Dolcet Mini

Moderate to severe acute & chronic pain.

Adult & childn ≥12 yr Initially 4 tab every 6 hr, adjusted according to level of pain & treatment responses. Max: 16 tab daily. Elderly Adult dose every ≥6 hr. Patient w/ moderate renal failure (CrCl 10-30 mL/min) Extend administration interval to 12 hr, moderate hepatic failure Consider extending administration interval.

May be taken with or without food.

Hypersensitivity. Patients w/ addiction to drugs acting on CNS eg, alcohol, hypnotics, centrally-acting analgesics, opiates or antipsychotics; severe resp depression; risk of obnubilation, in case of head injuries & brain lesions; peptic ulcer & severe hematologic abnormality; aspirin-induced asthma or w/ its history; acute, severe bronchial asthma in a non-monitored setting & w/o availability of resuscitative equipment; epilepsy who are not controlled w/ drugs; receive MAOIs or w/in 14 days recently; severe hepatic & renal impairment & heart failure. Lactation. Post-op management of childn <18 yr following tonsillectomy &/or adenoidectomy. Childn <12 yr.

Discontinue use immediately if any signs of skin rash or other hypersensitivity reactions occur. Reports of rarely fatal anaphylactoid reactions. Not to be received by patients w/ history of anaphylactoid reactions to codeine & other opioids. Should not be used in opioid-dependent patients. May exaggerate symptoms in patients w/ increased ICP or head injury. Excessive administration may increase hepatotoxicity to chronic alcoholics. May occasionally cause reversible adrenal insufficiency requiring monitoring & glucocorticoid replacement therapy. Patients who may be at risk for resp depression; are CYP2D6 ultra-rapid metabolizers; receive morphine concomitantly or continuously; receive CNS inhibitors eg, opiates, anesth, somnifacients, phenothiazine, tranquilizers & sedatives; w/ biliary tract diseases; w/ epilepsy or those who can have convulsion; have altered consciousness caused by shock state & unknown cause. W/drawal symptoms can be alleviated by reducing dose to discontinue. Evaluate patients on an ongoing basis for onset of new or worsening of existing sleep apnea. Monitor for signs & symptoms of hyponatremia in patients w/ predisposing risk factors. Assess patient's risk for opioid dependence & abuse prior to prescribing & monitor for development of tolerance, & physical & psychological dependence. Adjust dosing period or have w/drawal period temporarily in long-term administration. Not to be concomitantly used w/ other tramadol or paracetamol. Not recommended in combination w/ opioid agonist-antagonist eg, nalbuphine, buprenorphine & pentazocine. Avoid use during low level of anesth. May cause sleepiness or vertigo & may affect agility; caution in any actions of potential risk eg, driving or machinery operating. Not recommended in patients w/ hepatic impairment; severe renal failure (CrCl <10 mL/min). Prolonged use during pregnancy may lead to neonatal opioid w/drawal syndrome (risk particularly increased during last trimester). Administer in pregnant women or women capable of becoming pregnant only when benefits exceed risks. Monitor infants exposed through breast milk for excess sedation & resp depression. Avoid use in adolescents 12-18 yr w/ risk factors that may increase their sensitivity to the resp depressant effects of tramadol. Use during childbirth might result in resp depression in newborn infant. Tramadol: Increased risk of seizure w/ doses of tramadol above the recommended range; patients w/ epilepsy, history of seizures, or those w/ recognized risk for seizure (eg, head trauma, metabolic disorders, alcohol or drug w/drawal, CNS infections). Concomitant use w/ SSRIs (antidepressants or anorectics), TCAs, other tricyclic compd (eg, cyclobenzaprine, promethazine), other opioids, MAOIs, neuroleptics & other drugs that reduce seizure threshold; CNS depressants including alcohol or benzodiazepines. May lead to physical & psychological dependence.

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. Tramadol: 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 including mirtazapine & trazadone, & muscle relaxants eg, cyclobenzaprine, metaxalone). Decreased plasma conc of tramadol w/ CYP3A4 inducers (eg, rifampin, carbamazepine, phenytoin) resulting in decreased efficacy or onset of w/drawal syndrome in patients who have developed physical dependence to 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 including erythromycin, azole-antifungal agents including ketoconazole, PIs including ritonavir. May produce additive CNS depressant effects (eg, profound sedation & resp depression) w/ benzodiazepines & other CNS depressants including alcohol (eg, other sedatives/hypnotics, tranquilizers, muscle relaxants, general anesth, other opioids). Increased coagulation time (INR) w/ warfarin. Paracetamol: Report of high anion gap metabolic acidosis from pyroglutamic acid (5-oxoprolinemia) w/ flucloxacillin. Absorption rate may be increased w/ metoclopramide or domperidone. Reduced absorption w/ cholestyramine.

Analgesics (Opioid)

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

Rx