Ketorolac is a nonsteroidal anti-inflammatory agent (NSAID) with a pronounced analgesic effect.
Release form and composition
Ketorolaka Dosage Forms:
- Tablets, film-coated - round, biconvex, white or almost white in color (10 pcs. In blisters, 2 packs in a carton box);
- The solution for intramuscular injection is transparent, light yellow in color (1 ml each in ampoules of light-proof or amber glass, 5 ampoules in blisters, 1 or 2 packages in a carton box);
- The solution for intramuscular (IM) and intravenous (IV) administration is transparent, yellowish in color (1 ml each in dark glass ampoules: 5 pcs. In blisters, 1 or 2 packs in a carton box; 10 pieces in blisters, 1 pack in a carton box, 10 pcs in a carton box).
The active ingredient of the drug is ketorolac trometamol (ketorolac tromethamine). Its content is:
- 1 tablet - 10 mg;
- 1 ml of solution for intramuscular administration - 30 mg;
- 1 ml of solution for IM and IV administration - 30 mg.
- Tablets - microcrystalline cellulose, lactose monohydrate (milk sugar), crospovidone (kollidon DL), magnesium stearate, talc. Shell composition: macrogol 4000, titanium dioxide, talc, propylene glycol, hypromellose;
- Solution for i / m administration - ethanol (ethyl alcohol), disodium edetate dihydrate (Trilon B), sodium chloride, propylene glycol, sodium hydroxide 1 M solution, injectable water;
- Solution for the / m and / in the introduction - sodium chloride, disodium edetate, water for injection.
Indications for use
Ketorolac is designed to relieve pain syndrome of strong and moderate intensity:
- Rheumatic diseases;
- Arthralgia, myalgia, radiculitis, neuralgia;
- Dislocations, sprains and other injuries;
- Oncological diseases;
- Pain in the postoperative and postpartum period.
- A complete or incomplete combination of bronchial asthma with recurrent nasal polyposis and paranasal sinuses, intolerance to acetylsalicylic acid or other NSAIDs (now or in history);
- Indications in the history of the patient on the urticaria and / or rhinitis caused by taking NSAIDs;
- Severe renal failure (creatinine clearance less than 30 ml / minute);
- Hypovolemia of any genesis;
- Confirmed hyperkalemia;
- Erosive and ulcerative lesions of the gastrointestinal tract (GIT) in the acute stage;
- Inflammatory bowel disease;
- Blood clotting disorders, including hemophilia;
- Bleeding or high risk of their development;
- Hemorrhagic diathesis;
- Hemorrhagic stroke or suspicion of it;
- Violation of blood formation;
- Severe liver failure or active liver disease;
- Children's age up to 16 years;
- Condition after coronary artery bypass surgery;
- Intolerance of pyrazolone preparations;
- Hypersensitivity to components of Ketorolac, acetylsalicylic acid or other NSAIDs.
The drug is contraindicated to apply for sedation, supporting anesthesia, anesthesia in obstetric practice, before and during surgical operations, because high risk of bleeding.
Ketorolac is not used to treat chronic pain.
Special medical control during drug treatment is necessary in the following cases:
- Advanced age (over 65);
- The presence of factors that increase the toxicity of the gastrointestinal tract: cholecystitis, alcoholism and smoking;
- The postoperative period;
- The need for long-term use of NSAIDs;
- Simultaneous use of other NSAIDs, oral glucocorticosteroids (including prednisolone), antiplatelet agents (including clopidogrel), anticoagulants (including warfarin), selective reuptake inhibitors (including paroxetine, fluoxetine, citalopram, sertraline);
- Bronchial asthma;
- Dyslipidemia / hyperlipidemia;
- The presence of Helicobacter pylori infection;
- Ulcer lesions of the gastrointestinal tract in history;
- Impaired renal function (plasma creatinine below 50 mg / l);
- Creatinine clearance 30–60 ml / minute;
- Edema syndrome;
- Coronary heart disease;
- Arterial hypertension;
- Chronic heart failure;
- Cerebrovascular diseases;
- Systemic lupus erythematosus;
- Severe somatic diseases;
- Peripheral artery diseases;
- Active hepatitis.
Dosing and Administration
Ketorolac tablets are intended for oral administration. You can take the drug once, as needed, and 1 tablet, or again up to 4 times a day, depending on the severity of pain. The maximum daily dose of ketorolac is 4 tablets. The duration of treatment is not more than 5 days.
Parenteral solution is injected deep into the muscle or slowly (at least 15 seconds) intravenously. The dose is selected individually depending on the intensity of pain and tolerability of the drug.
With a single injection, a single dose for adult patients under the age of 65 years is 10-30 mg, for the elderly and patients with impaired renal function - 10-15 mg.
Doses with multiple i / m administration Ketorolaka:
- Children older than 16 years and adults - 10-60 mg, then - 10-30 mg every 6 hours;
- The elderly and patients with impaired renal function - 10-15 mg every 4-6 hours.
Doses with multiple jet in / in the introduction of Ketorolaka:
- Children over 16 years old and adults 10-30 mg every 6 hours. The initial dose for continuous infusion using an infusion pump is 30 mg, then the infusion rate is 5 mg / hour, the maximum duration of the intravenous infusion is 24 hours;
- The elderly and patients with impaired renal function - 10-15 mg every 6 hours.
Maximum daily doses for parenteral use of the drug:
- Children over 16 and adults - 90 mg;
- The elderly and patients with impaired renal function - 60 mg.
The duration of treatment is not more than 5 days.
When transferring a patient from parenteral administration of Ketorolac to oral administration, the total dose of both dosage forms should be considered. In this case, the dose of the drug in tablets on the day of transition should not exceed 30 mg.
- The digestive system: often (especially in older people with erosive and ulcerative lesions of the gastrointestinal tract in history) - diarrhea and gastralgia; less often - a feeling of fullness in the stomach, flatulence, vomiting, constipation, stomatitis; rarely - nausea, hepatitis, loss of appetite, acute pancreatitis, hepatomegaly, cholestatic jaundice, erosive and ulcerative lesions of the gastrointestinal tract (including bleeding and / or perforation), nausea, heartburn, melena, abdominal pain, “coffee grounds” type or with blood, burning or spasm in the epigastric region;
- Cardiovascular system: less often - increase in blood pressure; rarely - fainting;
- Urinary system: rarely - edema of renal genesis, decrease or increase in urine volume, nephritis, frequent urination, azotemia, hematuria, back pain, hemolytic – uremic syndrome (renal failure, hemolytic anemia, thrombocytopenia, purpura), acute renal failure;
- Hematopoietic system: rarely - leukopenia, eosinophilia, anemia;
- Central and peripheral nervous system: often - drowsiness, dizziness, headache; rarely, hyperactivity (including mood changes and anxiety), hallucinations, psychosis, depression, aseptic meningitis (including stiff neck and / or back muscles, severe headache, fever, seizures);
- Coagulant system of blood: rarely - bleeding (nose, rectal, from a postoperative wound);
- Respiratory system: rarely - laryngeal edema (including shortness of breath and difficulty breathing), rhinitis, dyspnea, bronchospasm, pulmonary edema;
- Skin: Infrequently - purpura and skin rash (including maculopapular); rarely - urticaria, exfoliative dermatitis (including swelling and / or tenderness of the tonsils, fever, sometimes with chills, induration, redness and / or peeling of the skin), Stevens-Johnson and Lyell's syndromes;
- Sense organs: rarely - tinnitus, hearing loss, visual impairment (including blurred vision);
- Allergic reactions: rarely - anaphylaxis, anaphylactoid reactions (including skin rash, urticaria, itching, discoloration of the skin of the face, chest tightness, shortness of breath and wheezing, shortness of breath, tachypnea or dyspnea, periorbital swelling and eyelid edema);
- Local reactions in parenteral administration: burning and / or pain at the injection site;
- Other: often - increase in body weight, edema (face, fingers, feet, ankles, legs); less often, excessive sweating; rarely fever, swelling of the tongue.
Overdose symptoms: nausea and / or vomiting, abdominal pain, erosive and ulcerative lesions of the digestive tract, metabolic acidosis, impaired renal function. If a high dose of Ketorolac was ingested, gastric lavage should be done and an adsorbent should be taken. In case of overdose as a result of parenteral use of the drug and further after oral administration, symptomatic therapy is carried out. With dialysis is not sufficiently displayed.
Ketorolac is intended for symptomatic therapy, i.e. to reduce pain and inflammation at the time of application, it does not affect the progression of the disease.
Before prescribing Ketorolac, it is important to examine the patient’s history of previous allergies to NSAIDs. Due to the risk of allergic reactions, the first dose of a / c or c / m is administered under close supervision.
If necessary, opioid analgesics can be used at the same time, but in lower doses.
With the joint use of other NSAIDs, fluid retention, arterial hypertension, cardiac decompensation is possible.
To reduce the risk of NSAID gastropathy, antacids, omeprazole or misoprostol are prescribed.
When hypovolemia increases the risk of side effects from the kidneys.
Simultaneously with paracetamol, Ketorolac should not be taken for more than 5 days.
Patients who have been diagnosed with coagulation disorders can receive the drug only if the number of platelets is regularly monitored, especially in the postoperative period.
Drowsiness, headache and dizziness are quite frequent side effects of the drug from the central nervous system with potentially dangerous consequences, therefore during the treatment period it is recommended to refrain from performing types of work that require quick reaction and increased attention (including driving vehicles).
Possible undesirable (including severe) reactions:
- Indirect anticoagulants, thrombolitics, antiplatelet agents, pentoxifylline, heparin, cefoperazone, cefotetan, - the development of bleeding;
- Ethanol, acetylsalicylic acid, other NSAIDs, calcium supplements, glucocorticosteroids, and corticotropin - the formation of gastrointestinal ulcers, gastrointestinal bleeding;
- Paracetamol and other nephrotoxic drugs, including gold preparations - nephrotoxicity;
- Verapamil and nifedipine - increasing their concentration in the blood plasma;
- Myelotoxic agents - increased hematotoxicity of ketorolac;
- Methotrexate and lithium - reduction of their clearance and increased toxicity;
- Valproic acid - violation of platelet aggregation;
- Probenecid and tubular secretion blocking drugs - reduced clearance of ketorolac, increasing its concentration in blood plasma.
Ketorolac reduces the effectiveness of diuretic and antihypertensive drugs, enhances the hypoglycemic effect of insulin and oral hypoglycemic agents (recalculation of doses is required).
With simultaneous use enhances the action of opioid analgesics, their dose is reduced.
In the form of a solution, ketorolac should not be mixed in the same syringe with morphine sulfate, hydroxyzine and promethazine, since precipitate falls.
Pharmaceutically incompatible with lithium preparations and tramadol solution. Compatible with infusion solutions containing heparin sodium salt, short-acting human insulin, dopamine hydrochloride, lidocaine hydrochloride, aminophylline, as well as the following solutions: Plasmalite, Ringer, Ringer-lactate, 5% dextrose, 0.9% sodium chloride.
Terms and conditions of storage
Keep out of reach of children, protected from light, dry (tablets) at a temperature of 15-25 ºС.
The shelf life of the solution - 2 years, tablets - 3 years.