Belcetra

Paracetamol 325 mg, tramadol HCl 37.5 mg

Symptomatic treatment of moderate to severe acute & chronic pain.

Adult & adolescent ≥12 yr Individualized dosage. Initially 2 tab. Additional doses can be taken at min of 6 hr intervals. Max daily dose: 8 tab/day. Elderly >75 yr Min interval between doses should not be <6 hr. Moderate renal insufficiency (CrCl 10-30 mL/min) Increase dosing to 12-hrly intervals.

May be taken with or without food.

Hypersensitivity. Severe resp depression (light resp depression may occur). Patients w/ risk of consciousness disturbance due to head injury or encephalopathy; peptic ulcer or severe blood disorder; aspirin asthma (induction of asthmatic attack caused by NSAIDs) or history thereof. Epilepsy not controlled by treatment. Acute intoxication w/ alcohol, hypnotic drugs, centrally-acting analgesics, opioids, or psychotropic drugs. Patients receiving MAOIs or w/in 2 wks of their w/drawal. Severe liver disease, renal disorder or severe renal failure.

Biliary tract disorders. Hepatic & renal disease. Pregnancy. Not recommended during lactation. Not recommended in childn <12 yr. Elderly. Tramadol: Patients w/ history of anaphylactoid reactions to codeine & other opioids. Increased risk of convulsions in patients w/ epilepsy, history of seizures, or those w/ recognized risk for seizure (eg, head trauma, metabolic disorders, alcohol & drug w/drawal, CNS infections). Patients w/ increased ICP or head injury. May induce psychic & physical dependence. Drug-dependent patients or those w/ possibility of drug abuse. Not a suitable substitute in opioid-dependent patients. Abrupt w/drawal. Patients receiving CNS depressants eg, opioid, anesth, hypnotic, phenothiazine, tranquilizer & sedatives. Concomitant use w/ SSRIs, TCAs & other tricyclic compd (eg, cyclobenzaprine, promethazine), or other opioids; MAOIs, neuroleptics or other drugs that reduce seizure threshold; morphine. Concomitant use w/ opioid agonists-antagonists (buprenorphine, nalbuphine, pentazocine) is not recommended. Avoid use w/ enflurane & nitrous oxide. May impair ability to drive or operate machinery. Paracetamol: Patient w/ chronic alcoholism.

Hypersensitivity eg, shock; anergia, fatigue, flushing, occasional chest pain, spasticity, syncope, w/drawal symptom; occasional HTN, exacerbation of HTN, hypotension, arrhythmia, palpitation, tachycardia; dizziness, headaches, tremor, occasional hyperkinesis, convulsion, HTN, migraine, exacerbation of migraine, contraction of involuntary muscle, sensory anomaly, stupor, vertigo; bellyache, constipation, diarrhea, dyspepsia, flatulence, dry mouth, nausea, vomiting, occasional dysphagia, melena, tongue edema; anorexia, anxiety, confusion, insomnia, nervousness, drowsiness, amnesia, depersonalization, depression, drug abuse & dependence, mood change, hallucinations, impotence, nightmares, abnormal thoughts; occasional anemia; occasional resp distress syndrome; proteinuria, dysuria, oliguria, urine retention; pruritus, rash, sweating, urticaria; hepatic dysfunction, wt loss, tinnitus, abnormal vision, chilling.

Increased risk of seizure w/ SSRIs, TCAs & other tricyclic compd (eg, promethazine) or other opioids; MAOIs. Tramadol: Reduced analgesic effect w/ carbamazepine. Inhibited metabolism w/ CYP2D6 inhibitors eg, fluoxetine, paroxetine, & amitriptyline; CYP3A4 inhibitors eg, ketoconazole & erythromycin. Paracetamol: Increased absorption 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