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Tapentadol oral prolonged release

Updated 2 Feb 2023 | Opioid analgesics


Prolonged release oral formulation of tapentadol.

Drugs List

  • ATIONDO SR 100mg prolonged release tablet
  • ATIONDO SR 150mg prolonged release tablet
  • ATIONDO SR 200mg prolonged release tablet
  • ATIONDO SR 250mg prolonged release tablet
  • ATIONDO SR 25mg prolonged release tablet
  • ATIONDO SR 50mg prolonged release tablet
  • PALEXIA SR 100mg prolonged release tablet
  • PALEXIA SR 150mg prolonged release tablet
  • PALEXIA SR 200mg prolonged release tablet
  • PALEXIA SR 250mg prolonged release tablet
  • PALEXIA SR 50mg prolonged release tablet
  • tapentadol 100mg prolonged release tablet
  • tapentadol 150mg prolonged release tablet
  • tapentadol 200mg prolonged release tablet
  • tapentadol 250mg prolonged release tablet
  • tapentadol 25mg prolonged release tablet
  • tapentadol 50mg prolonged release tablet
  • Therapeutic Indications


    Pain - severe chronic

    Severe chronic pain that can only be controlled by opioid analgesics.


    Dosing should be individualised according to the severity of pain.


    Initiation of therapy in patients not taking opioid analgesics
    50mg twice daily, every 12 hours.

    Initiation of therapy in patients currently taking opioid analgesics
    When switching from opioids to tapentadol prolonged release tablets and choosing the initial dose, the nature of the previous medical product, administration and the mean daily dose should be taken into account. This may require higher initial doses for patients currently taking opioid analgesics compared to those not taking opioid analgesics.

    Titration and Maintenance
    After initial treatment the dose should be titrated to provide adequate analgesia with minimal side effects.
    A suggested titration regimen is increments of 50mg as prolonged-release tablet twice daily every 3 days until adequate pain control is achieved.

    A total daily dose greater than 500mg has not been studied and is therefore not recommended.

    Patients with Hepatic Impairment

    Patients with moderate hepatic impairment should have treatment initiated with a dose not greater than 50mg once every 24 hours. Doses may be increased balancing adequate analgesia with acceptable toxicity.


    Acute alcohol intoxication
    Children under 18 years
    Drug intoxication
    Impaired consciousness
    Risk of paralytic ileus
    Within 2 weeks of discontinuing MAOIs
    Acute asthma
    Head trauma
    Paralytic ileus
    Raised intracranial pressure
    Severe asthma
    Severe hepatic impairment
    Severe renal impairment
    Severe respiratory depression

    Precautions and Warnings

    Predisposition to seizures
    Acute pancreatitis
    Biliary tract disorder
    Brain neoplasm
    Drug misuse
    Glucose-galactose malabsorption syndrome
    History of seizures
    Lactose intolerance
    Moderate hepatic impairment
    Respiratory depression
    Respiratory impairment

    Reduce dose in patients with moderate hepatic impairment
    Advise ability to drive/operate machinery may be affected by side effects
    Advise patient not to drive until they know how the medicine affects them
    Advise patient this medicine may be subject to driving restrictions
    Contains lactose
    May cause respiratory depression
    Monitor patients for signs and symptoms of Serotonin Syndrome
    Monitor patients with a history of alcoholism and drug abuse
    Neonate exposed in utero: Monitor for neonatal withdrawal syndrome
    Neonate exposed in utero: Monitor for respiratory depression
    Potential for drug abuse
    Consider dose reduction if sleep-related breathing disorders occur
    Increased risk of central sleep apnoea and sleep-related hypoxemia
    May cause dependence
    Avoid abrupt withdrawal
    To discontinue, reduce dose gradually
    Discontinue if paralytic ileus is suspected
    Maintain treatment at the lowest effective dose
    Advise patient to avoid alcohol during treatment
    Advise that effects are potentiated by CNS depressants (including alcohol)
    Advise patients that empty tablet/capsule may be observed in stools

    Use with caution in patients with impaired respiratory function as dose-related respiratory depression may be seen at high doses of tapentadol or in opioid sensitive patients. Tapentadol should only be used under careful medical supervision at the lowest effective dose in such patients. If respiratory depression occurs, it should be treated as any opioid induced respiratory depression.

    Use with caution in patients with biliary tract disorders (including acute pancreatitis); active substances with mu-opioid receptor agonist activity may cause spasm of the sphincter of Oddi.

    Pregnancy and Lactation


    Use tapentadol with caution during pregnancy.

    The manufacturers advise that tapentadol should only be used in pregnancy if the potential benefits outweigh the potential risk to the foetus. At the time of writing there is limited published information regarding use during pregnancy. Animal studies have not shown any teratogenic effect, however, delayed development and embryotoxicity were observed. The effect of tapentadol in labour and delivery in humans is unknown, therefore tapentadol is not recommended for use in women during or immediately before labour or delivery. Due to the opioid activity of tapentadol, newborn infants whose mothers have been taking tapentadol should be monitored for respiratory depression. Long term maternal use of opioids during pregnancy coexposes the foetus and the newborn may experience neonatal withdrawal syndrome. An antidote for the newborn should be readily available as neonatal opioid withdrawal syndrome can be life-threatening if not recognised and treated.


    Tapentadol is contraindicated during breastfeeding.

    The manufacturers advise that tapentadol should not be used during breastfeeding. At the time of writing there is no information on the excretion of tapentadol in human milk. Studies in animals have shown that tapentadol is excreted in breast milk therefore a risk to the child can not be excluded. Schaefer (2015) states that a single dose does not require any breastfeeding limitation, but repeated use is not recommended.

    Effects on Ability to Drive and Operate Machinery

    This class of medicine is in the list of drugs included in regulations under 5a of the Road Traffic Act 1988 (England and Wales). When prescribing this medicine: Advise patient the medicine can affect cognitive function and is likely to affect ability to drive. Advise patient not to drive until they know how the medicine affects them.

    Side Effects

    Abdominal discomfort
    Abnormal thinking
    Altered temperature sensation
    Attention disturbances
    Decrease in blood pressure
    Decrease in heart rate
    Decreased appetite
    Depressed mood
    Dream abnormalities
    Dry mouth
    Feeling abnormal
    Feeling drunk
    Feeling of relaxation
    Gastric disorders
    Hypersensitivity reactions
    Impaired co-ordination
    Impaired consciousness
    Impaired memory
    Increased heart rate
    Involuntary muscle contractions
    Perceptual disturbances
    Respiratory depression
    Serotonin syndrome
    Sexual dysfunction
    Sleep disturbances
    Urinary hesitancy
    Visual disturbances
    Weight loss
    Withdrawal symptoms


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: August 2021

    Reference Sources

    Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

    Summary of Product Characteristics: Ationdo SR prolonged-release tablets. Grunenthal Ltd. Revised April 2021.

    Summary of Product Characteristics: Palexia SR prolonged-release tablets. Grunenthal Ltd. Revised May 2021. Government departments. Department for Transport. Publications. Drug driving and medicine: Advice for healthcare professionals. Drug driving: Guidance for healthcare professionals on drug driving. Available at: Last accessed: 11 April 2019
    New drug driving offence: implications for medicines packaging. Medicines Regulatory News. 10 December 2013. Available at: Last accessed: 11 April 2019

    MHRA Drug Safety Update January 2019
    Available at:
    Last accessed: 16 August 2021

    NICE Evidence Services Available at: Last accessed: 16 August 2021

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