Toralin
Generic Name
Ketorolac Tromethamine
Manufacturer
Leading Pharmaceutical Company
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| toralin 60 mg injection | ৳ 95.00 | N/A |
Description
Overview of the medicine
Toralin 60 mg Injection contains Ketorolac Tromethamine, a non-steroidal anti-inflammatory drug (NSAID). It is used for the short-term management of moderate to severe acute pain, such as post-operative pain. It works by reducing pain, inflammation, and fever by inhibiting the production of certain natural substances in the body.
Uses & Indications
Dosage
Adults
Single IM dose: 60 mg. Multiple IM/IV doses: 30 mg every 6 hours. Total 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 or IV every 6 hours, with a maximum daily dose of 60 mg, is recommended. Total treatment duration should not exceed 5 days.
Renal_impairment
Contraindicated in advanced renal impairment. For mild to moderate renal impairment, dosage reduction is necessary (e.g., 15 mg every 6 hours, max 60 mg/day).
How to Take
Toralin 60 mg Injection can be administered either intramuscularly (IM) or intravenously (IV). For IV administration, it should be given slowly over a minimum of 15 seconds. It is intended for short-term use only, typically not exceeding 5 days.
Mechanism of Action
Ketorolac works by inhibiting the activity of cyclooxygenase (COX-1 and COX-2) enzymes, which are responsible for the synthesis of prostaglandins. Prostaglandins are lipid compounds that mediate pain, inflammation, and fever. By blocking prostaglandin synthesis, ketorolac effectively reduces these symptoms.
Pharmacokinetics
Onset
Analgesic effect typically begins within 30 minutes.
Excretion
Approximately 90% is excreted renally, with about 6% excreted in feces. Clearance is reduced in elderly patients and those with renal impairment.
Half life
Mean plasma elimination half-life is approximately 5 to 6 hours.
Absorption
Rapid and complete absorption after intramuscular (IM) administration. Peak plasma concentrations are achieved within 30 to 60 minutes.
Metabolism
Primarily hepatic, via glucuronidation and hydroxylation, to inactive metabolites.
Side Effects
Contraindications
- Known hypersensitivity to ketorolac, aspirin, or other NSAIDs.
- Active peptic ulcer disease, recent gastrointestinal bleeding or perforation, or a history of these conditions.
- Advanced renal impairment or risk of renal failure due to dehydration.
- Cerebrovascular bleeding or bleeding diathesis.
- Coagulation disorders or patients receiving anticoagulants.
- As prophylactic analgesic before major surgery or intra-operatively with hemostasis risk.
- During labor and delivery.
- In nursing mothers due to potential adverse effects on the infant.
- In patients with aspirin-sensitive asthma.
- For peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.
Drug Interactions
Lithium
Increased plasma lithium levels, potentially leading to toxicity.
Methotrexate
Increased plasma methotrexate levels, potentially leading to toxicity.
Corticosteroids
Increased risk of gastrointestinal ulceration and bleeding.
Diuretics (e.g., Furosemide)
Reduced diuretic and antihypertensive effects; increased risk of renal impairment.
Anticoagulants (e.g., Warfarin)
Increased risk of bleeding due to additive antiplatelet effects and potential displacement from protein binding.
SSRIs (Selective Serotonin Reuptake Inhibitors)
Increased risk of gastrointestinal bleeding.
Antiplatelet agents (e.g., Aspirin, Clopidogrel)
Increased risk of gastrointestinal bleeding.
ACE inhibitors/Angiotensin Receptor Blockers (ARBs)
Reduced antihypertensive effect and increased risk of renal impairment, especially in elderly or volume-depleted patients.
Storage
Store below 25°C (77°F) in a dry place. Protect from light. Do not freeze. Keep out of reach of children.
Overdose
Symptoms of ketorolac overdose may include abdominal pain, nausea, vomiting, lethargy, and tinnitus. More severe effects like acute renal failure, respiratory depression, and coma are possible with massive overdose. Management involves symptomatic and supportive care. There is no specific antidote. Dialysis may be beneficial in cases of massive overdose.
Pregnancy & Lactation
Toralin is contraindicated during the third trimester of pregnancy due to the risk of premature closure of the fetal ductus arteriosus and potential renal dysfunction in the fetus. It should be avoided during labor and delivery, and in nursing mothers as ketorolac is excreted in human milk and could have adverse effects on the infant.
Side Effects
Contraindications
- Known hypersensitivity to ketorolac, aspirin, or other NSAIDs.
- Active peptic ulcer disease, recent gastrointestinal bleeding or perforation, or a history of these conditions.
- Advanced renal impairment or risk of renal failure due to dehydration.
- Cerebrovascular bleeding or bleeding diathesis.
- Coagulation disorders or patients receiving anticoagulants.
- As prophylactic analgesic before major surgery or intra-operatively with hemostasis risk.
- During labor and delivery.
- In nursing mothers due to potential adverse effects on the infant.
- In patients with aspirin-sensitive asthma.
- For peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.
Drug Interactions
Lithium
Increased plasma lithium levels, potentially leading to toxicity.
Methotrexate
Increased plasma methotrexate levels, potentially leading to toxicity.
Corticosteroids
Increased risk of gastrointestinal ulceration and bleeding.
Diuretics (e.g., Furosemide)
Reduced diuretic and antihypertensive effects; increased risk of renal impairment.
Anticoagulants (e.g., Warfarin)
Increased risk of bleeding due to additive antiplatelet effects and potential displacement from protein binding.
SSRIs (Selective Serotonin Reuptake Inhibitors)
Increased risk of gastrointestinal bleeding.
Antiplatelet agents (e.g., Aspirin, Clopidogrel)
Increased risk of gastrointestinal bleeding.
ACE inhibitors/Angiotensin Receptor Blockers (ARBs)
Reduced antihypertensive effect and increased risk of renal impairment, especially in elderly or volume-depleted patients.
Storage
Store below 25°C (77°F) in a dry place. Protect from light. Do not freeze. Keep out of reach of children.
Overdose
Symptoms of ketorolac overdose may include abdominal pain, nausea, vomiting, lethargy, and tinnitus. More severe effects like acute renal failure, respiratory depression, and coma are possible with massive overdose. Management involves symptomatic and supportive care. There is no specific antidote. Dialysis may be beneficial in cases of massive overdose.
Pregnancy & Lactation
Toralin is contraindicated during the third trimester of pregnancy due to the risk of premature closure of the fetal ductus arteriosus and potential renal dysfunction in the fetus. It should be avoided during labor and delivery, and in nursing mothers as ketorolac is excreted in human milk and could have adverse effects on the infant.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2 to 3 years from the date of manufacture, depending on manufacturer specifications. Check packaging for exact expiry date.
Availability
Pharmacies, hospitals, clinics
Approval Status
Approved by regulatory authorities
Patent Status
Off-patent
WHO Essential Medicine
YesClinical Trials
Ketorolac has undergone extensive clinical trials demonstrating its efficacy and safety for acute pain management. Studies have shown its comparable analgesic efficacy to opioids in various post-operative pain settings, while also highlighting the importance of its short-term use due to potential risks.
Lab Monitoring
- Renal function tests (serum creatinine, BUN) before and during treatment, especially in patients with pre-existing renal impairment or risk factors.
- Liver function tests (ALT, AST) if treatment is extended or if symptoms of liver dysfunction occur.
- Complete blood count (CBC) to monitor for signs of anemia or bleeding if used for more than a few days.
- Stool for occult blood if gastrointestinal bleeding is suspected.
Doctor Notes
- Strictly adhere to the maximum 5-day treatment duration to minimize risk of adverse events.
- Thoroughly assess patient's cardiovascular, gastrointestinal, and renal risk factors before initiating therapy.
- Monitor for signs of bleeding, especially in patients on anticoagulants or with a history of GI issues.
- Consider lowest effective dose for the shortest duration.
- Contraindicated in patients with advanced renal disease and during the third trimester of pregnancy.
Patient Guidelines
- Toralin Injection is for short-term use only (maximum 5 days). Do not use for longer than prescribed.
- Inform your doctor about all your medical conditions and medications, especially if you have a history of stomach ulcers, kidney disease, heart disease, or bleeding disorders.
- Report any signs of unusual bleeding, black stools, severe stomach pain, or skin rash immediately to your doctor.
- Avoid consuming alcohol while on this medication as it may increase the risk of stomach problems.
Missed Dose Advice
As Toralin Injection is typically administered in a clinical setting for acute pain, a missed dose is unlikely. If part of a multi-dose regimen and a dose is missed, contact your doctor immediately for advice. Do not take a double dose to make up for a missed one.
Driving Precautions
Toralin (Ketorolac) may cause dizziness, drowsiness, or visual disturbances in some individuals. Patients should be advised to exercise caution when driving or operating machinery until they know how the medication affects them.
Lifestyle Advice
- Limit alcohol intake during treatment.
- Avoid activities that require alertness if experiencing dizziness or drowsiness.
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