Xidolac
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 |
|---|---|---|
| xidolac 30 mg injection | ৳ 55.00 | 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 is often used for post-operative pain or pain that requires opioid-level analgesia.
Uses & Indications
Dosage
Adults
Initial dose: 30 mg IM or IV single dose, or 30 mg IM or IV every 6 hours. Maximum daily dose: 120 mg. Treatment duration not to exceed 5 days.
Elderly
For patients ≥65 years, or those weighing <50 kg, or with moderately elevated serum creatinine, a lower dose is recommended: 15 mg IM or IV every 6 hours. Maximum daily dose: 60 mg. Not to exceed 5 days.
Renal_impairment
Contraindicated in patients with advanced renal impairment or at risk of renal failure. For mild to moderate renal impairment, dose reduction (e.g., 15 mg every 6 hours, max 60 mg/day) is recommended. Carefully monitor renal function.
How to Take
For intramuscular (IM) administration, inject slowly and deeply into a large muscle (e.g., gluteus maximus). For intravenous (IV) administration, administer the bolus dose over at least 15 seconds. It can be given as a single dose or multiple doses.
Mechanism of Action
Ketorolac works by inhibiting prostaglandin synthesis through the non-selective inhibition of cyclooxygenase (COX-1 and COX-2) enzymes. Prostaglandins are mediators of pain, inflammation, and fever.
Pharmacokinetics
Onset
Analgesia usually begins within 30 minutes following IM or IV administration.
Excretion
Primarily renal (approximately 90% of the dose is excreted in urine, with 60% as unchanged drug and 40% as metabolites). A small amount is excreted in feces.
Half life
Approximately 5-6 hours in healthy adults, but can be prolonged in elderly patients or those with renal impairment.
Absorption
Rapid and complete after intramuscular (IM) administration, with peak plasma concentrations occurring within 30-60 minutes. Bioavailability is 100%.
Metabolism
Primarily hepatic, mainly through hydroxylation and conjugation with glucuronic acid. Major metabolite is p-hydroxyketorolac.
Side Effects
Contraindications
- Hypersensitivity to ketorolac, aspirin, or other NSAIDs
- Active peptic ulcer, recent gastrointestinal bleeding or perforation
- Moderate to severe renal impairment or risk of renal failure
- Confirmed or suspected cerebrovascular bleeding, hemorrhagic diathesis, hemostatic abnormalities
- Patients on anticoagulants (e.g., warfarin, heparin)
- Before major surgery, due to increased risk of bleeding
- Pregnancy (especially third trimester), labor and delivery, breastfeeding
- Concurrent use with other NSAIDs, oxpentifylline, probenecid, or lithium
Drug Interactions
Lithium
Ketorolac can increase plasma lithium levels, potentially leading to lithium toxicity. Avoid concomitant use or monitor lithium levels closely.
Probenecid
Significantly increases ketorolac plasma levels and half-life. Concomitant use is contraindicated.
Methotrexate
Increases methotrexate levels and toxicity. Concomitant use should be avoided.
Corticosteroids
Increased risk of gastrointestinal ulceration and bleeding.
Other NSAIDs or Aspirin
Increased risk of GI adverse effects. Concomitant use is contraindicated.
Diuretics (e.g., furosemide, thiazides)
May reduce the natriuretic effect of diuretics and increase the risk of renal impairment.
Anticoagulants (e.g., warfarin, heparin)
Increased risk of severe bleeding. Concomitant use is contraindicated.
ACE inhibitors/Angiotensin Receptor Blockers (ARBs)
Increased risk of renal impairment, especially in elderly or dehydrated patients.
Storage
Store below 30°C, protected from light and moisture. Do not freeze. Keep out of reach of children.
Overdose
Symptoms of overdose may include abdominal pain, nausea, vomiting, lethargy, and drowsiness. Rare cases of gastrointestinal bleeding, acute renal failure, hypertension, and respiratory depression have occurred. Management involves symptomatic and supportive care. There is no specific antidote for ketorolac overdose. Gastric lavage and activated charcoal may be considered if recent oral ingestion (not applicable for injection overdose unless other substances were ingested).
Pregnancy & Lactation
Ketorolac is contraindicated during pregnancy, labor, and delivery, especially in the third trimester, due to potential adverse effects on the fetus (e.g., premature closure of the ductus arteriosus) and inhibition of uterine contractions. It is also not recommended during breastfeeding, as ketorolac is excreted in human milk and could potentially harm a nursing infant.
Side Effects
Contraindications
- Hypersensitivity to ketorolac, aspirin, or other NSAIDs
- Active peptic ulcer, recent gastrointestinal bleeding or perforation
- Moderate to severe renal impairment or risk of renal failure
- Confirmed or suspected cerebrovascular bleeding, hemorrhagic diathesis, hemostatic abnormalities
- Patients on anticoagulants (e.g., warfarin, heparin)
- Before major surgery, due to increased risk of bleeding
- Pregnancy (especially third trimester), labor and delivery, breastfeeding
- Concurrent use with other NSAIDs, oxpentifylline, probenecid, or lithium
Drug Interactions
Lithium
Ketorolac can increase plasma lithium levels, potentially leading to lithium toxicity. Avoid concomitant use or monitor lithium levels closely.
Probenecid
Significantly increases ketorolac plasma levels and half-life. Concomitant use is contraindicated.
Methotrexate
Increases methotrexate levels and toxicity. Concomitant use should be avoided.
Corticosteroids
Increased risk of gastrointestinal ulceration and bleeding.
Other NSAIDs or Aspirin
Increased risk of GI adverse effects. Concomitant use is contraindicated.
Diuretics (e.g., furosemide, thiazides)
May reduce the natriuretic effect of diuretics and increase the risk of renal impairment.
Anticoagulants (e.g., warfarin, heparin)
Increased risk of severe bleeding. Concomitant use is contraindicated.
ACE inhibitors/Angiotensin Receptor Blockers (ARBs)
Increased risk of renal impairment, especially in elderly or dehydrated patients.
Storage
Store below 30°C, protected from light and moisture. Do not freeze. Keep out of reach of children.
Overdose
Symptoms of overdose may include abdominal pain, nausea, vomiting, lethargy, and drowsiness. Rare cases of gastrointestinal bleeding, acute renal failure, hypertension, and respiratory depression have occurred. Management involves symptomatic and supportive care. There is no specific antidote for ketorolac overdose. Gastric lavage and activated charcoal may be considered if recent oral ingestion (not applicable for injection overdose unless other substances were ingested).
Pregnancy & Lactation
Ketorolac is contraindicated during pregnancy, labor, and delivery, especially in the third trimester, due to potential adverse effects on the fetus (e.g., premature closure of the ductus arteriosus) and inhibition of uterine contractions. It is also not recommended during breastfeeding, as ketorolac is excreted in human milk and could potentially harm a nursing infant.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24 to 36 months from the date of manufacture, when stored under recommended conditions.
Availability
Pharmacies, Hospitals
Approval Status
Approved
Patent Status
Off-patent
WHO Essential Medicine
YesClinical Trials
Ketorolac has been extensively studied in clinical trials for its efficacy and safety in various acute pain settings, including post-operative pain, comparing its analgesic effects with opioids and other NSAIDs. Trials have focused on optimal dosing and duration to minimize adverse effects.
Lab Monitoring
- Renal function tests (serum creatinine, BUN) before and during treatment, especially in elderly or patients with pre-existing renal impairment.
- Liver function tests (ALT, AST) periodically, particularly with prolonged use.
- Complete blood count (CBC) to monitor for signs of anemia or bleeding, especially with long-term use.
Doctor Notes
- Emphasize strict adherence to the maximum 5-day treatment limit to minimize severe adverse events.
- Contraindicated in patients with a history of GI bleeding, peptic ulcer disease, or significant cardiovascular/renal risk.
- Monitor patients for signs of bleeding, renal dysfunction, and fluid retention during therapy.
Patient Guidelines
- Xidolac injection is for short-term use only, typically not more than 5 days. Do not exceed the prescribed dose or duration.
- Report any signs of unusual bleeding, black or tarry stools, severe stomach pain, persistent nausea, or swelling to your doctor immediately.
- Do not take other NSAIDs (like ibuprofen, naproxen, or aspirin) concurrently with Xidolac unless specifically advised by your doctor.
Missed Dose Advice
Since Xidolac injection is usually given by a healthcare professional in a clinical setting, a missed dose is unlikely. If a scheduled dose is missed in an outpatient setting, contact your doctor for advice. Do not take a double dose to make up for a missed one.
Driving Precautions
Xidolac may cause dizziness, drowsiness, or visual disturbances in some patients. If you experience these effects, avoid driving or operating machinery until you know how the medicine affects you.
Lifestyle Advice
- Avoid or limit alcohol consumption during treatment, as it may increase the risk of stomach bleeding and irritation.
- Inform your doctor about all other medications, supplements, and herbal products you are taking.
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