Tramadol 24 hour oral modified release
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
24 hour modified release tablets containing tramadol hydrochloride
Drugs List
Therapeutic Indications
Uses
Pain - moderate to severe
Dosage
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.
Adults
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.
Elderly
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)
Children
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.
Contraindications
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
Coma
Galactosaemia
Long QT syndrome
Pregnancy
Renal impairment - creatinine clearance below 10ml/minute
Severe hepatic impairment
Torsade de pointes
Uncontrolled epileptic disorder
Precautions and Warnings
Anaesthesia
Debilitation
Family history of long QT syndrome
Impaired consciousness
Patients over 75 years
Predisposition to seizures
Shock
Adrenal insufficiency
Asthma
Benign prostatic hyperplasia
Biliary tract disorder
Breastfeeding
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
Hypotension
Hypothyroidism
Hypoxia
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
Pregnancy
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.
Lactation
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.
Counselling
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
Agitation
Allergic reaction
Anaphylactic reaction
Anaphylaxis
Angioedema
Anorexia
Anxiety
Asthma
Blurred vision
Bradycardia
Bronchospasm
Cardiovascular collapse
Changes in cognitive and sensorial capacity
Changes in mental activity
Circulatory collapse
Confusion
Constipation
Convulsions
Delusions
Dependence
Diarrhoea
Difficulty in micturition
Disturbances of appetite
Dizziness
Dry mouth
Dysphoria
Dyspnoea
Dysuria
Euphoria
Flatulence
Flushing
Gastric irritation
Gastrointestinal disorder
Hallucinations
Headache
Hiccups
Hyperalgesia
Hyperhidrosis
Hyperkinesia
Hypersensitivity reactions
Hypertension
Impairment of judgement
Increases in hepatic enzymes
Insomnia
Mood changes
Muscle weakness
Muzziness
Nausea
Nervousness
Nightmares
Oedema
Orthostatic hypotension
Palpitations
Paraesthesia
Postural hypotension
Pruritus
Quincke's oedema
Rash
Respiratory depression
Retching
Sleep apnoea
Sleep disturbances
Sweating
Tachycardia
Tremor
Urinary retention
Urticaria
Vomiting
Wheezing
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: 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: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Tramadol Last revised: 21 September 2020
Last accessed: 15 February 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: 6 January 2015
New drug driving offence implications for medicines packaging. Medicines Regulatory News. 10 December 2013. Available at: https://www.mhra.gov.uk Last accessed: 6 January 2015
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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