Ketofril, 10 mg, film-coated tablets, 20 pcs.

Ketofril

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

From the digestive system: often - gastralgia, diarrhea; less often - stomatitis, flatulence, constipation, vomiting, feeling of fullness in the stomach; 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 stool or melena, vomiting with blood or coffee type thick", nausea, heartburn, etc.), cholestatic jaundice, hepatitis, hepatomegaly, acute pancreatitis.

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

From the senses: rarely - hearing loss, ringing in the ears, visual impairment (including blurred visual perception).

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

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

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

From the hematopoietic organs: rarely - anemia, eosinophilia, leukopenia.

From the hemostasis system: rarely - bleeding from a postoperative wound, nosebleeds, rectal bleeding.

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

Local reactions: less often - burning or pain at the injection site.

Allergic reactions: rarely - anaphylaxis or anaphylactoid reactions (change in facial skin color, skin rash, urticaria, itching of the skin, tachypnea or shortness of breath, swelling of the eyelids, periorbital edema, shortness of breath, difficulty breathing, heaviness in the chest, wheezing).

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

Ketofril, 10 mg, film-coated tablets, 20 pcs.

Hypersensitivity to ketorolac and excipients; anamnestic data on an attack of bronchial obstruction, rhinitis, urticaria after taking acetylsalicylic acid or other NSAIDs (complete or incomplete combination of bronchial asthma, recurrent nasal polyposis or paranasal sinuses and intolerance to acetylsalicylic acid and other NSAIDs); angioedema; hypovolemia (regardless of the cause that caused it), dehydration; erosive and ulcerative changes in the mucous membrane of the stomach or duodenum, active gastrointestinal bleeding; inflammatory bowel diseases; inflammatory bowel diseases (Crohn's disease, nonspecific colitis) in the acute phase; hypocoagulation (including hemophilia); severe liver failure or active liver disease; severe renal failure (creatinine clearance less than 30 ml/min), progressive kidney disease, confirmed hyperkalemia; acute cerebrovascular accidents (ischemic, hemorrhagic stroke, confirmed or suspected), hemorrhagic diathesis, concomitant use with other NSAIDs, high risk of development or recurrence of bleeding (including after surgery), hematopoietic disorders; decompensated heart failure, the period after coronary artery bypass grafting; lactose intolerance, lactase deficiency or glucose-galactose malabsorption; simultaneous use with probenecid, pentoxifylline, acetylsalicylic acid and other NSAIDs (including cyclooxygenase-2 inhibitors), lithium salts, anticoagulants, including warfarin and heparin; pregnancy, childbirth, breastfeeding; children under 16 years of age (efficacy and safety have not been established). The drug is not used for prophylactic pain relief before and during major surgical interventions due to the high risk of bleeding, as well as for the treatment of chronic pain.

Carefully

- bronchial asthma; cholecystitis; chronic heart failure; coronary heart disease, edema syndrome, cerebrovascular diseases, arterial hypertension; dyslipidemia/hyperlipidemia, diabetes mellitus, peripheral arterial disease, smoking, impaired renal function (creatinine clearance less than 30–60 ml/min); cholestasis; active hepatitis; sepsis; systemic lupus erythematosus; old age (over 65 years); anamnestic data on the development of ulcerative lesions of the gastrointestinal tract, the presence of Helicobacter pylori infection, long-term use of NSAIDs, alcohol abuse, severe somatic diseases, concomitant therapy with the following drugs: antiplatelet agents (for example, clopidogrel), oral glucocorticosteroids (for example, prednisolone), selective serotonin reuptake inhibitors ( for example, citalopram, fluoxetine, paroxetine, sertraline).

To reduce the risk of developing adverse events from the gastrointestinal tract, the minimum effective dose should be used for the shortest possible short course.

Ketofril tablet film 10 mg x20

Description of the active components of the drug Ketofril (Ketofreel) The scientific information provided is general and cannot be used to make a decision about the possibility of using a particular drug. Update date: 2018.02.12

Release form, packaging and composition Clinical-pharmacological. group Pharmacotherapeutic group Pharmacological action Pharmacokinetics Indications of the drug Dosage regimen Side effects Contraindications for use Special instructions Drug interactions

Marketing authorization holder: TORRENT PHARMACEUTICALS, Ltd. (India) ATX code: M01AB15 (Ketorolac) Active substance: ketorolac (ketorolac) Rec.INN registered by WHO

Dosage form

Ketofril

Tab., cover. film coating, 10 mg: 10 or 20 pcs.reg. No.: LSR-007323/08 dated 09.12.08 - Valid

Release form, packaging and composition

Film-coated tablets 1 tab.

ketorolac trometamol (ketorolac tromethamine) 10 mg

10 pieces. — cellless contour packages (1) — cardboard packs. 10 pieces. — cellless contour packages (2) — cardboard packs.

Clinical and pharmacological group: NSAIDs with a pronounced analgesic effect Pharmacotherapeutic group: NSAIDs

Pharmacological action of NSAIDs, a derivative of pyrrolysine-carboxylic acid. It has a pronounced analgesic effect, and also has anti-inflammatory and moderate antipyretic effects. The mechanism of action is associated with inhibition of the activity of COX, the main enzyme in the metabolism of arachidonic acid, which is a precursor of prostaglandins, which play a major role in the pathogenesis of inflammation, pain and fever.

Pharmacokinetics

When taken orally, it is absorbed from the gastrointestinal tract. Cmax in blood plasma is achieved 40-50 minutes after both oral and intramuscular administration. Eating does not affect absorption. Plasma protein binding is more than 99%.

T1/2 - 4-6 hours both after oral administration and after intramuscular administration.

More than 90% of the dose is excreted in the urine, 60% unchanged, and the rest through the intestines.

In patients with impaired renal function and the elderly, the elimination rate decreases, T1/2 increases.

Indications of the drug For short-term relief of moderate and severe pain of various origins. ICD-10 codes

Dosage regimen The method of administration and dosage regimen of a particular drug depend on its release form and other factors. The optimal dosage regimen is determined by the doctor. The compliance of the dosage form of a particular drug with the indications for use and dosage regimen should be strictly observed.

For adults, when taken orally - 10 mg every 4-6 hours, if necessary - 20 mg 3-4 times a day.

For intramuscular administration, a single dose is 10-30 mg, the interval between injections is 4-6 hours. The maximum duration of use is 2 days.

Maximum doses: for oral or intramuscular administration - 90 mg/day, for patients weighing up to 50 kg, with impaired renal function, as well as for persons over 65 years of age - 60 mg/day.

Side effect

From the cardiovascular system: rarely - bradycardia, changes in blood pressure, palpitations, fainting.

From the digestive system: possible nausea, abdominal pain, diarrhea, rarely - constipation, flatulence, feeling of gastrointestinal fullness, vomiting, dry mouth, thirst, stomatitis, gastritis, erosive and ulcerative lesions of the gastrointestinal tract, liver dysfunction.

From the central nervous system and peripheral nervous system: possible anxiety, headache, drowsiness, rarely - paresthesia, depression, euphoria, sleep disturbances, dizziness, changes in taste, visual disturbances, motor disturbances.

From the respiratory system: rarely - respiratory failure, attacks of suffocation.

From the urinary system: rarely - increased frequency of urination, oliguria, polyuria, proteinuria, hematuria, azotemia, acute renal failure.

From the blood coagulation system: rarely - nosebleeds, anemia, eosinophilia, thrombocytopenia, bleeding from postoperative wounds.

Metabolism: possible increased sweating, edema, rarely - oliguria, increased levels of creatinine and/or urea in the blood plasma, hypokalemia, hyponatremia.

Allergic reactions: possible skin itching, hemorrhagic rash, in isolated cases - exfoliative dermatitis, urticaria, Lyell's syndrome, Stevens-Johnson syndrome, anaphylactic shock, bronchospasm, Quincke's edema, myalgia.

Other: possible fever.

Local reactions: pain at the injection site.

Contraindications for use Erosive and ulcerative lesions of the gastrointestinal tract in the acute phase, the presence or suspicion of gastrointestinal bleeding and/or cranial hemorrhage, a history of blood coagulation disorders, conditions with a high risk of bleeding or incomplete hemostasis, hemorrhagic diathesis, moderate and severe disorders renal function (serum creatinine content more than 50 mg/l), the risk of developing renal failure with hypovolemia and dehydration, “aspirin triad”, bronchial asthma, nasal polyps, history of angioedema, preventive analgesia before and during surgery, pediatric and adolescence up to 16 years, pregnancy, childbirth, lactation, hypersensitivity to ketorolac, acetylsalicylic acid and other NSAIDs.

Use during pregnancy and breastfeeding

Contraindicated during pregnancy, during childbirth and during lactation (breastfeeding).

Ketorolac is contraindicated for use as a premedication, maintenance of anesthesia and for pain relief in obstetric practice, since its influence may increase the duration of the first stage of labor. In addition, ketorolac may inhibit uterine contractility and fetal circulation.

Use for liver dysfunction Use with caution in patients with liver dysfunction.

Use for renal impairment

Contraindicated in cases of severe renal dysfunction (serum creatinine content more than 50 mg/l), the risk of developing renal failure due to hypovolemia and dehydration.

Use with caution in patients with impaired renal function.

Use in children Contraindicated in children and adolescents under 16 years of age.

Use in elderly patients Ketorolac should be used with caution in elderly patients, because The half-life of ketorolac is prolonged and plasma clearance may be reduced. In these patients, it is recommended to use ketorolac in doses close to the lower limit of the therapeutic range.

special instructions

Use with caution in patients with impaired liver and kidney function, chronic heart failure, arterial hypertension, in patients with erosive and ulcerative lesions of the gastrointestinal tract and a history of bleeding from the gastrointestinal tract.

Ketorolac should be used with caution in the postoperative period in cases where particularly careful hemostasis is required (including after resection of the prostate gland, tonsillectomy, in cosmetic surgery), as well as in elderly patients, because The half-life of ketorolac is prolonged and plasma clearance may be reduced. In this category of patients, it is recommended to use ketorolac in doses close to the lower limit of the therapeutic range. If symptoms of liver damage, skin rash, or eosinophilia appear, ketorolac should be discontinued. Ketorolac is not indicated for use in chronic pain syndrome.

Impact on the ability to drive vehicles and operate machinery

If drowsiness, dizziness, insomnia or depression appear during treatment with ketorolac, special care must be taken when engaging in potentially hazardous activities that require increased attention and speed of psychomotor reactions.

Drug interactions

With simultaneous use of ketorolac with other NSAIDs, the development of additive side effects is possible; with pentoxifylline, anticoagulants (including heparin in low doses) - an increase in the risk of bleeding is possible; with ACE inhibitors - there is a possible increase in the risk of developing renal dysfunction; with probenecid - the concentration of ketorolac in plasma increases and its half-life, with lithium preparations - a decrease in the renal clearance of lithium and an increase in its concentration in plasma is possible, with furosemide - a decrease in its diuretic effect.

When using ketorolac, the need for the use of opioid analgesics for pain relief is reduced.