Ketorolac tablets and injections: instructions for use, price, what the drug is used for

Release form

Ketorolac tablets are white-coated, biconvex. 10 such tablets in contour packaging; 1,2, 5 or 10 packs in a paper pack. 10 such tablets in a polymer jar; one such jar in a pack of paper. 25 of these tablets in contour packaging; 2 or 4 packs in a paper pack.
Ketorolac (i.v., i.m.) in ampoules contains a transparent solution of white-yellow color. 1 or 2 ml of this solution in an ampoule; 5 ampoules in contour packaging, 1 or 2 such packages in a cardboard box. 1 or 2 ml of this solution in an ampoule; 10 such ampoules in a cardboard box.

Pharmacodynamics and pharmacokinetics

Pharmacodynamics

It has a strong analgesic effect, moderate antipyretic and anti-inflammatory effect.

They are associated with indiscriminate inhibition of the enzyme cyclooxygenase of the first and second types in peripheral tissues, resulting in inhibition of the synthesis of prostaglandins - mediators of pain, inflammation and thermoregulation.

The drug has no effect on opioid receptors, does not cause addiction, does not depress breathing, and does not have a sedative or anxiolytic effect.

The strength of the analgesic effect is comparable to morphine and superior to other drugs in its group.

After oral administration, the analgesic effect is recorded after one hour, the greatest effect – after one to two hours. After an intramuscular injection, the onset of the analgesic effect is recorded after 30 minutes, the greatest effect – after one to two hours.

Pharmacokinetics

When taken internally and when administered by injection, it is actively absorbed from the intestines and tissues. The maximum concentration in the blood is recorded after 40-50 minutes, both after oral administration and after intramuscular injection. Eating does not affect absorption. Plasma protein binding is about 99%.

The half-life is approximately 6 hours. 90% of the dose is excreted by the kidneys, in its original form - 60%; the remaining amount is excreted through the digestive tract.

Ketorolac solution d/iv and intramuscular injection 30 mg/ml 1 ml No. 10

Compound

Active substance: ketorolac trometamol (ketorolac tromethamine) - 30 mg. Excipients: ethanol 95% (in terms of 100% substance) - 100 mg, sodium chloride - 4.35 mg, hydrochloric acid solution 1M or sodium hydroxide solution 1M - to pH 6.9-7.9, water for injection - up to 1 ml.

Pharmacokinetics

When taken orally, ketorolac is well absorbed from the gastrointestinal tract. Bioavailability is 80-100%. Cmax in blood plasma is 0.7-1.1 mcg/ml and is achieved 40 minutes after taking the drug on an empty stomach at a dose of 10 mg. Food rich in fat reduces the Cmax of the drug in the blood and delays its achievement by 1 hour.

With intramuscular administration, absorption is complete and rapid. After intramuscular administration of the drug at a dose of 30 mg, Cmax in blood plasma is 1.74-3.1 mcg/ml, at a dose of 60 mg - 3.23-5.77 mcg/ml. Tmax is respectively 15-73 min and 30-60 min.

After an intravenous infusion of the drug at a dose of 15 mg, Cmax is 1.96-2.98 mcg/ml, at a dose of 30 mg - 3.69-5.61 mcg/ml.

Plasma protein binding - 99%. With hypoalbuminemia, the amount of free substance in the blood increases.

Vd is 0.15-0.33 l/kg.

The time to reach Css when taken orally is 24 hours when used 4 times a day (above subtherapeutic). Css after oral administration at a dose of 10 mg is 0.39-0.79 mcg/ml.

Css with parenteral administration is achieved after 24 hours when used 4 times a day (above subtherapeutic) and with IM administration at a dose of 15 mg is 0.65-1.13 mcg/ml, with IM administration at a dose of 30 mg - 1.29-2.47 mcg /ml; with an intravenous infusion at a dose of 15 mg - 0.79-1.39 mcg/ml, with an intravenous infusion at a dose of 30 mg - 1.68-2.76 mcg/ml.

Poorly passes through the BBB, penetrates the placental barrier (10%).

Excreted in breast milk: when the mother takes 10 mg of ketorolac orally, Cmax in breast milk is achieved 2 hours after taking the first dose and is 7.3 ng/ml, 2 hours after taking the second dose of ketorolac (when using the drug 4 times a day) Cmax is 7.9 ng/ml.

When administered parenterally, it is excreted in breast milk in small quantities.

More than 50% of the administered dose is metabolized in the liver with the formation of pharmacologically inactive metabolites. The main metabolites are glucuronides and p-hydroxyketorolac.

Excreted in urine - 91% (40% in the form of metabolites), in feces - 6%. Not excreted by hemodialysis.

After oral administration, T1/2 in patients with normal renal function is 2.4-9 hours (average 5.3 hours).

After intramuscular administration of 30 mg T1/2 - 3.5-9.2 hours, after intravenous administration of 30 mg T1/2 - 4-7.9 hours.

The total clearance with intramuscular injection of 30 mg is 0.023 l/kg/h, with intravenous infusion of 30 mg - 0.03 l/kg/h.

In patients with renal failure, the Vd of the drug may increase by 2 times, and the Vd of its R-enantiomer by 20%. With a plasma creatinine concentration of 19-50 mg/l with intramuscular administration of 30 mg of the drug, the total clearance is 0.015 l/kg/h.

In patients with impaired renal function with a plasma creatinine concentration of 19-50 mg/l (168-442 µmol/l), T1/2 is 10.3-10.8 hours, with more severe renal failure - more than 13.6 hours.

Liver function has no effect on T1/2.

In elderly patients, the total clearance when administered intramuscularly at a dose of 30 mg is 0.019 l/kg/h. T1/2 lengthens in elderly patients and shortens in young ones.

Indications for use

Pain syndrome of severe and moderate severity: injuries, toothache, pain in the postoperative period, cancer, myalgia, arthralgia, neuralgia, radiculitis, dislocations, sprains, rheumatic diseases.

Intended for symptomatic therapy, reducing pain and inflammation at the time of use, does not affect the progression of the disease.

Contraindications

Hypersensitivity to ketorolac or to other components of the drug, complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses, intolerance to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (including a history), urticaria, rhinitis caused by taking non-steroidal anti-inflammatory drugs medications (history), dehydration.

Intolerance to pyrazolone-type drugs, hypovolemia (regardless of the cause), bleeding or a high risk of its development, condition after coronary artery bypass surgery, confirmed hyperkalemia, inflammatory bowel diseases.

Erosive and ulcerative lesions of the gastrointestinal tract in the acute stage, peptic ulcers, hypocoagulation (including hemophilia).

Severe liver and/or renal failure (creatinine clearance less than 30 ml/min).

Hemorrhagic stroke (confirmed or suspected), hemorrhagic diathesis, hematopoiesis disorder, intracranial hemorrhage or suspicion of it.

Concomitant use with probenecid, pentoxifylline, acetylsalicylic acid and other NSAIDs (including cyclooxygenase-2 inhibitors), lithium salts, anticoagulants, including warfarin and heparin is not recommended.

Pregnancy, childbirth and breastfeeding.

Children under 16 years of age (safety and effectiveness of use have not been established).

The drug is not used for pain relief before and during surgery due to the high risk of bleeding, as well as for the treatment of chronic pain.

Directions for use and doses

Intravenously, intramuscularly.

Injected deep into the muscle, slowly (or intravenously in a stream) for at least 15 seconds in the minimum effective doses, in a minimally short course.

Single doses for a single intramuscular or intravenous administration:

adults under 65 years of age and children over 16 years of age - 10-30 mg, depending on the severity of the pain syndrome;
adults over 65 years of age or with impaired renal function - 10-15 mg.

Doses for repeated parenteral administration:

intramuscularly

adults under 65 years of age and children over 16 years of age are given 10-60 mg (0.3-2 ml) for the first injection, then 10-30 mg (0.3-1 ml) every 6 hours (usually 30 mg ( 1 ml) every 6 hours);
adults over 65 years of age or with impaired renal function - 10-15 mg (0.3-0.5 ml) every 4-6 hours.

intravenously

adults under 65 years of age and children over 16 years of age are injected with 10-30 mg (0.3-1 ml), then 10-30 mg (0.3-1 ml) every 6 hours, with continuous infusion using an infusion pump the initial dose is 30 mg (1 ml), and then the infusion rate is 5 mg/h;
adults over 65 years of age or with impaired renal function are given a bolus of 10-15 mg (0.3-0.5 ml) every 6 hours.

The maximum daily dose for adults under 65 years of age and children over 16 years of age should not exceed 90 mg (3 ml), and for adults over 65 years of age or with impaired renal function - 60 mg (2 ml) for both intramuscular and intravenous routes of administration .

Continuous intravenous infusion should not last more than 24 hours.

The maximum duration of treatment should not exceed 2 days.

When switching from parenteral administration of the drug to oral administration, the total daily dose of both dosage forms on the day of transfer should not exceed 90 mg for adults under 65 years of age and children over 16 years of age and 60 mg for adults over 65 years of age or with impaired renal function. In this case, the dose of the drug in tablets on the day of transition should not exceed 30 mg.

Storage conditions

In a place protected from light, at a temperature not exceeding 25 ° C. Do not freeze.

Keep out of the reach of children.

Best before date

3 years. Do not use after expiration date.

special instructions

When used together with other NSAIDs, fluid retention, cardiac decompensation, and arterial hypertension may occur.
To reduce the risk of developing NSAID gastropathy, antacids, misoprostol, and omeprazole are prescribed.
The effect on platelet aggregation lasts for 24-48 hours.
Hypovolemia increases the risk of developing adverse reactions from the kidneys.
If necessary, can be prescribed in combination with opioid analgesics.
Do not use simultaneously with paracetamol for more than 5 days.
In patients with blood coagulation disorders, it is used only with constant monitoring of the platelet count, especially in the postoperative period, which requires careful monitoring of hemostasis.

Description

NSAIDs with a pronounced analgesic effect.

Dosage form

Solution for intravenous and intramuscular administration in the form of a clear, light yellow liquid.

Use in children

Contraindication: children and adolescents under 16 years of age (efficacy and safety have not been established).

Pharmacodynamics

NSAIDs have a pronounced analgesic (pain-relieving) effect, and also have anti-inflammatory and moderate antipyretic effects.

The mechanism of action is associated with non-selective inhibition of the activity of the enzymes COX-1 and COX-2, mainly in peripheral tissues, resulting in inhibition of the biosynthesis of prostaglandins - modulators of pain sensitivity, inflammation and thermoregulation. Ketorolac is a racemic mixture of R(+) and S(-)-enantiomers, with the analgesic (pain-relieving) effect due to the S(-)-enantiomer.

Ketorolac does not affect opioid receptors, does not depress respiration, does not cause drug dependence, and does not have a sedative or anxiolytic effect.

The strength of the analgesic (pain-relieving) effect is comparable to morphine and significantly superior to other NSAIDs.

After oral administration, the onset of analgesic (pain-relieving) effect is observed after 1 hour, the maximum effect is achieved after 2-3 hours.

After intramuscular administration, the onset of analgesic (pain-relieving) effect is noted after 0.5 hours, the maximum effect is achieved after 1-2 hours.

Side effects

From the digestive system: often (especially in elderly patients over 65 years of age with a history of erosive and ulcerative lesions of the gastrointestinal tract) - 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, melena, vomiting with blood or coffee grounds, nausea, heartburn), 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), frequent urination, increased or decreased urine volume, nephritis, edema of renal origin.

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

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

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

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

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

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

From the skin: less often - skin rash (including maculopapular), purpura; rarely - exfoliative dermatitis (including fever with or without chills, redness, thickening or flaking of the skin, swelling and/or tenderness of the tonsils), urticaria, Stevens-Johnson syndrome, Lyell's syndrome.

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

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

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

Use during pregnancy and breastfeeding

The use of the drug is contraindicated during pregnancy, during childbirth and during breastfeeding.

Interaction

The simultaneous use of ketorolac with acetylsalicylic acid or other NSAIDs, calcium preparations, corticosteroids, ethanol, corticotropin can lead to the formation of gastrointestinal ulcers and the development of gastrointestinal bleeding.
Co-administration with paracetamol increases nephrotoxicity, and with methotrexate - hepato- and nephrotoxicity.
Co-administration of ketorolac and methotrexate is possible only when using low doses of the latter (monitor the concentration of methotrexate in the blood plasma).
With the use of ketorolac, the clearance of methotrexate and lithium may decrease and the toxicity of these substances may increase.
Co-administration with indirect anticoagulants, heparin, thrombolytics, antiplatelet agents, cefoperazone, cefotetan and pentoxifylline increases the risk of bleeding.
Reduces the effect of antihypertensive and diuretic drugs (the synthesis of prostaglandins in the kidneys decreases).
When used simultaneously with opioid analgesics, the doses of the latter can be significantly reduced, because their effect is enhanced.
When used simultaneously, it enhances the hypoglycemic effect of insulin and oral hypoglycemic drugs (dose recalculation is necessary).
Co-administration with valproic acid causes disruption of platelet aggregation.
Increases the plasma concentration of verapamil and nifedipine.
When prescribed with other nephrotoxic drugs (including gold preparations), the risk of developing nephrotoxicity increases.
Probenecid and drugs that block tubular secretion reduce the clearance of ketorolac and increase its concentration in the blood plasma.
Myelotoxic drugs increase the manifestations of hematotoxicity of the drug.
Pharmaceutically incompatible with tramadol solution and lithium preparations.

Overdose

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

Treatment: there is no specific antidote; gastric lavage, administration of adsorbents (activated carbon) and symptomatic therapy (maintaining vital body functions) are recommended. Ketorolac is not sufficiently eliminated by dialysis.

Impact on the ability to drive vehicles and operate machinery

Since a significant proportion of patients using ketorolac develop side effects from the central nervous system (drowsiness, dizziness, headache), it is recommended to avoid performing work that requires increased attention and quick reaction (driving vehicles, working with machinery).

Indications for use

Moderate to severe pain syndrome :

toothache;
pain of traumatic etiology;
pain in the postoperative and postpartum period;
pain due to cancer ;
dislocations , sprains ;
arthralgia , neuralgia , myalgia , radiculitis ;
rheumatic diseases.

Used for symptomatic therapy, relief of inflammation and pain at the time of use, does not affect the development of the disease.

Ketorolac

Often - >3%; less often - 1–3%; rarely - <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 vision).

From the respiratory system:

rarely - bronchospasm or dyspnea, 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 SSS side:

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, hyperemia, thickening or peeling of the skin, enlargement and/or soreness 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, skin itching, tachypnea or dyspnea, 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.

Contraindications

Combination (complete or incomplete) of bronchial asthma , intolerance to aspirin (or other drugs in this group) and recurrent polyposis of the paranasal sinuses and nose .
Hypersensitivity.
Hypovolemia.
Intolerance pyrazolone drugs .
Exacerbation of erosive and ulcerative diseases of the gastrointestinal tract.
Hypocoagulation , high risk of bleeding.
Severe kidney or liver damage , liver disease.
Condition after coronary artery bypass surgery .
Hyperkalemia.
3rd trimester of pregnancy, childbirth and lactation.
Inflammatory intestinal lesions.
Age less than 16 years.

Use with caution for: bronchial asthma , alcoholism , chronic heart failure, cholecystitis , postoperative period, arterial hypertension , edema syndrome, kidney damage, active hepatitis, cholestasis, systemic lupus erythematosus, sepsis, coronary heart disease, dyslipidemia , cerebrovascular diseases, peripheral damage arteries, diabetes mellitus, ulcerative lesions of the digestive tract in the past, H. pylori infection, prolonged use of other non-steroidal anti-inflammatory drugs , old age, 1st and 2nd trimesters of pregnancy.

Ketorolac

According to the World Health Organization (WHO), adverse events are classified according to their frequency as follows: very common (≥ 10%), common (≥ 1% and < 10%), uncommon (≥ 0.1% and < 1% ), rare (≥ 0.01% and < 0.1%), very rare (< 0.01%), frequency unknown (frequency cannot be determined from available data).

Allergic reactions

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

Local reactions:

common - burning or pain at the injection site.

From the central nervous system:

very common - headache; frequent - dizziness, drowsiness, increased sweating; uncommon - tremor, unusual dreams, hallucinations, euphoria, extrapyramidal symptoms, vertigo, paresthesia, depression, insomnia, nervousness, pathological thinking, loss of concentration, hyperkinesis, confusion (stupor), aseptic meningitis (fever, severe headache, convulsions, stiffness of the neck and/or back muscles), psychosis, fainting.

From the skin:

common - itching, rash (including maculopapular rash); uncommon - urticaria, toxic epidermal necrolysis (Lyell's syndrome), malignant exudative erythema (Stevens-Johnson syndrome), exfoliative dermatitis (fever with or without chills, flushing, thickening or peeling of the skin, enlargement and/or soreness of the tonsils).

From the urinary system:

uncommon - hematuria, proteinuria, urinary retention, oliguria, polyuria, frequent urination, acute renal failure, low back pain with or without hematuria and/or azotemia, interstitial nephritis, hyponatremia, hyperkalemia, hemolytic uremic syndrome (hemolytic anemia, renal failure, thrombocytopenia, purpura).

From the digestive system:

very common - gastralgia, dyspepsia, nausea; frequent - diarrhea, constipation, flatulence, feeling of fullness in the stomach, vomiting, stomatitis; uncommon - increased or decreased appetite, anorexia, 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-ground type, nausea, heartburn), cholestatic jaundice, hepatitis, hepatomegaly. acute pancreatitis, polydipsia, dry mouth: frequency unknown - exacerbation of ulcerative colitis or Crohn's disease.

From the hematopoietic organs:

common - purpura; uncommon - anemia, eosinophilia.

From the respiratory system:

Uncommon: bronchospasm or shortness of breath, pulmonary edema, rhinitis, laryngeal edema (difficulty breathing).

From the senses:

Uncommon: taste disturbance, visual impairment (including blurred vision), hearing loss, ringing in the ears.

From the cardiovascular system:

frequent - increased blood pressure; infrequent - palpitations, pallor of the skin, fainting, hyperemia; frequency unknown - decreased blood pressure, heart failure, myocardial infarction, stroke.

From the hemostasis system:

uncommon - bleeding from a postoperative wound, nosebleeds, rectal bleeding.

Others

: frequent - swelling; uncommon - weight gain, fever, infections, asthenia, increased sweating, swelling of the tongue; frequency unknown - increased concentrations of urea and creatinine in the blood plasma.

Side effects

Reactions from the circulatory system: changes in pressure, bradycardia , rapid heartbeat , fainting.
Reactions from the digestive system: abdominal pain, diarrhea, flatulence, nausea, constipation , vomiting, thirst , gastritis, stomatitis , erosive and ulcerative changes in the digestive tract, liver damage.
Reactions from the nervous system: paresthesia , anxiety, sleep disturbances , drowsiness , depression , visual disturbances, dizziness , movement disorders.
Reactions from the respiratory system: attacks of suffocation.
Reactions from the genitourinary system: oliguria , increased urination, polyuria, proteinuria, hematuria, azotemia, acute renal failure .
Reactions from the hematopoietic system: nosebleeds, anemia , eosinophilia, thrombocytopenia.
Metabolic reactions: edema , hypokalemia , increased creatinine or urea in the blood, hyponatremia.
Allergic reactions: hemorrhagic rash, Stevens-Johnson syndrome , urticaria , Quincke's edema , Lyell's syndrome , anaphylactic shock, bronchospasm, myalgia .
Other reactions: fever .
Local reactions: pain in the injection area.

Instructions for use of KETOROLAC for injection

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 grounds” type, nausea, heartburn, etc.), cholestatic jaundice, hepatitis, hepatomegaly, acute pancreatitis.

From the urinary system:

rarely - acute renal failure, lower back pain, hematuria, azotemia, hemolyticouremic 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 vision).

From the respiratory system:

rarely - bronchospasm or dyspnea, rhinitis, pulmonary edema, laryngeal edema (shortness of breath, difficulty breathing).

From the central nervous system:

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, enlarged and/or painful tonsils), urticaria, malignant exudative erythema (Stevens syndrome -Johnson), toxic epidermal necrolysis (Lyell's syndrome).

Local reactions:

less often - burning or pain at the injection site.

Allergic reactions:

Other:

often - swelling (face, legs, ankles, fingers, feet, weight gain);

less often - increased sweating, rarely - swelling of the tongue, fever.

Instructions for use of Ketorolac (Method and dosage)

Ketorolac tablets instructions for use recommend using them orally. Single dose - 10 mg. The next time you use it, you can take 10 mg up to four times a day; the highest daily dose should not be more than 40 mg. The duration of treatment is up to 5 days.

Ketorolac injections instructions for use recommend that when administered intramuscularly, stick to a single dose of up to 30 mg once every 4-6 hours. The highest dose is 90 mg (three ampoules) per day. The longest duration of use of the drug is up to 2 days.

Interaction

Use with other drugs from the same group (OKPD - non-steroidal anti-inflammatory drugs ), glucocorticosteroids, corticotropin, ethanol, calcium supplements increases the risk of ulceration of the gastrointestinal tract and bleeding from the stomach and intestines.

Co-administration with heparin , coumarin derivatives, thrombolytics ( Streptokinase, Alteplase ), cephalosporins, antiplatelet agents, valproic acid and aspirin increases the risk of bleeding.

Ketorolac weakens the effect of diuretic and antihypertensive drugs.

Use together with methotrexate increases hepato- and nephrotoxicity .

Ketorolac enhances the effect of narcotic analgesics.

Myelotoxic drugs enhance the hematotoxic effect of the drug.

Ketorolac Welfarm, solution 30 mg/ml, ampoules 1 ml, 10 pcs.

The simultaneous use of ketorolac with acetylsalicylic acid or other NSAIDs, including cyclooxygenase-2 inhibitors, calcium preparations, glucocorticosteroids, ethanol, corticotropin can lead to the formation of ulcers of the gastrointestinal tract and the development of gastrointestinal bleeding.

The drug should not be used simultaneously with other NSAIDs (including cyclooxygenase-2 inhibitors), as well as simultaneously with probenecid, pentoxifylline, acetylsalicylic acid, lithium salts, anticoagulants (including warfarin and heparin). Do not use with paracetamol for more than 2 days. Co-administration with paracetamol increases nephrotoxicity, and with methotrexate - hepato- and nephrotoxicity. Co-administration of ketorolac and methotrexate is possible only when using low doses of the latter (monitor the concentration of methotrexate in the blood plasma).

Probenecid reduces the plasma clearance and volume of distribution of ketorolac, increases its concentration in the blood plasma and increases its half-life. With the use of ketorolac, the clearance of methotrexate and lithium may decrease and the toxicity of these substances may increase. Co-administration with indirect anticoagulants (for example, warfarin), heparin, thrombolytics, antiplatelet agents, cefoperazone, cefotetan and pentoxifylline increases the risk of bleeding. Reduces the effect of antihypertensive and diuretic drugs (the synthesis of prostaglandins in the kidneys is reduced). When combined with narcotic analgesics, the doses of the latter can be significantly reduced.

Antacids do not affect the complete absorption of the drug.

The hypoglycemic effect of insulin and oral hypoglycemic drugs increases (dose recalculation is necessary). Co-administration with valproic acid causes disruption of platelet aggregation. Increases the plasma concentration of verapamil and nifedipine.

When prescribed with other nephrotoxic drugs (including gold preparations), the risk of developing nephrotoxicity increases. Drugs that block tubular secretion reduce the clearance of ketorolac and increase its concentration in the blood plasma.

It is necessary to take into account possible interactions when ketorolac is simultaneously prescribed with cyclosporine, zidovudine, digoxin, tacrolimus, quinolone drugs, selective serotonin reuptake inhibitors, and mifepristone.

Zidovudine: Increased risk of red blood cell toxicity via effects on reticulocytes, with severe anemia occurring one week after starting NSAID treatment. It is necessary to perform a complete blood count and monitor the reticulocyte count once or twice a week after starting NSAID treatment.

Mifepristone: After using mifepristone, NSAIDs should not be used for 8 to 12 subsequent days as they may reduce the effects of mifepristone.

Cyclosporine and tacrolimus: NSAIDs may increase nephrotoxicity due to renal prostaglandin-related effects. When used together, it is necessary to monitor renal function.

special instructions

Before prescribing the drug, it is necessary to find out about the presence of a previous allergy to other non-steroidal anti-inflammatory drugs .

Hypovolemia increases the risk of developing kidney toxicity.

If necessary, Ketorolac can be prescribed with narcotic analgesics . The drug should not be used for premedication or to maintain anesthesia.

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

To reduce the risk of developing gastropathy , misoprostol, antacids, and omeprazole are prescribed simultaneously .

To reduce the risk of side effects, the lowest effective dose should be used for the shortest possible course.

During treatment with the drug, you must be careful when driving.

Ketorolac-LF solution for IM administration 30 mg/ml in 1 ml ampoules No. 5x2

Name

Ketorolac-LF.

Release form

Solution for intramuscular administration.

Dosage

1 ampoule of 1 ml, in a package of 10 pcs.

Description

Transparent light yellow liquid.

Compound

One ampoule contains: Active substance: ketorolac tromethamine – 30.0 mg. Excipients: ethanol, sodium chloride, disodium edetate, 1M sodium hydroxide solution or 1M hydrochloric acid solution, water for injection.

Pharmacotherapeutic group

Nonsteroidal anti-inflammatory and antirheumatic drugs. ATX code. M01AB15.

Pharmacodynamics

Non-steroidal anti-inflammatory drug. It has a pronounced analgesic effect, and also has anti-inflammatory and moderate antipyretic effects. The mechanism of action is associated with selective inhibition of the activity of the enzyme cyclooxygenase (COX-1 and COX-2), mainly in peripheral tissues, resulting in inhibition of prostaglandin biosynthesis. Does not affect opioid receptors, does not depress respiration, does not cause drug dependence, and does not have a sedative or anxiolytic effect. The strength of the analgesic effect is comparable to morphine, significantly superior to other NSAIDs. Ketorolac inhibits platelet aggregation and increases bleeding time. The functional state of platelets is restored 24-48 hours after discontinuation of the drug.

Pharmacokinetics

The bioavailability of ketorolac after intramuscular administration ranges from 80% to 100%. The pharmacokinetics of ketorolac under conditions of mid-therapeutic parenteral doses is a linear function. The equilibrium concentration of the drug in plasma is 50% higher than that determined after a single administration. More than 99% of the drug is bound to plasma proteins, resulting in an apparent volume of distribution of less than 0.3 l/kg. More than 50% of the administered dose is metabolized in the liver with the formation of pharmacologically inactive metabolites. The main metabolites are glucuronides and p-hydroxyketorolac. Ketorolac passes into breast milk. Excreted by the kidneys (91%) and through the intestines (6%). Glucuronides are excreted in the urine. The half-life in patients with normal renal function averages 5 hours. The total clearance is 0.025 l/kg/h. In patients with renal failure, the volume of distribution of ketorolac may increase by 2 times, and the volume of distribution of the R-enantiomer by 20%. The half-life is prolonged in elderly patients and shortened in younger patients. Liver function does not affect the half-life. In patients with impaired renal function with a plasma creatinine concentration of 19-50 mg/l (168-442 µmol/l), the half-life is 10.3-10.8 hours, with more severe renal failure - more than 13.6 hours. The total clearance in patients with renal failure at a plasma creatinine concentration of 0.016 l/kg/h. Ketorolac is not eliminated by hemodialysis.

Indications for use

Short-term relief of moderate and severe acute pain in the postoperative period. Treatment should be started only in a hospital setting, the maximum duration of treatment is 2 days.

Directions for use and dosage

Ketorolac-LF is intended for intramuscular administration; the drug should not be used for epidural or spinal administration. The solution is injected intramuscularly slowly deep into the muscle. The onset of the analgesic effect is about 30 minutes, the maximum severity is within 1-2 hours, the average duration of analgesia is 4-6 hours. Administration of the drug several times a day for more than 2 days is not recommended, since in most cases patients do not require longer-term analgesic therapy or can be transferred to oral administration of Ketorolac-LF. In this case, the duration of use of Ketorolac-LF parenterally and orally should not exceed 5 days in total. To achieve maximum analgesic effect in the early postoperative period, it is possible to use Ketorolac-LF and narcotic analgesics together; the daily dose of the latter in this case is reduced. Ketorolac-LF does not affect addiction to opioids and does not increase associated respiratory depression or sedation. Dose selection and adjustment should be made in accordance with the intensity of pain and response to the drug. To minimize side effects, it is recommended to use the minimum effective dose for the shortest possible course of treatment. Adults: The usually recommended initial dose of Ketorolac-LF is 10 mg, followed by 10-30 mg every 4-6 hours. In the early postoperative period, it is permissible to administer the drug every 2 hours, if necessary. The maximum daily dose is 90 mg/day, in patients weighing less than 50 kg – no more than 60 mg/day. Elderly patients (over 65 years of age): it is recommended to use the drug in the lowest effective dose, the total dose should not exceed 60 mg/day. Due to the higher risk of side effects in this group of patients, the minimum possible duration of treatment and regular monitoring of the patient’s condition to exclude gastrointestinal bleeding are recommended. Children: The safety and effectiveness of ketorolac in children have not been confirmed. Ketorolac-LF is not recommended for use in children under 16 years of age. Patients with renal impairment: The use of ketorolac is contraindicated in patients with severe to moderate renal impairment. In case of mild renal dysfunction, it is permissible to use Ketorolac-LF at a dose of no more than 60 mg/day. If combined parenteral and oral administration is necessary, the total daily dose of Ketorolac-LF should not exceed 90 mg (60 mg in patients over 65 years of age, patients weighing less than 50 kg or impaired renal function), while the dose of the drug taken orally should not exceed 40 mg/day. It is recommended to quickly transfer the patient only to the oral form of the drug.

Side effect

From the gastrointestinal tract: anorexia, feeling of discomfort in the abdomen, feeling of fullness of the stomach, nausea, dyspepsia, gastrointestinal pain, epigastric pain, diarrhea, flatulence, belching, vomiting, constipation, erosive and ulcerative changes, bleeding and gastrointestinal perforation -intestinal tract (sometimes fatal), vomiting blood, blood in the stool, gastritis, peptic ulcer, pancreatitis, ulcerative stomatitis, esophagitis, exacerbation of Crohn's disease and colitis. From the liver and biliary tract: impaired liver function, liver failure, jaundice, hepatitis, hepatomegaly, increased activity of liver transaminases. From the nervous system: headache, dizziness, fainting, increased fatigue, weakness, irritability, dry mouth, increased thirst, mood changes, anxiety, impaired concentration, euphoria, nervousness, confusion, paresthesia, unusual dreams, depression, drowsiness, sleep disturbance, insomnia, hallucinations, agitation, hyperkinesia, convulsions, pathological thoughts, aseptic meningitis, stiff neck, anxiety, vertigo, disorientation, thought disorder. From the senses: impaired taste, blurred visual perception, optic neuritis, tinnitus, decreased and loss of hearing. From the musculoskeletal system: myalgia. From the urinary system: pain at the site of the kidney projection, dysuria, frequent urination, oliguria, hematuria, proteinuria, increased levels of urea and creatinine in the blood serum, hyponatremia, hyperkalemia, urinary retention, renal failure, interstitial nephritis, papillary necrosis, nephrotic syndrome, hemolytic uremic syndrome. From the cardiovascular system: pallor, hyperemia, chest pain, palpitations, bradycardia, heart failure, arterial hypertension, edema. Data from clinical and epidemiological studies suggest that the use of some 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 blood side: purpura, leukopenia, eosinophilia, neutropenia, agranulocytosis, aplastic anemia, hemolytic anemia, thrombocytopenia, a possible decrease in the rate of blood clotting, the occurrence of hemorrhages under the skin, hematomas, nosebleeds, increased bleeding time, increased bleeding of postoperative wounds. From the respiratory system: – shortness of breath, tachypnea, bronchospasm, complication of asthma, pulmonary edema. From the reproductive system: infertility (in women). Skin: itching, urticaria, photosensitivity, Lyell's syndrome, exfoliative dermatitis, toxic epidermal necrolysis, erythema multiforme, Stevens-Johnson syndrome, skin rashes, including maculopapular and weeping, changes in facial skin color. Allergic reactions: anaphylactic and anaphylactoid reactions, urticaria, bronchospasm, laryngeal edema, angioedema, eyelid edema, periorbital edema, exfoliative dermatitis, bullous dermatosis. From the body as a whole: general malaise, swelling, fever, increased sweating, weight gain, pain, swelling and hyperemia at the injection site. To prevent possible side effects, one should strive to use the minimum effective doses of the drug, strictly adhere to the established dosages and administration regimens, take into account the patient’s condition (age, concomitant diseases, liver and kidney function, the state of water-electrolyte metabolism and the hemostatic system), as well as possible drug interactions with combination therapy.

Contraindications

Bronchial asthma. Complete or partial syndrome of nasal polyps, bronchospasm, angioedema in history; Peptic ulcer of the stomach and duodenum during the period of exacerbation, as well as a history of ulcers or gastrointestinal bleeding, the presence or suspicion of gastrointestinal bleeding; History of blood coagulation disorders, conditions with a high risk of bleeding, hemorrhagic diathesis, coagulopathies, hemorrhagic stroke, intracranial bleeding, simultaneous use with anticoagulants (including warfarin, low doses of heparin). Surgical interventions with a high risk of bleeding or the risk of incomplete stopping of bleeding; Moderate and severe renal failure (plasma creatinine more than 50 mg/l), risk of renal failure, hypovolemia, dehydration; Pregnancy, childbirth and breastfeeding; Hypersensitivity to ketorolac, aspirin, other NSAIDs or any component of the drug; Concomitant use of other NSAIDs (risk of additive side effects); Age up to 16 years; Congestive heart failure; The drug is not used for pain relief before and during surgery; The drug is not used for epidural and intrathecal administrations; Severe liver failure; Combined use with lithium preparations, pentoxifylline, probenecid.

Overdose

An overdose of ketorolac with a single or repeated use is usually manifested by pain in the abdomen, the occurrence of peptic ulcers of the stomach or erosive gastritis, impaired renal function, hyperventilation, metabolic acidosis, these symptoms are cured after stopping the drug. In these cases, gastric lavage, administration of adsorbents (activated carbon) and symptomatic therapy are recommended. Ketorolac is not sufficiently eliminated by dialysis.

Precautionary measures

Features of application. Ketorolac-LF is prescribed with caution to patients with impaired liver function. While taking Ketorolac-LF, it is possible to increase the level of liver enzymes. If there are functional abnormalities in the liver while taking ketorolac, a more severe pathology may develop. If signs of liver pathology are detected, treatment should be stopped. In patients with renal failure or a history of kidney disease, Ketorolac-LF is prescribed with caution. Elderly patients: since patients in this age group are more likely to develop adverse reactions, the minimum effective dose should be used (daily therapeutic dose not exceeding 60 mg for patients over 65 years of age). Children: there is insufficient data on the safety and effectiveness of Ketorolac-LF in children; therefore, the drug is not recommended for use in children under 16 years of age. Impact on laboratory test parameters: bleeding time may increase when studying coagulation parameters. Ketorolac can cause severe adverse reactions from the digestive tract at any stage of drug therapy after or without warning symptoms; such adverse reactions can be fatal. The risk of serious gastrointestinal bleeding is dose-related, but side effects can occur even with short-term therapy. In addition to a history of peptic ulcer disease, provoking factors are the simultaneous use of oral corticosteroids, anticoagulants, long-term therapy with non-steroidal anti-inflammatory drugs, smoking, drinking alcoholic beverages, and old age. If you suspect the development of adverse reactions from the gastrointestinal tract, ketorolac should be discontinued. NSAIDs should be used with caution in patients with a history of Crohn's disease and ulcerative colitis due to the possibility of worsening the course of the disease. Ketorolac inhibits platelet aggregation and prolongs bleeding time; platelet function returns to normal within 24-48 hours after discontinuation of the drug. In patients receiving anticoagulant therapy, the use of ketorolac may increase the risk of bleeding. Patients already taking anticoagulants or patients who require low-dose heparin should not receive ketorolac. In patients taking other drugs that affect hemostasis, ketorolac should be used with caution. In patients who have undergone surgery with a high risk of bleeding or incomplete hemostasis, ketorolac should not be used. Like other NSAIDs, ketorolac inhibits prostaglandin synthesis and may have toxic effects on the kidneys, so it should be used with caution in patients with impaired renal function or a history of kidney disease. Risk groups include patients with impaired renal function, hypovolemia, heart failure, liver dysfunction, patients using diuretics, and elderly patients. Fluid retention, sodium chloride retention, hypertension, oliguria and peripheral edema have been observed in some patients taking NSAIDs, including ketorolac, so it should be used with caution in patients with hypertension or heart failure. Before administering the drug, disturbances in water and electrolyte balance should be corrected. Clinical studies and epidemiological data suggest that the use of some NSAIDs, especially in high doses and for long periods of time, may be associated with an increased risk of arterial thrombotic complications such as myocardial infarction or stroke. Such a risk cannot be excluded for ketorolac. To minimize the potential risk of adverse cardiovascular complications in patients using NSAIDs, the minimum effective dose should be used for the shortest possible period of time. Ketorolac should be prescribed to patients with uncontrolled hypertension, congestive heart failure, established coronary artery disease, peripheral arterial and/or cerebrovascular disease only after a thorough assessment of all the advantages and disadvantages of such treatment. Ketorolac should be administered with caution to patients with impaired liver function or a history of liver disease. Significant increases (more than three times normal) in serum ALT and AST were observed in less than 1% of patients in controlled clinical studies. In addition, isolated cases of severe hepatic reactions have been reported, including jaundice, fulminant hepatitis, liver necrosis and liver failure, in some cases leading to death. If signs of liver dysfunction appear, ketorolac should be discontinued. Use of the drug in patients with systemic lupus erythematosus or connective tissue diseases may be associated with an increased risk of developing aseptic meningitis. There have been reports of serious skin reactions such as exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis. The highest risk of developing these reactions exists at the beginning of treatment. Serious anaphylactic and anaphylactoid reactions, such as bronchospasm, laryngeal edema, angioedema, and anaphylactic shock, have been reported. Ketorolac should not be used in patients with a history of bronchial asthma, nasal polyp syndrome, bronchospasm, or angioedema. If a rash or other manifestations of hypersensitivity appear, treatment with the drug should be discontinued. The drug Ketorolac-LF contains a small amount of ethanol (100 mg per 1 ml).

Interaction with other drugs

Ketorolac slightly reduces the degree of protein binding of warfarin. In vitro studies have shown the effect of therapeutic doses of salicylates on the degree of binding of ketorolac to plasma proteins downward from 99.2% to 97.5%. When combined with furosemide, its diuretic effect may be weakened by approximately 20%. Probenecid reduces the plasma clearance and volume of distribution of ketorolac, increasing its plasma concentration and increasing its half-life. With the use of ketorolac, the clearance of methotrexate and lithium may decrease and the toxicity of these substances may increase. A possible interaction between ketorolac and non-depolarizing muscle relaxants has been noted, leading to the development of apnea. It is possible that simultaneous use with ACE inhibitors may increase the risk of renal dysfunction. Rare cases of the development of convulsive attacks have been described when ketorolac is combined with anticonvulsants (phenytoin, carbamazepine). Hallucinations may occur during simultaneous use of ketorolac and psychostimulant drugs (fluoxetine, thiothixene, alprazolam). Concomitant use of ketorolac and NSAIDs, including selective COX-2 inhibitors, should be avoided due to an increased risk of serious adverse events. Ketorolac inhibits platelet aggregation, reduces thromboxane concentrations and prolongs bleeding time. Platelet function returns to normal within 24-28 hours after stopping ketorolac. Concomitant use of ketorolac and therapeutic doses of warfarin, prophylactic doses of heparin (2500-5000 units over 12 hours) and dextrans may be associated with an increased risk of bleeding. NSAIDs should not be used for 8 to 12 days after mifepristone administration due to the potential for decreased efficacy of mifepristone. Concomitant use of ketorolac and pentoxifylline increases the risk of bleeding. Caution should be used when coadministered with corticosteroids due to the increased risk of gastrointestinal ulceration or bleeding. Ketorolac reduces the need for opioid analgesics when used to relieve postoperative pain. Ketorolac may increase the risk of seizures in patients taking quinolines concomitantly. Concomitant use of NSAIDs and zidovudine increases the risk of hematological toxicity. When ketorolac is used concomitantly with tacrolimus or cyclosporine, the risk of nephrotoxicity increases. NSAIDs may worsen heart failure, reduce glomerular filtration rate, and increase plasma levels of cardiac glycosides when used together. Incompatibility. Ketorolac-LF, solution for intramuscular administration, should not be mixed in small containers (for example, in one syringe) with morphine sulfate, meperidine hydrochloride, promethazine hydrochloride or hydroxyzine hydrochloride, since ketorolac may precipitate. Ketorolac-LF is pharmaceutically incompatible with tramadol and lithium preparations.

Use during pregnancy and lactation

The safety and effectiveness of using the drug Ketorolac-LF during pregnancy has not been established. Drugs that affect the synthesis of prostanlandins, including ketorolac, can cause a decrease in fertility, and therefore are not recommended for use by women planning pregnancy. The safety of the drug in pregnant women has not been studied. A study on rats and rabbits at toxic doses did not reveal a teratogenic effect. In rats, prolongation of gestational age and delayed birth were noted. Due to the known negative effect of NSAID drugs on the cardiovascular system of the fetus (risk of occlusion of the ductus arteriosus), ketorolac is contraindicated in pregnant women. The use of ketorolac during labor is not recommended due to the increased risk of bleeding in mother and child. Ketorolac passes into milk; therefore, it is not recommended to take Ketorolac-LF during breastfeeding.

Impact on the ability to drive vehicles and operate machinery

Since a significant proportion of patients who are prescribed ketorolac develop side effects from the central nervous system (drowsiness, dizziness, headache), it is recommended to avoid performing work that requires increased attention and quick reaction.

Storage conditions

Store in a place protected from light at a temperature not exceeding 25 ºС. Keep out of the reach of children.

Best before date

3 years. Do not use after the expiration date stated on the packaging.

Package

1 ml of solution for intramuscular administration in dark glass ampoules with a break ring. 5 ampoules in a cell package. 1 or 2 blisters along with instructions for medical use in a cardboard box

Buy Ketorolac-LF solution for intramuscular injection. 30 mg/ml in amp. 1 ml per pack. No. 5x2 in the pharmacy

Price for Ketorolac-LF solution for intramuscular injection. 30 mg/ml in amp. 1 ml per pack. №5x2

Instructions for use for Ketorolac-LF solution for intramuscular injection. 30 mg/ml in amp. 1 ml per pack. №5x2

Analogs

Level 4 ATC code matches:
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Rapten

Zerodol

Dickloberl Retard

Dikloberl N 75

Dicloberl

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Panoxen

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Ortofen

Ketarolac analogues: Ketanov, Ketorol, Ketonort, Ketorolac-Credofarm and others.

Ketarolac price, where to buy

In Russia, the price of Ketorolac No. 10 ampoules is 99-101 rubles, the price of Ketorolac No. 20 tablets is approximately 18 rubles. In Ukraine, ampoules of drug No. 10 cost 54-75 hryvnia, tablets No. 10 cost 9-25 hryvnia.

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ZdravCity

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