Composition:
Troket Tablet: Each film-coated tablet contains Ketorolac Tromethamine USP 10 mg.

Indication:
Troket (Ketorolac Tromethamine) tablets are indicated for the short-term management of moderate to severe acute postoperative pain.

Dosage & Administration:
Troket (Ketorolac Tromethamine) tablets are recommended for short-term use only (up to 7 days) and are not recommended for chronic use.
Adults: 10 mg every 4 to 6 hours as required. Doses exceeding 40 mg per day are not recommended. Opioid analgesics are required for optimal analgesic effect in the early postoperative period when pain is most severe. Ketorolac does not interfere with opioid binding and does not exacerbate opioid-related respiratory depression or sedation. For patients receiving parenteral Ketorolac Tromethamine and who are converted to Ketorolac Tromethamine oral tablets, the total combined daily dose should not exceed 90 mg (60 mg for elderly, renally-impaired patients, and patients less than 50 kg), and the oral component should not exceed 40 mg on the day the change of formulation is made. Patients should be converted to oral treatment as soon as possible.
Elderly: A longer dosing interval, e.g. 6-8 hourly, is advisable in the elderly. The lower end of the dosage range is recommended for patients over 65 years of age.
Children: Ketorolac Tromethamine is not recommended for use in children under 16 years of age.

Contraindications & Precautions:

1. A history of peptic ulcer or gastrointestinal bleeding.
2. Suspected or confirmed cerebrovascular bleeding.
3. Haemorrhagic diathesis, including coagulation disorders.
4. Hypersensitivity to Ketorolac Tromethamine or other NSAIDs.
5. Concurrent treatment with other NSAIDs, Oxpentifyline, Probenecid, or Lithium salts.
6. Moderate or severe renal impairment (serum creatinine > 160 micromole/L).
7. A history of asthma.
Ketorolac Tromethamine is contraindicated intraoperatively because of the increased risk of bleeding.
Ketorolac Tromethamine is contraindicated in patients currently receiving Aspirin.

Side Effects:

The following side effects have been reported with Ketorolac Tromethamine:
Nausea, dyspepsia, gastrointestinal pain, gastrointestinal bleeding, abdominal discomfort, diarrhea, constipation, flatulence, anxiety, drowsiness, headache, sweating, dry mouth, pruritus, urticaria, etc.

Pregnancy & Lactation:
Pregnancy and lactation: US-FDA pregnancy category of Ketorolac Tromethamine is C. So, Ketorolac Tromethamine should be avoided in pregnancy and lactation unless the potential benefits to the mother outweigh the possible risks to the fetus. Up to 5 days (Innovator product).

Use in Children & Adolescent:
Safety and efficacy in children have not been established. Therefore, Ketorolac Tromethamine is contraindicated for use in children less than 16 years of age.

Drug Interactions:
Warfarin, Digoxin, Heparin, and Salicylate should be used carefully with Ketorolac Tromethamine.

Overdose:
No case of overdose has been reported. Overdose is unlikely to occur via the recommended method of administration. If accidentally ingested, drink fluids to dilute.

Storage:
Store below 30°C, in a cool & dry place. Keep away from light. Keep out of the reach of children.

How Supplied:
Troket Tablet: Each box contains 5 x 10 tablets in a blister strip.