Tapentadol phosphate oral prolonged release capsules
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Prolonged release oral formulation of tapentadol phosphate.
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 phosphate prolonged release capsules 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 capsule 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.
Additional Dosage Information
Tapentadol phosphate capsules may be swallowed whole with liquid. The capsules may also be opened and the capsule contents sprinkled onto a tablespoon of cold soft food (e.g. apple sauce) and taken immediately. This should be followed by drinking some fluids such as water.
Contraindications
Acute alcohol intoxication
Children under 18 years
Drug intoxication
Impaired consciousness
Risk of paralytic ileus
Within 2 weeks of discontinuing MAOIs
Acute asthma
Brain neoplasm
Breastfeeding
Chronic obstructive pulmonary disease
Coma
Head trauma
Hypercapnia
Paralytic ileus
Raised intracranial pressure
Severe asthma
Severe hepatic impairment
Severe renal impairment
Severe respiratory depression
Precautions and Warnings
Debilitation
Elderly
Predisposition to seizures
Shock
Acute pancreatitis
Adrenal insufficiency
Asthma
Benign prostatic hyperplasia
Biliary tract disorder
Drug misuse
Gastrointestinal obstruction
History of alcohol abuse
History of drug misuse
History of psychiatric disorder
History of seizures
Hypotension
Hypothyroidism
Inflammatory bowel disease
Labour
Moderate hepatic impairment
Myasthenia gravis
Pregnancy
Psychiatric disorder
Respiratory depression
Respiratory impairment
Sleep apnoea
Urethral stricture
Reduce dose in hypothyroidism
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
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
Reassess need for continued treatment at regular intervals
Tolerance and dependence may occur
Consider dose reduction if sleep-related breathing disorders occur
Increased risk of central sleep apnoea and sleep-related hypoxemia
May increase risk of seizure
Prolonged use at high doses may result in hyperalgesia
Avoid abrupt withdrawal
To discontinue, reduce dose gradually
Discontinue if paralytic ileus is suspected
Consider dose reduction or alternative opioid in cases of hyperalgesia
Consider reducing dose in elderly
Maintain treatment at the lowest effective dose
Reduce dose in debilitated patients
Advise patient not to take St John's wort concurrently
Advise patient to avoid alcohol during treatment
Advise that effects are potentiated by CNS depressants (including alcohol)
Use with caution in patients with impaired respiratory function as dose-related respiratory depression may be seen at high doses of tapentadol phosphate or in opioid sensitive patients. Tapentadol phosphate 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.
A strategy for ending treatment with tapentadol phosphate should be discussed with the patient before starting treatment in order to minimise the risk of addiction and drug withdrawal syndrome.
A full patient history should be established to document concomitant medications and past and present medical and psychiatric conditions. The risk of developing tolerance to tapentadol phosphate should be explained to the patient prior to treatment. All patients should be closely observed for signs of misuse, abuse or addiction. Patients at risk of opioid misuse may require additional support and monitoring.
Pregnancy and Lactation
Pregnancy
Use tapentadol phosphate with caution during pregnancy.
The manufacturers advise that tapentadol phosphate 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 phosphate in labour and delivery in humans is unknown, therefore tapentadol phosphate is not recommended for use in women during or immediately before labour or delivery. Due to the opioid activity of tapentadol phosphate, newborn infants whose mothers have been taking tapentadol phosphate 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 phosphate is contraindicated during breastfeeding.
The manufacturers advise that tapentadol phosphate should not be used during breastfeeding. At the time of writing there is no information on the excretion of tapentadol phosphate in human milk. Studies in animals have shown that tapentadol phosphate 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
Delirium
Dependence
Depressed mood
Diarrhoea
Disorientation
Dizziness
Dream abnormalities
Dry mouth
Dysarthria
Dyspepsia
Dyspnoea
Euphoria
Fatigue
Feeling abnormal
Feeling drunk
Feeling of relaxation
Flushing
Gastric disorders
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
Sexual dysfunction
Sleep disturbances
Somnolence
Syncope
Tremor
Urinary hesitancy
Urticaria
Visual disturbances
Vomiting
Weight loss
Withdrawal symptoms
Withdrawal Symptoms and Signs
Some or all of the opioid drug withdrawal syndrome side effects are: restlessness, lacrimation, rhinorrhoea, yawning, perspiration, chills, myalgia, mydriasis and palpitations. Other symptoms may also develop including irritability, agitation, anxiety, hyperkinesia, tremor, weakness, insomnia, anorexia, abdominal cramps, nausea, vomiting, diarrhoea, increased blood pressure, increased respiratory rate or heart rate.
When a patient no longer requires treatment, it is advisable to taper the dose gradually to minimise symptoms of withdrawal. Tapering from a high dose may take weeks to months.
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 2022
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: Tapimio 50mg, 100mg, 150mg, 200mg and 250mg prolonged-release capsules. Neuroxpharm UK Ltd. Revised February 2022.
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: 25 August 2022
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 25 August 2022
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