Tapentadol
Regulatory sources consulted
- openfda-label-7fef46e2-c049-44d8-962f-fdd233dad041
- aemps-cima-ft-73244
- ansm-bdpm-rcp-67934219
- PubMed PMID:39465454 ↗
- PubMed PMID:36786097 ↗
- PubMed PMID:34264611 ↗
- PubMed PMID:37670573 ↗
- PubMed PMID:38108561 ↗
- OpenFDA · N02AX06
- RxNorm rxcui 787390 ↗
Approved indications
- Management of severe and persistent pain in adults that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate.
- Management of severe and persistent neuropathic pain associated with diabetic peripheral neuropathy (DPN) in adults that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate.
Contraindications
Absolute
- 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 monoamine oxidase inhibitors (MAOIs) or use within the last 14 days.
- Hypersensitivity to tapentadol or any of the excipients.
Clinical warnings
- Boxed warning · Addiction, Abuse, and Misuse; Life-Threatening Respiratory Depression; Accidental Ingestion; Interaction with Alcohol; Risks from concomitant use with benzodiazepines or other CNS depressants; Neonatal Opioid Withdrawal Syndrome. — FDA
Drug interactions
- HighMonoamine Oxidase Inhibitors (MAOIs)N06AF
Mechanism: Additive effects on synaptic norepinephrine concentrations, which can lead to hypertensive crisis and serotonin syndrome.
Recommendation: Contraindicated. Avoid use of tapentadol during and within 14 days of MAOI therapy.
FDA labelANSM RCP
- HighBenzodiazepines and other CNS depressantsN05BA
Mechanism: Additive pharmacologic effect increases the risk of hypotension, respiratory depression, profound sedation, coma, and death.
Recommendation: Reserve concomitant prescribing for patients with no alternatives. Limit dosage and duration to the minimum. Closely monitor for sedation and respiratory depression.
FDA labelANSM RCP
- ModerateSerotonergic Drugs (SSRIs, SNRIs, TCAs)N06A
Mechanism: Concomitant use can result in serotonin syndrome due to additive effects on the serotonergic neurotransmitter system.
Recommendation: Evaluate the patient frequently, particularly during treatment initiation and dose adjustment. Discontinue tapentadol if serotonin syndrome is suspected.
FDA labelANSM RCP
Adverse events
Common (≥1%)
nausea · constipation · dizziness · headache · somnolence
Rare but serious
respiratory depression · serotonin syndrome · seizures · adrenal insufficiency · severe hypotension · paralytic ileus · angioedema
Pregnancy and lactation
Prolonged use during pregnancy can cause neonatal opioid withdrawal syndrome. Based on animal data, may cause fetal harm. Not recommended for use during lactation.
Recent literature (PubMed)
Revisión que describe los tratamientos disponibles para la neuropatía periférica diabética dolorosa (NPD). Destaca que la FDA de EE. UU. ha aprobado pregabalina, duloxetina, tapentadol y el parche de capsaicina al 8% para el tratamiento de la NPD dolorosa, posicionando al tapentadol como una opción terapéutica clave aprobada para esta indicación.
Revisión por un grupo de expertos europeos sobre el tratamiento del dolor en personas mayores. Menciona el tapentadol entre los opioides 'fuertes' para el dolor severo, junto con la morfina, oxicodona y otros. Enfatiza la necesidad de una evaluación geriátrica completa y ajuste de dosis, especialmente considerando la función renal.
Revisión narrativa sobre la neuropatía periférica diabética (NPD). Se mencionan los opioides (tramadol, tapentadol y oxicodona) como fármacos comúnmente administrados para tratar la NPD, junto con anticonvulsivos y antidepresivos, reforzando su rol en esta patología.
Revisión exhaustiva sobre opioides para el dolor oncológico. Encontró evidencia de certeza moderada a baja de que el tapentadol puede ser más eficaz que el placebo para el dolor de fondo en cáncer. Señala la escasez de ensayos controlados con placebo para los opioides en este contexto.
Revisión sobre el tratamiento del dolor agudo. Sugiere que para el dolor agudo severo o refractario, el tratamiento puede escalarse con medicamentos como tramadol o tapentadol, que actúan sobre los receptores opioides y monoaminérgicos, como un paso intermedio antes de combinaciones con opioides más fuertes.