Tramadol parenteral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Solution for injection and infusion containing tramadol hydrochloride
Drugs List
Therapeutic Indications
Uses
Pain - moderate to severe
Treatment of post-operative pain
Dosage
As with all analgesic drugs, the dose of tramadol should be adjusted according to the severity of the pain and the clinical response of the individual patient.
Adults
Moderate to severe pain
Usual dose is 50mg or 100mg 4 to 6 hourly by the intravenous or intramuscular route. Dosage should be adjusted according to pain severity and response. Intravenous injections must be given slowly over 2 to 3 minutes.
Post-operative pain
Administer an initial bolus of 100mg. During the 60 minutes following the initial bolus, further doses of 50mg may be given every 10 to 20 minutes, up to a total dose of 250mg including the initial bolus. Subsequent doses should be 50mg or 100mg 4 to 6 hourly, up to a total daily dose of 600mg.
A total parenteral daily dose of over 600 mg should not be exceeded except in special 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
The elimination of tramadol may be prolonged.
For patients with a creatinine clearance between 10 and 30ml/minute, the dosage interval should be increased to 12 hours.
As tramadol is only removed very slowly by haemodialysis or haemofiltration, post-dialysis administration to maintain analgesia is not usually necessary.
Patients with Hepatic Impairment
The elimination of tramadol may be prolonged.
In severe hepatic impairment the dosage interval should be increased to 12 hours.
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
Long QT syndrome
Pregnancy
Renal impairment - creatinine clearance below 10ml/minute
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
Head trauma
History of alcohol abuse
History of drug misuse
History of seizures
History of torsade de pointes
Hypotension
Hypothyroidism
Hypoxia
Inflammatory bowel disease
Myasthenia gravis
Opioid dependence
Psychiatric disorder
Raised intracranial pressure
Renal impairment - creatinine clearance 10-30ml/minute
Respiratory depression
Severe hepatic impairment
Sleep apnoea
Correct electrolyte disorders before treatment
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
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 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.
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
Aggravation of existing asthma
Allergic reaction
Anaphylaxis
Angioneurotic oedema
Anxiety
Bloating
Blurred vision
Bradycardia
Bronchospasm
Cardiovascular collapse
Changes in cognitive and sensorial capacity
Changes in mental activity
Confusion
Constipation
Dependence
Difficulty in micturition
Disturbances of appetite
Dizziness
Drowsiness
Dry mouth
Dysphoria
Dyspnoea
Epileptiform seizures
Fatigue
Flushing
Gastric irritation
Hallucinations
Headache
Hyperalgesia
Hypertension
Increases in hepatic enzymes
Mild elation
Mood changes
Motor disturbances
Mydriasis
Nausea
Nightmares
Palpitations
Paraesthesia
Postural hypotension
Pruritus
Rash
Respiratory depression
Retching
Sensory disturbances
Sleep apnoea
Sleep disturbances
Somnolence
Sweating
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: 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.
Handbook on Injectable Drugs, 15th Edition, Trissel, L. American Society of Health-System Pharmacists.
Medications and Mothers' Milk, 14th Edition (2010) Hale, T. Hale Publishing, Amarillo, Texas.
Martindale: The Complete Drug Reference, 37th edition (2011) ed. Sweetman, S. Pharmaceutical Press, London.
Summary of Product Characteristics: Zydol injection. Grunenthal Ltd. Revised March 2020.
Summary of Product Characteristics: Zamadol injection. Meda Pharmaceuticals. Revised September 2012
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
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.