Rotalac
Generic Name
Ketorolac Tromethamine
Manufacturer
Example Pharma Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| rotalac 30 mg injection | ৳ 55.00 | N/A |
Description
Overview of the medicine
Rotalac 30 mg Injection contains Ketorolac Tromethamine, a potent NSAID primarily used for the short-term management of moderate to severe acute pain, especially post-operative pain. It works by reducing hormones that cause pain and inflammation in the body.
Uses & Indications
Dosage
Adults
Initially 30 mg IM/IV, then 15-30 mg every 6 hours as needed. Max 90 mg/day for 5 days. For patients under 50 kg or over 65 years, initial 15 mg, then 15 mg every 6 hours, max 60 mg/day for 5 days.
Elderly
Initial 15 mg IM/IV, then 15 mg every 6 hours as needed. Max 60 mg/day for 5 days.
Renal_impairment
Contraindicated in severe renal impairment. For mild to moderate, dose reduction to 15 mg every 6 hours, max 60 mg/day, with close monitoring.
How to Take
Administer intramuscularly (IM) or intravenously (IV) slowly over at least 15 seconds. Should not be administered epidurally or intrathecally. Maximum duration of therapy for injection is 5 days.
Mechanism of Action
Ketorolac inhibits prostaglandin synthesis by non-selectively inhibiting cyclooxygenase (COX-1 and COX-2) enzymes. This reduces the formation of inflammatory mediators and thus alleviates pain and inflammation.
Pharmacokinetics
Onset
Within 30 minutes (IM/IV)
Excretion
Mainly renal (about 91% as unchanged drug and metabolites), some fecal excretion (6%).
Half life
Approximately 4-6 hours (increases in elderly and renal impairment)
Absorption
Rapid and complete absorption after intramuscular administration. Peak plasma concentrations are reached within 30-60 minutes.
Metabolism
Primarily hepatic, mainly by glucuronidation. No significant active metabolites.
Side Effects
Contraindications
- Hypersensitivity to ketorolac or other NSAIDs
- Active peptic ulcer, GI bleeding or perforation
- Advanced renal impairment or at risk of renal failure
- Peri-operative pain in coronary artery bypass graft (CABG) surgery
- Concomitant use with other NSAIDs, aspirin, or anticoagulants
- Pregnancy (especially third trimester) and lactation
- History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs
Drug Interactions
Lithium
Increased plasma lithium levels, leading to toxicity.
Methotrexate
Increased plasma methotrexate levels, leading to toxicity.
Warfarin, Heparin
Increased risk of bleeding.
Other NSAIDs, Aspirin
Increased risk of GI adverse events.
ACE inhibitors, Diuretics
Reduced antihypertensive effect; increased risk of renal impairment.
Storage
Store below 30°C, protected from light and moisture. Do not freeze. Keep out of reach of children.
Overdose
Symptoms may include epigastric pain, nausea, vomiting, lethargy, and drowsiness. Rare cases of gastrointestinal bleeding, acute renal failure, hypertension, and respiratory depression. Management is primarily supportive and symptomatic. Gastric lavage and activated charcoal may be considered if ingestion was recent. Hemodialysis does not significantly remove ketorolac from the blood.
Pregnancy & Lactation
Pregnancy Category C (first and second trimesters), Category D (third trimester) due to risk of premature closure of ductus arteriosus and renal dysfunction in the fetus. Contraindicated in the third trimester and during labor and delivery. Not recommended during breastfeeding as it is excreted in breast milk and may cause adverse effects in infants.
Side Effects
Contraindications
- Hypersensitivity to ketorolac or other NSAIDs
- Active peptic ulcer, GI bleeding or perforation
- Advanced renal impairment or at risk of renal failure
- Peri-operative pain in coronary artery bypass graft (CABG) surgery
- Concomitant use with other NSAIDs, aspirin, or anticoagulants
- Pregnancy (especially third trimester) and lactation
- History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs
Drug Interactions
Lithium
Increased plasma lithium levels, leading to toxicity.
Methotrexate
Increased plasma methotrexate levels, leading to toxicity.
Warfarin, Heparin
Increased risk of bleeding.
Other NSAIDs, Aspirin
Increased risk of GI adverse events.
ACE inhibitors, Diuretics
Reduced antihypertensive effect; increased risk of renal impairment.
Storage
Store below 30°C, protected from light and moisture. Do not freeze. Keep out of reach of children.
Overdose
Symptoms may include epigastric pain, nausea, vomiting, lethargy, and drowsiness. Rare cases of gastrointestinal bleeding, acute renal failure, hypertension, and respiratory depression. Management is primarily supportive and symptomatic. Gastric lavage and activated charcoal may be considered if ingestion was recent. Hemodialysis does not significantly remove ketorolac from the blood.
Pregnancy & Lactation
Pregnancy Category C (first and second trimesters), Category D (third trimester) due to risk of premature closure of ductus arteriosus and renal dysfunction in the fetus. Contraindicated in the third trimester and during labor and delivery. Not recommended during breastfeeding as it is excreted in breast milk and may cause adverse effects in infants.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 months
Availability
Pharmacies, Hospitals
Approval Status
Approved by FDA/DGDA
Patent Status
Generic available (patent expired)
WHO Essential Medicine
YesClinical Trials
Numerous clinical trials have established Ketorolac's efficacy and safety for acute pain management. Post-marketing surveillance continues to monitor long-term effects and rare adverse events.
Lab Monitoring
- Complete blood count (CBC)
- Renal function tests (serum creatinine, BUN)
- Liver function tests (ALT, AST)
- Stool for occult blood (if GI symptoms present)
Doctor Notes
- Careful patient selection is crucial, especially regarding GI, renal, and cardiovascular risk factors.
- Limit treatment duration to 5 days to minimize adverse effects.
- Consider lowest effective dose for shortest duration.
- Monitor renal function, especially in elderly or patients with pre-existing conditions.
Patient Guidelines
- Inform your doctor about all current medications, especially blood thinners or other NSAIDs.
- Do not exceed the prescribed dose or duration of treatment (maximum 5 days for injection).
- Report any signs of stomach pain, black stools, or unusual bleeding/bruising to your doctor immediately.
- Do not self-administer; this injection must be given by a healthcare professional.
Missed Dose Advice
As Rotalac Injection is usually administered by a healthcare professional, a missed dose is unlikely. If a scheduled dose is missed, inform your doctor or nurse as soon as possible to reschedule.
Driving Precautions
May cause dizziness, drowsiness, or visual disturbances. Patients should be cautioned against driving or operating machinery if they experience these effects.
Lifestyle Advice
- Limit alcohol consumption while on this medication.
- Avoid smoking, as it may increase the risk of GI bleeding.
- Stay hydrated.
- Follow a balanced diet.
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