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TEVA-OXYCOCET 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 .................................................................................................. 3 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
For acute pain, it is recommended that TEVA-OXYCOCET be used for a maximum of 7 days at the lowest dose that provides adequate pain relief. All doses of opioids carry an inherent risk of fatal or non-fatal adverse events. This risk is increased with higher doses.
If TEVA-OXYCOCET is used for more than 7 days for the management of chronic non-cancer, non-palliative pain, it is recommended that the daily dose not exceed 12 tablets, which is 60 mg oxycodone (90 morphine milligram equivalent). Physicians and patients should also take into account any other sources of acetaminophen to ensure the maximum 4000 mg daily dose is not exceeded.
Each patient should be assessed for their risk prior to prescribing TEVA-OXYCOCET 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 level of pain should be assessed routinely to confirm the most appropriate dose and the need for further use of TEVA-OXYCOCET (see DOSAGE AND ADMINISTRATION - Adjustment or reduction of Dosage). g. non-opioid analgesics).
TEVA-OXYCOCET must be swallowed whole. Cutting, breaking, crushing, chewing, or dissolving TEVA-OXYCOCET can lead to dangerous adverse events including death (see WARNINGS AND PRECAUTIONS).
Recommended Dose and Dosage Adjustment Adults:
Dosage should be adjusted according to the severity of the pain and the patient's response. It may occasionally be necessary to exceed the usual dosage recommended below in cases of more severe pain or in those patients who have become tolerant to the analgesic effect of opioids.
The usual adult dose is one tablet every six hours as needed for pain. Provided there is no concomitant use of other products with acetaminophen, the maximum daily dose of TEVA-OXYCOCET is 12 tablets, which is 60 mg oxycodone and 3900 mg acetaminophen (see Drug Interactions, Use with Other Acetaminophen-Containing Products).
TEVA-OXYCOCET 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). TEVA-OXYCOCET is not indicated for rectal administration.
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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Patients Not Receiving Opioids at the Time of Initiation of Oxycodone Hydrochloride and Acetaminophen Treatment: The usual initial adult dose of TEVA-OXYCOCET for patients 16 who have not previously received opioid analgesics is one tablet every six hours as needed for pain.
Patients Currently Receiving Opioids:
For patients who are receiving an alternate opioid, the "oral oxycodone equivalent" of the analgesic presently being used, should be determined. Having determined the total daily dosage of the present analgesic, TABLE 2 can be used to calculate the approximate daily oral oxycodone dosage that should provide equivalent analgesia.
It is usually appropriate to treat a patient with only one opioid at a time. Further dose reductions should be considered due to incomplete cross-tolerance between opioids. 2 6 *** Methadone Morphine dose equivalence is not reliably established *** The maximum recommended daily dose of tramadol is 300 mg - 400 mg depending on the formulation.
Busse J. The 2017 Canadian guideline for opioids for chronic non-cancer pain.
Hamilton (ON):
McMaster University; 2017 Patients with Hepatic Impairment: TEVA-OXYCOCET is contraindicated in patients with severe hepatic insufficiency or active liver disease (see CONTRAINDICATIONS). Acetaminophen should be used with caution in cases of hepatic insufficiency (see WARNINGS AND PRECAUTIONS, Hepatic Effects).
Patients with Renal Impairment:
TEVA-OXYCOCET should be given with caution to patients with renal insufficiency (creatinine clearance ≤30 mL/min) (see WARNINGS AND PRECAUTIONS).
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.
TEVA-OXYCOCET should be initiated at a low dose 17 and slowly titrated to effect (see WARNINGS AND PRECAUTIONS and ACTION AND CLINICAL PHARMACOLOGY).
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:
Physical dependence with or without psychological dependence tends to occur with chronic administration of opioids, including TEVA-OXYCOCET. 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 […]