Rolac
Generic Name
Ketorolac
Manufacturer
ACI Limited
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 |
rolac 10 mg injection | ৳ 32.13 | N/A |
rolac 30 mg injection | ৳ 55.21 | N/A |
rolac 60 mg injection | ৳ 95.36 | N/A |
Description
Overview of the medicine
Rolac (Ketorolac) is a potent non-steroidal anti-inflammatory drug (NSAID) used for the short-term management of moderate to severe acute pain. It is often used post-operatively or for other acute pain conditions where opioid analgesics may be considered.
Uses & Indications
Dosage
Adults
Oral: 10 mg every 4-6 hours as needed, not to exceed 40 mg/day. Total treatment duration should not exceed 5 days. IM/IV: Single dose of 30 mg or 30 mg every 6 hours, not to exceed 120 mg/day. Total treatment duration should not exceed 5 days.
Elderly
Lower doses may be required. For IM/IV, max 60 mg/day. Close monitoring for adverse effects is recommended.
Renal_impairment
Significant dose reduction or avoidance is necessary depending on the degree of renal impairment. Contraindicated in severe renal impairment.
How to Take
Oral tablets should be taken with food or milk to minimize gastrointestinal upset. Injections can be given intramuscularly (IM) or intravenously (IV).
Mechanism of Action
Ketorolac inhibits prostaglandin synthesis by non-selectively blocking the cyclooxygenase (COX-1 and COX-2) enzymes. This reduction in prostaglandins leads to its analgesic, anti-inflammatory, and antipyretic effects.
Pharmacokinetics
Onset
Oral: 30-60 minutes; Intramuscular/Intravenous: within 10 minutes.
Excretion
Mainly via urine (about 92%), with a small portion excreted in feces.
Half life
Approximately 5-6 hours.
Absorption
Rapidly and completely absorbed after oral administration. Peak plasma concentrations are reached within 30-60 minutes.
Metabolism
Primarily hepatic, mainly through glucuronidation and hydroxylation.
Side Effects
Contraindications
- Active peptic ulcer, recent gastrointestinal bleeding or perforation, history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs.
- Severe renal impairment (creatinine clearance <30 mL/min).
- Peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.
- Advanced liver disease.
- Hypersensitivity to Ketorolac or any component of the formulation.
- Children below 17 years for parenteral use.
Drug Interactions
Lithium
Increased plasma lithium concentrations (reduced renal clearance of lithium).
Methotrexate
Increased methotrexate toxicity (reduced renal clearance).
Corticosteroids
Increased risk of GI ulceration and bleeding.
ACE inhibitors, ARBs, Diuretics
May reduce antihypertensive and diuretic effects; increased risk of renal impairment.
Anticoagulants (e.g., Warfarin, Heparin)
Increased risk of bleeding.
Antiplatelet agents (e.g., Aspirin, Clopidogrel)
Increased risk of GI bleeding.
Storage
Store below 30°C in a dry place, away from direct sunlight and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose may include nausea, vomiting, epigastric pain, GI bleeding, lethargy, drowsiness, and acute renal failure. Management involves supportive and symptomatic treatment. Gastric lavage and activated charcoal may be considered within the first hour of ingestion. Monitor renal and liver function.
Pregnancy & Lactation
Pregnancy: Category C in early pregnancy, Category D in third trimester. Avoid in the third trimester due to potential for premature closure of the fetal ductus arteriosus. Lactation: Small amounts are excreted in breast milk. Use with caution or avoid during breastfeeding, weighing potential risks against benefits.
Side Effects
Contraindications
- Active peptic ulcer, recent gastrointestinal bleeding or perforation, history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs.
- Severe renal impairment (creatinine clearance <30 mL/min).
- Peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.
- Advanced liver disease.
- Hypersensitivity to Ketorolac or any component of the formulation.
- Children below 17 years for parenteral use.
Drug Interactions
Lithium
Increased plasma lithium concentrations (reduced renal clearance of lithium).
Methotrexate
Increased methotrexate toxicity (reduced renal clearance).
Corticosteroids
Increased risk of GI ulceration and bleeding.
ACE inhibitors, ARBs, Diuretics
May reduce antihypertensive and diuretic effects; increased risk of renal impairment.
Anticoagulants (e.g., Warfarin, Heparin)
Increased risk of bleeding.
Antiplatelet agents (e.g., Aspirin, Clopidogrel)
Increased risk of GI bleeding.
Storage
Store below 30°C in a dry place, away from direct sunlight and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose may include nausea, vomiting, epigastric pain, GI bleeding, lethargy, drowsiness, and acute renal failure. Management involves supportive and symptomatic treatment. Gastric lavage and activated charcoal may be considered within the first hour of ingestion. Monitor renal and liver function.
Pregnancy & Lactation
Pregnancy: Category C in early pregnancy, Category D in third trimester. Avoid in the third trimester due to potential for premature closure of the fetal ductus arteriosus. Lactation: Small amounts are excreted in breast milk. Use with caution or avoid during breastfeeding, weighing potential risks against benefits.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24-36 months from the date of manufacture, specific details on packaging.
Availability
Available in pharmacies and hospitals
Approval Status
Approved
Patent Status
Off-patent
WHO Essential Medicine
YesClinical Trials
Ketorolac has undergone extensive clinical trials demonstrating its efficacy in acute pain management, often compared to opioids. Trials consistently show its potent analgesic effect but also highlight its dose- and duration-dependent risks, particularly GI and renal complications.
Lab Monitoring
- Renal function (serum creatinine, BUN) before and during treatment, especially in patients at risk of renal impairment.
- Liver function tests (ALT, AST) periodically, particularly with long-term use.
- Complete blood count (CBC) if used for more than a few days, especially if there's a risk of bleeding.
Doctor Notes
- Emphasize the strict 5-day maximum duration for all routes of administration to minimize GI and CV risks.
- Consider patient's cardiovascular and renal history before prescribing.
- Co-administration with other NSAIDs, antiplatelets, or anticoagulants should be carefully evaluated due to increased bleeding risk.
Patient Guidelines
- Take exactly as prescribed and do not exceed the recommended dose or duration of treatment (maximum 5 days).
- Report any signs of gastrointestinal bleeding (e.g., black, tarry stools, vomiting blood) or allergic reactions immediately.
- Inform your doctor about all other medications you are taking, including over-the-counter drugs and herbal supplements.
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 continue with 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 medication affects them.
Lifestyle Advice
- Avoid alcohol consumption while taking Ketorolac, as it may increase the risk of gastrointestinal bleeding. Discuss any history of stomach ulcers, heart disease, or kidney problems with your doctor before starting treatment.
- Maintain adequate hydration.
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