Tramadol

May be taken with or without food.

Acute intoxication with centrally acting analgesics, hypnotics, psychotropic drugs, alcohol, or other opioids; uncontrolled epilepsy, significant respiratory depression, acute or severe bronchial asthma (in unmonitored setting or lack of resuscitative equipment), known or suspected gastrointestinal obstruction (including paralytic ileus). Children <12 years and in children <18 years who have undergone tonsillectomy and/or adenoidectomy. CYP2D6 ultrarapid and poor metabolisers. Concomitant use or within 14 days after MAOI therapy. Use for narcotic withdrawal treatment or during light planes of anaesthesia.

Patient with history of epilepsy or those with susceptibility to seizures (e.g. alcohol or drug withdrawal, metabolic disorders, CNS infection, malignancy), head injury, intracranial lesions, increased intracranial pressure, mental health conditions (e.g. anxiety disorders, depression, post-traumatic stress disorder), hypovolaemia, CV disease (e.g. acute MI), acute abdominal conditions, adrenal insufficiency (e.g. Addison disease), delirium tremens, toxic psychosis, prostatic hyperplasia and/or urinary stricture, significant COPD or cor pulmonale, substantially decreased respiratory reserve, hypoxia, hypercapnia, pre-existing respiratory depression, thyroid dysfunction, biliary tract disease (including acute pancreatitis), history of drug abuse or acute alcoholism. Morbidly obese, cachectic, or debilitated patients. Avoid use in suicidal patients and in patients with circulatory shock, impaired consciousness or coma. Not recommended in children in whom respiratory function may be compromised (e.g. neuromuscular disorders, upper respiratory or lung infections, multiple trauma or extensive surgical procedures). Not recommended in patients with severe renal impairment (CrCl <10 mL/min). Avoid abrupt withdrawal following prolonged use. Renal and hepatic impairment. Children ≥12 years (particularly when used for post-operative pain relief) and elderly. Pregnancy and lactation. Concomitant use with other serotonergic agents, CNS depressant drugs; CYP3A4 inducers and CYP3A4 or CYP2D6 inhibitors. Patient Counselling This drug may cause dizziness and drowsiness, if affected, do not drive or operate machinery. Monitoring Parameters Monitor renal function, LFTs, pain relief, respiratory status (particularly within the 1st 24-72 hours of initial therapy and dose increases), mental status or alertness, blood pressure, heart rate, blood glucose (if hypoglycaemia is suspected), bowel function. Evaluate patient's alcohol use, history of alcoholism, risk for addiction, misuse, or abuse before initiating and regularly during therapy. Monitor for signs and symptoms of serotonin syndrome (e.g. mental status changes, autonomic instability, neuromuscular changes, gastrointestinal symptoms), hyponatraemia (particularly during initial treatment), tolerance, addiction, abuse, misuse, or suicidal ideation. Observe for withdrawal symptoms, mood changes, pain control, and use of other substances upon discontinuation.

Significant: Sleep-related breathing disorders (e.g. sleep-related hypoxaemia, central sleep apnoea), withdrawal symptoms, convulsions, reversible adrenal insufficiency, severe hypotension (including syncope and orthostatic hypotension), hyponatraemia (including severe cases), CNS depression, spasm of the sphincter of Oddi. Rarely, drug dependence (prolonged use) and abuse; hypoglycaemia (including severe cases). Cardiac disorders: Palpitations, tachycardia. Gastrointestinal disorders: Nausea, vomiting, dry mouth, constipation, abdominal discomfort, dyspepsia. General disorders and administration site conditions: Fatigue, asthenia. Musculoskeletal and connective tissue disorders: Muscle spasticity. Nervous system disorders: Dizziness, drowsiness, headache, tremor. Psychiatric disorders: Anxiety, agitation, emotional lability, euphoria, hallucinations, nervousness. Reproductive system and breast disorders: Menopausal symptoms. Skin and subcutaneous tissue disorders: Pruritus, urticaria, rash, hyperhidrosis, toxic epidermal necrolysis, Stevens-Johnson syndrome.
Potentially Fatal: Serotonin syndrome, respiratory depression (particularly in children), neonatal withdrawal syndrome (long-term use during pregnancy). Rarely, serious anaphylactoid reactions; hypoglycaemia (including severe cases).

Increased risk of INR elevation and ecchymoses with coumarin derivatives (e.g. warfarin). Increased risk of convulsions with SSRIs, serotonin-norepinephrine reuptake inhibitors (SNRIs), anorectics, TCAs, antipsychotics, and other seizure-threshold lowering agents (e.g. bupropion, mirtazapine). Concomitant use with mixed agonist/antagonist analgesics (e.g. buprenorphine, butorphanol, nalbuphine, pentazocine) may precipitate withdrawal symptoms and/or diminish analgesic effect in patients after prolonged therapy with tramadol. Concomitant use with CYP2D6 inhibitors (e.g. paroxetine, fluoxetine, quinidine, bupropion) may increase plasma levels of tramadol and decrease plasma concentration of M1 (active metabolite). Concomitant use with CYP3A4 inhibitors (e.g. erythromycin, ketoconazole, ritonavir) may increase tramadol plasma concentration which may result in greater amount of metabolism by CYP2D6 isoenzyme and increased levels of M1. May decrease plasma levels with CYP3A4 inducers (e.g. rifampicin, carbamazepine, phenytoin).

Analgesics (Opioid)

N02AX02 - tramadol ; Belongs to the class of other opioids. Used to relieve pain.