Ketorol tablets p/o 10mg №10×2

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Ketorol tab. p / o 10 mg in bl. in pack. No. 10×2
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Coated tablets, green, round, biconvex, marked ‘S’ on one side and smooth on the other. The main active ingredient Ketorolac Release form text Dosage 10 mg in bl. in pack. №10×2 Pharmacodynamics Ketorolac, being a non-steroidal anti-inflammatory drug, has an analgesic, antipyretic and anti-inflammatory effect. The mechanism of action at the biochemical level is the inhibition of the cyclooxygenase enzyme, mainly in peripheral tissues, which results in inhibition of the biosynthesis of prostaglandins – modulators of pain sensitivity, thermoregulation and inflammation. Ketorolac is a racemic mixture of the -S and -P enantiomers, with the analgesic effect due to the -S form. The drug does not affect opioid receptors, does not depress respiration, does not inhibit intestinal motility, does not have a sedative and anxiolytic effect, does not cause drug dependence, does not affect the progression of the disease. Ketorolac inhibits platelet aggregation and increases bleeding time. The functional state of platelets is restored within 24-48 hours after discontinuation of the drug. The pharmacokinetics of the bioavailability of ketorolac after oral administration ranges from 80% to 100%. The maximum plasma concentration is reached within 30-60 minutes. The pharmacokinetics of ketorolac under the conditions of prescribing medium therapeutic doses is a linear function. The equilibrium concentration of the drug in plasma is 50% higher than that determined after a single dose. More than 99% of the drug binds to plasma proteins, resulting in an apparent volume of distribution of less than 0.3 l / kg. Ketorolac is metabolized mainly with the formation of conjugated forms of glucuronic acid, which are excreted through the kidneys. Metabolites do not have analgesic activity. The half-life of the drug is on average 5 hours. Indications for use Ketorol 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 due to the possibility of increasing the frequency and severity of adverse reactions. Consider the potential benefits and risks and options for using another drug before taking Ketorol. Use the lowest effective dose for the shortest time possible. Patients should be switched to alternative treatment as soon as possible. Method of administration and doses The duration of the course of Ketorolac should not exceed 5 days, long-term administration, as well as oral administration at a dose of more than 40 mg per day is not recommended. To reduce the risk of side effects, it is recommended to use the minimum effective dose for the minimum time necessary to relieve pain. Adults: 10 mg every 4 or 6 hours as needed. The total daily dose when switching from parenteral administration of the drug to oral administration should not exceed 90 mg (60 mg for elderly patients, patients with renal insufficiency, patients weighing less than 50 kg), and the part of the dose administered orally with combined administration should not exceed 40 mg per day of changing the form of administration. Elderly patients: it is recommended to lengthen the intervals between doses of the drug, i.e. 6-8 hours. Patients over 65 years of age are recommended to prescribe a dose of the drug corresponding to the lower limit of the therapeutic dose. Adults weighing less than 50 kg or with impaired renal function: the frequency of use of the drug is reduced to 1-2 times a day. Use during pregnancy and lactation Efficacy and safety have not been established. Drugs that affect the synthesis of prostaglandins, including ketorolac, can cause a decrease in fertility, and therefore are not recommended for use by women planning to become pregnant. Precautions The course of treatment with Ketorol should not exceed 5 days. Taking Ketorol can lead to peptic ulcer disease and fatal gastrointestinal bleeding. The use of NSAIDs can lead to the development of cardiovascular diseases, myocardial infarction and stroke. Ketorol is contraindicated for postoperative treatment during coronary artery replacement. It is also not recommended to use in the postpartum period in obstetric practice in order to prevent possible massive atonic bleeding. Before the introduction of Ketorolac, hypovolemia and hypoproteinemia should be eliminated, as well as the water and electrolyte balance should be restored. Delay in the body of fluid, sodium chloride, oliguria, an increase in the concentration of urea nitrogen and plasma creatinine were observed during clinical studies, and therefore, ketorolac should be used with caution in patients with heart failure, arterial hypertension or pathological conditions with similar manifestations. Since ketorolac has an effect on platelet aggregation, the use in patients with pathology of the blood coagulation system should be carefully monitored. With extreme caution, ketorolac is prescribed simultaneously with anticoagulants. In patients over 65 years of age, adverse reactions characteristic of NSAIDs are more likely to occur, therefore, it is recommended to prescribe doses that are at the lower limit of the therapeutic range for this category of patients. Appointment to patients with impaired liver function: administered with caution. While taking ketorolac, an increase in the level of liver enzymes is possible. In the presence of functional abnormalities in the liver while taking ketorolac, a more severe pathology may develop. If signs of liver pathology are detected, treatment should be discontinued. Patients with renal insufficiency or a history of kidney disease: Ketorolac is prescribed with caution. Appointment to elderly patients: since patients of this age group often develop adverse reactions, the minimum effective dose should be used (daily therapeutic dose of not more than 60 mg for patients over 65 years of age). Interaction with other drugs Ketorolac slightly reduces the degree of binding to warfarin proteins. In vitro studies have shown the effect of therapeutic doses of salicylates on the degree of binding of ketorolac to plasma proteins downward from 99.2% to 97.5%. When combined with furosemide, its diuretic effect may be reduced by approximately 20%. Probenecid reduces the plasma clearance and volume of distribution of ketorolac, increases its plasma concentration and increases its half-life. Against the background of the use of ketorolac, a decrease in the clearance of methotrexate and lithium and an increase in the toxicity of these substances are possible. A possible interaction of ketorolac and non-depolarizing muscle relaxants, leading to the development of apnea, was noted. It is possible that concomitant use with ACE inhibitors may increase the risk of impaired renal function. Rare cases of the development of convulsive seizures have been described when Ketorolac is combined with anticonvulsants (phenytoin, carbamazepine). Perhaps the occurrence of hallucinations against the background of the simultaneous administration of ketorolac and psychostimulant drugs (fluoxetine, thiothixene, alprazolam). Contraindications Bronchial asthma, complete or partial nasal polyp syndrome, bronchospasm, angioedema in history. Peptic ulcer of the stomach and duodenum during an exacerbation, as well as a history of ulcers or gastrointestinal bleeding, the presence or suspicion of gastrointestinal or intracranial bleeding. History of coagulation disorders, conditions with a high risk of bleeding, hemorrhagic diathesis, coagulopathy, hemorrhagic stroke, low-dose heparin therapy. Surgical interventions with a high risk of bleeding or the risk of incomplete bleeding. Moderate and severe renal failure (plasma creatinine more than 50 mg / l), risk of renal failure, hypovolemia, dehydration. Pregnancy, childbirth and lactation. Hypersensitivity to ketorolac, aspirin, other NSAIDs or any component of the drug. Simultaneous use of other NSAIDs (risk of summation of side effects). Age up to 16 years. Congestive heart failure. The drug is not used for pain relief before and during surgical operations. Ketorolac is not used for epidural and intrathecal injections. Active ingredient – ketorolac tromethamine – 10 mg; excipients – microcrystalline cellulose, pregelatinized starch, corn starch, anhydrous colloidal silicon dioxide, magnesium stearate (E170). Shell: opadry 03K51148 green (hypromellose 6cP, titanium dioxide (E171), triacetin/glycerol triacetate, iron dioxide yellow (E172), FD&C blue/brilliant blue FCF lacquer (E133)). Overdose Ketorolac overdose with a single or repeated use is usually manifested by pain in the abdomen, the occurrence of peptic ulcers of the stomach or erosive gastritis, impaired renal function, hyperventilation, metabolic acidosis. These symptoms are cured after discontinuation of the drug. In these cases, gastric lavage, the introduction of adsorbents (activated charcoal) and symptomatic therapy are recommended. Ketorolac is not sufficiently eliminated by dialysis. Side effects The most common are gastrointestinal disorders, among which more than 10% of patients have nausea, pain in the stomach and intestines, dyspepsia; often there is diarrhea (7%). The central nervous system is characterized by disorders in the form of headache (17%), drowsiness (6%), dizziness (7%). Edema develops in 4% of cases. Somewhat less often, but more than 1% of patients develop hypertension, pruritus, rash, stomatitis, vomiting, constipation, flatulence, a feeling of heaviness in the abdomen, sweating and hemorrhagic rash. Less than 1% of patients may experience weight loss, fever, asthenia; palpitations, pallor of the skin, fainting; skin rash; gastritis, bleeding from the rectum, loss or increase in appetite, belching; nosebleeds, anemia, eosinophilia, tremor, sleep disturbances, hallucinations, euphoria, extrapyramidal syndromes, paresthesia, depression, nervousness, thirst, dryness of the oral mucosa, visual impairment, impaired attention, hyperkinesis, stupor; shortness of breath, pulmonary edema, rhinitis, cough; hematuria, proteinuria, oliguria, urinary retention, polyuria, increased urination. There have been cases of hypersensitivity reactions (in the form of anaphylaxis, anaphylactoid reaction, laryngeal edema, tongue edema); hypotension and flushing of the skin; Lyell’s syndrome, Stevens-Johnson syndrome, exfoliative dermatitis, maculopapular rash, urticaria; the formation of ulcers in the gastric mucosa, gastrointestinal bleeding, perforation of the walls of the organs of the gastrointestinal tract, melena, acute pancreatitis; postoperative wound bleeding, thrombocytopenia, leukopenia; hepatitis, liver failure, cholestatic jaundice; convulsions, psychoses, aseptic meningitis; bronchospasm, acute renal failure, pain in the kidney area, hematuria and azotemia, hyponatremia, hyperkalemia, hemolytic uremic syndrome. To prevent possible side effects, one should strive to use the minimum effective doses of the drug, strictly observe the established dosages and administration regimens, take into account the patient’s condition (age, kidney function, the state of the gastrointestinal tract, water-electrolyte metabolism and the hemostasis system), as well as possible drug interactions. with combination therapy. Storage conditionsStore in a dry, dark place at temperatures up to 25°C. Keep out of the reach of children. Buy Ketorol tablets p/o 10mg No. 10×2