Tapentadol oral prolonged release
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Prolonged release oral formulation of tapentadol.
Drugs List
Therapeutic Indications
Uses
Pain - severe chronic
Severe chronic pain that can only be controlled by opioid analgesics.
Dosage
Dosing should be individualised according to the severity of pain.
Adults
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.
Contraindications
Acute alcohol intoxication
Children under 18 years
Drug intoxication
Impaired consciousness
Risk of paralytic ileus
Within 2 weeks of discontinuing MAOIs
Acute asthma
Breastfeeding
Coma
Galactosaemia
Head trauma
Hypercapnia
Paralytic ileus
Raised intracranial pressure
Severe asthma
Severe hepatic impairment
Severe renal impairment
Severe respiratory depression
Precautions and Warnings
Elderly
Predisposition to seizures
Acute pancreatitis
Biliary tract disorder
Brain neoplasm
Drug misuse
Glucose-galactose malabsorption syndrome
History of seizures
Lactose intolerance
Moderate hepatic impairment
Pregnancy
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
Pregnancy
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.
Lactation
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
Addiction
Agitation
Altered temperature sensation
Anxiety
Asthenia
Ataxia
Attention disturbances
Confusion
Constipation
Convulsions
Decrease in blood pressure
Decrease in heart rate
Decreased appetite
Dependence
Depressed mood
Diarrhoea
Disorientation
Dizziness
Dream abnormalities
Dry mouth
Dysarthria
Dyspepsia
Dyspnoea
Euphoria
Faintness
Fatigue
Feeling abnormal
Feeling drunk
Feeling of relaxation
Flushing
Gastric disorders
Hallucinations
Headache
Hyperhidrosis
Hypersensitivity reactions
Hypoaesthesia
Impaired co-ordination
Impaired consciousness
Impaired memory
Increased heart rate
Involuntary muscle contractions
Irritability
Nausea
Nervousness
Oedema
Palpitations
Paraesthesia
Perceptual disturbances
Pollakiuria
Presyncope
Pruritus
Rash
Respiratory depression
Restlessness
Sedation
Serotonin syndrome
Sexual dysfunction
Sleep disturbances
Somnolence
Syncope
Tremor
Urinary hesitancy
Urticaria
Visual disturbances
Vomiting
Weight loss
Withdrawal symptoms
Overdosage
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 ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
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.
Gov.uk. 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: https://www.gov.uk/ Last accessed: 11 April 2019
New drug driving offence: implications for medicines packaging. Medicines Regulatory News. 10 December 2013. Available at: https://www.mhra.gov.uk Last accessed: 11 April 2019
MHRA Drug Safety Update January 2019
Available at: https://www.mhra.gov.uk
Last accessed: 16 August 2021
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 16 August 2021
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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