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TRIATEC-30 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 ................................................................................…
Verbatim from this product's HC label. Tap a section to expand.
Pediatrics: (see also INDICATIONS) Treatment of cough:
TRIATEC-30 is not indicated for treatment of cough in patients younger than 18 years of age because of the risk of opioid toxicity due to the variable and unpredictable metabolism of codeine to morphine and because the benefits of symptomatic treatment of cough associated with allergies or the common cold do not outweigh the risks for use of codeine in these patients.
Contraindication in children under 12, any use:
Regardless of clinical setting, codeine (including TRIATEC-30) should not be used in children below the age of 12 years because of the risk of opioid toxicity due to the variable and unpredictable metabolism of codeine to morphine (see INDICATIONS).
Increasing Risk with Higher Doses All doses of opioids carry an inherent risk of fatal or non-fatal adverse events. This risk is increased with higher doses. For the management of chronic non-cancer, non-palliative pain, it is recommended that the maximum daily dosage of 12 tablets of TRIATEC-30 totaling 360 mg of codeine (54 morphine milligram equivalent) not be exceeded.
Each patient should be assessed for their risk prior to prescribing TRIATEC-30, as the likelihood of experiencing serious adverse events can depend upon the type of opioid, duration of treatment, level of pain as well as the patient’s own level of tolerance.
In addition, the coughing or the level of pain should be assessed routinely to confirm the most appropriate dose and the need for further use of TRIATEC-30 (see D&A - Adjustment or reduction of Dosage). , non-opioid analgesics). TRIATEC-30 must be swallowed whole.
Cutting, breaking, crushing, chewing, or dissolving TRIATEC-30 can lead to dangerous adverse events including death (see WARNINGS AND PRECAUTIONS). For acute pain, it is recommended that TRIATEC-30 be used for a maximum of 7 days at the lowest dose that provides adequate pain relief.
Dosing Considerations TRIATEC-30 (acetaminophen and codeine phosphate tablets) should be used with caution within 12 hours pre-operatively and within the first 12-24 hours post-operatively (see WARNINGS AND PRECAUTIONS, Peri-operative Considerations).
TRIATEC-30 is not indicated for rectal administration. Dosing should be as needed every 4-6 hours and not on scheduled intervals. TRIATEC-30 Page 22 of 39 TRIATEC-30 may be taken with or without food, with a glass of water.
, 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 Misuse TRIATEC-30 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 TRIATEC-30, and all patients should be monitored regularly for the development of these behaviours or conditions (see WARNINGS AND PRECAUTIONS). TRIATEC-30 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 TRIATEC-30. 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 TRIATEC-30 or following a dose increase.
Tablets:
TRIATEC-30 must be swallowed whole. Cutting, breaking, crushing, chewing, or dissolving TRIATEC-30 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 TRIATEC-30, especially by children, can result in a fatal overdose of acetaminophen and codeine phosphate (see DOSAGE AND ADMINISTRATION, Disposal, for instructions on proper disposal).
Neonatal Opioid Withdrawal Syndrome Prolonged maternal use of TRIATEC-30 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 TRIATEC-30 should be avoided as it may result in dangerous additive effects causing serious injury or death (see WARNINGS AND PRECAUTIONS and DRUG INTERACTIONS).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Recommended Dose and Dosage Adjustment Adults:
Take 1 tablet every 4-6 hours as required, do not exceed 12 tablets in 24 hours. If pain does not respond to 1 tablet, take 2 tablets at next dose. Codeine, including TRIATEC-30, should be prescribed at the lowest effective dose for the shortest period of time.
Dosage should be adjusted according to the severity of pain and the response of the patient. Acetaminophen with codeine is given orally. It should be kept in mind that tolerance to codeine can develop with continued use and that the incidence of untoward effects is dose related.
Patients Not Receiving Opioids at the Time of Initiation of TRIATEC-30 Treatment The usual initial adult dose is 1 to 2 tablets every 6 hours as required or as prescribed.
Geriatrics:
Respiratory depression has occurred in the elderly following administration of large initial doses of opioids to patients who were not opioid-tolerant or when opioids were co-administered with other agents that can depress respiration.
TRIATEC-30 should be initiated at a low dose and slowly titrated to effect (see WARNINGS AND PRECAUTIONS and ACTION AND CLINICAL PHARMACOLOGY).
Use with Non-Opioid Medications:
Do not co-administer with other drugs containing acetaminophen. TRIATEC-30 should not be used above the dosage recommended. Overdose may result in severe or possibly fatal liver damage.
Dose Titration:
Dose titration is the key to success with opioid analgesic therapy. Proper optimization of doses scaled to the relief of the individual's pain should aim at administration of the lowest dose which will achieve the overall treatment goal of satisfactory pain relief with acceptable side effects.
Dosage adjustments should be based on the patient's clinical response.
Adjustment or Reduction of Dosage:
Because headache often involves a significant psychological component, a narcotic analgesic should only be employed for the treatment of headache when no other treatment is effective, in order to minimize the risk or psychological and physical dependence.
This product is inappropriate even in high doses for severe or intractable pain. Adult doses of codeine higher than 60 mg fail to give commensurate relief of pain, but merely prolong analgesia and are associated with an appreciably increased incidence of undesirable side effects.
TRIATEC-30 Page 23 of 39 Physical dependence with or without psychological dependence tends to occur with chronic administration of opioids, including TRIATEC-30. Withdrawal (abstinence) symptoms may occur following abrupt discontinuation of therapy.
These symptoms may include body aches, diarrhea, gooseflesh, loss of appetite, nausea, nervousness or restlessness, runny nose, sneezing, tremors or shivering, stomach cramps, tachycardia, trouble with sleeping, unusual increase in sweating, palpitations, unexplained fever, weakness and yawning.
Following successful relief of moderate to severe pain, periodic attempts to reduce the opioid dose should be made. Smaller doses or complete discontinuation may become feasible due to a change in the patient’s condition or mental state.
Patients on prolonged therapy should be withdrawn gradually from the drug if it is no longer required for pain control. In patients who are appropriately treated with opioid analgesics and who undergo gradual withdrawal for the drug, these symptoms are usually mild (see WARNINGS AND PRECAUTIONS).
Tapering should be individualised and carried out under medical supervision. Patient […]
Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants TRIATEC-30 Page 7 of 39 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 TRIATEC-30 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 TRIATEC-30 (acetaminophen and codeine phosphate) tablets to anyone other than the patient for whom it was prescribed, as such inappropriate use may have severe medical consequences, including death.
TRIATEC-30 should be stored securely to avoid theft or misuse. TRIATEC-30 should only be prescribed by persons knowledgeable in the continuous 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 TRIATEC-30 as it may increase the chance of experiencing serious adverse events, including death. Hyperalgesia that will not respond to a further dose increase of acetaminophen and codeine phosphate can occur at particularly high doses.
An acetaminophen and codeine phosphate dose reduction or change in opioid may be required. Patients should be counselled to discontinue codeine products and to seek urgent medical help at the earliest sign of codeine toxicity including symptoms such as confusion, shallow breathing, or extreme sleepiness which may be life threatening.
Abuse and Misuse Like all opioids, TRIATEC-30 is a potential drug of abuse and misuse, which can lead to overdose and death. Therefore, TRIATEC-30 should be prescribed and handled with caution. Patients should be assessed for their clinical risks for opioid abuse or addiction prior to being prescribed opioids.
All patients receiving opioids should be routinely monitored for signs of misuse and abuse. Opioids, such as TRIATEC-30 , should be used with particular care in patients with a history of alcohol and illicit/prescription drug abuse.
However, concerns about abuse, addiction, and diversion should not prevent the proper management of pain. TRIATEC-30 Page 8 of 39 TRIATEC-30 is intended for oral use only. The tablets should be swallowed whole, and not chewed or crushed.
Abuse of oral dosage forms can be expected to result in serious adverse events, including death. Cardiovascular Codeine phosphate administration may result in severe hypotension in patients whose ability to maintain adequate blood pressure is compromised by reduced blood volume, or concurrent administration of drugs such as phenothiazines and other tranquilizers, sedative/hypnotics, tricyclic antidepressants or general anesthetics.
These patients should be monitored for signs of hypotension after initiating or titrating the dose of TRIATEC-30. The use of TRIATEC-30 in patients with circulatory shock should be avoided as it may cause vasodilation that can further reduce cardiac output and blood pressure.
Dependence/Tolerance As with other opioids, tolerance and physical dependence may develop upon repeated administration of TRIATEC-30 and there is a potential for development of psychological dependence. Physical dependence and tolerance reflect the neuroadaptation of the […]