Active substanceKetorolacKetorolac
Similar drugsTo uncover
  • Akyular LS
    drops d / eye 
    Allergen, Inc.     USA
  • Vatorlak
    solution w / m in / in 
    Novator Pharma, LLC     United Kingdom
  • Dolac
    solution w / m in / in 
  • Dolac
    pills inwards 
  • Dolomin®
    solution w / m in / in 
  • Cetadrope®
    drops d / eye 
  • Ketalgin®
    pills inwards 
  • Ketalgin®
    solution w / m in / in 
  • Ketanov®
    pills inwards 
  • Ketanov®
    solution w / m 
  • Ketokam®
    pills inwards 
  • Ketolac®
    solution w / m in / in 
    ALTAYVITAMINS, CJSC     Russia
  • Ketolac®
    pills inwards 
    ALTAYVITAMINS, CJSC     Russia
  • Ketorol®
    solution w / m in / in 
  • Ketorol®
    gel externally 
  • Ketorol®
    pills inwards 
  • Ketorolac
    pills inwards 
    VERTEKS, AO     Russia
  • Ketorolac
    solution w / m in / in 
  • Ketorolac
    pills inwards 
  • Ketorolac
    solution w / m 
  • Ketorolac
    solution w / m in / in 
    ELFA NPC, CJSC     Russia
  • Ketorolac
    pills inwards 
  • Ketorolac
    solution w / m in / in 
    BIOSINTEZ, PAO     Russia
  • Ketorolac
    solution w / m in / in 
    ELLARA, LTD.     Russia
  • Ketorolac
    pills inwards 
    LEKHIM-KHARKOV, CJSC     Ukraine
  • Ketorolac
    pills inwards 
  • Ketorolac
    solution w / m in / in 
  • Ketorolac
    solution w / m 
    TRIVIUM-XXI, LLC     Russia
  • Ketorolac
    solution w / m in / in 
  • Ketorolac
    solution w / m 
  • Ketorolac - SOLOFARM
    solution w / m in / in 
    GROTEKS, LLC     Russia
  • Ketorolac Rhompharm
    solution w / m in / in 
  • Ketorolac-OBL
    pills inwards 
  • Ketorolak-Eskom
    solution w / m in / in 
    ESKOM NPK, OAO     Russia
  • Ketofril®
    pills inwards 
  • Ketofril®
    solution w / m in / in 
  • Dosage form: & nbspfilm coated tablets
    Composition:

    1 tablet, film-coated, contains:

    active substance: ketorolac trometamol (ketorolac tromethamine) 10 mg;

    Excipients: cellulose microcrystalline 120 mg, lactose monohydrate (tablets 80 mesh) 69 mg, magnesium stearate 1 mg, opadrai II [hydroxypropylmethylcellulose (hypromellose), lactose monohydrate, macrogol 4000, titanium dioxide] 5 mg.

    Description:The tablets covered with a film cover, white color, rough, round, biconcave form.
    Pharmacotherapeutic group:non-steroidal anti-inflammatory drug (NSAID)
    ATX: & nbsp

    M.01.A.B.15   Ketorolac

    Pharmacodynamics:Non-steroidal anti-inflammatory drug. Has a pronounced analgesic effect, has also anti-inflammatory and moderate antipyretic action. The mechanism of action is associated with nonselective inhibition of cyclooxygenase activity1 and cyclooxygenases2, which catalyzes the formation of prostaglandins from arachidonic acid, which play an important role in the pathogenesis of pain, inflammation and fever.By the strength of the analgesic effect comparable to morphine, it is much superior to other non-steroidal anti-inflammatory drugs.

    After ingestion, the onset of analgesic action is noted through 0,5-1 h, the maximum effect is achieved in 2-3 hours.

    Pharmacokinetics:

    Absorption at intake - fast, bioavailability - 80-100%. The maximum concentration (Cmah) after taking 10 mg - 0.82-1.46 μg / ml, the time to reach the maximum concentration (TCmah) - 10-78 minutes.

    The equilibrium concentration (Css) is achieved after 24 hours in the appointment 4 once a day and is after taking 10 mg - 0.39-0.79 μg / ml. The connection with plasma proteins is 99%.

    The volume of distribution is 0.15-0.33 l / kg. In patients with renal insufficiency, the volume of ketorolac distribution may increase 2-fold, and the volume of distribution of ketorolac R-enantiomer by 20%.

    Penetrates into breast milk: when the mother receives 10 mg of ketorolac, the maximum concentration (Cmah) in milk is achieved 2 hours after the first dose and is 7.3 ng / ml, 2 hours after the second dose of ketorolac (using the drug 4 times a day) - 7.9 ng / l.

    More than 50% of the administered dose is metabolized in the liver with the formation of pharmacologically inactive metabolites.The main metabolites are glucuronides, which are excreted by the kidneys, and p-hydroxycetorolac.

    It is excreted on 91% by kidneys, 6% - through the intestinesto.

    The half-life in patients with normal renal function is 2.4-9 hours after taking 10 mg. Half-life is prolonged in elderly patients and is shortened in young patients. The function of the liver has no effect on the half-life. In patients with impaired renal function with a creatinine concentration in the plasma of 19-50 mg / l (168-442 μmol / L), the half-life is 10.3-10.8 hours, with more pronounced renal failure - more than 13.6 hours.

    The total clearance is 10 mg 0.025 l / h / kg; in patients with renal insufficiency with a plasma creatinine concentration of 19-50 mg / l with 10 mg - 0.016 l / h / kg.

    It is not excreted by hemodialysis.

    Indications:Pain syndrome of strong and moderate severity: trauma, toothache, pain in the postpartum and postoperative period, oncological diseases, myalgia, arthralgia, neuralgia, sciatica, ligament injuries, rheumatic diseases.
    Contraindications:

    Hypersensitivity, a complete or incomplete combination of bronchial asthma,recurrent nasal polyposis and paranasal sinuses and intolerance to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (including anamnesis), urticaria, rhinitis caused by the use of non-steroidal anti-inflammatory drugs (in the anamnesis); intolerance to drugs of pyrazolone series, hypovolemia (regardless of the cause that caused it), erosive and ulcerative lesions of the gastrointestinal tract in the acute stage, hypocoagulation (including hemophilia), bleeding or a high risk of their development, severe renal failure (creatinine clearance less than 30 ml / min), severe hepatic insufficiency or active liver disease, condition after aortocoronary shunting, confirmed hyperkalemia, pregnancy (III trimester), inflammatory diseases intestine, delivery, lactation, children under 16 years of age (safety and efficacy not established).

    Carefully:

    Bronchial asthma, the presence of factors that increase gastrointestinal toxicity: alcoholism, tobacco smoking and cholecystitis; postoperative period, chronic heart failure, edematous syndrome,arterial hypertension, impaired renal function (plasma creatinine below 50 mg / L), cholestasis, active hepatitis, sepsis, systemic lupus erythematosus, simultaneous administration with other non-steroidal anti-inflammatory drugs, coronary heart disease, cerebrovascular disease, dyslipidemia / hyperlipidemia, diabetes mellitus, diseases peripheral arteries, chronic renal failure (creatinine clearance 30-60 ml / min), ulcerative lesions of the gastrointestinal tract in an anamnesis, the presence of infection H.pylori, long-term use of non-steroidal anti-inflammatory drugs, severe somatic diseases, simultaneous administration of oral glucocorticosteroids (including prednisolone), anticoagulants (including warfarin), antiplatelet agents (including clopidogrel), selective serotonin reuptake inhibitors ( including citalopram, fluoxetine, paroxetine, sertraline), elderly age (over 65 years), pregnancy.

    Dosing and Administration:

    Inside.

    Patients from 16 to 64 years with a body weight exceeding 50 kg, the recommended dose is 20 mg in the first dose, then 10 mg 4 times a day, but not more than 40 mg / day.

    Adult patients with a body weight of less than 50 kg or with kidney failure - 10 mg in the first dose and then 10 mg 4 times a day.

    The maximum daily dose is 40 mg.

    The duration of treatment should not exceed 5 days.

    Side effects:

    Often - more than 3%, less often - 1-3%, rarely - less than 1%.

    From the digestive system: often (especially in elderly patients over 65 years of age, having a history of erosive and ulcerative lesions of the gastrointestinal tract) - gastralgia, diarrhea; less often - stomatitis, flatulence, constipation, vomiting, sensation of stomach overflow; rarely - loss of appetite, nausea, erosive and ulcerative lesions of the gastrointestinal tract (including with perforation and / or bleeding - abdominal pain, spasm or burning in the epigastric region, blood in the feces or melena, vomiting with blood or by type " coffee grounds, "nausea, heartburn and others), cholestatic jaundice, hepatitis, hepatomegaly, acute pancreatitis.

    From the urinary system: rarely acute renal failure, back pain, hematuria, azotemia, hemolytic-uremic syndrome (hemolytic anemia, renal failure, thrombocytopenia, purpura), increased urination, increased or decreased urine volume, nephritis, edema of renal genesis.

    From the sense organs: rarely - hearing loss, ringing in the ears, visual impairment (including blurred vision).

    From the respiratory system: rarely - bronchospasm or dyspnoea, rhinitis, pulmonary edema, laryngeal edema (shortness of breath, difficulty breathing).

    From the central nervous system: often - headache, dizziness, drowsiness; rarely - aseptic meningitis (fever, severe headache, cramps, stiffness in the neck muscles and / or back), hyperactivity (mood changes, anxiety), hallucinations, depression, psychosis, fainting.

    From the cardiovascular system: less often - increased blood pressure.

    On the part of the organs of hematopoiesis: rarely - anemia, eosinophilia, leukopenia.

    From the side of the hemostasis system: rarely - bleeding from a postoperative wound, epistaxis, rectal bleeding.

    From the skin: less often - skin rash (including maculopapular rash), purpura; rarely exfoliative dermatitis (fever with chills or without, hyperemia, densification or flaking of the skin, swelling and / or tenderness of the tonsils), urticaria, malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome).

    Allergic reactions: rarely anaphylaxis or anaphylactoid reactions (skin color change of the face, skin rash, hives, skin itch, tachypnea or dyspnea, edema of the eyelids, periorbital edema, shortness of breath, shortness of breath, chest pain, wheezing).

    Other: often - swelling (face, legs, ankles, fingers, feet, weight gain); less often - increased sweating, rarely - swelling of the tongue, fever.

    Overdose:

    Symptoms: nausea, vomiting, abdominal pain, erosive and ulcerative lesions of the gastrointestinal tract, renal dysfunction metabolic acidosis.

    Treatment: symptomatic therapy (maintenance of vital body functions). Dialysis is ineffective.
    Interaction:

    Co-administration with paracetamol increases the nephrotoxicity of ketorolac.

    Use with other non-steroidal anti-inflammatory drugs, glucocorticosteroids, ethanol, corticotropin, calcium preparations increases the risk of ulceration of the gastrointestinal mucosa and the development of gastrointestinal bleeding.

    Simultaneous administration with anticoagulants-derivatives of coumarin and indanedione,

    heparin, thrombolytics (alteplase, streptokinase, urokinase), antiplatelet agents, cephalosporins, valproic acid and acetylsalicylic acid increases the risk of bleeding.

    Reduces the effect of antihypertensive and diuretic drugs (reduces the synthesis of prostaglandin in the kidneys).

    The appointment together with methotrexate increases hepato- and nephrotoxicity (their joint appointment is possible only with the use of low doses of the latter and control of its concentration in the plasma).

    At appointment with other nefrotoksicnymi medical products (including with preparations of gold) the risk of development nefrotoksichnosti raises.

    Drugs that block tubular secretion, reduce the clearance of ketorolac and increase its concentration in the plasma.

    Increases the effect of narcotic analgesics.

    Myelotoxic drugs - increased hematotoxicity.

    Special instructions:

    Before prescribing the drug, it is necessary to clarify the question of a previous allergy on a drug or non-steroidal anti-inflammatory drug (NSAID). Because of the risk of developing allergic reactions, the first dose is administered under close supervision of the doctor.

    Hypovolemia increases the risk of developing nephrotoxic adverse reactions.

    If necessary, you can prescribe in combination with narcotic analgesics.

    It is not recommended to be used as a medicine for premedication, maintenance of anesthesia.

    When combined with other non-steroidal anti-inflammatory drugs, fluid retention, cardiac decompensation, and increased blood pressure may occur. The effect on platelet aggregation stops after 24-48 hours.

    Do not use simultaneously with paracetamol for more than 5 days.

    Patients with blood clotting disorder are appointed only with a constant control of the number of platelets, it is especially important for postoperative patients requiring careful control of hemostasis.

    The risk of developing drug complications increases with prolonged treatment (in patients with chronic pain) and an increase in the dose of the drug more than 40 mg / day.

    To reduce the risk of NSAID-gastropathy, antacid medicines are prescribed, misoprostol, omeprazole.
    Effect on the ability to drive transp. cf. and fur:

    During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

    Form release / dosage:

    Tablets, film-coated, 10 mg.

    Packaging:

    For 10 or 20 tablets in a contour mesh package.

    1, 2 contourcell packs of 10 tablets or 1 circuit cell pack of 20 tablets together with instructions for use are placed in a pack of cardboard.

    Storage conditions:

    In a dry, the dark place at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use after the time specified on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-000902
    Date of registration:18.10.2011
    The owner of the registration certificate:TATHIMFARMPREPARATY, JSC TATHIMFARMPREPARATY, JSC Russia
    Manufacturer: & nbsp
    Representation: & nbspTATHIMFARM PREPARATIONS OJSC TATHIMFARM PREPARATIONS OJSC Russia
    Information update date: & nbsp18.10.2011
    Illustrated instructions
      Instructions
      Up