Tramadol + Paracetamol


Concise Prescribing Info
Indications/Uses
Moderate to severe pain.
Dosage/Direction for Use
Adult : PO Each tab contains tramadol HCl 37.5 mg and paracetamol 325 mg: 2 tab 6 hrly. Max: 8 tab/day. Max duration: 5 days.
Dosage Details
Oral
Moderate to severe pain
Adult: Each tab contains tramadol HCl 37.5 mg and paracetamol 325 mg: 2 tab 6 hrly. Max: 8 tab/day. Max duration: 5 days.
Renal Impairment
CrCl Dosage
<10 Not recommended.
10-30 Max: Increase dosing interval to 12 hrly.
Hepatic Impairment
Moderate: Increase dosing interval. Severe: Contraindicated.
Administration
May be taken with or without food. Swallow whole, do not divide/chew/crush.
Contraindications
Acute intoxication w/ alcohol, hypnotics, centrally-acting analgesics, opioids, or psychotropic drugs; uncontrolled epilepsy. Severe hepatic impairment. Concurrent use or w/in 2 wk of discontinuation from MAOIs.
Special Precautions
Patient w/ epilepsy controlled by treatment, risk of seizure, cranial trauma, biliary tract disorder, altered state of consciousness for unknown reasons, problems affecting the resp centre or resp function, increased intracranial pressure, suicidal tendency or patients in a state of shock. Not a suitable substitute in opioid-dependent patients. May cause withdrawal symptoms, dependence and abuse. Severe renal impairment. Elderly. Pregnancy and lactation.
Adverse Reactions
Postural hypotension, resp depression, hepatotoxicity, Stevens-Johnson syndrome, toxic epidermal necrolysis, bradycardia, collapse, allergic reactions w/ resp symptoms (e.g. dyspnoea, bronchospasm, wheezing, angioneurotic oedema), changes in appetite, motor weakness, changes in mood, activity, cognitive and sensorial capacity; exacerbation of asthma, withdrawal symptoms (e.g. agitation, anxiety), skin rash, blood dyscrasias, hypoprothrombinemia.
Patient Counseling Information
May impair ability to drive or operate machinery.
MonitoringParameters
Monitor pain relief, resp rate, BP, and pulse rate; signs of tolerance, abuse, or suicidal ideation.
Overdosage
Symptoms: Miosis, vomiting, cardiovascular collapse, consciousness disorders up to coma, convulsions, resp depression leading to resp arrest, pallor, nausea, vomiting, anorexia, abdominal pain, liver damage, abnormalities of glucose metabolism, metabolic acidosis; hepatic failure, acute renal failure w/ acute tubular necrosis, cardiac arrhythmia, pancreatitis. Management: Supportive treatment w/ maintenance of resp and circulatory functions. Naloxone may be used to reverse resp depression. Seizures can be controlled w/ diazepam.
Drug Interactions
Increased risk of seizures and serotonin syndrome w/ SSRIs, SNRIs, TCAs, and 5-HT agonists (e.g. sumatriptan). Increased CNS depression w/ barbiturates, benzodiazepines, other anxiolytics, hypnotics, sedative antidepressants, sedative antihistamines, neuroleptics, centrally-acting antihypertensive drugs, thalidomide and baclofen. Decreased analgesic efficacy w/ ondansetron. Increased INR w/ warfarin.
Potentially Fatal: May enhance serotonergic, neuroexcitatory and/or seizure-potentiating effect of MAOIs.
Food Interaction
Increased sedative effect w/ alcohol. Food may delay time to peak plasma levels.
Action
Description: Tramadol is a centrally acting opioid analgesic which binds to mu-opioid receptors and weakly inhibits the reuptake of norepinephrine and serotonin. Paracetamol, a para-aminophenol derivative, has analgesic, antipyretic and weak anti-inflammatory activity. Together, tramadol and paracetamol has faster onset of action compared to tramadol alone and longer duration of action compared to paracetamol alone.
Duration: 5 hr.
Pharmacokinetics:
Absorption: Readily absorbed from GI tract. Tramadol: Bioavailability: Approx 70-75% (oral); 100% (IM). Paracetamol: Time to peak plasma concentration: 10-60 min.
Distribution: Widely distributed, crosses the placenta and distributesd into the breast milk. Plasma protein binding: Approx 20% (tramadol); negligible (paracetamol).
Metabolism: Tramadol: Undergoes N- and O-demethylation by CYP3A4 and CYP2D6 isoenzymes and also by glucuronidation and sulfation. Paracetamol: Hepatic via glucuronic and sulfuric acid conjugation.
Excretion: Tramadol: Via urine as metabolites. Elimination half-life: Approx 6 hr. Paracetamol: Via urine as glucuronide and sulfate conjugates; <5% as unchanged drug Elimination half life: Approx 1-3 hr.
Storage
Store at 25°C.
References
Anon. Acetaminophen and Tramadol. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 30/07/2014.

Buckingham R (ed). Paracetamol. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 30/07/2014.

Buckingham R (ed). Tramadol Hydrochloride. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 30/07/2014.

Ultracet Tablet, Coated (Janssen Pharmaceuticals, Inc). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 30/07/2014.

Wickersham RM. Tramadol Hydrochloride/Acetaminophen. Facts and Comparisons [online]. St. Louis, MO. Wolters Kluwer Clinical Drug Information, Inc. https://www.wolterskluwercdi.com/facts-comparisons-online/. Accessed 30/07/2014.

Disclaimer: This information is independently developed by MIMS based on Tramadol + Paracetamol from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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