
Do not use internally, only for rectal administration.
Suppositories should be injected into the rectum as deeply as possible, preferably after bowel cleansing.
The starting dose is usually 100–150 mg / day. With unexpressed symptoms, as well as with prolonged therapy, a dose of 75-100 mg / day is sufficient.
Divide the daily dose into 2-3 doses. In order to avoid night pain or morning stiffness, Dikloberl is prescribed in the form of rectal suppositories before bedtime for the use of the preparation during the day (the daily dose should not exceed 150 mg).
In primary dysmenorrhea, the daily dose is selected individually, usually it is 50–150 mg / day. The initial dose can reach 50-100 mg / day, but if necessary, it can be increased over several menstrual cycles to a maximum of 200 mg / day. The use of the preparation should be started after the onset of the first pain symptoms and continued for several days, depending on the dynamics of regression of symptoms.
To stop a migraine attack, start the course at a dose of 100 mg when its first signs appear. If necessary, a second suppository (100 mg diclofenac) can be used on the same day. If necessary, on the following days, treatment can be continued (the daily dose should not exceed 150 mg, the dose should be divided into 2-3 applications).
In the treatment of juvenile rheumatoid arthritis, the daily dose can be up to 3 mg / kg of body weight, which is the maximum daily dose, and should not exceed 150 mg / day. For children over the age of 14, suppositories of 50 mg can be prescribed.
Elderly patients. Although in elderly patients, the pharmacokinetics of the preparation Dicloberl does not deteriorate to any clinically significant degree, NSAIDs should be used with caution, since patients in this age category are usually more prone to developing adverse reactions. In particular, debilitated elderly patients or patients with low body weight are recommended to use the minimum effective dose, and patients should also be examined for gastrointestinal bleeding when treating NSAIDs.
Contraindications
Hypersensitivity to the active substance or any other component of the preparation; acute stomach or intestinal ulcer; gastrointestinal bleeding or perforation; high risk of postoperative bleeding, blood clotting disorders, hemostasis disorders, hematopoietic disorders or cerebrovascular bleeding; a history of bleeding or perforation of the gastrointestinal tract associated with previous NSAID treatment; active gastric ulcer / bleeding or recurrent stomach ulcer / history of bleeding (2 or more separate episodes of diagnosed ulcer or bleeding); inflammatory bowel disease (eg Crohn's disease or ulcerative colitis); iii trimester of pregnancy; liver failure; renal failure; congestive heart failure (nyha ii – iv); ischemic heart disease in patients with angina pectoris, myocardial infarction; cerebrovascular disease in patients who have had a stroke, or who have episodes of transient ischemic attacks; peripheral arterial disease; relief of perioperative pain with coronary artery bypass grafting (or using a heart-lung machine); 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; proctitis.
Side effects
The following side effects include events that have been reported with short-term or long-term use of the preparation.
From the blood and lymphatic system: thrombocytopenia, pancytopenia, agranulocytosis, leukopenia, anemia (hemolytic anemia, aplastic anemia). The first signs may be fever, pharyngitis, superficial sores in the mouth, flu-like symptoms, severe lethargy, nosebleeds, and bleeding from the skin.
From the immune system: hypersensitivity reactions such as skin rash and itching, urticaria, anaphylactic and anaphylactoid reactions (including narrowing of the airways, respiratory arrest, heart palpitations, arterial hypotension and shock), angioedema, including edema of the face, tongue, internal swelling of the pharynx, allergic vasculitis and pneumonia.
Mental disorders: disorientation, depression, insomnia, irritability, nightmares, psychotic disorders, other mental disorders.
From the nervous system: headache, dizziness, agitation or drowsiness, anxious, episodic dizziness, drowsiness, fatigue, paresthesia, memory impairment, convulsions, anxiety, tremor, aseptic meningitis, taste disorders, stroke, confusion, hallucinations, impaired sensitivity, general malaise.
From the side of the organ of vision: visual impairment, blurred vision, diplopia, optic neuritis.
From the organ of hearing and labyrinth: vertigo, ringing in the ears, hearing impairment.
From the side of the cardiovascular system: palpitations, chest pain, heart failure, myocardial infarction, hypertension, arterial hypotension, vasculitis.
From the respiratory system, chest and mediastinal organs: BA (including shortness of breath), pneumonitis.
From the digestive system: nausea, vomiting, diarrhea, dyspepsia, abdominal pain, flatulence, anorexia, gastritis, gastrointestinal bleeding (bloody vomiting, melena, diarrhea mixed with blood), stomach or intestinal ulcers with or without bleeding or with perforation (sometimes fatal, especially in elderly patients), colitis (including hemorrhagic colitis and exacerbation of ulcerative colitis or Crohn's disease), constipation, stomatitis (including ulcerative stomatitis), glossitis, esophageal dysfunction, diaphragmatic bowel stenosis, pancreatitis.
From the hepatobiliary system: increased levels of transaminases, hepatitis, jaundice, liver disorders, fulminant hepatitis, hepatonecrosis, liver failure.
Infection and infection: exacerbation of inflammation associated with infections (for example, the development of necrotizing fasciitis) has been reported with the systemic use of NSAIDs. This is possibly due to the mechanism of action of NSAIDs. If, when using the preparation Dikloberl, signs of infection occur or worsen, the patient is advised to immediately consult a doctor. It is necessary to investigate whether this condition warrants antimicrobial / antibiotic therapy. Very rarely, when using diclofenac, symptoms of aseptic meningitis with neck stiffness, headache, nausea, vomiting, fever or confusion developed. Patients with autoimmune diseases (systemic lupus erythematosus (SLE), mixed connective tissue disease) are considered prone.
Skin and subcutaneous tissue disorders: hair loss, manifestations of exanthema, eczema, erythema, erythema multiforme, Stevens-Johnson syndrome, Lyell's syndrome (toxic epidermal necrolysis), exfoliative dermatitis, photosensitivity reactions, purpura, including allergic, itching.
From the kidneys and urinary system: edema, especially in patients with hypertension or renal failure, acute renal failure, hematuria, proteinuria, interstitial nephritis, nephrotic syndrome, papillary necrosis of the kidney.
General disorders and disorders at the injection site: when using suppositories, there may be: changes at the injection site, including local irritation, mucus mixed with blood, or painful bowel movements.
On the part of the reproductive system and mammary glands: impotence.
Clinical research data and epidemiological data indicate an increased risk of thrombotic complications (for example, myocardial infarction or stroke) associated with the use of diclofenac, in particular in high therapeutic doses (150 mg / day) and with prolonged use.
Special instructions
General. to minimize side effects, treatment should be started at the lowest effective dose for the shortest period of time necessary to control symptoms.
The simultaneous use of the preparation Dicloberl with systemic NSAIDs, such as selective COX-2 inhibitors, should be avoided due to the lack of any evidence of a synergistic effect and due to potential additive side effects.
Care must be taken in relation to elderly patients. In particular, it is recommended to use the minimum effective dose in debilitated elderly patients with low body weight.
As with other NSAIDs, allergic reactions, including anaphylactic / anaphylactoid reactions, may occur, even without prior exposure to diclofenac.
Due to its pharmacodynamic properties, Dicloberl, like other NSAIDs, can mask the signs and symptoms of infection.
Effects on the digestive tract. With the use of all NSAIDs, including diclofenac, cases of gastrointestinal bleeding (vomiting of blood, melena), ulceration or perforation have been reported, which can be fatal and occur at any time during treatment with or without warning symptoms or a previous history of serious events with sides of the digestive tract. These phenomena usually have serious consequences in elderly patients. If patients receiving diclofenac experience gastrointestinal bleeding or ulceration, the preparation should be discontinued.
As with other NSAIDs, including diclofenac, medical supervision and extreme caution are imperative for patients with symptoms suggestive of gastrointestinal disorders. The risk of bleeding, ulceration or perforation in the gastrointestinal tract increases with increasing doses of NSAIDs, including diclofenac, and in patients with a history of ulcers, especially with complications such as bleeding or perforation, and in elderly patients.
Elderly patients have an increased frequency of adverse reactions to the use of NSAIDs, especially in relation to gastrointestinal bleeding and perforation, which can be fatal.
To reduce the risk of such toxic effects on the digestive tract, treatment is started and maintained with low effective doses.
For these patients, as well as those requiring concomitant use of medicines containing acetylsalicylic acid or other medicines in low doses, which are likely to increase the risk of unwanted effects on the digestive tract, the use of combination therapy with protective agents should be considered ( e.g. proton pump inhibitors or misoprostol). Patients with a history of gastrointestinal toxicity, especially the elderly, should report any unusual abdominal symptoms (especially bleeding in the digestive tract). Cautions are also needed for patients receiving concomitant medications that may increase the risk of ulcers or bleeding, such as systemic corticosteroids, anticoagulants (eg warfarin), antithrombotics (eg acetylsalicylic acid), or selective serotonin reuptake inhibitors.
Effects on the liver. Careful medical supervision is necessary when Dicloberl is prescribed to patients with impaired liver function, as their condition may worsen.
As with other NSAIDs, including diclofenac, the level of one or more liver enzymes may increase.
During long-term treatment with Dicloberl, regular monitoring of liver function and liver enzyme levels is prescribed as a precautionary measure. If liver dysfunctions persist or worsen and if clinical signs or symptoms may be associated with progressive liver disease or if other manifestations are observed (eg eosinophilia, rash), the use of Dicloberl should be discontinued. Diseases such as hepatitis may progress without prodromal symptoms.
Cautions are necessary if Dicloberl is used in patients with hepatic porphyria, due to the likelihood of provoking an attack.
Effects on the kidneys. Since cases of fluid retention and edema have been reported in the treatment of NSAIDs, including diclofenac, special attention should be paid to patients with impaired cardiac or renal function, a history of hypertension, elderly patients, patients receiving diuretic therapy or preparations that significantly affect renal function. as well as patients with a significant decrease in extracellular fluid volume for any reason, for example, before or after major surgery. In such cases, monitoring of renal function is recommended as a precautionary measure. Discontinuation of therapy usually results in a return to the condition that preceded treatment.
Effects on the skin. In connection with the use of NSAIDs, including the preparation Dicloberl, in very rare cases, serious skin reactions have been reported (some of them were fatal), including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis. In patients, the highest risk of developing these reactions is noted at the beginning of the course of therapy: reactions occur in most cases during the first month of treatment. The use of the preparation Dikloberl should be discontinued at the first appearance of skin rashes, mucosal lesions or any other signs of hypersensitivity.
Systemic lupus erythematosus and mixed connective tissue diseases. Patients with systemic lupus erythematosus and mixed connective tissue diseases may have an increased risk of developing aseptic meningitis.
Cardiovascular and cerebrovascular effects. For patients with a history of hypertension and / or congestive heart failure of mild to moderate severity, appropriate monitoring and adherence to recommendations is necessary, since in connection with the use of NSAIDs, including diclofenac, cases of fluid retention and edema have been reported.
Clinical studies and epidemiological data indicate that the use of diclofenac, especially in high doses (150 mg / day) and with long-term treatment, may be associated with a slight increase in the risk of arterial thrombotic events (for example, myocardial infarction or stroke).
Diclofenac is not recommended for patients with uncontrolled hypertension, congestive heart failure, persistent coronary artery disease, peripheral arterial disease and / or cerebrovascular disease; if necessary, use is possible only after a careful assessment of the risk / benefit ratio only in a dosage of no more than 100 mg / day. Such an assessment should be performed before starting long-term treatment of patients with risk factors for cardiovascular events (for example, hypertension, hyperlipidemia, diabetes mellitus and smokers).
Patients should be informed about the possibility of serious thrombotic events (chest pain, shortness of breath, weakness, speech impairment) at any time. In this case, you should immediately consult a doctor.
Influence on hematological parameters. With long-term use of this preparation, like other NSAIDs, monitoring of a complete blood count is recommended.
Dicloberl can temporarily suppress platelet aggregation. Patients with impaired hemostasis, hemorrhagic diathesis or hematological disorders should be carefully monitored.
History of asthma. Patients with AD, seasonal allergic rhinitis, nasal swelling (i.e. nasal polyps), COPD, or chronic respiratory tract infections (especially those associated with allergic rhinitis-like symptoms) are more likely to experience NSAID reactions such as exacerbation of AD ( so-called intolerance to analgesics / analgesic asthma), Quincke's edema, urticaria. In this regard, in relation to such patients, special measures are recommended (readiness to provide emergency medical care). This also applies to patients with allergic reactions to other substances, such as rash, itching, hives.
Like other preparations that suppress the activity of prostaglandin synthetase, diclofenac sodium and other NSAIDs can provoke the development of bronchospasm when used in patients with asthma or patients with a history of asthma.
Fertility in women. With regard to female fertility (see Use during pregnancy and lactation).
General. Acute hypersensitivity reactions (eg, anaphylactic shock) are rare. At the first signs of a hypersensitivity reaction after using the preparation Dicloberl, therapy should be stopped.
With prolonged use of painkillers, a headache may occur, which should not be stopped by increasing the dose of the preparation.
With the simultaneous use of alcohol, adverse reactions associated with the action of the active substance, especially those that affect the gastrointestinal tract or the central nervous system, may be exacerbated by the use of NSAIDs.
Use during pregnancy and lactation. Pregnancy. In the I and II trimester of pregnancy, the preparation Dicloberl can be prescribed only when the expected benefit to the mother outweighs the potential risk to the fetus, and only in the minimum effective dose, and the duration of treatment should be as short as possible. As in the case of the use of other NSAIDs, the preparation is contraindicated in the last 3 months of pregnancy (suppression of the contractility of the uterus and premature closure of the ductus arteriosus in the fetus are possible).
Inhibition of prostaglandin synthesis can adversely affect the course of pregnancy and / or the development of the embryo / fetus. Epidemiological data indicate an increased risk of miscarriages and / or the risk of developing heart defects and gastroschisis after using an inhibitor of prostaglandin synthesis in early pregnancy. The absolute risk of cardiovascular disease was increased from 1% to approximately 1.5%.
It is possible that the risk increases with the dose and duration of treatment. It has been shown that in animals the administration of an inhibitor of prostaglandin synthesis leads to an increase in pre- and post-implantation loss and mortality of the embryo / fetus.
In addition, in animals that received an inhibitor of prostaglandin synthesis during the period of organogenesis, an increased frequency of various malformations, including those of the cardiovascular system, was recorded. If Dicloberl is used by a woman who seeks to become pregnant, or in the first trimester of pregnancy, the dose should be as low as possible, and the duration of treatment should be as short as possible.
In the third trimester of pregnancy, all inhibitors of prostaglandin synthesis can affect the fetus as follows:
cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension);
impaired renal function, which can progress to renal failure with oligohydramnios.
Effects on mother and newborn, and late pregnancy:
possible prolongation of bleeding time, antiplatelet effect, which can develop even at very low doses;
inhibition of uterine contractions, which leads to a delay or lengthening of labor.
So, Dikloberl is contraindicated in the third trimester of pregnancy.
Lactation. Like other NSAIDs, diclofenac passes into breast milk in small amounts. In this regard, Dicloberl should not be used in women during breastfeeding in order to avoid unwanted effects on the baby.
Fertility in women. Like other NSAIDs, Dicloberl can negatively affect female fertility, so it is not recommended to prescribe the preparation to women who are planning a pregnancy. For women who have problems with conception or are undergoing infertility tests, the advisability of discontinuing the preparation Dicloberl should be considered.
Children. Dikloberl 100 suppositories are not used in children due to the high content of the active substance in them. Dikloberl 50 should not be prescribed to children under the age of 14 because of the high content of the active substance in it; the preparation can be used in children over the age of 14 years.
The ability to influence the reaction rate when driving or working with other mechanisms. Patients who experience visual impairment, vertigo, drowsiness, central nervous system disorders, lethargy or fatigue during therapy with Dicloberl should not drive vehicles or operate machinery.
Interactions
Below are the interactions noted with the use of diclofenac in the form of enteric tablets and / or in other dosage forms.
Lithium. Provided the simultaneous use of diclofenac can increase the concentration of lithium in the blood plasma. Monitoring of serum lithium levels is recommended.
Digoxin. If used simultaneously, diclofenac can increase the concentration of digoxin in the blood plasma. Monitoring of serum digoxin levels is recommended.
Diuretics and antihypertensive preparations. Like other NSAIDs, the simultaneous use of diclofenac with diuretics and antihypertensive agents (for example, β-adrenergic receptor blockers, ACE inhibitors) can lead to a decrease in their antihypertensive effect by inhibiting the synthesis of vasodilating prostaglandins. Thus, such a combination is used with a reservation, and patients, especially the elderly, should be closely monitored for blood pressure. Patients should receive adequate hydration, it is also recommended to monitor renal function after the initiation of concomitant therapy and on a regular basis thereafter, mainly in relation to diuretics and ACE inhibitors, due to an increased risk of nephrotoxicity.
Preparations known to cause hyperkalemia. Concomitant treatment with potassium-sparing diuretics, cyclosporine, tacrolimus or trimethoprim may be associated with an increase in serum potassium levels, so patients should be monitored more frequently.
Anticoagulants and antithrombotic agents. Concomitant use can increase the risk of bleeding, so it is recommended to take precautions. Although clinical studies do not indicate the effect of diclofenac on the activity of anticoagulants, there are some data on an increased risk of bleeding in patients using simultaneously diclofenac and anticoagulants. Therefore, to ensure that no changes in the dosage of anticoagulants are required, careful monitoring of such patients is recommended. Like other NSAIDs, high doses of diclofenac can temporarily suppress platelet aggregation.
Other NSAIDs, including selective COX-2 inhibitors, and corticosteroids. Concomitant use of diclofenac and other NSAIDs or corticosteroids may increase the risk of gastrointestinal bleeding or ulcers. The simultaneous use of two or more NSAIDs should be avoided.
Selective serotonin reuptake inhibitors. The simultaneous use of NSAIDs and selective reuptake inhibitors may increase the risk of gastrointestinal bleeding.
Antidiabetic preparations. Clinical studies have shown that diclofenac can be used in combination with oral hypoglycemic agents, which does not affect their therapeutic effect. However, there are some reports of the development in such cases of both hypoglycemia and hyperglycemia, which necessitated a change in the dose of antidiabetic agents during the use of diclofenac. For this reason, it is recommended to monitor blood glucose levels during combination therapy as a precautionary measure.
Methotrexate. Diclofenac can suppress the renal tubular clearance of methotrexate, resulting in increased methotrexate levels. Care should be taken when prescribing NSAIDs, including diclofenac, less than 24 hours before using methotrexate, since in such cases the concentration of methotrexate in the blood may increase and its toxic effect may increase. Cases of serious toxicity have been reported when the interval between the use of methotrexate and NSAIDs, including diclofenac, was within 24 hours. This interaction is mediated through the accumulation of methotrexate as a result of impaired renal excretion in the presence of NSAIDs.
Cyclosporine. The effect of diclofenac, like other NSAIDs, on the synthesis of prostaglandins in the kidneys may increase the nephrotoxicity of cyclosporin, therefore, diclofenac should be used in lower doses than in patients not using cyclosporin.
Tacrolimus. When using NSAIDs with tacrolimus, an increased risk of nephrotoxicity is possible, which may be mediated through the renal antiprostaglandin effects of NSAIDs and a calcineurin inhibitor.
Antibacterial quinolones. It is possible that seizures develop in patients taking quinolone derivatives and NSAIDs at the same time. This can occur in patients with or without a history of epilepsy and seizures. Thus, caution should be exercised when deciding whether to prescribe quinolones to patients who are already receiving NSAIDs.
Phenytoin. When using phenytoin simultaneously with diclofenac, it is recommended to monitor the concentration of phenytoin in the blood plasma in connection with the expected increase in the effect of phenytoin.
Probenecid. Medicines containing probenecid can inhibit the excretion of sodium diclofenac.
Colestipol and cholestyramine. These preparations may delay or decrease the absorption of diclofenac. Therefore, it is recommended to prescribe diclofenac at least 1 hour before or 4–6 hours after the use of colestipol / cholestyramine.
Cardiac glycosides. The simultaneous use of cardiac glycosides and NSAIDs can increase heart failure, reduce the glomerular filtration rate and increase the level of glycosides in the blood plasma.
Mifepristone. NSAIDs should not be used within 8–12 days after taking mifepristone, as NSAIDs can reduce the effect of mifepristone.
Potent inhibitors of CYP 2C9. It is recommended to be careful when prescribing diclofenac in combination with potent inhibitors of CYP 2C9 (for example, with voriconazole), which can lead to a significant increase in plasma Cmax and exposure to diclofenac due to inhibition of the metabolism of diclofenac.
Overdose
Symptoms there is no typical clinical picture characteristic of diclofenac overdose. overdose can cause symptoms such as headache, nausea, vomiting, epigastric pain, gastrointestinal bleeding, diarrhea, dizziness, disorientation, agitation, coma, drowsiness, tinnitus, or seizures. opn and liver damage are possible in case of severe intoxication.
Treatment. If necessary, treatment is symptomatic. Within 1 hour after using a potentially toxic amount of the preparation, the possibility of taking activated charcoal should be considered. In addition, in adults, gastric lavage should be considered within 1 hour after using a potentially toxic amount of the preparation. With frequent or prolonged convulsions, it is necessary to administer IV diazepam. Taking into account the clinical condition of the patient, other measures may be indicated.
Storage conditions
At a temperature not higher than 25 ° C.
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