Rolac
Generic Name
Ketorolac Tromethamine
Manufacturer
Incepta Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
rolac 10 mg tablet | ৳ 12.00 | ৳ 168.00 |
Description
Overview of the medicine
Rolac 10 mg Tablet contains Ketorolac Tromethamine, a non-steroidal anti-inflammatory drug (NSAID) used for the short-term management of moderately severe acute pain that requires analgesia at the opioid level, typically post-operative pain. It works by reducing hormones that cause pain and inflammation in the body.
Uses & Indications
Dosage
Adults
Typically 10 mg every 4-6 hours as needed, not to exceed 40 mg/day. Treatment duration should not exceed 5 days.
Elderly
Lower doses (e.g., 10 mg every 6-8 hours) may be required due to increased risk of adverse effects. Max 20 mg/day for elderly over 65 years, or if body weight < 50 kg or creatinine > 1.4 mg/dL.
Renal_impairment
Reduced dosage is necessary. Contraindicated in severe renal impairment. For moderate impairment, dose reduction and careful monitoring are crucial.
How to Take
Take the tablet orally with a glass of water, with or without food. To minimize gastrointestinal upset, it is often recommended to take it with food or milk.
Mechanism of Action
Ketorolac works by inhibiting cyclooxygenase (COX) enzymes, primarily COX-1 and COX-2, which are responsible for the synthesis of prostaglandins. Prostaglandins are mediators of pain, inflammation, and fever. By inhibiting prostaglandin synthesis, ketorolac produces its analgesic, anti-inflammatory, and antipyretic effects.
Pharmacokinetics
Onset
Approximately 30 minutes for analgesic effect.
Excretion
Mainly via urine (61% as unchanged drug and metabolites), with a small amount in feces (36%).
Half life
About 5-6 hours.
Absorption
Rapidly and completely absorbed orally. Peak plasma concentrations are reached within 30-60 minutes.
Metabolism
Primarily in the liver by hydroxylation and conjugation. A major metabolite is p-hydroxyketorolac.
Side Effects
Contraindications
- Hypersensitivity to ketorolac or other NSAIDs
- Active peptic ulcer, gastrointestinal bleeding or perforation
- History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs
- Advanced renal impairment
- Peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery
- Concomitant use with other NSAIDs, aspirin, anticoagulants (e.g., warfarin), probenecid, or pentoxifylline
- Pregnancy (especially third trimester) and lactation
- Children under 16 years of age
Drug Interactions
Lithium
Increased plasma lithium levels, leading to toxicity.
Probenecid
Increased plasma levels of ketorolac (contraindicated).
Methotrexate
Increased methotrexate toxicity.
Pentoxifylline
Increased risk of bleeding (contraindicated).
ACE inhibitors/ARBs
Increased risk of renal impairment, especially in dehydrated patients.
Other NSAIDs/Aspirin
Increased risk of GI adverse effects.
Diuretics (e.g., Furosemide)
Reduced diuretic and antihypertensive effects.
Warfarin, Heparin, other anticoagulants
Increased risk of bleeding.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms may include drowsiness, nausea, vomiting, epigastric pain, lethargy, and gastrointestinal bleeding. Management is primarily supportive and symptomatic. Gastric lavage or activated charcoal may be considered if ingestion is recent. Monitor renal function and electrolyte balance.
Pregnancy & Lactation
Contraindicated during the third trimester of pregnancy due to risk of premature closure of the fetal ductus arteriosus. Use during other trimesters only if the potential benefit outweighs the potential risk. Contraindicated during lactation as ketorolac is excreted in breast milk.
Side Effects
Contraindications
- Hypersensitivity to ketorolac or other NSAIDs
- Active peptic ulcer, gastrointestinal bleeding or perforation
- History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs
- Advanced renal impairment
- Peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery
- Concomitant use with other NSAIDs, aspirin, anticoagulants (e.g., warfarin), probenecid, or pentoxifylline
- Pregnancy (especially third trimester) and lactation
- Children under 16 years of age
Drug Interactions
Lithium
Increased plasma lithium levels, leading to toxicity.
Probenecid
Increased plasma levels of ketorolac (contraindicated).
Methotrexate
Increased methotrexate toxicity.
Pentoxifylline
Increased risk of bleeding (contraindicated).
ACE inhibitors/ARBs
Increased risk of renal impairment, especially in dehydrated patients.
Other NSAIDs/Aspirin
Increased risk of GI adverse effects.
Diuretics (e.g., Furosemide)
Reduced diuretic and antihypertensive effects.
Warfarin, Heparin, other anticoagulants
Increased risk of bleeding.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms may include drowsiness, nausea, vomiting, epigastric pain, lethargy, and gastrointestinal bleeding. Management is primarily supportive and symptomatic. Gastric lavage or activated charcoal may be considered if ingestion is recent. Monitor renal function and electrolyte balance.
Pregnancy & Lactation
Contraindicated during the third trimester of pregnancy due to risk of premature closure of the fetal ductus arteriosus. Use during other trimesters only if the potential benefit outweighs the potential risk. Contraindicated during lactation as ketorolac is excreted in breast milk.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24 to 36 months from manufacturing date.
Availability
Pharmacies, hospitals, clinics
Approval Status
Approved by regulatory authorities (e.g., FDA, DGDA)
Patent Status
Generic available, original patent expired
Clinical Trials
Ketorolac has been extensively studied in numerous clinical trials demonstrating its efficacy in acute pain management, particularly post-operative pain, and its comparison to opioids and other NSAIDs. Trials also highlight its safety profile, especially the risks associated with prolonged use.
Lab Monitoring
- Complete blood count (CBC)
- Renal function (creatinine, BUN)
- Liver function tests (ALT, AST)
- Stool for occult blood (if GI symptoms develop)
Doctor Notes
- Emphasize short-term use (max 5 days) due to significant GI and CV risks.
- Carefully assess renal function before and during treatment, especially in elderly or patients with pre-existing renal issues.
- Avoid concomitant use with other NSAIDs, anticoagulants, or drugs that increase GI toxicity.
- Patients should be adequately hydrated.
Patient Guidelines
- Do not use for more than 5 days.
- Take exactly as prescribed by your doctor.
- Report any signs of unusual bleeding, severe stomach pain, or black/tarry stools immediately.
- Avoid alcohol and other NSAIDs while taking this medicine.
- Inform your doctor about all other medications you are taking.
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 resume your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
May cause dizziness or drowsiness. Patients should be cautious when driving or operating machinery until they know how the drug affects them.
Lifestyle Advice
- Maintain adequate hydration.
- Avoid activities requiring mental alertness if dizziness or drowsiness occurs.
- Discuss dietary modifications with your doctor if you have a sensitive stomach.
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