Rotalac
Generic Name
Ketorolac Tromethamine
Manufacturer
Leading Pharmaceutical Manufacturer
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| rotalac 10 mg tablet | ৳ 12.00 | ৳ 180.00 |
Description
Overview of the medicine
Rotalac 10 mg Tablet contains Ketorolac Tromethamine, a non-steroidal anti-inflammatory drug (NSAID) used for the short-term management of moderate to moderately severe acute pain. It works by reducing hormones that cause inflammation and pain in the body.
Uses & Indications
Dosage
Adults
Oral: 10 mg every 4-6 hours as needed, not to exceed 40 mg in 24 hours. Treatment duration should not exceed 5 days.
Elderly
Lower doses may be required (e.g., 10 mg every 6-8 hours). Use with caution and monitor renal function.
Renal_impairment
Dosage reduction is necessary. Contraindicated in severe renal impairment (creatinine clearance <30 mL/min).
How to Take
Take the tablet orally with a full glass of water. It can be taken with food or milk to minimize gastrointestinal upset.
Mechanism of Action
Ketorolac Tromethamine inhibits prostaglandin synthesis by blocking the enzyme cyclooxygenase (COX-1 and COX-2). This reduces the production of prostaglandins, which are involved in pain, inflammation, and fever.
Pharmacokinetics
Onset
Approximately 1 hour (oral).
Excretion
Mainly excreted in urine (91%), with a small portion (6%) excreted in feces. Renal clearance is the primary elimination route.
Half life
Approximately 4-6 hours.
Absorption
Rapidly and completely absorbed after oral administration. Peak plasma concentrations are reached within 30-60 minutes.
Metabolism
Primarily hepatic, mainly by glucuronidation. Some hydroxylation occurs.
Side Effects
Contraindications
- Hypersensitivity to Ketorolac or other NSAIDs
- Active peptic ulcer, gastrointestinal bleeding or perforation
- Severe renal impairment or advanced renal disease
- History of cerebrovascular bleeding or clotting disorders
- Pregnancy (especially third trimester) and lactation
- Concomitant use with other NSAIDs, aspirin, or anticoagulants
- Before major surgery due to increased risk of bleeding
Drug Interactions
Lithium
Increased plasma lithium concentrations, potentially leading to toxicity.
SSRIs/SNRIs
Increased risk of bleeding.
Methotrexate
Increased methotrexate toxicity.
Other NSAIDs/Aspirin
Increased risk of gastrointestinal side effects and bleeding.
ACE inhibitors/Diuretics
Reduced antihypertensive and diuretic effects, increased risk of renal impairment.
Anticoagulants (e.g., Warfarin)
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 of overdose may include nausea, vomiting, abdominal pain, drowsiness, lethargy, and renal dysfunction. Management is primarily supportive; there is no specific antidote. Gastric decontamination (e.g., activated charcoal) may be considered if ingestion is recent.
Pregnancy & Lactation
Contraindicated during late pregnancy due to potential for premature closure of the fetal ductus arteriosus. Not recommended during breastfeeding as ketorolac is excreted in breast milk and may cause adverse effects in the infant.
Side Effects
Contraindications
- Hypersensitivity to Ketorolac or other NSAIDs
- Active peptic ulcer, gastrointestinal bleeding or perforation
- Severe renal impairment or advanced renal disease
- History of cerebrovascular bleeding or clotting disorders
- Pregnancy (especially third trimester) and lactation
- Concomitant use with other NSAIDs, aspirin, or anticoagulants
- Before major surgery due to increased risk of bleeding
Drug Interactions
Lithium
Increased plasma lithium concentrations, potentially leading to toxicity.
SSRIs/SNRIs
Increased risk of bleeding.
Methotrexate
Increased methotrexate toxicity.
Other NSAIDs/Aspirin
Increased risk of gastrointestinal side effects and bleeding.
ACE inhibitors/Diuretics
Reduced antihypertensive and diuretic effects, increased risk of renal impairment.
Anticoagulants (e.g., Warfarin)
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 of overdose may include nausea, vomiting, abdominal pain, drowsiness, lethargy, and renal dysfunction. Management is primarily supportive; there is no specific antidote. Gastric decontamination (e.g., activated charcoal) may be considered if ingestion is recent.
Pregnancy & Lactation
Contraindicated during late pregnancy due to potential for premature closure of the fetal ductus arteriosus. Not recommended during breastfeeding as ketorolac is excreted in breast milk and may cause adverse effects in the infant.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
2-3 years from manufacturing date.
Availability
Pharmacies, Hospitals
Approval Status
Approved (Globally widely used)
Patent Status
Off-patent
WHO Essential Medicine
YesClinical Trials
Extensively studied in numerous clinical trials for its efficacy and safety in managing acute pain, particularly post-operative pain. Trials confirm its effectiveness as a short-term analgesic.
Lab Monitoring
- Complete Blood Count (CBC) (especially with prolonged use)
- Renal function tests (Serum creatinine, BUN)
- Liver function tests (ALT, AST)
Doctor Notes
- Emphasize short-term use (maximum 5 days) due to significant risks.
- Always prescribe the lowest effective dose.
- Monitor renal function, especially in elderly patients or those with pre-existing renal conditions.
- Caution advised in patients with cardiovascular risk factors.
- Educate patients on symptoms of GI bleeding and cardiovascular events.
Patient Guidelines
- Take this medicine exactly as prescribed by your doctor and do not exceed the recommended dose or duration of treatment (maximum 5 days).
- Take with food or milk to reduce stomach upset.
- Report any signs of unusual bleeding, black/tarry stools, severe stomach pain, or allergic reactions (rash, swelling, difficulty breathing) to your doctor immediately.
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 double the dose to catch up.
Driving Precautions
This medicine may cause dizziness, drowsiness, or visual disturbances. If you experience these effects, avoid driving or operating machinery.
Lifestyle Advice
- Avoid alcohol consumption while taking this medicine, as it may increase the risk of stomach bleeding.
- Do not smoke, as smoking can increase the risk of stomach ulcers.
- Stay adequately hydrated.
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