Tramadol + paracetamol


Full Generic Medicine Info
Dosage/Direction for Use

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 (ml/min)Dosage Recommendation
10-30Increase dosing interva to 12 hr.ly
<10Not recommended.
Hepatic impairment: Moderate: Increase dosing interval. Severe: Contraindicated.
Contraindications
Acute intoxication w/ alcohol, hypnotics, centrally-acting analgesics, opioids, or psychotropic drugs; uncontrolled epilepsy. Severe hepatic impairment. Concomitant use w/ MAOIs or w/in 2 wk after withdrawal of 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. Patient Counselling May impair ability to drive or operate machinery. Monitoring Parameters Monitor pain relief, resp rate, BP, and pulse rate; signs of tolerance, abuse, or suicidal ideation.
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.
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: Increased risk of seizure and serotonin sydrome w/ MAOIs.
Food Interaction
Increased sedative effect w/ alcohol. Food may delay time to peak plasma levels.
Action
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.
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 distributed into 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
Oral: Store at 25°C.
ATC Classification
N02BE01 - paracetamol ; Belongs to the class of anilide preparations. Used to relieve pain and fever.
N02AX02 - tramadol ; Belongs to the class of other opioids. Used to relieve pain.
Disclaimer: This information is independently developed by CIMS 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 CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS 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 © 2021 CIMS. All rights reserved. Powered by CIMSAsia.com
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