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APO-TRAMADOL/ACET is a brand name for Acetaminophen (also known as Paracetamol), supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ............................................................................. 3 CONTRAINDICATIONS .............................................................................................. 4 WARNINGS AND PRECAUTIONS ................................................................................ 4…
Verbatim from this product's HC label. Tap a section to expand.
APO-TRAMADOL/ACET (tramadol hydrochloride and acetaminophen) tablets is contraindicated in: Patients who are hypersensitive to the active substance (tramadol hydrochloride and acetaminophen) or other opioid analgesics or to any ingredient in the formulation.
For a complete listing, see the DOSAGE FORMS, COMPOSITION AND PACKAGING section of the Product Monograph. , ileus of any type). , acute appendicitis or pancreatitis). Patients with severe hepatic or renal impairment (creatinine clearance of less than 30 mL/min and/or Child-Pugh Class C).
Patients with mild pain that can be managed with other pain medications. Patients with acute or severe bronchial asthma, chronic obstructive airway, or status asthmaticus. Patients with acute respiratory depression, elevated carbon dioxide levels in the blood, and cor pulmonale.
Patients with acute alcoholism, delirium tremens, and convulsive disorders. Patients with severe CNS depression, increased cerebrospinal or intracranial pressure, and head injury. Patients taking monoamine oxidase inhibitors (MAOIs) (or within 14 days following discontinuation of such therapy).
Women who are pregnant, nursing or during labour and delivery. Any situation where opioids are contraindicated, including acute intoxication with any of the following: alcohol, hypnotics, centrally acting analgesics, opioids or psychotropic drugs.
APO-TRAMADOL/ACET may worsen central nervous system and respiratory depression in these patients. Pediatric patients less than 18 years of age who have undergone tonsillectomy and/or adenoidectomy for obstructive sleep apnea syndrome.
Pediatric patients less than 12 years of age. , non- opioid analgesics) are ineffective, not tolerated, or would be otherwise inadequate to provide appropriate management of pain (see DOSAGE AND ADMINISTRATION). Page 5 of 70 Addiction, Abuse, and Misuse APO-TRAMADOL/ACET poses risks of opioid addiction, abuse, and misuse, which can lead to overdose and death.
Each patient’s risk should be assessed prior to prescribing APO-TRAMADOL/ACET, and all patients should be monitored regularly for the development of these behaviours or conditions (see WARNINGS AND PRECAUTIONS). APO-TRAMADOL/ACET should be stored securely to avoid theft or misuse.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Acetaminophen in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Life-threatening Respiratory Depression:
OVERDOSE Serious, life-threatening, or fatal respiratory depression may occur with use of APO- TRAMADOL/ACET. Infants exposed in-utero or through breast milk are at risk of life- threatening respiratory depression upon delivery or when nursed.
Patients should be monitored for respiratory depression, especially during initiation of APO- TRAMADOL/ACET or following a dose increase. APO-TRAMADOL/ACET must be swallowed whole. Cutting, breaking, crushing, chewing or dissolving APO-TRAMADOL/ACET can lead to dangerous adverse events including death (see WARNINGS AND PRECAUTIONS).
Further, instruct patients of the hazards related to taking opioids including fatal overdose. Accidental Exposure Accidental ingestion of even one dose of APO-TRAMADOL/ACET, especially by children, can result in a fatal overdose of tramadol hydrochloride and acetaminophen (see DOSAGE AND ADMINISTRATION, Disposal, for instructions on proper disposal).
Neonatal Opioid Withdrawal Syndrome Prolonged maternal use of APO-TRAMADOL/ACET during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening (see WARNINGS AND PRECAUTIONS). Interaction with Alcohol The co-ingestion of alcohol with APO-TRAMADOL/ACET should be avoided as it may result in dangerous additive effects, causing serious injury or death (see WARNINGS AND PRECAUTIONS and DRUG INTERACTIONS).
Hepatotoxicity APO-TRAMADOL/ACET contains acetaminophen. Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed the maximum daily limits, and often involve more than one acetaminophen-containing product.
Risks From Concomitant Use With Benzodiazepines or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death (see WARNINGS AND PRECAUTIONS, Neurologic and DRUG INTERACTIONS).
Page 6 of 70 Reserve concomitant prescribing of APO-TRAMADOL/ACET and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required.
Follow patients for signs and symptoms of respiratory depression and sedation. General Patients should be instructed not to give APO-TRAMADOL/ACET (tramadol hydrochloride and acetaminophen) tablets to anyone other than the patient for whom it was prescribed, as such inappropriate use may have severe medical consequences, including death.
APO- TRAMADOL/ACET should be stored securely to avoid theft or misuse. APO-TRAMADOL/ACET should only be prescribed by persons knowledgeable in the administration of potent opioids, in the management of patients receiving potent opioids for the treatment of pain, and in the detection and management of respiratory depression, including the use of opioid antagonists.
Patients should be cautioned not to […]