Rolac
Generic Name
Ketorolac Tromethamine
Manufacturer
Example Pharmaceutical Co. Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
rolac 60 mg injection | ৳ 95.36 | N/A |
Description
Overview of the medicine
Rolac 60 mg Injection contains Ketorolac Tromethamine, a potent non-steroidal anti-inflammatory drug (NSAID) primarily used for the short-term management of moderately severe acute pain. It works by reducing hormones that cause pain and inflammation in the body.
Uses & Indications
Dosage
Adults
Single IM dose of 60 mg, or multiple IM/IV doses of 30 mg every 6 hours. Maximum daily dose should not exceed 120 mg. Treatment duration should not exceed 5 days.
Elderly
For patients ≥65 years, a reduced dose of 15 mg IM/IV every 6 hours, with a maximum daily dose not exceeding 60 mg, is recommended.
Renal_impairment
Significant dose reduction is required; often contraindicated in patients with moderate to severe renal impairment. In mild impairment, consider a reduced dose of 15 mg every 6 hours, maximum 60 mg/day.
How to Take
For intramuscular administration, inject slowly and deeply into a large muscle. For intravenous administration, administer slowly over at least 15 seconds. Should not be mixed with morphine, pethidine, promethazine, or hydroxyzine in a syringe as precipitation may occur.
Mechanism of Action
Ketorolac inhibits prostaglandin synthesis by non-selectively blocking the cyclooxygenase (COX-1 and COX-2) enzymes. This action reduces inflammation, pain, and fever.
Pharmacokinetics
Onset
Analgesia usually begins within 30 minutes after IM/IV administration.
Excretion
Primarily excreted in the urine (approximately 91%), with a smaller amount excreted in the feces (approximately 6%).
Half life
Approximately 5-6 hours in healthy adults.
Absorption
Rapid and complete absorption after intramuscular (IM) administration. Peak plasma concentrations are achieved within 30-60 minutes.
Metabolism
Extensively metabolized in the liver, primarily via hydroxylation and conjugation.
Side Effects
Contraindications
- Hypersensitivity to ketorolac, aspirin, or other NSAIDs.
- Active peptic ulcer disease, recent gastrointestinal bleeding or perforation.
- Moderate to severe renal impairment or risk of renal failure.
- History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs.
- Coagulopathy, suspected or confirmed cerebrovascular hemorrhage, hemorrhagic diathesis.
- As prophylactic analgesic before major surgery or intraoperatively (due to increased risk of bleeding).
- Pregnancy, labor and delivery, and lactation.
Drug Interactions
Lithium
Increased plasma lithium levels, leading to toxicity.
SSRIs/SNRIs
Increased risk of GI bleeding.
Methotrexate
Increased methotrexate toxicity.
ACE Inhibitors/ARBs
Increased risk of renal impairment, reduced antihypertensive effect.
Other NSAIDs/Aspirin
Increased risk of gastrointestinal adverse effects.
Diuretics (e.g., Furosemide)
Reduced natriuretic and diuretic effect.
Anticoagulants (e.g., Warfarin, Heparin)
Increased risk of bleeding.
Storage
Store below 30°C in a cool, dry place. Protect from light and moisture. Do not freeze. Keep out of reach of children.
Overdose
Symptoms of overdose may include nausea, vomiting, epigastric pain, lethargy, drowsiness, and occasionally diarrhea. Rare cases of gastrointestinal bleeding, hypertension, acute renal failure, and respiratory depression have occurred. Management is primarily supportive, including gastric emptying (if ingestion was recent and significant) and close monitoring of vital signs and renal function.
Pregnancy & Lactation
Contraindicated during pregnancy, labor, and delivery due to potential fetal harm (e.g., premature closure of the ductus arteriosus) and increased risk of bleeding. Also contraindicated during lactation as ketorolac passes into breast milk and may harm the nursing infant.
Side Effects
Contraindications
- Hypersensitivity to ketorolac, aspirin, or other NSAIDs.
- Active peptic ulcer disease, recent gastrointestinal bleeding or perforation.
- Moderate to severe renal impairment or risk of renal failure.
- History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs.
- Coagulopathy, suspected or confirmed cerebrovascular hemorrhage, hemorrhagic diathesis.
- As prophylactic analgesic before major surgery or intraoperatively (due to increased risk of bleeding).
- Pregnancy, labor and delivery, and lactation.
Drug Interactions
Lithium
Increased plasma lithium levels, leading to toxicity.
SSRIs/SNRIs
Increased risk of GI bleeding.
Methotrexate
Increased methotrexate toxicity.
ACE Inhibitors/ARBs
Increased risk of renal impairment, reduced antihypertensive effect.
Other NSAIDs/Aspirin
Increased risk of gastrointestinal adverse effects.
Diuretics (e.g., Furosemide)
Reduced natriuretic and diuretic effect.
Anticoagulants (e.g., Warfarin, Heparin)
Increased risk of bleeding.
Storage
Store below 30°C in a cool, dry place. Protect from light and moisture. Do not freeze. Keep out of reach of children.
Overdose
Symptoms of overdose may include nausea, vomiting, epigastric pain, lethargy, drowsiness, and occasionally diarrhea. Rare cases of gastrointestinal bleeding, hypertension, acute renal failure, and respiratory depression have occurred. Management is primarily supportive, including gastric emptying (if ingestion was recent and significant) and close monitoring of vital signs and renal function.
Pregnancy & Lactation
Contraindicated during pregnancy, labor, and delivery due to potential fetal harm (e.g., premature closure of the ductus arteriosus) and increased risk of bleeding. Also contraindicated during lactation as ketorolac passes into breast milk and may harm the nursing infant.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24 to 36 months from the date of manufacture.
Availability
Pharmacies, Hospitals, Clinics
Approval Status
Approved
Patent Status
Off-patent
WHO Essential Medicine
YesClinical Trials
Ketorolac has been extensively studied in numerous clinical trials for its efficacy and safety in various acute pain settings, including post-surgical pain, musculo-skeletal pain, and cancer pain. Trials have confirmed its potent analgesic effect and established guidelines for its short-term use.
Lab Monitoring
- Renal function tests (BUN, serum creatinine) - particularly with prolonged use or in at-risk patients.
- Liver function tests (ALT, AST) - periodically for prolonged use.
- Complete blood count (CBC) - for signs of anemia or bleeding, especially with long-term use.
- Blood pressure monitoring.
Doctor Notes
- Ketorolac is a potent NSAID indicated for short-term (<5 days) management of moderately severe acute pain requiring opioid-level analgesia.
- Thoroughly assess patient's cardiovascular, gastrointestinal, and renal risk factors before initiation.
- Avoid concomitant use with other NSAIDs, aspirin, or anticoagulants.
- Monitor for signs of GI bleeding, renal impairment, and cardiovascular events.
Patient Guidelines
- This medicine is for short-term use only (maximum 5 days).
- Report any signs of unusual bleeding, black tarry stools, or severe stomach pain to your doctor immediately.
- Seek emergency medical attention if you experience chest pain, shortness of breath, sudden weakness, or slurred speech.
- Avoid concurrent use of other NSAIDs or aspirin without consulting your doctor.
Missed Dose Advice
Since Rolac 60 mg Injection is administered by a healthcare professional, a missed dose is unlikely. If you think a dose might have been missed, inform your doctor or nurse immediately.
Driving Precautions
Rolac 60 mg Injection may cause dizziness, drowsiness, or visual disturbances. Patients should be cautioned against driving or operating machinery if they experience these side effects.
Lifestyle Advice
- Maintain adequate hydration during treatment.
- Avoid heavy alcohol consumption while using this medicine, as it can increase the risk of stomach problems.
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