Ketonic® is a potent analgesic agent of the non-steroidal anti-inflammatory drugs (NSAID) class. Its mode of action is to inhibit the cyclo-oxygenase enzyme system and hence prostaglandin synthesis and it demonstrates a minimal anti-inflamatory effect at its analgesic dose.

Adult Patients: Ketonic® is indicated for the short-term management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Therapy should always be initiated with Ketonic® IV/IM, and tablet ketorolac is to be used only as continuation treatment, if necessary. Combined use of Ketonic® IV/IM and tablet is not exceeding 5 days of use because of the potential of increasing the frequency and severity of adverse reaction associated with the recommended doses.
Paediatric patients: The safety and effectiveness of single dose of Ketonic® IV/IM have been established in paediatric patients between the ages of 2 and 16 years. Ketorolac as a single injectable dose has been shown to be effective in the management of moderately severe acute pain that requires analgesia at the opioid level, usually in the postoperative setting. Safety and effectiveness have not been established in paediatric patients below the age of 2 years.
 

Ketonic® Injection:
Adult patients < 65 years of age: The recommended initial dose of Ketonic® is 10 mg, followed by 10 to 30 mg every four to six hours as required. In the initial post-operative period, Ketonic® may be given as often as every two hours if needed. The lowest effective dose should be given. A total daily dose of 90 mg for non-elderly and 60 mg for the elderly, renal impaired patients and patients less than 50 kg should not be exceeded. The maximum duration of treatment should not exceed two days. Reduce dosage in patients under 50 kg.
Patients > 65 years of age: For patients over 65 years, the lower end of the dosage range is recommended; a total daily dose of 60 mg should not be exceeded.
Paediatric patients (2-16 years):
IM Dosing: a single dose of 1 mg/kg up to a maximum of 30 mg.
IV Dosing: a single dose of 0.5 mg/kg up to a maximum of 15 mg.
Transition from Ketonic® Injection to Ketonic® tablet:
Ketonic® tablet should only be administered as a continuation therapy to Ketonic® IV/IM for the management of moderately severe acute pain that requires analgesia at the opioid level.
Adult patients <65 years of age: 2 tablets as a first oral dose for patients who received 60 mg IM single dose, 30 mg IV single dose or 30 mg multiple doses. Ketonic® IV/IM followed by 1 tablet every 4 to 6 hours, not to exceed 40 mg/24 hours of tablet ketorolac tromethamine.
Patients > 65 years of age: 1 tablet as a first oral dose for patients who received 30 mg IM single dose, 15 mg IV single dose or 15 mg multiple dose. Ketonic® IV/IM followed by 1 tablet every 4 to 6 hours, not to exceed 40 mg/24 hours of tablet ketorolac tromethamine.
 

Ketorolac tromethamine is contraindicated:
In patients with active peptic ulcer disease, recent gastrointestinal bleeding or perforation and in patients with a history of peptic ulcer disease or gastrointestinal bleeding.
In patients with advanced renal impairment or in patients at risk for renal failure due to volume depletion.
In labor and delivery because, through its prostaglandin synthesis inhibitory effect, it may adversely affect fetal circulation and inhibit uterine contractions, thus increasing the risk of uterine hemorrhage.
In nursing mothers because of the potential adverse effects of prostaglandin-inhibiting drugs on neonates.
In patients with previously demonstrated hypersensitivity to ketorolac, allergic manifestations to aspirin or other nonsteroidal antiinflammatory drugs (NSAIDs).

As prophylactic analgesic before any major surgery and is contraindicated intraoperatively when hemostasis is critical because of the increased risk of bleeding.
 

As with other drugs known to inhibit prostaglandin synthesis, use of it should be avoided in late pregnancy because it may cause premature closure of the ductus arteriosus. There are no adequate and well-controlled studies of Ketorolac in pregnant women. Ketorolac should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Because of the possible adverse effects of prostaglandin-inhibiting drugs on neonates, use in nursing mothers is contraindicated.
 

Body as a Whole: edema, weight gain, fever, asthenia, hypersensitivity reactions such as anaphylaxis, anaphylactoid reaction, laryngeal edema and tongue edema.
Cardiovascular: hypertension, palpitation, pallor, syncope, hypotension, flushing.
Dermatologic: pruritus, rash, urticaria, Lyell's syndrome, Stevens-Johnson syndrome, exfoliative dermatitis and maculopapular rash.
Gastrointestinal: nausea, dyspepsia, gastrointestinal pain, diarrhoea, constipation, flatulence, fullness of stomach, vomiting, stomatitis, gastritis, rectal bleeding, anorexia, peptic ulceration, GI hemorrhage, GI perforation, melena, acute pancreatitis, hematemesis, esophagitis.
Hemic and Lymphatic: purpura, epistaxis, anemia, eosinophilia, postoperative wound hemorrhage, thrombocytopenia, leukopenia.
Nervous System: headache, drowsiness, dizziness, tremors, abnormal dreams, hallucinations, euphoria, extrapyramidal symptoms, vertigo, paresthesia, depression, insomnia, nervousness, excessive thirst, dry mouth, abnormal thinking, inability to concentrate, hyperkinesis, stupor, convulsions, psychosis, aseptic meningitis.
Respiratory: dyspnea, pulmonary edema, rhinitis, cough, asthma, bronchospasm.
Urogenital: hematuria, proteinuria, oliguria, urinary retention, polyuria, increased urinary frequency, acute renal failure, flank pain with or without hematuria and/or azotemia, interstitial nephritis, hyponatremia, hyperkalemia, hemolytic uremic syndrome.
Special Senses: abnormal taste, abnormal vision, blurred vision, tinnitus, hearing loss.
 

The in vitro binding of warfarin to plasma proteins is only slightly reduced by ketorolac tromethamine. When ketorolac tromethamine plasma concentrations reach 5 to 10µg/mL. Ketorolac tromethamine does not alter digoxin protein binding. In vitro studies indicate that, at therapeutic concentrations of salicylate (300µg/mL), the binding of ketorolac tromethamine was reduced from approximately 99.2% to 97.5%, representing a potential twofold increase in unbound ketorolac tromethamine plasma levels.
Ketorolac tromethamine reduced the diuretic response to furosemide in normovolemic healthy subjects by approximately 20%.
Concomitant administration of ketorolac tromethamine and probenecid resulted in decreased clearance of ketorolac tromethamine and significant increases in ketorolac tromethamine plasma levels and terminal half-life. Therefore, concomitant use of Ketorolac tromethamine and probenecid is contraindicated.
Inhibition of renal lithium clearance, leading to an increase in plasma lithium concentration, has been reported with some prostaglandin synthesis-inhibiting drugs. The effect of Ketorolac tromethamine on plasma lithium has not been studied, but cases of increased lithium plasma levels during Ketorolac tromethamine therapy have been reported.
Concomitant administration of methotrexate and some NSAIDs has been reported to reduce the clearance of methotrexate, enhancing the toxicity of methotrexate.
Concomitant use of ACE inhibitors may increase the risk of renal impairment, particularly in volume-depleted patients.
Sporadic cases of seizures have been reported during concomitant use of Ketorolac tromethamine and antiepileptic drugs (phenytoin, carbamazepine).
Hallucinations have been reported when Ketorolac tromethamine was used in patients taking psychoactive drugs (fluoxetine, thiothixene, alprazolam).
Ketorolac tromethamine has been administered concurrently with morphine in several clinical trials of postoperative pain without evidence of adverse interactions. It has been advised not to mix Ketorolac tromethamine and morphine in the same syringe.
 

Hepatic Effects: Ketorolac tromethamine should be used with caution in patients with impaired hepatic function or a history of liver disease. Treatment with Ketorolac tromethamine may cause elevations of liver enzymes, and, in patients with pre-existing liver dysfunction, it may lead to the development of a more severe hepatic reaction. The administration of Ketorolac tromethamine should be discontinued in patients in whom an abnormal liver test has occurred as a result of Ketorolac therapy.
Hematologic Effects: Ketorolac tromethamine inhibits platelet aggregation and may prolong bleeding time; therefore, it is contraindicated as a preoperative medication, and caution should be used when hemostasis is critical. Unlike aspirin, the inhibition of platelet function by Ketorolac disappears within 24 to 48 hours after the drug is discontinued. Ketorolac tromethamine does not appear to affect platelet count, prothrombin time (PT) or partial thromboplastin time (PTT).
 

Store in a cool (below 25°C, but excursion permitted from 15°C to 30°C), dry place, away from light. Keep out of reach of children.
 

Ketonic® tablet : Box containing 2 strips of 10 tablets each. Each film-coated tablet contains Ketorolac tromethamine USP 10 mg.
Ketonic® 10 IM / IV Injection : Box containing one strip of 5 ampoules. Each ampoule (1 ml) contains Ketorolac tromethamine USP 10 mg.
Ketonic® 30 IM / IV Injection : Box containing one strip of 5 ampoules. Each ampoule (1 ml) contains Ketorolac tromethamine USP 30 mg. 
 
 

Injection manufactured by: ESKAYEF BANGLADESH LTD DHAKA, BANGLADESH at Renata Limited ® REGD.TRADEMARK

Tablet manufactured by: ESKAYEF BANGLADESH LTD GAZIPUR, BANGLADESH ® REGD.TRADEMARK