Rolac
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 |
|---|---|---|
| rolac 10 mg injection | ৳ 32.13 | N/A |
Description
Overview of the medicine
Ketorolac is a potent non-steroidal anti-inflammatory drug (NSAID) used for the short-term management of moderately severe acute pain. It works by inhibiting prostaglandin synthesis, thereby reducing pain, inflammation, and fever.
Uses & Indications
Dosage
Adults
Initial dose 30 mg IM or IV, then 10-30 mg every 4-6 hours as needed. Maximum dose 90 mg/day for up to 5 days. For patients <50 kg or >65 years, maximum 60 mg/day.
Elderly
Reduced dosage recommended, maximum 60 mg/day.
Renal_impairment
Contraindicated in severe renal impairment. Reduced dosage (e.g., maximum 30 mg/day) in moderate impairment, with close monitoring.
How to Take
Administered intramuscularly (IM) or intravenously (IV). For IV administration, inject slowly over at least 15 seconds. IM injection should be given deep into a large muscle.
Mechanism of Action
Ketorolac inhibits prostaglandin synthesis by blocking the cyclooxygenase (COX-1 and COX-2) enzymes, which are responsible for converting arachidonic acid into prostaglandins, mediators of pain and inflammation.
Pharmacokinetics
Onset
Analgesic effect typically begins within 1 hour after IM or IV administration.
Excretion
Primarily renal, with approximately 91% of the dose excreted in urine and 6% in feces.
Half life
Approximately 5-6 hours in healthy adults, prolonged in elderly and renally impaired patients.
Absorption
Rapid and complete absorption after intramuscular (IM) administration, with peak plasma concentrations occurring within 30-60 minutes. Bioavailability is 100%.
Metabolism
Primarily hepatic, mainly via hydroxylation and conjugation with glucuronic acid. Major metabolites are inactive.
Side Effects
Contraindications
- Active peptic ulcer disease, recent gastrointestinal bleeding or perforation, or history of such conditions.
- History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs.
- Severe renal impairment, advanced heart failure, or at risk of renal failure.
- Peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.
- Coagulation disorders, hemorrhagic diathesis, or patients on anticoagulants.
- Pregnancy, labor and delivery, and lactation.
- Hypersensitivity to ketorolac or any component of the formulation.
- Concomitant use with other NSAIDs, aspirin, or probenecid.
- Neuroaxial (epidural or intrathecal) administration.
Drug Interactions
Lithium
Ketorolac can increase plasma lithium levels, leading to toxicity.
Probenecid
Increases ketorolac plasma levels and half-life, leading to increased toxicity.
SSRIs/SNRIs
Increased risk of gastrointestinal bleeding.
Methotrexate
Increases methotrexate toxicity.
Other NSAIDs
Concomitant use with other NSAIDs or aspirin increases the risk of adverse effects.
Corticosteroids
Increased risk of gastrointestinal ulceration/bleeding.
ACE inhibitors/ARBs
Increased risk of renal impairment and reduced antihypertensive effect.
Diuretics (e.g., Furosemide, Thiazides)
May reduce diuretic and antihypertensive effects; risk of renal impairment.
Anticoagulants (e.g., Warfarin, Heparin)
Increased risk of bleeding.
Antiplatelet agents (e.g., Aspirin, Clopidogrel)
Increased risk of gastrointestinal bleeding.
Storage
Store below 25°C (77°F). Protect from light. Do not freeze. Keep out of reach of children.
Overdose
Symptoms of overdose include abdominal pain, nausea, vomiting, lethargy, headache, tinnitus, and drowsiness. Severe cases may involve gastrointestinal bleeding, acute renal failure, respiratory depression, and coma. Management is supportive and symptomatic; gastric lavage or activated charcoal is not usually effective for injections. Hemodialysis is not considered effective in removing ketorolac from circulation.
Pregnancy & Lactation
Contraindicated during pregnancy, particularly in the third trimester due to the risk of premature closure of the fetal ductus arteriosus. Contraindicated during labor and delivery, and in breastfeeding mothers as ketorolac is excreted in breast milk.
Side Effects
Contraindications
- Active peptic ulcer disease, recent gastrointestinal bleeding or perforation, or history of such conditions.
- History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs.
- Severe renal impairment, advanced heart failure, or at risk of renal failure.
- Peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.
- Coagulation disorders, hemorrhagic diathesis, or patients on anticoagulants.
- Pregnancy, labor and delivery, and lactation.
- Hypersensitivity to ketorolac or any component of the formulation.
- Concomitant use with other NSAIDs, aspirin, or probenecid.
- Neuroaxial (epidural or intrathecal) administration.
Drug Interactions
Lithium
Ketorolac can increase plasma lithium levels, leading to toxicity.
Probenecid
Increases ketorolac plasma levels and half-life, leading to increased toxicity.
SSRIs/SNRIs
Increased risk of gastrointestinal bleeding.
Methotrexate
Increases methotrexate toxicity.
Other NSAIDs
Concomitant use with other NSAIDs or aspirin increases the risk of adverse effects.
Corticosteroids
Increased risk of gastrointestinal ulceration/bleeding.
ACE inhibitors/ARBs
Increased risk of renal impairment and reduced antihypertensive effect.
Diuretics (e.g., Furosemide, Thiazides)
May reduce diuretic and antihypertensive effects; risk of renal impairment.
Anticoagulants (e.g., Warfarin, Heparin)
Increased risk of bleeding.
Antiplatelet agents (e.g., Aspirin, Clopidogrel)
Increased risk of gastrointestinal bleeding.
Storage
Store below 25°C (77°F). Protect from light. Do not freeze. Keep out of reach of children.
Overdose
Symptoms of overdose include abdominal pain, nausea, vomiting, lethargy, headache, tinnitus, and drowsiness. Severe cases may involve gastrointestinal bleeding, acute renal failure, respiratory depression, and coma. Management is supportive and symptomatic; gastric lavage or activated charcoal is not usually effective for injections. Hemodialysis is not considered effective in removing ketorolac from circulation.
Pregnancy & Lactation
Contraindicated during pregnancy, particularly in the third trimester due to the risk of premature closure of the fetal ductus arteriosus. Contraindicated during labor and delivery, and in breastfeeding mothers as ketorolac is excreted in breast milk.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Generally 24 to 36 months from the date of manufacture, depending on the manufacturer and specific formulation. Refer to the product packaging for exact details.
Availability
Pharmacies, Hospitals
Approval Status
Approved
Patent Status
Off-patent
WHO Essential Medicine
YesClinical Trials
Ketorolac has undergone extensive clinical trials demonstrating its efficacy in managing acute pain across various surgical and medical conditions. Studies have shown it to be an effective alternative or adjunct to opioid analgesics for short-term pain relief.
Lab Monitoring
- Renal function tests (serum creatinine, BUN) periodically, especially in elderly or patients with pre-existing renal impairment.
- Liver function tests (ALT, AST) if signs of liver dysfunction develop.
- Complete blood count (CBC) with differential, especially if prolonged use is considered (though not recommended).
- Coagulation parameters (PT/INR, aPTT) in patients on anticoagulants or with bleeding risk.
Doctor Notes
- Emphasize the strict 5-day maximum duration of treatment due to serious risks.
- Assess renal, cardiovascular, and gastrointestinal risk factors before and during treatment.
- Not recommended for chronic pain management.
Patient Guidelines
- Inform your doctor about your complete medical history, especially heart, kidney, or liver disease, and any allergies.
- Report any signs of stomach bleeding (e.g., black, tarry stools; vomiting blood) or allergic reactions immediately.
- Do not use this medication for more than 5 days due to increased risk of serious side effects.
- Inform your doctor about all other medications, including over-the-counter drugs, herbal supplements, and vitamins.
Missed Dose Advice
As Rolac Injection is typically used for acute pain, administer the dose as soon as remembered if still needed. Do not administer a double dose to make up for a missed one.
Driving Precautions
Rolac Injection may cause dizziness, drowsiness, or visual disturbances. Patients should exercise caution when driving or operating machinery until they know how the medication affects them.
Lifestyle Advice
- Avoid alcohol consumption while taking this medication as it increases the risk of gastrointestinal adverse effects.
- Maintain adequate hydration.
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