Formulary
Tapentadol: Indications, Dosing, Side Effects and Interactions
Tapentadol clinical drug profile including indications, dosing, side effects, cautions and interactions.
MedNext Academy | 4 min read
Tapentadol: Indications, Dosing, Side Effects and Interactions
Tapentadol clinical drug profile including indications, dosing, side effects, cautions and interactions.
Indications and dose
**Moderate to severe acute pain which can be managed only with opioid analgesics**
- **Adult** (By Mouth Using Immediate-Release Medicines): Initially 50 mg every 4-6 hours, adjusted according to response, on the first day of treatment, an additional dose of 50 mg may be taken 1 hour after the initial dose; maximum 700 mg in the first 24 hours; maximum 600 mg per day.
**Severe chronic pain which can be managed only with opioid analgesics**
- **Adult** (By Mouth Using Modified-Release Medicines): Initially 50 mg every 12 hours, adjusted according to response; maximum 500 mg per day.
**Moderate to severe acute pain which can be managed only with opioid analgesics for tapentadol**
- **Child 2-17 years (specialist supervision in hospital) (body-weight 16 kg and above)** (By mouth using oral solution): 1.25 mg/kg every 4 hours (max. per dose 100 mg) for up to 3 days, the dose for children with a high BMI must not exceed the calculated dose for a body-weight at the 97.5 percentile for the given age.
Cautions
Adrenocortical insufficiency (reduced dose is recommended); asthma (avoid during an acute attack); central sleep apnoea; convulsive disorders; current or history of mental health disorder; current or history of substance use disorder; debilitated patients (reduced dose is recommended); diseases of the biliary tract; elderly (reduced dose is recommended); hypotension; hypothyroidism (reduced dose is recommended); impaired respiratory function (avoid in chronic obstructive pulmonary disease); inflammatory bowel disorders; myasthenia gravis; obstructive bowel disorders; prostatic hypertrophy; shock; urethral stenosis Cautions, further information Dependence and addiction Prolonged use of opioid analgesics may lead to drug dependence and addiction, even at therapeutic doses. There is an increased risk in individuals with current or history of substance use disorder or mental health disorders. See also Important safety information . Central sleep apnoea Opioids cause a dose-dependent increased risk of central sleep apnoea, consider total opioid dose reduction. M Palliative care In the control of pain in terminal illness, the cautions listed should not necessarily be a deterrent to the use of opioid analgesics. M Elderly Screening Tool of Older Persons' potentially inappropriate Prescriptions (STOPP) criteria to aid medication reviews (see Prescribing in the elderly for information). Potentially inappropriate: if prescribed a strong , oral , or transdermal opioid (i.e. morphine, oxycodone, fentanyl, buprenorphine, diamorphine, methadone, tramadol, pethidine, pentazocine) as first-line therapy for mild pain (WHO analgesic ladder not observed) if used regularly without concomitant laxative (risk of severe constipation) if prescribed a long-acting (modified-release) opioid without a short-acting (immediate-release) opioid for breakthrough pain (risk of persistence of severe pain)
Contraindications
Acute respiratory depression; comatose patients; head injury (opioid analgesics interfere with pupillary responses vital for neurological assessment); raised intracranial pressure (opioid analgesics interfere with pupillary responses vital for neurological assessment); risk of paralytic ileus
Side effects
Common or very common Arrhythmias; confusion; constipation; dizziness; drowsiness; dry mouth; euphoric mood; flushing; hallucination; headache; hyperhidrosis; hypotension (with high doses); miosis; nausea (more common on initiation); palpitations; respiratory depression (with high doses); skin reactions; urinary retention; vertigo; visual impairment; vomiting (more common on initiation); withdrawal syndrome Uncommon Drug dependence; dysphoria; seizure Side-effects, further information Respiratory depression Respiratory depression is a major concern with opioid analgesics and it may be treated by artificial ventilation or be reversed by naloxone. Dependence, addiction, and withdrawal Long term use of opioids in non-malignant pain (longer than 3 months) carries an increased risk of dependence and addiction, even at therapeutic doses. At the end of treatment the dosage should be tapered slowly to reduce the risk of withdrawal effects; tapering from a high dose may take weeks or months. See also Important safety information . Overdose Opioids (narcotic analgesics) cause coma, respiratory depression, and pinpoint pupils. For details on the management of poisoning, see Opioids, under Emergency treatment of poisoning and consider the specific antidote, naloxone hydrochloride. Side-effects For tapentadol Common or very common Anxiety; appetite decreased; asthenia; concentration impaired; depressed mood; diarrhoea; dyspnoea; feeling of body temperature change; gastrointestinal discomfort; mucosal dryness; muscle contractions involuntary; muscle spasms; oedema; sleep disorders; tremor Uncommon Cognitive impairment; dysarthria; feeling abnormal; irritability; level of consciousness decreased; memory impairment; movement disorders; perception altered; sensation abnormal; sexual dysfunction; syncope; urinary disorders; weight decreased Rare or very rare Impaired gastric emptying
Interactions
**Other interactions (1):**
- John's Wort [ Hypericum perforatum ], opioids [e.g., fentanyl and its analogues, tramadol, dextromethorphan, tapentadol, pethidine, methadone, pentazocine, buprenorphine and buprenorphine/naloxone...
Pregnancy
Respiratory depression and withdrawal symptoms can occur in the neonate if opioid analgesics are used during delivery; also gastric stasis and inhalation pneumonia has been reported in the mother if opioid analgesics are used during labour.
Breast feeding
Avoid-no information available.
Hepatic impairment
Caution in moderate impairment; avoid in severe impairment (no information available). M Dose adjustments Reduce initial daily dose in moderate impairment. For immediate-release tablets , initiate at 50 mg up to every 8 hours; for oral solution , initiate at 25 mg up to every 8 hours; for modified-release preparations , initiate at 50 mg up to once every 24 hours. M
Renal impairment
Manufacturer advises avoid in severe impairment (no information available).
Medicinal forms
Tablet,Tablet,Solution
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
Inside MedNext for this topic
- 411 MedNext-authored chapters
- 80,000+ MCQ bank
- 15 study modes
- Growing visual cheat sheets
Study modes
- Notes
- MCQ
- Audio
- Video
- Visual
- 3D Anatomy
- Trace
- Flashcards
- Mnemonics
- Image Bank
- Clinical
- Microscopy
- Audio QBank
- Cadaver
- Book Match
Continue reading
Subject HubPharmacology Hub
All pharmacology resources in one place.
Drug SchedulesIndian Drug Schedules
Schedule H, H1, X and G classifications.
FormularyBrowse all drugs
Search 1,850+ drug profiles.
Study Tapentadol in the MedNext app
Challenge yourself with targeted pharmacology MCQs on this drug class. Every explanation links back to the chapter that teaches the concept.
Start drug challengeExplore the full formulary

