ISP Tablet

Composition

Each film-coated tablet contains Ketorolac Tromethamine USP 10 mg.

Pharmacology

Ketorolac Tromethamine is a nonsteroidal anti-inflammatory drug (NSAID) with strong analgesic, anti-inflammatory, and antipyretic properties. It inhibits prostaglandin synthesis and acts as a peripherally acting analgesic. Its analgesic effect is stronger than most conventional NSAIDs.

Indications

  • Short-term management of moderate to severe post-operative pain
  • Relief from acute and chronic musculoskeletal pain as a continuation of treatment

Dosage & Administration

  • Adults: 10 mg every 4–6 hours
  • Elderly: 10 mg every 6–8 hours
  • Maximum Dose: 40 mg per day
  • Duration: Not to exceed 7 days of oral use

Contraindications

  • History of peptic ulcer or gastrointestinal bleeding
  • Cerebrovascular bleeding or coagulation disorders
  • Renal impairment, asthma, or hypersensitivity to Ketorolac
  • Children under 16 years of age

Warnings & Precautions

  • Combined oral and injectable use should not exceed 5 days
  • Not recommended for chronic or long-term use
  • Use with caution in patients with liver dysfunction
  • High doses (e.g., 80–120 mg/day) may cause serious GI issues like ulceration or perforation

Side Effects

  • Common: Dry mouth, nausea, vomiting, diarrhea, dizziness, peptic ulcer, sweating, convulsion, myalgia
  • Rare: Water retention, infections, hyperkalemia, high blood pressure, stomatitis, skin rash, allergic reactions

Use in Pregnancy & Lactation

  • Use only if clearly needed during the first 6 months of pregnancy
  • Not recommended in the last 3 months of pregnancy
  • Passes into breast milk – breastfeeding is not recommended during use

Use in Children & Adolescents

Not recommended for children under 16 years due to lack of safety data.

Drug Interactions

  • Avoid with high doses of aspirin, cidofovir, or other NSAIDs (e.g., ibuprofen, naproxen)
  • Probenecid increases the risk of toxicity
  • High-fat meals may delay absorption slightly
  • Take with food or snacks to reduce stomach upset

Overdose Symptoms

Severe stomach pain, vomiting, extreme drowsiness, slow or shallow breathing, loss of consciousness. Seek medical attention immediately.

Caution

Keep out of reach of children.

Storage

Store below 30°C. Protect from light and moisture.

Packing

Each box contains 20 tablets (2 x 10's) in a blister pack.