Abridged prescribing information:

Composition:
Ketovalor-30 injection: Each ml injection contains Ketorolac tromethamine USP 30 mg.
Pharmacology:
Ketorolac Tromethamine is a potent analgesic of the non-steroidal anti-inflammatory drugs (NSAIDs). It acts by inhibiting the cyclooxygenase engyme system and hence inhibits prostaglandin synthesis.It demonstrates a minimal anti-inflammatory effect at its analgesic dose.
Indication:
Ketovalor injection is indicated for the short-term management of moderate to severe acute post-operative pain.
Dosage & Administration:
For adult patients (<65 years), Ketorolac tromethamine is for administration by intramuscular or bolus intravenous injection. Initial dose is 60 mg IM (single) or 30 mg IV(Single). Maintenance dose is 30 mg IM/IV 6 hourly. Maximum dose is 120 mg/day.
For elderly patients(>65 years), patients with renal Impairment & those weighing less than 50 kg, Initial dose is 30 mg IM. Maintenance dose is 10-15 mg IM/IV 6 hourly.Maximum dose is 60 mg/day. The maximum duration of treatment should not exceed two days.
Contraindications:
Ketorolac is contraindicated in patients having hypersensitivity to this drug or other NSAIDs and those patients in whom Aspirin or other prostaglandin synthesis inhibitors induce allergic reactions. It is also contraindicated in a history of gastro-intestinal bleeding, asthma, moderate or severe renal impairment (serum creatinine>160 micromol/L).
Ketorolac is contraindicated as prophylactic analgesic before surgery due to inhibition of platelet aggregation and also contraindicated intraoperatively because of the increased risk of bleeding.
Warning & Precautions:
Caution should be exercised in patients over the age of 65 years. Caution should also be taken in patients with active or suspected paptic ulcer or gastrointestinal bleeding or asthma and liver dysfunction.
Side Effect:
Commonly occurring side-effects are nausea, vomiting, gastrointestinal bleeding, melaena, peptic ulcer, pancreatitis, anxiety, drowsiness, dizziness, headache, hallucinations, excessive thirst, inability to concentrate, insomnia, malaise, fatigue, pruritus, urticaria, skin photosensitivity, Lyell’s syndrome, Stevens-Johnson syndrome, flushing, bradycardia, hypertension, palpitations, chest pain, infertility in female, dyspnoea, asthma, pulmonary oedema, fever, injection site pain.
Use in Pregnancy & Lactation:
Safety in human pregnancy has not been established. Ketorolac tromethamine has been detected in human milk at low levels. Ketorolac tromethamine is therefore contraindicated during pregnancy, labour or delivery, or in mothers who are breast feeding.
Use in Children & Adolescents:
Ketorolac tromethamine is not indicated for use in pediatric patients. The safety and effectiveness of ketorolac tromethamine in pediatric patients below the age of 17 have not been established.
Drug Interaction:
Warfarin, Digoxin, Salicylate, Heparin, Aspirin, Diuretics, Probenecid, Methotrexate, ACE Inhibitors, SSRIs, Antiepileptic drugs, Psychoactive drugs should be used carefully with Ketorolac Tromethamine.
Overdose:
Overdosage of Ketorolac Tromethamine may cause abdominal pain, peptic ulcers which are usually healed after discontinuation of doses. Metabolic acidosis has been reported following intentional overdose.
Storage:
Protect from light, store in dry place at or below 300C.
Keep out of reach of children.
Packaging :
Ketovalor-30 injection: Each box containing 5 ampoules in blister pack (with disposable syringe).