Rativol

Ketorolac trometamol.

Each film-coated tablet contains: Ketorolac Trometamol 10 mg.

Pharmacology: Ketorolac Trometamol is a potent analgesic agent of the non-steroidal anti-inflammatory class (NSAID). It performs by inhibiting prostaglandin biosynthesis and inhibiting cyclooxygenase enzyme. Administrations of Ketorolac Trometamol per oral, i.m. or i.v. are not distributed widely. More than 99% Ketorolac bound on plasma protein but not irreversible bound to ocular tissue. Approximately 90% of Ketorolac is excreted through urine in permanent form and less Ketorolac and its metabolite are excreted through feces.

Ketorolac Trometamol is indicated for the short-term management (therapy is not exceed 5 days) of moderate acute post-operative pain.

Ketorolac tablets are not recommended for chronic use.
The recommended oral dosage is 10 mg every 4-6 hours for pain as needed. A total daily dose is 40 mg/day should not be exceeded. Long Interval dosage 6-8 hours, recommended for elderly patients. Low dosage recommended for patients with age over 60 years.
Kidney disorder: Ketorolac Trometamol and its metabolites are excreted in the kidney. Ketorolac is contraindicated moderate to severe renal impairment (serum creatinine > 160 μmol/L); patients with mild kidney disorder can receiving the lower dose and kidney condition should be monitored.

There is no experience of acute overdose, so the character of the sequelae and effectiveness assessment of the antidote cannot be determined. On gastroscopic examination in healthy individual who received 350 mg at intervals of 8 hours five days in a row (three times the highest recommended dose) Ketorolac caused abdominal pain and peptic ulcer was healed after the dose had been stopped.

A history of active peptic ulceration or gastrointestinal bleeding.
Suspected or confirmed cerebrovascular bleeding.
Haemorrhagic diatheses including coagulation disorders.
Hypersensitivity to Ketorolac Trometamol or other NSAIDs and those patients in whom Acetosal or other prostaglandin synthesis inhibitors induce allergic reactions.
The complete or partial syndrome of nasal polyps, angioedema or bronchospasm.
Concurrent treatment with other NSAIDs, Oxpentifylline, Probenecid or Lithium salts.
Hypovolaemia from any cause or dehydration.
A history of asthma.
Patients who have had operations with a high risk of haemorrhage or incomplete haemostasis.
Patients on anticoagulants including low dose heparin (2500-5000 units twelve hourly).
During pregnancy, labour, delivery or lactation.
Children under 16 years of age.
Ketorolac Trometamol is contraindicated in patients currently receiving Acetosal.
Moderate or severe renal impairment (serum creatinine > 160 μmol/L).
Neuraxial (epidural or intrathecal) administration.
Prophylactic administration before major surgery or intraoperatively when haemostasis is critical because of the increased risk of bleeding.

Ketorolac Trometamol can cause gastrointestinal irritation, ulcers, perforation or bleeding with or without previous symptoms and should be given under close supervision to patients with a history of gastrointestinal tract disease.
The use of drugs which inhibits prostaglandin synthesis might be expected to further decrease renal blood flow. Caution is advised if Ketorolac Trometamol is used in such circumstances. Close monitoring of urine output, serum urea and serum creatinine is recommended until the patient is normovolaemic.
Inhibits platelet aggregation and may prolong bleeding time. It does not change the thromboses amount, Prothrombin Time (PT), and Partial Thromboplastin Time (PTT).
Borderline elevations of one or more liver tests may occur. These abnormalities may progress, may remain unchanged or may be transient with discontinued therapy. Patients with impaired hepatic function from cirrhosis do not have any clinically important changes in Ketorolac clearance. Ketorolac Trometamol is not recommended for use as a pre-operative medication, for support of anesthesia or in obstetrical analgesia.
It is not recommended that Ketorolac Trometamol used with other non-steroidal anti-inflammatory drugs, because of potential for additive side effects.
Renal function should be monitored in patients who have had more than a single i.m. dosage of Ketorolac, particularly in elderly patients.
Fluid retention and oedema have been reported with the use of Ketorolac Trometamol therefore, it should be used with caution in patients with cardiac decompensation, hypertension or similar conditions.
Ketorolac Trometamol is not recommended during pregnancy, labour, or delivery.
Ketorolac Trometamol is not recommended for treatment of nursing mother. Secretion of Ketorolac in human milk after ingestion of Ketorolac is limited.
Ketorolac Trometamol is not recommended for use in children under 16 years of age because of safety and efficacies in children have not been established.
Patients over 65 years may be at greater risk than younger patients for adverse events. This age related risk is common to drugs that inhibit prostaglandin synthesis. The lowest effective dose should be used in elderly patients.

Ketorolac Trometamol is not recommended during pregnancy, labour, or delivery.
Ketorolac Trometamol is not recommended for treatment of nursing mother. Secretion of Ketorolac inhuman milk after ingestion of Ketorolac is limited.

Gastrointestinal tract: abdominal discomfort, constipation, diarrhea, dyspepsia, eructation, flatulence, fullness, gastritis, gastrointestinal bleeding, gastrointestinal pain, nausea, pancreatitis, peptic ulcer, perforation, stomatitis, vomiting, melaena, rectal bleeding, haemorrhage.
Central nervous/musculoskeletal system: abnormal dreams, abnormal taste and vision, abnormal thinking, aseptic meningitis, convulsions, depression, dizziness, drowsiness, dry mouth, euphoria, excessive thirst, functional disorders, hallucinations, headache, hearing loss, hyperkinesias, insomnia, myalgia, nervousness, paresthesia, stimulation, sweating, vertigo, anxiety.
Urinary tract and kidney: acute renal failure, flank pain (with or without haematuria), glomerular nephritis, haemolytics uremic syndrome, hyperkalemia, hyponatremia, increased urinary frequency, interstitial nephritic, nephritic syndrome, oliguria, raised serum urea and creatinine, renal papillary necrosis, urinary retention.
Cardiovascular/haematological system: bradycardia, flushing, hypertension, pallor, purpura, thrombocytopenia, palpitation, chest pain.
Respiratory system: asthma, dyspnea, pulmonary oedema.
Skin: exfoliative dermatitis, Lyell's syndrome, maculopapular rash, pruritus, Stevens-Johnson syndrome, urticaria.
Hypersensitivity reactions: anaphylaxis, bronchospasm, flushing and rash, hypotension, laryngeal oedema.
Bleeding: epistaxis, haematomata, post-operative wound haemorrhage, increased bleeding time.
Other: abnormal liver function tests, asthenia, oedema, injection site pain, weight gain, hepatitis, liver failure, fever.

Ketorolac is highly bound to human plasma protein, it will influence other drugs bound with plasma protein but not to influence plasma therapeutic from Digoxin, Warfarin, Ibuprofen, Naproxen, Acetaminophen, Phenytoin, Tolbutamide, or Piroxicam.
Although there is no significant interaction between Ketorolac and anticoagulant drug (i.e. Heparin, Warfarin), the administration of Ketorolac should be carefully and closely monitored.
Concomitantly use of Ketorolac Trometamol and Methotrexate should be used with caution since some prostaglandin synthesis inhibiting drugs have been reported to reduce the clearance of Methotrexate, and thus possibly enhance the toxicity of Methotrexate.
Concomitantly use of Ketorolac Trometamol with ACE inhibitor and other NSAIDs might raise the risk of renal disorder, especially in dehydrated patients.
Ketorolac Trometamol reduces the diuretic response to Furosemide in normovolaemic healthy subjects by approximately 20%.
Sporadic cases of seizures have been reported during concomitant use of Ketorolac and antiepileptic drugs (Phenytoin, Carbamazepine).
Hallucination has been reported when Ketorolac Trometamol was used in patients taking psychoactive drugs.
Concomitantly use of Ketorolac Trometamol with Acetosal or other NSAIDs might worsen the adverse reactions.
Concomitantly use of Ketorolac Trometamol with Lithium and Methotrexate will prolong Lithium and Methotrexate clearance through kidney.
Concomitantly use of Ketorolac Trometamol with probenecid will reduce Ketorolac elimination in kidney that will increase Ketorolac assay.
Ketorolac ampoules are compatible with normal saline, 5% dextrose, Ringer's solution, Ringer lactate solution, or Plasmalyte solution.

Store below 30°C.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

M01AB15 - ketorolac ; Belongs to the class of acetic acid derivatives and related substances of non-steroidal antiinflammatory and antirheumatic products.

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