Ketomed

Ketomed

ketorolac

Manufacturer:

Medhaus

Distributor:

Medhaus
Full Prescribing Info
Contents
Ketorolac trometamol.
Action
Pharmacologic Classification: Non-Steroidal Anti-Inflammatory.
Pharmacology: Pharmacokinetics: Ketorolac tromethamine is absorbed following intramuscular or oral administration. At physiological pH ketorolac tromethamine dissociates to form an anionic ketorolac molecule which is less hydrophilic than the tromethamine salt. The peak plasma concentration of ketorolac is reached within about 30 to 60 minutes; absorption following intramuscular administration may be slower than that following oral administration in some individuals. Ketorolac is over 99% bound to plasma protein. It does not readily penetrate the blood-brain barrier. Ketorolac crosses the placenta and small amounts of drug are distributed into breast milk. The terminal plasma half-life is about 4 to 6 hours, but is about 6 to 7 hours in the elderly and 9 to 10 hours in patients with renal dysfunction. The major metabolic pathway is glucuronic acid conjugation; there is some para-hydroxylation. About 90% of a dose is excreted in urine as unchanged drug and conjugated and hydroxylated metabolites, the remainder is excreted in the faeces.
Indications/Uses
Ketorolac tromethamine is indicated for the short-term management of moderate to severe acute pain that requires analgesia at the opioid level.
It is NOT indicated for chronic painful conditions.
Dosage/Direction for Use
The recommended oral dose is 10 mg every 4 to 6 hours. Or as prescribed by the physician.
Overdosage
Symptoms: Abdominal pain, nausea, vomiting, hyperventilation, peptic ulceration, erosive gastritis and renal dysfunction.
Management: Symptomatic and supportive treatment. Consider gastric lavage or admin of activated charcoal w/in 1 hour of ingestion.
Contraindications
Ketorolac tromethamine is contraindicated in patients with active or a history of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy. Active, or history of recurrent peptic ulcer/hemorrhage (two or more distinct episodes of proven ulceration or bleeding). As with other NSAIDs, Ketorolac tromethamine is contraindicated in patients with severe heart failure.
Ketorolac tromethamine is contraindicated in patients with moderate or severe renal impairment (serum creatinine >442 mol/l) or in patients at risk for renal failure due to volume depiction or dehydration.
Ketorolac tromethamine is contraindicated in labour and delivery. Ketorolac tromethamine is contraindicated in patients with previously demonstrated hypersensitivity to Ketorolac tromethamine or other NSAIDs and patients in whom aspirin or other prostaglandin synthesis inhibitors induce allergic reactions (severe anaphylactic-like reactions have been observed in such patients). Ketorolac tromethamine is contraindicated as prophylactic analgesic before surgery due to inhibition of platelet aggregation and is contraindicated intraoperatively because of the increased risk of bleeding. Ketorolac tromethamine inhibits platelet function and is, therefore, contraindicated in patients with suspected or confirmed cerebrovascular bleeding patients who have had operations with a high risk of hemorrhage or incomplete hemostasis and those at high risk of bleeding.
Ketorolac tromethamine is contraindicated in patients currently receiving ASA or other NSAIDs.
Special Precautions
Should not be given to patients with peptic ulcerations and should be used with caution, if at all, in patients with history of such disorders. To reduce the risk of gastrointestinal effects, NSAIDs may be taken with or after food or milk.
NSAIDs should be used with caution in patients with infections, since symptoms such as fever and inflammation may be masked, and should also be used with caution in patients with asthma or allergic disorders.
Other general precautions to be observed include administration to patients with haemorrhagic disorders, hypertension, and impaired renal, hepatic, or cardiac function. Patients undergoing therapy with some NSAIDs may need to be monitored for the development of blood, kidney, liver or eye disorders. NSAIDs should be used with caution in the elderly and may need to be given in reduced doses.
Use In Pregnancy & Lactation
Pregnancy: Category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
Drug Interactions
Enhanced effects of anticoagulants eg, warfarin. Increased risk of GI bleeding w/ antiplatelet agents & SSRIs. Increased risk of inducing serious NSAID-related adverse events w/ ASA or other NSAIDs. Increased tendency of bleeding w/ oxpentifylline. Decreased plasma clearance & vol of distribution, increased plasma concentration & half-life w/ probenecid. Reduced clearance & possibly enhanced toxicity of methotrexate. Increased plasma concentration of lithium. Reduced diuretic response to furosemide particularly in patients w/ cardiac decompensation. Reduced effect of diuretics & antihypertensive drugs. Risk of acute renal insufficiency w/ ACEIs &/or angiotensin II receptor antagonists especially in patients w/ compromised renal function & elderly. Oral administration of ketorolac trometamol after a high-fat meal resulted in decreased peak & delayed time-to-peak conc by about 1 hr.
Storage
Protect from light. Store at temperatures not exceeding 30°C.
ATC Classification
M01AB15 - ketorolac ; Belongs to the class of acetic acid derivatives and related substances of non-steroidal antiinflammatory and antirheumatic products.
Presentation/Packing
FC tab 10 mg x 100's. Soln for inj (amp) 30 mg/mL x 1 mL x 10's.
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