Ketanov tablets p/o 10mg №10×10

Name:
Ketanov tabl p/o 10mg in a blister. in pack. No. 10×10 The main active ingredient Ketorolac Release formtext Compositiontablets
Description:
white or almost white, round, biconvex film-coated tablets, marked “K.VT” on one side. Dosage 10 mg Indications for use 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 (creatinine clearance in blood serum is more than 160 µmol/l); suspected or confirmed cerebrovascular bleeding, hemorrhagic diathesis, including bleeding disorders and a 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 breastfeeding; children’s age up to 16 years. 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 Ketanov is contraindicated during lactation. Children Do not apply to children under 16 years of age. Dosage and administration Tablets are preferably taken during or after meals. The drug is recommended only for short-term use (up to 5 days). 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. Before starting treatment, it is necessary to achieve normovolemia. Adult Ketans are prescribed 10 mg every 4-6 hours if necessary. It is not recommended to use the drug in doses that exceed 40 mg per day. Opioid analgesics (eg, morphine, pethidine) can be used in parallel, ketorolac does not affect the binding of opioid drugs and does not increase the respiratory depression or sedation that is characteristic of opioids. For patients who receive parenteral ketorolac and who are prescribed ketorolac orally in tablet form, the total combined daily dose should not exceed 90 mg (60 mg for the elderly, patients with impaired renal function and patients weighing less than 50 kg), and the dosage of the oral form of the drug should not exceed 40 mg per day if the use of the drug release form is changed. Patients should be switched to oral administration of the drug as soon as possible. Elderly patients Elderly patients have a higher risk of developing severe complications, in particular from the digestive tract. During treatment with NSAIDs, you should regularly monitor the patient’s condition, usually a longer interval between the use of the drug is recommended, for example 6-8 hours. 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, violation of taste sensations 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 side of 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. 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. Interaction with other drugs 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 with 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. Drugs 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 weaken 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, concomitant corticosteroids should be used 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 medicinal products 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. Since 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 Store in a dry, dark place at a temperature not exceeding 25 ° C. Keep out of the reach of children. Buy Ketan tablets p / o 10 mg No. 10×10 10mg №10×10