Tramapan

Moderate to severe pain.

Adult & childn ≥16 yr Max single dose: 1-2 tab every 4-6 hr as needed for pain relief up to max of 8 tab/day. Renal impairment (CrCl <30 mL/min) Max dose: 2 tab every 12 hr.

May be taken with or without food: Swallow whole, do not divide/chew.

Hypersensitivity to tramadol, paracetamol or opioids. Acute intoxication w/ alcohol, hypnotics, centrally-acting analgesics, opioids or psychotropic drugs. Patients using MAOI concurrently or w/in the last 14 days. Patients w/ significant resp depression. Post-op management in childn <18 yr following tonsillectomy &/or adenoidectomy. Childn <12 yr.

History of anaphylactic reactions to codeine & other opioids. Advise patients to seek immediate medical attention if they experience any symptoms of hypersensitivity reactions. Possible serious skin reactions (eg, acute generalized exanthematous pustulosis, SJS & TEN in patients receiving paracetamol; discontinue use at 1st appearance of skin rash or any other sign of hypersensitivity. Possible seizure. May increase seizure risk w/ tramadol doses above recommended range; patients w/ epilepsy, those w/ history of seizures or w/ recognized risk for seizure (eg, head trauma, metabolic disorders, alcohol & drug w/drawal, CNS infections); those taking serotonergic drugs including SSRI antidepressants or anorectics, TCAs & other tricyclic compd (eg, cyclobenzaprine, promethazine) or opioids; MAOIs, neuroleptics or other drugs that reduce seizure threshold. Patients w/ significant resp depression or acute, severe bronchial asthma are at increased risk of life-threatening resp depression when treated w/ opioids. Evaluate patients on ongoing basis for onset of new sleep apnea or worsening of existing sleep apnea; consider reducing or stopping opioid treatment if appropriate. Alternative medication, dose reduction &/or increased monitoring for signs of tramadol overdose (eg, resp depression) is recommended in patients known to be CYP2D6 ultra-rapid metabolizers. Concomitant use of tramadol w/ CNS depressants including alcohol. Patients w/ increased intracranial pressure or head injury. Assess each patient's risk for opioid dependence & abuse prior to prescribing Tramapan & monitor all patients receiving Tramapan for development of these behaviors. Not to be used in opioid-dependent patients. Not recommended for severe resp insufficiency. May increase risk of liver toxicity from excessive paracetamol use in chronic heavy alcohol abusers. W/drawal symptoms may occur if abruptly discontinued. Monitor signs & symptoms of hyponatremia in patients w/ predisposing risk factors (eg, elderly &/or patients using concomitant medications that may cause hyponatremia). Monitor for potential development of acute pancreatitis in patients w/ disorders of biliary tract or history of biliary surgery. Reduce or taper off opioid dose or may require change in opioid when opioid-induced hyperalgesia is suspected. Long-term opioid use may be associated w/ increased prolactin levels & decreased sex hormone levels; possible adrenal insufficiency. Appropriate lab testing is recommended & consider treatment discontinuation if hyperprolactinemia or adrenal insufficiency is suspected. Do not exceed recommended dose. Not to be co-administered w/ other tramadol- or paracetamol-containing compd. May impair mental & physical abilities to drive or operate machinery. Not recommended in patients w/ severe hepatic impairment. Renal impairment. Not recommended for use during pregnancy & breastfeeding. Use of opioids during childbirth may result in resp depression in newborn infant. May lead to neonatal opioid w/drawal syndrome w/ prolonged use of Tramapan or other opioids during pregnancy; increased risk particularly during last trimester. Avoid use in adolescents <18 yr who have other risk factors that may increase their sensitivity to resp depressant effects of tramadol. Not recommended in childn 12-<16 yr. Elderly >75 yr.

Decreased appetite; insomnia, depression; dizziness, headache, somnolence; nausea, vomiting, constipation, dry mouth, diarrhea, dyspepsia, abdominal pain & discomfort, flatulence; pruritus, hyperhidrosis, rash; fatigue; hot flush. Tramadol: Anaphylactic reaction, SJS, TEN; affect lability, delirium, suicidal ideation; hypertonia, movement disorder, serotonin syndrome, speech disorder; mydriasis; orthostatic hypotension; hepatitis; gait disturbance; prolonged prothrombin time.

May precipitate w/drawal syndrome w/ opioid agonists/antagonists (eg, buprenorphine, nalbuphine, pentazocine). Tramadol: May increase plasma conc of tramadol & decrease plasma conc of M1 w/ CYP2D6 inhibitors (eg, quinidine, fluoxetine, paroxetine, amitriptyline & bupropion). May increase plasma conc w/ CYP3A4 inhibitors [eg, macrolide antibiotics (eg, erythromycin), azole-antifungal agents (eg, ketoconazole), PIs (eg, ritonavir)]. May decrease plasma conc w/ CYP3A4 inducers (eg, rifampin, carbamazepine, phenytoin). May produce additive CNS depressant effects (eg, profound sedation & resp depression) w/ CNS depressants (eg, benzodiazepines & other sedatives/hypnotics, anesth agents, phenothiazines, tranquilizers, opioids or alcohol). Increased risk of seizures & serotonin syndrome w/ serotonergic drugs [eg, SSRIs, SNRIs, TCAs, triptans, 5-HT3 receptor antagonists, drugs that affect serotonin neurotransmitter system (eg, mirtazapine & trazodone) & some muscle relaxants (eg, cyclobenzaprine, metaxalone)]; MAOIs or use w/in 14 days of discontinuation. Possible alteration of warfarin effect including elevation of prothrombin time. Possible digoxin toxicity. Paracetamol: May produce hypoprothrombinemia w/ warfarin-like compd. Increased plasma levels w/ diflunisal. Possible high anion gap metabolic acidosis w/ flucloxacillin.

Analgesics (Opioid)

N02AJ13 - tramadol and paracetamol ; Belongs to the class of opioids in combination with other non-opioid analgesics. Used to relieve pain.

POM