Toralin
Generic Name
Ketorolac Tromethamine
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| toralin 30 mg injection | ৳ 55.00 | N/A |
Description
Overview of the medicine
Toralin 30 mg Injection contains Ketorolac Tromethamine, a potent non-steroidal anti-inflammatory drug (NSAID) primarily used for the short-term management of moderately severe to severe acute pain. It is often used post-operatively or for other acute pain conditions where opioid analgesics may be considered, but with a non-opioid alternative.
Uses & Indications
Dosage
Adults
Initial dose 30 mg IV or IM. Subsequent doses of 15 mg or 30 mg can be given every 6 hours as needed. Maximum daily dose should not exceed 120 mg. Treatment duration should not exceed 5 days.
Elderly
For patients ≥ 65 years, the initial and subsequent doses should be 15 mg every 6 hours. Maximum daily dose should not exceed 60 mg. Treatment duration should not exceed 5 days.
Renal_impairment
Contraindicated in patients with moderate to severe renal impairment (serum creatinine > 1.6 mg/dL). For mild renal impairment, the dose should be reduced to 15 mg every 6 hours, with a maximum daily dose of 60 mg. Treatment duration should not exceed 5 days.
How to Take
For IV administration, Toralin 30 mg Injection should be given as a single intravenous bolus over no less than 15 seconds. For IM administration, it should be injected slowly and deeply into a large muscle. Oral therapy should be substituted as soon as possible.
Mechanism of Action
Ketorolac Tromethamine is a non-selective NSAID that exerts its analgesic, anti-inflammatory, and antipyretic effects by inhibiting prostaglandin synthesis through the inhibition of cyclooxygenase (COX-1 and COX-2) enzymes. This reduces the formation of prostaglandins, which are mediators of pain, inflammation, and fever.
Pharmacokinetics
Onset
Analgesia typically begins within 30 minutes after IM and within 1 minute after IV administration.
Excretion
Mainly excreted by the kidneys (approximately 91% of the dose), with a small amount excreted in feces (approximately 6%).
Half life
The elimination half-life is approximately 4-6 hours in healthy adults, but can be prolonged in elderly patients or those with renal impairment.
Absorption
Rapid and complete absorption after intramuscular (IM) or intravenous (IV) administration. Peak plasma concentrations are reached within 30-50 minutes after IM and 1-3 minutes after IV administration.
Metabolism
Primarily metabolized in the liver via hydroxylation and glucuronide conjugation. The metabolites are inactive.
Side Effects
Contraindications
- Active peptic ulcer disease, recent gastrointestinal (GI) bleeding or perforation, history of GI bleeding or perforation related to NSAID use.
- Advanced renal impairment or at risk of renal failure due to volume depletion.
- Cerebrovascular bleeding or other bleeding disorders, including confirmed or suspected hemorrhagic diathesis.
- Hypersensitivity to ketorolac, aspirin, or other NSAIDs (e.g., patients with aspirin-induced asthma, urticaria, or allergic-type reactions).
- Concomitant use with other NSAIDs, aspirin, anticoagulants (e.g., warfarin), pentoxifylline, or probenecid.
- As prophylactic analgesic before major surgery or during surgery with a high risk of hemorrhage.
- During labor and delivery.
- Patients undergoing coronary artery bypass graft (CABG) surgery.
Drug Interactions
Lithium
Increased plasma lithium concentrations and potential for lithium toxicity.
Probenecid
Reduced clearance of ketorolac, leading to increased plasma levels and prolonged half-life (contraindicated).
Methotrexate
Increased plasma concentrations of methotrexate, potentially leading to increased toxicity.
Pentoxifylline
Increased risk of bleeding (contraindicated).
Other NSAIDs and Aspirin
Increased risk of gastrointestinal adverse events, including bleeding and ulceration.
Warfarin and other Anticoagulants
Increased risk of serious bleeding events.
Diuretics (e.g., Furosemide, Thiazides)
Reduced natriuretic and diuretic effect.
ACE Inhibitors and Angiotensin Receptor Blockers (ARBs)
Reduced antihypertensive effect and increased risk of renal impairment, especially in elderly or volume-depleted patients.
Storage
Store below 30°C. Protect from light. Do not freeze. Keep out of reach of children.
Overdose
Symptoms of overdose may include nausea, vomiting, epigastric pain, lethargy, drowsiness. Rarely, GI bleeding, hypertension, acute renal failure, respiratory depression, and coma may occur. Management is symptomatic and supportive. There is no specific antidote. Gastric decontamination or activated charcoal may be considered if an oral overdose occurred recently.
Pregnancy & Lactation
Pregnancy: Category C in early pregnancy; Category D in the third trimester. Use in late pregnancy should be avoided as it may cause premature closure of the fetal ductus arteriosus. Lactation: Ketorolac is excreted in human milk. Due to the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Side Effects
Contraindications
- Active peptic ulcer disease, recent gastrointestinal (GI) bleeding or perforation, history of GI bleeding or perforation related to NSAID use.
- Advanced renal impairment or at risk of renal failure due to volume depletion.
- Cerebrovascular bleeding or other bleeding disorders, including confirmed or suspected hemorrhagic diathesis.
- Hypersensitivity to ketorolac, aspirin, or other NSAIDs (e.g., patients with aspirin-induced asthma, urticaria, or allergic-type reactions).
- Concomitant use with other NSAIDs, aspirin, anticoagulants (e.g., warfarin), pentoxifylline, or probenecid.
- As prophylactic analgesic before major surgery or during surgery with a high risk of hemorrhage.
- During labor and delivery.
- Patients undergoing coronary artery bypass graft (CABG) surgery.
Drug Interactions
Lithium
Increased plasma lithium concentrations and potential for lithium toxicity.
Probenecid
Reduced clearance of ketorolac, leading to increased plasma levels and prolonged half-life (contraindicated).
Methotrexate
Increased plasma concentrations of methotrexate, potentially leading to increased toxicity.
Pentoxifylline
Increased risk of bleeding (contraindicated).
Other NSAIDs and Aspirin
Increased risk of gastrointestinal adverse events, including bleeding and ulceration.
Warfarin and other Anticoagulants
Increased risk of serious bleeding events.
Diuretics (e.g., Furosemide, Thiazides)
Reduced natriuretic and diuretic effect.
ACE Inhibitors and Angiotensin Receptor Blockers (ARBs)
Reduced antihypertensive effect and increased risk of renal impairment, especially in elderly or volume-depleted patients.
Storage
Store below 30°C. Protect from light. Do not freeze. Keep out of reach of children.
Overdose
Symptoms of overdose may include nausea, vomiting, epigastric pain, lethargy, drowsiness. Rarely, GI bleeding, hypertension, acute renal failure, respiratory depression, and coma may occur. Management is symptomatic and supportive. There is no specific antidote. Gastric decontamination or activated charcoal may be considered if an oral overdose occurred recently.
Pregnancy & Lactation
Pregnancy: Category C in early pregnancy; Category D in the third trimester. Use in late pregnancy should be avoided as it may cause premature closure of the fetal ductus arteriosus. Lactation: Ketorolac is excreted in human milk. Due to the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 to 36 months from the date of manufacture, depending on the manufacturer.
Availability
Pharmacies, hospitals, clinics
Approval Status
Approved by major regulatory bodies
Patent Status
Generic available
WHO Essential Medicine
YesClinical Trials
Extensive clinical trials have demonstrated ketorolac's efficacy in managing acute pain, often comparing its analgesic potency to that of opioids in various surgical and non-surgical settings. Studies also focus on its safety profile, particularly concerning gastrointestinal and cardiovascular risks with short-term use.
Lab Monitoring
- Renal function tests (serum creatinine, BUN) before and during treatment, especially in elderly or renally impaired patients.
- Liver function tests (ALT, AST) if treatment exceeds 5 days or if symptoms of liver dysfunction occur.
- Complete Blood Count (CBC) if long-term use is unavoidable.
Doctor Notes
- Ensure total treatment duration with ketorolac (all formulations combined) does not exceed 5 days to minimize serious adverse effects.
- Carefully assess renal function before initiating treatment, especially in elderly or dehydrated patients.
- Avoid concomitant use with other NSAIDs or drugs that increase bleeding risk.
- Monitor for signs of GI bleeding or renal impairment.
- Patients transitioning from parenteral to oral ketorolac should have their total daily dose not exceeding the recommended maximums for either route.
Patient Guidelines
- This medicine is for short-term use only, typically not exceeding 5 days.
- Report any signs of unusual bleeding, such as black stools, vomit resembling coffee grounds, or easy bruising.
- Immediately inform your doctor if you experience severe stomach pain, allergic reactions (rash, swelling, difficulty breathing), or changes in urine output.
- Do not take other NSAIDs or aspirin concurrently without consulting your doctor.
- Avoid alcohol consumption during treatment.
- The injection will be administered by a healthcare professional.
- Ensure you inform your doctor about all your current medications and medical conditions.
Missed Dose Advice
Since this medicine is given under medical supervision, a missed dose is unlikely. If a scheduled dose is missed, inform your doctor or nurse immediately to reschedule.
Driving Precautions
Toralin may cause dizziness, drowsiness, or visual disturbances. Patients should be cautioned against operating machinery or driving if they experience these effects.
Lifestyle Advice
- Maintain adequate hydration by drinking plenty of fluids.
- Avoid activities that could lead to injury or falls while on medication, especially if experiencing dizziness.
- Discuss any dietary restrictions or preferences with your healthcare provider.
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