Maxdol
Generic Name
Ketorolac Tromethamine
Manufacturer
Acme Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| maxdol 60 mg injection | ৳ 90.00 | N/A |
Description
Overview of the medicine
Maxdol 60 mg Injection contains Ketorolac Tromethamine, a potent non-steroidal anti-inflammatory drug (NSAID) primarily used for the short-term management of moderately severe acute pain, often post-operative. It provides strong pain relief, anti-inflammatory effects, and antipyretic action.
Uses & Indications
Dosage
Adults
Single dose: 60 mg IM or 30 mg IV. Multiple dose: 30 mg IM or IV every 6 hours, not to exceed 120 mg/day for IM/IV administration. Treatment duration should not exceed 5 days.
Elderly
For patients ≥65 years, a lower dose is recommended: 30 mg IM or IV every 6 hours, not to exceed 60 mg/day. Treatment duration should not exceed 5 days.
Renal_impairment
For patients with moderate to severe renal impairment (serum creatinine >1.4 mg/dL), dosage should be reduced to 30 mg every 12 hours, not to exceed 60 mg/day. Ketorolac is contraindicated in advanced renal failure.
How to Take
Maxdol 60 mg Injection can be administered intramuscularly (IM) or intravenously (IV). For IM administration, inject slowly into a large muscle. For IV administration, it can be given as a bolus over at least 15 seconds or as an infusion. Do not use for epidural or intrathecal administration. It should not be mixed with morphine sulfate, pethidine hydrochloride, or promethazine hydrochloride due to precipitation.
Mechanism of Action
Ketorolac Tromethamine primarily acts by inhibiting cyclooxygenase (COX-1 and COX-2) enzymes, which are responsible for the synthesis of prostaglandins. Prostaglandins are mediators of pain, inflammation, and fever. By reducing prostaglandin synthesis, ketorolac effectively alleviates these symptoms.
Pharmacokinetics
Onset
Analgesic effect usually begins within 30 minutes, with peak effect observed within 1-2 hours.
Excretion
Mainly renal, with approximately 92% of the dose excreted in urine (60% as unchanged drug and 40% as metabolites). About 6% is excreted in feces.
Half life
Approximately 4-6 hours (ranges from 3.8 to 8.6 hours), slightly longer in elderly and renally impaired patients.
Absorption
Rapid and complete absorption after intramuscular (IM) administration. Peak plasma concentrations are achieved within 30-60 minutes.
Metabolism
Primarily hepatic, through hydroxylation and conjugation. The major metabolite is a para-hydroxy metabolite, which is pharmacologically inactive.
Side Effects
Contraindications
- Hypersensitivity to ketorolac, aspirin, or other NSAIDs.
- Active peptic ulcer disease, recent gastrointestinal bleeding or perforation, or history of such conditions.
- Advanced renal impairment or risk of renal failure due to volume depletion.
- History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs.
- As prophylactic analgesic before major surgery or during surgery (due to inhibition of platelet function).
- Concurrent use with other NSAIDs, aspirin, pentoxifylline, or probenecid.
- Labor and delivery.
- Cerebrovascular bleeding, hemorrhagic diathesis, or incomplete hemostasis.
- Patients at high risk of bleeding.
Drug Interactions
Lithium
Increased plasma lithium levels, leading to lithium toxicity.
Probenecid
Increased ketorolac plasma levels and half-life.
Methotrexate
Increased methotrexate toxicity due to reduced renal clearance.
Pentoxifylline
Increased risk of bleeding.
Diuretics (e.g., Furosemide, Thiazides)
Reduced diuretic and antihypertensive effects, increased risk of renal impairment.
ACE Inhibitors, Angiotensin Receptor Blockers (ARBs)
Reduced antihypertensive effect and increased risk of renal impairment.
Warfarin, Heparin, Antiplatelet agents (e.g., Aspirin, Clopidogrel)
Increased risk of bleeding.
Storage
Store below 30°C. Protect from light. Do not freeze. Keep out of reach of children.
Overdose
Symptoms of overdose may include abdominal pain, nausea, vomiting, lethargy, drowsiness, and headache. Gastric bleeding can occur. Rare symptoms include hypertension, acute renal failure, respiratory depression, and coma. Management is primarily supportive and symptomatic. There is no specific antidote. Gastric decontamination may be considered within the first hour of ingestion (not applicable for injection overdose, but general NSAID overdose advice). Hemodialysis does not significantly clear ketorolac from the blood.
Pregnancy & Lactation
Pregnancy Category C (first and second trimesters), Category D (third trimester). Should be avoided in the third trimester due to potential premature closure of the fetal ductus arteriosus. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Ketorolac is excreted in human milk; therefore, it is not recommended for use by nursing mothers due to the potential for serious adverse reactions in breastfed infants.
Side Effects
Contraindications
- Hypersensitivity to ketorolac, aspirin, or other NSAIDs.
- Active peptic ulcer disease, recent gastrointestinal bleeding or perforation, or history of such conditions.
- Advanced renal impairment or risk of renal failure due to volume depletion.
- History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs.
- As prophylactic analgesic before major surgery or during surgery (due to inhibition of platelet function).
- Concurrent use with other NSAIDs, aspirin, pentoxifylline, or probenecid.
- Labor and delivery.
- Cerebrovascular bleeding, hemorrhagic diathesis, or incomplete hemostasis.
- Patients at high risk of bleeding.
Drug Interactions
Lithium
Increased plasma lithium levels, leading to lithium toxicity.
Probenecid
Increased ketorolac plasma levels and half-life.
Methotrexate
Increased methotrexate toxicity due to reduced renal clearance.
Pentoxifylline
Increased risk of bleeding.
Diuretics (e.g., Furosemide, Thiazides)
Reduced diuretic and antihypertensive effects, increased risk of renal impairment.
ACE Inhibitors, Angiotensin Receptor Blockers (ARBs)
Reduced antihypertensive effect and increased risk of renal impairment.
Warfarin, Heparin, Antiplatelet agents (e.g., Aspirin, Clopidogrel)
Increased risk of bleeding.
Storage
Store below 30°C. Protect from light. Do not freeze. Keep out of reach of children.
Overdose
Symptoms of overdose may include abdominal pain, nausea, vomiting, lethargy, drowsiness, and headache. Gastric bleeding can occur. Rare symptoms include hypertension, acute renal failure, respiratory depression, and coma. Management is primarily supportive and symptomatic. There is no specific antidote. Gastric decontamination may be considered within the first hour of ingestion (not applicable for injection overdose, but general NSAID overdose advice). Hemodialysis does not significantly clear ketorolac from the blood.
Pregnancy & Lactation
Pregnancy Category C (first and second trimesters), Category D (third trimester). Should be avoided in the third trimester due to potential premature closure of the fetal ductus arteriosus. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Ketorolac is excreted in human milk; therefore, it is not recommended for use by nursing mothers due to the potential for serious adverse reactions in breastfed infants.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from the date of manufacture when stored under recommended conditions.
Availability
Available in hospitals, clinics, and pharmacies
Approval Status
Approved
Patent Status
Patent expired
Clinical Trials
Ketorolac has undergone extensive clinical trials demonstrating its efficacy and safety for short-term management of acute pain, particularly in post-operative settings. Trials have compared its analgesic effects with opioids and other NSAIDs.
Lab Monitoring
- Renal function tests (serum creatinine, BUN) before and during therapy, especially in elderly or renally impaired patients.
- Liver function tests (ALT, AST) periodically, particularly during prolonged use (though short-term use is recommended).
- Complete Blood Count (CBC) including hemoglobin and hematocrit, especially if signs of bleeding are present.
Doctor Notes
- Strictly limit use to a maximum of 5 days.
- Carefully assess cardiovascular and gastrointestinal risk factors before initiation, especially in elderly patients or those with a history of GI issues.
- Monitor renal function, particularly in patients with pre-existing renal impairment or those on diuretics/ACE inhibitors.
- Avoid concurrent use with other NSAIDs, aspirin, or anticoagulants due to increased bleeding risk.
- Not indicated for chronic pain management.
Patient Guidelines
- This injection is for short-term use only (maximum 5 days) for acute pain.
- Report any signs of gastrointestinal bleeding (e.g., black, tarry stools, vomiting blood) immediately.
- Inform your doctor about all other medications you are taking, especially blood thinners or other pain relievers.
- Do not take other NSAIDs or aspirin while on Maxdol injection unless advised by your doctor.
- Avoid alcohol consumption as it may increase the risk of stomach problems.
Missed Dose Advice
Maxdol 60 mg Injection is typically administered in a hospital or clinical setting for acute pain. If a scheduled dose in a multi-dose regimen is missed, contact your healthcare provider for advice. Do not double the dose to catch up.
Driving Precautions
Maxdol injection may cause dizziness, drowsiness, or visual disturbances. Patients should be cautioned against operating machinery or driving if these side effects occur.
Lifestyle Advice
- Stay well-hydrated.
- Avoid activities requiring mental alertness if you experience dizziness or drowsiness.
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