Ketorolac-LF tablets p/o 10mg №10×5

Name Ketorolac-lf. Forms of release Tablets. INNKetorolac. Pharmacotherapeutic groupNon-steroidal anti-inflammatory and antirheumatic drugs. Derivatives of acetic acid and their analogues. ATC code M01AB15 Composition Each tablet contains: active substance: ketorolac tromethamine – 10 mg; excipients: microcrystalline cellulose, corn starch, anhydrous colloidal silicon dioxide, magnesium stearate, lactose monohydrate, white opadra II (partially hydrolyzed polyvinyl alcohol, titanium dioxide, macrogol/PEG, talc). Indications for use Ketorolac-LF, film-coated tablets, 10 mg is used for the short-term treatment of acute pain (including postoperative pain) of moderate intensity, only as a continuation of previous parenteral (intramuscular or intravenous) therapy in a hospital setting, if necessary. The total duration of parenteral and oral therapy with ketorolac should not exceed 5 days. Method of application and dosageFor oral administration. The maximum daily dose is 4 tablets (40 mg). Course duration – no more than 5 days. The dosage regimen is set individually depending on the pain syndrome. In order to minimize side effects, the drug should be used at the lowest effective dose for the shortest period of time necessary to control symptoms. Children under 16 years of age – use is contraindicated. Adults from 16 to 64 years old, weighing more than 50 kg, are prescribed 1 tablet (10 mg) 3-4 times a day. For adults over 64 years of age, and / or with a body weight of less than 50 kg, and / or with impaired renal function, the frequency of use of the drug is reduced to 1-2 times a day. Side effects: From the digestive tract: peptic ulcer, perforation or gastrointestinal bleeding, sometimes fatal (especially in the elderly), nausea, dyspepsia, gastrointestinal pain, abdominal discomfort, hematemesis, gastritis, esophagitis, diarrhea, belching , constipation, flatulence, feeling of fullness in the stomach, melena, rectal bleeding, ulcerative stomatitis, vomiting, hemorrhage, perforation, pancreatitis, exacerbation of colitis and Crohn’s disease. From the side of the central nervous system: anxiety, visual impairment, optic neuritis, drowsiness, dizziness, increased sweating, dry mouth, nervousness, paresthesia, functional disorders, depression, euphoria, convulsions, inability to concentrate, insomnia, increased fatigue, agitation, vertigo , impaired taste and vision, myalgia, unusual dreams, confusion, hallucinations, hyperkinesia, hearing loss, tinnitus, psychotic reactions, thought disorders. Infectious diseases: aseptic meningitis (especially in patients with autoimmune diseases such as systemic lupus erythematosus, mixed connective tissue disease), neck stiffness, headache, nausea, vomiting, fever, confusion. Metabolism and nutrition: anorexia, hyponatremia, hyperkalemia. From the urinary system: increased frequency of urination, oliguria, acute renal failure, hemolytic uremic syndrome, pain in the side (with / without hematuria), elevated serum urea and creatinine, interstitial nephritis, urinary retention, nephrotic syndrome, infertility, renal failure. On the part of the liver: abnormal liver function, hepatitis, jaundice and liver failure, an increase in functional tests. From the cardiovascular system: flushing, bradycardia, pallor, hypertension, hypotension, palpitation, chest pain, edema, heart failure. Data from clinical and epidemiological studies suggest that the use of some NSAIDs, especially at high doses and for a long time, may be associated with an increased risk of developing arterial thromboembolic complications (myocardial infarction or stroke). From the respiratory system: epistaxis, shortness of breath, asthma, pulmonary edema. From the blood system: purpura, thrombocytopenia, neutropenia, agranulocytosis, aplastic and hemolytic anemia. From the skin: itching, urticaria, skin photosensitivity, Lyell’s syndrome, bullous reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis (very rarely), exfoliative dermatitis, maculopapular rashes. Impact on reproductive function: the use of ketorolac, like any drug that inhibits the synthesis of cyclooxygenase / prostaglandin, can cause infertility. Hypersensitivity: Hypersensitivity reactions have been reported that include non-specific allergic reactions and anaphylaxis, respiratory tract reactivity including asthma, worsening of asthma, bronchospasm, laryngeal edema or dyspnea, and a variety of skin disorders that include various types of rash, itching , urticaria, purpura, angioedema, and in single cases, exfoliative and bullous dermatitis (including epidermal necrolysis and erythema multiforme). Such reactions may occur in patients with or without known hypersensitivity to ketorolac or other non-steroidal anti-inflammatory drugs. They can also be seen in individuals with a history of angioedema, bronchospastic reactivity (eg, asthma and nasal polyps). Anaphylactoid reactions such as anaphylaxis can be fatal. Others: postoperative wound bleeding, hematoma, prolongation of bleeding, asthenia, edema, weight gain, fever, excessive thirst, fatigue, malaise, fever, chest pain. Contraindications Hypersensitivity to ketorolac or any component of the drug. Patients with active peptic ulcer, with recent gastrointestinal bleeding or perforation, with a history of peptic ulcer or gastrointestinal bleeding. Bronchial asthma, rhinitis, angioedema or urticaria caused by the use of acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (due to the possibility of severe anaphylactic reactions). Bronchial asthma in history. Do not use as an analgesic before and during surgery. Severe heart failure. Complete or partial nasal polyp syndrome, Quincke’s edema or bronchospasm. Do not use in patients who have had surgery with a high risk of hemorrhage or incomplete bleeding and in patients who receive anticoagulants, including low doses of heparin (2500-5000 units every 12 hours). Hepatic or moderate and severe renal insufficiency (serum creatinine more than 160 µmol/l). Suspected or confirmed cerebrovascular bleeding, hemorrhagic diathesis, including bleeding disorders and high risk of bleeding. Simultaneous treatment with other non-steroidal anti-inflammatory drugs (NSAIDs) (including selective cyclooxygenase inhibitors), acetylsalicylic acid, warfarin, pentoxifylline, probenecid or lithium salts. Hypovolemia, dehydration. The period of pregnancy, contractions, childbirth and lactation. Children’s age up to 16 years. Overdose Symptoms: headache, nausea, vomiting, epigastric pain, gastrointestinal bleeding; rarely – diarrhea, disorientation, agitation, coma, drowsiness, dizziness, tinnitus, loss of consciousness, sometimes convulsions. In cases of severe poisoning, acute renal failure and liver damage are possible. Anaphylactoid reactions have been observed after the therapeutic use of NSAIDs, which may occur after an overdose. Treatment: gastric lavage, use of activated charcoal. It is necessary to provide sufficient diuresis. The function of the kidneys and liver should be carefully monitored. Patients should be observed for at least 4 hours after ingestion of a potentially toxic amount. Frequent or prolonged seizures should be treated with intravenous diazepam. Other measures may be prescribed depending on the clinical condition of the patient. Therapy is symptomatic. Precautions The maximum duration of treatment should not exceed 5 days. Effect on fertility. The use of ketorolac, as with any drug that inhibits cyclooxygenase/prostaglandin synthesis, may impair fertility and is not recommended for use in women who are planning to become pregnant. For women who are unable to conceive or are undergoing fertility tests, discontinuation of ketorolac should be considered. Gastrointestinal bleeding, ulceration and perforation. Gastrointestinal bleeding, ulceration, or perforation, which can be fatal, has been reported with NSAIDs used at any time during treatment with or without warning symptoms or with a history of severe gastrointestinal disturbances. The risk of developing severe gastrointestinal bleeding depends on the dosage of the drug. This, in particular, applies to elderly patients who use ketorolac in an average daily dose above 60 mg. For these patients, as well as for patients who are simultaneously using low doses of acetylsalicylic acid or other drugs that may increase the risk to the digestive tract, combination treatment with protective agents (for example, misoprostol or proton pump inhibitors) should be considered. Ketorolac-LF is used with caution in patients receiving concomitant medications that may increase the risk of ulceration or bleeding, such as oral corticosteroids, selective serotonin reuptake inhibitors, or antiplatelet agents such as acetylsalicylic acid. In the event of gastrointestinal bleeding or ulceration in patients receiving Ketorolac-LF, the course of treatment should be discontinued. Respiratory dysfunction. Caution is necessary in the case of the use of the drug in patients with bronchial asthma (or with a history of asthma), since it has been reported that NSAIDs in such patients accelerate the onset of bronchospasm. Effect on the kidneys. Inhibitors of prostaglandin biosynthesis (including NSAIDs) have been reported to have nephrotoxic effects. With caution, the drug is prescribed to patients with impaired renal function, heart, liver, since the use of NSAIDs can lead to a deterioration in kidney function. Patients with mildly impaired renal function are prescribed lower doses of ketorolac (those that do not exceed 60 mg per day intramuscularly or intravenously), and the condition of the kidneys in such patients should be carefully monitored. As with other drugs that inhibit prostaglandin synthesis, there have been reports of increases in serum urea, creatinine and potassium while taking ketorolac tromethamine, which can occur after taking a single dose. Violation of the cardiovascular system, kidneys and liver. With caution, the drug is prescribed to patients with conditions that lead to a decrease in blood volume and / or renal blood flow, when renal prostaglandins play a supporting role in ensuring renal perfusion. In these patients, renal function should be monitored. The decrease in volume should be corrected and the serum urea and creatinine levels, as well as the volume of urine that is excreted, should be carefully monitored until the patient becomes normovolemia. In patients on renal dialysis, the clearance of ketorolac was approximately halved compared to the normal rate, and the terminal elimination half-life was approximately trebled. Patients with impaired liver function due to cirrhosis had no clinically significant changes in ketorolac clearance or terminal half-life. Marginal increases in values may be observed on one or more liver function tests. These abnormalities may be temporary, may remain unchanged, or may progress with continued treatment. If clinical signs and symptoms indicate the development of liver disease or if systemic manifestations are observed, the drug should be discontinued. Fluid retention and swelling. Fluid retention and edema have been reported during the use of ketorolac, so it should be administered with caution to patients with cardiac decompensation, arterial hypertension or similar conditions. Cardiovascular and cerebrovascular effects. There is currently insufficient information to assess this risk for ketorolac tromethamine. Patients with uncontrolled arterial hypertension, congestive heart failure, diagnosed coronary heart disease, peripheral arterial disease and / or cerebrovascular disease should be under medical supervision. Systemic lupus erythematosus and mixed connective tissue diseases. Patients with systemic lupus erythematosus and various mixed connective tissue diseases have an increased risk of developing aseptic meningitis. Dermatological reactions. The drug should be discontinued at the first sign of skin rash, mucosal lesions or any other sign of hypersensitivity. Anaphylactic (anaphylactoid) reactions. As with other NSAIDs, anaphylactic (anaphylactoid) reactions (including anaphylaxis, bronchospasm, hyperemia, rash, arterial hypotension, laryngeal edema, Quincke’s edema) may occur in patients who have no or no history of hypersensitivity to aspirin, other NSAIDs or ketorolac. This complex of symptoms can also be observed in individuals who have a history of bronchospastic reactivity (eg, asthma) and nasal polyps. Anaphylactoid reactions such as anaphylaxis can be fatal. Therefore, ketorolac should not be taken in patients with a history of asthma and in patients with complete or partial nasal polyp syndrome, angioedema, and bronchospasm. If anaphylactoid reactions occur, seek emergency medical attention. hematological effects. Patients with bleeding disorders should not be prescribed the drug. Patients receiving anticoagulant therapy may have an increased risk of bleeding if ketorolac is used concomitantly. The condition of patients who receive other drugs that can affect the rate of bleeding should be carefully monitored when prescribing ketorolac to them. In controlled clinical trials, the incidence of significant postoperative bleeding was less than 1%. Ketorolac inhibits platelet aggregation and prolongs bleeding time. In patients with normal bleeding time, the duration of bleeding increased, but did not go beyond the normal range of values of 2-11 minutes. In contrast to the long-term effect as a result of the use of acetylsalicylic acid, platelet function returns to normal within 24-48 hours after the withdrawal of ketorolac. Ketorolac should not be given to patients who have undergone surgery with a high risk of bleeding or incomplete bleeding. Caution should be exercised if mandatory bleeding control is critical. Ketorolac-LF is not an anesthetic and has no sedative or anxiolytic properties, therefore, it is not recommended as a premedication before surgery to maintain anesthesia. Do not use in patients with rare hereditary diseases: congenital galactosemia, lactase deficiency, glucose / galactose malabsorption syndrome. Children Do not use in children under 16 years of age. Use during pregnancy and lactation The safety of ketorolac during pregnancy in humans has not been established. Given the known effect of NSAIDs on the fetal cardiovascular system (risk of premature closure of the ductus arteriosus), ketorolac is contraindicated during pregnancy, labor and childbirth. The onset of labor may be delayed and the duration prolonged, with an increased tendency for both mother and child to bleed. Ketorolac is excreted in breast milk in small amounts, so the drug Ketorolac-LF is contraindicated during lactation. Influence on the ability to drive vehicles and control mechanisms Some patients in the case of the use of ketorolac may feel drowsiness, dizziness, vertigo, insomnia, fatigue, blurred vision or depression. If patients experience the above or other similar side effects, they should not drive or use machines. Interaction with other drugs Ketorolac readily binds to plasma proteins (mean value 99.2%), and the degree of binding depends on the concentration. Do not use simultaneously with Ketorolac. Due to the possibility of side effects, ketorolac should not be administered with other NSAIDs, including selective cyclooxygenase-2 inhibitors, or in patients receiving acetylsalicylic acid, warfarin, lithium, probenecid, cyclosporine. NSAIDs should not be administered within 8-12 days after the use of mifepristone, since NSAIDs may weaken the effect of mifepristone. Medicines in combination with ketorolac should be administered with caution. In healthy subjects with normovolemia, ketorolac reduces the diuretic effect of furosemide by approximately 20%, therefore, the drug is prescribed with particular caution in patients with cardiac decompensation. NSAIDs may exacerbate heart failure, decrease glomerular filtration rate, and increase plasma levels of cardiac glycosides when administered concomitantly with cardiac glycosides. Ketorolac and other non-steroidal anti-inflammatory drugs may reduce the effect of antihypertensive drugs. In the case of simultaneous use of ketorolac with ACE inhibitors, there is an increased risk of impaired renal function, especially in patients with a reduced blood volume in the body. There is a possible risk of nephrotoxicity if NSAIDs are co-administered with tacrolimus. Co-administration with diuretics may lead to a weakening of the diuretic effect and an increased risk of NSAID nephrotoxicity. As with all NSAIDs, corticosteroids should be given concurrently with caution due to an increased risk of gastrointestinal ulceration or bleeding. There is an increased risk of gastrointestinal bleeding if NSAIDs are given in combination with antiplatelet agents and selective serotonin reuptake inhibitors. Caution is advised if methotrexate is given concomitantly, as some prostaglandin synthesis inhibitors have been reported to reduce the clearance of methotrexate and therefore possibly increase its toxicity. Patients taking NSAIDs and quinolones may be at an increased risk of developing seizures. The simultaneous use of NSAIDs with zidovudine leads to an increased risk of hematological toxicity. There is an increased risk of hemarthrosis and hematoma in HIV-infected patients who have hemophilia and who are treated concomitantly with zidovudine and ibuprofen. The following drugs are unlikely to interact with ketorolac. Ketorolac did not affect the binding of digoxin to plasma protein. In vitro studies indicate that at therapeutic concentrations of salicylate (300 µg/ml) and higher, the binding of ketorolac decreased from approximately 99.2% to 97.5%. Therapeutic concentrations of digoxin, warfarin, paracetamol, phenytoin and tolbutamide did not affect the binding of ketorolac to plasma protein. Because ketorolac is a highly active drug and its plasma concentration is low, it is not expected to significantly replace other drugs that bind to plasma proteins. In animal and human studies, there was no evidence that ketorolac tromethamine induces or inhibits liver enzymes that are capable of metabolizing it or other drugs. Therefore, ketorolac is not expected to alter the pharmacokinetics of other drugs through an enzyme induction or inhibition mechanism. Storage conditions In a place protected from moisture and light at a temperature not exceeding 25 ° C. Keep out of the reach of children. Shelf life 2 years. Do not use after the expiry date stated on the package. Packing: 10 tablets in a blister pack made of polymer film and aluminum foil. Two, three or five blister packs along with instructions for medical use in a cardboard pack. Conditions of release By prescription. Buy Ketorolac-LF tablets p/o 10mg No. 10×5 Price for Ketorolac-LF tablets p/o 10mg No. 10×5