Dolcet

Management of moderate to severe pain.

Adult & childn ≥16 yr 1-2 tab every 4-6 hr. Max: 8 tab daily. Patient w/ CrCl <30 mL/min Increase dosing interval not to exceed 2 tab every 12 hr.

May be taken with or without food.

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

Discontinue use at 1st appearance of skin rash or any other sign of hypersensitivity. Reports of serious & rarely fatal anaphylactic reactions. Not to be given in patients w/ history of anaphylactic reactions to codeine & other opioids. Not to be used in opioid-dependent patients. Excessive use may increase risk of liver toxicity in chronic heavy alcohol abusers. Caution in patients at risk for resp depression; who are CYP2D6 ultra-rapid metabolizers; w/ increased ICP or head injury. W/drawal symptoms may be relieved by tapering medication. Evaluate patients on an ongoing basis for onset of a new or worsening of an existing sleep apnea. Assess risk for opioid dependence & abuse prior to prescribing & monitor all patients w/ personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (eg, major depression). Monitor for signs & symptoms of hyponatremia in patients w/ predisposing risk factors; potential development of acute pancreatitis in patients w/ biliary tract disorders or history of biliary surgery. Not to be co-administered w/ other tramadol or paracetamol-containing products. May impair mental or physical abilities required in potentially hazardous tasks eg, driving car or operating machinery. Not recommended in patients w/ severe hepatic impairment. Has not been studied in patients w/ renal impairment. Safe use in pregnancy has not been established. Use during childbirth might result in resp depression in newborn infant. Prolonged use during pregnancy may lead to neonatal opioid w/drawal syndrome (especially during last trimester of pregnancy). Breast-feeding is not recommended during treatment. Avoid use in adolescents <18 yr w/ other risk factors including conditions associated w/ hypoventilation eg, post-op status, obstructive sleep apnea & concomitant use of other medications that cause respiratory depression. Safety & effectiveness in childn 12 to <16 yr have not been established. Tramadol: Increased seizure risk w/ doses above recommended range; w/ concomitant use w/ SSRIs (antidepressants or anorectics), TCAs, & other tricyclic compounds (eg, cyclobenzaprine, promethazine), or opioids; in patients taking MAOIs, neuroleptics or other drugs that reduce seizure threshold; in patients w/ epilepsy, history of seizures, or recognized risk for seizure (eg, head trauma, metabolic disorders, alcohol & drug w/drawal, CNS infections). Concomitant use w/ CNS depressants, including alcohol.

Decreased appetite; insomnia, depression; dizziness, headache, somnolence; nausea, vomiting, constipation, dry mouth, diarrhea, dyspepsia, abdominal pain & discomfort, flatulence; pruritus, hyperhidrosis, rash; fatigue; hot flush.

Increased risk of seizures & serotonin syndrome w/ MAOIs eg, phenelzine, tranylcypromine, linezolid. Reports of increased INR w/ warfarin. Tramadol: May increase plasma conc of tramadol w/ CYP2D6 inhibitors eg, quinidine, fluoxetine, paroxetine, amitriptyline, & bupropion. Increased plasma conc of tramadol & may result in greater amount of metabolism w/ CYP3A4 inhibitors eg, macrolides (eg, erythromycin), azole-antifungal agents (eg, ketoconazole), PIs (eg, ritonavir). Decreased plasma conc of tramadol w/ CYP3A4 inducers (eg, rifampin, carbamazepine, phenytoin). May produce additive CNS depressant effects (eg, profound sedation & resp depression) w/ benzodiazepines & other sedatives/hypnotics, tranquilizers, muscle relaxants, general anesth, other opioids, alcohol. Increased risk of adverse events including seizures & serotonin syndrome w/ serotonergic drugs eg, SSRIs, SNRIs, TCAs, triptans, 5-HT3 receptor antagonists, drugs that affect serotonin neurotransmitter system (eg, mirtazapine & trazadone), & some muscle relaxants (eg, cyclobenzaprine, metaxalone). Paracetamol: Reports of high anion gap metabolic acidosis from pyroglutamic acid (5-oxoprolinemia) w/ flucloxacillin.

Analgesics (Opioid) / Supportive Care Therapy

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

Rx