Instructions Prodex solution for injection 50 mg/2 ml ampoule 2 ml No. 5
Composition
active ingredient: dexketoprofen;
1 ml of solution contains 36.9 mg of dexketoprofen trometamol, equivalent to 25 mg of dexketoprofen (1 ampoule of 2 ml contains 73.8 mg of dexketoprofen trometamol, equivalent to 50 mg of dexketoprofen);
Excipients: ethanol 96%, sodium chloride, sodium hydroxide, water for injections.
Dosage form
Solution for injection.
Main physicochemical properties: clear colorless liquid.
Pharmacotherapeutic group
Nonsteroidal anti-inflammatory and antirheumatic drugs. Propionic acid derivatives. Dexketoprofen. ATX code M01A E17.
Pharmacological properties
Pharmacodynamics
Dexketoprofen trometamol is the tromethamine salt of S-(+)-2-(3-benzoylphenyl) propionic acid, which has analgesic, anti-inflammatory and antipyretic effects and belongs to the class of non-steroidal anti-inflammatory drugs (NSAIDs).
Mechanism of action
The mechanism of action of NSAIDs is based on a decrease in prostaglandin synthesis by inhibiting cyclooxygenase activity. In particular, the conversion of arachidonic acid to cyclic endoperoxides PGG2 and PGH2 is inhibited, from which prostaglandins PGE1, PGE2, PGF2a, PGD2 are formed, as well as prostacyclin PGI2 and thromboxanes ThA2 and ThB2. In addition, inhibition of prostaglandin synthesis may affect other inflammatory mediators, such as kinins, which may also indirectly affect the main effect of the drug.
Pharmacodynamics.
The inhibitory effect of dexketoprofen trometamol on the activity of cyclooxygenase-1 and cyclooxygenase-2 has been demonstrated experimentally in laboratory animals and humans.
Clinical efficacy and safety
Clinical studies in various types of pain have demonstrated that dexketoprofen trometamol has a pronounced analgesic effect. The analgesic effect of dexketoprofen trometamol when administered intramuscularly and intravenously to patients with moderate to severe pain has been studied in various types of pain during surgical interventions (orthopedic and gynecological operations, abdominal operations), as well as in musculoskeletal pain (acute low back pain) and renal colic. During the studies, the analgesic effect of the drug began quickly and reached a maximum within the first 45 minutes. The duration of the analgesic effect after the use of 50 mg of dexketoprofen trometamol is usually 8 hours. Clinical studies have demonstrated that the use of Prodex allows for a significant reduction in the dose of opiates when used simultaneously for the purpose of relieving postoperative pain. In studies of postoperative pain, where patients were administered morphine using a patient-controlled analgesia device, those given dexketoprofen trometamol required significantly less morphine (35–45%) than those given placebo.
Pharmacokinetics
Absorption
After intramuscular administration of dexketoprofen trometamol to humans, the maximum concentration is reached after approximately 20 minutes (10–45 minutes). It has been proven that with a single intramuscular or intravenous administration of 25–50 mg of the drug, the area under the AUC curve (“concentration – time”) is proportional to the dose. Pharmacokinetic studies of multiple use of the drug have shown that AUC and Cmax (mean maximum value) after the last intramuscular and intravenous administration do not differ from those after a single administration, which indicates the absence of drug accumulation.
Distribution
Similar to other drugs with a high degree of binding to plasma proteins (99%), the volume of distribution of dexketoprofen is on average 0.25 l/kg. The half-life is approximately 0.35 hours, and the half-life is 1–2.7 hours.
Biotransformation and excretion
Dexketoprofen is mainly metabolized by conjugation with glucuronic acid and subsequent renal excretion. After administration of dexketoprofen trometamol, only the S-(+) optical isomer is detected in the urine, indicating that there is no transformation of the drug into the R-(-) optical isomer in humans.
Elderly patients
Pharmacological safety, genotoxicity and immunopharmacology studies did not reveal any particular hazard for humans. Chronic toxicity studies in animals allowed to identify the maximum dose of the drug that does not cause adverse reactions, which is 2 times higher than the dose recommended for humans. When administering higher doses of the drug to monkeys, the main adverse reaction was blood in the stool, decreased body weight gain, and at the highest dose - pathologies of the gastrointestinal tract in the form of erosions. These reactions occurred at doses at which the exposure to the drug was 14–18 times higher than at the maximum dose recommended for humans. Carcinogenicity studies in animals were not conducted.
Like all NSAIDs, dexketoprofen can cause embryo or fetal death in animals by directly affecting its development, or indirectly by damaging the gastrointestinal tract of the mother.
Indication
Symptomatic treatment of acute pain of moderate to severe intensity in cases where oral administration of the drug is inappropriate, for example, in postoperative pain, renal colic and low back pain.
Contraindication
Hypersensitivity to dexketoprofen, any other NSAID or to the excipients of the drug; use in patients in whom substances with a similar mechanism of action, such as acetylsalicylic acid and other NSAIDs, provoke attacks of bronchial asthma, bronchospasm, acute rhinitis or lead to the development of nasal polyps, urticaria or angioedema; if photoallergic or phototoxic reactions occurred during treatment with ketoprofen or fibrates; with a history of gastrointestinal bleeding or perforation associated with previous NSAID therapy; peptic ulcer in the active phase/gastrointestinal bleeding or a history of gastrointestinal bleeding, ulcers or perforations; with chronic dyspepsia; with gastrointestinal bleeding, other bleeding in the active phase or with increased bleeding; Crohn's disease or non-specific ulcerative colitis; severe heart failure; moderate or severe renal impairment (creatinine clearance ≤ 59 ml/min); severe liver impairment (10–15 points on the Child-Pugh scale); hemorrhagic diathesis and other blood clotting disorders; severe dehydration (due to vomiting, diarrhea or insufficient fluid intake); in the third trimester of pregnancy and during breastfeeding. Due to the ethanol content in the drug, Prodex is contraindicated for neuraxial (intrathecal or epidural) administration.
Interaction with other medicinal products and other types of interactions
The simultaneous use of the following drugs with NSAIDs is not recommended:
other NSAIDs (including selective cyclooxygenase-2 inhibitors), including salicylates in high doses (≥ 3 g/day). With the simultaneous use of several NSAIDs, the risk of gastrointestinal ulcers and gastrointestinal bleeding increases due to their mutually reinforcing effect; anticoagulants: NSAIDs enhance the effect of anticoagulants, such as warfarin, due to the high degree of binding of dexketoprofen to blood plasma proteins, as well as inhibition of platelet function and damage to the gastric and duodenal mucosa. If simultaneous use is necessary, it should be carried out under the close supervision of a physician and appropriate laboratory parameters; heparins: the risk of bleeding increases (due to inhibition of platelet function and damage to the gastric and duodenal mucosa). If simultaneous use is necessary, it should be carried out under the close supervision of a physician and appropriate laboratory parameters; corticosteroids: the risk of developing ulcers in the digestive tract and gastrointestinal bleeding increases; lithium preparations (there have been reports for several NSAIDs): NSAIDs increase the level of lithium in the blood, which can lead to intoxication (reduced renal excretion of lithium). Therefore, at the beginning of the use of dexketoprofen, when adjusting the dose or canceling the drug, it is necessary to monitor the level of lithium in the blood; methotrexate in high doses (not less than 15 mg per week). Due to the decrease in renal clearance of methotrexate against the background of the use of NSAIDs, its negative effect on the blood system is generally increased; hydantoin derivatives and sulfonamides: increased toxicity of these substances is possible.
diuretics, angiotensin-converting enzyme (ACE) inhibitors, aminoglycoside antibiotics and angiotensin II receptor antagonists. Dexketoprofen reduces the effectiveness of diuretics and other antihypertensive agents. In some patients with impaired renal function (e.g., in cases of dehydration or in the elderly), the use of cyclooxygenase inhibitors with ACE inhibitors, angiotensin II receptor antagonists or aminoglycoside antibiotics may worsen renal function, which is usually reversible. When using dexketoprofen simultaneously with any diuretic, it is necessary to ensure that the patient is not dehydrated, and at the beginning of treatment it is necessary to monitor renal function; methotrexate when used in low doses (less than 15 mg per week): due to a decrease in the renal clearance of methotrexate against the background of the use of NSAIDs, its toxic effect on the blood system as a whole is increased. In the first weeks of simultaneous use, it is necessary to perform a blood test every week. Even with a slight impairment of renal function, as well as in elderly patients, treatment should be carried out under strict medical supervision; pentoxifylline: increases the risk of bleeding. It is necessary to strengthen control and check the bleeding time more often; zidovudine: there is a risk of increasing the toxic effect on erythrocytes due to the effect on reticulocytes, which after the 1st week of use of NSAIDs leads to severe anemia. Within 1-2 weeks after the start of use of NSAIDs, a blood test should be done and the reticulocyte content should be checked; sulfonylureas: NSAIDs can enhance the hypoglycemic effect of these agents by replacing sulfonylurea drugs in compounds with blood plasma proteins.
Possible interactions should be considered when using the following agents:
beta-blockers: NSAIDs can weaken their antihypertensive effect by inhibiting prostaglandin synthesis; cyclosporine and tacrolimus: possible increase in nephrotoxicity due to the effect of NSAIDs on renal prostaglandins. In combination therapy, renal function should be monitored; thrombolytic agents: increased risk of bleeding; antiplatelet agents and selective serotonin reuptake inhibitors: increased risk of gastrointestinal bleeding; probenecid: possible increase in dexketoprofen plasma concentration, which is likely due to inhibition of renal tubular secretion and conjugation of the drug with glucuronic acid and requires dose adjustment of dexketoprofen; cardiac glycosides: NSAIDs can increase the concentration of glycosides in blood plasma; mifepristone: theoretically there is a risk of changing the effectiveness of mifepristone under the influence of prostaglandin synthetase inhibitors. Limited data suggest that co-administration of NSAIDs on the same day as prostaglandin does not adversely affect the efficacy of mifepristone or prostaglandin in cervical ripening or contractility, nor does it reduce the clinical efficacy of drugs for medical termination of pregnancy; quinolone antibiotics: animal studies have shown that the risk of convulsions is increased when high doses of quinolone antibiotics are used in combination with NSAIDs; tenofovir: when used concomitantly with NSAIDs, blood urea nitrogen and creatinine concentrations may increase - therefore, renal function should be monitored to assess the possible effect of the concomitant use of these drugs; deferasirox: when used concomitantly with NSAIDs, the risk of gastrointestinal toxicity may increase. When using this drug concomitantly with deferasirox, careful patient monitoring is necessary; Pemetrexed: Pemetrexed elimination may be reduced when co-administered with NSAIDs; therefore, caution should be exercised when high doses of NSAIDs are used. In patients with mild to moderate renal impairment (creatinine clearance 45 to 79 ml/min), concomitant use of pemetrexed and NSAIDs should be avoided for two days before and two days after pemetrexed administration.
Application features
Use with caution in patients with a history of allergic conditions. Avoid using Prodex in combination with other NSAIDs, including selective cyclooxygenase-2 inhibitors. Adverse reactions can be minimized by using the lowest effective dose for the shortest time necessary to improve the condition.
Gastrointestinal safety.
Elderly: Elderly patients are more likely to experience adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, sometimes fatal. Treatment should be started at the lowest possible dose in these patients.
Before starting the use of dexketoprofen trometamol, patients with a history of esophagitis, gastritis and/or peptic ulcer disease should be sure that these diseases are in remission. In patients with existing symptoms of gastrointestinal pathology and with a history of gastrointestinal diseases, the condition of the gastrointestinal tract should be monitored for possible disorders during the use of the drug, especially gastrointestinal bleeding. NSAIDs should be prescribed with caution to patients with a history of gastrointestinal diseases (ulcerative colitis, Crohn's disease), as there is a risk of their exacerbation. The use of NSAIDs can lead to relapses of nonspecific ulcerative colitis, as well as Crohn's disease in patients who are in remission. For such patients and patients taking low-dose acetylsalicylic acid or other agents that increase the risk of gastrointestinal adverse reactions, combination therapy with protective agents, such as misoprostol or proton pump inhibitors, should be considered.
Patients, especially the elderly, who have a history of adverse reactions from the digestive tract, should notify their doctor of all unusual symptoms related to the digestive system, in particular gastrointestinal bleeding, especially in the initial stages of treatment.
Caution should be exercised when prescribing the drug to patients who are concomitantly taking agents that may increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants (e.g. warfarin), selective serotonin reuptake inhibitors or antiplatelet agents such as acetylsalicylic acid.
Kidney safety.
Caution should be exercised in prescribing the drug to patients with impaired renal function, since they may experience deterioration of renal function, fluid retention and edema while taking NSAIDs. Due to the increased risk of nephrotoxicity, the drug should be used with caution in patients receiving diuretics and in patients who may develop hypovolemia. Adequate fluid intake should be ensured during treatment to avoid dehydration, which may lead to increased renal toxicity.
Like all NSAIDs, the drug is capable of increasing the level of urea nitrogen and creatinine in the blood plasma. Like other prostaglandin synthesis inhibitors, its use may be accompanied by adverse reactions from the kidneys, leading to glomerulonephritis, interstitial nephritis, papillary necrosis, nephrotic syndrome and acute renal failure. Renal dysfunction occurs more often in elderly patients.
Liver safety.
The drug should be prescribed with caution to patients with impaired liver function. As with other NSAIDs, the drug may cause a temporary and slight increase in the values of some liver parameters, as well as a pronounced increase in the level of AST and ALT. If these parameters increase, therapy should be discontinued.
Most liver dysfunction occurs in elderly patients.
Safety regarding the cardiovascular system and cerebral circulation.
Non-selective NSAIDs can reduce platelet aggregation and prolong bleeding time by inhibiting prostaglandin synthesis. The simultaneous use of dexketoprofen trometamol and low molecular weight heparin in prophylactic doses in the postoperative period was studied in clinical studies and no effect on coagulation parameters was found. However, patients who use dexketoprofen trometamol simultaneously with drugs that affect hemostasis, such as warfarin, other coumarin drugs or heparins, should be under close medical supervision. Cardiovascular disorders are most common in elderly patients.
Skin reactions.
There have been very rare reports of serious skin reactions (some fatal) with NSAIDs, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis. Patients appear to be at greatest risk at the start of treatment, with most patients experiencing these reactions within the first month of treatment. Prodex should be discontinued if skin rash, signs of mucosal involvement or other signs of hypersensitivity occur.
Other information.
Particular caution should be exercised when prescribing the drug to patients:
- with hereditary disorders of porphyrin metabolism (for example, with acute intermittent porphyria);
- with dehydration;
- immediately after radical surgery. If the doctor considers it necessary to prescribe long-term therapy with dexketoprofen, it is necessary to regularly monitor liver and kidney function, blood tests. In very rare cases, severe acute hypersensitivity reactions (e.g. anaphylactic shock) have been observed. Treatment should be discontinued at the first signs of severe hypersensitivity reactions after taking Prodex. Depending on the symptoms, any treatment necessary in such cases should be carried out under the supervision of a doctor.
Patients with bronchial asthma in combination with chronic rhinitis, chronic sinusitis and/or nasal polyps are more prone to allergic reactions to the use of acetylsalicylic acid and/or NSAIDs than other patients. The use of this drug may cause an asthma attack or bronchospasm, especially in patients with allergies to acetylsalicylic acid or NSAIDs.
Severe infectious complications of the skin and soft tissues may develop in the setting of chickenpox. Currently, there is no data to completely exclude the role of NSAIDs in the exacerbation of this infectious process. Therefore, Prodex is not recommended for use in chickenpox.
Prodex should be administered with caution to patients with hematopoietic disorders, systemic lupus erythematosus, and mixed connective tissue diseases.
As with other NSAIDs, dexketoprofen trometamol may mask the symptoms of infectious diseases during its use. In isolated cases, exacerbation of soft tissue infections has been reported during the use of NSAIDs. Therefore, if symptoms of a bacterial infection appear or worsen during use, patients are advised to consult a doctor immediately.
Each ampoule of Prodex contains 12.35% by volume of ethanol, i.e. 200 mg per dose, which is equivalent to 5 ml of beer or 2.08 ml of wine per dose. The drug may have a negative effect on people suffering from alcoholism. The ethanol content should be taken into account when used by pregnant and breastfeeding women, children and patients at risk, for example, with liver disease, as well as patients with epilepsy.
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially 'sodium-free'.
Ability to influence reaction speed when driving vehicles or other mechanisms
While using Prodex, dizziness, visual disturbances, or drowsiness may occur. In such cases, the ability to react quickly, navigate the road situation, and drive vehicles or other mechanisms may be impaired.
Use during pregnancy or breastfeeding
The use of Prodex is contraindicated in the third trimester of pregnancy and during breastfeeding.
Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or fetal development. Epidemiological studies have shown that the use of drugs that inhibit prostaglandin synthesis in early pregnancy increases the risk of miscarriage, fetal heart defects and anterior abdominal wall nonunion. Thus, the absolute risk of developing cardiovascular anomalies increased from < 1% to approximately 1.5%. It is believed that the risk of such events increases with increasing dose and duration of therapy. The use of prostaglandin synthesis inhibitors in animals caused an increase in pre- and post-implantation losses and increased embryo-fetal lethality. In addition, in animals treated with prostaglandin synthesis inhibitors during organogenesis, the incidence of fetal malformations, including cardiovascular anomalies, increased. However, studies of dexketoprofen trometamol in animals did not reveal toxicity in relation to the reproductive organs. Dexketoprofen trometamol should be prescribed during the first and second trimesters of pregnancy only if clearly needed. When dexketoprofen trometamol is prescribed to women planning to become pregnant or during the first and second trimesters of pregnancy, the lowest effective dose should be used for the shortest possible duration of treatment.
During the third trimester, all prostaglandin synthesis inhibitors cause the following:
Risks to the fetus:
cardiopulmonary toxic syndrome (premature closure of the ductus arteriosus and pulmonary hypertension); impaired renal function, which may progress to renal failure with the development of oligohydramnios.
Risks for mother and baby at the end of pregnancy:
increased bleeding time due to inhibition of platelet aggregation, which is possible even when using the drug in low doses; inhibition of uterine contractile activity, which leads to prolongation and delay of labor.
Breast-feeding.
There is no data on the penetration of dexketoprofen into breast milk. The drug Prodex is contraindicated during breastfeeding.
Fertility.
As with all NSAIDs, dexketoprofen trometamol may impair female fertility and is therefore not recommended in women attempting to conceive. Women who have difficulty conceiving or are undergoing investigation of infertility should consider discontinuing the drug.
Method of administration and doses
Adults. The recommended dose is 50 mg every 8–12 hours. If necessary, a second dose should be administered after 6 hours. The total daily dose should not exceed 150 mg. Prodex is intended for short-term use, therefore it should be used only during the period of acute pain (no longer than 2 days). Patients should be transferred to oral analgesics, if possible. Adverse reactions can be minimized by using the minimum effective dose for the shortest possible time necessary to improve the condition. For moderate to severe postoperative pain, the drug can be used according to indications in the same recommended doses in combination with opioid analgesics.
Elderly patients: Dose adjustment is usually not required. However, due to physiological decline in renal function, a lower dose is recommended, with a maximum daily dose of 50 mg in mild renal impairment.
Hepatic impairment. Patients with mild to moderate liver disease (Child-Pugh score 5-9) should reduce the total maximum daily dose to 50 mg and monitor liver function closely. The drug is contraindicated in severe liver disease (Child-Pugh score 10-15).
Renal impairment. In patients with mild renal impairment (creatinine clearance 60–89 ml/min), the total daily dose should be reduced to 50 mg. In patients with moderate or severe renal impairment (creatinine clearance < 59 ml/min), Prodex is contraindicated.
Children and adolescents: The drug should not be used in children and adolescents due to lack of data on its efficacy and safety.
Method of application.
Intramuscular administration. The solution for injection should be injected slowly deep into the muscle.
Intravenous infusion. For intravenous infusion, the contents of a 2 ml ampoule should be diluted in 30–100 ml of 0.9% sodium chloride solution, 5% glucose solution or lactated Ringer's solution. The infusion solution should be prepared under aseptic conditions, avoiding exposure to natural daylight. The prepared solution should be clear. The infusion should be carried out within 10–30 minutes. Avoid exposure to natural daylight on the prepared solution.
Prodex, diluted in 100 ml of 0.9% sodium chloride solution or 5% glucose solution, can be mixed with dopamine, heparin, hydroxyzine, lidocaine, morphine, pethidine and theophylline.
Prodex should not be mixed in an infusion solution with promethazine and pentazocine.
Intravenous injection (bolus administration).
If necessary, the contents of one ampoule (2 ml of solution for injection) should be administered intravenously over at least 15 seconds.
Prodex should not be mixed in small volumes (e.g. in a syringe) with solutions of dopamine, promethazine, pentazocine, pethidine and hydroxyzine because a white precipitate forms.
The drug can only be mixed with the medicines listed above.
For intramuscular or intravenous injection, the drug should be administered immediately after withdrawal from the ampoule. The solution for intravenous infusion should be used immediately after preparation.
When storing diluted drug solutions in polyethylene bags or in products made of ethyl vinyl acetate, cellulose propionate, low-density polyethylene, and polyvinyl chloride designed for administration, no changes in the content of the active substance due to sorption were observed.
Prodex is intended for single use, therefore any remaining solution should be discarded. Before administering the drug, ensure that the solution is clear and colorless. Do not use a solution containing visible particles.
Children
The drug should not be used in children and adolescents due to a lack of data on its efficacy and safety.
Overdose
Symptoms of overdose are unknown. Similar drugs cause disorders of the digestive tract (vomiting, anorexia, abdominal pain) and the nervous system (drowsiness, dizziness, disorientation, headache). In case of accidental overdose, symptomatic treatment should be immediately initiated according to the patient's condition. Dexketoprofen trometamol is removed from the body by dialysis.
Adverse reactions
Adverse reactions are divided into: frequent - ≥ 1/100 - 1/10; sometimes - ≥ 1/1000 - < 1/100; rarely ≥ 1/10000 - < 1/100; very rare - < 1/10000.
From the blood/lymphatic system: sometimes - anemia; very rarely - neutropenia, thrombocytopenia.
On the part of the immune system: rarely - laryngeal edema; very rarely - anaphylactic reactions, including anaphylactic shock.
Nutritional and metabolic disorders: rarely - hyperglycemia, hypoglycemia, hypertriglyceridemia, anorexia, lack of appetite.
Mental disorders: sometimes - insomnia, anxiety.
From the nervous system: sometimes - headache, dizziness, drowsiness; rarely - paresthesia, fainting.
On the part of the organs of vision: sometimes - blurred vision.
On the part of the auditory organs: sometimes - vertigo; rarely - tinnitus.
On the part of the heart: sometimes - palpitations; rarely - extrasystole, tachycardia.
From the vascular system: sometimes - arterial hypotension, hot flashes; rarely - arterial hypertension, thrombophlebitis of superficial veins.
From the respiratory tract, thoracic and mediastinal organs: rarely - bradypnea; very rarely - bronchospasm, shortness of breath.
On the part of the digestive tract: often - nausea, vomiting; sometimes - abdominal pain, dyspepsia, diarrhea, constipation, vomiting with blood, dry mouth; rarely - peptic ulcer, bleeding or perforation; very rarely - pancreatitis.
From the hepatobiliary system: rarely - hepatocellular pathology.
From the skin and subcutaneous tissue: sometimes - dermatitis, itching, rash, increased sweating; rarely - urticaria, acne; very rarely - Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), angioedema, facial edema, photosensitivity.
Musculoskeletal and connective tissue disorders: rarely - muscle rigidity, joint stiffness, muscle cramps, back pain.
From the kidneys and urinary tract: rarely - acute renal failure, polyuria, renal pain, ketonuria, proteinuria; very rarely - nephritis, nephrotic syndrome.
From the reproductive system: rarely - menstrual disorders, prostate dysfunction.
General and local disorders: often - pain at the injection site, injection site reactions, including inflammation, hematoma, bleeding; sometimes - fever, fatigue, pain, chills, asthenia, malaise; rarely - tremor, peripheral edema.
Laboratory indicators: rarely - abnormalities in liver tests.
Gastrointestinal disorders were observed most frequently.
Peptic ulcer, perforation or gastrointestinal bleeding may develop, sometimes with fatal outcome, especially in elderly patients. According to available data, nausea, vomiting, diarrhea, flatulence, constipation, dyspeptic phenomena, abdominal pain, melena, hematomesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease may occur with the use of the drug. Gastritis is less common. Edema, arterial hypertension and heart failure, which may be caused by the use of NSAIDs, have also been noted. As with other NSAIDs, the following adverse reactions are possible: aseptic meningitis, which mainly occurs in patients with systemic lupus erythematosus or mixed connective tissue diseases, and blood reactions (purpura, aplastic and hemolytic anemia, agranulocytosis and bone marrow hypoplasia). Bullous reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis (very rare), are possible.
According to clinical trial results and epidemiological data, the use of some NSAIDs, especially in high doses and for long periods, may be associated with a slightly increased risk of developing pathologies caused by arterial thrombosis, such as myocardial infarction and stroke.
Reporting suspected adverse reactions after a medicinal product has been authorised plays an important role. This allows for continued monitoring of the benefit/risk balance of the medicinal product.
Healthcare professionals should report any suspected adverse reactions through the national reporting system.
Expiration date
2 years.
Do not use the drug after the expiration date indicated on the package.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Store the diluted solution for no more than 30 minutes. Do not allow exposure to natural daylight on the prepared solution.
Packaging
2 ml of solution in an ampoule. 5 ampoules in a cassette, 1 cassette in a pack.
Vacation category
According to the recipe.
Producer
Public Joint-Stock Company "Scientific and Production Center "B"
