tapentadol maleate hemihydrate at a glance
Medicine class
Strong opioid analgesic with additional noradrenaline reuptake inhibition.
Licensed use
Severe chronic pain in adults when an opioid is required.
Administration
Swallow prolonged-release tablets whole with liquid; do not divide, chew or crush them.
Food
May be taken with or without food.
Key safety issue
Can cause sedation, breathing suppression, tolerance, dependence and opioid use disorder.
What is tapentadol maleate hemihydrate used for?
The selected prolonged-release tablet is licensed for:
Management of severe chronic pain in adults that can only be adequately managed with opioid analgesics.
How does tapentadol maleate hemihydrate work?
Tapentadol activates mu-opioid receptors, reducing the transmission and perception of pain. It also inhibits noradrenaline reuptake, strengthening descending pain-control pathways. Its analgesic effect comes from tapentadol itself rather than an active metabolite.
tapentadol maleate hemihydrate preparations and strengths
Modified-release tablet
Route: Oral
Strengths: 50 mg, 100 mg, 150 mg, 200 mg
How to take tapentadol maleate hemihydrate
Take it exactly as directed by the prescriber. The prolonged-release design must remain intact to prevent rapid release of tapentadol.
Swallow tablets whole with sufficient liquid.
Do not divide, chew or crush them.
Take with or without food.
The inactive tablet matrix may occasionally appear in the stool after the active substance has been absorbed.
Do not stop treatment without discussing it with the prescriber.
tapentadol maleate hemihydrate side effects
Common or expected effects
- Nausea or vomiting
- Constipation
- Dizziness, drowsiness or headache
- Diarrhoea or indigestion
- Reduced appetite
- Tiredness or weakness
- Anxiety, low mood, sleep disturbance or restlessness
- Itching, rash or increased sweating
- Difficulty concentrating or tremor
Get urgent medical advice
- Slow or shallow breathing, extreme sedation or loss of consciousness
- Severe allergic reaction, including facial or throat swelling, wheezing, collapse or widespread hives
- Seizure
- Possible serotonin syndrome: agitation, sweating, fever, tremor, muscle stiffness, exaggerated reflexes or rhythmic muscle jerking
- Symptoms suggesting dependence, opioid use disorder or clinically significant withdrawal
tapentadol maleate hemihydrate in pregnancy
Human pregnancy data are very limited. Use requires an individual prescriber assessment of maternal benefit and fetal risk. Prolonged opioid exposure can cause neonatal withdrawal, and use near childbirth may suppress the newborn's breathing; contact the prescriber promptly if pregnancy occurs during treatment.
tapentadol maleate hemihydrate while breastfeeding
The selected product should not be used while breastfeeding because human milk-transfer data are unavailable and risk to the infant cannot be excluded. A prescriber or specialist medicines-in-breastfeeding service can advise on a better-studied alternative.
tapentadol maleate hemihydrate interactions
Check prescribed, over-the-counter and herbal products before treatment. Important interactions include:
Alcohol, benzodiazepines, sedating antihistamines, antipsychotics, barbiturates and other opioids
Additive sedation and breathing suppression can lead to coma or death; alcohol should be avoided.
Gabapentin or pregabalin
Combined use increases the risk of profound sedation, opioid overdose and respiratory depression.
SSRIs, SNRIs and tricyclic antidepressants
May increase seizure risk and have been associated with serotonin syndrome.
Common questions about tapentadol maleate hemihydrate
Answers are fully visible for fast scanning and source review.
What is tapentadol used for?
The selected prolonged-release tapentadol product is licensed for severe chronic pain in adults when adequate management requires an opioid.
How does tapentadol work?
It reduces pain through mu-opioid receptors and by increasing noradrenaline signalling in descending pain-control pathways.
Can tapentadol prolonged-release tablets be crushed or split?
Sources
These sources were used to prepare and review this medicine page.
Prepared and reviewed by the iatroX editorial team.