tramadol + paracetamol


Samchundang Pharm


Bell-Kenz Pharma
Concise Prescribing Info
Paracetamol 325 mg, tramadol HCl 37.5 mg
Symptomatic treatment of moderate to severe acute, chronic pain.
Dosage/Direction for Use
Adult & adolescent ≥12 yr Individualized dosage. Initially 2 tab at the min 6 hr intervals. Max: 8 tab/day. Elderly Min interval between doses should be not <6 hr, due to tramadol presence. Moderate renal impairment (CrCl 10-30 mL/min) Increase dosing to 12-hrly intervals.
May be taken with or without food.
Hypersensitivity to paracetamol or tramadol. Acute intoxication w/ alcohol, hypnotics, centrally acting analgesics, opioids or psychotropic drugs. Severe resp depression; peptic ulcer or severe blood disorder; severe liver disease, renal disorder or severe renal failure; epilepsy uncontrolled by treatment. Patients w/ risk of consciousness disturbance due to head injury or encephalopathy; who are receiving MAOIs or w/in 2 wk of w/drawal; w/ aspirin asthma (induction of asthmatic attack caused by NSAIDs) or history thereof. Moderate hepatic failure.
Special Precautions
Do not use w/ other paracetamol- (including over-the-counter) or tramadol HCl-containing products. Avoid long-term use. Perform periodic evaluation of prothrombin time. Concomitant use w/ warfarin like compd. Not recommended in severe renal impairment. Pregnancy. Not recommended during lactation. Childn <12 yr. Elderly >75 yr. Paracetamol: Chronic alcoholism, liver toxicity. Tramadol: Convulsions. Concomitant use w/ SSRIs & anorectic agent, TCAs & other tricyclic compd (eg, cyclobenzaprine, promethazine), other opioid; MAOIs, neuroleptic, other drugs that reduce seizure threshold; anesth medications or alcohol; naloxone; CNS depressants (eg, hypnotic, phenothiazine, tranquilizer & sedatives); morphine; opioid agonists-antagonists (nalbuphine, buprenorphine, pentazocine); sedative antihistamines, centrally-acting antihypertensives, thalidomide or baclofen. Epilepsy, history of seizures or recognized risk for seizure (eg, head trauma, metabolic disorders, alcohol & drug w/drawal, CNS infections); serious anaphylactoid reactions; increased intracranial pressure or head injury. Alcohol consumption (>3 cups); liver damage. May induce psychic & physical dependence of morphine-type (μ-opioid). Biliary tract disorders; hepatic & renal disease; hypersensitivity to opioid; state of shock, altered state of unconsciousness for unknown reasons. Drug-dependent patients or patients w/ possibility of drug abuse. Avoid abrupt w/drawal; use during light planes of anesth. History of anaphylactoid to codeine or other opioids. May cause drowsiness or dizziness.
Adverse Reactions
Hypersensitivity eg, shock; anergia, fatigue, flushing, occasional chest pain, spasticity, syncope, w/drawal symptom; occasional HTN, exacerbation of HTN, hypotension, arrhythmia, palpitation & tachycardia; dizziness, headaches, tremor, occasional hyperkinesis, convulsion, migraine, exacerbation of migraine, contraction of involuntary muscle, sensory anomaly, stupor & vertigo; bellyache, constipation, diarrhea, dyspepsia, flatulence, dry mouth, nausea, vomiting & occasional dysphagia, melena & tongue edema; anorexia, anxiety, confusion, insomnia, nervousness, drowsiness, amnesia, depersonalization, depression, drug abuse & dependence, mood change, hallucinations, impotence, nightmares & abnormal thought; occasional anemia; occasional resp distress syndrome; proteinuria, dysuria, oliguria & urine retention; pruritus, rash, sweating & urticaria; hepatic dysfunction, wt loss, tinnitus, abnormal vision & chilling.
Drug Interactions
Paracetamol: Increased absorption w/ metoclopramide or domperidone. Decreased absorption w/ cholestyramine. Tramadol: Increased risk of seizure w/ SSRIs, TCAs & other tricyclic compd (eg, promethazine), other opioid. May enhance seizure risk w/ MAOIs & neuroleptics. Reduced analgesic effect w/ carbamazepine. Increased conc w/ quinidine. Inhibition of metabolism w/ CYP2D6 inhibitors eg, fluoxetine, paroxetine, amitriptyline; CYP3A4 inhibitors eg, ketoconazole & erythromycin.
MIMS Class
Analgesics (Opioid)
ATC Classification
N02AJ13 - tramadol and paracetamol ; Belongs to the class of opioids in combination with other non-opioid analgesics. Used to relieve pain.
Cetadol tab
100's (P26.5/tab, P2,650/box)
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