Tramadol + paracetamol

Hypersensitivity to tramadol or paracetamol. Significant respiratory depression, acute or severe bronchial asthma (in unmonitored setting or lack of resuscitative equipment), known or suspected gastrointestinal obstruction, including paralytic ileus; uncontrolled epilepsy. Acute intoxication with centrally-acting analgesics, opioids, hypnotics, psychotropic drugs, or alcohol. CYP2D6 ultrarapid and poor metabolisers. Severe hepatic impairment. Children <12 years; post-operative use in children <18 years who have undergone tonsillectomy and/or adenoidectomy; adolescents between 12-18 years who have other risk factors (e.g. obesity, obstructive sleep apnoea) that may increase their sensitivity to respiratory depression. Concomitant use or within 2 weeks after MAOI therapy.

Patient with hypovolaemia, CV disease (including acute MI); history of seizures or risk factors for seizures (e.g. CNS infection, metabolic disorders, malignancy, alcohol/drug withdrawal), delirium tremens, head injury, intracranial lesions, elevated intracranial pressure, toxic psychosis, emotional disturbance including depression, history of drug abuse or acute alcoholism; acute abdominal conditions, adrenal insufficiency (e.g. Addison disease); biliary tract dysfunction, acute pancreatitis; prostatic hyperplasia, urinary stricture, significant COPD or cor pulmonale, substantially decreased respiratory reserve, hypoxia, hypercapnia, pre-existing respiratory depression; G6PD deficiency; thyroid dysfunction. Not recommended in patients with severe respiratory insufficiency. Avoid use in patients with circulatory shock, impaired consciousness or coma, moderate to severe sleep-disordered breathing and suicidal patients. Cachectic, debilitated or morbidly obese patients. Avoid abrupt withdrawal. Renal and mild to moderate hepatic impairment. Elderly. Pregnancy and lactation. Patient Counselling This drug may cause dizziness and drowsiness, if affected, do not drive or operate machinery. Monitoring Parameters Monitor pain relief, blood pressure, heart rate, respiratory and mental status; bowel function. Observe for signs of tolerance, misuse, abuse, addiction, or suicidal ideation. Closely monitor for signs and symptoms of respiratory depression (particularly during initiation or dose increases), serotonin syndrome, sedation, hypotension, and hyponatraemia (in at-risk patients).

Significant: CNS depression, severe hypotension (including orthostatic hypotension and syncope), seizures, sleep-related breathing disorders (e.g. central sleep apnoea, sleep-related hypoxaemia); reversible adrenal insufficiency, spasm of sphincter of Oddi, decreased bowel motility particularly in post-operative patients; drug tolerance, misuse, abuse, or addiction; withdrawal symptoms. Rarely, hyponatraemia. Gastrointestinal disorders: Nausea, vomiting, constipation, dry mouth, diarrhoea, abdominal pain, dyspepsia, flatulence. Metabolism and nutrition disorders: Anorexia. Nervous system disorders: Dizziness, somnolence, headache, trembling. Psychiatric disorders: Confusional state, altered mood, anxiety, nervousness, euphoric mood, sleep disorders, insomnia. Skin and subcutaneous tissue disorders: Hyperhidrosis, pruritus.
Potentially Fatal: Acute liver failure, respiratory depression, serotonin syndrome; neonatal withdrawal syndrome (long-term use during pregnancy). Rarely, serious anaphylactoid reactions and serious skin reactions (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalised exanthematous pustulosis).

Tramadol: May increase the risk of convulsions with SSRIs, serotonin-norepinephrine reuptake inhibitors (SNRIs), TCAs and other seizure threshold lowering-drugs (e.g. bupropion, mirtazapine). Decreased serum concentrations with CYP3A4 inducers (e.g. rifampicin, carbamazepine, phenytoin). CYP2D6 inhibitors (e.g. quinidine, fluoxetine) may increase plasma levels of tramadol and decrease plasma concentrations of M1 (active metabolite). CYP3A4 inhibitors (e.g. erythromycin, ketoconazole, ritonavir) may elevate tramadol plasma levels and result in increased amount of metabolism by CYP2D6 isoenzyme and higher M1 levels. Mixed opioid agonist/antagonists (e.g. nalbuphine, pentazocine) may reduce the analgesic effect or precipitate withdrawal symptoms of tramadol. May result in serotonin syndrome with serotonergic agents (e.g. triptans, SSRIs, SNRIs, TCAs). May lead to increased INR when used with warfarin. Paracetamol: Increased risk of hepatotoxicity when given with other potentially hepatotoxic agents. Decreased absorption with colestyramine. May decrease the serum concentrations with rifampicin and some anticonvulsants (e.g. phenytoin, phenobarbital, carbamazepine, primidone). Enhances the anticoagulant effect of warfarin. Increased absorption with metoclopramide. May increase the serum concentration with probenecid.

Analgesics (Non-Opioid) & Antipyretics / Analgesics (Opioid)

N02BE01 - paracetamol ; Belongs to the class of anilide preparations. Used to relieve pain and fever.
N02AX02 - tramadol ; Belongs to the class of other opioids. Used to relieve pain.