Tramadol 12 hour oral modified release
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations of tramadol hydrochloride (with a 12 hour modified release).
Drugs List
Therapeutic Indications
Uses
Pain - moderate to severe
Dosage
Dosage should be adjusted depending on the intensity of the pain and the individual clinical response of the patient.
Depending on the needs of the patient, subsequent doses may be administered earlier than 12 hours, but must not be administered earlier than 8 hours after the previous dose. Under no circumstances should more than 2 doses be taken in any one 24 hour period.
Adults
Initial dose 50mg to 100mg twice daily (morning and evening), increasing to 150mg or 200mg twice daily as required.
A total daily dose of 400mg should not be exceeded except in special clinical circumstances.
Children
Children aged 12 years and over
(See Dosage; Adults)
Contraindications
Acute alcohol intoxication
Children under 12 years
Drug intoxication
Risk of paralytic ileus
Within 2 weeks of discontinuing MAOIs
Acute asthma
Acute respiratory depression
Chronic obstructive pulmonary disease
Coma
Long QT syndrome
Pregnancy
Severe hepatic impairment
Severe renal impairment
Torsade de pointes
Uncontrolled epileptic disorder
Precautions and Warnings
Anaesthesia
Debilitation
Family history of long QT syndrome
Impaired consciousness
Opioid-naive patients
Patients over 75 years
Predisposition to seizures
Shock
Adrenal insufficiency
Benign prostatic hyperplasia
Biliary tract disorder
Breastfeeding
CYP2D6 poor metaboliser genotype
CYP2D6 ultra-rapid metaboliser genotype
Diabetes mellitus
Drug misuse
Electrolyte imbalance
Epileptic disorder
Excessive bronchial secretions
Galactosaemia
Gastrointestinal obstruction
Glucose-galactose malabsorption syndrome
Head trauma
Hepatic impairment
Hereditary fructose intolerance
History of alcohol abuse
History of drug misuse
History of seizures
History of torsade de pointes
Hypotension
Hypothyroidism
Hypoxia
Inflammatory bowel disease
Lactose intolerance
Myasthenia gravis
Opioid dependence
Psychiatric disorder
Raised intracranial pressure
Renal impairment
Respiratory depression
Respiratory impairment
Sleep apnoea
Children under 18 years: Increased risk of rare and severe adverse effects
Correct electrolyte disorders before treatment
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 not to drive until they know how the medicine affects them
Advise patient this medicine may be subject to driving restrictions
May reduce seizure threshold
Not suitable as a substitute in opioid-dependent patients
Some formulations contain hydroxybenzoate
Some formulations contain lactose
Some formulations contain sucrose
Consider monitoring ECG in patients at risk of QT prolongation
Monitor for signs of tolerance and dependence
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
Potential for drug abuse
Reassess need for continued treatment at regular intervals
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 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
Consider dose reduction or alternative opioid in cases of hyperalgesia
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 that effects are potentiated by CNS depressants (including alcohol)
Not recommended during potentially light planes of general anaesthesia due to a possibly increased intra-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.
Side Effects
Abdominal discomfort
Addiction
Aggravation of existing asthma
Allergic reaction
Anaphylaxis
Angioedema
Anxiety
Blurred vision
Bradycardia
Bronchospasm
Cardiovascular collapse
Changes in cognitive and sensorial capacity
Changes in mood
Confusion
Constipation
Convulsions
Delirium
Dependence
Diarrhoea
Disturbances of appetite
Dizziness
Drowsiness
Dry mouth
Dysphoria
Dyspnoea
Dysuria
Euphoria
Faintness
Fatigue
Flushing
Gastric irritation
Hallucinations
Headache
Hyperalgesia
Hyperhidrosis
Hypertension
Hypoglycaemia
Impaired co-ordination
Increases in hepatic enzymes
Involuntary muscle contractions
Micturition disorders
Miosis
Muscle weakness
Muzziness
Mydriasis
Nausea
Nightmares
Oedema
Palpitations
Paraesthesia
Postural hypotension
Pruritus
Rash
Respiratory depression
Retching
Sleep apnoea
Sleep disturbances
Somnolence
Speech disturbances
Sweating
Syncope
Tachycardia
Tremor
Urinary retention
Urticaria
Vertigo
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: December 2017
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.
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.
Summary of Product Characteristics: Brimisol PR 100mg prolonged-release tablets. Bristol Laboratories Ltd. Revised May 2020.
Summary of Product Characteristics: Brimisol PR 200mg prolonged-release tablets. Bristol Laboratories Ltd. Revised May 2020.
Summary of Product Characteristics: Invodol SR prolonged-release tablets. Ennogen Healthcare Ltd. Revised November 2016.
Summary of Product Characteristics: Larapam SR tablets. Sandoz Ltd. Revised November 2010.
Summary of Product Characteristics: Maneo prolonged-release tablets. Mylan Ltd. Revised July 2015.
Summary of Product Characteristics: Mabron 100mg prolonged release tablets. Morningside Healthcare Ltd. Revised June 2017.
Summary of Product Characteristics: Mabron 150mg prolonged release tablets. Morningside Healthcare Ltd. Revised June 2017.
Summary of Product Characteristics: Mabron 200mg prolonged release tablets. Morningside Healthcare Ltd. Revised June 2017.
Summary of Product Characteristics: Marol prolonged-release tablets. Morningside Healthcare Ltd. Revised December 2012.
Summary of Product Characteristics: Maxitram SR prolonged-release capsules. Trinity-Chiesi Pharmaceuticals Ltd. Revised December 2012.
Summary of Product Characteristics: Tilodol SR tablets. Sandoz Ltd. Revised January 2013.
Summary of Product Characteristics: Tramquel SR capsules. Beechmere Pharmaceuticals Ltd. Revised December 2012.
Summary of Product Characteristics: Tramulief SR tablets. Sovereign Medical. Revised December 2012.
Summary of Product Characteristics: Zamadol SR capsules. Meda Pharmaceuticals. Revised August 2011.
Summary of Product Characteristics: Zeridame SR tablets. Actavis UK Ltd. Revised December 2012.
Summary of Product Characteristics: Zydol SR 50mg Tablets. Grunenthal Ltd. Revised March 2020.
Summary of Product Characteristics: Zydol SR Tabs 100mg. Grunenthal Ltd. Revised March 2020.
Summary of Product Characteristics: Zydol SR Tabs 150mg. Grunenthal Ltd. Revised March 2020.
Summary of Product Characteristics: Zydol SR Tabs 200mg. Grunenthal Ltd. Revised March 2020.
Summary of Product Characteristics: Zytram SR tablets prolonged release tablets. Qdem Pharmaceuticals. Revised December 2017.
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
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 16 March 2018
US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://www.ncbi.nlm.nih.gov/books/NBK501922/
Tramadol Last revised: 21 September 2020
Last accessed: 15 February 2021
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.