Sanoket
Generic Name
Ketorolac Tromethamine
Manufacturer
Sanofi
Country
Bangladesh
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
sanoket 10 mg tablet | ৳ 10.03 | ৳ 100.30 |
Description
Overview of the medicine
Sanoket 10 mg Tablet contains Ketorolac Tromethamine, a non-steroidal anti-inflammatory drug (NSAID) used for the short-term management of moderately severe acute pain.
Uses & Indications
Dosage
Adults
Initially 10 mg every 4-6 hours, as needed. Maximum daily dose 40 mg. Treatment duration not to exceed 5 days.
Elderly
Lower doses (e.g., 10 mg every 6-8 hours) may be required. Maximum daily dose 40 mg. Treatment duration not to exceed 5 days.
Renal_impairment
Reduced dosage required. Severe renal impairment (creatinine clearance <30 mL/min) is a contraindication. For moderate impairment, dose reduction and careful monitoring are necessary.
How to Take
Administer orally with food or milk to minimize gastrointestinal upset. Swallow the tablet whole with a glass of water.
Mechanism of Action
Ketorolac inhibits prostaglandin synthesis by reversibly blocking cyclooxygenase (COX-1 and COX-2) enzymes, thereby reducing pain, inflammation, and fever.
Pharmacokinetics
Onset
Analgesic effect usually starts within 30 minutes, peak effect within 1-2 hours.
Excretion
Mainly renal (kidney) excretion (approximately 90% as metabolites and unchanged drug), some fecal excretion.
Half life
Approximately 4-6 hours (range 2.5-9 hours), slightly longer in elderly and renally impaired patients.
Absorption
Rapidly and completely absorbed orally. Peak plasma concentrations reached within 30-60 minutes.
Metabolism
Primarily hepatic (liver) metabolism, mainly by glucuronidation.
Side Effects
Contraindications
- Known hypersensitivity to ketorolac, aspirin, or other NSAIDs
- Active peptic ulcer, recent gastrointestinal bleeding or perforation
- Advanced renal impairment
- Patients at risk of renal failure due to volume depletion
- Coagulation disorders or patients on anticoagulants
- Cerebrovascular bleeding
- Pregnancy (especially third trimester) and lactation
- As prophylactic analgesic before major surgery
- Children under 16 years
Drug Interactions
Lithium
Increased lithium plasma levels and toxicity.
Methotrexate
Increased methotrexate toxicity.
Corticosteroids
Increased risk of gastrointestinal ulceration and bleeding.
ACE inhibitors/ARBs
Increased risk of renal impairment, reduced antihypertensive effect.
Other NSAIDs/Aspirin
Increased risk of gastrointestinal adverse effects and bleeding.
Diuretics (e.g., Furosemide)
Reduced diuretic and antihypertensive effects, potential for renal impairment.
Anticoagulants (e.g., Warfarin, Heparin)
Increased risk of bleeding.
Storage
Store in a cool, dry place below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose may include drowsiness, nausea, vomiting, epigastric pain, lethargy, and gastrointestinal bleeding. Management involves supportive care and symptomatic treatment. Gastric lavage or activated charcoal may be considered within an hour of ingestion. Dialysis may not be effective due to high protein binding.
Pregnancy & Lactation
Pregnancy Category C (first and second trimester), Category D (third trimester). Contraindicated in the third trimester due to risk of premature closure of the fetal ductus arteriosus. Not recommended during breastfeeding as it is excreted in breast milk.
Side Effects
Contraindications
- Known hypersensitivity to ketorolac, aspirin, or other NSAIDs
- Active peptic ulcer, recent gastrointestinal bleeding or perforation
- Advanced renal impairment
- Patients at risk of renal failure due to volume depletion
- Coagulation disorders or patients on anticoagulants
- Cerebrovascular bleeding
- Pregnancy (especially third trimester) and lactation
- As prophylactic analgesic before major surgery
- Children under 16 years
Drug Interactions
Lithium
Increased lithium plasma levels and toxicity.
Methotrexate
Increased methotrexate toxicity.
Corticosteroids
Increased risk of gastrointestinal ulceration and bleeding.
ACE inhibitors/ARBs
Increased risk of renal impairment, reduced antihypertensive effect.
Other NSAIDs/Aspirin
Increased risk of gastrointestinal adverse effects and bleeding.
Diuretics (e.g., Furosemide)
Reduced diuretic and antihypertensive effects, potential for renal impairment.
Anticoagulants (e.g., Warfarin, Heparin)
Increased risk of bleeding.
Storage
Store in a cool, dry place below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose may include drowsiness, nausea, vomiting, epigastric pain, lethargy, and gastrointestinal bleeding. Management involves supportive care and symptomatic treatment. Gastric lavage or activated charcoal may be considered within an hour of ingestion. Dialysis may not be effective due to high protein binding.
Pregnancy & Lactation
Pregnancy Category C (first and second trimester), Category D (third trimester). Contraindicated in the third trimester due to risk of premature closure of the fetal ductus arteriosus. Not recommended during breastfeeding as it is excreted in breast milk.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from manufacturing date.
Availability
Pharmacies, hospitals, clinics
Approval Status
Approved by drug regulatory authorities in various countries (e.g., FDA, DGDA for Bangladesh)
Patent Status
Generic available (original patent expired)
WHO Essential Medicine
YesClinical Trials
Extensively studied in numerous clinical trials demonstrating efficacy in acute pain management. Trials have evaluated different routes of administration and compared efficacy with other analgesics.
Lab Monitoring
- Renal function (BUN, creatinine) periodically, especially in elderly or renally impaired patients
- Liver function (ALT, AST) periodically
- Complete blood count (CBC) if long-term use is anticipated or if signs of bleeding occur
- Blood pressure monitoring
Doctor Notes
- Emphasize short-term use (max 5 days) due to significant GI and CV risks.
- Carefully assess patient's history for GI disease, cardiovascular risk factors, and renal impairment before prescribing.
- Concomitant use with other NSAIDs, anticoagulants, or corticosteroids should be avoided.
- Monitor renal function and blood pressure during treatment, especially in high-risk patients.
Patient Guidelines
- Do not exceed the recommended dose or duration of treatment (max 5 days).
- Take with food or milk to reduce stomach upset.
- Avoid alcohol and other NSAIDs during treatment.
- Report any signs of gastrointestinal bleeding (e.g., black tarry stools, coffee-ground vomit) to your doctor immediately.
- Do not use if you are pregnant (especially in the third trimester) or breastfeeding.
Missed Dose Advice
If a dose is missed, take it as soon as you remember. If it is almost time for the next dose, skip the missed dose and resume your regular dosing schedule. Do not double the dose.
Driving Precautions
May cause dizziness, drowsiness, or visual disturbances. Patients should be cautioned against driving or operating machinery if these effects occur.
Lifestyle Advice
- Maintain adequate hydration.
- Avoid activities requiring mental alertness if dizziness or drowsiness occurs.
- Limit alcohol intake.
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