Loading…
TEVA-TRAMADOL/ACETAMINOPHEN 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 .............................................................................. 5…
Verbatim from this product's HC label. Tap a section to expand.
SERIOUS WARNINGS AND PRECAUTIONS
, non-opioid analgesics) are ineffective, not tolerated, or would be otherwise inadequate to provide appropriate management of pain (see DOSAGE AND ADMINISTRATION). Addiction, Abuse, and Misus e TEVA-TRAMADOL/ACETAMINOPHEN 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 TEVA-TRAMADOL/ACETAMINOPHEN, and all patients should be monitored regularly for the development of these behaviours or conditions (see WARNINGS AND PRECAUTIONS). TEVA-TRAMADOL/ACETAMINOPHEN should be stored securely to avoid theft or misuse.
Life-threatening Respiratory Depression:
OVERDOSE Serious, life-threatening, or fatal respiratory depression may occur with use of TEVA- TRAMADOL/ACETAMINOPHEN. Infants exposed in-utero or through breast milk are at risk of lifethreatening respiratory depression upon delivery or when nursed.
Patients should be monitored for respiratory depression, especially during initiation of TEVA- TRAMADOL/ACETAMINOPHEN or following a dose increase. TEVA-TRAMADOL/ACETAMINOPHEN must be swallowed whole. Cutting, breaking, crushing, chewing or dissolving TEVA-TRAMADOL/ACETAMINOPHEN 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 TEVA-TRAMADOL/ACETAMINOPHEN, especially by children, can result in a fatal overdose of tramadol and acetaminophen (see DOSAGE AND ADMINISTRATION, Disposal, for instructions on proper disposal).
Neonatal Opioid Withdrawal Syndrome Prolonged maternal use of TEVA-TRAMADOL/ACETAMINOPHEN 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 TEVA-TRAMADOL/ACETAMINOPHEN should be avoided as it may result in dangerous additive effects, causing serious injury or death (see WARNINGS AND PRECAUTIONS and DRUG INTERACTIONS).
Page 6 of 65 Hepatotoxicity TEVA-TRAMADOL/ACETAMINOPHEN 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.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Acetaminophen in Canada.
Know a brand we are missing in Canada? Suggest a brand →
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.
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).
Reserve concomitant prescribing of TEVA-TRAMADOL/ACETAMINOPHEN and benzodiazepines or other CNS depressants for use in patients for whom alte rnative 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 TEVA-TRAMADOL/ACETAMINOPHEN (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.
TEVA-TRAMADOL/ACETAMINOPHEN should be stored securely to avoid theft or misuse. TEVA-TRAMADOL/ACETAMINOPHEN 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 consume alcohol while taking TEVA- TRAMADOL/ACETAMINOPHEN as it may increase the chance of experiencing serious adverse events, including death. Hyperalgesia that will not respond to a further dose increase of opioids can occur at particularly high doses.
A tramadol and acetaminophen dose reduction or change in opioid may be required. Seizure Risk Seizures have been reported in patients receiving tramadol within the recommended dosage range. Spontaneous post-marketing reports indicate that seizure risk is increased with doses of tramadol above the recommended range (see Neurologic and DRUG INTERACTIONS, Drug- Drug Interactions).
); or opioids. Page 7 of 65 Administration of tramadol may enhance the seizure risk in patients taking: monoamine oxidase inhibitors (MAOIs) (see CONTRAINDICATIONS); neuroleptics; or other drugs that reduce the seizure threshold.
Risk of convulsions may also increase in patients with epilepsy, those with a history of seizures or in patients with a recognized risk for seizure (such as head trauma, metabolic disorders, alcohol and drug withdrawal, CNS infections).
In tramadol overdose, naloxone administration may increase the risk of seizure (see OVERDOSAGE, Treatment). Anaphylactic Reactions Serious and rarely fatal anaphylactic reactions have been reported in patients receiving therapy with tramadol.
When these rare reactions do occur, it is often […]