Ketanov instruction for using
About the drug:
Anesthetic drug that also exhibits anti-inflammatory, weak antipyretic activity.
Indications and dosage:
Relief of moderate-intensity and strong postoperative pain for a short time.
Tablets should preferably be taken during or after meals. The drug is recommended only for short-term use (up to 7 days).
To minimize the side effects of the drug should be used in minimum effective dose for the shortest possible period of time necessary to control symptoms. Before treatment is necessary to achieve normovolemia.
Ketanov adults appoint 10 mg every 4-6 hours as needed. It is not recommended to use the drug in doses exceeding 40 mg/day. Opioid analgesics (e.g. morphine, pethidine) may be used in parallel, Ketorolac does not affect the binding of opioid drugs and does not increase the respiratory depression or sedation caused by opioids. For patients who receive parenteral Ketorolac and Ketorolac assigned 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 with body weight <50 kg), the dosage of oral forms of the drug should not exceed 40 mg/day if the modified application of mold release of the drug. Patients need to transfer to oral drug as soon as possible.
Patients of advanced age. Elderly patients have a higher risk of developing severe complications, in particular from the digestive tract. During treatment with the use of NSAIDs should regularly monitor the patient's condition, we typically recommend longer intervals between drug administration, such as 6-8 hours.
Solution for injections.
It is recommended to use parenteral Ketorolac in the hospital setting. After the/m introduction, the analgesic effect is observed after approximately 30 min, and the maximum analgesia occurs within 1-2 h. In General, the average duration of analgesia is 4-6 hours Dose should be adjusted depending on severity of pain and patient response to treatment. Constant in/m introduction of multiple daily doses of Ketorolac should not last >2 days, as prolonged use increases the risk of adverse reactions. Experience prolonged use is limited, since the vast majority of patients were transferred to oral ingestion of the drug or after a period in a/m patients were no longer required analgesic therapy.
The possibility of side effects can be minimized by applying the minimum effective dose for the shortest time necessary to control symptoms.
The drug can be epidural or intraspinal.
Adults. The recommended initial dose of Ketorolac trometamina, R-RA in/m injection is 10 mg, followed by administration of 10-30 mg every 4-6 hours (if necessary). In the initial postoperative period Ketorolac tromethamine if necessary, you can enter every 2 hours you Should assign the minimum effective dose. The total daily dose should not exceed 90 mg for young patients, 60 mg for elderly patients, patients with renal insufficiency and body weight <50 kg. Maximum duration of treatment should not exceed 2 days. In patients with body weight <50 kg, the dose should be reduced. Possible concomitant use of opioid analgesics (morphine, pethidine). Ketorolac has no negative impact on the binding of opioid receptors and does not increase respiratory depression or sedative effects of opioid drugs.
For patients who receive parenteral drug Ketanov injection and are transferred to oral Ketorolac tromethamine, tablets, the total combined daily dose should not exceed 90 mg (60 mg for elderly patients, patients with impaired renal function and body weight <50 kg), and a day change the dosage form dose oral component should not exceed 40 mg. For the oral form of patients should be transferred as quickly as possible.
Patients of advanced age. Patients older than 65 years is recommended to assign the lowest value of the range of dosing. The total daily dose should not exceed 60 mg.
Patients with impaired renal function. Ketorolac is contraindicated in violation of kidney function of moderate and severe degree. With less pronounced violations, it is necessary to reduce the dosing (no more than 60 mg/day/m).
Symptoms: inhibited state, drowsiness, nausea, vomiting, epigastric pain, gastrointestinal bleeding, hypertension, acute renal failure, respiratory depression and coma. It was reported on the development of anaphylactoid reactions, which may occur in overdose.
Treatment: symptomatic and supportive therapy. There is no specific antidote. Patients not later than 4 hours after taking the drug, with overdose symptoms or following a large overdose (when taken orally doses exceeding the normal 5-10 times) shown to cause vomiting, take activated charcoal (60-100 g in adults) and/or to take an osmotic laxative. The use of forced diuresis, alkylation of the urine, hemodialysis or blood transfusion is inefficient due to high binding of the drug with blood plasma proteins. A single overdose of Ketorolac at different times led to abdominal pain, nausea, vomiting, hyperventilation, peptic ulcers and/or erosive gastritis and impaired renal function, which took place after discontinuation of the drug.
Gastrointestinal: peptic ulcer, perforation or gastrointestinal haemorrhage, sometimes fatal (especially in elderly), nausea, dyspepsia, abdominal pain, feeling of abdominal discomfort, gastritis, oesophagitis, diarrhoea, eructation, constipation, flatulence, feeling of fullness of the stomach, melena, intestinal bleeding, ulcerative stomatitis, vomiting, haemorrhage, perforation, pancreatitis, exacerbation of colitis and Crohn's disease.
CNS: anxiety, blurred vision, optic neuritis, drowsiness, dizziness, headache, sweating, dry mouth, nervousness, paraesthesia, functional disorders, depression, euphoria, convulsions, increased thirst, inability to concentrate, insomnia, malaise, fatigue, agitation, vertigo, disturbance of taste and vision, myalgia, abnormal dreams, confusion, hallucinations, hyperkinesis, hearing loss, tinnitus, aseptic meningitis with the corresponding symptoms, psychotic reaction, a thought disorder.
From the urinary system: increased frequency of urination, oliguria, acute renal failure, hyponatremia, hyperkalemia, hemolytic uremic syndrome, flank pain (with/without hematuria), the high content of urea and creatinine in blood serum, interstitial nephritis, urinary retention, nephrotic syndrome, infertility, renal failure.
Hepatobiliary system: abnormal liver function, hepatitis, jaundice and hepatic failure.From the side of cardiovascular system: a rush of blood to the face, bradycardia, pallor, hypertension, palpitation, pain in the chest, the occurrence of edema, cardiac failure.
The respiratory system: shortness of breath, asthma, pulmonary edema.From blood system: purpura, thrombocytopenia, neutropenia, agranulocytosis, aplastic and hemolytic anemia, postoperative hemorrhage, hematoma, epistaxis, bleeding, prolongation of bleeding time.
The skin: itching, urticaria, skin photosensitivity, Lyell's syndrome, bullous reactions, including Stevens — Johnson syndrome and toxic epidermal necrolysis (very rare), exfoliative dermatitis, maculopapular rash.
Hypersensitivity: reported on the development of hypersensitivity reactions, which include non-specific allergic reactions and anaphylaxis, respiratory tract reactivity, including asthma, worsening of asthma, bronchospasm, laryngeal edema or shortness of breath, and a variety of disorders of the skin, which include rashes of various types, pruritus, urticaria, purpura, angioedema and, in a few 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 NSAIDs. They can also occur in individuals who have a history of angioedema, bronchospastic reactivity (e.g. asthma or adenoid vegetation). Anaphylactoid reactions, like anaphylaxis, may have fatal consequences.Reproductive system: female infertility.
Other: swelling, weight gain, increase in body temperature.
Data from clinical and epidemiological studies suggest that use of some NSAIDs particularly at high doses and for a long time may be associated with an increased risk of arterial thromboembolic complications (myocardial infarction or stroke).
hypersensitivity to Ketorolac or any component of the drug;
patients with active peptic ulcer, recent gastrointestinal bleeding or perforation; peptic ulcer or gastrointestinal bleeding in anamnesis;
ASTHMA, rhinitis, angioedema or urticaria caused by acetylsalicylic acid or other NSAIDs (because of the possibility of severe anaphylactic reactions);
BA in history;
not used as analgesic before and during surgery;
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 hemostasis, and patients who receive anticoagulants including low dose heparin (2500-5000 UNITS every 12 hours);
hepatic or moderate and severe renal insufficiency (creatinine clearance in the serum >160 µmol/l);
suspected or confirmed cerebrovascular bleeding, hemorrhagic diathesis, including a clotting disorder and a high risk of bleeding;
concurrent treatment with other NSAIDs (including selective COX inhibitors), acetylsalicylic acid, warfarin, with pentoxifylline, probenecid or lithium salts;
pregnancy, labour, delivery and lactation;
children under the age of 16 years.
Interaction with other medications and alcohol:
Ketorolac easy binds with the plasma protein (mean 99.2% for), and the degree of binding depends on the concentration.
The safety of Ketorolac during pregnancy in humans is not established. Given the known effects of NSAIDs on the cardiovascular system of the fetus (risk of premature closure of the ductus arteriosus), Ketorolac is contraindicated during pregnancy, labour and childbirth. Onset of labor may be delayed and duration prolonged with the increasing trend in the occurrence of bleeding at the mother and the child. Ketorolac passes into breast milk in low concentrations, so caution is contraindicated during breast-feeding.
The impact on fertility. The use of Ketorolac, as with any drug, inhibiting the synthesis of COX/prostaglandin, may weaken fertility and is not recommended for use in women who are planning pregnancy. For women who can't get pregnant or pass an examination regarding fertility, you should consider the question of the abolition of Ketorolac.
Composition and properties:
Ketorolac. Other ingredients: sodium chloride, ethyl alcohol, disodium edetate, sodium hydroxide, water for injections.
Form of issue:
Tablets 10 mg, #10
Solution for injection 30 mg/ml amp. 1 ml, #10
In a dry, dark place at temperatures up to 25 °C.