What are ketorolac ketane tablets for? Ketanov - an indispensable helper for toothache or a gentle killer? Use during pregnancy and lactation


  • Instructions for use Ketanov
  • Composition of the drug Ketanov
  • Indications for the drug Ketanov
  • Storage conditions for the drug Ketanov
  • Shelf life of the drug Ketanov

ATX Code: Musculoskeletal system (M) > Anti-inflammatory and antirheumatic drugs (M01) > Non-steroidal anti-inflammatory drugs (M01A) > Derivatives acetic acid(M01AB) > Ketorolac (M01AB15)

Release form, composition and packaging

tab., cover coated, 10 mg: 10 or 100 pcs.
Reg. No.: 695/95/2000/05/10/15 dated 12/03/2015 - Valid

Film-coated tablets white or almost white, round, biconvex, marked "KVT" on one side.

Excipients: microcrystalline cellulose, corn starch, magnesium stearate, talc, colloidal anhydrous silicon dioxide, hypromellose, macrogol, titanium dioxide (E171).

10 pieces. - blisters (1) - cardboard boxes.
10 pieces. - blisters (10) - cardboard boxes.

Description medicinal product KETANOV based on officially approved instructions for use of the drug and made in 2017. Date updated: 12/22/2017


pharmachologic effect

Ketorolac tromethamine is a non-narcotic analgesic, NSAID. Shows anti-inflammatory and weak antipyretic activity. Ketorolac tromethamine inhibits prostaglandin synthesis and is considered a peripherally acting analgesic. Has no known effect on opioid receptors. Following the use of ketorolac tromethamine, no events indicating respiratory depression were observed in controlled clinical studies. Ketorolac tromethamine does not cause pupillary constriction.

Pharmacokinetics

Suction

After oral administration, ketorolac is absorbed quickly and completely from the gastrointestinal tract, with Cmax in plasma reached after 50 minutes and amounting to 0.87 mcg/ml. A diet rich in fat reduces the rate of absorption, but not the volume, while antacids do not affect the absorption of ketorolac.

Distribution

After intravenous administration of a single dose, Vd is 0.25 l/kg. More than 99% of ketorolac in blood plasma is protein bound. After single and repeated use, the pharmacokinetics of ketorolac is linear. C ss in blood plasma is achieved after 1 day when used 4 times a day. No changes were observed with long-term use.

Removal

After intravenous administration of a single dose, T1/2 is 5 hours, clearance is 0.55 ml/min/kg. In healthy volunteers, terminal T1/2 from blood plasma is, on average, 5.4 hours.

Ketorolac and its metabolites (conjugates and p-hydroxymetabolites) are excreted mainly in the urine - 91.4%, the rest - in feces.

Pharmacokinetics in special clinical situations

In elderly patients ( average age 72 years old) T 1/2 is 6.2 hours.

Indications for use

  • short-term treatment acute pain(including postoperative pain) of moderate intensity, only as a continuation of previous parenteral (IM or IV) therapy in a hospital setting, if necessary.

The total duration of parenteral and oral therapy with ketorolac should not exceed 5 days.

Dosage regimen

The drug is taken orally during or after meals.

In order to minimize side effects the drug should be used in the least effective dose for the shortest period of time necessary to control symptoms.

Before starting treatment, it is necessary to achieve normovolemia.

For adults Prescribe 10 mg every 4-6 hours if necessary. It is not recommended to use the drug in doses exceeding 40 mg/day.

In patients who simultaneously receive ketorolac parenterally and orally (in tablet form), the total daily dose ketorolac should not exceed 90 mg, in elderly patients, patients with impaired renal function and patients weighing less than 50 kg- 60 mg. Patients must be transferred to oral administration drug as early as possible.

Elderly patients have a higher risk of developing severe complications, in particular, from the side digestive tract. During treatment with NSAIDs, the patient's condition should be regularly monitored; a longer interval between doses of the drug is usually recommended, for example, 6-8 hours.

Side effects

From the outside digestive system: anorexia, dry mouth, 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 of the stomach, melena, rectal bleeding, ulcerative stomatitis, vomiting, hemorrhage, perforation, pancreatitis, exacerbation of colitis and Crohn's disease, impaired liver function, hepatitis, jaundice and liver failure, changes in functional tests.

From the nervous system: anxiety, drowsiness, dizziness, nervousness, paresthesia, depression, euphoria, convulsions, inability to concentrate, insomnia, agitation, disturbance taste sensations, unusual dreams, confusion, hallucinations, hyperkinesia, psychotic reactions, thinking disorders.

From the side of the organ of vision: visual impairment, optic neuritis.

Hearing and vestibular disorders: vertigo, hearing loss, ringing in the ears.

From the side of metabolism: hyponatremia, hyperkalemia.

From the outside of cardio-vascular system: flushing of the face, bradycardia, pallor, hypertension, hypotension, palpitation, pain in chest, the occurrence of edema, heart failure. Data from clinical and epidemiological studies indicate that the use of certain NSAIDs, especially in high doses and for long periods of time, may be associated with an increased risk of arterial thromboembolic complications (myocardial infarction or stroke).

From the respiratory system: nosebleeds, shortness of breath, asthma, pulmonary edema.

From the hematopoietic system: thrombocytopenia, neutropenia, agranulocytosis, aplastic and hemolytic anemia.

From the urinary system: increased frequency of urination, oliguria, acute renal failure, hemolytic uremic syndrome, increased content serum urea and creatinine, interstitial nephritis, urinary retention, nephrotic syndrome, kidney failure.

For the skin and subcutaneous tissues: itching, urticaria, photosensitivity of the skin, Lyell's syndrome, bullous reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis (very rare), exfoliative dermatitis, maculopapular rashes, increased sweating.

Influence at reproductive function: the use of ketorolac, like any drug that inhibits COX/prostaglandin synthesis, can cause infertility.

Infectious diseases: aseptic meningitis (especially in patients with autoimmune diseases, such as systemic lupus erythematosus, mixed disease connective tissue).

Allergic reactions: reactions have been reported hypersensitivity which include nonspecific allergic reactions and anaphylaxis, respiratory tract reactivity including asthma, worsening asthma, bronchospasm, laryngeal edema or shortness of breath, and a variety of skin disorders that include rashes different types, itching, urticaria, purpura, angioedema, and in isolated 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 may also occur in individuals with a history of angioedema, bronchospastic reactivity (eg, asthma and nasal polyposis). Anaphylactoid reactions, such as anaphylaxis, can be fatal.

Others: postoperative bleeding from a wound, purpura, hematoma, prolongation of bleeding time, asthenia, edema, weight gain, increased body temperature, excessive thirst, fatigue, malaise, fever, chest pain, myalgia, increased fatigue.

Contraindications for use

  • active peptic ulcer with recent gastrointestinal bleeding or perforation;
  • peptic ulcer stomach and duodenum or a history of gastrointestinal bleeding;
  • bronchial asthma, rhinitis, angioedema or urticaria caused by use acetylsalicylic acid or other NSAIDs (due to the potential for severe anaphylactic reactions);
  • history of bronchial asthma;
  • as an analgesic before and during surgery;
  • severe heart failure;
  • complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses, Quincke's edema and intolerance to acetylsalicylic acid or other NSAIDs;
  • surgery a history of high risk of hemorrhage or incomplete bleeding control;
  • simultaneous use of anticoagulants, including low doses of heparin (2500-5000 units every 12 hours);
  • liver failure;
  • moderate and severe renal failure (serum creatinine concentration more than 160 µmol/l);
  • suspected or confirmed cerebrovascular bleeding;
  • bleeding diathesis, including blood clotting disorders and a high risk of bleeding;
  • simultaneous treatment with other NSAIDs (including selective COX inhibitors), acetylsalicylic acid, warfarin, pentoxifylline, probenecid or lithium salts;
  • hypovolemia, dehydration;
  • pregnancy, labor and childbirth;
  • breastfeeding period;
  • age up to 16 years;
  • hypersensitivity to ketorolac or any component of the drug.

Use during pregnancy and breastfeeding

The safety of ketorolac during pregnancy in humans has not been established. Given the known effect of NSAIDs on the cardiovascular system of the fetus (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 bleeding to occur in both mother and baby.

Ketorolac is excreted in breast milk in small quantities, therefore Ketanov is contraindicated during breastfeeding.

The use of ketorolac, as with any drug that inhibits COX/prostaglandin synthesis, may impair fertility and is not recommended for use in women who are planning to become pregnant. For women who are unable to become pregnant or are undergoing fertility investigations, discontinuation of ketorolac should be considered.

Use for renal impairment

The use of the drug is contraindicated in moderate and severe renal failure (serum creatinine concentration more than 160 µmol/l).

special instructions

The maximum duration of treatment should not exceed 5 days.

Gastrointestinal bleeding, ulceration and perforation

Gastrointestinal bleeding, ulceration or perforation, which may be fatal, has been reported with the use of NSAIDs at any time during treatment, with or without warning symptoms or in the case of a history of severe gastrointestinal disorders. The risk of severe gastrointestinal bleeding depends on the dosage of the drug. This particularly applies to elderly patients who use ketorolac at an average daily dose of more than 60 mg. For these patients, as well as for patients who are concomitantly using low doses of acetylsalicylic acid or other drugs that may increase gastrointestinal risk, combination treatment with protective agents (eg, misoprostol or proton pump inhibitors) should be considered. Ketanov is used with caution in patients who are concomitantly receiving drugs that may increase the risk of ulceration or bleeding, such as oral corticosteroids, selective serotonin reuptake inhibitors, or antiplatelet agents such as acetylsalicylic acid. If gastrointestinal bleeding or ulceration occurs in patients receiving Ketanov, treatment should be discontinued.

Respiratory dysfunction

Caution is required when using the drug in patients with bronchial asthma(or with a history of asthma), since NSAIDs have been reported to precipitate the onset of bronchospasm in such patients.

Effect on kidney function

Prostaglandin biosynthesis inhibitors (including NSAIDs) have been reported to have nephrotoxic effects. The drug should be prescribed with caution to patients with impaired renal, cardiac, or liver function, since use of NSAIDs may lead to deterioration of kidney function. Patients with minor renal impairment are prescribed lower doses of ketorolac (those that do not exceed 60 mg/day IM or IV), and the renal condition of such patients should also be carefully monitored. As with other drugs that inhibit prostaglandin synthesis, increases in serum urea, creatinine and potassium have been reported during use of ketorolac tromethamine, which may occur after a single dose.

Cardiovascular, renal and liver disorders

The drug is prescribed with caution to patients with conditions that lead to a decrease in blood volume and/or a decrease in renal blood flow, when renal prostaglandins play a supporting role in ensuring renal perfusion. In these patients, renal function should be monitored. The volume reduction should be corrected and serum urea and creatinine levels and the volume of urine excreted carefully monitored until the patient becomes normovolemic. In patients on renal dialysis, the clearance of ketorolac was reduced by approximately half the normal rate, and the final T1/2 increased approximately threefold. Patients with impaired liver function due to cirrhosis did not have any clinically significant changes in ketorolac clearance or terminal T1/2. Borderline elevated values ​​on one or more liver function tests may occur. These abnormalities may be temporary, may remain unchanged, or may progress with continued treatment. If Clinical signs and symptoms indicate the development of liver disease or if systemic manifestations are observed, Ketanov should be discontinued.

Fluid retention and swelling

Fluid retention and edema have been reported during use of ketorolac, so the drug should be administered with caution to patients with cardiac decompensation, hypertension, or similar conditions.

Cardiovascular and cerebrovascular effects

There is currently insufficient information to assess such a risk for ketorolac tromethamine. Patients with uncontrolled hypertension, congestive heart failure, diagnosed coronary artery disease, peripheral arterial disease and/or cerebrovascular disease should be under medical supervision.

Systemic lupus erythematosus and mixed connective tissue diseases

In patients with systemic lupus erythematosus and various mixed connective tissue diseases, the risk of developing aseptic meningitis increases.

Dermatological reactions

Ketanov should be discontinued at the first signs of a skin rash, damage to the mucous membranes or any other signs of hypersensitivity.

Anaphylactic (anaphylactoid) reactions

As with the use of other NSAIDs, anaphylactic (anaphylactoid) reactions (including anaphylaxis, bronchospasm, flushing, rash, hypotension, laryngeal edema, angioedema) may occur in patients who have no or no history of hypersensitivity reactions to aspirin, other NSAIDs or ketorolac. This complex symptoms may also occur in individuals with a history of bronchospastic reactivity (eg, asthma) and nasal polyps. Anaphylactoid reactions, such as anaphylaxis, can be fatal. Therefore, ketorolac should not be taken by patients with a history of asthma and patients with a complete or incomplete combination of bronchial asthma, recurrent nasal polyposis and paranasal sinuses, and Quincke's edema. If anaphylactoid reactions occur, seek emergency medical attention.

Hematological effects

Patients with bleeding disorders should not be prescribed Ketanov. Patients receiving anticoagulant therapy may have an increased risk of bleeding if ketorolac is used concomitantly. The condition of patients who are receiving other drugs that can affect the rate of bleeding control should be carefully monitored when prescribing ketorolac. In controlled clinical trials, the incidence of significant postoperative bleeding was less than 1%. Ketorolac inhibits platelet aggregation and prolongs bleeding time. In patients with normal bleeding time, the duration of bleeding increased, but did not go beyond the normal range of 2-11 minutes. In contrast to the long-term effects resulting from the use of acetylsalicylic acid, platelet function returns to normal within 24-48 hours after discontinuation of ketorolac. Ketorolac should not be prescribed to patients who have undergone surgery with a high risk of bleeding or incomplete control of bleeding. Caution should be used if mandatory bleeding control is critical. Ketanov is not an anesthetic agent and does not have sedative or anxiolytic properties; therefore, it is not recommended as a pre-operative sedative to maintain anesthesia.

Use in pediatrics

The drug is not used in children and adolescents under 16 years of age.

Impact on the ability to drive vehicles and operate machinery

Some patients may experience drowsiness, dizziness, vertigo, insomnia, fatigue, blurred vision, or depression when using ketorolac. If the patient experiences the above or other similar side effects, you should not drive or operate machinery.

Overdose

Symptoms: headache, nausea, vomiting, epigastric pain, gastrointestinal bleeding;

  • rarely - diarrhea, disorientation, agitation, coma, drowsiness, dizziness, ringing in the ears, 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 use of NSAIDs in therapeutic doses, which can occur after an overdose.
  • Treatment: gastric lavage, application activated carbon. It is necessary to ensure sufficient diuresis. Kidney and liver function should be carefully monitored. Patients should be monitored for at least 4 hours after ingestion of a potentially toxic amount. Frequent or prolonged seizures should be treated with IV diazepam. Other measures may be prescribed depending on the patient's clinical condition. Carrying out symptomatic therapy.

    Drug interactions

    Opioid analgesics (eg, morphine, pethidine) can be used concomitantly; ketorolac does not affect the binding of opioid drugs and does not increase respiratory depression or sedative effect, which is typical for opioids.

    Contraindicated combinations

    Due to the possibility of side effects, ketorolac should not be prescribed with other NSAIDs, including selective COX-2 inhibitors, or in patients receiving acetylsalicylic acid, warfarin, lithium, probenecid, cyclosporine.

    NSAIDs should not be prescribed within 8-12 days after using mifepristone, since NSAIDs may weaken the effect of mifepristone.

    Combinations to use with caution

    In healthy normovolemic individuals, ketorolac reduces the diuretic effect of furosemide by approximately 20%; therefore, the drug is prescribed with particular caution to patients with cardiac decompensation.

    NSAIDs may worsen heart failure, reduce glomerular filtration rate, and increase plasma concentrations of cardiac glycosides when coadministered with cardiac glycosides.

    Ketorolac and other NSAIDs may weaken the effect of antihypertensive drugs. In case of simultaneous use of ketorolac with ACE inhibitors there is an increased risk of renal dysfunction, especially in patients with reduced blood volume.

    Exists possible risk manifestations of nephrotoxicity if NSAIDs are prescribed together 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, caution is required when coadministering corticosteroids due to the increased risk of gastrointestinal ulcers or bleeding.

    There is an increased risk of gastrointestinal bleeding if NSAIDs are prescribed in combination with antiplatelet agents and selective serotonin reuptake inhibitors.

    Caution is advised if methotrexate is coadministered 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 have an increased risk of developing seizures.

    Concomitant 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 with hemophilia who are treated with both zidovudine and ibuprofen.

    Drugs that are unlikely to interact with ketorolac

    Ketorolac did not affect the binding of digoxin to plasma proteins. In vitro studies indicate that at therapeutic concentrations of salicylate (300 μg/ml) and higher, ketorolac binding was reduced by approximately 99.2% to 97.5%. Therapeutic concentrations of digoxin, warfarin, paracetamol, phenytoin and tolbutamide did not affect the binding of ketorolac to plasma proteins. Because ketorolac is a highly active drug and its available plasma concentration is low, it is not expected to significantly replace other drugs that bind to plasma proteins. There is no evidence from animal or human studies 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 mechanisms of enzyme induction or inhibition.

    Contacts for inquiries

    SUN PHARMACEUTICAL INDUSTRIES Ltd. LLC, representative office, (India)

    Ketanov is a non-steroidal anti-inflammatory drug with pronounced analgesic, anti-inflammatory and moderate antipyretic effects, a derivative of pyrrolysine-carboxylic acid.

    Release form and composition

    Ketanov is available in the form:

    • Film-coated tablets of white or almost white color, round, biconvex shape (10 pieces in a blister; in a cardboard pack there are 1, 2, 3 or 10 blister packs);
    • Solution for intramuscular injection, transparent, colorless or pale yellow (1 ml in ampoules; 5 or 10 ampoules in a cardboard box).

    The active ingredient is ketorolac tromethamine (10 mg in 1 tablet and 30 mg in 1 ml of solution for injection).

    Auxiliary components of tablets: colloidal silicon dioxide, magnesium stearate, corn starch, microcrystalline cellulose.

    Film shell composition: macrogol 400, titanium dioxide, hydroxypropyl methylcellulose, purified talc, purified water (lost during the production process).

    Auxiliary components of the solution: disodium edetate, sodium hydroxide, ethanol, sodium chloride, water for injection.

    Indications for use

    Ketanov is used for pain of various origins of medium and severe intensity (including pain in the postoperative period and for cancer).

    Contraindications

    Contraindications to the use of Ketanov are:

    • Renal and/or liver failure (with plasma creatinine levels above 50 mg/ml);
    • Peptic ulcers, erosive-ulcerative lesions gastrointestinal tract in the acute stage, hypocoagulation (including hemophilia);
    • Hemorrhagic diathesis, hemorrhagic stroke(suspected or confirmed), impaired hematopoiesis, high risk of relapse or bleeding (including after surgery);
    • Treatment of chronic pain;
    • Anesthesia before or during surgery (due to the increased risk of bleeding);
    • Simultaneous administration with other NSAIDs;
    • Children's and adolescence up to 16 years of age, since safety and effectiveness have not been established;
    • Pregnancy, childbirth, breastfeeding period;
    • Hypersensitivity to ketorolac or other NSAIDs, angioedema, bronchospasm, aspirin asthma, dehydration and hypovolemia.

    Ketanov is prescribed with caution to persons over 65 years of age and to patients with the following diseases:

    • Chronic heart failure;
    • Bronchial asthma;
    • Arterial hypertension;
    • Cholecystitis;
    • Impaired renal function (with plasma creatinine levels below 50 mg/ml);
    • Sepsis;
    • Active hepatitis;
    • Cholestasis;
    • Systemic lupus erythematosus;
    • Polyps of the nasopharynx and nasal mucosa.

    Directions for use and dosage

    Ketanov tablets are taken orally. The frequency of administration depends on the severity pain syndrome. The single dose is 10 mg, repeated doses are 10 mg up to four times a day; the maximum daily dose is no more than 40 mg.

    When administered orally, the duration of treatment should not exceed 5 days.

    Ketanov in the form of an injection solution is administered deeply intramuscularly. It is recommended to prescribe the minimum effective dose, selected in accordance with the patient's response and pain intensity. If necessary, simultaneous administration of opioid analgesics in reduced doses is possible.

    Single doses of the drug with a single intramuscular injection:

    • 10-30 mg – for patients under 65 years of age (depending on the intensity of pain);
    • 10-15 mg - patients with impaired renal function and persons over 65 years of age.

    Doses of the drug for repeated intramuscular administration: 10-30 mg – starting dose, then:

    • 10-30 mg every 4-6 hours (patients under 65 years of age);
    • 10-15 mg every 4-6 hours (patients with impaired renal function and those over 65 years of age).

    The maximum daily dose of Ketanov for intramuscular administration:

    • No more than 90 mg for patients under 65 years of age;
    • Not more than 60 mg for patients with impaired renal function and persons over 65 years of age.

    When administering the drug parenterally, the duration of the course should also not exceed 5 days.

    In case of switching from intramuscular administration of Ketanov to oral administration, the daily dose of both forms on the day of transfer should be no more than 90 mg for persons under 65 years of age and 60 mg for patients with impaired renal function and patients over 65 years of age. It should also be taken into account that on the day of transition, the dose of the drug in tablets should not exceed 30 mg.

    Side effects

    When using Ketanov, the following side effects from systems and organs are possible:

    • Cardiovascular system - changes in blood pressure, palpitations, bradycardia, fainting (rarely);
    • Digestive system - possible abdominal pain, nausea, diarrhea: rarely - flatulence, constipation, vomiting, feeling of gastrointestinal fullness, thirst, dry mouth, gastritis, stomatitis, liver dysfunction, erosive and ulcerative lesions of the gastrointestinal tract;
    • Central and peripheral nervous system – drowsiness, headache and anxiety are possible; rarely - depression, sleep disturbance, euphoria, dizziness, paresthesia, blurred vision, changes in taste, movement disorders;
    • Respiratory system – attacks of suffocation and breathing problems (rare);
    • Urinary system - oliguria, proteinuria, polyuria, hematuria, increased urination, acute renal failure, azotemia (rare);
    • Hematopoietic system - anemia, thrombocytopenia, nosebleeds, eosinophilia, postoperative bleeding (rare);
    • Metabolism – possible swelling and increased sweating; rarely - hyponatremia, hypokalemia, increased levels of urea and/or creatinine in the blood plasma;
    • Allergic reactions - possible hemorrhagic rash and itchy skin; in isolated cases - urticaria, bronchospasm, Stevens-Johnson syndrome, exfoliative dermatitis, anaphylactic shock, Lyell's syndrome, myalgia, Quincke's edema;
    • Others – fever;
    • Local reactions – possible pain at the injection site.

    special instructions

    Ketanov ceases to affect platelet aggregation only after 24-48 hours.

    Hypovolemia increases the risk of developing renal side effects. If necessary, Ketanov can be prescribed together with narcotic analgesics.

    The use of the drug as an anesthetic in obstetric practice, as well as for preliminary drug preparation of the patient for general anesthesia and as a means of maintenance anesthesia.

    Ketanov should not be used together with paracetamol for more than 5 days. In case of blood clotting disorders, the drug is prescribed only if the platelet count is regularly monitored. This is especially important in the postoperative period, when careful monitoring of hemostasis is necessary.

    While taking Ketanov, due to the risk of developing side effects from the central nervous system, it is advisable to avoid performing any activity that requires increased attention and speed of psychomotor reactions (working with machinery, driving a car, etc.).

    Analogs

    Structural analogues of the drug are: Ketorolac, Dolak, Adolor and Ketalgin.

    Terms and conditions of storage

    Ketanov should be stored in a dry place, protected from light and out of reach of children, at a temperature of no more than 25 °C.

    Shelf life – 3 years.

    Ketanov belongs to the group of painkillers and is rightly considered one of the best medicines, non-narcotic origin

    Ketanov belongs to the group of strong painkillers. The drug is rightly considered one of the best medicines of non-narcotic origin. The tablets also have anti-inflammatory and antipyretic properties. The medication is able to eliminate pain of various origins. Let's take a closer look at the instructions for use.

    About the drug

    Ketanov is available in the form of white tablets, coated with an edible coating. There is an engraving of the name of the drug. The active ingredient is ketorolac tromethamine. The concentration in one tablet is 10 mg. Auxiliary components include potato starch, magnesium stearate, cellulose and silicon dioxide.

    Ketanov is presented in contour packs of 10 pieces. Despite strong effect, the tablets do not affect the psychomotor functions of the body. There is no depression of the nervous systems, no effect on arterial pressure, no pronounced sedative effect, no addiction.

    The drug acts on the enzyme cyclooxygenase 1, due to which the threshold of pain sensitivity in tissues and organs is lowered. Ketanov relieves discomfort, which is especially necessary when receiving injuries or in the postoperative period.

    When should Ketanov be used?

    • after surgical interventions;
    • discomfort due to the development of tumors;
    • pain after muscle and tissue injuries;
    • toothache;
    • radicular syndrome;
    • pain due to osteoarthritis;
    • pain when a nerve is pinched;
    • renal colic;
    • menstrual pain.

    Advice: Ketanov cannot be used as treatment. The tablets only block attacks of pain, but do not affect their cause and do not cure the disease. For achievement best effect It is recommended to take the medication as part of complex therapy.

    Contraindications

    The drug has an impressive list of contraindications: gastrointestinal ulcers, liver failure, disruption of hematopoiesis, aspirin-induced asthma, bronchospasms, pregnancy and lactation, sensitivity to the active components of the drug, risk of bleeding, hypovolemia, chronic attacks of pain (since tablets can hide symptoms illness, as a result of which timely treatment may not occur).

    Ketanov can be taken only with the permission of a doctor if the patient is diagnosed with heart failure, sepsis, cholestasis, polyps on the mucous membranes, active hepatitis, creatinine, hypertension, cholecystitis. The drug should be used with extreme caution in elderly people over 60 years of age.

    Possible side effects:

    1. diarrhea, flatulence, dry mouth, severe thirst;
    2. stomatitis;
    3. sleep disturbances, taste disturbances;
    4. disorders of the musculoskeletal system;
    5. attacks of suffocation;
    6. nosebleeds;
    7. hypokalemia;
    8. swelling;
    9. skin itching, urticaria.

    How to take Ketanov?

    The tablets are taken orally, without chewing, after which you need to drink a sufficient amount of water. The medication can be used regardless of meals. However, if you drink Ketanov after a meal, the risk negative influence on the intestines is significantly reduced. If the patient takes the pill after a hearty lunch with a lot of fatty food, the effect of the drug will slow down by 15-20%.

    Ketanov instructions for use of the tablet:

    • single dose – 10 mg (one piece), you can take the medication again if the pain syndrome has not been eliminated;
    • You cannot take more than 4 tablets per day;
    • the duration of the course should not exceed 5-7 days;
    • You can take the drug as needed or according to a schedule - 3-4 tablets per day at regular intervals;
    • in case of switching from taking Ketanov intramuscularly to tablets, the recommended daily dose should not exceed 3 pieces;
    • for elderly or underweight patients, a minimum dosage is recommended (no more than 2 tablets per day).

    Price review and analogues

    The cost of the tablets may vary depending on the pharmacy chosen. The most reasonable prices are presented here: Zdrav pharmacy (50 rubles), IFK pharmacy (60 rubles), EuroPharm (67 rubles).

    Popular analogues: Adolor, Ketocam, Dolomin, Ketorolac, Dolak, Ketofril, Asinac, Bioran, Diklak, Metindol, Naklofen, Ortofen, Panoxen, Flotak, Arthrotek, Indomethacin.

    Important aspects:

    • Ketanov is a potent drug, so the tablets are available with a prescription;
    • While taking the drug, it is recommended to refrain from potentially dangerous species activities, since the medication can cause drowsiness and dizziness;
    • Ketanov should not be taken with other NSAIDs, otherwise you risk causing side effects of the drugs;
    • You cannot use tablets and inhibitors, otherwise there is a risk of developing renal failure.

    Ketanov is an excellent pain reliever that is prescribed as symptomatic therapy and for complex treatment. The medicine is available in the form of tablets and solution for injection. We will tell you what doses should be used to relieve pain and describe all the side effects of the drug.

    Doctors prescribe injections or pills to relieve severe pain. The drug is excellent for short-term use. Ketanov can cope with the following types of pain syndromes:

    1. Moderate to severe pain after major surgery;
    2. Pain due to gynecological diseases;
    3. Discomfort after an orthopedic diagnosis;
    4. To relieve urological pain;
    5. As symptomatic therapy after visiting the dentist;
    6. At acute injury muscles;
    7. For fractures and tissue ruptures;
    8. Relieves pain from sprains and severe sprains.

    In addition, doctors prescribe Ketanov to relieve an attack of short-term pain in the following cases:

    • After drug withdrawal;
    • Fighting toothache;
    • For caries and pulpitis;
    • In case of pericoronitis;
    • For colic in the kidneys. Prescribed in combination with antispasmodics;
    • Relieves pain after childbirth;
    • With otitis media;
    • To relieve an attack of sciatica;
    • At the time of fibromyalgia;
    • Spasms due to osteoarthritis;
    • Relief of the syndrome at the time of radiculitis;
    • Relieving back pain due to osteochondrosis;
    • For pathology in tissues and muscles.

    For each case, the doctor prescribes a certain dosage of Ketanov. Therefore, it is important to consult a doctor and undergo an examination before taking the medicine. The wrong dose may not relieve pain or cause side effects.

    How to use the tablets?

    Usually, to relieve severe pain, the doctor prescribes 1 tablet every 4 hours. This is 10 mg of active ingredient. The course of taking Ketanov should not last more than 7 days. Some patients may need a lower dosage:

    1. Elderly people over 65 years of age;
    2. Patients weighing less than 50 kg;
    3. People with liver and kidney problems.

    Dosage of the drug in the form of a solution

    Ketanov in the form of an injection solution is prescribed intramuscularly. To relieve the first attack of pain, 10 mg of the drug must be administered. After 5 hours, the dosage should increase to 30 mg. The attending physician should supervise the administration of the medication.

    The maximum dose of Ketanov per day is no more than 90 mg. Elderly patients should be administered no more than 60 mg of the drug.

    Injections with the drug are allowed for 2 days to relieve pain. After this, the patient can take Ketanov tablets for another 5-7 days until the pain symptoms completely disappear.

    After the first injection unpleasant pain goes away in 30 minutes. Complete pain relief will occur within 2 hours. The doctor must change the dosage based on the patient's diagnosis and general condition. To reduce the likelihood side effects, do not prescribe too high a dose.

    Contraindications for use

    For some patients, it is strictly forbidden to use Ketanov as an anesthetic. The drug will not relieve the unpleasant symptom and will only harm your health. Here are the cases in which doctors do not recommend taking the medicine:

    • Allergy to any component in the tablets or solution;
    • If the patient has an active ulcer;
    • With bleeding in the stomach;
    • At the time of peptic ulcer disease;
    • Dangerous for bronchial asthma;
    • Not prescribed for angioedema;
    • For rhinitis;
    • Dangerous for urticaria;
    • Not used before surgery and during manipulation of blood vessels;
    • Dangerous if the heart fails;
    • If polyps occur in the nose;
    • For bronchospasm disease;

    • Not prescribed for Quincke's edema;
    • Dangerous for postoperative patients who have previously had frequent bleeding;
    • Not prescribed for contractions in pregnant women;
    • When using other painkillers;
    • Dangerous for hemorrhagic diathesis;
    • If the patient has bleeding disorders.

    Taking Ketanov in such cases can cause severe complications and worsening pain. It is imperative to consult a doctor before taking this painkiller and inform the doctor about all past diagnoses. It is best to undergo diagnostics, which will help identify hidden disorders in the body.

    Use of the drug during pregnancy

    It is also not recommended to take the medicine while breastfeeding. Through milk, the substance can enter the baby’s body and cause an allergic reaction. If a woman begins to experience severe pain and the doctor prescribes Ketanov, then she should immediately stop breastfeeding.

    Interaction with other drugs

    If Ketanov is taken in parallel with other medications, this may cause complications or lead to a decrease in the analgesic effect. Here is a list of the main interactions to look out for:

    1. It is forbidden to take Warfarin together with Ketanov. Otherwise, the analgesic effect will decrease to 97 percent. Also, you should not drink digoxin, heparitis and other salicylates at the same time;
    2. Use together with acetylsalicylic acid. It is not recommended to combine two drugs, as there are risks of side effects;
    3. Use of Probenecid. When taken in parallel, the effect of Ketanov is reduced. Doctors do not recommend combining these drugs;
    4. Taking Cyclosporine. May lead to nephrotoxic side effects. Not used together with Ketanov;
    5. Concurrent use of Oxpentifilin. This leads to the development of dangerous hemorrhage;
    6. Use together with Mifepristone. Effect this drug will disappear completely if you start taking Ketanov;
    7. Concurrent use of drugs with lithium is prohibited;
    8. Use of anticoagulants. If taken together with Ketanov, this leads to the risk of bleeding. Simultaneous use is strictly contraindicated.

    If you take the drugs described above in parallel, this can lead to dangerous side effects and worsening general condition. Be sure to tell your doctor what medications you are taking. this moment take it so he can adjust the therapy.

    Drug overdose

    When taking too large a dose of Ketanov, such unpleasant symptoms:

    • The reaction slows down;
    • A severe headache appears;
    • Feeling drowsy and lethargic;
    • Nausea and vomiting;
    • Severe abdominal pain;
    • If you take too large a dose - bleeding in the stomach;
    • Attacks of arterial hypertension;
    • The occurrence of renal failure;
    • In extreme cases, breathing problems, seizures and coma can occur.

    Doctors reported that Ketanov was long-term use in a high dose, was fatal. Therefore, it is important to immediately go to the hospital at the first sign of side effects.

    Doctors are required to prescribe symptomatic therapy for the patient. No later than 4 hours after an overdose, you need to induce vomiting or take activated charcoal. The required dose is 100 grams for an adult patient. Doctors often prescribe osmotic drugs to relieve symptoms.

    With a one-time overdose of the drug, abdominal pain and nausea begin. Typically, such symptoms disappear immediately after stopping Ketanov.

    If you ignore unpleasant symptoms and do not consult a doctor, take large doses can lead to dangerous complications.

    Side effects of the drug

    Ketanov has some side effects that your doctor should warn you about. Symptoms usually occur due to taking a large dose or the body's intolerance to the medicine.

    Where do they arise?Side effects
    The following complications may occur in digestion:Attack of nausea and vomiting;
    The emergence of anorexia;
    Uncomfortable sensations in the abdomen;
    Pain and cramps in the stomach;
    The patient feels changes in taste in the mouth;
    Ulcers in the stomach area;
    Severe bleeding, which can be fatal. Occurs in elderly patients;
    An attack of diarrhea;
    Feeling of dry mouth;
    Intense thirst;
    The occurrence of flatulence and constipation;
    Attacks of pancreatitis;
    Feeling of fullness in the stomach;
    Emergence initial stage gastritis;
    Severe belching;
    Manifestation of colitis and Crohn's disease;
    The occurrence of esophagitis.
    These side effects occur in the liverThe functioning of the organ is disrupted;
    Manifestation of renal failure;
    In rare cases, jaundice occurs;
    Attacks of elevated liver enzymes;
    The occurrence of hepatitis and hepatomegaly.
    IN nervous system such complications can be observedFatigue and feeling drowsy;
    Problems with memory and concentration;
    Severe headaches;
    Anxiety and panic attacks;
    Your head starts to feel dizzy;
    Manifestation of insomnia;
    Overexcitation of the body;
    The patient feels unwell;
    Stress occurs and irritability is severe;
    A person sees unusual dreams at night;
    Disorientation occurs in space;
    Fever and convulsions begin;
    Mood changes and anxiety;
    Severe hallucinations;
    The person may faint;
    Manifestation of psychosis.
    The following side effects can be noted in the functioning of the cardiac system:Rush of blood to the head;;
    Pale skin;
    The heart begins to beat faster;
    The appearance of palpitation;
    Severe pain in the chest area;
    Swelling on the skin;
    Failure of the heart;
    Development of arterial complications;
    In extreme cases, myocardial infarction or stroke.
    IN circulatory system such side effectsManifestation of aplastic anemia;
    The appearance of purpura;
    Attacks of leukopenia;
    Severe agranulocytosis;
    The occurrence of thrombocytopenia;
    Neutropenia.
    In the bronchi the drug causes such complicationsAttacks of bronchospasm;
    Severe shortness of breath;
    Edema in the lungs and larynx;
    Attacks of bronchial asthma;
    Exacerbation of lung disease.
    Side effects in the urinary systemIncreased frequency of urination;
    Attacks of nephrotic syndrome;
    Delays when going to the toilet;
    Increased cratinin in urine;
    The occurrence of papillary necrosis;
    Severe pain in the lumbar region;
    Kidney failure;
    Attacks of hematuria.
    The following complications can occur on the skin:Severe rash;
    Dermatitis;
    The skin begins to peel off;
    The tonsils become enlarged;
    Attacks of photosensitivity.
    IN immune system identify such complicationsAllergy to the composition of the drug;
    Anaphylactoid reactions, which can be fatal;
    The color of the skin on the face may change;
    Hives appear on the body;
    Severe itching;
    The patient's eyelids swell.
    The following side effects appear in the senses:Hearing loss;
    Tinnitus;
    Decreased vision;
    The occurrence of neuritis in the optic nerve;
    Blurred vision.
    Other side effectsThe patient's body begins to sweat heavily;
    Myalgia attacks;
    Change in skin color at the injection site;
    Swelling of the face and hands;
    Increased body weight;
    High fever;
    There is a chill in the body.

    Features of the drug use

    In order for Ketanov to relieve severe pain and not harm the health of the body, you need to know some rules of administration. Doctors give the following useful advice:

    1. To reduce the likelihood of side effects, the doctor should first prescribe a minimum dose of Ketanov. It is better to take the drug for only a couple of days, since long-term therapy can cause complications in some organs;
    2. After the injection, the pain goes away only after 30 minutes. Therefore, you need to be patient and not take several painkillers at once. Otherwise, dangerous drug interactions will begin;
    3. You should not take pills for more than 5 days in a row;
    4. If the patient has problems with the kidneys and liver, it is advisable to minimize the dose and be under the supervision of a doctor. The specialist is required to regularly monitor diuresis and kidney function;
    5. For women who cannot become pregnant for a long time, it is necessary to stop taking Ketanov;
    6. If a patient has Crohn's disease, he needs to be prescribed the drug in tablets with great caution;
    7. For patients with a weak heart it is necessary regular monitoring. It is better to be in the hospital next to the attending physician during therapy.

    Rules for storing medicine

    The drug Ketanov must be kept in a dark place at a temperature no higher than 25 degrees. It is important that children do not have access to the medicine. The shelf life of Ketanov is no more than 3 years from the date of manufacture. Do not take the medicine after this time under any circumstances.

    Analogues of the drug

    The doctor may prescribe a different medicine for the patient's pain. It will be similar in composition and method of action to Ketanov. Here is a list of all similar drugs:


    Each remedy has its own contraindications and a number of side effects. It is necessary to study this information and carefully read the instructions for use.

    Medicine price

    You can buy the drug Ketanov in any pharmacy without a doctor's prescription. Cost of medicine in different forms:

    1. Ketanov in the form of tablets of 10 mg - from 67 to 73 rubles for 20 pieces;
    2. Ketanov in tablets of 10 mg - from 200-230 rubles per 100 pieces;
    3. Ketanov in the form of a solution for injection - from 113 to 125 rubles for 10 ampoules.

    Compound

    active substance: ketorolac tromethamine;

    1 film-coated tablet contains ketorolac tromethamine 10 mg

    Excipients: microcrystalline cellulose, corn starch, colloidal silicon dioxide, magnesium stearate, polyethylene glycol 400, talc, titanium dioxide (E 171).

    Dosage form"type="checkbox">

    Dosage form

    Film-coated tablets.

    Basic physical and chemical properties: white or off-white, round, biconvex, film-coated tablets marked “KVT” on one side.

    Pharmacological group

    Nonsteroidal anti-inflammatory and antirheumatic drugs. ATX code M01A B15.

    Pharmacological properties"type="checkbox">

    Pharmacological properties

    Pharmacological .

    The pain reliever Ketorolac tromethamine is a non-narcotic analgesic. This is an NSAID that exhibits anti-inflammatory and mild antipyretic activity. Ketorolac tromethamine inhibits prostaglandin synthesis and is considered a peripherally acting analgesic. It has no known effect on opiate receptors. Following the use of ketorolac tromethamine, no events indicating respiratory depression were observed in controlled clinical studies. Ketorolac tromethamine does not cause pupillary constriction.

    Pharmacokinetics .

    Ketorolac tromethamine is rapidly and completely absorbed after oral administration with a peak plasma concentration of 0.87 mg/kg 50 minutes after a single 10 mg dose. In healthy volunteers, the terminal plasma half-life averages 5.4 hours. In older people (average age 72 years) it is 6.2 hours. 99% of ketorolac in blood plasma is protein bound. In humans, after taking single or multiple doses, the pharmacokinetics of ketorolac is linear. Stationary level in blood plasma is achieved after 1 day when used 4 times a day. No changes were observed with long-term dosing. After a single dose, the volume of distribution is 0.25 L/kg, the half-life is 5:00, and the clearance is 0.55 ml/min/kg. The main route of excretion of ketorolac and its metabolites (conjugates and p-hydroxymetabolites) is urine (91.4%), and the rest is excreted in feces. A diet rich in fat reduces the rate of absorption, but not the volume, while antacids do not affect the absorption of ketorolac.

    Indications

    Short-term treatment of moderate pain, including post-operative pain.

    Contraindications

    Hypersensitivity to ketorolac or other components of the drug.

    • Active ulcer, recent gastrointestinal bleeding or perforation, peptic ulcer disease or history of 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)
    • history of bronchial asthma
    • do not use as an analgesic before and during major surgery and after manipulations on the coronary vessels;
    • severe heart failure
    • complete or partial syndrome of nasal polyps, angioedema or bronchospasm;
    • do not use in patients who have undergone surgery with a high risk of hemorrhage or incomplete bleeding control and in patients receiving anticoagulants, including low doses of heparin (2500-5000 units every 12:00)
    • hepatic or moderate severe renal failure (serum creatinine level more than 160 µmol/l);
    • suspected or confirmed cerebrovascular bleeding, bleeding diathesis, including blood coagulation disorders and 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;
    • risk of renal failure due to decreased fluid volume.

    Interaction with other drugs and other types of interactions

    Ketorolac easily binds to plasma proteins (average value 99.2%), and the degree of binding depends on the concentration.

    Cannot be used simultaneously with ketorolac.

    Due to the possibility of side effects, ketorolac should not be prescribed with other NSAIDs, including selective COX-2 inhibitors, or in patients receiving acetylsalicylic acid, warfarin, lithium, probenecid, cyclosporine. NSAIDs should not be prescribed within 8-12 days after using mifepristone, since NSAIDs may weaken the effect of mifepristone.

    Medicines in combination with ketorolac should be prescribed with caution.

    In healthy normovolemic individuals, ketorolac reduces the diuretic effect of furosemide by approximately 20%. The drug should be prescribed with extreme caution to patients with cardiac decompensation. NSAIDs may worsen heart failure, reduce glomerular filtration rate and increase plasma levels of cardiac glycosides when administered simultaneously 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 renal dysfunction, 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, caution should be exercised when co-prescribing corticosteroids due to the increased risk of gastrointestinal ulcers or bleeding. There is an increased risk of gastrointestinal bleeding if NSAIDs are prescribed in combination with antiplatelet agents and selective serotonin reuptake inhibitors. Caution is advised when co-administering methotrexate 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 increased risk of developing seizures.

    Concomitant 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 people with hemophilia who are treated with both zidovudine and ibuprofen.

    It is unlikely that the following medicines interact with ketorolac.

    Ketorolac did not affect the binding of digoxin to plasma proteins. Research in vitro indicate that at therapeutic concentrations of salicylate (300 μg/ml) and above, ketorolac binding was reduced by approximately 99.2% to 97.5%. Therapeutic concentrations of digoxin, warfarin, paracetamol, phenytoin and tolbutamide did not affect the binding of ketorolac to plasma proteins. Because ketorolac is a highly active drug and its available plasma concentration is low, it is not expected to significantly replace other drugs that bind to blood proteins. There is no evidence from animal or human studies 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 mechanisms of enzyme induction or inhibition.

    Antiepileptic drugs.

    Isolated cases of epileptic seizures have been reported during the simultaneous use of ketorolac and antiepileptic drugs (phenytoin, carbamazepine).

    Psychotropic drugs.

    With the simultaneous use of ketorolac and psychotropic drugs (fluoxetine, thiotexene, alprazolam), hallucinations have been reported.

    Effect on laboratory test results.

    Ketorolac inhibits platelet aggregation and may prolong bleeding time.

    Features of application

    Maximum duration treatment should not exceed 5 days.

    Effect on fertility .

    The use of ketorolac, like any drug, inhibits cyclooxygenase/prostaglandin synthesis, may impair fertility and is not recommended for use in women planning pregnancy. For women who are unable to become pregnant or are undergoing fertility evaluation, discontinuation of ketorolac should be considered.

    Gastrointestinal bleeding, ulceration and perforation.

    Gastrointestinal bleeding, ulceration or perforation, which may be fatal, has been reported with the use of NSAIDs at any time during treatment, with or without warning symptoms or in the case of a history of severe gastrointestinal disorders. The risk of severe gastrointestinal bleeding depends on the dosage of the drug. This, in particular, applies to elderly patients; ketorolac is used in an average daily dose of more than 60 mg. For these patients, as well as for patients concomitantly taking low doses of acetylsalicylic acid or other drugs that may increase gastrointestinal risk, combination treatment with protective agents (eg misoprostol or inhibitors) should be considered. proton pump). Ketanov should be used with caution in patients receiving concomitant drug treatment which may increase the risk of ulcers or bleeding, such as oral corticosteroids, selective serotonin reuptake inhibitors or antiplatelet agents such as acetylsalicylic acid. If gastrointestinal bleeding or ulceration occurs in patients receiving Ketanov, treatment should be discontinued.

    Respiratory dysfunction.

    Caution is required when using the drug in patients with bronchial asthma (or a history of asthma), since it has been reported that NSAIDs in such patients accelerate the onset of bronchospasm.

    Effect on the kidneys.

    Prostaglandin biosynthesis inhibitors (including NSAIDs) have been reported to have nephrotoxic effects. Prescribe with caution to patients with impaired renal, cardiac, or liver function, since the use of NSAIDs may lead to deterioration of renal function. For patients with mild renal impairment, lower doses of ketorolac (not to exceed 60 mg intramuscularly or intravenously) should be prescribed, and the renal condition of these patients should be carefully monitored. As with other drugs that inhibit prostaglandin synthesis, increases in serum urea, creatinine and potassium have been reported during use of ketorolac tromethamine, which may occur after a single dose.

    From the cardiovascular system, kidneys and liver.

    Use with caution in patients with conditions that result in decreased blood volume and/or renal blood flow where renal prostaglandins play a supportive role in renal perfusion. In such patients, renal function must be monitored. Volume reduction should be corrected and serum urea and creatinine levels and urine volume excreted carefully monitored until the patient becomes normovolemic. In patients on renal dialysis, creatinine clearance was reduced by approximately half the normal value, and the elimination half-life was approximately tripled. Patients with impaired liver function due to cirrhosis did not have any clinically important changes in ketorolac clearance or residual half-life. Marginal elevations in one or more liver function tests may occur. These abnormalities may be temporary, may remain unchanged, or may progress with continued treatment. If clinical signs and symptoms indicate the development of liver disease or if systemic manifestations are observed, Ketanov should be discontinued.

    Prescribe ketorolac with caution to patients with a history of cardiovascular disorders.

    Fluid retention and swelling.

    Fluid retention and edema have been reported with ketorolac use and should be used with caution in patients with cardiac decompensation, hypertension, or similar conditions.

    Cardiovascular and cerebrovascular effects.

    There is not yet sufficient information to assess the risk for ketorolac tromethamine. Patients with uncontrolled hypertension, congestive heart failure, diagnosed coronary artery disease, peripheral arterial disease and/or cerebrovascular disease should be under medical supervision.

    Systemic lupus erythematosus and mixed connective tissue diseases.

    Patients with systemic lupus erythematosus and various mixed connective tissue diseases have an increased risk of developing aseptic meningitis.

    Dermatological.

    Ketanov should be discontinued at the first signs of skin rashes, damage to the mucous membranes or any other signs of hypersensitivity.

    Hematological effects.

    Patients with bleeding disorders should not be prescribed Ketanov. Patients receiving anticoagulant therapy may have an increased risk of bleeding if ketorolac is coadministered. Patients receiving other drugs that may affect the rate of bleeding control should be carefully monitored when ketorolac is prescribed to them. In controlled clinical trials, the incidence of significant postoperative bleeding was less than 1%. Ketorolac inhibits platelet aggregation and increases bleeding time. In patients with normal bleeding time, the duration of bleeding increased, but did not go beyond the normal range of 2-11 minutes. In contrast to long-term effects due to the use of acetylsalicylic acid, platelet function returns to normal within 24-48 hours after discontinuation of ketorolac. Ketorolac should not be prescribed to patients who have undergone surgery with a high risk of bleeding or incomplete control of bleeding. Caution should be used if mandatory bleeding control is critical. Hypovolemia should be corrected before starting the use of ketorolac.

    Increasing the dose of ketorolac tablets above the daily dose of 40 mg does not increase its effectiveness, but increases the risk of adverse reactions.

    Ketorolac does not cause dependence; if the drug was stopped, no withdrawal syndrome was recorded.

    Use during pregnancy or breastfeeding

    The safety of ketorolac during pregnancy in humans has not been established. Given the known effect of NSAIDs on the cardiovascular system of the fetus (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 bleeding to occur in both mother and baby.

    Ketorolac penetrates into breast milk V low levels, therefore Ketanov is contraindicated during breastfeeding.

    The ability to influence the reaction rate when driving vehicles or other mechanisms

    Some patients may experience drowsiness, dizziness, insomnia, fatigue, blurred vision or depression when using ketorolac. If patients experience the above or other similar effects, they should not drive or operate machinery.

    Directions for use and doses

    It is advisable to take the tablets 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 minimum effective dose for the short period of time necessary to control symptoms. Before starting treatment, it is necessary to achieve normovolemia. For adults, Ketanov is prescribed 10 mg every 4-6 hours if necessary. It is not recommended to use the drug in doses exceeding 40 mg per day. Opioid analgesics (eg, morphine, pethidine) can be used concomitantly; ketorolac does not affect the binding of opioid drugs and does not increase respiratory depression or sedation caused by opioids. It has been demonstrated that in cases of postoperative pain, the simultaneous use of ketorolac with opioid analgesics reduced the need for the latter. For patients receiving parenteral ketorolac and who are given oral ketorolac tablets, 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 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 early as possible.

    Elderly patients.

    Elderly patients are at greater risk of developing severe complications, particularly from the digestive tract. During treatment with NSAIDs, the patient's condition should be regularly monitored; a longer interval between drug doses, for example 6-8 hours, is usually recommended.

    Children

    Do not use in children under 16 years of age.

    Overdose

    Symptoms: headache, nausea, vomiting, epigastric pain, gastrointestinal bleeding; rarely - diarrhea, disorientation, agitation, coma, drowsiness, dizziness, ringing in the ears, loss of consciousness, convulsions. In cases of severe poisoning, acute renal failure and liver damage are possible.

    Treatment: gastric lavage, taking activated carbon. It is necessary to ensure sufficient diuresis. Kidney and liver function 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 diazepam. Other measures may be prescribed depending on the patient's clinical condition. SPECIAL. Dialysis does not remove ketorolac from the circulation.

    Adverse reactions"type="checkbox">

    Adverse reactions

    From the digestive tract: peptic ulcer, perforation or gastrointestinal bleeding, sometimes with fatal(especially in older people), nausea, dyspepsia, gastrointestinal pain, abdominal discomfort, spasm or burning in the epigastric region, vomiting with blood, gastritis, esophagitis, diarrhea, belching, constipation, flatulence, feeling of fullness in the stomach, ground, rectal bleeding, ulcerative stomatitis, vomiting, hemorrhage, perforation, pancreatitis, exacerbation of colitis and Crohn's disease.

    From the side of the central nervous system: anxiety, drowsiness, dizziness, headache, nervousness, paresthesia, functional disorders, depression, euphoria, convulsions, inability to concentrate, insomnia, malaise, fatigue, agitation, vertigo, unusual dreams, confusion, hallucinations, hyperkinesia, aseptic meningitis with associated symptoms, psychotic reactions, impaired thinking.

    From the side of the organ of vision: visual impairment, blurred vision, optic neuritis.

    From the hearing organs: hearing loss, tinnitus.

    From the urinary system: increased frequency of urination, oliguria, acute renal failure, hyponatremia, hyperkalemia, hemolytic uremic syndrome, flank pain (with/without hematuria), increased serum urea and creatinine, interstitial nephritis, urinary retention, nephrotic syndrome, renal failure.

    From the outside reproductive system: female infertility.

    From the digestive system: liver dysfunction, hepatitis, jaundice and liver failure, hepatomegaly.

    From the cardiovascular system: hot flashes, bradycardia, pallor, arterial hypertension, palpitation, chest pain, swelling, heart failure.

    Data from clinical and epidemiological studies indicate that the use of certain NSAIDs, especially in high doses and for a long time, may be associated with an increased risk of arterial thromboembolic complications (myocardial infarction or stroke).

    From the respiratory system: shortness of breath, asthma, pulmonary edema.

    From the blood side: purpura, thrombocytopenia, neutropenia, agranulocytosis, aplastic and hemolytic anemia, eosinophilia.

    From 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: Hypersensitivity reactions have been reported, including nonspecific allergic reactions and anaphylaxis, respiratory tract reactivity including asthma, worsening asthma, bronchospasm, laryngeal edema or shortness of breath, and various disorders on the skin, include rashes of various types, itching, urticaria, purpura, angioedema and, in isolated 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 may also occur in individuals with a history of angioedema, bronchospasm reactivity (eg, asthma and nasal polyps). Anaphylactoid reactions, such as anaphylaxis, can be fatal.