tramadol + paracetamol




Concise Prescribing Info
Tramadol HCl 37.5 mg, paracetamol 325 mg
Short-term treatment of acute pain.
Dosage/Direction for Use
Adult & childn >16 yr 1-2 caplets every 4 to 6 hr, up to max of 8 caplets daily.
May be taken with or without food.
Hypersensitivity to tramadol, paracetamol or other opioids. Acute intoxication w/ alcohol, hypnotics, narcotics, centrally acting analgesics, opioids or psychotropic drugs. Patients using MAOIs concurrently or w/in the last 14 days.
Special Precautions
History of anaphylactoid reactions to codeine & other opioids. Significant resp depression or acute severe bronchial asthma. Resp depression w/ anesth medications or alcohol. Medications eg, tranquilizers, hypnotics or other opiate containing analgesics. Patients w/ increased intracranial pressure or head injury. Concomitant use w/ SSRIs may increase risk of adverse events. Not to be used concomitantly w/ alcohol consumption, other tramadol or paracetamol containing products, including over-the counter prep. W/drawal symptoms may occur if treatment is discontinued abruptly. Assess each patient's risk for opioid dependence & abuse prior to use. Monitor for development of physical dependence & abuse. Increased risk in patients w/ personal or family history of substance abuse or mental illness. Recommended dose should not be exceeded. May complicate the clinical assessment of patients w/ acute abdominal conditions. May impair mental or physical abilities required for the performance of potentially hazardous tasks eg, driving a car or operating machinery. Impaired renal function. Not recommended in patients w/ hepatic impairment. Increased risk of hepatotoxicity w/ alcohol use. Inform the physician if pregnant, think might become pregnant, or are trying to become pregnant. Not recommended for breast-feeding mothers. Increased risk of neonatal opioid w/drawal syndrome w/ long-term use during 1st trimester of pregnancy. Childn <16 yr. Elderly ≥65 yr. Tramadol: Increased risk of convulsions in patients w/ epilepsy, history or recognized risk for seizures (eg, head trauma, metabolic disorders, alcohol & drug w/drawal, CNS infections). Increased risk of seizures w/ naloxone. Papillary changes may obscure the existence, extent, or course of intracranial pathology. May induce physic & physical dependence of the morphine-type (μ-opioid). Not to be used in opioid-dependent patients. Paracetamol: Serious skin reactions including acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson syndrome (SJS) & toxic epidermal necrolysis (TEN). Discontinue treatment if hypersensitivity occurs.
Adverse Reactions
Nausea, dizziness & somnolence. Asthenia, fatigue, hot flushes; headache, tremor; GI disorders; psychiatric disorders; pruritus, rash, increased sweating.
Drug Interactions
Tramadol: Increased risk of seizures & serotonin syndrome w/ MAOIs, neuroleptics or other drugs that reduce the seizure threshold; SSRIs or anorectics, TCAs & other tricyclic compounds (eg, cyclobenzaprine, promethazine) or other opioids. Additive CNS depressant effects w/ CNS depressants eg, benzodiazepines & other sedatives/hypnotics, anesth agents, phenothiazines, tranquilizers, opioids or alcohol. Reduced analgesic effect w/ carbamazepine. Increased conc w/ quinidine. Increased INR w/ warfarin like compd. Inhibited metabolism w/ CYP2D6 inhibitor eg, fluoxetine, paroxetine & amitriptyline.
MIMS Class
Analgesics (Opioid)
ATC Classification
N02AJ13 - tramadol and paracetamol ; Belongs to the class of opioids in combination with other non-opioid analgesics. Used to relieve pain.
Catramol FC caplet
3 × 10's (Rp210,000/boks)
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