Ketanov tab p / 10 mg of the film 20 pc


Ketanov tab p / 10 mg of the film 20 pc



Active substance:
1 coated tablet contains: ketorolac trometamol -10.00 mg.
Corn Starch – 44.76 mg, Microcrystalline Cellulose – 122.41 mg Colloidal silicon dioxide – 1.83 mg magnesium stearate – 1.00 mg hypromellose – 2.91 mg macrogol-400 – 0.68 mg talc peeled – 0.16 mg titanium dioxide – 1.25 mg.
Round biconvex tablets, film-coated, white or almost white color with «KVT» engraved on one side.
Product form:
Tablets, film-coated, 10 mg. 10 tablets in a blister made of aluminum foil and a film or a PVC blister of OPA-A1-PVC / A1. 1, 2, 3 or 10 blisters together with instructions for use in a cardboard box.
Hypersensitivity (including to other non-steroidal anti-inflammatory drugs);
Full or partial combination of asthma. recurrent nasal polyposis and paranasal sinuses and intolerance to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (including history); erosive and ulcerative lesions of the gastrointestinal tract and duodenal ulcer, active gastrointestinal bleeding, inflammatory bowel disease:
Severe renal impairment (creatinine clearance less than 30 mL / min). liver disease (exacerbation);
thyroid disease; Confirmed by hyperkalemia; Acute myocardial infarction;
Since the aortocoronary bypass surgery; Acute stroke (ischemic, hemorrhagic stroke); bone marrow and blood disease (leukopenia, including history, thrombocytopenia, hemophilia), myelosuppression; Severe myopathy, myasthenia gravis; Pregnancy, lactation, children’s age (16 years); The simultaneous use of probenecid;
The simultaneous use of pentoxifylline; The simultaneous use of aspirin and other nonsteroidal anti-inflammatory agents (including cyclo-oxygenase-2 inhibitors);
The simultaneous use of lithium salts; The simultaneous use of anticoagulants (including warfarin and heparin). The drug is not used: prophylactic analgesia before and during major surgery because of the high risk of bleeding; for the treatment of chronic pain.
Precautions: gastric ulcer and duodenal ulcer, ulcerative colitis, Crohn’s disease, a history of liver disease, hepatic porphyria, chronic renal failure (creatinine clearance of 30-60 ml / min), chronic heart failure, arterial hypertension, a significant reduction in circulating blood volume (including after surgery), elderly patients (including those receiving diuretics, debilitated patients with low body weight), bronchial asthma, simultaneous glyukokortikoste roidov (including prednisone), anticoagulants (including warfarin), antiplatelet agents (including acetylsalicylic acid, clopidogrel), selective serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxetine, sertraline), coronary heart disease, cerebrovascular diseases, dyslipidemia / hyperlipidemia, diabetes mellitus, peripheral arterial disease, smoking, presence of infection Helicobacter pylori, long-term use of anti-inflammatory drugs nesteroidngh, tuberculosis, expression osteoporosis, alcoholism, severe somatic diseases, hypotension, hypertension.
Pain syndrome secondary to severe intensity of various origins (including postoperative, for cancer and others).
Interaction with other drugs
The simultaneous use of ketorolac with acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (including cyclooxygenase-2 inhibitors), calcium preparations, glucocorticosteroids, ethanol, corticotropin may lead to results in a significant increase in the risk of adverse reactions, including ulceration of the gastrointestinal tract and the development of gastro -kishechnyh bleeding. The simultaneous use of nonsteroidal anti-inflammatory drugs is contraindicated. The simultaneous use of paracetamol enhances nephrotoxicity. MTX – hepato-and nephrotoxicity. Simultaneous application of ketorolac and methotrexate only possible by using low doses of the latter (to control the concentration of methotrexate in the blood plasma) and diuretic drugs (prostaglandin synthesis decreases in the kidneys). When combined with the opioid analgesic doses of the latter may be significantly reduced.
Antacids do not affect the absorption of the drug. Ketorolac enhances hypoglycemic effect of insulin and oral hypoglycemic agents (requires recalculation of the dose). The simultaneous use of sodium valproate causes disturbance of platelet aggregation. Increases plasma concentrations of nifedipine and verapamil. When applied with other nephrotoxic drugs (including those with gold preparations) increases the risk of nephrotoxicity. Drugs that block tubular secretion, reduce ketorolac clearance and increase its concentration in blood plasma. The simultaneous use of probenecid leads to an increase in the plasma concentration and half-life of ketorolac. The simultaneous use of probenecid is contraindicated. Concomitant use of lithium salts, and certain drugs that suppress the synthesis of prostaglandins. leads to disruption of excretion and increase plasma concentrations of lithium salts. The simultaneous use of lithium salts is contraindicated. With simultaneous application of cyclosporine, tacrolimus with ketorolac (and other NSAIDs) caution is recommended due to increased risk of nephrotoxicity. Reported cases of hematoma formation in HIV-infected patients with hemophilia who received both zidovudine and ibuprofen. Therefore, caution should be exercised while the use of NSAIDs and zidovudine. Ketorolac does not affect the bond of blood digoxin sbelkami. According to studies on animals, while the use of NSAIDs with quinolone antibiotics number increases the risk of seizures. Within 8-12 days after mifepristone is not recommended to use NSAIDs. because it is possible to reduce the effect of mifepristone.
Symptoms: abdominal pain, nausea, vomiting, occurrence of peptic ulcers or gastric erosive gastritis, renal failure, metabolic acidosis. Treatment: gastric lavage, administration of adsorbents (activated charcoal) and symptomatic therapy (maintenance of vital functions in the body). It does not appear sufficiently by dialysis.
pharmachologic effect
Pharmacological group:
Nonsteroidal anti-inflammatory drug (NSAID).
Ketorolac has a pronounced analgesic action, also has anti-inflammatory and antipyretic action moderate. The mechanism of action is related to non-selective inhibition of the activity of the enzyme cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2), mainly in the peripheral tissues, resulting in the inhibition of prostaglandins biosintaza – modulators of pain sensitivity and thermoregulation inflammation. Ketorolac is a racemic mixture of [-] S and [+] R enantiomers with the analgesic effect is due to [-] S shape. The drug has no effect on the opioid receptors, does not inhibit respiration does not cause drug dependence, no sedative and anxiolytic effects. By the force of an analgesic effect comparable to morphine is significantly superior to other non-steroidal anti-inflammatory drugs. After ingestion beginning analgesic effect observed after 1 hour, respectively, the maximum effect is achieved after 1 to 2 hours.
After oral administration of ketorolac is well absorbed in the gastrointestinal tract – the maximum concentration (Cmax) in plasma (0.7-1.1 ug / ml) is achieved within 40 minutes after taking the fasting dose of 10 mg. Fat-rich foods reduces the maximum concentration of drug in the blood and inhibits its achievement at 1:00. 99% of the drug is bound to plasma proteins, and hypoalbuminemia in blood increases the amount of free substance. Bioavailability – 80-100%). Time achieve equilibrium concentration (Css) when administered orally – 24 hours at 4 appointment times a day (subtherapeutic above) and after oral administration of 10 mg of 0,39-0,79 g / ml. The volume of distribution 0,15-0,33 l / kg. In patients with renal insufficiency volume of distribution of the drug can be increased by 2 times, and the volume of distribution of its R-enantiomer – 20%. Penetrates into breast milk, after receiving the first and second mother dose of 10 mg ketorolac Cmax is reached within 2 h in milk and is respectively 7.3 ng / ml and 7.9 g / l. More than 50% of the dose is metabolized in the liver to pharmacologically inactive metabolites formation. The major metabolites are glucuronides that are excreted by the kidneys, and p-gidroksiketorolak. Is displayed on the kidneys 91%, 6% – through the intestine. The half-life (T1 / 2) in patients with normal renal function is 2,4-9 hours after ingestion of 10 mg. T1 / 2 longer in the elderly and in young shortened. liver function has no effect on the T1 / 2. Patients with impaired renal function in creatinine concentration in blood plasma of 19-50 mg / l (168-442 micromol / L). T1 / 2 is 10,3-10,8 h, more renal failure – over 13.6 hours total clearance is the ingestion of 10 mg – 0.025 L / kg / hr.; in renal failure at a concentration in the blood plasma creatinine 19-50 mg / l when administered 10 mg to 0,016 l / kg / hr. It does not appear in hemodialysis.
Pregnancy and breast-feeding
Safety of use during pregnancy, this drug has not been established. Use during the third trimester of pregnancy drugs. violating prostaglandin synthesis, it may cause premature closure of the ductus arteriosus and the weakening of uterine capacity. Due to violation of uterine contractions a slowing of labor and increases the risk of uterine bleeding. Ketorolac gets into breast milk. As a mother and a child increases the risk of bleeding. Use of the drug Ketanov contraindicated in pregnancy and during breastfeeding.
Conditions of supply of pharmacies
At temperatures above 25 ° C. Keep out of the reach of children.
side effects
By frequency side effects are separated according to WHO criteria into the following categories: very often (> 1: 10), often (> 1: 100 and
special instructions
Ketorolac inhibits platelet aggregation and increases the blood clotting. Effect on platelet aggregation is terminated after 24-48 hours. Hypovolemia increases the risk of adverse reactions from the kidney. If necessary, can be administered in combination with a narcotic analgesic. Ketanov not recommended for use as an agent for sedation and anesthesia support. When ketorolac reported cases of fluid retention, hypertension and edema. Caution should be exercised when administered to patients with heart failure, hypertension. The simultaneous use of other nonsteroidal anti-inflammatory drugs may lead to disturbance as a decompensation of heart failure, high blood pressure. Patients with impaired blood clotting prescribe the drug only under constant control of the number of platelets, which is especially important in the postoperative period, requiring careful control of hemostasis. According to clinical studies, the use of certain non-steroidal anti-inflammatory drugs at high doses can lead to an increased risk of arterial thrombotic complications (e.g., myocardial infarction, stroke). Despite the fact that on such complications have been reported with the use of ketorolac, existing data are insufficient to eliminate the risk of such complications. The risk of adverse reactions increases the elongational treatment period and increasing oral doses of 40 mg / day. To reduce the risk of developing NSAID-gastropathy recommended to use antacids, misoprostol, and drugs that reduce gastric acid secretion (histamine blockers Hl-receptors, proton pump inhibitors). Effect of the drug for medical use in the ability to operate vehicles, machinery. During the period of treatment may develop side effects from the central nervous system (drowsiness, dizziness, headache), which reduces the rate of mental and motor reactions, and therefore it is necessary to refrain from driving vehicles and Occupation other potentially hazardous activities that require high concentration and psychomotor speed reactions.
Storage conditions
At temperatures above 25 ° C. Keep out of the reach of children.
Dosing and Administration
In tablets Ketanov administered orally once or repeated depending on the severity of pain. A single dose – 10 mg, repeated at reception recommended to take 10 mg up to 4 times a day depending on the severity of pain; the maximum daily dose should not exceed 40 mg. If ingestion course duration should not exceed 5 days.
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist

Additional information

Weight0.100 kg

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