Zilic-TR
Generic Name
Tramadol Hydrochloride + Paracetamol
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| zilic tr 150 mg capsule | ৳ 3.00 | N/A |
Description
Overview of the medicine
Zilic-TR is a fixed-dose combination analgesic containing Tramadol Hydrochloride, an opioid analgesic, and Paracetamol, a non-opioid analgesic and antipyretic. It is used for the management of moderate to severe pain.
Uses & Indications
Dosage
Adults
Usually 1-2 tablets every 4-6 hours as needed, not exceeding 8 tablets per day (Tramadol 300 mg / Paracetamol 2600 mg). Maximum daily dose for Paracetamol is 4000 mg, but in this combination, it's limited by Tramadol.
Elderly
No dosage adjustment is generally needed for elderly patients (up to 75 years old) unless renal or hepatic impairment is present. For patients over 75 years, the dose interval may be extended.
Renal_impairment
For creatinine clearance <30 mL/min, the dosing interval should be extended to 12 hours. Not recommended in severe renal impairment (CrCl <10 mL/min).
How to Take
Oral, with or without food. Swallow whole, do not crush or chew.
Mechanism of Action
Tramadol acts centrally, binding to mu-opioid receptors and inhibiting the reuptake of norepinephrine and serotonin. Paracetamol produces analgesia by inhibiting prostaglandin synthesis in the central nervous system and possibly by modulating the endocannabinoid system.
Pharmacokinetics
Onset
Within 30-60 minutes
Excretion
Mainly renal excretion for both components and their metabolites.
Half life
Tramadol: ~6 hours; Paracetamol: ~2-3 hours
Absorption
Both Tramadol and Paracetamol are rapidly and almost completely absorbed after oral administration. Tramadol has an absolute bioavailability of about 75%. Paracetamol is well-absorbed from the GI tract.
Metabolism
Tramadol is extensively metabolized in the liver by CYP2D6 (to active O-desmethyltramadol) and CYP3A4. Paracetamol is primarily metabolized in the liver via glucuronidation and sulfation, with a small portion metabolized by CYP2E1 to a toxic intermediate (NAPQI).
Side Effects
Contraindications
- Hypersensitivity to Tramadol, Paracetamol, or any component
- Acute intoxication with alcohol, hypnotics, centrally acting analgesics, opioids, or psychotropic drugs
- Patients receiving MAO inhibitors or who have taken them within the last 14 days
- Severe hepatic impairment
- Severe respiratory depression
Drug Interactions
Warfarin
Increased INR/bleeding risk due to paracetamol.
Carbamazepine
Decreased tramadol levels.
MAO Inhibitors
Increased risk of serotonin syndrome or hypertensive crisis.
SSRIs, TCAs, other opioids
Increased risk of serotonin syndrome.
CNS Depressants (e.g., alcohol, benzodiazepines)
Increased risk of 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, and hepatic necrosis (due to paracetamol). Management involves maintaining an open airway, providing respiratory support, naloxone for tramadol-induced respiratory depression, and N-acetylcysteine for paracetamol overdose.
Pregnancy & Lactation
Category C in pregnancy. Not recommended during pregnancy, especially in the third trimester due to risk of neonatal withdrawal syndrome. Both tramadol and paracetamol are excreted in breast milk; use with caution or avoid during lactation.
Side Effects
Contraindications
- Hypersensitivity to Tramadol, Paracetamol, or any component
- Acute intoxication with alcohol, hypnotics, centrally acting analgesics, opioids, or psychotropic drugs
- Patients receiving MAO inhibitors or who have taken them within the last 14 days
- Severe hepatic impairment
- Severe respiratory depression
Drug Interactions
Warfarin
Increased INR/bleeding risk due to paracetamol.
Carbamazepine
Decreased tramadol levels.
MAO Inhibitors
Increased risk of serotonin syndrome or hypertensive crisis.
SSRIs, TCAs, other opioids
Increased risk of serotonin syndrome.
CNS Depressants (e.g., alcohol, benzodiazepines)
Increased risk of 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, and hepatic necrosis (due to paracetamol). Management involves maintaining an open airway, providing respiratory support, naloxone for tramadol-induced respiratory depression, and N-acetylcysteine for paracetamol overdose.
Pregnancy & Lactation
Category C in pregnancy. Not recommended during pregnancy, especially in the third trimester due to risk of neonatal withdrawal syndrome. Both tramadol and paracetamol are excreted in breast milk; use with caution or avoid during lactation.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
36 months
Availability
Pharmacies nationwide in Bangladesh
Approval Status
Approved by DGDA
Patent Status
Generic available
Clinical Trials
Extensive clinical trials have demonstrated the efficacy and safety of tramadol/paracetamol combination for various pain conditions.
Lab Monitoring
- Liver function tests (especially with prolonged use or high doses)
- Renal function tests
Doctor Notes
- Caution with elderly, patients with renal/hepatic impairment, and those with a history of seizures or substance abuse.
- Educate patients on potential for dependence and proper disposal of unused medication.
- Monitor for signs of serotonin syndrome, especially when co-administered with serotonergic drugs.
Patient Guidelines
- Do not exceed the prescribed dose.
- Do not take with alcohol or other CNS depressants.
- Report any unusual symptoms, especially severe drowsiness, breathing difficulties, or yellowing of skin/eyes.
- Do not stop abruptly if used for long term, consult doctor for tapering off.
Missed Dose Advice
Take the missed dose 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
May cause dizziness, somnolence, or blurred vision. Patients should be warned not to drive or operate hazardous machinery if affected.
Lifestyle Advice
- Avoid driving or operating heavy machinery until you know how the medicine affects you.
- Stay hydrated.
- Avoid activities requiring mental alertness immediately after taking the dose if experiencing drowsiness.
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