Tamadol
Generic Name
tamadol-50-mg-capsule
Manufacturer
Example Pharmaceutical Co. Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| tamadol 50 mg capsule | ৳ 7.25 | N/A |
Description
Overview of the medicine
Tamadol 50 mg capsule contains Tramadol Hydrochloride, a centrally acting synthetic opioid analgesic used for the treatment of moderate to moderately severe pain. It works by binding to specific opioid receptors in the brain and spinal cord, and also by inhibiting the reuptake of norepinephrine and serotonin, which modifies the body's perception of pain.
Uses & Indications
Dosage
Adults
50-100 mg every 4-6 hours as needed, not to exceed 400 mg/day.
Elderly
For patients over 75 years, maximum daily dose should not exceed 300 mg. Dosage reduction may be necessary due to decreased renal/hepatic function.
Renal_impairment
For creatinine clearance <30 mL/min, the dose should be reduced to 50 mg every 12 hours. Not recommended for severe renal impairment (CrCl <10 mL/min).
How to Take
Oral administration. Can be taken with or without food. Swallow the capsule whole with water.
Mechanism of Action
Tramadol and its active metabolite (O-desmethyltramadol) bind to mu-opioid receptors in the central nervous system, producing analgesia. It also weakly inhibits the reuptake of norepinephrine and serotonin, which contributes to its pain-relieving effects.
Pharmacokinetics
Onset
Analgesia typically begins within 1 hour after oral administration.
Excretion
Approximately 90% of a tramadol dose is excreted via the kidneys (unchanged and as metabolites).
Half life
The elimination half-life of tramadol is approximately 6-7 hours, and for its active metabolite (O-desmethyltramadol), it is approximately 9 hours.
Absorption
Rapidly absorbed after oral administration, with an absolute bioavailability of approximately 75%. Peak plasma concentrations occur about 2 hours after administration.
Metabolism
Primarily metabolized in the liver by O-demethylation (via CYP2D6) and N-demethylation (via CYP3A4) to several metabolites, including the active O-desmethyltramadol.
Side Effects
Contraindications
- Hypersensitivity to tramadol or any component of the formulation.
- Acute intoxication with alcohol, hypnotics, analgesics, opioids, or psychotropic drugs.
- Patients receiving monoamine oxidase inhibitors (MAOIs) or within 14 days of discontinuing them.
- Epilepsy not controlled by adequate treatment.
- Severe respiratory depression.
Drug Interactions
Carbamazepine
Significantly decreases tramadol plasma concentrations, potentially reducing analgesic effect.
MAO Inhibitors
Concomitant use is contraindicated due to increased risk of serotonin syndrome or central nervous system excitation.
CNS Depressants
Increased risk of sedation, respiratory depression, coma, and death with concurrent use of alcohol, benzodiazepines, other opioids, or sedatives.
Serotonergic Drugs
Increased risk of serotonin syndrome with SSRIs, SNRIs, tricyclic antidepressants, triptans, or other drugs that affect serotonin neurotransmission.
Storage
Store below 30°C in a dry place, away from direct sunlight and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include respiratory depression, seizures, miosis, cardiovascular collapse, and coma. Management involves supportive care, maintaining an open airway, and administration of naloxone (an opioid antagonist) to reverse respiratory depression. In case of seizures, benzodiazepines may be considered.
Pregnancy & Lactation
Pregnancy Category C. Not recommended during pregnancy due to potential for neonatal opioid withdrawal syndrome. Not recommended during breastfeeding as tramadol and its metabolites are excreted in breast milk and can cause serious adverse reactions in nursing infants.
Side Effects
Contraindications
- Hypersensitivity to tramadol or any component of the formulation.
- Acute intoxication with alcohol, hypnotics, analgesics, opioids, or psychotropic drugs.
- Patients receiving monoamine oxidase inhibitors (MAOIs) or within 14 days of discontinuing them.
- Epilepsy not controlled by adequate treatment.
- Severe respiratory depression.
Drug Interactions
Carbamazepine
Significantly decreases tramadol plasma concentrations, potentially reducing analgesic effect.
MAO Inhibitors
Concomitant use is contraindicated due to increased risk of serotonin syndrome or central nervous system excitation.
CNS Depressants
Increased risk of sedation, respiratory depression, coma, and death with concurrent use of alcohol, benzodiazepines, other opioids, or sedatives.
Serotonergic Drugs
Increased risk of serotonin syndrome with SSRIs, SNRIs, tricyclic antidepressants, triptans, or other drugs that affect serotonin neurotransmission.
Storage
Store below 30°C in a dry place, away from direct sunlight and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include respiratory depression, seizures, miosis, cardiovascular collapse, and coma. Management involves supportive care, maintaining an open airway, and administration of naloxone (an opioid antagonist) to reverse respiratory depression. In case of seizures, benzodiazepines may be considered.
Pregnancy & Lactation
Pregnancy Category C. Not recommended during pregnancy due to potential for neonatal opioid withdrawal syndrome. Not recommended during breastfeeding as tramadol and its metabolites are excreted in breast milk and can cause serious adverse reactions in nursing infants.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
2 to 3 years from the date of manufacture, depending on specific manufacturer and formulation.
Availability
Available in pharmacies and hospitals
Approval Status
Approved by regulatory bodies (e.g., FDA, DGDA)
Patent Status
Generic available
WHO Essential Medicine
YesClinical Trials
Tramadol has undergone numerous clinical trials demonstrating its efficacy and safety for moderate to moderately severe pain, including studies for acute post-operative pain and chronic conditions like osteoarthritis.
Lab Monitoring
- Renal function tests (for long-term use or in impaired patients).
- Hepatic function tests (for long-term use or in impaired patients).
Doctor Notes
- Emphasize the potential for addiction and misuse, especially in patients with a history of substance abuse.
- Counsel patients on the risks of respiratory depression, particularly when co-administered with other CNS depressants.
- Monitor for signs of serotonin syndrome if co-prescribed with serotonergic drugs.
- Educate patients on proper storage to prevent accidental ingestion by children.
Patient Guidelines
- Do not exceed the prescribed dose.
- Avoid alcohol while taking this medicine.
- Report any unusual side effects or signs of addiction to your doctor.
- Do not stop taking this medicine abruptly without consulting your doctor, as withdrawal symptoms may occur.
Missed Dose Advice
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not double the dose to catch up.
Driving Precautions
Tamadol 50 mg capsule can cause dizziness, drowsiness, and impaired judgment, which can affect your ability to drive or operate machinery safely. Patients should be advised to exercise caution or avoid such activities until they are certain they are not experiencing these effects.
Lifestyle Advice
- Avoid driving or operating heavy machinery until you know how this medicine affects you, as it may cause dizziness or drowsiness.
- Inform your doctor if you have a history of drug abuse or mental health conditions.
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