Index
It is a non-steroidal anti-inflammatory drug (NSAID) with a pronounced analgesic, antipyretic effect.
Tromethamine is also called ketorolac tromethamine because of its active principle.
Form of issue and composition
Coated tablets: 10 pcs. in blisters, in a cardboard pack of 1, 2, 3 or 10 blisters.
Solution for intramuscular (IM) administration: 1 ml in ampoules, in a cardboard pack of 5 or 10 ampoules.
The active substance of the drug is ketorolac tromethamine: 1 tablet – 10 mg, in 1 ml of the solution – 30 mg.
Auxiliary components of tablets: microcrystalline cellulose, corn starch, magnesium stearate, silicon dioxide colloid.
The composition of the tablet film coating: polyethylene glycol 400, titanium dioxide, hydroxypropylmethylcellulose, talc and purified water, which is lost during production.
Additional components of the solution: disodium edetate, sodium chloride, sodium hydroxide, ethanol and water for injection.
Indications for use
Tromethamine is intended for arrest of a pain syndrome of various genesis of average and strong intensity, including in cancer and the postoperative period .
Contraindications
- Chronic pain.
- Peptic ulcers, exacerbation of erosive ulcerative lesions of the gastrointestinal tract (GIT).
- Hypocoagulation (including hemophilia).
- Hemorrhagic stroke or suspicion of its presence.
- Hemorrhagic diathesis.
- Hematopoiesis disorder.
- High risk of developing or recurring bleeding (even in the postoperative period).
- Hepatic / renal failure (with plasma creatinine greater than 50 mg / l).
- Anesthesia before surgery and during surgery (due to the high risk of bleeding).
- Simultaneous reception of other NSAIDs.
- Children under 16 years of age (due to lack of data on efficacy and safety of use).
- Pregnancy, childbirth and lactation period.
- Dehydration, hypovolemia (regardless of the cause).
- Hypersensitivity to ketorolac.
- Auxiliaries or other NSAIDs.
- Angioedema.
- Broncoespasmo.
Special observation is required during treatment in the following cases:
- Age over 65 years.
- Active hepatitis.
- Arterial hypertension.
- Chronic heart failure
- Cholecystitis.
- Cholestasis
- Impaired kidney function (if plasma creatinine is less than 50 mg / l).
- Polyps of the nasal mucosa and nasopharynx.
- Systemic lupus erythematosus.
- Bronchial asthma.
- Septicemia.
Dosage and administration
In the form of tablets, the drug is taken orally. A single dose is 10 mg (1 tablet). If necessary, repeated administration designates 1 tablet up to 4 times a day, depending on the severity of the pain syndrome.
The maximum duration of admission is 5 days.
The solution is administered intramuscularly in minimally effective doses, which are selected individually taking into account the intensity of the pain syndrome and the effectiveness of the drug.
Recommended single doses
Patients under 65 years of age – 10-30 mg.
Patients over 65 years of age and patients with kidney failure – 10-15 mg.
If it is necessary to repeatedly use the drug between injections, intervals of 4-6 hours are observed.
The course of treatment is no more than 5 days.
Maximum daily doses allowed for IV administration
For patients under 65 years – 90 mg, for patients over 65 years and for patients with renal dysfunction 60 mg.
When transferring a patient from parenteral drug administration to oral administration, the total daily dose of both dosage forms must be taken into account. On the day of transition, the tablet dose should not exceed 30 mg.
Side effects
Undesirable reactions are classified as follows:
- Often more than 3% of patients.
- Less often – 1-3%.
- Rarely less than 1%.
Possible side effects
The digestive system – often manifested (especially in people over 65 years of age, in whose anamnesis there are indications of erosive and ulcerative lesions of the digestive tract):
- Diarrhea.
- Gastralgia less frequently.
- Flatulence.
- Overflow sensation of the stomach.
- Vomiting
- Constipation.
- Estomatitis.
- Rarely erosive lesions.
- Ulcers of the gastrointestinal tract (including bleeding and / or perforation – burning or spasm in the epigastric region, abdominal pain, heartburn, nausea, vomiting, etc).
- Sickness.
- Hepatitis.
- Acute pancreatitis.
- Cholestatic jaundice.
- Hepatomegalia.
Urinary system
It may rarely include:
- Frequent urination
- Edema of renal genesis.
- Nephritis, increased or decreased volume of urine.
- Hemolytic uremic syndrome (hemolytic anemia, purpura, thrombocytopenia, kidney failure).
- Back pain (including hematuria and / or azotemia).
- Acute renal failure.
Central Nervous System
It often includes:
- Drowsiness.
- Dizziness and headache
- Rarely hyperactivity (anxiety, mood swings).
- Hallucinations
- Psychosis.
- Depression.
- Aseptic meningitis (severe headache, fever, stiffness of the back and / or neck muscles, seizures).
Cardiovascular system
It can occur less frequently:
- Increased blood pressure.
- Rarely syncope, pulmonary edema.
Respiratory system
It rarely includes:
- Rhinitis.
- Dyspnea or bronchospasm
- Laryngeal edema : shortness of breath and shortness of breath.
Sensory organs
It can rarely include:
- Ringing in the ears.
- Hearing loss.
- Visual impairment (including blurred vision).
- Hemopoyesis : rarely eosinophilia, anemia, leukopenia.
Special instructions
It is not recommended for use as an anesthetic in obstetric practice, as well as for premedication and maintenance anesthesia.
In hypovolaemic patients, the incidence of kidney adverse reactions is increased.
The drug can be prescribed in combination with narcotic pain relievers (in reduced doses).
Do not take tromethamine simultaneously with acetaminophen for more than 5 days.
Drug interactions
When the use of ketorolac is combined with ethanol, glucocorticosteroids, corticotropin, calcium preparations, acetylsalicylic acid or other NSAIDs, the formation of gastrointestinal ulcers and the development of gastrointestinal bleeding is possible.
The risk of bleeding also increases indirect anticoagulants:
- Antiagregantes.
- Thrombolytics.
- Heparin.
- Pentoxifilina.
- Cefotetan.
- Cefoperazona.
When applied simultaneously with paracetamol and other nephrotoxic agents (even with gold preparations), nephrotoxicity increases, with lithium and methotrexate, nephro and hepatotoxicity.
The combination of ketorolac with methotrexate is possible only with the appointment of lower doses of the latter, while in the course of treatment it is necessary to monitor its concentration in the blood plasma.
The combination of ketorolac tromethamine with sodium valproate leads to impaired platelet aggregation.
Probenicid and drugs that block tubular secretion, reduce the plasma clearance of ketorolac and increase its concentration in plasma.
The drug increases the effect of oral hypoglycemic agents and insulin, requiring a recalculation of their doses.
Ketorolac reduces the effectiveness of diuretic and antihypertensive drugs, increases the concentration in the blood plasma of nifedipine and verapamil.
Antacids do not affect the absorption of ketorolac.
The solution for injection cannot be mixed in a syringe with hydroxyzine, promethazine, and morphine sulfate, tk.
Ketorolac is pharmaceutically incompatible with lithium preparations and tramadol solution.
Ketorolac injection solution is compatible with 5% dextrose, Plasmalitis, Ringer, Ringer-lactate solutions and also with infusion solutions containing heparin, sodium salt, dopamine hydrochloride, lidocaine hydrochloride, aminophylline and human insulin of action. short.
Terms and conditions of storage
- Store at temperatures up to 25 ° C in a place protected from light, dry and out of the reach of children.
- Shelf life: 3 years
