Zydol
Generic Name
Tramadol Hydrochloride
Manufacturer
Grünenthal
Country
Germany (Innovator)
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| zydol 50 mg capsule | ৳ 7.52 | N/A |
Description
Overview of the medicine
Zydol 50 mg Capsule is an opioid analgesic used to relieve moderate to moderately severe pain. It acts on the central nervous system to alter the body's perception of pain.
Uses & Indications
Dosage
Adults
50-100 mg every 4-6 hours as needed. Maximum dose: 400 mg/day.
Elderly
For patients >75 years, maximum dose is 300 mg/day. Consider starting at a lower dose.
Renal_impairment
Creatinine clearance <30 mL/min: 50-100 mg every 12 hours. Maximum 200 mg/day. Not recommended for severe impairment or dialysis.
How to Take
Swallow capsules whole with a glass of water, with or without food. Do not chew or crush.
Mechanism of Action
Tramadol is a centrally acting analgesic. It has a dual mechanism of action: it is a weak agonist at mu-opioid receptors and also inhibits the reuptake of norepinephrine and serotonin, which contributes to its analgesic effect.
Pharmacokinetics
Onset
Approximately 30-60 minutes.
Excretion
Mainly renal (approximately 90%), with a small amount excreted in feces.
Half life
Approximately 5-7 hours (for parent drug and active metabolite O-desmethyltramadol).
Absorption
Rapid and almost complete absorption after oral administration. Absolute bioavailability is approximately 75%.
Metabolism
Primarily hepatic via CYP2D6 (to active O-desmethyltramadol) and CYP3A4 (to inactive N-desmethyltramadol) enzymes.
Side Effects
Contraindications
- Hypersensitivity to tramadol or any component.
- Acute intoxication with alcohol, hypnotics, other opioid analgesics, psychotropic drugs.
- Patients receiving MAO inhibitors or within 14 days of stopping them.
- Uncontrolled epilepsy.
- Severe respiratory depression.
Drug Interactions
Warfarin
Increased INR and bleeding risk.
Quinidine
Increased tramadol concentration (in extensive CYP2D6 metabolizers).
Carbamazepine
Decreased tramadol plasma concentration and analgesic effect.
MAO Inhibitors
Increased risk of serotonin syndrome and seizures. Contraindicated.
SSRIs, SNRIs, TCAs
Increased risk of serotonin syndrome and seizures.
CNS Depressants (e.g., alcohol, benzodiazepines)
Increased risk of CNS depression, respiratory depression, sedation, and coma.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms include respiratory depression, somnolence, coma, seizures, cardiovascular collapse. Treatment involves supportive care, maintaining airway, and administration of naloxone for opioid effects. Naloxone may not reverse seizures.
Pregnancy & Lactation
Not recommended during pregnancy due to risk of neonatal opioid withdrawal syndrome. Should not be used during lactation as tramadol and its metabolites are excreted in breast milk and may affect the infant.
Side Effects
Contraindications
- Hypersensitivity to tramadol or any component.
- Acute intoxication with alcohol, hypnotics, other opioid analgesics, psychotropic drugs.
- Patients receiving MAO inhibitors or within 14 days of stopping them.
- Uncontrolled epilepsy.
- Severe respiratory depression.
Drug Interactions
Warfarin
Increased INR and bleeding risk.
Quinidine
Increased tramadol concentration (in extensive CYP2D6 metabolizers).
Carbamazepine
Decreased tramadol plasma concentration and analgesic effect.
MAO Inhibitors
Increased risk of serotonin syndrome and seizures. Contraindicated.
SSRIs, SNRIs, TCAs
Increased risk of serotonin syndrome and seizures.
CNS Depressants (e.g., alcohol, benzodiazepines)
Increased risk of CNS depression, respiratory depression, sedation, and coma.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms include respiratory depression, somnolence, coma, seizures, cardiovascular collapse. Treatment involves supportive care, maintaining airway, and administration of naloxone for opioid effects. Naloxone may not reverse seizures.
Pregnancy & Lactation
Not recommended during pregnancy due to risk of neonatal opioid withdrawal syndrome. Should not be used during lactation as tramadol and its metabolites are excreted in breast milk and may affect the infant.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years, refer to product packaging for exact date.
Availability
Pharmacies, hospitals, clinics
Approval Status
Approved (FDA, DGDA)
Patent Status
Expired
WHO Essential Medicine
YesClinical Trials
Tramadol has undergone extensive clinical trials for various pain indications. Ongoing post-marketing surveillance and studies continue to evaluate its efficacy and safety in diverse populations and chronic pain conditions.
Lab Monitoring
- Monitor renal and hepatic function during long-term therapy or in patients with pre-existing impairment.
Doctor Notes
- Thoroughly assess patient's risk factors for abuse, addiction, and misuse before initiating treatment and periodically during therapy.
- Monitor for signs of respiratory depression, especially during initiation or dose escalation.
- Counsel patients on safe storage, disposal, and the risks associated with concomitant use of CNS depressants, including alcohol.
Patient Guidelines
- Do not exceed the prescribed dose.
- Do not stop taking Zydol abruptly to avoid withdrawal symptoms.
- Avoid alcohol during treatment.
- Be aware of the potential for addiction and misuse.
- Consult your doctor if you experience severe side effects or if your pain is not controlled.
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 dose.
Driving Precautions
Zydol can cause dizziness, drowsiness, or blurred vision. Do not drive or operate machinery until you know how this medicine affects you.
Lifestyle Advice
- Avoid activities requiring mental alertness, such as driving or operating heavy machinery, until you know how Zydol affects you.
- Report any signs of unusual mood changes or thoughts of self-harm to your doctor immediately.
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