Epicet-XR
Generic Name
Tramadol Hydrochloride & Acetaminophen Extended Release
Manufacturer
Reputable Pharmaceutical Company
Country
Bangladesh
Loading images...
Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| epicet xr 500 mg tablet | ৳ 30.00 | ৳ 180.00 |
Description
Overview of the medicine
Epicet-XR 500 mg Tablet is an extended-release combination analgesic containing Tramadol Hydrochloride and Acetaminophen, used for the management of moderate to moderately severe chronic pain.
Uses & Indications
Dosage
Adults
Usually 1 tablet every 12 hours. Maximum dose is typically 2 tablets every 12 hours (not to exceed 300 mg Tramadol and 4000 mg Acetaminophen per day from all sources).
Elderly
Careful dose selection, starting at the lower end of the dosing range, is generally appropriate, considering the greater frequency of decreased hepatic, renal, or cardiac function.
Renal_impairment
Dose adjustment required. For patients with creatinine clearance less than 30 mL/min, the dosing interval should be increased. Not recommended for severe renal impairment.
How to Take
Take orally, with or without food. Swallow the tablet whole; do not crush, chew, or split. Taking with food may reduce gastrointestinal upset.
Mechanism of Action
Tramadol acts centrally by binding to mu-opioid receptors and inhibiting the reuptake of norepinephrine and serotonin. Acetaminophen is a centrally acting analgesic, primarily inhibiting prostaglandin synthesis.
Pharmacokinetics
Onset
Analgesic effect usually starts within 1-2 hours due to the extended-release formulation.
Excretion
Both tramadol and its metabolites, and acetaminophen metabolites are primarily excreted renally.
Half life
Tramadol: approximately 5-9 hours; Acetaminophen: approximately 2-4 hours. The XR formulation affects the overall pharmacokinetic profile.
Absorption
Tramadol is well absorbed, and Acetaminophen is rapidly absorbed. The extended-release formulation prolongs absorption over 12 hours.
Metabolism
Tramadol undergoes hepatic metabolism, primarily via CYP2D6 (O-demethylation) and CYP3A4 (N-demethylation). Acetaminophen is primarily metabolized in the liver by glucuronidation and sulfation pathways.
Side Effects
Contraindications
- Hypersensitivity to Tramadol, Acetaminophen, or any component of the formulation.
- Acute intoxication with alcohol, hypnotics, centrally acting analgesics, opioids, or psychotropic drugs.
- Severe respiratory depression.
- Uncontrolled epilepsy.
- Severe hepatic impairment.
Drug Interactions
Warfarin
Increased INR and bleeding risk with acetaminophen.
Carbamazepine
Significantly decreases tramadol levels, potentially reducing analgesic efficacy.
MAO Inhibitors
Increased risk of serotonin syndrome or opioid toxicity. Concomitant use is contraindicated.
SSRIs, SNRIs, TCAs
Increased risk of seizures and serotonin syndrome.
CYP2D6 Inhibitors (e.g., quinidine, fluoxetine)
May increase tramadol levels and decrease active metabolite levels.
CNS Depressants (e.g., alcohol, sedatives, benzodiazepines)
Increased risk of sedation, respiratory depression, coma, and death.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include respiratory depression, somnolence, coma, seizures, cardiac arrest, and hepatic necrosis (due to acetaminophen). Management involves maintaining a patent airway, supportive care, naloxone for opioid effects, and N-acetylcysteine for acetaminophen toxicity.
Pregnancy & Lactation
Not recommended during pregnancy due to potential for neonatal opioid withdrawal syndrome. Excreted in breast milk; use during lactation should be avoided.
Side Effects
Contraindications
- Hypersensitivity to Tramadol, Acetaminophen, or any component of the formulation.
- Acute intoxication with alcohol, hypnotics, centrally acting analgesics, opioids, or psychotropic drugs.
- Severe respiratory depression.
- Uncontrolled epilepsy.
- Severe hepatic impairment.
Drug Interactions
Warfarin
Increased INR and bleeding risk with acetaminophen.
Carbamazepine
Significantly decreases tramadol levels, potentially reducing analgesic efficacy.
MAO Inhibitors
Increased risk of serotonin syndrome or opioid toxicity. Concomitant use is contraindicated.
SSRIs, SNRIs, TCAs
Increased risk of seizures and serotonin syndrome.
CYP2D6 Inhibitors (e.g., quinidine, fluoxetine)
May increase tramadol levels and decrease active metabolite levels.
CNS Depressants (e.g., alcohol, sedatives, benzodiazepines)
Increased risk of sedation, respiratory depression, coma, and death.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include respiratory depression, somnolence, coma, seizures, cardiac arrest, and hepatic necrosis (due to acetaminophen). Management involves maintaining a patent airway, supportive care, naloxone for opioid effects, and N-acetylcysteine for acetaminophen toxicity.
Pregnancy & Lactation
Not recommended during pregnancy due to potential for neonatal opioid withdrawal syndrome. Excreted in breast milk; use during lactation should be avoided.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 to 36 months from manufacturing date.
Availability
Available in pharmacies and hospitals
Approval Status
Approved by regulatory authorities (e.g., DGDA)
Patent Status
Off-patent (Generic available)
Clinical Trials
Clinical trials have demonstrated the efficacy and safety of Tramadol/Acetaminophen Extended Release for chronic pain management, comparing it to placebo and individual components.
Lab Monitoring
- Liver function tests (especially with prolonged use or high doses of acetaminophen).
- Renal function tests.
Doctor Notes
- Carefully assess patient history for substance abuse before prescribing.
- Monitor for signs of respiratory depression, especially during initiation or dose escalation.
- Educate patients on the risks of concomitant use with CNS depressants and alcohol.
- Regularly reassess the need for continued opioid therapy.
Patient Guidelines
- Do not exceed the prescribed dose.
- Do not crush, chew, or split the tablet; swallow it whole.
- Avoid alcohol while taking this medicine.
- Be aware of potential dizziness or drowsiness, and avoid driving or operating heavy machinery until you know how it affects you.
- Report any signs of liver damage (e.g., dark urine, yellowing of skin/eyes) or severe allergic reactions immediately.
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 take a double dose to make up for a missed one.
Driving Precautions
This medicine may cause dizziness, drowsiness, or blurred vision, which could impair your ability to drive or operate machinery. Avoid such activities until you are certain you can perform them safely.
Lifestyle Advice
- Maintain adequate hydration.
- For constipation, increase fluid and fiber intake if appropriate.
- Engage in light physical activity if pain allows.
Alternative Medicines in Bangladesh
Similar medicines available in the market
Global Brand Names
International brand names for this medicine. Click a brand to search for detailed information.
Other Medicines in Epicet-XR Brand
Other medicines available under the same brand name
