Ketorol tablets - instructions for use. Send information about complaints and adverse drug reactions to:

Country of origin

Product group

Nonsteroidal anti-inflammatory drug (NSAID)

Release forms

• 10 tablets in a blister pack. 20 or 100 tablets in a glass or polymer jar. 1, 2, 3, 4, 5 or 10 blister packs of 1 ml - dark glass ampoules (5) - blister packs (1) - cardboard packs. 1 ml - dark glass ampoules (5) - contour cell packaging (2) - cardboard packs. 1 ml - dark glass ampoules (5) - contour cell packaging (2) - cardboard packs. 1.0 ml - ampoules (5) - plastic trays (2) - cardboard packs 10 - blister packs (2) - cardboard packs 10 ampoules of 1 ml per package 10 tablets in blister packs made of polyvinyl chloride film and printed varnished aluminum foil . 10 pieces. - contour cell packaging (2) - cardboard packs. 20 tablets per pack Solution for intravenous and intramuscular administration 30 mg/ml, 1 ml in ampoules - 10 pcs per pack. Film-coated tablets, 10 mg: 10 tablets in a blister pack. 20 or 100 tablets in a glass or polymer jar. 1, 2, 3, 4, 5 or 10 blister packs, pack of 10 ampoules of 1 ml, pack of 20 tablets

Description of the dosage form

• transparent liquid of light yellow color with a faint odor. film-coated tablets, white, with a biconvex surface. Transparent colorless or slightly colored liquid. Transparent, colorless to yellowish solution. Solution for intravenous and intramuscular administration. Solution for intravenous and intramuscular administration is transparent, yellowish in color. The solution for intravenous and intramuscular administration is transparent, light yellow in color. The solution for intramuscular administration is light yellow in color, a transparent solution for intramuscular administration. tablets Film-coated tablets film-coated tablets Film-coated tablets are white, rough, round, biconvex.

pharmachologic effect

Pharmacokinetics

Special conditions

Compound

• 1 ml of ketorolac trometamol (ketorolac tromethamine) 30 mg, one tablet contains: active ingredient – ​​ketorolac tromethamine - 10 mg; excipients: lactose monohydrate, potato starch, microcrystalline cellulose, calcium stearate, opadry II 1 ml ketorolac trometamol (ketorolac tromethamine) 30 mg Excipients: ethanol (in terms of anhydrous) - 100 mg, sodium chloride - 4.35 mg, sodium hydroxide solution 1 M or hydrochloric acid solution 1 M - up to pH 6.9-7.9, water d/i - up to 1 ml. 1 tab. ketorolac tromethamine 10 mg Excipients: microcrystalline cellulose 120 mg, lactose monohydrate (80 mesh tablet) 69 mg, magnesium stearate 1 mg. 1 ml of solution contains - active ingredient: ketorolac tromethamine - 30 mg; excipients: sodium chloride, disodium salt of ethylenediaminetetraacetic acid, rectified ethyl alcohol, tromethamine, water for injection. ketorolac tromethamine 10 mg; Excipients: lactose, potato starch, low molecular weight medical polyvinylpyrrolidone (povidone), magnesium stearate, talc, collidon CL-M. ketorolac tromethamine 10 mg; Excipients: MCC, lactose, croscarmellose sodium, magnesium stearate ketorolac tromethamine 30 mg Excipients: ethanol 96% - 100 mg, sodium chloride - 4.35 mg, disodium edetate dihydrate - 0.5 mg, 1M hydrochloric acid and sodium hydroxide solution - up to pH 7.4 -7.5, d/i water - up to 1 ml. ketorolac tromethamine -10 mg Excipients: milk sugar (lactose), potato starch, low molecular weight polyvinylpyrrolidone (povidone), magnesium stearate, talc, collidon CL M; shell: hydroxypropyl methylcellulose or hydroxypropyl methylcellulose (hypromellose), talc, titanium dioxide, polyethylene glycol 4000, propylene glycol. ketorolac tromethamine 30 mg Excipients: sodium chloride, disodium salt of ethylenediaminetetraacetic acid (Trilon B), water for injection. ketorolac tromethamine 30 mg Excipients: disodium edetate dihydrate (Trilon B), ethanol (ethyl alcohol in terms of anhydrous), propylene glycol, sodium chloride, sodium hydroxide (1M solution), water for injection. One tablet contains: Active substance: ketorolac tromethamine -10 mg Excipients: milk sugar (lactose), potato starch, low molecular weight polyvinylpyrrolidone (povidone), magnesium stearate, talc, collidon CL M; shell: hydroxypropyl methylcellulose or hydroxypropyl methylcellulose (hypromellose), talc, titanium dioxide, polyethylene glycol 4000, propylene glycol

Ketorolac indications for use

• Pain syndrome of severe and moderate severity: injuries, toothache, pain in the postpartum and postoperative period, cancer, myalgia, arthralgia, neuralgia, radiculitis, dislocations, sprains, rheumatic diseases. Intended for symptomatic therapy, reducing pain and inflammation at the time of use, does not affect the progression of the disease.

Ketorolac contraindications

• Hypersensitivity to ketorolac or other non-steroidal anti-inflammatory drugs, aspirin-induced 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, concomitant use with other NSAIDs, high risk of development or recurrence of bleeding (including after surgery), impaired hematopoiesis. Pregnancy, childbirth and lactation. Children under 16 years of age (efficacy and safety have not been established). The drug is not used for pain relief before and during surgery due to the high risk of bleeding, as well as for the treatment of chronic pain. With caution - bronchial asthma; cholecystitis; chronic heart failure

Ketorolac dosage

• 10 mg 10 mg 30 mg/ml 30 mg/ml 30 mg/ml

Ketorolac side effects

• According to the World Health Organization (WHO), adverse events are classified according to their frequency as follows: very common (> 10%), common (> 1% and 0.1% and 0.01% and

Drug interactions

Overdose

Storage conditions

• store in a dry place
• store at room temperature 15-25 degrees
• keep away from children
• store in a place protected from light

Synonyms

• Dolak, Ketalgin, Ketanov, Ketorol, Ketorolac,

Catad_pgroup NSAIDs

Ketorol for injection - official instructions for use

Registration number:

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.

When administered intramuscularly, 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 reached 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. Intended for symptomatic therapy, reducing pain and inflammation at the time of use. Does not affect the progression of the disease.

Contraindications

Hypersensitivity to ketorolac;

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, coronary 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, old age (over 65 years), history of gastrointestinal ulceration, 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 (eg, 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 is given 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 – 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.

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 symptomatic therapy (maintaining vital body functions). 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 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 when taken together 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 influence of a medicinal product for medical use on the ability to drive vehicles and machinery

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 packaging.

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.

Ketorolac is a nonsteroidal anti-inflammatory drug (NSAID) with a strong analgesic and moderate antipyretic effect. Its main purpose is to relieve pain of various origins. Pain is a subjective sensation that serves as an indicator of tissue damage. To select the optimal analgesic, it is necessary to clearly understand its analgesic activity, selectivity for COX (cyclooxygenase 1 and 2), bioavailability, the presence of various routes of administration, the speed of onset of the therapeutic effect, and the safety profile. Ketorolac is a non-selective (non-selective) NSAID, the mechanism of action of which is associated with the suppression of the activity of COX-1 and COX-2 in peripheral tissues, as a result of which the synthesis of prostaglandins, mediators of pain and inflammation, is inhibited. The drug does not interact with opioid receptors, does not affect respiratory function, is not addictive, and does not have a sedative effect. The analgesic effect is similar to that of morphine and is much superior to other NSAIDs. After oral administration, the analgesic effect develops after 1 hour, the peak effect of the drug occurs in the 2nd hour. In fact, ketorolac is the only NSAID used to relieve acute pain. The drug is devoid of most of the negative side effects characteristic of opioids (sedation, respiratory depression, drug dependence). The high analgesic activity of ketorolac has been demonstrated in a number of clinical trials. Ketorolac is the drug of choice for relieving acute pain, but its short-term use is also possible in case of exacerbation of chronic pain (for example, osteoarthritis, rheumatoid arthritis). Thus, for severe spinal pain, according to one study, the effectiveness of ketorolac was comparable to that of meperidine and codeine, and the side effects were much less pronounced.

In renal colic, 30 mg of ketorolac in the form of a solution for intravenous administration had the same analgesic effect as 2.5 mg of metamizole in combination with antispasmodics with fewer negative side reactions. In accordance with experimental data, blocking the synthesis of prostaglandins in the kidneys with ketorolac suppresses peristalsis and reduces pressure in the urinary tract, relieves spasm and reduces the intensity of renal blood flow. The drug is quickly absorbed in the intestines. Due to its high (80-100%) bioavailability, the analgesic effect develops quite quickly. The duration of the therapeutic effect of ketorolac is up to 10 hours. The incidence of negative side reactions during treatment with ketorolac does not exceed 2.7%. The most characteristic in this regard is dyspeptic symptoms. Of particular interest is the study of the effectiveness and safety of injectable forms of ketorolac in comparison with other NSAIDs: metamizole, diclofenac and lornoxicam. It was found that lornoxicam and ketorolac had the best analgesic efficacy, superior to metamizole and diclofenac. These NSAIDs also differed in tolerability. It should be noted that single administration of all study drugs was relatively safe. Moreover, the use of metamizole and diclofenac in a number of cases was associated with the occurrence of local reactions at the injection site. There was 1 case of tissue necrosis at the injection site after the administration of diclofenac and several cases of infiltrates after the administration of metamizole. The result of the study indicates that the use of ketorolac for the treatment of acute pain is justified, and this drug is more effective for injuries and musculoskeletal pain compared to other NSAIDs.

Pharmacology

Ketorolac 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 the enzyme cyclooxygenase 1 and 2, mainly. in peripheral tissues, resulting in inhibition of the biosynthesis of prostaglandins - modulators of pain sensitivity, thermoregulation and inflammation. 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.

The strength of the analgesic effect is comparable to morphine, significantly superior to other NSAIDs.

After oral administration, the onset of the analgesic effect is noted after 1 hour, the maximum effect is achieved after 1-2 hours.

Pharmacokinetics

When taken orally, Ketorolac-Verte is well absorbed from the gastrointestinal tract, Cmax in blood plasma (0.7-1.1 μg/ml) is achieved 40 minutes after taking a dose of 10 mg on an empty stomach. Fat-rich foods reduce the Cmax of the drug in the blood and delay its achievement by 1 hour.

99% of the drug binds to blood plasma proteins and with hypoalbuminemia the amount of free substance in the blood increases.

Bioavailability - 80-100%. The time to reach Css with oral administration is 24 hours when administered 4 times a day (above subtherapeutic) and after oral administration of 10 mg is 0.39-0.79 mcg/ml. The volume of distribution is 0.15-0.33 l/kg. In patients with renal failure, the volume of distribution of the drug may increase by 2 times, and the volume of distribution of its R-enantiomer by 20%. Penetrates into breast milk: when the mother takes 10 mg of ketorolac, Cmax 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 using the drug 4 times a day) is 7.9 ng /ml.

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 is, on average, 5.3 hours. T1/2 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 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. Not excreted during hemodialysis.

Release form

10 pieces. - contour cellular packaging (1) - cardboard packs.
10 pieces. - contour cell packaging (2) - cardboard packs.
10 pieces. - contour cell packaging (5) - cardboard packs.
10 pieces. - contour cell packaging (10) - cardboard packs.
25 pcs. - contour cell packaging (2) - cardboard packs.
25 pcs. - contour cell packaging (4) - cardboard packs.
10 pieces. - polymer jars (1) - cardboard packs.

Dosage

Ketorolac-Verte is used orally once or repeatedly depending on the severity of the pain syndrome. Single dose - 10 mg, when repeated, it is recommended to take 10 mg up to 4 times a day, depending on the severity of pain; the maximum daily dose should not exceed 40 mg.

When taken orally, the duration of the course should not exceed 5 days.

Overdose

Symptoms: abdominal pain, nausea, vomiting, peptic ulcers or erosive gastritis, impaired renal function, metabolic acidosis.

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

Interaction

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

Co-administration with paracetamol increases nephrotoxicity, and with methotrexate - hepato- and nephrotoxicity. Co-administration of ketorolac and methotrexate is possible only when using low doses of the latter (monitor the concentration of methotrexate in the blood plasma).

Probenicid 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, 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.

The hypoglycemic effect of insulin and oral hypoglycemic drugs increases (dose recalculation is necessary). Co-administration with sodium valproate 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.

Side effects

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

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, vomiting like “coffee grounds”, nausea, heartburn, etc.), 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 renal origin.

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

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

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

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

From the hematopoietic organs: rarely - anemia, eosiophilia, 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 peeling of the skin, swelling and/or tenderness of the tonsils), urticaria, Stevens syndrome - Johnson, Lyell's syndrome.

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

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

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

Indications

Pain syndrome of moderate and severe intensity of various origins (including in the postoperative period, with cancer, etc.).

Contraindications

• hypersensitivity to ketorolac or other NSAIDs, aspirin-induced asthma, bronchospasm, angioedema;
• hypovolemia (regardless of the cause that caused it), 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);
• hematopoietic disorder;
• pregnancy, childbirth and lactation;
• children under 16 years of age (efficacy and safety have not been established);
• pain relief before and during surgery (since there is a high risk of bleeding);

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; old age (over 65 years); polyps of the nasal and nasopharyngeal mucosa.

Features of application

Use during pregnancy and breastfeeding

Use for liver dysfunction

Use for renal impairment

Contraindicated in renal failure (plasma creatinine above 50 mg/l).

Use with caution in case of impaired renal function (plasma creatinine below 50 mg/l).

Use in children

Contraindicated in children under 16 years of age (efficacy and safety have not been established).

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.

Impact on the ability to drive vehicles and operate machinery

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

Thank you

Ketorol is a very powerful non-narcotic painkiller with anti-inflammatory activity and moderate antipyretic effect. However, the main effect of Ketorol is pain relief (analgesic). Thanks to its powerful analgesic effect, the drug is ideal for relieving moderate to severe pain, especially associated with traumatic tissue damage.

Varieties, names and forms of release

• Gel for external use;
• Tablets for oral administration;
• Solution for intramuscular and intravenous administration.

The gel is a homogeneous transparent substance with a characteristic odor. The solution for injection is clear and colorless or pale yellow. The tablets are colored green, have a round, biconvex shape and are engraved in the form of the letter “S” on one side. When broken, the tablet is white or almost white, with a uniform structure.

The gel is produced in aluminum tubes with a volume of 30 g, the solution in ampoules with a volume of 1 ml, 10 pieces per pack, and tablets - 20 pieces per pack.

Ketorol - composition

The composition of the Ketorol gel

• Propylene glycol;
• Dimethyl sulfoxime;
• Carbomer;
• Sodium methyl parahydroxybenzoate;
• Tromethamine;
• Flavor "Drymon Inde";
• Ethanol;
• Glycerol.

• Microcrystalline cellulose;
• Corn starch;
• Colloidal silicon dioxide;
• Magnesium stearate;
• Sodium carboxymethyl starch (type A);
• Hypromellose;
• Propylene glycol;
• Olive green.

• Ethanol;
• Disodium edetate;
• Octoxynol;
• Propylene glycol;
• Sodium hydroxide;
• Deionized water.

Ketorol - recipe

The recipe for Ketorol tablets is as follows:
Rp: Tab. "Ketoroli" 10 mg
D.t.d. 20 tablets
S. Take 1 tablet orally every 8 hours.

The recipe for Ketorol gel is as follows:
Rp: Gel "Ketoroli" 2%
D.t.d. in tuba 30 g
S. Apply externally to areas of skin in which pain is felt

In all of these recipes, after the letters “Rp,” the release form (Sol., Tab., Gel) and the name Ketorol in Latin are indicated in quotation marks, since it is commercial. In the second line after the letters "D.t.d." indicates how much of the drug the pharmacist in the pharmacy must dispense to the person presenting the prescription. In the third line after the letter "S." it is indicated for the person himself how to use the drug.

Therapeutic effect of the drug Ketorol

The mechanism of action of the drug is associated with its ability to block the work of a special enzyme - cyclooxygenase . This enzyme converts arachidonic acid into prostaglandins - special substances that cause the development of an inflammatory reaction, pain and an increase in body temperature. Thus, Ketorol, by blocking the work of cyclooxygenase, stops the production of prostaglandins, as a result of which it stops the formation of an inflammatory reaction and pain, as well as an increase in temperature.

However, Ketorol has such a powerful analgesic effect that it literally overshadows and overshadows the anti-inflammatory and antipyretic effects. Therefore, the drug is used specifically as a pain reliever.

Ketorol is not a narcotic analgesic and does not cause the following adverse effects:

• Impact on the central nervous system;
• Respiratory depression;
• Weakening of intestinal peristaltic activity;
• Urinary retention;
• Increased blood pressure.

Ketorol - indications for use

So, indications for use for Ketorol tablets and injections is the relief of pain of any location and severity. This means that tablets or injections can be used to eliminate dental, headache, menstrual, muscle, joint, bone pain, as well as postoperative pain, pain due to cancer, etc. You should know that Ketorol is intended only for the relief of acute pain, but not for the treatment of chronic pain syndrome.

Indications for use of Ketorol gel are the following states:

• Injuries (bruises, soft tissue inflammation, ligament damage, bursitis, tendinitis, synovitis, etc.);
• Pain after injury;
• Pain in muscles and joints;
• Rheumatic diseases (gout, psoriatic arthritis, ankylosing spondylitis).

Instructions for use

Ketorol tablets - instructions for use

The tablets must be taken occasionally if necessary to relieve moderate or severe pain. The dosage of Ketorol for a single dose is 10 mg (1 tablet), and the maximum permissible daily dose is 40 mg (4 tablets). That is, you can take a maximum of 4 tablets of the drug per day. This means that one tablet is enough for a person to relieve pain for several hours, after which it returns, and then it is necessary to take a second tablet, etc. To relieve pain without consulting a doctor, you are allowed to take Ketorol in tablets for a maximum of 5 days.

If a person switches from using Ketorol injections to taking tablets, then the total daily dosage should not exceed 90 mg for people under 65 years of age and 60 mg for those over 65 years of age. Moreover, in these dosages the maximum permissible number of tablets is 30 mg (3 tablets).

Ketorol injections (ampoules) - instructions for use

To administer the solution intramuscularly, it is necessary to use disposable syringes of small volume - 0.5 - 1 ml. The syringe and its needle must be removed from the package immediately before the injection, and not beforehand. For injection, you need to open the ampoule of the solution, draw the required amount with a syringe, remove it and lift the needle up. Using your fingers, tap the surface of the syringe in the direction from the piston to the needle so that air bubbles rise and come off the walls. Then, to remove air, you need to lightly press the syringe plunger so that a drop appears at the tip of the needle. After this, the syringe must be put aside and the injection site should be treated with an antiseptic. The needle is inserted completely into the selected location perpendicular to the skin (to its entire length), after which, pressing on the piston, the solution is slowly and carefully injected. After administering the solution, the needle is removed from the tissue and discarded, and the injection site is again wiped with an antiseptic.

If necessary, Ketorol from an ampoule can be added to a dropper and administered slowly along with other solutions. Ketorol is compatible in one bottle with the following solutions and medications:

• Saline;
• 5% dextrose solution;
• Ringer's solution;
• Ringer-Locke solution;
• Plasmalit solution;
• Aminophylline solution;
• Lidocaine solution;
• Dopamine solution;
• Short-acting human insulin solution;
• Heparin solution.

For people over 65, as well as those suffering from kidney disease or with a body weight of less than 50 kg, a single dosage of the solution is 10 - 15 mg (0.3 - 0.5 ml), which can also be administered every 4 - 6 hours if pain comes back again. The maximum permissible daily dosage of Ketorol for people over 65 years of age, weighing less than 50 kg and suffering from kidney disease is 60 mg (2 ampoules).

The duration of continuous use of Ketorol without consulting a doctor should not exceed 5 days.

Ketorol gel – instructions for use

Before applying the gel, you must wash your hands and the intended area of ​​skin on which Ketorol will be distributed with warm water and soap. Then dry the surface of the skin and hand with a towel, then squeeze out 1–2 cm of gel from the tube and distribute it in a thin layer over the area of ​​the skin in which pain is felt. If the area to be treated is large, the amount of gel can be increased. The gel should be rubbed into the skin with gentle massaging movements until almost completely absorbed. You can apply a breathable bandage (for example, gauze or a regular bandage, etc.) over the treated area of ​​skin or do not cover it with anything. Do not apply an airtight bandage to skin treated with Ketorol gel.

The gel can be applied to the skin 3 – 4 times a day. The gel should not be used more than 4 times a day, and an interval of at least 4 hours must be maintained between two subsequent applications of the drug to the skin. Without consulting a doctor, the gel can be used for a maximum of 10 consecutive days.

special instructions

It is also important to remember that low circulating blood volume increases the likelihood of side effects from the kidneys.

In older people (over 65 years of age), the risk of developing Ketorol side effects is higher, so they should use any form of the drug in minimal dosages.

If a person suffers from any kidney disease, then during the entire course of use it is necessary to monitor the function of the organ by regularly taking a general urine test.

When using Ketorol solution or tablets, it is possible to increase the activity of liver transaminases in the blood (AST, ALT), so the drugs must be used for liver diseases with caution and only in short courses. If liver dysfunction develops while using Ketorol, the drug should be stopped immediately and consult a doctor.

The use of Ketorol simultaneously with the following medications may cause severe side effects:

• Valproates – possible disruption of platelet aggregation and the development of difficult to stop bleeding;
• Non-depolarizing muscle relaxants (Pipecuronium, Pancuronium, Tubocurarine, etc.) – possible development of shortness of breath;
• Antiepileptic drugs (Phenytoin, Carbamazepine, etc.) – the frequency of epileptic seizures increases;
• Antidepressants (Fluoxetine, Thiotixine, Alprazolam, etc.) – hallucinations may appear;
• Pentoxifylline, Cefoperazone, Cefotetan, heparin, thrombolytics (drugs that enhance the destruction of blood clots) and anticoagulants (drugs that reduce blood clots) - increases the risk of possible bleeding;
• Angiotensin-converting enzyme inhibitors (Berlipril, Vazolapril, Enalapril, Captopril, etc.) – increases the risk of developing kidney disorders.

Use during pregnancy and breastfeeding

Ketorol gel can be used with caution during the first and second trimesters of pregnancy, that is, up to the 27th week of gestation inclusive. Caution lies in careful prevention of possible accidental ingestion of the drug, for example, licking off the gel remaining on the lips after they were rubbed with hands that were not washed after applying the product, etc.

In the third trimester of pregnancy, that is, from the 28th week until delivery, Ketorol gel cannot be used, as this can cause post-term pregnancy or complications of labor.

Ketorol for toothache

If Ketorol is used to relieve toothache before visiting a dentist, then you should remember that the drug cannot be taken for more than 5 days, and postponing a visit to a specialist is inappropriate, since any pain in the teeth indicates the need for their treatment or removal. Moreover, a long-term attempt to relieve pain with Ketorol can lead to a worsening of the clinical situation, and where only tooth treatment was required, its removal may be necessary.

For toothache, Ketorol is best taken in tablets, since this form is quite effective and at the same time convenient. Usually, to relieve pain, take 1 tablet. The second tablet can be taken no earlier than 4 hours later. If after 4 hours there is still no pain, then taking the next Ketorol tablet should be postponed until the pain syndrome appears again. During the day, you can take a maximum of 4 tablets to relieve toothache.

Ketorol for children

The ban on the use of Ketorol for children is due to the fact that the drug can cause severe complications in children, such as nephritis (inflammation of the kidneys), depression, hearing and vision impairment, allergic reactions, pulmonary edema, etc.

Therefore, for children it is necessary to choose other painkillers that have a milder effect compared to Ketorol and a low risk of developing severe side effects, such as, for example, Ibuprofen, Nimesulide, etc.

Side effects of the drug Ketorol

Ketorol®

Latin name: Ketorol
NDV: Ketorolac*
Dr. Reddy's Laboratories Ltd. (India)
Pharmaceutical group: Non-narcotic analgesics, including non-steroidal and other anti-inflammatory drugs.
ATX: M01AB15 Ketorolac.
TFR: Medicines.
Nosological classification (ICD-10): R52 Pain not elsewhere classified. R52.1 Constant intractable pain. R52.2 Other persistent pain. Z100* CLASS XXII Surgical practice.
Composition and release form: Film-coated tablets - 1 tablet.
ketorolac tromethamine – 10 mg
Excipients: MCC; lactose; corn starch; magnesium stearate; colloidal silicon anhydrous; sodium starch glycolate; hypromellose; propylene glycol; titanium dioxide; olive green
in a blister pack 10 pcs.; in a cardboard pack 2 packs.
Solution for injection - 1 ml
ketorolac tromethamine – 30 mg
excipients: sodium chloride; alcohol; disodium edetate; octoxynol; propylene glycol; sodium hydroxide; water for injections
in ampoules of 1 ml; in a blister pack 10 pcs.
Description of the dosage form: Tablets: round, biconvex, green, with the letter S on one side. Broken appearance: the core is white or almost white.
Solution for injection: clear, colorless or pale yellow liquid, free of visible foreign particles.
Characteristics: NSAID, racemic mixture of /-/S and /+/R enantiomers (the analgesic effect is due to the /-/S form).
pharmachologic effect: Analgesic, anti-inflammatory, antipyretic. Inhibits the activity of the enzyme cyclooxygenase 1 and 2, mainly in peripheral tissues, as a result, inhibits the biosynthesis of PG - modulators of pain sensitivity, thermoregulation and inflammation.
Pharmacokinetics: When taken orally, it is well absorbed from the gastrointestinal tract. C_max in blood plasma (0.7-1.1 μg/ml) is achieved 40 minutes after taking a dose of 10 mg on an empty stomach. Food rich in fat reduces C_max and delays its achievement by 1 hour. It binds to blood plasma proteins by 99% and with hypoalbuminemia the amount of free substance in the blood increases. Bioavailability - 80-100%. Absorption with intramuscular administration is complete and rapid. After intramuscular administration at a dose of 30 mg C_max (1.74-3.1 µg/ml) is achieved in 15-73 minutes, 60 mg - C_max (3.23-5.77 µg/ml) is achieved in 30-60 min. The time to reach equilibrium concentration with parenteral and oral administration is 24 hours when administered 4 times a day. Depending on the dose and route of administration, it is 0.65-1.13 µg/ml for intramuscular administration, 30 mg – 1.29-2.47 µg/ml; after oral administration of 10 mg - 0.39-0.79 mcg/ml. Volume of distribution - 0.15-0.33 l/kg. In patients with renal failure, the volume of distribution may increase by 2 times, and the volume of distribution of the R-enantiomer by 20%.
Penetrates into breast milk: when taken by the mother at a dose of 10 mg, C_max in milk is achieved 2 hours after taking the first dose and is 7.3 ng/ml, 2 hours after taking the second dose (when using the drug 4 times a day) - 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.
T_1/2 in patients with normal renal function - on average 5.3 hours (3.5-9.2 hours after intramuscular administration of 30 mg and 2.4-9 hours after oral administration of 10 mg). T_1/2 increases in elderly patients and decreases in young ones. Liver function has no effect on T_1/2. In patients with impaired renal function with creatinine Cl 19-50 mg/l (168-442 µmol/l) T_1/2 - 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/kg/h (0.019 l/kg/h in elderly patients), with oral administration of 10 mg is 0.025 l/kg/h; in patients with renal failure with creatinine Cl 19-50 mg/l with intramuscular administration of 30 mg - 0.015 l/kg/h, oral administration of 10 mg - 0.016 l/kg/h.
Not excreted during hemodialysis.
Pharmacodynamics: 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 and oral administration, the onset of analgesic action is observed after 0.5 and 1 hour, respectively, the maximum effect is achieved after 1-2 hours.
Indications: Pain syndrome of moderate and severe intensity of various origins (including pain in the postoperative period, cancer, etc.).
Contraindications: Hypersensitivity to ketorolac or other NSAIDs, “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, concomitant use with other NSAIDs, high risk of development or recurrence of bleeding (including after surgery) , hematopoietic disorders, pre- and surgical period (high risk of bleeding), chronic pain, pregnancy, childbirth, breastfeeding, children under 16 years of age.
Use during pregnancy and breastfeeding: Contraindicated during pregnancy. Breastfeeding should be stopped during treatment.
Side effects: From the digestive system: often (more than 3%) (especially in elderly patients over 65 years old with a history of erosive and ulcerative lesions of the gastrointestinal tract) - gastralgia, diarrhea; less often (1-3%) - stomatitis, flatulence, constipation, vomiting, feeling of fullness in the stomach; rarely (less than 1%) - 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 etc.), cholestatic jaundice, hepatitis, hepatomegaly, acute pancreatitis.
From the urinary system: rarely (less than 1%) - acute renal failure, low back pain with or without hematuria and/or azotemia, hemolytic uremic syndrome (hemolytic anemia, renal failure, thrombocytopenia, purpura), frequent urination, increased or decreased volume urine, nephritis, edema of renal origin.
From the senses: rarely (less than 1%) - hearing loss, ringing in the ears, visual impairment (including blurred vision).
From the respiratory system: rarely (less than 1%) - bronchospasm or dyspnea, rhinitis, laryngeal edema (shortness of breath, difficulty breathing).
From the side of the central nervous system: often (more than 3%) - headache, dizziness, drowsiness; rarely (less than 1%) - 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 (1-3%) - increased blood pressure; rarely (less than 1%) - pulmonary edema, fainting.
From the hematopoietic organs: rarely (less than 1%) - anemia, eosinophilia, leukopenia.
From the hemostatic system: rarely (less than 1%) - bleeding from a postoperative wound, nosebleeds, rectal bleeding.
From the skin: less often (1-3%) - skin rash (including maculopapular rash), purpura; rarely (less than 1%) - 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 (1-3%) - burning or pain at the injection site.
Allergic reactions: rarely (less than 1%) - anaphylaxis or anaphylactoid reactions (change in facial skin color, skin rash, urticaria, itching of the skin, tachypnea or dyspnea, swelling of the eyelids, periorbital edema, shortness of breath, difficulty breathing, heaviness in the chest, wheezing ).
Other: often (more than 3%) - swelling (of the face, legs, ankles, fingers, feet), weight gain; less often (1-3%) - increased sweating; rarely (less than 1%) - swelling of the tongue, fever.
Interaction: Simultaneous use of ketorolac with acetylsalicylic acid or other NSAIDs, calcium preparations, glucocorticoids, 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 (monitoring the concentration of methotrexate in the blood plasma is necessary).
Probenecid reduces plasma clearance and volume of distribution of ketorolac, increases its concentration in blood plasma and increases T_1/2. With the use of ketorolac, the clearance of methotrexate and lithium may decrease and the toxicity of these substances may increase. Co-administration with indirect anticoagulants, heparin, thrombolytics, antiplatelet agents, cefoperazone, cefotetan and pentoxifylline increases the risk of bleeding. Reduces the effect of antihypertensive and diuretic drugs (PG synthesis 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.
The hypoglycemic effect of insulin and oral hypoglycemic drugs increases (dose recalculation is necessary). Co-administration with sodium valproate 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.
The injection solution should not be mixed in the same syringe with morphine sulfate, promethazine and hydroxyzine due to precipitation. Pharmaceutically incompatible with tramadol solution and lithium preparations.
The injection solution is compatible with saline solution, 5% dextrose solution, Ringer's solution and Ringer-lactate, Plasmalit solution, as well as infusion solutions containing aminophylline, lidocaine hydrochloride, dopamine hydrochloride, short-acting human insulin and heparin sodium salt.
Overdose: Symptoms: abdominal pain, nausea, vomiting, peptic ulcer, erosive gastritis, renal dysfunction, metabolic acidosis.
Treatment: gastric lavage, administration of adsorbents (activated carbon), symptomatic therapy (maintaining vital functions of the body). Not eliminated sufficiently by dialysis.
Mode of application and doses: Tablets. Orally, once or repeatedly, depending on the severity of the pain syndrome. Single dose - 10 mg, with repeated doses - 10 mg up to 4 times a day; the maximum daily dose should not exceed 40 mg. The duration of the course is no more than 5 days.
Injection. IM deep, in minimally effective doses, selected in accordance with the intensity of pain and the patient’s response. If necessary, in combination with opioid analgesics in reduced doses.
Single doses for a single intramuscular injection: patients under 65 years of age - 10-30 mg (depending on the severity of the pain syndrome), over 65 years of age or with impaired renal function - 10-15 mg.
Doses for repeated intramuscular administration: patients under 65 years of age - 10-30 mg, then - 10-30 mg every 4-6 hours, over 65 years of age or with impaired renal function - 10-15 mg every 4-6 hours .
The maximum daily dose for patients under 65 years of age is no more than 90 mg, for patients over 65 years of age or with impaired renal function - 60 mg.
When administered parenterally, the duration of the course is no more than 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.
Precautions: Prescribed with caution for bronchial asthma, cholecystitis, chronic heart failure, arterial hypertension, renal dysfunction (plasma creatinine Cl below 50 mg/l), cholestasis, active hepatitis, sepsis, systemic lupus erythematosus, polyps of the nasal and nasopharyngeal mucosa , in old age (over 65 years).
Special instructions: Hypovolemia increases the risk of adverse reactions from the kidneys. If necessary, can be prescribed in combination with narcotic analgesics. The effect on platelet aggregation ceases after 24-48 hours.
Ketorol is not recommended for use as a means of premedication, maintenance of anesthesia and pain relief in obstetric practice.
Do not use simultaneously with paracetamol for more than 5 days. For patients with blood clotting disorders, the drug is prescribed only with constant monitoring of the platelet count; This is especially important in the postoperative period and requires careful monitoring of hemostasis.
Since a significant proportion of patients who are prescribed Ketorol develop side effects from the central nervous system (drowsiness, dizziness, headache), it is recommended to avoid performing work that requires increased attention and quick reaction (driving a vehicle, working with machinery, etc.).
Shelf life: 3 years
Storage conditions: List B. In a dry place, protected from light, at a temperature not exceeding 25 °C