Ketorolac in Latin. Ketorol for injection - instructions for use. Film-coated tablets

Ketorolac Film-coated tablets 10 mg - polymer jar (jar) 20, cardboard pack 1 - No. LS-001005, 2010-08-26 from Sintez OJSC (Russia)

Latin name

Ketorolac

Active substance

Ketorolac*(Ketorolac*)

ATX

M01AB15 Ketorolac

Pharmacological group

NSAIDs - Derivatives acetic acid and related compounds Description active substance. Given scientific information is general and cannot be used to make a decision about the possibility of using a specific medicinal product.

Indications of the drug

Pain syndrome of moderate and severe severity, incl. V postoperative period(after abdominal, gynecological, orthopedic, urological and other operations), pain syndrome due to injuries (dislocation, fracture, ruptures and sprains), pain syndrome due to osteoarthritis, osteochondrosis, neuralgia, pain due to cancer, toothache, pain after dental interventions, with pericoronitis, pulpitis, back and muscle pain.

Contraindications

Hypersensitivity (including to other NSAIDs), “aspirin” asthma (a combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses, as well as intolerance to acetylsalicylic acid and pyrazolone-type drugs), bronchospasm, angioedema, erosive and ulcerative lesions of the gastrointestinal tract in the acute stage, peptic ulcers, hypovolemia, dehydration, hypocoagulation (including hemophilia), high risk development of bleeding or its recurrence (including after operations), hematopoietic disorders, hemorrhagic stroke (confirmed or suspected), hemorrhagic diathesis, renal and/or liver failure(plasma creatinine above 50 mg/l), concomitant use with other NSAIDs, labor and delivery, age up to 16 years. Do not use for pain relief before or during surgical operations because of high risk bleeding, as well as for the treatment of chronic pain.

Use during pregnancy and breastfeeding

Teratogenic effects. Reproduction studies performed during organogenesis using daily oral doses of ketorolac tromethamine 3.6 mg/kg (0.37 MRV) in rabbits and 10 mg/kg (1.0 MRV) in rats did not demonstrate fetal teratogenicity. . However, reproductive studies in animals do not always predict effects in humans.

There are no adequate and strictly controlled studies in pregnant women. Use during pregnancy is possible if the expected effect of therapy exceeds the potential risk to the fetus.

Non-teratogenic effects. Since NSAIDs are known to have an adverse effect on the cardiovascular system of the fetus (premature closure of the ductus arteriosus), use should be avoided during pregnancy (especially in later stages). Oral doses of ketorolac tromethamine 1.5 mg/kg (0.14 MRV) in rats administered after gestation day 17 caused obstructed labor and increased pup mortality.

Childbirth and delivery. The use of ketorolac tromethamine is contraindicated because, by inhibiting the synthesis of prostaglandins, it can adversely affect the blood circulation of the fetus and weaken the contractile activity of the uterus, which increases the risk of uterine bleeding.

After a single oral dose of 10 mg of ketorolac tromethamine, the maximum concentration determined in human breast milk is 7.3 ng/ml, the maximum milk/plasma ratio is 0.037; after one day of administration (4 times a day), the same indicators are 7.9 ng/ml, after 0.025. Since drugs that inhibit PG synthesis can cause adverse effects in newborns, treatment should be stopped during treatment. breast-feeding.

Side effects

The incidence of side effects increases with increasing dose. During clinical trials, the following were noted: side effects Possibly associated with the use of ketorolac tromethamine:

From the gastrointestinal tract: gastralgia (13%), nausea (12%), dyspepsia (12%), diarrhea (7%) - >1% - constipation, flatulence, feeling of fullness in the stomach, vomiting, stomatitis - %26le-1% - gastritis, belching, anorexia, increased appetite, dry mouth.

From the outside nervous system and sense organs: headache(17%), dizziness (7%), drowsiness (6%) - %26le-1% - asthenia, tremor, unusual dreams, insomnia, hallucinations, euphoria, extrapyramidal symptoms, vertigo, paresthesia, depression, nervousness, thinking disorders, inability to concentrate, hyperkinesis, stupor, excessive thirst, taste disturbances, visual impairment (including blurred vision), hearing loss, ringing in the ears.

From the outside of cardio-vascular system and blood (hematopoiesis, hemostasis): >1% - increased blood pressure - %26le-1% - palpitations, pallor, fainting, anemia, eosinophilia.

From the respiratory system: %26le-1% - dyspnea, rhinitis, pulmonary edema, cough.

From the outside genitourinary system:%26le-1% - hematuria, proteinuria, oliguria, urinary retention, frequent urination.

From the skin: >1% - itching, rash.

Allergic reactions:

Other: edema (4%), >1% - purpura, increased sweating- %26le-1% - nosebleeds, rectal bleeding, weight gain, fever, infection.

Local reactions: pain at the injection site (2% - with repeated injections).

The following side effects have been reported in post-marketing studies:

From the gastrointestinal tract: erosive and ulcerative lesions of the gastrointestinal tract (including with perforation and/or bleeding - abdominal pain, spasm or burning in the epigastric region, melena, “coffee grounds” vomiting, nausea, heartburn, etc.) , cholestatic jaundice, liver dysfunction, hepatitis, hepatomegaly, acute pancreatitis.

From the nervous system and sensory organs: convulsions, psychosis, aseptic meningitis (fever, severe headache, convulsions, stiffness of the neck and/or back muscles).

From the cardiovascular system and blood (hematopoiesis, hemostasis): hypotension, flushing, thrombocytopenia, leukopenia.

From the respiratory system: %26le-1% - asthma, bronchospasm.

From the genitourinary system: acute renal failure, low back pain with or without hematuria and/or azotemia, hemolytic uremic syndrome ( hemolytic anemia, renal failure, thrombocytopenia), hyponatremia, hyperkalemia, nephritis, edema of renal origin.

From the skin: Lyell's syndrome, Stevens-Johnson syndrome, exfoliative dermatitis, maculopapular rash, urticaria.

Allergic reactions: anaphylaxis or anaphylactoid reactions, laryngeal edema, tongue edema, angioedema.

Other: bleeding from postoperative wound, myalgia.

Precautionary measures

In patients receiving NSAIDs, incl. ketorolac tromethamine, severe complications of treatment are possible, such as gastrointestinal ulceration, bleeding and perforation, postoperative bleeding, acute renal failure, anaphylactic and anaphylactoid reactions, liver failure.

The risk of developing complications of drug therapy increases with lengthening of treatment and increasing the oral dose of the drug to more than 40 mg/day. Patients with blood clotting disorders are prescribed only when constant monitoring platelet count, this is especially important for postoperative patients who require careful hemostasis. Hypovolemia increases the risk of developing adverse reactions from the kidneys. Do not use simultaneously with paracetamol for more than 5 days. It is not recommended to use the drug for pain relief during labor (due to the lack of adequate studies and the possible effect of NSAIDs on uterine contractility).

The possible occurrence of drowsiness, dizziness, insomnia or depression during treatment makes it necessary to exercise caution when engaging in potentially hazardous activities that require increased attention and speed of psychomotor reactions (driving vehicles).

Storage conditions for the drug Ketorolac

In a dry place, protected from light, at a temperature of 15-25 °C.

Keep out of the reach of children.

Shelf life of the drug Ketorolac

2 years.

Other packaging options for the drug are Ketorolac.

Ketorolac Solution for intravenous and intramuscular administration 30 mg/ml - dark glass ampoule 1 ml, cardboard pack 10- No. P N003584/01, 2009-12-22 from Sintez OJSC (Russia) Ketorolac Solution for intravenous and intramuscular administration 30 mg/ml - dark glass ampoule 1 ml, contour plastic packaging (pallets) 5, cardboard pack 1 - EAN code: 4602565010225- No. P N003584/01, 2009-12-22 from Sintez OJSC (Russia) Ketorolac Solution for intravenous and intramuscular administration 30 mg /ml - dark glass ampoule 1 ml, contour plastic packaging (pallets) 10, cardboard pack 1- No. P N003584/01, 2009-12-22 from Sintez OJSC (Russia) Ketorolac Solution for intravenous and intramuscular administration 30 mg/ml- dark glass ampoule 1 ml, contour packing 10, cardboard pack 1 - No. P N003584/01, 2009-12-22 from Sintez OJSC (Russia) Ketorolac Solution for intravenous and intramuscular administration 30 mg/ml - dark glass ampoule 1 ml, contour plastic packaging (pallets) 5, cardboard pack 2 - EAN code: 4602565009038 - No. P N003584/01, 2009-12-22 from Sintez OJSC (Russia) Ketorolac Solution for intravenous and intramuscular administration 30 mg/ml - dark glass ampoule 1 ml, contour cell packaging 5, cardboard pack 1- No. Р N003584/01, 2009-12-22 from Sintez OJSC (Russia) Ketorolac Solution for intravenous and intramuscular administration 30 mg/ml - dark glass ampoule 1 ml, contour cell packaging 5 , cardboard pack 2- No. P N003584/01, 2009-12-22 from Sintez OJSC (Russia) Ketorolac Solution for intravenous and intramuscular administration 30 mg/ml - dark glass ampoule 1 ml, package 5, plastic tray 2 - EAN code: 4607037190672- No. LP-002008, 2013-02-19 from Elfa Research and Production Center CJSC (Russia) - manufacturer: Elfa Laboratories (India) Ketorolac Solution for intramuscular administration 30 mg/ml - dark glass ampoule 1 ml with ampoule knife, packaging contour plastic (pallets) 5, cardboard pack 1 - No. LSR-008611/10, 2010-08-24 from Moskhimfarmpreparaty im. N.A. Semashko (Russia) Ketorolac Solution for intramuscular administration 30 mg/ml - dark glass ampoule 1 ml with ampoule knife, contour plastic packaging (pallets) 5, cardboard pack 2 - EAN code: 4600828004257 - No. LSR-008611/10 , 2010-08-24 from Moskhimfarmpreparaty im. N.A. Semashko (Russia) Ketorolac Solution for injection 30 mg/ml - ampoule with a point or break ring 1 ml, cardboard box (box) 10- No. LP-002090, 2013-06-04 from Borisov plant medical supplies (Republic of Belarus) Ketorolac Solution for injection 30 mg/ml - 1 ml ampoule with ampoule knife, cardboard pack 10- No. LP-002090, 2013-06-04 from Borisov Medical Preparations Plant (Republic of Belarus) Ketorolac Solution for injection 30 mg/ ml - ampoule 1 ml with ampoule knife, contour pack 10, cardboard pack 1 - No. LP-002090, 2013-06-04 from Borisov Medical Preparations Plant (Republic of Belarus) Ketorolac Tablets 10 mg - contour pack 10, cardboard pack 1 - EAN code: 4607003241049- No. LSS 000243, 2010-08-31 from Vertex (Russia) Ketorolak tablets 10 mg- Contour cell package 10, pack of cardboard 2- Code EAN: 4820014490712- No. n014251/01, 2008-08-08-08- 14 from Lekhim-Kharkov (Ukraine) Ketorolac Tablets 10 mg - polymer jar (jar) 10, cardboard pack 1 - EAN code: 4607003241056- No. LS-000243, 2010-08-31 from VERTEX (Russia) Ketorolac Tablets 10 mg - packaging contour strip 10, cardboard pack 2 - EAN code: 4607003244415- No. LS-000243, 2010-08-31 from VERTEX (Russia) Ketorolac Tablets 10 mg - contour strip pack 10, cardboard pack 5 - No. LS-000243, 2010-08 -31 from VERTEX (Russia) Ketorolac Tablets 10 mg - contour pack 10, cardboard pack 10- No. LS-000243, 2010-08-31 from VERTEX (Russia) Ketorolac Tablets 10 mg - contour pack 25, cardboard pack 2- No. LS-000243, 2010-08-31 from VERTEX (Russia) Ketorolac Tablets 10 mg - contour pack 25, cardboard pack 4 - No. LS-000243, 2010-08-31 from VERTEX (Russia) Ketorolac Tablets 10 mg - package contour strip 20, cardboard pack 1- EAN code: 4690567009552- No. LS-000243, 2010-08-31 from VERTEX (Russia) Ketorolac Tablets 10 mg - contour strip pack 10, cardboard pack 2- EAN code: 4690567007688- No. LS- 000243, 2010-08-31 from VERTEX (Russia) Ketorolac Film-coated tablets 10 mg - contour strip packaging 10, cardboard pack 1 - EAN code: 4602565011673- No. LS-001005, 2005-12-09 from Sintez OJSC (Russia) - Expired date Ketorolac Tablets 10 mg - contour strip packaging 20, cardboard pack 1 - EAN code: 4607003246136- No. LS-000243, 2010-08-31 from VERTEX (Russia) Ketorolac Film-coated tablets 10 mg - contour strip packaging 10, pack cardboard 2- EAN code: 4602565011680- No. LS-001005, 2005-12-09 from Sintez OJSC (Russia) - Expiration date Ketorolac Film-coated tablets 10 mg - contour pack 10, cardboard pack 3- No. LS-001005, 2005- 12-09 from Sintez OJSC (Russia) - Expiration date Ketorolac Coated tablets 10 mg - contour strip packaging 10, cardboard pack 4 - No. LS-001005, 2005-12-09 from Sintez OJSC (Russia) - Expiration date Ketorolac Coated tablets coated 10 mg - contour strip packaging 10, cardboard pack 5 - No. LS-001005, 2005-12-09 from Sintez OJSC (Russia) - Ketorolac Coated tablets 10 mg have expired - contour strip packaging 10, cardboard pack 10 - No. LS -001005, 2005-12-09 from Sintez OJSC (Russia) - Expired Ketorolac Film-coated tablets 10 mg - can (jar) 100, cardboard pack 1- No. LS-001005, 2005-12-09 from Sintez OJSC (Russia) - Ketorolac Film-coated tablets 10 mg - jar (jar) 20, cardboard pack 1 - No. LS-001005, 2005-12-09 from Sintez OJSC (Russia) has expired - Ketorolac Film-coated tablets 10 mg - jar (jar) has expired polymer 20, cardboard pack 1- No. LS-001005, 2005-12-09 from Sintez OJSC (Russia) - Ketorolac Film-coated tablets 10 mg have expired - polymer jar (jar) 100, cardboard pack 1- No. LS-001005, 2005 -12-09 from Sintez OJSC (Russia) - Expired date Ketorolac Film-coated tablets 10 mg - contour pack 10, cardboard pack 2 - No. LP-002140, 2013-07-12 from Borisov Medical Preparations Plant (Republic of Belarus) Ketorolac Tablets , film-coated 10 mg - contour strip packaging 10, cardboard pack 1 - No. LP-002140, 2013-07-12 from Borisov Medical Preparations Plant (Republic of Belarus) Ketorolac Film-coated tablets 10 mg - contour strip packaging 10, cardboard pack 3 - No. LP-002140, 2013-07-12 from the Borisov Medical Preparations Plant (Republic of Belarus) Ketorolac Film-coated tablets 10 mg - contour packing 10, cardboard pack 5 - No. LP-002140, 2013-07-12 from the Borisov Plant medical preparations (Republic of Belarus) Ketorolac Film-coated tablets 10 mg - contour pack packaging 10 for hospitals, cardboard box (box) 200 - No. LP-002140, 2013-07-12 from Borisov Medical Preparations Plant (Republic of Belarus) Ketorolac Tablets, film-coated 10 mg - contour cellular packaging 10 for hospitals, cardboard box (box) 500 - No. LP-002140, 2013-07-12 from Borisov Medical Preparations Plant (Republic of Belarus) Ketorolac Film-coated tablets 10 mg - bag (bag) 1 kg, cardboard box (box) 5- No. LP-002140, 2013-07-12 from Borisov Medical Preparations Plant (Republic of Belarus) Ketorolac Film-coated tablets 10 mg - packet (bag) 0.015 kg, cardboard box (box)

NSAIDs with a pronounced analgesic effect

Active substance

Release form, composition and packaging

Solution for intramuscular administration colorless or pale yellow, transparent, free from visible foreign particles.

Excipients: ethanol, disodium edetate, octoxynol, propylene glycol, sodium hydroxide, water for injection.

1 ml - dark glass ampoules (10) - blisters.

pharmachologic effect

NSAIDs have a pronounced analgesic effect, as well as anti-inflammatory and moderate antipyretic effects. The mechanism of action is associated with non-selective inhibition of the activity of COX-1 and COX-2, which catalyze the formation of prostaglandins from arachidonic acid, which play an important role in the pathogenesis of pain, inflammation and fever. Ketorolac is a racemic mixture of (-)S- and (+)R-enantiomers, with the analgesic effect due to the (-)S-form.

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

After intramuscular administration, the development of an analgesic effect is noted after 0.5 hours, the maximum effect is achieved after 1-2 hours.

Pharmacokinetics

Bioavailability - 80-100%. Absorption with intramuscular administration is complete and rapid. After intramuscular administration of 30 mg of the drug, Cmax is 1.74-3.1 µg/ml, 60 mg - 3.23-5.77 µg/ml, the time to reach Cmax is 15-73 minutes and 30-60 minutes, respectively. The time to reach C ss with parenteral administration is 24 hours when administered 4 times a day (above subtherapeutic) and is 0.65-1.13 μg/ml with intramuscular administration, 30 mg - 1.29-2.47 μg/ml. Vd is 0.15-0.33 l/kg. In patients with renal failure, the Vd of the drug may increase by 2 times, and the Vd of its R-enantiomer by 20%.

Penetrates into breast milk: when the mother takes 10 mg of ketorolac, Cmax in 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) is 7.9 ng /l.

More than 50% of the administered dose is metabolized in the liver with the formation of pharmacologically inactive metabolites. The main metabolites are glucuronides, which are excreted by the kidneys, and p-hydroxyketorolac. It is excreted 91% by the kidneys, 6% through the intestines.

T1/2 in patients with normal renal function averages 5.3 hours (3.5-9.2 hours after intramuscular administration of 30 mg). T 1/2 is lengthened in elderly patients and shortened in young ones. Liver function has no effect on T1/2. In patients with impaired renal function with a blood 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.

The total clearance is 0.023 l/kg/h with intramuscular administration of 30 mg (0.019 l/kg/h in elderly patients); in patients with renal failure with a plasma creatinine concentration of 19-50 mg/l with intramuscular administration of 30 mg - 0.015 l/kg/h.

Not excreted during hemodialysis.

Indications

- moderate to severe pain syndrome of various origins(including in the postoperative period, for cancer, etc.)

Contraindications

- “aspirin” asthma;

- bronchospasm;

- angioedema;

- hypovolemia (regardless of the cause), dehydration;

- erosive and ulcerative lesions of the gastrointestinal tract in the acute stage, peptic ulcers;

— hypocoagulation (including hemophilia);

- liver and/or renal failure (plasma creatinine above 50 mg/l);

- hemorrhagic stroke (confirmed or suspected);

- hemorrhagic diathesis;

- simultaneous use with other NSAIDs;

- high risk of development or recurrence of bleeding (including after operations);

- hematopoiesis disorder;

- pregnancy, childbirth;

- lactation period;

childhood up to 16 years old;

increased sensitivity to ketorolac or other NSAIDs.

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.

WITH caution - bronchial asthma; cholecystitis; chronic heart failure; arterial hypertension; impaired renal function (plasma creatinine below 50 mg/l); cholestasis; active hepatitis; sepsis; systemic lupus erythematosus; elderly age(over 65 years old); polyps of the nasal and nasopharyngeal mucosa.

Dosage

In the form of an injection solution, Ketorol is administered deeply intramuscularly, in minimally effective doses, selected in accordance with the intensity of pain and the patient’s response. If necessary, additional opioid analgesics can be prescribed at the same time in reduced doses.

Single doses for a single intramuscular injection: patients under 65 years of age- 10-30 mg depending on severity pain syndrome, - 10-15 mg.

Doses for repeated intravenous administration: patients under 65 years of age 10-30 mg is administered, then 10-30 mg every 4-6 hours, patients over 65 years of age or with impaired renal function- 10-15 mg every 4-6 hours.

Maximum daily dose for patients under 65 years of age should not exceed 90 mg, and for patients over 65 years of age or with impaired renal function- 60 mg.

When administered parenterally, the duration of treatment should not exceed 5 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 patients under 65 years of age and 60 mg - for patients 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.

Side effects

Often - more than 3%; less often - 1–3%; rarely - less than 1%.

From the outside 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 - 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 like "coffee grounds", nausea, heartburn), cholestatic jaundice, hepatitis, hepatomegaly, acute pancreatitis.

From the urinary system: rarely - acute renal failure, lower back pain with or without hematuria and/or azotemia, hemolytic uremic syndrome (hemolytic anemia, renal failure, thrombocytopenia, purpura), frequent 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 outside respiratory system: rarely - bronchospasm, shortness of breath, rhinitis, laryngeal edema.

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.

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

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, 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 (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 chest, wheezing).

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

Overdose

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

Treatment: symptomatic therapy (maintenance of vital important functions organism). Not eliminated sufficiently by dialysis.

Drug interactions

The simultaneous use of ketorolac with 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. The simultaneous administration of ketorolac and methotrexate is possible only when using low doses of the latter (it is necessary to monitor the concentration of methotrexate in the blood plasma).

Probenecid reduces the plasma clearance and Vd of ketorolac, increases its concentration in the blood plasma and increases T1/2.

With the use of ketorolac, the clearance of methotrexate and lithium may decrease and the toxicity of these substances may increase.

Simultaneous 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 combined with opioid analgesics, the doses of the latter can be significantly reduced.

Antacids do not affect the complete absorption of the drug.

Increases the hypoglycemic effect of insulin and oral hypoglycemic drugs (dose recalculation is necessary).

Co-administration with causes a violation 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.

The injection solution should not be mixed in the same syringe with promethazine and hydroxyzine due to precipitation. Pharmaceutically incompatible with tramadol solution and lithium preparations.

The injection solution is compatible with saline, 5% dextrose solution, and Ringer's lactate, Plasmalit solution, as well as with infusion solutions containing aminophylline, lidocaine hydrochloride, dopamine hydrochloride, human insulin short acting and heparin sodium salt.

special instructions

The effect on platelet aggregation ceases after 24-48 hours.

Hypovolemia increases the risk of developing adverse reactions from the kidneys. If necessary, can be prescribed in combination with narcotic analgesics.

Do not use simultaneously with paracetamol for more than 5 days. Patients with blood coagulation disorders are prescribed the drug only with constant monitoring of the platelet count, which is especially important in the postoperative period, which requires careful monitoring of hemostasis.

In a dry place, protected from light, at a temperature not exceeding 25°C. Keep out of the reach of children. Shelf life - 3 years.

Trade name of the drug:

Ketorol ®

International nonproprietary name of the drug:

ketorolac.

Dosage form:

solution for intravenous and intramuscular administration.

Compound

1 ml of solution contains:

active substance: ketorolac tromethamine (ketorolac trometamol) 30 mg;

Excipients: octoxynol 0.07 mg, disodium edetate 1 mg, sodium chloride 4.35 mg, ethanol 0.115 ml, propylene glycol 400 mg, sodium hydroxide 0.725 mg, water for injection up to 1 ml.

Description

Transparent, colorless or light yellow solution.

Pharmacotherapeutic group:

non-steroidal anti-inflammatory drug.

ATX code:М01АВ15

Pharmacological properties

Pharmacodynamics

A non-steroidal anti-inflammatory drug (NSAID), has a pronounced analgesic effect, has anti-inflammatory and moderate antipyretic effects. The mechanism of action is associated with non-selective inhibition of the activity of cyclooxygenase (COX) - COX-1 and COX-2, which catalyzes the formation of prostaglandins from arachidonic acid, which play an important role in the pathogenesis of pain, inflammation and fever. Ketorolac is a racemic mixture of [-]S and [+]R enantiomers, and the analgesic effect is due to the [-]S form. The strength of the analgesic effect is comparable to morphine, significantly superior to other NSAIDs.

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

Pharmacokinetics

The pharmacokinetics of ketorolac after single and repeated intravenous and intramuscular administration is linear.

At intramuscular injection absorption is complete and rapid. The maximum concentration of the drug (C max) after intramuscular administration of 30 mg is 1.74-3.1 μg/ml, 60 mg is 3.23-5.77 μg/ml, time to reach maximum concentration (T Cmax) is 15-73 min and 30-60 min, respectively. Cmax after intravenous administration of 15 mg – 1.96-2.98 µg/ml, 30 mg – 3.69-5.61 µg/ml, T Cmax – 0.4-1.8 min and 1.1-4 ,7 min, respectively. Communication with plasma proteins – 99%. The time to reach the equilibrium concentration of the drug (Css) with parenteral administration of 30 mg 4 times a day is 24 hours; with intramuscular administration, 15 mg – 0.65–1.13 µg/ml, 30 mg – 1.29-2.47 µg/ml.

The volume of distribution (V d) with intramuscular administration is 0.136-0.214 l/kg, with intravenous administration - 0.166-0.254 l/kg. In patients with renal failure, the volume of distribution of the drug may double, and the volume of distribution of its R-enantiomer may increase by 20%.

Penetrates into breast milk: when the mother takes 10 mg of ketorolac, Cmax in 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) - 7.9 ng/l. About 10% of ketorolac passes through the placenta.

More than 50% of the administered dose is metabolized in the liver with the formation of pharmacologically inactive metabolites. The main metabolites are glucuronides, which are excreted by the kidneys, and the pharmacologically inactive p-hydroxyketorolac. It is excreted 91% by the kidneys, 6% through the intestines.

The half-life (T 1/2) in patients with normal renal function is 3.5-9.2 hours after parenteral administration of 30 mg. T1/2 increases in elderly patients and shortens in young ones. Changes in liver function do not affect T1/2. In patients with impaired renal function, with a plasma creatinine concentration of 19-50 mg/l (168-442 µmol/l), T1/2 - 10.3-10.8 hours, with more severe renal failure - more than 13, 6 hours

When 30 mg of ketorolac is administered intramuscularly, the total clearance is 0.023 l/h/kg (0.019 l/h/kg in elderly patients); in patients with renal failure (with a plasma creatinine concentration of 19-50 mg/l) – 0.015 l/h/kg. When 30 mg of ketorolac is administered intravenously, the total clearance is 0.03 l/h/kg.

Not excreted by hemodialysis.

Indications for use

Pain syndrome of strong and moderate severity of various origins due to injuries, toothache, pain in the postoperative period, with oncological and rheumatic diseases, myalgia, arthralgia, neuralgia, radiculitis. Created for symptomatic therapy, reducing pain and inflammation at the time of use. Does not affect the progression of the disease.

Contraindications

Hypersensitivity to ketorolac;

Complete or incomplete combination of bronchial asthma, recurrent nasal polyposis or paranasal sinuses and intolerance to acetylsalicylic acid and other NSAIDs (including a history);

Erosive and ulcerative changes in the mucous membrane of the stomach and duodenum, active gastrointestinal bleeding; cerebrovascular or other bleeding;

Inflammatory bowel diseases (Crohn's disease, ulcerative colitis) in the acute phase;

Hemophilia and other bleeding disorders;

Decompensated heart failure;

Liver failure or active liver disease;

Severe renal failure (creatinine clearance less than 30 ml/min), progressive kidney disease, confirmed hyperkalemia;

Postoperative period after coronary artery bypass surgery;

Concomitant use with probenecid, pentoxifylline, acetylsalicylic acid and other NSAIDs (including cyclooxygenase-2 inhibitors), lithium salts, anticoagulants (including warfarin and heparin);

The drug is not used for prophylactic pain relief before and during major surgical interventions due to the high risk of bleeding;

Pregnancy, childbirth, lactation;

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

Carefully

Bronchial asthma, ischemic disease heart disease, congestive heart failure, edema syndrome, arterial hypertension, cerebrovascular diseases, pathological dyslipidemia or hyperlipidemia, renal dysfunction (creatinine clearance 30-60 ml/l), diabetes mellitus, cholestasis, sepsis, systemic lupus erythematosus, peripheral arterial disease, smoking , elderly age (over 65 years), anamnestic data on the development of ulcerative lesions gastrointestinal tract, 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).

Directions for use and doses

Intravenously, intramuscularly.

A solution of the drug Ketorol ® is used in minimally effective doses, selected according to the intensity of pain. If necessary, narcotic analgesics can be prescribed at the same time in reduced doses.

For parenteral use in patients aged 16 to 64 years with a body weight exceeding 50 kg, no more than 60 mg is administered intramuscularly (including oral administration). Usually - 30 mg every 6 hours; intravenously - 30 mg (no more than 6 doses in 2 days). Intramuscularly, in adult patients weighing less than 50 kg or with chronic renal failure (CRF), a single dose of no more than 30 mg is administered (including oral administration); usually – 15 mg (no more than 8 doses in 2 days); intravenously - no more than 15 mg every 6 hours (no more than 8 doses in 2 days). The maximum daily doses for intramuscular and intravenous administration are 90 mg/day for patients from 16 to 64 years of age with a body weight exceeding 50 kg; adult patients weighing less than 50 kg or with chronic renal failure, as well as elderly patients (over 65 years of age) - for intramuscular and intravenous administration 60 mg. The duration of treatment should not exceed 2 days.

When administered intravenously, the dose must be administered over at least 15 seconds. Intramuscular injection carried out slowly, deep into the muscle. The onset of analgesic action is noted after 30 minutes, maximum pain relief occurs after 1-2 hours. The analgesic effect lasts about 4-6 hours.

Side effect

The frequency of side effects is classified depending on the frequency of occurrence: often (1-10%), sometimes (0.1-1%), rarely (0.01-0.1%), very rarely (less than 0.01%) , including individual messages.

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 – 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, “coffee grounds” vomiting, nausea, heartburn and others), cholestatic jaundice, hepatitis, hepatomegaly, acute pancreatitis.

From the urinary system: rarely - acute renal failure, lower back pain with or without hematuria and/or azotemia, hemolytic-uremic syndrome (hemolytic anemia, renal failure, thrombocytopenia, purpura), frequent 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, rhinitis, laryngeal edema (shortness of breath, difficulty breathing).

From 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.

From the cardiovascular system: less often – increase blood pressure; rarely – pulmonary edema, fainting.

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, redness, thickening or flaking of the skin, swelling and/or tenderness of the tonsils), urticaria, Stevens-Johnson syndrome, 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, shortness of breath, swelling of the eyelids, periorbital edema, difficulty breathing, heaviness in the chest, wheezing).

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

Overdose

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

Treatment: gastric lavage, administration of adsorbents ( Activated carbon) and carrying out symptomatic therapy (maintaining vital functions of the body). Not eliminated sufficiently by dialysis.

Interaction with other drugs

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 gastrointestinal ulcers 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.

special instructions

Ketorol® has two dosage forms(film-coated tablets and solution for intravenous and intramuscular administration). The choice of method of drug administration depends on the severity of the pain syndrome and the patient’s condition.

Before prescribing the drug, it is necessary to clarify the issue of a previous allergic reaction to the drug or NSAID. Due to the risk of developing allergic reactions The first dose is administered under close medical supervision.

Hypovolemia increases the risk of nephrotoxic adverse reactions.

If necessary, can be prescribed in combination with narcotic analgesics.

The drug should not be used together with NSAIDs (including cyclooxygenase-2 inhibitors), since joint reception with other NSAIDs, fluid retention, cardiac decompensation, and increased blood pressure may occur. The effect on platelet aggregation ceases after 24–48 hours.

The drug may change the properties of platelets.

Patients with blood coagulation disorders are prescribed only with constant monitoring of platelet counts, especially important for postoperative patients who require careful monitoring of hemostasis.

The risk of developing drug complications increases with lengthening of treatment (in patients with chronic pain) and increasing the dose of the drug to more than 90 mg/day. To reduce the risk of adverse events, the minimum effective dose should be used for the shortest possible short course.

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

The effect of the drug on medical use on the ability to manage vehicles, mechanisms

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

Release form

Solution for intravenous and intramuscular administration, 30 mg/ml.

1 ml in Class I (USP) dark glass ampoules. At the top of the ampoule there is a ring and a breaking point. A label is placed on the ampoule.

10 ampoules with instructions for use are placed in a PVC/aluminum blister.

Storage conditions

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

Do not freeze!

Keep out of the reach of children!

Best before date

Do not use after the expiration date stated on the package.

Conditions for dispensing from pharmacies

On prescription.

Manufacturer

Dr. Reddy's Laboratories Ltd., India

Dr. Reddy's Laboratories Ltd., India

Address of production place

Unit-I, Plot No. 137, 138 & 146, S.V.CO-OP, Industrial Estate, Bollaram, Jinnaram Mandal, Medak District, India.

Send information about complaints and adverse drug reactions to:

Representative office of Dr. Reddy's Laboratories Ltd.

Instructions

Ketorolac belongs to drug group non-hormonal anti-inflammatory drugs. It has high analgesic properties and is used to eliminate pain of various origins. It should be remembered that this is a symptomatic remedy, the use of which requires a competent approach.

Name

The INN of the drug in question is Ketorolac.

Latin name

In Latin the drug is called Ketorolacum.

Chemical name

According to the IUPAC nomenclature, the active component of the drug is called (±)-5-benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid, it is isolated as a compound with 2-amino-2-hydroxymethyl-1-butanol.

Release forms and composition

The drug is produced in the following dosage forms:

  1. Pills.
  2. Tablet version in enteric coating.
  3. An injection solution used both intravenously and intramuscularly.

The active ingredient in them is tromethamine (trometamol) of ketorolac.

Solution for intravenous and intramuscular administration

The injection liquid is homogeneous, transparent and colored light yellow color. The content of ketorolac in it is 30 mg/ml. In addition to water for injection, the solution also contains propylene glycol, ethanol, sodium chloride and hydroxide, EDTA (Trilon B). The liquid is poured into darkened glass ampoules of 1 ml, which are placed in polymer blister packs. IN cardboard box There are 5 or 10 ampoules and an instruction leaflet. The kit may include a scarifier.

Pills

The tablet form contains 10 mg of ketorolac. Additional composition represented by starch, monohydrate lactose, cellulose, colloidal silicon dioxide and calcium stearate. The tablets are white, may have a cream tint. Their shape is round, flat, with chamfered edges. They are packaged in blister packs of 10, 20 or 25 pcs. Blisters are distributed into cardboard packs of 1, 2, or several pieces; the total number of tablets in a package can reach 100 pieces. The drug is sometimes packaged in 10 tablets in polymer jars, which are placed in cardboard boxes.

Film-coated tablets

This form of the drug is white in color and has a round, biconvex shape. The active component is present here in an amount of 0.01 g. Additional composition includes anhydrous lactose, potato starch, microcellulose, calcium stearate. Film casing made of opadra II, which consists of polyethylene glycol, talc, titanium dioxide and polyvinyl alcohol.

The drug is packaged in jars or blisters. Polymer jars can contain 10, 20, 30, 40, 50 or 100 tablets, and blister sheets - 10, 20 or 25 pcs. The outer packaging is made of cardboard. Blister packs can contain up to 100 tablets.

pharmachologic effect

The active component of the drug is a non-steroidal anti-inflammatory drug and is a derivative of acetic acid. It has not only anti-inflammatory, but also a strong analgesic effect, exhibits antipyretic and antiplatelet properties, and eliminates edema.

Its mechanism of action is the nonspecific inhibition of both forms of cyclooxygenase, which is involved in the biosynthesis of prostanoids, including prostaglandins. As a result, the severity of inflammatory symptoms decreases and weakening or disappearance pain.

The analgesic effect of Ketorolac is superior to other NSAIDs. Its strength is comparable to morphine, of which it is only 2.5 times weaker. This allows this medication to be used not only as an antirheumatic drug, but also as an analgesic for patients with cancer.

Pharmacokinetics

Absorption occurs quickly: with intramuscular administration, maximum concentrations are reached in 15-30 minutes (depending on the dose), with oral administration - in 40 minutes. The presence of fatty foods in the stomach impairs absorption from the gastrointestinal tract. The analgesic effect appears 30 minutes after the injection and reaches its maximum after 1-2 hours. When taken orally, the analgesic effect is fully revealed after about 2.5 hours. The duration of exposure lasts up to 6 hours, sometimes up to 8 hours.

The bioavailability of the active substance reaches 100%. About 99% of ketorolac binds to blood proteins, so hemodialysis is useless. The drug can pass into breast milk. Metabolization with the formation of inactive products is carried out by the liver. The main burden of drug elimination falls on the kidneys. A small proportion of the drug is evacuated along with feces. With normal renal activity, the half-life reaches 9 hours. With age, this indicator increases; liver dysfunction does not affect it.

What does Ketorolac help with?

The analgesic effect of the drug is especially appreciated. Indications for its use:

  • pain syndrome due to injuries;
  • headaches, migraines;
  • pain, including high intensity, during the postpartum or postoperative period;
  • abdominal pain;
  • myalgia;
  • arthralgia;
  • rheumatoid manifestations;
  • radiculitis;
  • neuralgia;
  • toothache;
  • oncological lesions;
  • diffuse pain.

The medicine also stops inflammation, reducing phenomena associated with this process, such as fever, swelling, and limited mobility of the joint apparatus. But it should be borne in mind that this is a symptomatic remedy that does not affect the development of the underlying disease, but only facilitates its course and relieves acute attacks. Therefore, it is not applicable for therapeutic purposes as a single drug and should be prescribed in combination with other drugs.

Contraindications

The medication should not be used if you are hypersensitive to the effects of ketorolac or intolerant to the auxiliary components, as well as if you have a history of allergies to aspirin or other NSAIDs. Other contraindications:

  • hypovolemia;
  • dehydration;
  • spasm of the bronchial tubes;
  • ulcerative lesions of the gastrointestinal tract (with exacerbations);
  • colitis, Crohn's disease;
  • severe renal and hepatic abnormalities, hypokalemia;
  • preoperative period;
  • maintenance anesthesia;
  • heart failure, coronary bypass surgery;
  • pregnancy, labor;
  • blood clotting disorders;
  • bleeding or tendency to it, cerebral hemorrhage;
  • natural feeding of babies;
  • age up to 16 years.

The drug is used with caution in the presence of bronchial asthma, smoking, alcohol dependence, ischemia, hypertension, a tendency to the appearance of edema, cholestasis, sepsis, diabetes, hepatitis, systemic lupus erythematosus, damage to the peripheral vascular network, lipid metabolism disorders, severe systemic lesions, in old age.

Method of administration and dosage of Ketorolac

The dosage and treatment regimen are determined by the doctor depending on big picture and intensity of pain. A single dose is administered at intervals of 4-6 hours. Reduced dosing is recommended for special categories of patients:

  • representatives of the older age group (over 65 years old);
  • adults weighing less than 50 kg;
  • in the presence of renal pathologies;
  • severely weakened patients.

To reduce the negative impact on the gastrointestinal tract, tablets should be taken with food or at the end of a meal. They drink 1 piece at a time. 4 times a day. If necessary, you can take the drug orally up to 6 times a day, although it is undesirable for the daily dose to exceed 40 mg.

Due to the high risk of developing allergic manifestations, parenteral administration of the first dose of the drug should be carried out under direct control doctor The recommended single dosage is 15-30 mg. At severe pain 30-60 mg of the drug is administered at a time. The daily dose should not exceed 90 mg, and for these special categories of patients - 60 mg.

Injections cannot be used for longer than 5 days. It is recommended to switch from injections to oral Ketorolac as quickly as possible. Allowed simultaneous use different forms medications taking into account the total daily dose. The maximum duration of oral administration is 1 week. The course of treatment with the drug should be as short as possible using the lowest effective dosages. This will minimize unwanted reactions.

What side effects can Ketorolac cause?

The use of the drug in question can have various negative consequences. The following side effects are possible:


About everyone alarming symptoms You should inform your doctor to adjust the dosage or replace the drug.

Overdose

If the dosage is exceeded, nausea, vomiting, headache, increased acidity, ulceration of the gastrointestinal mucosa, and impaired renal function occur. Dialysis for overdose is ineffective; there is no special antidote. Gastric lavage and sorbent intake are recommended. Symptomatic treatment is prescribed. In severe cases, monitoring of vital signs is required.

Features of application

Before prescribing, you should make sure that there is no history of allergy to NSAIDs.

Combining Ketorolac with narcotic drugs is allowed.

The effect of the drug on platelet aggregation continues for 1-2 days after taking the last dose.

In case of coagulation disorders, monitoring of blood composition is required, especially for patients after surgery.

Long-term use of the drug should be avoided. Combination with other NSAIDs increases the risk of cardiac dysfunction, possible dehydration and surges in blood pressure.

During pregnancy and lactation

The drug is not prescribed to pregnant women and nursing mothers.

Effect on concentration

While taking Ketorolac, many patients experience various reactions from the central nervous system. Therefore, it is advisable to refrain from driving a car or operating potentially dangerous machinery.

Drug interactions

When including the drug in therapeutic complexes, possible drug interactions should be taken into account.

With other drugs

To avoid severe damage to various structures of the body, you should not use this remedy in conjunction with medications such as:

  • glucocorticosteroids;
  • anti-inflammatory drugs (combination with Paracetamol should not exceed 2 days);
  • Corticotropin;
  • Tramadol;
  • antacids;
  • cephalosporins;
  • Heparin, indanediones and coumarins;
  • thrombolytics and antiplatelet agents;
  • Valproic acid;
  • Pentoxifylline;
  • Digoxin;
  • Zidovudine;
  • Tacrolimus;
  • Mifepristone;
  • antidepressants;
  • calcium, lithium and gold preparations.

Methotrexate can be prescribed in a minimal amount, provided that its plasma concentrations are monitored. Probenecid inhibits the excretion of Ketorolac and increases its content in the blood. Under the influence of the drug in question, the effectiveness of diuretics decreases and antihypertensive drugs, and the effectiveness of opioid analgesics increases. Mixing the drug in one syringe with Meperidine, Hydroxyzine, Promethazine, Morphine is unacceptable.

To reduce the likelihood of non-steroidal gastropathy, Omeprazole, Misoprostol, and antacids are used.

Alcohol compatibility

The combination of the anti-inflammatory drug in question with ethanol increases the risk of injury digestive tract. Therefore, during treatment, drinking alcohol is contraindicated.

Storage conditions and periods

The drug should be kept away from children and should not be exposed to direct sunlight. Storage temperature should not exceed +25 °C. The shelf life of the injection solution is 2 years, tablet products - 3 years from the date of manufacture.

Conditions for dispensing from pharmacies

Access to this medicine limited.

Is it sold without a prescription?

The drug must be dispensed only with a prescription.

What is the price

The cost of film-coated tablets is from 24 rubles. for 20 pcs. The price of the injection solution is from 6 rubles. per ampoule.

Analogs

Injectable versions of the drug are Eskom and SOLOpharm. Available with ketorolac eye drops and gel for external application. Analogues also include:

  • Ketoprofen;
  • Ketanov;
  • Dolak;
  • Ketolong;
  • Vatorlak;
  • Dolomin;
  • Ketalgin;
  • Ketocam;
  • Ketofril et al.

74103-06-3

Characteristics of the substance Ketorolac

NSAIDs. Ketorolac is a racemic mixture of S(−) and R(+) forms. Ketorolac can exist in three crystalline forms. All forms are equally soluble in water. Ketorolac has a pKa of 3.5 and an n-octanol/water partition coefficient of 0.26. Molecular mass 376,41.

Pharmacology

pharmachologic effect- anti-inflammatory, antipyretic, analgesic, antiplatelet.

Pharmacodynamics

Ketorolac is a NSAID, has a pronounced analgesic effect, and also has anti-inflammatory and moderate antipyretic effects. The mechanism of action is associated with non-selective inhibition of the activity of COX-1 and COX-2, which catalyzes the formation of PGs from arachidonic acid, which play an important role in the pathogenesis of pain, inflammation and fever. Ketorolac is a racemic mixture of S(−)- and R(+)-enantiomers, and the analgesic effect is due to the S(−)-form. The analgesic effect is comparable to morphine and significantly superior to other NSAIDs. The onset of the analgesic effect of ketorolac in the form of a solution for IV and IM administration is noted after 0.5 hours, the maximum effect is achieved after 1-2 hours and lasts about 4-6 hours. After oral administration in the form of tablets, the onset of the analgesic effect is noted after 1 hour, maximum effect is achieved after 2-3 hours.

Eye drops

After topical ophthalmic use, ketorolac reduces the PG content in aqueous humor. At systemic use ketorolac does not cause pupil constriction. According to the results of clinical studies, ketorolac does not have a significant effect on IOP.

At local application causes a weakening or disappearance of pain at the site of application of the gel, incl. pain in the joints at rest and during movement, reduces morning stiffness and swelling of the joints. Helps increase range of motion.

Pharmacokinetics

Solution for intravenous and intramuscular administration

Suction. Bioavailability is complete and rapid. After intramuscular administration of 30 mg, Cmax is 1.74-3.1 μg/ml, 60 mg is 3.23-5.77 μg/ml, Tmax is 15-73 and 30-60 minutes, respectively. After intravenous administration at a dose of 15 mg, C max is 1.96-2.98 mcg/ml, at a dose of 30 mg, C max is 3.69-5.61 mcg/ml.

Distribution. Communication with plasma proteins - 99%. The time to reach C ss is 24 hours, C ss is 0.65-1.13 µg/ml with intramuscular administration of 15 mg 4 times a day, 30 mg – 1.29-2.47 µg/ml.

V d - 0.15-0.33 l/kg. In patients with renal failure, the Vd of ketorolac may increase by 2 times, and the Vd of its R(+)-enantiomer by 20%.

Penetrates into breast milk: after administration of 10 mg of ketorolac, its Tmax in milk is 2 hours and Cmax is 7.3 ng/ml, 2 hours after administration of the second dose of ketorolac (when used 4 times a day) Cmax is 7. 9 ng/l.

Metabolism. More than 50% of the administered dose is metabolized in the liver with the formation of pharmacologically inactive metabolites. The main metabolites are glucuronides, which are excreted by the kidneys, and p-hydroxyketorolac. It is excreted 91% by the kidneys, 6% through the intestines.

Excretion. T1/2 in patients with normal renal function averages 5.3 hours (3.5-9.2 hours after intramuscular administration of 30 mg). T 1/2 increases in the elderly and decreases in young patients. Liver function does not affect T1/2. 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 The total clearance with intramuscular administration of 30 mg is 0.023 l/h/kg, with intravenous administration of 30 mg - 0.03 l/kg/h.

Ketorolac is not eliminated by hemodialysis.

Pills

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

Distribution. 99% of ketorolac binds to plasma proteins. With hypoalbuminemia, the amount of free ketorolac in the blood plasma increases.

The time to reach C ss when taken orally is 24 hours when used 4 times a day (above the subtherapeutic dose). C ss in blood plasma after oral administration of 10 mg of ketorolac is 0.39-0.79 mcg/ml. Vd is 0.15-0.33 l/kg.

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

Excretion. Excreted by the kidneys - 91%, through the intestines - 6%.

After oral administration of 10 mg of ketorolac, T1/2 in patients with normal renal function averages 5.3 hours (2.4-9 hours), total clearance is 0.025 l/kg/hour.

Not excreted during hemodialysis.

Special patient groups

Renal dysfunction. In patients with renal failure, the Vd of ketorolac may increase by 2 times, and the Vd of its R(+)-enantiomer by 20%. In case of renal failure 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 - >13.6 hours.

The total clearance in renal failure with a plasma creatinine concentration of 19-50 mg/l when administered orally with 10 mg of ketorolac is 0.016 l/kg/h.

Liver dysfunction. Liver function does not affect T1/2.

Elderly and young patients. T1/2 is lengthened in elderly patients and shortened in young ones.

Nursing women. Ketorolac penetrates into breast milk: when the mother takes 10 mg of ketorolac, C max in milk is reached 2 hours after taking the first dose and is 7.3 ng/ml, 2 hours after taking the second dose of ketorolac (when used 4 times a day) - 7.9 ng/ml.

Eye drops

Solutions of ketorolac (0.1 and 0.5%) or placebo were instilled in patients 12 and 1 hour before surgery. When using a 0.1% solution, the concentration of ketorolac in the aqueous humor at the time of surgery in one patient was at the lower detection limit (40 ng/ml), in 7 patients it was below the detection limit. When using a 0.5% solution, the average content of ketorolac in the aqueous humor of patients was 95 ng/ml. PGE 2 concentrations in aqueous humor were 80, 40 and 28 pg/ml when patients were administered placebo, 0.1 and 0.5% solutions of ketorolac, respectively.

In a 21-day repeated-dose (3 times daily) tolerability study in healthy volunteers, only 1 of 13 subjects experienced next dose ketorolac was detected in plasma (0.021 μg/ml). In another group of 13 people, only 4 subjects had very low plasma concentrations of ketorolac (0.011-0.023 μg/ml) 15 minutes after instillation.

Thus, the higher aqueous humor content of ketorolac and very low or undetectable plasma concentrations after ophthalmic administration suggest that the use of ketorolac by the ophthalmic route for the treatment of eye diseases results in fairly low systemic absorption in patients.

Application of the substance Ketorolac

Solution for intravenous and intramuscular administration, tablets

Pain syndrome of severe and moderate severity: injuries, toothache, pain in the postpartum and postoperative period, oncological diseases, 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.

Eye drops

Temporary relief of itching in seasonal allergic conjunctivitis; treatment of postoperative inflammation in patients undergoing cataract extraction.

Gel for external use

Local use for pain relief: for injuries (soft tissue bruise, soft tissue inflammation, including post-traumatic origin, ligament damage, bursitis, tendonitis, epicondylitis, synovitis); for pain in muscles (myalgia) and joints (arthralgia), neuralgia, radiculitis, rheumatic diseases. Intended for symptomatic therapy, reducing the intensity of pain and inflammation at the time of use, does not affect the progression of the disease.

Contraindications

Solution for intravenous and intramuscular administration, tablets

Hypersensitivity to ketorolac; anamnestic data on an attack of bronchial obstruction, rhinitis, urticaria after taking acetylsalicylic acid or other NSAIDs (complete or incomplete combination of bronchial asthma, nasal polyposis and paranasal sinuses and intolerance to acetylsalicylic acid and other NSAIDs); hypovolemia (regardless of the cause that caused it); erosive and ulcerative lesions of the gastrointestinal tract in the acute stage, peptic ulcers, bleeding or a high risk of their development, hypocoagulation (including hemophilia), inflammatory diseases intestines (Crohn's disease, ulcerative colitis); severe liver failure or active liver disease; severe renal failure (serum creatinine >700 µmol/l), progressive kidney disease; confirmed hypokalemia; decompensated heart failure, condition after coronary artery bypass grafting; pain relief before and during surgery due to the high risk of bleeding; simultaneous use with probenecid, pentoxifylline, lithium salts; simultaneous use with anticoagulants, including warfarin and heparin; intracranial hemorrhage or suspicion of it; confirmed hyperkalemia; pregnancy, childbirth, breastfeeding; children under 16 years of age (efficacy and safety have not been established).

Eye drops

Hypersensitivity to ketorolac, acetylsalicylic acid(including history), phenylacetic acid derivatives, such as diclofenac or other NSAIDs used in ophthalmology, as well as other systemic NSAIDs; children under 18 years of age.

Gel for external use

Hypersensitivity to ketorolac; weeping dermatoses, eczema, infected or open wounds (at the site of application of the gel); complete or incomplete combination of bronchial asthma, recurrent nasal polyposis or paranasal sinuses and intolerance to acetylsalicylic acid and other NSAIDs (history of bronchospasm, urticaria or rhinitis caused by taking acetylsalicylic acid); pregnancy (III trimester); period of breastfeeding (lactation); children up to 16 years of age.

Restrictions on use

Solution for intravenous and intramuscular administration, tablets

Hypersensitivity to other NSAIDs; bronchial asthma; the presence of factors that increase gastrointestinal toxicity (alcoholism, smoking, cholecystitis); postoperative period; chronic heart failure, coronary heart disease, edema syndrome, arterial hypertension; moderate renal failure (serum creatinine 300-700 µmol/l); cholestasis; sepsis; systemic lupus erythematosus; simultaneous use with other NSAIDs, long-term use of NSAIDs; cerebrovascular diseases; dyslipidemia, hyperlipidemia, diabetes mellitus; peripheral arterial disease; history of ulcerative lesions of the gastrointestinal tract, presence of infection Helicobacter pylori ; severe somatic diseases; systemic diseases connective tissue; inflammatory bowel diseases without exacerbation; simultaneous use of oral corticosteroids (including prednisolone), anticoagulants (including warfarin), angioplatelet agents (including clopidogrel), SSRIs (including citalopram, fluoxetine, paroxetine, sertraline), elderly age (over 65 years old).

Eye drops

Hypersensitivity to acetylsalicylic acid, phenylacetic acid derivatives and other NSAIDs due to possible cross-sensitivity to ketorolac; tendency to bleeding and concomitant use of drugs that increase bleeding time; patients with ophthalmological complications in the postoperative period, with impaired innervation of the cornea, defects of the corneal epithelium, diabetes mellitus, diseases of the mucous membrane of the eyes (for example, dry eye syndrome), with accompanying rheumatoid arthritis, as well as with short intervals between repeated ophthalmological operations due to the high risk of developing undesirable reactions from the cornea, which can threaten vision loss.

Gel for external use

Exacerbation of hepatic porphyria; erosive and ulcerative lesions of the gastrointestinal tract; severe renal/liver failure; chronic heart failure; bronchial asthma; elderly age; pregnancy (I and II trimester).

Use during pregnancy and breastfeeding

Solution for intravenous and intramuscular administration, tablets, eye drops

It is not recommended to use ketorolac during pregnancy (adverse effects on the fetal cardiovascular system - premature closure of the ductus arteriosus), during childbirth, in early postpartum period(inhibits the synthesis of PG, can negatively affect the blood circulation of the fetus and weaken the contractile activity of the uterus, which increases the risk of uterine bleeding) and during breastfeeding (ketorolac passes into breast milk). If necessary, use during lactation should stop breastfeeding.

After a single oral dose of 10 mg of ketorolac, Cmax, determined in human breast milk, is 7.3 ng/ml, the maximum milk/plasma ratio is 0.037; after one day of administration (4 times a day), the same indicators are 7.9 ng/ml and 0.025. Since other PG synthesis inhibitors may cause adverse effects in newborns, breastfeeding should be discontinued during treatment.

Side effects of the substance Ketorolac

Solution for intravenous and intramuscular administration, tablets

According to WHO, adverse events are classified as follows: very common (≥10%); often (≥1%,<10%); нечасто (≥0,1%, <1 %); редко (≥0,01%, <0,1 %); очень редко (<0,01 %); частота неизвестна (частота не может быть определена на основе имеющихся данных).

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: often - burning or pain at the site of parenteral administration.

From the side of the central nervous system: very often - headache; often - 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: often - itching, rash (including maculopapular); 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, hemolyticouremic syndrome (hemolytic anemia, renal failure, thrombocytopenia, purpura).

From the digestive system: very often - gastralgia, dyspepsia, nausea; often - 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 type coffee grounds, 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: often - purpura; infrequently - anemia, eosinophilia.

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 SSS side: often - increased blood pressure; infrequently - 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: often - 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.

Eye drops

Clinical studies of ketorolac in the form of eye drops revealed the following side effects.

From the side of the organ of vision: very often - eye irritation, eye pain, short-term burning sensation, foreign body sensation and blurred vision; often - conjunctival hyperemia, superficial keratitis, iritis, swelling of the eye and/or eyelid, eye infection; uncommon - corneal ulcer, corneal infiltrate, epiphora, dry eyes, iritis, temporary blurred vision; rarely - corneal damage (thinning, erosion, epithelial rupture or perforation).

From the immune system: often - hypersensitivity reactions, urticaria, rash, itching, angioedema, anaphylactic reactions.

From the respiratory system: frequency unknown - bronchospasm, exacerbation of bronchial asthma.

From the nervous system: infrequently - headache.

Systemic reactions: frequency unknown - increased blood pressure, nasal congestion, increased heart rate, as well as prolongation of blood clotting time and increased bleeding of the operated eye with intraocular use of NSAIDs.

From the side of the cornea. The use of local forms of NSAIDs can lead to the development of keratitis. In some sensitive patients, long-term use of NSAIDs may lead to destruction of the corneal epithelium, thinning of the cornea, and development of corneal erosion, ulceration, or perforation, which may threaten vision. Patients with signs of corneal impairment should immediately discontinue use of NSAIDs, including ketorolac eye drops, and closely monitor their corneal condition.

Post-marketing experience with NSAIDs suggests that in patients with complications from ocular surgery, corneal denervation, corneal epithelial defects, diabetes mellitus, certain syndromes (eg, dry eye syndrome), rheumatoid arthritis, or repeated ocular surgery within a short period of time may There may be an increased risk of corneal side effects, which may be vision-threatening. Topical NSAIDs should be used with caution in these patients.

Post-marketing experience with NSAIDs also suggests that use of topical NSAIDs more than 1 day before surgery or for more than 14 days after surgery may increase the risk and severity of corneal side effects.

Cross-hypersensitivity to acetylsalicylic acid, phenylacetic acid and other NSAIDs is possible. Therefore, caution should be exercised when using ketorolac in patients who have previously demonstrated hypersensitivity to these drugs.

Gel for external use

Local reactions: itching, urticaria, peeling.

If any adverse reactions occur, you should stop using ketorolac in the form of a gel for external use.

When applying the gel to large areas of the skin, the development of systemic adverse reactions is possible: heartburn, nausea, vomiting, diarrhea, gastralgia, ulceration of the gastrointestinal mucosa, increased activity of liver transaminases; headache, dizziness; fluid retention, hematuria; allergic reactions (anaphylactic shock, skin rash); thrombocytopenia, leukopenia, anemia, agranulocytosis, prolongation of bleeding time.

Interaction

Solution for intravenous and intramuscular administration, tablets

The simultaneous use of ketorolac with other NSAIDs, corticosteroids, ethanol, corticotropin, calcium-containing drugs increases the risk of ulceration of the gastrointestinal mucosa and the development of gastrointestinal bleeding.

Simultaneous use with paracetamol increases the nephrotoxicity of ketorolac, and with methotrexate increases hepato- and nephrotoxicity. Do not use simultaneously with paracetamol for more than 2 days. The combined use of ketorolac and methotrexate is possible only when using low doses of the latter and monitoring its concentration in the blood plasma. When prescribed with other nephrotoxic drugs (including gold-containing drugs), the risk of developing nephrotoxicity increases.

Probenecid reduces the plasma clearance and Vd of ketorolac, increases its concentration in the blood plasma and increases T1/2.

Concomitant use with anticoagulants (coumarin and indanediol derivatives), heparin, thrombolytics (alteplase, streptokinase, urokinase), antiplatelet drugs, cephalosporins, valproic acid and acetylsalicylic acid increases the risk of bleeding.

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

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

When combined with opioid analgesics, the doses of the latter can be significantly reduced.

Increases the hypoglycemic effect of insulin and oral hypoglycemic drugs (dose recalculation is necessary).

Increases the plasma concentration of verapamil and nifedipine.

Myelotoxic drugs enhance the manifestation of hematotoxicity of ketorolac.

Ketorolac should not be mixed in the same syringe with morphine sulfate, meperidine hydrochloride, promethazine hydrochloride or hydroxyzine hydrochloride (ketorolac precipitates from solution). Pharmaceutically incompatible with tramadol solution, lithium-containing drugs.

Eye drops

Ketorolac can be used in combination with antibiotics, β-blockers, carbonic anhydrase inhibitors, cycloplegics and mydriatics in the form of eye drops.

When using ketorolac simultaneously with other eye drops, it is necessary to take a break between instillations of at least 5 minutes.

Delayed healing. Topical NSAIDs, including ketorolac, may delay healing. Topical forms of corticosteroids are also known to slow healing. Concomitant use of NSAIDs and topical steroids may cause problems with healing after surgery.

Gel for external use

A pharmacokinetic interaction with drugs that compete for association with blood plasma proteins cannot be ruled out.

Caution should be exercised when using ketorolac simultaneously with digoxin, phenytoin, lithium-containing drugs, diuretics, cyclosporine, methotrexate, other NSAIDs, antihypertensive and antidiabetic drugs.

Overdose

Solution for intravenous and intramuscular administration, tablets

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.

Eye drops

An overdose usually does not lead to the development of symptoms that threaten vital organs and systems. If accidentally swallowed, drink plenty of liquid.

Gel for external use

Cases of gel overdose have not been described. If you accidentally ingest the gel, you must empty your stomach (induce vomiting, take activated charcoal). Further treatment, if necessary, is symptomatic.

Routes of administration

IV jetly, inside, locally, externally.

Precautions for the substance Ketorolac

Solution for intravenous and intramuscular administration, tablets

Before prescribing ketorolac, it is necessary to clarify the issue of a previous allergy to this drug or other NSAIDs. Due to the risk of developing allergic reactions, the first dose of ketorolac in the form of a solution is administered under the close supervision of a physician.

Hypovolemia increases the risk of nephrotoxic adverse reactions.

If necessary, can be used with opioid analgesics.

When used together with other NSAIDs, fluid retention, cardiac decompensation, and increased blood pressure may occur.

In patients with bleeding disorders, ketorolac is used only with constant monitoring of platelet counts and hemostasis, which is especially important in the postoperative period. The effect on platelet aggregation ceases after 24-48 hours.

The risk of developing drug complications increases with lengthening of treatment (in patients with chronic pain) and increasing the dose of ketorolac.

To reduce the risk of developing NSAID gastropathy, antacid drugs, misoprostol, and omeprazole are used.

Impact on the ability to drive vehicles and machinery. During the treatment period, care must be taken when driving vehicles, machinery and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions, because A significant proportion of patients using ketorolac develop side effects from the central nervous system (drowsiness, dizziness, headache).

Eye drops

If you are prone to bleeding and with concomitant use of drugs that increase bleeding time, the use of ophthalmic forms of NSAIDs after ophthalmic surgery may increase the risk of hemorrhage in the tissues of the eye, incl. collections of blood in the anterior chamber of the eye (hyphema).

In patients with signs of destruction of the corneal epithelium, the use of ketorolac should be immediately discontinued and the condition of the cornea should be carefully monitored. In patients with complications in the postoperative period, with impaired innervation of the cornea, defects of the corneal epithelium, diabetes mellitus, diseases of the mucous membrane of the eyes (for example, dry eye syndrome), concomitant rheumatoid arthritis, as well as with short intervals between repeated ophthalmological operations, due to the high risk of developing undesirable reactions from the cornea that may threaten vision loss, ketorolac should be used with caution.

Use of topical NSAIDs for 24 hours or more before corneal surgery and for more than 14 days after surgery may increase the risk and severity of corneal complications.

In patients with a complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses and intolerance to acetylsalicylic acid or other NSAIDs (including a history), ketorolac in the form of eye drops can provoke the development of an attack of bronchial asthma. If an allergic reaction develops, use should be discontinued.

Influence on the ability to drive vehicles and operate machinery. After using eye drops, the clarity of visual perception may decrease, so immediately after instillation it is not recommended to drive a car or engage in activities that require increased attention and speed of psychomotor reactions.

Gel for external use

It is recommended to apply only to intact areas of the skin, avoiding contact with open wounds. Avoid getting the gel into the eyes and other mucous membranes. Do not use the gel under airtight dressings.

Ketorolac-VERTEX