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Tapentadol Hydrochloride: Brands, Price & Uses in Bangladesh
Tapentadol Hydrochloride is an opioid analgesic indicated for the relief of pain, with evidence-based use classified as follows: Established/FDA-Approved Uses Acute pain (immediate-release…
About Tapentadol Hydrochloride
Indications of Tapentadol Hydrochloride
Tapentadol Hydrochloride is an opioid analgesic indicated for the relief of pain, with evidence-based use classified as follows:
Established/FDA-Approved Uses
- Acute pain (immediate-release formulation): Management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate, in adults and in pediatric patients 6 years of age and older weighing at least 40 kg.
- Chronic pain (extended-release formulation): Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatments are inadequate, in adults.
- Neuropathic pain associated with diabetic peripheral neuropathy (extended-release formulation): Management of moderate to severe chronic neuropathic pain associated with diabetic peripheral neuropathy in adults, when a continuous, around-the-clock opioid analgesic is needed for an extended period.
Important Note
Tapentadol Hydrochloride is reserved for pain severe enough to require opioid treatment and for which alternative, non-opioid treatment options are inadequate or not tolerated; it is not intended for use on an as-needed basis for mild pain.
Dosage & Administration of Tapentadol Hydrochloride
Dosing of Tapentadol Hydrochloride must be individualized based on the severity of pain, patient response, and prior opioid exposure. Use the lowest effective dose for the shortest duration consistent with treatment goals.
| Indication | Formulation | Typical Adult Dosing |
|---|---|---|
| Acute pain | Immediate-release | 50 mg to 100 mg orally every 4 to 6 hours as needed; maximum 700 mg on day one, 600 mg per day thereafter |
| Chronic pain | Extended-release | Initially 50 mg twice daily (approximately every 12 hours); titrate in increments of 50 mg twice daily no more often than every 3 days, up to a maximum of 500 mg/day |
| Diabetic peripheral neuropathic pain | Extended-release | Same titration schedule as chronic pain, individualized to response and tolerability |
Pediatric Dosing (Immediate-release, acute pain only; 6 years and older, weighing 40 kg or more)
| Body Weight | Dose |
|---|---|
| 40-59 kg | 50 mg every 4 hours as needed (maximum single dose 50 mg) |
| 60-79 kg | 50-75 mg every 4 hours as needed (maximum single dose 75 mg) |
| 80 kg or more | 50-100 mg every 4 hours as needed (maximum single dose 100 mg) |
Maximum pediatric daily dose should not exceed 7.5 mg/kg/day. Extended-release Tapentadol Hydrochloride is not established as safe and effective in pediatric patients.
Hepatic and Renal Impairment
In patients with moderate hepatic impairment, immediate-release Tapentadol Hydrochloride should be initiated at 50 mg no more frequently than every 8 hours; use in severe hepatic impairment and extended-release use in any hepatic impairment is not recommended. Use in severe renal impairment is not recommended.
Side Effects of Tapentadol Hydrochloride
The most common adverse effects of Tapentadol Hydrochloride (occurring in 10% or more of adult patients) are:
- Nausea
- Dizziness
- Vomiting
- Somnolence (drowsiness)
Other commonly reported effects include constipation, headache, pruritus (itching), dry mouth, and fatigue. In pediatric patients, vomiting, constipation, nausea, pruritus, and fever have been reported.
Serious but less common effects include respiratory depression, serotonin syndrome, seizures, severe hypotension, and adrenal insufficiency; see Precautions and Warnings for details.
Contraindications of Tapentadol Hydrochloride
Tapentadol Hydrochloride is contraindicated in:
- Known hypersensitivity to tapentadol or any component of the formulation.
- Significant respiratory depression.
- Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment.
- Known or suspected gastrointestinal obstruction, including paralytic ileus.
- Concurrent use of, or use within 14 days of, monoamine oxidase inhibitors (MAOIs).
Frequently Asked Questions about Tapentadol Hydrochloride
What is Tapentadol Hydrochloride used for?
Tapentadol Hydrochloride is an opioid analgesic used to manage moderate to severe acute pain (immediate-release form) or chronic pain, including neuropathic pain from diabetic peripheral neuropathy, that requires around-the-clock opioid treatment (extended-release form), when alternative treatments are inadequate.
Is Tapentadol Hydrochloride addictive?
Yes. Tapentadol Hydrochloride carries a boxed warning for the risk of addiction, abuse, and misuse, which can lead to overdose and death, even when taken as prescribed. It should be used only under close medical supervision and for the shortest duration necessary.
Can I drink alcohol while taking Tapentadol Hydrochloride?
No. Alcohol should be avoided while taking Tapentadol Hydrochloride, as combining the two significantly increases the risk of serious, potentially fatal side effects such as severe drowsiness, slowed breathing, and respiratory depression.
Can I take Tapentadol Hydrochloride during pregnancy?
Tapentadol Hydrochloride should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus, and only under close medical supervision, because prolonged use can cause neonatal opioid withdrawal syndrome in the newborn. Always consult a physician before use during pregnancy.
What should I do if I miss a dose or think I have taken too much?
If you miss a dose of Tapentadol Hydrochloride, take it as soon as you remember unless it is close to the next dose. If you suspect an overdose (symptoms include severe drowsiness, slow or shallow breathing, or loss of consciousness), seek immediate medical attention or contact emergency services, as overdose can be life-threatening.
Can I stop taking Tapentadol Hydrochloride suddenly?
No. Do not stop Tapentadol Hydrochloride abruptly after prolonged use, as this can cause withdrawal symptoms. Your physician will guide you on gradually tapering the dose if treatment needs to be discontinued.
Disclaimer
The information provided is accurate to the best of our knowledge, but it does not replace professional medical advice. We cannot guarantee its completeness or accuracy, and the absence of specific information about a drug should not be taken as an endorsement. We are not responsible for any consequences arising from this information, so please consult a healthcare professional for any concerns or questions.