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.
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.
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.
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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