tramadol + paracetamol




Zuellig Pharma
Concise Prescribing Info
Tramadol HCl 37.5 mg, paracetamol 325 mg
Management of moderate to severe pain.
Dosage/Direction for Use
Adult & childn ≥16 yr 1-2 tab 4-6 hr. Max: 8 tab daily.
May be taken with or without food: Swallow whole, do not divide/chew/crush.
Hypersensitivity to tramadol, paracetamol or opioids. Significant resp depression. Acute intoxication w/ alcohol, hypnotics, narcotics, centrally-acting analgesics, opioids or psychotropic drugs. Concomitant or use of MAOI w/in last 14 days. Childn <18 yr to treat pain after surgery to remove tonsils &/or adenoids; adolescents between 12 & 18 yr who are obese or w/ conditions eg, obstructive sleep apnea or severe lung disease; childn <12 yr.
Special Precautions
Discontinue use if severe skin reactions occur. Increased risk of seizures, anaphylactoid reactions, resp depression, increased ICP or head trauma. Adrenal insufficiency; hyponatremia. CYP2D6 ultra-rapid metabolisers. Monitor patients for risk of drug dependence & potential for abuse. Increased risk of hepatotoxicity w/ alcohol use. May affect sexual function/reproduction in long-term use. W/drawal symptoms in abrupt discontinuation. Not to be taken concomitantly w/ other paracetamol-containing medicines. Concomitant use w/ CNS depressants including alcohol; SSRIs; benzodiazepines. May impair ability to drive or use machines. Renal & hepatic impairment. Not recommended during pregnancy & lactation. Not recommended in patients <12 yr. Elderly.
Adverse Reactions
Nausea, dizziness, vomiting, headache, somnolence, constipation. Cutaneous hypersensitivity reactions including skin rashes, angioedema, SJS/TEN. Decreased appetite; insomnia; dry mouth, diarrhea, dyspepsia, abdominal pain & discomfort, flatulence; pruritus, hyperhidrosis, rash; fatigue; depression; hot flush.
Drug Interactions
Increased plasma conc w/ CYP2D6 inhibitors eg, Quinidine, fluoxetine, paroxetine, amitriptyline, bupropion; CYP3A4 inhibitors eg, macrolide antibiotics (eg, erythromycin), azole-antifungal agents (eg, ketoconazole), PIs (eg, ritonavir). Decreased plasma conc w/ CYP3A4 inducers eg, rifampin, carbamazepine, phenytoin. Additive CNS depressant effects w/ CNS depressants eg, benzodiazepines & other sedatives/hypnotics, anesth agents, phenothiazines, tranquilizers, opioids or alcohol. Serotonin syndrome w/ serotonergic drugs. Increased risk of seizures & serotonin syndrome w/ MAOIs. Monitor prothrombin time w/ wardarin. Additive or synergistic effect w/ flucloxacillin.
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.
Ultracet tab
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Already a member? Sign in
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Already a member? Sign in