Xidolac
Generic Name
Ketorolac Tromethamine
Manufacturer
Beximco Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| xidolac 10 mg injection | ৳ 30.00 | N/A |
Description
Overview of the medicine
Xidolac 10 mg Injection contains Ketorolac tromethamine, a non-steroidal anti-inflammatory drug (NSAID) used for the short-term management of moderately severe acute pain that requires opioid-level analgesia.
Uses & Indications
Dosage
Adults
Single IM dose: 30-60 mg; multiple IM doses: 30 mg every 6 hours, not exceeding 120 mg/day for maximum 5 days. Single IV dose: 15-30 mg; multiple IV doses: 15-30 mg every 6 hours, not exceeding 120 mg/day for maximum 5 days. For 10mg injection, often used as single dose or as part of a regimen.
Elderly
Lower doses (e.g., 15 mg IM/IV every 6 hours) are recommended, not exceeding 60 mg/day, due to increased risk of side effects.
Renal_impairment
Contraindicated in patients with moderate to severe renal impairment. In mild impairment, lower doses are recommended (e.g., 15 mg every 6 hours), not exceeding 60 mg/day.
How to Take
For intramuscular (IM) or intravenous (IV) administration. IV bolus should be administered over at least 15 seconds. Should not be administered epidurally or intrathecally.
Mechanism of Action
Ketorolac works by inhibiting prostaglandin synthesis through non-selective cyclooxygenase (COX-1 and COX-2) enzyme inhibition, thereby reducing inflammation, pain, and fever.
Pharmacokinetics
Onset
Within 30 minutes after IM/IV administration.
Excretion
Excreted primarily in the urine (approximately 90%) and feces (approximately 6%), mainly as metabolites.
Half life
Approximately 4-6 hours in healthy adults, may be prolonged in renal impairment.
Absorption
Rapid and complete absorption after intramuscular (IM) administration, reaching peak plasma concentrations within 45-60 minutes.
Metabolism
Extensively metabolized in the liver, primarily via hydroxylation and conjugation with glucuronic acid.
Side Effects
Contraindications
- Hypersensitivity to ketorolac, aspirin, or other NSAIDs.
- Active peptic ulcer, gastrointestinal bleeding or perforation, or history of such events.
- Advanced renal impairment or risk of renal failure.
- Coagulation disorders or patients receiving anticoagulants (e.g., warfarin).
- History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs.
- As prophylactic analgesia before major surgery or during surgery with a high risk of hemorrhage.
- Pregnancy (especially third trimester), labor and delivery, and breastfeeding.
- Concomitant use with other NSAIDs, including aspirin, or probenecid, or pentoxifylline.
Drug Interactions
Lithium
Increased plasma lithium levels and risk of lithium toxicity.
Probenecid
Decreased clearance of ketorolac, leading to increased plasma levels and risk of toxicity.
Methotrexate
Increased methotrexate levels and toxicity.
Pentoxifylline
Increased risk of bleeding.
ACE inhibitors/ARBs
Increased risk of renal impairment, especially in elderly or dehydrated patients.
Other NSAIDs, aspirin
Increased risk of gastrointestinal adverse effects.
Diuretics (e.g., furosemide)
Reduced natriuretic effect of diuretics, risk of renal impairment.
Anticoagulants (e.g., warfarin, heparin)
Increased risk of bleeding.
Storage
Store at controlled room temperature (20°C to 25°C), excursions permitted to 15°C to 30°C. Protect from light. Do not freeze.
Overdose
Symptoms may include epigastric pain, nausea, vomiting, lethargy, and drowsiness. Rare cases of GI bleeding, metabolic acidosis, hypertension, acute renal failure, and respiratory depression. Management involves symptomatic and supportive care. No specific antidote.
Pregnancy & Lactation
Contraindicated in pregnancy (especially third trimester), labor, delivery, and breastfeeding due to potential fetal harm (premature closure of ductus arteriosus, renal dysfunction) and effects on labor, and excretion in breast milk.
Side Effects
Contraindications
- Hypersensitivity to ketorolac, aspirin, or other NSAIDs.
- Active peptic ulcer, gastrointestinal bleeding or perforation, or history of such events.
- Advanced renal impairment or risk of renal failure.
- Coagulation disorders or patients receiving anticoagulants (e.g., warfarin).
- History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs.
- As prophylactic analgesia before major surgery or during surgery with a high risk of hemorrhage.
- Pregnancy (especially third trimester), labor and delivery, and breastfeeding.
- Concomitant use with other NSAIDs, including aspirin, or probenecid, or pentoxifylline.
Drug Interactions
Lithium
Increased plasma lithium levels and risk of lithium toxicity.
Probenecid
Decreased clearance of ketorolac, leading to increased plasma levels and risk of toxicity.
Methotrexate
Increased methotrexate levels and toxicity.
Pentoxifylline
Increased risk of bleeding.
ACE inhibitors/ARBs
Increased risk of renal impairment, especially in elderly or dehydrated patients.
Other NSAIDs, aspirin
Increased risk of gastrointestinal adverse effects.
Diuretics (e.g., furosemide)
Reduced natriuretic effect of diuretics, risk of renal impairment.
Anticoagulants (e.g., warfarin, heparin)
Increased risk of bleeding.
Storage
Store at controlled room temperature (20°C to 25°C), excursions permitted to 15°C to 30°C. Protect from light. Do not freeze.
Overdose
Symptoms may include epigastric pain, nausea, vomiting, lethargy, and drowsiness. Rare cases of GI bleeding, metabolic acidosis, hypertension, acute renal failure, and respiratory depression. Management involves symptomatic and supportive care. No specific antidote.
Pregnancy & Lactation
Contraindicated in pregnancy (especially third trimester), labor, delivery, and breastfeeding due to potential fetal harm (premature closure of ductus arteriosus, renal dysfunction) and effects on labor, and excretion in breast milk.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years, depending on the manufacturer and storage conditions. Refer to the product label.
Availability
Pharmacies, hospitals, clinics
Approval Status
Approved by regulatory bodies (e.g., FDA, DGDA)
Patent Status
Off-patent
WHO Essential Medicine
YesClinical Trials
Extensive clinical trials have established ketorolac's efficacy and safety in various acute pain settings, demonstrating its potent analgesic effects comparable to opioids but with different side effect profiles.
Lab Monitoring
- Renal function (creatinine, BUN)
- Liver function tests (ALT, AST)
- Complete blood count (CBC) if used for prolonged periods or in high-risk patients
- Blood pressure monitoring
Doctor Notes
- Maximum treatment duration must not exceed 5 days.
- Careful patient selection is crucial, especially regarding GI, renal, and cardiovascular history.
- Monitor renal function, especially in elderly or patients with pre-existing conditions.
Patient Guidelines
- Report any signs of GI bleeding (e.g., black, tarry stools, coffee-ground vomit) immediately.
- Do not use for more than 5 days for acute pain management.
- Inform your doctor about all other medications you are taking, especially blood thinners or other NSAIDs.
Missed Dose Advice
Since this is an injection administered by a healthcare professional, a missed dose is unlikely. If a scheduled dose is missed, inform your doctor or nurse immediately 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
- Avoid alcohol consumption.
- Stay hydrated unless contraindicated.
- Follow your doctor's instructions for rest and activity.
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