Instructions for Ketolong-Darnitsa tablets 10 mg No. 10
Composition
active ingredient: ketorolac tromethamine;
1 tablet contains ketorolac tromethamine 10 mg;
Excipients: lactose monohydrate, microcrystalline cellulose, crospovidone, magnesium stearate.
Dosage form
Pills.
Main physicochemical properties: round tablets of white color with a faint yellowish tint, flat-cylindrical shape, with a bevel.
Pharmacotherapeutic group
Nonsteroidal anti-inflammatory and antirheumatic drugs. Ketorolac. ATC code M01A B15.
Pharmacological properties
Pharmacodynamics
Ketorolac tromethamine is a non-narcotic analgesic. It is a nonsteroidal anti-inflammatory drug (NSAID) that exhibits anti-inflammatory and mild antipyretic activity. Ketorolac tromethamine inhibits prostaglandin synthesis and is considered a peripherally acting analgesic. It has no known effect on opiate receptors. No evidence of respiratory depression has been observed in controlled clinical trials with ketorolac tromethamine. Ketorolac tromethamine does not cause mydriasis.
Pharmacokinetics
Ketorolac tromethamine is rapidly and completely absorbed after oral administration with a peak plasma concentration of 0.87 mg/kg 45 minutes after a single 10 mg dose. Ketorolac penetrates the brain tissue with great difficulty. A small amount of it can be detected in breast milk. In a healthy person, less than 50% of the administered dose is metabolized. The important metabolites are the glucuronide conjugate and 4-hydroxy-ketorolac, the metabolites of which are no longer pharmacologically active. In humans, the pharmacokinetics of ketorolac after single or multiple doses are linear. Steady-state plasma levels are reached after 1 day when administered 4 times a day. No changes were observed with long-term dosing. In healthy volunteers, the terminal plasma half-life is 4-6 hours (mean 5.4 hours). The plasma half-life is increased in patients with renal insufficiency and in elderly patients. In elderly patients (mean age 72 years) it is 6.2 hours. After a single intravenous dose, the volume of distribution is 0.25 l/kg, the half-life is 5 hours, and the clearance is 0.55 ml/min/kg. The main route of excretion of ketorolac and its metabolites (conjugates and p-hydroxymetabolites) is urine (90%), the remainder is excreted in feces. A high-fat, poorly digestible meal reduces the rate of absorption, but not the extent, while antacids do not affect the absorption of ketorolac.
Indication
Short-term treatment of moderate pain, including postoperative pain.
Contraindication
Hypersensitivity to ketorolac or to other NSAIDs or to any component of the drug;
patients with active and/or recurrent peptic ulcer, with a recent history of gastrointestinal bleeding or perforation associated with NSAID use, with ulcer disease or gastrointestinal bleeding (two or more episodes) in the acute stage or in history;
Hypersensitivity reactions such as bronchial asthma, rhinitis, angioedema or urticaria caused by the use of acetylsalicylic acid or other NSAIDs (due to the possibility of severe anaphylactic reactions);
history of bronchial asthma;
do not use as an analgesic before and during surgery and after manipulations on coronary vessels due to inhibition of platelet aggregation, which may cause bleeding;
severe heart failure;
complete or partial syndrome of nasal polyps, angioedema or bronchospasm;
do not use in patients who have had surgery with a high risk of hemorrhage or incomplete bleeding and in patients receiving anticoagulants, including low-dose heparin (2500–5000 units every 12 hours);
hepatic or moderate/severe renal failure (serum creatinine clearance above 160 μmol/l);
suspected or confirmed cerebrovascular bleeding, hemorrhagic diathesis, including blood clotting disorders and high risk of bleeding;
simultaneous treatment with other NSAIDs (including selective cyclooxygenase inhibitors), acetylsalicylic acid, warfarin, pentoxifylline, probenecid or lithium salts;
violation of hematopoiesis of unknown etiology;
hypovolemia, dehydration;
risk of kidney failure due to fluid depletion;
the drug is contraindicated during pregnancy, labor and delivery, and during breastfeeding;
children and adolescents under 16 years of age.
Interaction with other medicinal products and other types of interactions
Ketorolac binds readily to plasma proteins (mean 99.2%), and the extent of binding is concentration dependent.
Cannot be used simultaneously with ketorolac.
Thromboxane: Ketorolac inhibits platelet aggregation, reduces thromboxane concentrations, and prolongs bleeding time. In contrast to the long-term effects of acetylsalicylic acid, platelet function is restored within 24–48 hours after discontinuation of ketorolac.
Anticoagulants: Although studies have not shown a significant interaction between ketorolac and warfarin or heparin, concomitant use of ketorolac and therapies that affect hemostasis, including therapeutic doses of anticoagulants (warfarin), prophylactic low-dose heparin (2500–5000 units 12 hourly), and dextrans, may increase the risk of bleeding. Concomitant use with anticoagulants (such as warfarin) is contraindicated.
Lithium salts. Possible inhibition of renal clearance of lithium by some drugs that inhibit prostaglandin synthesis leads to increased plasma lithium concentrations. Cases of increased plasma lithium concentrations have been reported during ketorolac therapy.
Probenecid: Probenecid should not be administered concomitantly with ketorolac due to a decrease in the plasma clearance and volume of distribution of ketorolac, an increase in the plasma concentration of ketorolac, and an increase in its half-life.
Mifepristone: NSAIDs should not be administered for 8–12 days after mifepristone administration, as NSAIDs may reduce the effect of mifepristone.
Pentoxifylline (oxpentifylline). Not recommended due to increased risk of bleeding.
Drugs in combination with ketorolac should be prescribed with caution.
Glucocorticosteroids: As with all NSAIDs, caution should be exercised when co-prescribing corticosteroid drugs due to an increased risk of gastrointestinal ulceration or bleeding.
Antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs): There is an increased risk of gastrointestinal bleeding when NSAIDs are administered in combination with antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs).
Methotrexate: Caution is advised when methotrexate is co-administered, as some prostaglandin synthesis inhibitors have been reported to reduce the clearance of methotrexate and therefore possibly increase its toxicity.
Diuretics. In healthy, normovolemic individuals, ketorolac reduces the diuretic effect of furosemide by approximately 20%, therefore, the drug should be prescribed with extreme caution to patients with cardiac decompensation.
Cardiac glycosides: NSAIDs may exacerbate heart failure, reduce glomerular filtration rate, and increase plasma levels of cardiac glycosides when administered concomitantly with cardiac glycosides.
Concomitant administration with diuretics may lead to a weakening of the diuretic effect and an increased risk of NSAID nephrotoxicity.
Cyclosporine antibiotics. Ketorolac should be administered with caution simultaneously with cyclosporine due to the increased risk of nephrotoxicity.
Tacrolimus: There is a possible risk of nephrotoxicity if NSAIDs are administered concomitantly with tacrolimus.
ACE inhibitors, angiotensin receptor blockers (ARBs). Ketorolac and other NSAIDs may reduce the effect of antihypertensive agents. There is an increased risk of renal dysfunction when ketorolac is used concomitantly with ACE inhibitors or ARBs, especially in patients with reduced blood volume or in the elderly. In such patients, careful monitoring of renal function is necessary at the beginning of treatment and periodically during therapy.
Opioid analgesics: Opioid analgesics (e.g., morphine, pethidine) may be used concomitantly; ketorolac does not affect the binding of opioid drugs and does not potentiate the respiratory depression or sedative effects of opioids. In cases of postoperative pain, the concomitant use of ketorolac with opioid analgesics has been shown to reduce the need for opioid analgesics.
Administration of ketorolac tablets after a high-fat meal resulted in a decrease in peak plasma ketorolac concentrations and an increase in time to peak plasma concentrations by approximately 1 hour. Antacids do not affect the extent of absorption.
Quinolones: Patients taking NSAIDs and quinolones may be at increased risk of developing seizures.
Concomitant use of NSAIDs with zidovudine increases the risk of hematological toxicity. There is an increased risk of hemarthrosis and hematoma in HIV-infected patients with hemophilia treated concomitantly with zidovudine and ibuprofen.
Medicines containing garlic, onions, ginkgo biloba may enhance the effect of ketorolac and increase the risk of hemorrhagic complications.
Laboratory Test Effects: Ketorolac inhibits platelet aggregation and may prolong bleeding time.
Ketorolac does not affect the binding of digoxin to plasma proteins. In vitro studies indicate that at therapeutic concentrations of salicylate (300 μg/mL) and above, ketorolac binding was reduced from approximately 99.2% to 97.5%. Therapeutic concentrations of digoxin, warfarin, ibuprofen, naproxen, piroxicam, paracetamol, acetaminophen, phenytoin, and tolbutamide did not affect the binding of ketorolac to plasma proteins. Since ketorolac is a highly active drug and its available plasma concentrations are low, it is not expected to significantly displace other drugs bound to plasma proteins.
In animal and human studies, there was no evidence that ketorolac induces or inhibits hepatic enzymes that are capable of metabolizing it or other drugs. Therefore, ketorolac is not expected to alter the pharmacokinetics of other drugs through the mechanism of enzyme induction or inhibition.
Antiepileptics: Isolated cases of epileptic seizures have been reported during concomitant use of ketorolac and antiepileptics (phenytoin, carbamazepine).
Psychotropic drugs: Hallucinations have been reported with the concomitant use of ketorolac and psychotropic drugs (fluoxetine, thiotexene, alprazolam).
Application features
To reduce the risk of adverse effects, treatment with ketorolac should be for the shortest duration and at the lowest dose necessary to control pain. The maximum duration of treatment should not exceed 5 days.
Gastrointestinal bleeding, ulceration and perforation.
Gastrointestinal bleeding, ulceration or perforation, which can be fatal, has been reported with NSAIDs (including ketorolac), at any time during treatment with or without warning symptoms or a history of serious gastrointestinal disorders. The risk of serious gastrointestinal bleeding, ulceration or perforation is dose-related and increases with increasing dose in patients with a history of ulcer, especially if complicated by bleeding or perforation, and in the elderly. Therefore, these patients should be started on the lowest available dose, especially in elderly and debilitated patients receiving ketorolac at a mean daily dose of more than 60 mg. The highest number of deaths due to gastrointestinal adverse reactions associated with NSAIDs has been observed in elderly or debilitated patients. Such patients should be warned to report any unusual gastrointestinal symptoms (especially gastrointestinal bleeding), especially in the initial stages of treatment. For these patients, as well as for patients who are concomitantly taking low doses of acetylsalicylic acid or other drugs that may increase the risk for the gastrointestinal tract, the possibility of combined treatment with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered. Ketolong-Darnitsa® should be used with caution in patients receiving concomitant medication that may increase the risk of ulceration or bleeding, such as oral corticosteroids, SSRIs or antiplatelet agents such as acetylsalicylic acid. In the event of gastrointestinal bleeding or ulceration in patients receiving Ketolong-Darnitsa®, the course of treatment should be discontinued.
NSAIDs, including ketorolac, may be associated with an increased risk of gastrointestinal anastomotic rupture. Close medical supervision and caution are recommended when ketorolac is used following gastrointestinal surgery.
NSAIDs should be used with caution in patients with inflammatory bowel disease (Crohn's disease, ulcerative colitis).
Hematological effects.
Patients with bleeding disorders should not be prescribed Ketolong-Darnitsa®. Patients receiving anticoagulant therapy may be at increased risk of bleeding if they use ketorolac concomitantly. Patients receiving other drugs that may affect the rate of bleeding should be carefully monitored when prescribing ketorolac. In controlled clinical trials, the incidence of major postoperative bleeding was less than 1%. Ketorolac inhibits platelet aggregation and prolongs bleeding time. In patients with normal bleeding times, bleeding time increased, but did not exceed the normal range of 2–11 minutes. In contrast to the prolonged effect of acetylsalicylic acid, platelet function returns to normal within 24–48 hours after discontinuation of ketorolac. Ketorolac should not be prescribed to patients who have undergone surgery with a high risk of bleeding or incomplete bleeding. Caution should be exercised if mandatory stopping of bleeding is critical.
Respiratory dysfunction.
Caution is required when using the drug in patients with bronchial asthma (or with a history of asthma), since NSAIDs have been reported to precipitate bronchospasm in such patients.
Prostaglandin biosynthesis inhibitors (including NSAIDs) have been reported to be nephrotoxic. Caution should be exercised in patients with impaired renal, cardiac, or hepatic function, and in patients with pre-existing renal disease, as NSAIDs may worsen renal function due to inhibition of prostaglandin synthesis (see above). Since ketorolac trometamol and its metabolites are primarily excreted by the kidneys, patients with moderate to severe renal impairment (serum creatinine > 160 μmol/l) should not take Ketolong-Darnitsa®. Patients with mild renal impairment should be given lower doses of ketorolac (not exceeding 60 mg/day intramuscularly or intravenously), and renal function should be closely monitored in such patients. As with other drugs that inhibit prostaglandin synthesis, increases in serum urea, creatinine and potassium have been reported with ketorolac, which may occur after a single dose. Withdrawal of the drug usually results in recovery of renal function.
Disorders of the cardiovascular system, kidneys and liver.
Caution should be exercised in patients with conditions that result in decreased blood volume and/or renal blood flow, where renal prostaglandins play a supporting role in maintaining renal perfusion. Renal function should be monitored in these patients. Volume depletion should be corrected and serum urea and creatinine levels and urine output should be closely monitored until the patient is normovolemic, as there is a risk of renal failure if these recommendations are not followed.
In patients on renal dialysis, creatinine clearance was reduced to approximately half of the normal rate and the terminal half-life was increased to approximately threefold.
Ketorolac should be used with caution in patients with impaired hepatic function or a history of liver disease. Significant increases (more than 3 times the upper limit of normal) in serum ALT and AST were observed in less than 1% of patients in controlled clinical trials. In addition, isolated cases of severe hepatic reactions, including jaundice and fatal fulminant hepatitis, hepatic necrosis and hepatic failure, some of which were fatal, have been reported.
Patients with hepatic impairment due to cirrhosis did not have any clinically significant changes in ketorolac clearance or terminal half-life. Borderline elevations in one or more liver function tests (ALT/AST) may occur. These abnormalities may be transient, may remain unchanged, or may progress with continued treatment. If clinical signs and symptoms suggest the development of liver disease or if systemic manifestations occur, Ketolong-Darnitsa® should be discontinued.
Ketolong-Darnitsa® should be prescribed with caution to patients with a history of cardiovascular disorders.
Fluid retention and swelling.
Fluid retention, hypertension, and edema have been reported with ketorolac, so it should be administered with caution to patients with mild to moderate heart failure, hypertension, or similar conditions.
Cardiovascular and cerebrovascular effects.
There is currently insufficient information to assess this risk for ketorolac tromethamine. Patients with uncontrolled hypertension, congestive heart failure, established ischemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should be monitored closely, as the use of the drug may be associated with a slightly increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke). Clinical trials and epidemiological data suggest that the use of coxibs and some NSAIDs (predominantly at high doses) may be associated with a slightly increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke). Although treatment with ketorolac has not been shown to increase the incidence of thrombotic events such as myocardial infarction, there is insufficient data to exclude such a risk for ketorolac.
Systemic lupus erythematosus and mixed connective tissue diseases.
Patients with systemic lupus erythematosus and various mixed connective tissue diseases are at increased risk of developing aseptic meningitis.
Anaphylactic reactions
Anaphylactic/anaphylactoid reactions (including but not limited to anaphylaxis, bronchospasm, flushing, rash, hypotension, laryngeal edema, and angioedema) have occurred in patients with a history of hypersensitivity to acetylsalicylic acid or any other NSAID or to intravenous ketorolac. They may also occur in people with angioedema, bronchospasm (e.g., asthma), and adenoids. Anaphylactoid reactions, such as anaphylaxis, may develop slowly. Therefore, ketorolac is contraindicated in patients with a history of asthma and in patients with complete or partial nasal polyposis syndrome, angioedema, and bronchospasm.
Severe skin reactions, sometimes fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs (see Adverse Reactions). The risk of such reactions is increased at the beginning of treatment.
Ketolong-Darnitsa® should be discontinued at the first signs of skin rashes, mucous membrane lesions, or any other signs of hypersensitivity.
Other important information.
Ketolong-Darnitsa® is not an anesthetic and does not have sedative or anxiolytic properties, therefore, it is not recommended as a premedication before surgery to maintain anesthesia.
Hypovolemia should be corrected before initiating ketorolac.
Increasing the dose of ketorolac tablets above the daily dose of 40 mg does not increase its effectiveness, but increases the risk of adverse reactions.
Ketolong-Darnitsa® is not addictive; no withdrawal syndrome was recorded in the event of discontinuation of the drug.
Important information about excipients.
This medicinal product contains lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Use during pregnancy or breastfeeding
Pregnancy.
The safety of ketorolac during pregnancy has not been established. Approximately 10% of ketorolac crosses the placenta.
Given the known effect of NSAIDs on the cardiovascular system of the fetus (risk of premature closure of the ductus arteriosus), the drug is contraindicated during pregnancy, labor and delivery. The onset of labor may be delayed and the duration prolonged due to suppression of uterine contractility. The risk of bleeding in both mother and child increases.
After the use of NSAIDs, inhibition of prostaglandin synthesis in early pregnancy may lead to embryo/fetal malformations; heart defects and gastroschisis, urinary system disorders with the development of oligohydramnios. Starting from the 20th week of pregnancy, the use of Ketolong-Darnitsa® may cause oligohydramnios due to fetal renal dysfunction. This disorder may occur shortly after the start of treatment and is usually reversible after discontinuation of treatment. In addition, there are reports of narrowing of the ductus arteriosus after treatment in the second trimester of pregnancy, which in most cases disappeared after discontinuation of treatment. It may be advisable to conduct prenatal monitoring for oligohydramnios and narrowing of the ductus arteriosus after exposure to ketorolac for several days, starting from the 20th week of gestation.
The absolute risk of cardiovascular malformation with NSAIDs increases from less than 1% to approximately 1.5%. The risk is thought to increase with dose and duration of therapy. Epidemiological studies have shown an increased risk of spontaneous abortion (miscarriage).
In the third trimester of pregnancy, all prostaglandin synthesis inhibitors can affect the fetus in the following ways:
cardiopulmonary toxicity (premature narrowing/closure of the ductus arteriosus and pulmonary hypertension);
renal dysfunction with possible further development of renal failure with oligohydramnios (see above).
At the end of pregnancy, prostaglandin synthesis inhibitors can affect the woman and fetus in the following ways:
prolonged bleeding time, antiplatelet effect, even after very low doses, increased bleeding in both mother and child;
inhibition of uterine contractions, which can lead to a delay or prolongation of labor.
Approximately 10% of ketorolac crosses the placenta.
Breast-feeding.
Ketorolac passes into breast milk in small amounts, so the drug is contraindicated during breastfeeding.
Impact on fertility.
The use of ketorolac, as with any drug that inhibits cyclooxygenase/prostaglandin synthesis, may impair fertility and is not recommended in women attempting to conceive. For women who are unable to conceive or are undergoing investigation of their fertility, discontinuation of ketorolac should be considered.
Ability to influence reaction speed when driving vehicles or other mechanisms
Some patients may experience drowsiness, dizziness, vertigo, insomnia, fatigue, visual disturbances, headache, or depression when taking ketorolac. If patients experience these or similar effects, they should not drive or operate machinery.
Method of administration and doses
It is advisable to take the tablets during or after meals. The drug is recommended for short-term use only. The total duration of treatment (parenteral administration followed by oral administration) should not exceed 5 days.
To minimize side effects, the drug should be used at the lowest effective dose for the shortest period of time necessary to control symptoms. Normovolemia should be achieved before starting treatment.
If the treatment is a continuation of injection treatment:
patients aged 16 to 64 years, with a body weight of at least 50 kg and with normal kidney function - initially prescribe 20 mg once, then 10 mg a maximum of 4 times a day with an interval of 4 to 6 hours if necessary, but not more than 40 mg per day;
Elderly patients or patients with impaired renal function, patients weighing less than 50 kg - prescribe 10 mg a maximum of 4 times a day with an interval of 4 to 6 hours if necessary, but not more than 40 mg per day.
For patients receiving parenteral ketorolac and who are prescribed ketorolac orally in tablet form, the total combined daily dose should not exceed 90 mg in adults and 60 mg in the elderly, patients with renal impairment, and patients weighing less than 50 kg. The oral dosage should not exceed 40 mg per day if the dosage form is changed. Patients should be switched to oral administration as soon as possible.
Elderly patients.
Elderly patients are at greater risk of developing serious complications, particularly from the digestive tract. During treatment with NSAIDs, the patient's condition should be regularly monitored, and a longer interval between drug administration, for example, 6–8 hours, is usually recommended.
Children
The efficacy and safety of the drug in children under 16 years of age have not been established, therefore it should not be prescribed to this category of patients.
Overdose
Symptoms: headache, nausea, vomiting, epigastric pain, peptic ulcers, erosive gastritis, gastrointestinal bleeding, hyperventilation, hypertension; rarely - diarrhea, disorientation, agitation, respiratory depression, coma, drowsiness, lethargy, dizziness, tinnitus, loss of consciousness, other convulsions. In cases of severe poisoning, acute renal failure and liver damage are possible. Anaphylactoid reactions have been reported, which can also occur with overdose.
Treatment: gastric lavage, administration of activated charcoal. Adequate diuresis should be ensured. Renal and hepatic function should be closely monitored. Patients should be observed for at least 4 hours after ingestion of a potentially toxic amount. Frequent or prolonged convulsions should be treated with intravenous diazepam. Other measures may be prescribed depending on the clinical condition of the patient. Treatment is symptomatic. There is no specific antidote. Dialysis does not remove ketorolac from the circulation.
Side effects
On the part of the organs of vision: optic neuritis, visual impairment, blurred vision.
From the side of the organs of hearing and vestibular apparatus: hearing loss, tinnitus, possible hearing loss.
Respiratory, thoracic and mediastinal disorders: shortness of breath, bronchial asthma, pulmonary edema.
Gastrointestinal: peptic ulcer, perforation or gastrointestinal bleeding, sometimes fatal (especially in the elderly), nausea, dyspepsia, gastrointestinal pain, abdominal discomfort, dry mouth, vomiting, vomiting with blood, gastritis, esophagitis, diarrhea, constipation, belching, flatulence, feeling of fullness of the stomach, melena, rectal bleeding, stomatitis, ulcerative stomatitis, hemorrhages, perforation, pancreatitis, exacerbation of colitis and Crohn's disease, pain, spasm or burning in the epigastric region.
Liver and biliary tract disorders: liver dysfunction, hepatitis, jaundice and liver failure, hepatomegaly, abnormal laboratory values.
On the part of the kidneys and urinary system: increased urinary frequency, oliguria, renal failure (including acute), hyponatremia, hyperkalemia, hemolytic uremic syndrome, flank pain (with/without hematuria), increased serum urea and creatinine, interstitial nephritis, urinary retention, nephrotic syndrome.
Metabolism: anorexia.
Nervous system: drowsiness, dizziness, fainting, headache, dry mouth, increased thirst, nervousness, paresthesia, functional disorders, depression, euphoria, convulsions, inability to concentrate, sleep disorders, insomnia, unusual dreams, malaise, increased fatigue, weakness, agitation, vertigo, confusion, hallucinations, hyperkinesia, aseptic meningitis with corresponding symptoms (rigidity of the neck muscles, headache, nausea, vomiting, fever or disorientation).
On the part of the psyche: hyperactivity (mood swings, restlessness), anxiety, psychotic reactions, thinking disorders.
Cardiovascular system: palpitations, hot flashes, bradycardia, pallor, hypertension, hypotension, palpitations, chest pain, edema, heart failure.
From the blood and lymphatic system: purpura, thrombocytopenia, leukopenia, neutropenia, eosinophilia, agranulocytosis, aplastic and hemolytic anemia, postoperative wound bleeding, hematoma, nosebleeds, prolonged bleeding time.
Immune system disorders: Hypersensitivity reactions including non-specific allergic reactions and anaphylaxis, airway reactivity including bronchial asthma, worsening of bronchial asthma, bronchospasm, laryngeal edema or dyspnea, and various skin disorders including rashes of various types, pruritus, urticaria, purpura, angioedema and, in rare cases, exfoliative and bullous dermatitis (including epidermal necrolysis and erythema multiforme) have been reported.
Such reactions may occur in patients with or without known hypersensitivity to ketorolac or other NSAIDs. They may also occur in individuals with a history of angioedema, bronchospastic reactivity (e.g. bronchial asthma and nasal polyps). Anaphylactoid reactions, such as anaphylaxis, may be fatal.
Skin and subcutaneous tissue disorders: hyperemia, itching, urticaria, skin photosensitization, Lyell's syndrome, bullous reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis (very rare), exfoliative dermatitis, rashes (including maculopapular and weeping), facial skin discoloration.
Musculoskeletal and connective tissue disorders: myalgia, functional disorders.
From the reproductive system and mammary gland function: female infertility.
General disorders: asthenia, malaise, swelling of the face, lower legs, fingers, feet, swelling of the tongue, taste disturbance, weight gain, increased sweating, increased body temperature.
Reporting of suspected adverse reactions.
Reporting suspected adverse reactions after the marketing authorisation of a medicinal product is an important procedure. It allows for continued monitoring of the benefit-risk balance of the medicinal product in question. Healthcare professionals should report any suspected adverse reactions via the national reporting system.
Expiration date
2 years.
Storage conditions
Store in original packaging at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Packaging
10 tablets in a contour blister pack; 1 contour blister pack in a pack.
Vacation category
According to the recipe.
Producer
PrJSC "Pharmaceutical Company "Darnitsa".
Address
Ukraine, 02093, Kyiv, Boryspilska St., 13.
