ketorin (Ketorolac) is one of the potent non-steroidal anti-inflammatorydrugs, which has actions similar to other NSAIDs. As an analgesicKetorolac is 350 and 50 times more potent than Aspirin and Naproxenrespectively and as an anti-inflammatory drug Ketorolac is 5 time morepotent than Naproxen.

Ketorin tablet: Each tablet contains Ketorolac Tromethamine USP 10 mg.Ketorin-30 injection: Each ampoule (1ml) contains Ketorolac TromethamineUSP 30 mg

Ketorin (Ketotolac) is rapidly and almost completely absorbed after oraldosing. Peak plasma concentration reaches with 30-60 minutes after oraldosing. Mean plasma half-life is 5.4 hours. Following IV administrationof 15 or 30 mg doses of Ketorolac injection peak plasma concentrationreaches within 1 or 3 minutes. Onset of analgesic action is 10 minutesafter IM administration.

Ketorin (Ketorolac) is indicated for the short-term management ofmoderate to severe pain. Major indications are

• l Post-operative pain associated with abdominal, gynecologic, oral,     orthopedic or urologic surgery.

• l Acute renal colic

• l Pain associated with trauma

• l Musculoskeletal pain

• l Visceral pain associated with cancer

Ketorin (Ketorolac) like other NSAIDs, achieves its effects primarily byinhibiting the enzyme cyclooxygenase and thus inhibitis the synthesis ofprostaglandins, prostacycline & thromboxanes. In Keeping with most ofthe currently used NSAIDs, Ketorolac preferentially inhibits theconstitutive isoenzyme cyclooxygenase-1 rather than the induclible form,cyclooxygenase-2.

By mouth: 10 mg every 4-6 hours (Elderly every 6-8 hours); maximum 40mg daily.By IM/IV injection: Initially 10 mg, then 10-30 mg every 4-6 hours whenrequired (every 2 hours in initial post-operative period); maximum 90 mgdaily (for elderly and patients weighing less than 50 kg: 60 mg daily).Maximum duration: 2 days for IM/IV injection, 7 days for oral dose.Total dose of oral and injection should not exceed 90 mg/day.

Ketorin (ketorolac) is contraindicated in the following situations:

• l Patients previously sensitive to ketorolac or Aspirin or other NSAIDs.

• l Patients with active or suspected peptic or duodenal ulcer or who have     GI or other bleeding disorders.

• l In severe heart failure and renal or hepatic insufficiency

• l Syndrome of rhinitis and nasal polyposis

• l Concurrent high dose therapy of Methotrexate

• l Blood coagulation disorder

• l Liver cirrhosis with ascites

• l Cerebrovascular hemorrhage

Ketorin (Ketorolac) should be used with caution in patients sufferingfrom GI disease and history of peptic ulceration, cerebrovascularbleeding, ulcerative colitis, cardiac decompensation, hypertension, renaland hepatic impairment. Dose should be reduced in elderly.

Ketorin (Ketorolac) is contraindicated in the later stages of pregnancyand should only be used earlier in the pregnancy if there is a compellingreasons. Because ketorolac is distributed in milk, it should not be usedduring lactation.Use in Renal and Hepatic ImpairementDoses may need to be adjusted in patients with reduced renal function.The need for Ketorin (Ketorolac) dosage adjustment in patients withhepatic impairment has not been fully determined, but evidence frompatients with liver cirrhosis suggests that modification may not benecessary.

Drug interactions may occur with Methotrexate, Diuretics.Antihypertensive drug, ACE inhibitors and Warfarin.

Hypersensitivity reaction: Anaphylaxis, bronchospasm, laryngeal edema,facial swelling and hypotension may occur.GI effects: Dyspepsia, abdominal pain, nausea, peptic ulceration,pancreatitis, flatulence, gastritis, constipation, vomiting.Renal effects: Hematuria, Proteinuria etc may occur.Other effects : Vasodilation, flushing, syncope, palpitation, dyspnea,myalgia etc.

Acute overdosage has not been reported with Ketorolac. Symptoms andmanagement of overdosage are likely to be similar to other NSAIDs thatinvolves gastric lavage or induced vomiting, activated charcoal and H2-blocker etc.

Store in cool and dry place, away from light.

Ketorin tablet : Box containing 2 x 10 tablets in blister pack.Ketorin-30 inj. : Box containing 1 x 5 ampoules in blister pack.