Medicine Information

Ketopac

Name: Ketopac
Brand: Ketopac
Rating: 4.5 (117 reviews)

Tablet1 mgNon-steroidal Anti-inflammatory Drugs (NSAIDs)ATC: M01AB15

Generic Name

Ketorolac Tromethamine

Manufacturer

Square Pharmaceuticals Ltd.

Country

Bangladesh

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Price Details

Current market pricing information

Variant	Unit Price	Strip Price
ketopac 1 mg tablet	৳ 2.30	৳ 23.00

Description

Overview of the medicine

Ketopac-1-mg-tablet contains Ketorolac Tromethamine, a non-steroidal anti-inflammatory drug (NSAID) used for the short-term management of moderate to severe acute pain. It works by reducing hormones that cause inflammation and pain in the body.

Uses & Indications

Short-term management of moderate to severe acute pain

Postoperative pain

Musculoskeletal pain that requires strong analgesia

Dosage

Adults

Oral: Typically 10 mg every 4-6 hours as needed, not to exceed 40 mg/day for a maximum of 5 days. A 1 mg tablet would require multiple tablets to reach the usual therapeutic dose, or it might be intended for a very specific low-dose regimen.

Elderly

Lower doses may be required, generally not exceeding 20 mg/day, due to potential impairment in renal function and increased susceptibility to adverse effects.

Renal_impairment

Contraindicated in moderate to severe renal impairment. For mild impairment, dosage reduction is necessary; maximum 20 mg/day.

How to Take

Take Ketopac-1-mg-tablet orally, preferably with food or milk to minimize gastrointestinal upset. Do not chew or crush the tablet.

Mechanism of Action

Ketorolac inhibits prostaglandin synthesis by blocking cyclooxygenase (COX-1 and COX-2) enzymes. This inhibition reduces the formation of prostaglandins, which are mediators of pain, inflammation, and fever.

Pharmacokinetics

Onset

Analgesia usually begins within 1 hour after oral administration.

Excretion

Primarily renal, with approximately 90% of a dose excreted in the urine and a small amount in feces.

Half life

Approximately 4-6 hours, but may vary based on age and renal function.

Absorption

Rapid and complete oral absorption. Peak plasma concentrations are typically achieved within 30-60 minutes.

Metabolism

Primarily hepatic, through hydroxylation and conjugation. Main metabolite is p-hydroxyketorolac.

Side Effects

Contraindications

Hypersensitivity to ketorolac, aspirin, or other NSAIDs
Active peptic ulcer disease, recent gastrointestinal bleeding or perforation
Advanced renal impairment or risk of renal failure due to volume depletion
Coagulation disorders or patients on anticoagulants
Peri-operative pain in coronary artery bypass graft (CABG) surgery
Concomitant use with other NSAIDs, aspirin, probenecid, or pentoxifylline
Pregnancy (especially third trimester) and lactation

Drug Interactions

Lithium

Ketorolac may increase plasma lithium levels, leading to lithium toxicity.

Methotrexate

Increased methotrexate toxicity, especially with high doses of methotrexate.

ACE inhibitors/ARBs

Increased risk of renal impairment, especially in elderly or volume-depleted patients.

Other NSAIDs/Aspirin

Concomitant use increases the risk of gastrointestinal adverse events.

Warfarin/Anticoagulants

Increased risk of serious bleeding.

Diuretics (e.g., Furosemide, Thiazides)

Reduced diuretic and antihypertensive effects, potential for renal impairment.

Storage

Store below 30°C in a dry place, away from direct light and moisture. Keep out of reach of children.

Overdose

Symptoms of overdose may include epigastric pain, nausea, vomiting, lethargy, and drowsiness. Rare cases of gastrointestinal bleeding, hypertension, acute renal failure, and respiratory depression have occurred. Treatment is supportive and symptomatic; gastric lavage and activated charcoal may be considered within an hour of ingestion.

Pregnancy & Lactation

Contraindicated during pregnancy, especially in the third trimester, due to the risk of premature closure of the fetal ductus arteriosus and fetal renal dysfunction. Ketorolac is excreted in breast milk and is therefore not recommended during lactation.

Frequently Asked Questions

Common questions about this medicine

Pack Sizes

10 tablets per blister strip30 tablets per box

Shelf Life

2-3 years from the date of manufacture, depending on storage conditions.

Availability

Pharmacies, Hospitals

Approval Status

Approved

Patent Status

Expired

WHO Essential Medicine

Yes

Clinical Trials

Ketorolac has undergone extensive clinical trials demonstrating its efficacy in acute pain management. However, these trials also highlighted the importance of short-term use due to potential risks of gastrointestinal and cardiovascular adverse events.

Lab Monitoring

Renal function (serum creatinine, BUN) should be monitored, especially in elderly or renally impaired patients.
Liver function tests (ALT, AST) should be performed during prolonged therapy.
Complete blood count (CBC) may be monitored for signs of bleeding or anemia.
Blood pressure should be monitored regularly.

Doctor Notes

Emphasize the critical importance of short-term use (maximum 5 days) to minimize severe adverse reactions, particularly GI and CV risks.
Careful patient selection is crucial, especially for those with a history of GI disease, renal impairment, cardiovascular disease, or bleeding disorders.
Monitor patients for signs of GI bleeding (e.g., black stools, abdominal pain), renal dysfunction (e.g., decreased urine output), and fluid retention.
Coadministration with other NSAIDs, aspirin, or anticoagulants should be strictly avoided.

Patient Guidelines

Take this medicine exactly as prescribed by your doctor and do not exceed the recommended dose or duration (maximum 5 days).
Swallow the tablet whole with water; do not crush or chew.
Report any signs of stomach pain, black or tarry stools, or unusual bleeding/bruising to your doctor immediately.
Avoid taking other NSAIDs or aspirin concurrently without consulting your doctor.

Missed Dose Advice

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and return to your regular dosing schedule. Do not take a double dose to make up for a missed one.

Driving Precautions

Ketorolac may cause dizziness, drowsiness, or visual disturbances. Patients should exercise caution when driving or operating machinery until they know how the medicine affects them.

Lifestyle Advice

Maintain adequate hydration by drinking plenty of fluids.
Avoid alcohol consumption during treatment, as it may increase the risk of gastrointestinal bleeding.
Avoid smoking, as it may also increase the risk of GI adverse events.