Tramadol oral standard release
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Standard release oral formulations of tramadol hydrochloride.
Drugs List
Therapeutic Indications
Uses
Pain - moderate to severe
Dosage
As with all analgesic drugs, the dose of tramadol hydrochloride should be adjusted according to the intensity of the pain and the clinical response of the individual patients.
Adults
Acute pain
An initial dose of 50 to 100mg (20 to 40 drops of oral drops) is usually necessary. This can be followed by doses of 50mg or 100mg not more frequently than 4 hourly, and duration of therapy should be matched to clinical need. Oral drops should be given three to four times a day. The lowest effective dose should be used in all formulations.
A total daily dose of 400mg (160 oral drops) should not be exceeded except in special clinical circumstances.
Pain associated with chronic conditions
Initial dose of 50mg (20 oral drops) and then titrate dose according to pain severity.
Increasing the dosage in increments every 2 to 3 days should reduce the incidence of adverse events.
A total daily dose of 400mg (160 oral drops) should not be exceeded except in special clinical circumstances.
Children
12 years and over
(See Dosage; Adults)
Patients with Renal Impairment
Glomerular filtration rate 10 to 20ml/minute: Initially 50mg to 100mg every 8 hours.
Glomerular filtration rate less than 10ml/minute: Initially 50mg every 8 hours.
Some brands recommend:
Creatinine clearance between 10 and 30ml/minute: Increase dosage interval to 12 hours.
Creatinine clearance less than 10ml/minute: Not recommended.
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
Head trauma
Long QT syndrome
Pregnancy
Raised intracranial pressure
Severe hepatic impairment
Severe renal impairment
Torsade de pointes
Uncontrolled epileptic disorder
Precautions and Warnings
Anaesthesia
Children aged 12 to 18 years
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
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
Mild hepatic impairment
Mild renal impairment
Myasthenia gravis
Opioid dependence
Phenylketonuria
Psychiatric disorder
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
Some formulations contain aspartame - caution in phenylketonuria
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 propylene glycol
Some formulations contain sucrose
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 for signs and symptoms of Serotonin Syndrome
Monitor patients receiving concurrent anticoagulants
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
Consider dose reduction or discontinuation if serotonin syndrome suspected
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
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 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.
Strategy for ending treatment with tramadol hydrochloride should be discussed with the patient before starting treatment in order to minimise risk of drug withdrawal syndrome and addiction.
Pregnancy and Lactation
Pregnancy
Tramadol hydrochloride is contraindicated during pregnancy.
The manufacturer does not recommend the use of tramadol hydrochloride during pregnancy. Prolonged use of tramadol hydrochloride 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 (2021) 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 the capsules should be taken whole, not divided or chewed, with sufficient liquid, independent of meals.
Advise patients that the orodispersible tablet should be allowed to rapidly disperse in the mouth before swallowing. Alternatively, the tablet may be dispersed in half a glass of water, stirred and drunk immediately, independent of meals.
Advise patients that the soluble tablet should be dissolved in at least 50ml of water and taken independently of meals.
Advise patients that the oral drops should be diluted with water, and taken independently of meals.
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
Aggravation of existing asthma
Allergic reaction
Anaphylaxis
Angioedema
Anxiety
Bloating
Blood dyscrasias
Blurred vision
Bradycardia
Bronchospasm
Cardiovascular collapse
Changes in cognitive and sensorial capacity
Changes in mental activity
Confusion
Constipation
Convulsions
Dependence
Diarrhoea
Difficulty in micturition
Disturbances of appetite
Dizziness
Drowsiness
Dry mouth
Dysphoria
Dyspnoea
Dysuria
Epileptiform seizures
Euphoria
Fatigue
Flushing
Gastric irritation
Hallucinations
Headache
Hypertension
Impaired co-ordination
Increases in hepatic enzymes
Involuntary muscle contractions
Mood changes
Muscle weakness
Mydriasis
Nausea
Nightmares
Orthostatic hypotension
Palpitations
Paraesthesia
Pruritus
Rash
Respiratory depression
Retching
Serotonin syndrome
Sleep disturbances
Somnolence
Speech disturbances
Sweating
Syncope
Tachycardia
Tremor
Urinary retention
Urticaria
Vomiting
Wheezing
Withdrawal symptoms
Withdrawal Symptoms and Signs
Withdrawal symptoms may occur after long-term use on abrupt cessation. When patient no longer requires treatment, advise to taper dose gradually to prevent withdrawal. Tapering dose may take weeks to months. Risk of neonatal withdrawal syndrome in newborn infants if used during pregnancy. The opiod drug withdrawal syndrome is characterised by some or all of the following: restlessness, lacrimation, rhinorrhoea, yawning, perspiration, chills, myalgia 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.
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
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.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 17 March 2022
Summary of Product Characteristics: Tramadol hydrochloride capsules. Actavis UK Ltd. Revised November 2012.
Summary of Product Characteristics: Tramadol Hydrochloride 10mg/ml Oral Solution. Morningside Healthcare Ltd. Revised November 2021.
Summary of Product Characteristics: Tramadol 100mg/ml oral drops. Mercury Pharma Group. Revised April 2012.
Summary of Product Characteristics: Zamadol capsules. Meda Pharmaceuticals. Revised September 2012.
Summary of Product Characteristics: Zamadol Melt. Meda Pharmaceuticals. Revised September 2012.
Summary of Product Characteristics: Zydol Soluble Tablets. Grunenthal Ltd. Revised March 2020.
Summary of Product Characteristics: Zydol capsules. Grunenthal Ltd. Revised March 2020.
The Renal Drug Handbook. Fifth Edition (2019) ed. Ashley, C. and Dunleavy, A. Radcliffe Publishing Ltd, London.
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: 20 September 2021
Last accessed: 17 March 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: 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
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.