Tramadol with paracetamol oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations containing tramadol hydrochloride with paracetamol.
Drugs List
Therapeutic Indications
Uses
Pain - moderate to severe
Dosage
Dosage should be individually adjusted according to intensity of pain and response of the patient.
Adults
37.5mg/325mg preparations:
Initial dose: 2 tablets.
Additional doses may be taken if required. Maximum dose of 8 tablets per day.
The dosing interval should not be less than 6 hours.
75mg/650mg preparations:
Initial dose: 1 tablet.
Additional doses may be taken if required. Maximum dose of 4 tablets per day.
The dosing interval should not be less than 6 hours.
Elderly
(See Dosage; Adult)
The elimination half life of tramadol may be increased by 17% following oral administration in patients over 75 years of age.
Patients with Renal Impairment
In moderate renal impairment (creatinine clearance 10 to 30 ml/minute) the dosing interval should be increased to 12 hourly intervals.
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
In moderate hepatic impairment an increase in the dosing interval should be considered.
Contraindications
Acute alcohol intoxication
Children under 12 years
Drug intoxication
Within 2 weeks of discontinuing MAOIs
Breastfeeding
Long QT syndrome
Pregnancy
Renal impairment - creatinine clearance below 10ml/minute
Severe hepatic impairment
Severe respiratory impairment
Torsade de pointes
Uncontrolled epileptic disorder
Precautions and Warnings
Anaesthesia
Family history of long QT syndrome
Impaired consciousness
Patients over 75 years
Predisposition to seizures
Restricted sodium intake
Shock
Alcoholism
Biliary tract disorder
Electrolyte imbalance
Epileptic disorder
Galactosaemia
Glucose-galactose malabsorption syndrome
Head trauma
History of drug misuse
History of seizures
History of torsade de pointes
Hypoxia
Lactose intolerance
Moderate hepatic impairment
Non-cirrhotic alcoholic liver disease
Opioid dependence
Raised intracranial pressure
Renal impairment - creatinine clearance 10-30ml/minute
Respiratory 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
Sodium content of effervescent preparation may be significant
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
Not suitable as a substitute in opioid-dependent patients
Some formulations contain lactose
Some formulations contain sunset yellow (E110); may cause allergic reaction
Consider monitoring ECG in patients at risk of QT prolongation
Monitor serum electrolytes
Patients on long-term therapy should be regularly reviewed
Potential for drug abuse
Tolerance and dependence may occur
May increase risk of seizure
Potential for withdrawal symptoms
Avoid abrupt withdrawal
Maintain treatment at the lowest effective dose
Not for long term use
Advise patient not to take St John's wort concurrently
Advise that effects are potentiated by CNS depressants (including alcohol)
Advise patient not to exceed stated dose
Not recommended during light planes of general anaesthesia due to a possibly increased intra-operative recall reported.
Pregnancy and Lactation
Pregnancy
Tramadol with paracetamol is contraindicated in pregnancy.
Use of a combined product is not recommended by manufacturers due to the lack of flexible dosing of the individual drug components. Available data is largely restricted to use of tramadol or paracetamol as separate agents, not in combination. Briggs (2015) suggests that the use of tramadol with paracetamol during organogenesis has low association with congenital birth defects, however the long-term effects on neurobehaviour is unknown.
Additional information for tramadol
At the time of writing, there are insufficient data available regarding the safety of tramadol in pregnant women. When administered before or during birth it is unlikely to affect uterine contractility. It may induce neonatal changes in respiratory rate but these are not thought to be clinically relevant. Long term treatment may lead to withdrawal symptoms in the newborn.
Additional information for paracetamol
Paracetamol alone is the analgesia of choice in pregnancy. It crosses the placenta, however it is routinely used during all stages of pregnancy as an analgesic. In therapeutic doses paracetamol alone appears safe for short term use (Schaefer, 2015).
Lactation
Tramadol with paracetamol is contraindicated in breastfeeding.
Use of a combined product is not recommended by manufacturers due to the lack of flexible dosing of the individual drug components. Available data is largely restricted to use of tramadol or paracetamol as separate agents, not in combination.
Additional information for tramadol
Tramadol and its metabolites are found in small amounts in human breast milk, therefore the manufacturers do not recommend the use of tramadol during breastfeeding.
LactMed indicates that no adverse effects have been found, however infants should be monitored for increased sleepiness, difficulty breastfeeding, breathing difficulties or limpness and referred to a physician immediately if any of these occur.
Hale (2014) recommends caution when using this medication in mothers who have the CY92D6 ultra-rapid metaboliser genotype.
Additional information for paracetamol
Paracetamol is excreted into breastmilk but not in clinically significant amounts, paracetamol alone is the analgesia of choice in lactation.
LactMed indicates that adverse effects in breastfed infants appear to be rare and the quantity of drug that passes into the milk is very small, representing only a small proportion of a normal therapeutic infant dose.
Schaefer, 2015 states that since metabolism and renal excretion are not fully developed in the newborn, accumulation can not be ruled out in the case of long term treatment.
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 pain
Albuminuria
Allergic reaction
Amnesia
Anaphylaxis
Angioneurotic oedema
Anxiety
Arrhythmias
Ataxia
Blood disorders
Blurred vision
Bradycardia
Bronchospasm
Changes in cognitive and sensorial capacity
Chest pain
Chills
Collapse
Confusion
Constipation
Convulsions
Delirium
Dependence
Depression
Diarrhoea
Disturbances of appetite
Dizziness
Dry mouth
Dyspepsia
Dysphagia
Dysphoria
Dyspnoea
Dysuria
Euphoria
Exacerbation of pre-existing asthma
Flatulence
Hallucinations
Headache
Hot flushes
Hyperhidrosis
Hypersensitivity reactions
Hypertension
Hypoglycaemia
Increase of liver transaminases
Involuntary muscle contractions
Melaena
Micturition disorders
Mood changes
Motor disturbances
Muscular coordination disorders
Nausea
Nervousness
Nightmares
Palpitations
Paraesthesia
Postural hypotension
Prothrombin time increased
Pruritus
Rash
Respiratory depression
Seizures
Shivering
Skin reactions
Sleep disturbances
Somnolence
Speech disturbances
Sweating
Syncope
Tachycardia
Thoracic pain
Tinnitus
Tolerance
Trembling
Urinary retention
Urticaria
Vomiting
Wheezing
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: February 2019
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: Tramacet 37.5mg/ 325mg effervescent tablets. Grunenthal. Revised October 2019.
Summary of Product Characteristics: Tramacet 37.5mg/ 325mg film-coated tablets. Grunenthal. Revised October 2019.
Summary of Product Characteristics: Tramadol hydrochloride/Paracetamol 37.5mg/325mg film-coated tablets. Consillient Health Ltd. Revised August 2016.
Summary of Product Characteristics: Tramadol hydrochloride and Paracetamol 37.5mg/325mg film-coated tablets. Aurobindo Pharma - Milpharm Ltd. Revised August 2016.
Summary of Product Characteristics: Tramadol hydrochloride/Paracetamol 37.5mg/325mg film-coated tablets. Aspire Pharma Ltd. Revised August 2016.
Summary of Product Characteristics: Trapadex 37.5mg/ 325mg film-coated tablets. Noumed Life Sciences Ltd. Revised February 2018.
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: 22 February 2019
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 22 February 2019
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: 03 December 2018
Last accessed: 25 February 2019
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
Acetaminophen. Last revised: 31 October 2018
Last accessed: 25 February 2019
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