Tapendol
Generic Name
Tapentadol 75 mg Tablet
Manufacturer
Example Pharma Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
tapendol 75 mg tablet | ৳ 17.00 | ৳ 170.00 |
Description
Overview of the medicine
Tapentadol is an opioid pain medication used to treat moderate to severe acute and chronic pain. It works through a dual mechanism: as an agonist at the mu-opioid receptor and as a norepinephrine reuptake inhibitor.
Uses & Indications
Dosage
Adults
For acute pain: 50-100 mg orally every 4-6 hours as needed. For chronic pain: Initial dose typically 50 mg twice daily; titrate as needed up to a maximum of 250 mg twice daily for extended-release formulations.
Elderly
No specific dosage adjustment is usually needed, but cautious titration is recommended due to potential for decreased renal/hepatic function and increased sensitivity.
Renal_impairment
Severe renal impairment (CrCl < 30 mL/min) is generally not recommended. In moderate impairment, use with caution, consider dose reduction and extended dosing interval.
How to Take
For oral administration. Can be taken with or without food. Swallow tablets whole; do not crush, chew, or break them.
Mechanism of Action
Tapentadol has a dual mechanism of action: it is an agonist at the mu-opioid receptor and a norepinephrine reuptake inhibitor (NRI). These actions synergistically contribute to its analgesic effects, reducing pain perception.
Pharmacokinetics
Onset
Approximately 30 minutes to 1 hour.
Excretion
Primarily via urine as metabolites (99%), with less than 1% excreted unchanged in urine and feces.
Half life
Approximately 4 hours.
Absorption
Rapidly absorbed after oral administration; absolute bioavailability is approximately 32%. Peak plasma concentrations are reached within 1.25 hours.
Metabolism
Extensively metabolized, primarily by glucuronidation (phase II metabolism) via UGT enzymes. A minor amount is metabolized by N-demethylation via CYP2C9 and CYP2C19. The major metabolites are inactive.
Side Effects
Contraindications
- Significant respiratory depression
- Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
- Known or suspected paralytic ileus
- Concomitant use of monoamine oxidase inhibitors (MAOIs) or within 14 days of discontinuing MAOIs
- Hypersensitivity to tapentadol or any component of the formulation
Drug Interactions
MAO Inhibitors
Contraindicated. May enhance the effects of MAOIs, including serotonergic effects, leading to serotonin syndrome.
Serotonergic Drugs (e.g., SSRIs, SNRIs, TCAs, triptans)
Increased risk of serotonin syndrome. Monitor patients closely.
CNS Depressants (e.g., alcohol, benzodiazepines, other opioids, sedatives)
Increased risk of respiratory depression, profound sedation, coma, and death. Avoid concomitant use.
Mixed Agonist/Antagonist Opioid Analgesics (e.g., buprenorphine, pentazocine)
May reduce the analgesic effect of tapentadol or precipitate withdrawal symptoms.
Storage
Store below 30°C (86°F) in a dry place, protected from light and moisture. Keep out of reach of children and pets. Do not freeze.
Overdose
Symptoms of overdose include respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and possibly death. Management involves immediate administration of naloxone (an opioid antagonist) and supportive care, including maintaining a patent airway and assisted ventilation.
Pregnancy & Lactation
Pregnancy Category C. Use only if the potential benefit justifies the potential risk to the fetus. Prolonged use during pregnancy can result in neonatal opioid withdrawal syndrome. Not recommended during breastfeeding, as tapentadol and its metabolites are excreted in human milk.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
2 to 3 years from the date of manufacture, depending on storage conditions.
Availability
Pharmacies, Hospitals
Approval Status
Approved by major regulatory authorities
Patent Status
Off-patent (generic versions available)
Clinical Trials
Extensive clinical trials have demonstrated the efficacy and safety of tapentadol for the treatment of moderate to severe acute pain and chronic pain, including neuropathic pain. Studies have also evaluated its tolerability profile.
Lab Monitoring
- Monitor liver and kidney function tests for prolonged use, especially in patients with pre-existing impairment.
- Monitor respiratory rate and level of sedation, particularly during treatment initiation and dose titration.
Doctor Notes
- Assess the patient's risk for opioid abuse, addiction, or misuse before prescribing and periodically during treatment.
- Monitor for signs of respiratory depression, especially during initiation of therapy or dose escalation.
- Advise patients against abrupt discontinuation to prevent withdrawal symptoms and to taper the dose gradually under medical supervision.
- Consider the potential for serotonin syndrome when co-prescribing with other serotonergic agents.
Patient Guidelines
- Do not exceed the prescribed dose or frequency.
- Avoid alcohol and other CNS depressants during treatment.
- Inform your doctor about all other medications, including over-the-counter drugs and herbal supplements.
- Do not stop taking the medicine abruptly to avoid potential withdrawal symptoms; consult your doctor for dose tapering.
- Store the medicine safely away from children and pets, ideally in a locked cabinet.
Missed Dose Advice
If a dose is missed, 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
Tapentadol may cause dizziness, drowsiness, or impaired judgment. Patients should be cautioned against driving or operating hazardous machinery until they are reasonably certain that Tapentadol does not adversely affect their ability to engage in such activities.
Lifestyle Advice
- To manage constipation, increase fiber intake in your diet, drink plenty of fluids, and engage in regular physical activity if possible.
- Avoid activities requiring mental alertness (e.g., driving, operating heavy machinery) until you know how the medicine affects you, as it may cause dizziness or drowsiness.
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Global Brand Names
International brand names for this medicine. Click a brand to search for detailed information.