Ketorolac - Instructions For Use, Indications, Doses, Analogues

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Ketorolac

Instructions for use:

1. 1. Release form and composition
2. 2. Indications for use
3. 3. Contraindications
4. 4. Method of application and dosage
5. 5. Side effects
6. 6. Special instructions
7. 7. Drug interactions
8. 8. Analogs
9. 9. Terms and conditions of storage
10. 10. Terms of dispensing from pharmacies

Prices in online pharmacies:

from 17 rubles.

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Ketorolac is a drug with analgesic, antipyretic and anti-inflammatory effects.

Release form and composition

Ketorolac is available in the following dosage forms:

• Solution for intravenous and intramuscular administration: yellowish, transparent (1 ml in ampoules, 5, 10 ampoules in pallets, 1 or 2 pallets in a cardboard box; 2 ml in dark glass ampoules, 10 ampoules in a cardboard box);
• Solution for intramuscular injection: transparent, light yellow (1 ml in ampoules, 5 ampoules in pallets, 1 or 2 pallets in a cardboard box, or 5 or 10 ampoules in a cardboard box; 2 ml in dark glass ampoules, 10 ampoules in a cardboard box);
• Tablets (10 pcs. In blister packs, 1, 2, 5, 10 packs in a cardboard box; 20 pcs. In blister packs, 1 pack in a cardboard box; 25 pcs. In blister packs, each 2, 4 packages in a cardboard box; 10 pcs. In polymer cans, 1 can in a cardboard box);
• Film-coated tablets: white, biconvex (10 pcs. In blisters, 1-3, 5 packs in a cardboard box);
• Film-coated tablets: biconvex, round, almost white or white; the cross section shows two layers (10 pcs. in blisters, 1-5, 10 packs in a cardboard box; 20, 100 pcs. in cans, 1 can in a cardboard box).

The composition of 1 ml solution for intravenous and intramuscular administration includes:

• Active ingredient: ketorolac trometamol - 30 mg (ketorolac tromethamine);
• Auxiliary components: sodium chloride, disodium edetate (ethylenediamine-N, N, N ', N'-tetraacetic acid disodium salt 2-aqueous (Trilon B)), water for injection.

The composition of 1 ml of solution for intramuscular administration includes:

• Active ingredient: ketorolac trometamol - 30 mg;
• Auxiliary components: disodium edetate dihydrate (Trilon B), ethanol (ethyl alcohol in terms of anhydrous), propylene glycol, sodium chloride, sodium hydroxide (1M solution), water for injection.

The active ingredient is a part of 1 tablet: ketorolac tromethamine - 10 mg.

The composition of 1 film-coated tablet contains:

• Active ingredient: ketorolac trometamol - 10 mg (ketorolac tromethamine);
• Auxiliary components: lactose, potato starch, microcrystalline cellulose, calcium stearate, Opadry II.

The composition of 1 tablet, film-coated, includes:

• Active ingredient: ketorolac trometamol - 10 mg (ketorolac tromethamine);
• Auxiliary components: microcrystalline cellulose, magnesium stearate, talc, crospovidone (Kollidon CL), milk sugar (lactose monohydrate).

Shell composition: hydroxypropyl methylcellulose (hypromellose), titanium dioxide, talc, propylene glycol, macrogol 4000 (polyethylene oxide 4000, polyethylene glycol 4000).

Indications for use

Ketorolac is prescribed for moderate to severe pain syndrome, including trauma, toothache, pain in the postoperative period, cancer, myalgia, neuralgia, arthralgia, sciatica, rheumatic diseases, sprains, dislocations.

Ketorolac has no effect on the progression of the disease. The drug should be used only for symptomatic treatment, to reduce inflammation and pain at the time of use.

Contraindications

• Rhinitis, urticaria caused by taking non-steroidal anti-inflammatory drugs (in history);
• Full or partial combination of recurrent polyposis of the paranasal sinuses and nose and bronchial asthma with intolerance to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (including in history);
• Dehydration, hypovolemia (regardless of the cause that caused it);
• Intolerance to drugs of the pyrazolone series;
• Bleeding, high risk of their occurrence;
• Confirmed hyperkalemia;
• Condition after coronary artery bypass grafting;
• Erosive and ulcerative lesions of the gastrointestinal tract (with exacerbation), peptic ulcers;
• Inflammatory bowel disease;
• Hypocoagulation (including hemophilia);
• Severe renal failure (with creatinine clearance less than 30 ml per minute);
• Hemorrhagic stroke (suspected or confirmed);
• Active liver disease or severe liver failure;
• Violation of hematopoiesis;
• Hemorrhagic diathesis;
• Age up to 16 years (the effectiveness and safety of using the drug for this age group of patients have not been established);
• Pregnancy and the period of breastfeeding (lactation);
• Childbirth;
• Hypersensitivity to drug components and other non-steroidal anti-inflammatory drugs.

The drug should not be used to treat chronic pain.

Due to the high risk of bleeding, Ketorolac is not used as a means of supportive anesthesia, premedication, and pain relief before and during surgery (including obstetric practice).

Ketorolac should be used with caution in the following diseases / conditions:

• Arterial hypertension;
• Bronchial asthma;
• Chronic heart failure;
• Cholecystitis;
• Functional renal disorders (with plasma creatinine below 50 mg / l);
• Cholestasis;
• Sepsis;
• Active hepatitis;
• Systemic lupus erythematosus;
• Polyps of the mucous membrane of the nasopharynx and nose, simultaneous administration with other non-steroidal anti-inflammatory drugs;
• Cerebrovascular disease;
• The presence of factors that increase the toxicity of the gastrointestinal tract, including tobacco smoking and alcoholism;
• Edematous syndrome;
• Postoperative period;
• Hyperlipidemia / dyslipidemia;
• Cardiac ischemia;
• Peripheral artery disease;
• Diabetes;
• Creatinine clearance less than 60 ml per minute;
• History of ulcerative lesions of the gastrointestinal tract;
• Helicobacter pylori infection;
• Severe somatic diseases;
• Elderly age (over 65);
• Long-term use of non-steroidal anti-inflammatory drugs;
• Concomitant use of oral glucocorticosteroids (including prednisolone), antiplatelet agents (including clopidogrel), anticoagulants (including warfarin), selective serotonin reuptake inhibitors (including citalopram, paroxetine, fluoxetine, sertraline).

Method of administration and dosage

Ketorolac in tablet form is taken orally.

Depending on the severity of the pain syndrome, the drug is used once (at a dose of 10 mg) or repeatedly (10 mg up to 4 times a day).

The maximum daily dose is 40 mg.

Ketorolac solution is injected deeply intramuscularly or intravenously (jet) slowly (not less than 15 seconds) in the smallest effective doses, which are selected depending on the intensity of pain and the patient's response. If necessary, simultaneous use with opioid analgesics in reduced doses is possible.

Depending on the severity of the pain syndrome, an adult single dose with a single administration (intramuscular or intravenous) is 10-30 mg. Patients over 65 years of age or with functional impairment of the kidneys are usually prescribed 10-15 mg.

With repeated parenteral administration of Ketorolac, the following dosage regimens are used:

• Intramuscular injection: adults up to 65 years old and children from 16 years old - 10-60 mg in the first injection, then every 6 hours, 10-30 mg (usually 30 mg); elderly patients (from 65 years old) or with functional disorders of the kidneys - every 4-6 hours, 10-15 mg;
• Intravenous administration: adults up to 65 years old and children from 16 years old - 10-30 mg in a stream in the first injection, then - every 6 hours at 10-30 mg, the initial dose for continuous infusion using an infusion pump is 30 mg, then the infusion rate is 5 mg per hour; elderly patients (over 65 years old) or with functional disorders of the kidneys - every 6 hours, 10-15 mg in a stream.

The maximum daily dose of Ketorolac for intramuscular and intravenous administration is:

• Adults under 65 and children from 16 years old - 90 mg;
• Elderly patients (over 65 years old) or with functional disorders of the kidneys - 60 mg.

Continuous intravenous infusion should not last longer than 24 hours.

The duration of the course when taking Ketorolac orally and with parenteral administration should not exceed 5 days.

When switching from intramuscular and intravenous administration to taking Ketorolac inside, the total daily dose on the day of transfer should not be more:

• Adults under 65 and children from 16 years old - 90 mg;
• Elderly patients (over 65 years old) or with functional disorders of the kidneys - 60 mg.

Moreover, on the day of transition, the dose of the drug in the form of tablets should not exceed 30 mg.

Side effects

During the use of Ketorolac, it is possible to develop disorders on the part of some body systems, manifesting themselves with different frequencies (often -> 3%; less often - 1-3%; rarely - <1%):

• Central and peripheral nervous system: often - drowsiness, dizziness, headache; rarely - aseptic meningitis (including seizures, fever, severe headache, stiff back and / or neck muscles), hyperactivity (including anxiety, mood changes), depression, hallucinations, psychosis;
• Respiratory system: rarely - dyspnea, bronchospasm, pulmonary edema, rhinitis, laryngeal edema (including shortness of breath, difficulty breathing);
• Cardiovascular system: less often - increased blood pressure; rarely - fainting;
• Digestive system: often (especially in patients over 65 years of age with a history of erosive and ulcerative lesions of the gastrointestinal tract) - diarrhea, gastralgia; less often - flatulence, stomatitis, vomiting, constipation, feeling of fullness in the stomach; rarely - nausea, decreased appetite, erosive and ulcerative lesions of the gastrointestinal tract (including with bleeding and / or perforation - melena, abdominal pain, burning or cramping in the epigastric region, nausea, vomiting with blood or coffee-like thick”, heartburn), hepatomegaly, cholestatic jaundice, acute pancreatitis, hepatitis;
• The blood coagulation system: rarely - rectal and nose bleeding, bleeding from a postoperative wound;
• Hematopoietic system: rarely - eosinophilia, anemia, leukopenia;
• Urinary system: rarely - back pain, acute renal failure, azotemia, hematuria, hemolytic-uremic syndrome (renal failure, hemolytic anemia, purpura, thrombocytopenia), increased or decreased urine volume, increased urination, renal edema, nephritis;
• Skin: less common - purpura, skin rash (including maculopapular); rarely - exfoliative dermatitis (including fever with / without chills, redness, peeling or thickening of the skin, tenderness and / or swelling of the tonsils), Lyell's syndrome, Stevens-Johnson syndrome, urticaria;
• Sense organs: rarely - ringing in the ears, hearing loss, visual impairment (including blurred vision);
• Local reactions: less often - pain or burning at the injection site;
• Allergic reactions: rarely - anaphylactoid reactions or anaphylaxis (including discoloration of the face, skin rash, urticaria, dyspnea or tachypnea, itching of the skin, periorbital edema, swelling of the eyelids, shortness of breath, shortness of breath, wheezing, heaviness in the chest);
• Others: often - an increase in body weight, edema (including ankles, face, fingers, legs, feet); less often - increased sweating; rarely - fever, swelling of the tongue.

special instructions

With the simultaneous use of Ketorolac with other non-steroidal anti-inflammatory drugs, fluid retention, the development of cardiac decompensation, and arterial hypertension may occur.

To reduce the risk of developing gastropathies associated with the use of non-steroidal anti-inflammatory drugs, misoprostol, antacids, omeprazole are prescribed.

The effect on platelet aggregation after the use of Ketorolac lasts for 24-48 hours.

Hypovolemia increases the risk of side effects from the kidneys.

Simultaneously with paracetamol, Ketorolac should not be used for more than 5 days.

For patients with blood clotting disorders, the drug is prescribed only with constant monitoring of the platelet count, especially in the postoperative periods, requiring careful control of hemostasis.

Due to the fact that a significant part of patients during therapy develop side effects from the central nervous system (headache, dizziness, drowsiness), performing work that requires high attention and quick reactions (working with mechanisms, driving vehicles) is not recommended.

Drug interactions

With the simultaneous use of Ketorolac with some drugs, undesirable effects may occur:

• Acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs, glucocorticosteroids, calcium preparations, ethanol, corticotropin: ulceration of the gastrointestinal tract and the development of gastrointestinal bleeding;
• Paracetamol: increased nephrotoxicity;
• Methotrexate: increased hepato- and nephrotoxicity (simultaneous administration is possible only when used in low doses while controlling the concentration in the blood plasma);
• Methotrexate, lithium: decreasing their clearance and increasing toxicity;
• Indirect anticoagulants, heparin, thrombolytics, antiplatelet agents, cefoperazone, cefotetan and pentoxifylline: increased risk of bleeding;
• Probenecid and drugs that block tubular secretion: a decrease in the clearance of Ketorolac and an increase in its concentration in blood plasma;
• Antihypertensive and diuretic drugs: reducing their effect;
• Opioid analgesics: increasing their action (doses can be significantly reduced);
• Insulin and oral hypoglycemic drugs: increased hypoglycemic action (dose recalculation is necessary);
• Valproic acid: violation of platelet aggregation;
• Verapamil, nifedipine: increasing their concentration in blood plasma;
• Other nephrotoxic drugs (including gold preparations): increased risk of nephrotoxicity;
• Myelotoxic drugs: increased manifestation of drug hematotoxicity.

Ketorolac in the form of a solution for injection should not be mixed in one syringe with morphine sulfate, hydroxyzine and promethazine (due to precipitation).

Ketorolac is pharmaceutically incompatible with lithium preparations and tramadol solution; compatible with 5% dextrose (glucose) solution, 0.9% sodium chloride solution, Plasmalit solution, Ringer's lactate and Ringer's solution, as well as with infusion solutions containing aminophylline, lidocaine hydrochloride, dopamine hydrochloride, short-acting human insulin and heparin sodium salt.

Analogs

Analogues of Ketorolac are: Dolak, Ketanov, Ketorol, Ketorolac-Credopharm, Ketonort, Ketofril.

Terms and conditions of storage

Store in a dark, dry place out of reach of children at temperatures up to 25 ° C.

Shelf life:

• Tablets - 3 years;
• Solution for intravenous and intramuscular administration - 2 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Ketorolac: prices in online pharmacies

Drug name Price Pharmacy

Ketorolac 10 mg film-coated tablets 10 pcs. RUB 17 Buy

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Ketorolac 10 mg film-coated tablets 20 pcs. RUB 29 Buy

Ketorolac tablets p.p. 10mg 20 pcs. 35 RUB Buy

Ketorolac (for injection) 30 mg / ml solution for intravenous and intramuscular administration 1 ml 10 pcs. RUB 49 Buy

Ketorolac (for injection) 30 mg / ml solution for intravenous and intramuscular administration 1 ml 10 pcs. RUB 50 Buy

Ketorolac (for injection) 30 mg / ml solution for intramuscular administration 1 ml 10 pcs. RUB 51 Buy

Ketorolac (for injection) 30 mg / ml solution for intravenous and intramuscular administration 1 ml 10 pcs. RUB 53 Buy

Ketorolac 10 mg film-coated tablets 20 pcs. RUB 56 Buy

Ketorolac (for injection) 30 mg / ml solution for intravenous and intramuscular administration 1 ml 10 pcs. RUB 62 Buy

Ketorolac solution for intravenous and intramuscular injection. 30mg / ml apm. 1ml 10 pcs. RUB 68 Buy

Ketorolac (for injection) 30 mg / ml solution for intramuscular administration 1 ml 10 pcs. 77 RUB Buy

Ketorolac solution for intravenous and intramuscular injection. 30mg / ml amp. 1ml 10 pcs. RUB 81 Buy

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Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!