Zydol
Generic Name
Tramadol Hydrochloride
Manufacturer
Various Manufacturers (e.g., Square Pharmaceuticals Ltd. in Bangladesh)
Country
Various
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| zydol 100 mg injection | ৳ 18.05 | N/A |
Description
Overview of the medicine
Zydol 100 mg Injection contains Tramadol Hydrochloride, a synthetic opioid analgesic used for the relief of moderate to moderately severe pain. It acts on the central nervous system to reduce pain perception.
Uses & Indications
Dosage
Adults
Initial dose 50-100 mg IV/IM/SC every 4-6 hours as needed. Maximum daily dose 400 mg. Administer IV slowly over 2-3 minutes or by infusion.
Elderly
For patients >75 years, maximum daily dose usually 300 mg. Dosage reduction may be necessary.
Renal_impairment
For CrCl <30 mL/min, 50-100 mg every 12 hours. Maximum daily dose 200 mg.
How to Take
Zydol 100 mg injection can be administered intravenously (IV), intramuscularly (IM), or subcutaneously (SC). For IV administration, inject slowly over 2-3 minutes or dilute in infusion fluid (e.g., normal saline, dextrose 5%) and administer as an infusion.
Mechanism of Action
Tramadol acts as a centrally acting opioid analgesic with a dual mechanism of action. It is an opioid agonist binding to µ-opioid receptors and also inhibits the reuptake of norepinephrine and serotonin, which modulates descending pain pathways.
Pharmacokinetics
Onset
IV: 5-10 minutes; IM: 15-30 minutes
Excretion
Primarily via the kidneys (urine) as metabolites (approx. 90%) and unchanged drug (approx. 10%).
Half life
Approximately 6-7 hours (for tramadol and O-desmethyltramadol)
Absorption
Rapid and complete absorption. Bioavailability of injection is 100%. Peak plasma concentrations achieved within 1 hour after intramuscular administration.
Metabolism
Primarily in the liver by CYP2D6 and CYP3A4, forming active metabolite O-desmethyltramadol (M1) and other inactive metabolites.
Side Effects
Contraindications
- Hypersensitivity to tramadol or any excipients
- Acute intoxication with alcohol, hypnotics, analgesics, opioids, or psychotropic drugs
- Patients receiving MAO inhibitors or within 14 days of stopping them
- Epilepsy not controlled by treatment
- Breastfeeding mothers
Drug Interactions
Carbamazepine
Significantly decreases tramadol plasma levels, reducing analgesic effect.
MAO Inhibitors
Increased risk of serotonin syndrome and seizures. Contraindicated.
Warfarin and other coumarin derivatives
Increased INR and bleeding risk.
CNS Depressants (e.g., benzodiazepines, alcohol)
Increased risk of respiratory depression, profound sedation, coma, and death. Use with caution; consider dosage reduction of one or both drugs.
Serotonergic drugs (e.g., SSRIs, TCAs, Triptans)
Increased risk of serotonin syndrome.
Storage
Store below 25°C (77°F). Protect from light. Do not freeze. Keep in the original container.
Overdose
Symptoms of overdose include respiratory depression, somnolence progressing to coma, seizures, pinpoint pupils, skeletal muscle flaccidity, cold and clammy skin, and potentially death. Management involves immediate emergency medical attention, supportive care, and administration of naloxone to reverse opioid effects, though naloxone may increase the risk of seizures.
Pregnancy & Lactation
Pregnancy Category C. Not recommended during pregnancy, especially in the third trimester or near term, due to potential for neonatal opioid withdrawal syndrome. Tramadol is excreted in breast milk; therefore, Zydol is not recommended for breastfeeding mothers.
Side Effects
Contraindications
- Hypersensitivity to tramadol or any excipients
- Acute intoxication with alcohol, hypnotics, analgesics, opioids, or psychotropic drugs
- Patients receiving MAO inhibitors or within 14 days of stopping them
- Epilepsy not controlled by treatment
- Breastfeeding mothers
Drug Interactions
Carbamazepine
Significantly decreases tramadol plasma levels, reducing analgesic effect.
MAO Inhibitors
Increased risk of serotonin syndrome and seizures. Contraindicated.
Warfarin and other coumarin derivatives
Increased INR and bleeding risk.
CNS Depressants (e.g., benzodiazepines, alcohol)
Increased risk of respiratory depression, profound sedation, coma, and death. Use with caution; consider dosage reduction of one or both drugs.
Serotonergic drugs (e.g., SSRIs, TCAs, Triptans)
Increased risk of serotonin syndrome.
Storage
Store below 25°C (77°F). Protect from light. Do not freeze. Keep in the original container.
Overdose
Symptoms of overdose include respiratory depression, somnolence progressing to coma, seizures, pinpoint pupils, skeletal muscle flaccidity, cold and clammy skin, and potentially death. Management involves immediate emergency medical attention, supportive care, and administration of naloxone to reverse opioid effects, though naloxone may increase the risk of seizures.
Pregnancy & Lactation
Pregnancy Category C. Not recommended during pregnancy, especially in the third trimester or near term, due to potential for neonatal opioid withdrawal syndrome. Tramadol is excreted in breast milk; therefore, Zydol is not recommended for breastfeeding mothers.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Generally 2-3 years from the date of manufacture. Refer to the product packaging for the exact expiry date.
Availability
Pharmacies, Hospitals
Approval Status
Approved
Patent Status
Off-patent
WHO Essential Medicine
YesClinical Trials
Tramadol has undergone extensive clinical trials demonstrating its efficacy and safety for various pain conditions. Ongoing research continues to explore its role in chronic pain management and specific patient populations, including studies on its pharmacokinetic variability.
Lab Monitoring
- Renal function (for patients with renal impairment to adjust dosage)
- Liver function (for patients with hepatic impairment)
Doctor Notes
- Individualize dosage based on patient's pain intensity and response, starting with the lowest effective dose.
- Caution in patients with a history of substance abuse or psychiatric disorders due to the risk of addiction and misuse.
- Monitor for signs of respiratory depression, especially with concomitant use of other CNS depressants.
- Avoid abrupt discontinuation to prevent withdrawal syndrome.
Patient Guidelines
- Always use Zydol injection exactly as prescribed by your doctor.
- Do not exceed the recommended dose or duration of treatment.
- Do not stop the medication abruptly without consulting your doctor to avoid withdrawal symptoms.
- Report any unusual or severe side effects immediately to your healthcare provider.
- Keep this medicine out of the sight and reach of children.
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
Zydol may cause drowsiness, dizziness, or blurred vision. Do not drive or operate heavy machinery if you experience these effects or feel impaired.
Lifestyle Advice
- Avoid consuming alcohol while undergoing treatment with Zydol, as it can intensify side effects.
- Maintain a high-fiber diet and adequate fluid intake to help prevent constipation, a common side effect.
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