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. 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), SJS & TEN. Discontinue treatment if hypersensitivity occurs.
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