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Tramadol 24 hour oral modified release

Updated 2 Feb 2023 | Opioid analgesics


24 hour modified release tablets containing tramadol hydrochloride

Drugs List

  • TRADOREC XL 100mg tablets
  • TRADOREC XL 200mg tablets
  • TRADOREC XL 300mg tablets
  • tramadol 100mg 24 hour modified release tablets
  • tramadol 150mg 24 hour modified release tablets
  • tramadol 200mg 24 hour modified release tablets
  • tramadol 300mg 24 hour modified release tablets
  • tramadol 400mg 24 hour modified release tablets
  • ZAMADOL 150mg 24 hour modified release tablets
  • ZAMADOL 200mg 24 hour modified release tablets
  • ZAMADOL 300mg 24 hour modified release tablets
  • ZAMADOL 400mg 24 hour modified release tablets
  • ZYDOL XL 400mg tablets
  • Therapeutic Indications


    Pain - moderate to severe


    Dose should be adjusted individually according to severity of pain and clinical response.

    Patients transferring from immediate release preparations should have their total daily dose calculated and then transferred to the nearest dose of modified release tablet.

    Titration to higher doses should be carried out slowly to minimise transient side effects.


    Initial dose 100 to 150mg tablet once daily. The dose may then be titrated upwards to an optimum dosage level, which controls pain while causing no or minimal tolerable side effects for a full 24 hours.

    A maximum dose of 400mg daily should not be exceeded, except in special clinical circumstances.


    In patients over 75 years, there tends to be an increase in tramadol bioavailability and the elimination half-life of tramadol was increased by 17%.
    (See Dosage; Adults)


    12 years and over
    (See Dosage; Adults)

    Patients with Renal Impairment

    Initially 100mg daily but dose titration must be carefully monitored. Elimination of tramadol may be prolonged in patients with renal impairment. The dose interval may need to be increased.

    As tramadol is only removed slowly by haemodialysis or haemofiltration, it is usually not necessary to administer post-dialysis doses.

    Patients with Hepatic Impairment

    Initially 100mg daily but dose titration must be carefully monitored. Elimination of tramadol may be prolonged in patients with hepatic impairment. The dose interval may need to be increased.


    Acute alcohol intoxication
    Children under 12 years
    Risk of paralytic ileus
    Within 2 weeks of discontinuing MAOIs
    Acute asthma
    Acute respiratory depression
    Chronic obstructive pulmonary disease
    Long QT syndrome
    Renal impairment - creatinine clearance below 10ml/minute
    Severe hepatic impairment
    Torsade de pointes
    Uncontrolled epileptic disorder

    Precautions and Warnings

    Family history of long QT syndrome
    Impaired consciousness
    Patients over 75 years
    Predisposition to seizures
    Adrenal insufficiency
    Benign prostatic hyperplasia
    Biliary tract disorder
    CYP2D6 poor metaboliser genotype
    CYP2D6 ultra-rapid metaboliser genotype
    Electrolyte imbalance
    Epileptic disorder
    Excessive bronchial secretions
    Gastrointestinal obstruction
    Glucose-galactose malabsorption syndrome
    Head trauma
    History of alcohol abuse
    History of drug misuse
    History of seizures
    History of torsade de pointes
    Inflammatory bowel disease
    Lactose intolerance
    Mild hepatic impairment
    Myasthenia gravis
    Opioid dependence
    Psychiatric disorder
    Raised intracranial pressure
    Renal impairment - creatinine clearance 10-30ml/minute
    Respiratory depression
    Sleep apnoea

    Children under 18 years: Increased risk of rare and severe adverse effects
    Correct electrolyte disorders before treatment
    Corticosteroid cover required in adrenal insufficiency
    CYP2D6 ultra-rapid metaboliser genotype: Increased risk of opioid toxicity
    Reduce dose and/or alter dose interval in patients with hepatic impairment
    Reduce dose and/or alter dose interval in patients with renal impairment
    Advise patient ability to drive or operate machinery may be impaired
    Advise patient drowsiness may affect ability to drive or operate machinery
    Advise patient not to drive until they know how the medicine affects them
    Advise patient this medicine may be subject to driving restrictions
    Not suitable as a substitute in opioid-dependent patients
    Some formulations contain lactose
    Consider monitoring ECG in patients at risk of QT prolongation
    Monitor at regular intervals as withdrawal symptoms & dependence may occur
    Monitor patient for signs and symptoms of respiratory depression
    Monitor patients with a history of alcoholism and drug abuse
    Monitor serum electrolytes
    Neonate exposed in utero: Monitor for neonatal withdrawal syndrome
    Patients on long-term therapy should be regularly reviewed
    Potential for drug abuse
    Tolerance and dependence may occur
    When used with SSRIs, risk of Serotonin syndrome
    Consider dose reduction if sleep-related breathing disorders occur
    Consider dose reduction or change in opioid if evidence of hyperalgesia
    Increased risk of central sleep apnoea and sleep-related hypoxemia
    May cause convulsions
    May cause transient adrenocortical insufficiency
    May increase risk of seizure
    Neonate exposed in labour: Risk of respiratory depression
    Prolonged use at high doses may result in hyperalgesia
    Withdrawal symptoms after long-term normal use on abrupt cessation
    Avoid abrupt withdrawal
    Withdraw gradually after long-term use
    Maintain treatment at the lowest effective dose
    Reduce dose and/or alter dose interval in elderly 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)

    Not recommended during potentially light planes of general anaesthesia due to a possibly increased operative recall reported.

    Not recommended in children at risk of impaired respiratory function including those with neuromuscular disorders, severe cardiac or respiratory conditions, upper respiratory or lung infections, multiple trauma or extensive surgical procedures. Extreme caution and monitoring for signs of opioid toxicity is also advised in children following tonsillectomy and/or adenoidectomy for obstructive sleep apnoea.

    Pregnancy and Lactation


    Tramadol is contraindicated during pregnancy.

    The manufacturer does not recommend the use of tramadol during pregnancy. Prolonged use of tramadol during pregnancy may result in drug dependency in the foetus and withdrawal symptoms in the neonate.

    At the time of writing there is limited published information regarding the use of tramadol during pregnancy, however tramadol is known to cross the placenta, and administration of tramadol during labour may cause respiratory depression in the neonate (Briggs, 2015). Tramadol does not affect uterine contractility. Animal studies have shown adverse effects on the development of organs, bone formation and neonatal mortality with very large concentrations of tramadol. No teratogenic effects have been observed.


    Use tramadol with caution during breastfeeding.

    The manufacturer does not recommend the use of tramadol during breastfeeding, tramadol and its metabolites are secreted into breast milk, which may cause respiratory depression in the infant.

    LactMed (2020) state that healthy full term infants are unlikely to be adversely affected by exposure to tramadol via breast milk, however, if used in infants, the infant should be monitored for increased sleepiness, breathing difficulties, difficulty breastfeeding and limpness, and medical advice sought immediately should any of these occur.

    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.


    Advise patients that tablets must be taken at 24-hourly intervals, and must be swallowed whole, not chewed.

    Tramadol may cause drowsiness, and this effect may be potentiated by alcohol and other CNS depressants. Ambulant patients should be warned not to drive or operate machinery if affected.

    Side Effects

    Abdominal discomfort
    Aggravation of existing asthma
    Allergic reaction
    Anaphylactic reaction
    Blurred vision
    Cardiovascular collapse
    Changes in cognitive and sensorial capacity
    Changes in mental activity
    Circulatory collapse
    Difficulty in micturition
    Disturbances of appetite
    Dry mouth
    Gastric irritation
    Gastrointestinal disorder
    Hypersensitivity reactions
    Impairment of judgement
    Increases in hepatic enzymes
    Mood changes
    Muscle weakness
    Orthostatic hypotension
    Postural hypotension
    Quincke's oedema
    Respiratory depression
    Sleep apnoea
    Sleep disturbances
    Urinary retention
    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: April 2013

    Reference Sources

    British National Formulary, 65th Edition (March - September 2013) Pharmaceutical Press, London.

    BNF for Children (2012-2013) Pharmaceutical Press, London.

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

    Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.

    Medications and Mothers' Milk, Sixteenth Edition (2014) Hale, T and Rowe, H, Hale Publishing, Plano, Texas.

    Summary of Product Characteristics: Tradorec XL. Paladin Labs Europe Ltd. Revised January 2013.

    Summary of Product Characteristics: Zamadol 24hr. Meda Pharmaceuticals. Revised December 2012.

    Summary of Product Characteristics: Zydol XL 400mg tabs. Grunenthal Ltd. Revised May 2021.

    US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
    Available at:
    Tramadol Last revised: 21 September 2020
    Last accessed: 15 February 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: 6 January 2015

    New drug driving offence implications for medicines packaging. Medicines Regulatory News. 10 December 2013. Available at: Last accessed: 6 January 2015

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