2 October

Ketorolac - instructions for use , indications, dosage

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

release form and composition

Ketorolac is available in the following dosage forms:

  • solution for intravenous and intramuscular administration: yellowish, transparent (1 ml ampoules, 5, 10 vials in trays 1 or 2 palletcardboard bundle; 2 ml glass vials in the dark at 10 ampoules in a cardboard bundle);
  • solution for intramuscular injection: clear, pale yellow (1 ml ampoules, 5 vials in trays by 1 or 2 of the pallet in a cardboard bundle either 5 or 10 vials in a carton box, 2 mL in dark glassampoules of 10 vials in a cardboard bundle);
  • Tablets (10 pcs in blisters, 1, 2, 5, 10 packs per carton box;. 20 pieces in blisters, 1 package in carton box;. 25 pieces in blisters.at 2, 4 packs in a carton box, 10 pieces in plastic cans, 1 bank in a carton box).;
  • coated tablets: white, lenticular (10 pieces in blisters, 1-3, 5 packs per carton box.);
  • tablets, film-coated: biconvex, round, off-white, or white;in cross section two lay
    ers are visible (10 pieces in blisters at 1-5, 10 packs per carton box;. 20, 100 units in the banks, and 1 bank in a carton box.).

The composition 1 ml solution for intravenous and intramuscular injection include:

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

The composition 1 ml solution for intramuscular injection include:

  • Active substance: ketorolac trometamol - 30 mg;
  • Auxiliary components: disodium edetate dihydrate (Trilon B), ethanol (ethyl alcohol, based on the anhydrous), propylene glycol, sodium chloride, sodium hydroxide (1M), water for injection.

The composition 1 tablet includes the active substance: ketorolac tromethamine - 10 mg.

In part 1 coated tablet include:

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

The composition 1 tablet, film-coated, includes:

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

shell composition: hydroxypropylmethylcellulose (hypromellose), titanium dioxide, talc, propylene glycol, macrogol 4000 (polyethylene 4000, polyethylene glycol 4000).

Indications

Ketorolac is prescribed for pain syndrome of moderate to severe severity, including injuries, toothache, pain in the postoperative period, cancer, myalgia, neuralgia, arthralgia, sciatica, rheumatism,sprains, dislocations.

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

Contraindications

  • rhinitis, urticaria, caused by the use of nonsteroidal anti-inflammatory drugs (in history);
  • Full or partial combination of recurrent polyposis, paranasal sinuses and nasal and bronchial asthma intolerant of aspirin or other nonsteroidal anti-inflammatory drugs (including history);
  • dehydration, hypovolemia (regardless of the reason, it caused);
  • intolerance drugs pirazolonovogo series;
  • bleeding, a high risk of their occurrence;
  • Confirmed hyperkalemia;
  • condition after coronary artery bypass surgery;
  • erosive and ulcerative lesions of the gastrointestinal tract (during exacerbation), peptic ulcers;
  • Inflammatory bowel disease;
  • Hypocoagulation (including hemophilia);
  • Severe renal insufficiency (with creatinine clearance less than 30 mL per minute);
  • hemorrhagic stroke (suspected or confirmed);
  • active liver disease or severe hepatic impairment;
  • hemodyscrasia;
  • hemorrhagic diathesis;
  • age of 16 years (effectiveness and safety of the drug for patients in this age group have not been established);
  • Pregnancy and breast-feeding (lactation);
  • Genera;
  • hypersensitivity to the drug and other nonsteroidal anti-inflammatory drugs.

For the treatment of chronic pain, the drug should not be used.

Due to the high risk of bleeding Ketorolac is not used as a means for supporting the anesthesia, sedation and analgesia prior to and during surgery (including obstetric practice).

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

  • Hypertension;
  • Bronchial asthma;
  • Chronic heart failure;
  • cholecystitis;
  • functional renal impairment (with serum creatinine less than 50 mg / l);
  • cholestasis;
  • Sepsis;
  • active hepatitis;
  • Systemic lupus erythematosus;
  • polyps of the mucous membrane of the nose and nasopharynx, concomitant use with other nonsteroidal anti-inflammatory drugs;
  • Cerebrovascular disease;
  • presence of factors that increase the toxicity of the gastrointestinal tract, including tobacco and alcohol;
  • edema syndrome;
  • postoperative period;
  • hyperlipidemia / dyslipidemia;
  • Coronary heart disease;
  • Peripheral Arterial Disease;
  • Diabetes;
  • creatinine clearance less than 60 ml per minute;
  • ulcerative lesions of the gastrointestinal tract in history;
  • infection Nelisobacter pylori;
  • Severe somatic diseases;
  • Older age (over 65 years);
  • Prolonged use of nonsteroidal anti-inflammatory drugs;
  • Simultaneous use of oral corticosteroids (including prednisone), antiplatelet agents (including clopidogrel), anticoagulants (including warfarin), selective inhibitors of serotonin reuptake (including citalopram, paroxetine, fluoxetine, sertraline).

Dosage and Administration

Ketorolac in the form of tablets taken by mouth.

Depending on the severity of pain medication used once (10 mg) or recycled (10 mg up to 4 times a day).

maximum daily dose - 40 mg.Ketorolac

solution was injected deep intramuscularly or intravenously (bolus) slowly (at least 15 seconds) in the smallest effective dose, which is selected depending on the intensity of the pain and the patient's response.If necessary, possible simultaneous use of opioid analgesics in small doses.

Depending on the severity of pain adult unit dose in a single administration (intramuscular or intravenous) is 10-30 mg.Patients older than 65 years or with renal functional disorders are usually given 10-15 mg.

Repeated parenteral administration of Ketorolac use the following dosing regimens:

  • Intramuscular: Adults up to 65 years and children from 16 years - 10-60 mg in the first introduction, and then - every 6 hours at 10-30 mg (usually - on30 mg);elderly patients (65 years) or functional renal impairment - every 4-6 hours for 10-15 mg;
  • Intravenous: adults up to 65 years and children from 16 years - 10-30 mg bolus in the first administration, then - every 6 hours at 10-30 mg starting dose for continuous infusion using infusomats - 30 mg, then the infusion rateis 5 mg per hour;elderly patients (65 years) or functional renal impairment - every 6 hours bolus of 10-15 mg.

maximum daily dose of Ketorolac intramuscular and intravenous administration is:

  • Adults up to 65 years and children aged 16 - 90 mg;
  • elderly patients (65 years) or functional disorders of the kidneys - 60 mg.

continuous intravenous infusion should not last longer than 24 hours.

Duration of the course while taking Ketorolac inside and parenteral administration must not be longer than 5 days.

In the transition from intramuscular and intravenous administration to receive Ketorolac into the total daily dose per day of translation should not be more than:

  • Adults up to 65 years and children aged 16 - 90 mg;
  • elderly patients (65 years) or functional disorders of the kidneys - 60 mg.

In the transition day dose in tablet form should not exceed 30 mg.

Side effects

During ketorolac may develop disorders of some systems of the body that are manifested at different rates (often - & gt; 3%, less often - 1-3%, rarely -

  • central and peripheral nervous system:often - drowsiness, dizziness, headache, rarely - aseptic meningitis (including cramps, fever, severe headache, stiffness in the muscles of the back and / or neck), hyperactivity (including anxiety, mood changes), depression, hallucinations, psychosis;
  • Respiratorysystem: 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 inpatients older than 65 years with erosive and ulcerative lesions of the gastrointestinal tract in history) - diarrhea, gastralgia;less frequently - flatulence, stomatitis, vomiting, constipation, feeling of fullness;rarely - nausea, loss of appetite, erosive and ulcerative lesions of the gastrointestinal tract (including bleeding and / or perforation - melena, abdominal pain, burning sensation or spasms in the epigastric region, nausea, vomiting of blood, or of the type "coffeegrounds ", heartburn), hepatomegaly, cholestatic jaundice, acute pancreatitis, hepatitis;
  • blood coagulation system: rarely - rectal and nasal bleeding, bleeding from the surgical wound;
  • hemopoiesis system: seldom - eosinophilia, anemia, leukopenia;
  • urinary system: rarely - back pain, acute renal failure, azotemia, hematuria, hemolytic-uremic syndrome (renal failure, hemolytic anemia, purpura, thrombocytopenia), increase or decrease the amount of urine, frequent urination, swelling of renal genesis, jade;
  • Skin: less often - purpura, skin rash (including maculopapular);rarely - exfoliative dermatitis (including fever with / without fever, redness, peeling, or thickening of the skin, pain and / or swelling of the tonsils), Lyell's syndrome, Stevens-Johnson syndrome, urticaria;
  • Senses: rarely - ringing in the ears, hearing loss, visual disturbances (including blurred vision);
  • Local reactions: less often - pain or burning at the injection site;
  • Allergic reactions: rare - anaphylactoid reactions, or anaphylaxis (including changes in skin color, skin rash, urticaria, dyspnea or tachypnea, itchy skin, periorbital edema, swelling of the eyelids, difficulty breathing, shortness of breath, wheezing, heaviness in the chest);
  • Other: often - weight gain, edema (including ankles, face, fingers, legs, feet);less often - sweating;rarely - fever, swelling of the tongue.

Cautions

Simultaneous ketorolac with other NSAIDs may experience fluid retention, development of cardiac decompensation, hypertension.

To reduce the risk of gastropathy associated with NSAIDs, misoprostol, antacids, omeprazole.

Effect on platelet aggregation after application Ketorolac is maintained for 24-48 hours.

Hypovolaemia increases the risk of side effects in the kidneys.

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

patients with impaired blood clotting drug is prescribed only under the constant control of the number of platelets, especially in the postoperative period, requiring careful hemostasis control.

Due to the fact that a significant proportion of patients during therapy develop side effects in the central nervous system (headache, dizziness, drowsiness) perform activities requiring alertness and quick reactions (work with mechanisms, vehicle driving), notrecommended.

Drug Interactions

With simultaneous use of Ketorolac with some medicines may occur undesirable effects:

  • acetylsalicylic acid or other non-steroidal anti-inflammatory drugs, steroids, calcium supplements, ethanol, corticotropin: ulceration of the gastrointestinal tract and the development of gastrointestinalbleeding;
  • Paracetamol: increased nephrotoxicity;
  • Methotrexate: increased hepato-and nephrotoxicity (simultaneous reception is possible only when it is used in low doses in controlling plasma concentration);
  • methotrexate, lithium: a decrease in their clearance and increased toxicity;
  • Indirect anticoagulants, heparin, thrombolytics, antiplatelet agents, ceftazidime, tsefotetan and pentoxifylline: increased risk of bleeding;
  • Probenecid and drugs that block tubular secretion: Ketorolac decrease clearance and increase its concentration in blood plasma;
  • Antihypertensive and diuretic drugs: reduction of their effect;
  • Opioid analgesics: strengthening their actions (the dose can be significantly reduced);
  • insulin and oral hypoglycemic agents: increased hypoglycemic action (requires recalculation of dose);
  • valproic acid: violation of platelet aggregation;
  • verapamil, nifedipine: increasing their concentration in plasma;
  • other nephrotoxic drugs (including gold preparations): increased risk of nephrotoxicity;
  • myelotoxicity drugs: increased expression gematotoksichnosti drug.

Ketorolac as a solution for injection mixed in the same syringe with morphine sulfate, Hydroxyzine and promethazine should not be (due to precipitation).

Ketorolac pharmaceutically incompatible with drugs lithium and sodium tramadol;compatible with 5% dextrose (glucose), 0.9% sodium chloride solution "Plazmalit" Ringer's solution and lactated Ringer's, as well as infusion solutions containing aminophylline, lidocaine hydrochloride, dopamine hydrochloride, human insulin and rapid-actingheparin sodium salt.

Terms and conditions of storage

Store in a dark, dry place inaccessible to children at temperature up to 25 ° C.

Shelf life:

  • Tablets - 3 years;
  • solution for intravenous and intramuscular injection - 2 years.

Latest Blog Post

Sab Simplex - instruction , use of neonatal reviews
October 09, 2016

Sab simplex - the pharmacological action of the drug with a carminative, used even in infants. composition and the form of release According ...

Rowan Common - useful properties, application , composition
October 09, 2016

Sorbus aucuparia - a deciduous tree belonging to the family Rosaceae. Description This small tree can reach a height of 15 m, it has a dense ...

Fish oil - instructions for use , benefit , reviews
October 09, 2016

Fish oil - the drug of animal origin, provider A and D-vitamin and lipid-lowering effect. Pharmacological action active ingredients Fish Oil ...