Proxitab Tablet
Acetaminophen (paracetamol) + Tramadol Hydrochloride
325mg + 37.5mg
Biogain Remedies Pvt. Ltd.
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Indications
Proxitab Tablet is used for:
Moderate to severe pain
Adult Dose
Oral
Moderate to severe pain
Adult: 1-2 tab 6 hrly.
Max: 8 tab/day. Max duration: 5 days.
Hepatic impairment: Moderate: Increase dosing interval. Severe: Contraindicated.
Child Dose
Not recommended in child under 18 years of age.
Renal Dose
Renal impairment:
CrCl (ml/min) Dosage Recommendation
10-30 Increase dosing interva to 12 hr.ly
<10 Not recommended.
Administration
May with or without food.
Contra Indications
Hypersensitivity to tramadol, paracetamol or opioids. Situations where opioid use may be contra-indicated (e.g. acute intoxication with alcohol, hypnotic drugs, centrally-acting analgesics, opioids or psychotropic drugs). Severe hepatic impairment, uncontrolled epilepsy. Concurrent use or within 2 wk of discontinuation from MAOIs.
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.
Pregnancy-Lactation
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.
Adverse Effects
Side effects of Acetaminophen (paracetamol) + Tramadol Hydrochloride :
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.
Potentially Fatal: Severe anaphylactic reactions.
Mechanism of 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.
Note
Proxitab 325mg + 37.5mg Tablet manufactured by Biogain Remedies Pvt. Ltd.. Its generic name is Acetaminophen (paracetamol) + Tramadol Hydrochloride. Proxitab is availble in Nepal.
Farmaco Nepal drug index information on Proxitab Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.