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TEVA-OXYCODAN is a brand name for Aspirin (also known as Acetylsalicylic Acid), supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Adults TEVA-OXYCODAN (oxycodone hydrochloride and acetylsalicylic acid (ASA)) is indicated for: • the relief of mild to moderately severe pain, including conditions accompanied by fever and/or inflammation. TEVA-OXYCODAN is not indicated as an as-needed (prn) analgesic. 1.1 Pediatrics (< 18 years of age) The safety…
Verbatim from this product's HC label. Tap a section to expand.
, Disposal).
Risk in Pregnancy:
TEVA-OXYCODAN is contraindicated for use during pregnancy Use of NSAIDS at approximately 20 weeks of gestation or later may cause fetal renal dysfunction leading to oligohydramnios and neonatal renal impairment or failure (see 7 WARNINGS AND PRECAUTIONS).
During the third trimester, there is risk of premature closure of the ductus arteriosus and uterine inertia (prolonged parturition) (see also 7 WARNINGS AND PRECAUTIONS, Neonatal Opioid Withdrawal Syndrome (NOWS), and Special Populations, Pregnant Women).
Neonatal Opioid Withdrawal Syndrome Prolonged maternal use of TEVA-OXYCODAN during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening (see 7 WARNINGS AND PRECAUTIONS). Interaction with Alcohol The co-ingestion of alcohol with TEVA-OXYCODAN should be avoided as it may result in dangerous additive effects, causing serious injury or death (see 7 WARNINGS AND PRECAUTIONS and 9 DRUG INTERACTIONS).
Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants Concomitant TEVA-OXYCODAN (Page 6 of 42) 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 7 WARNINGS AND PRECAUTIONS, Neurologic and 9 DRUG INTERACTIONS).
• Reserve concomitant prescribing of TEVA-OXYCODAN 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.
1 Dosing Considerations For acute pain, it is recommended that TEVA-OXYCODAN 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. For the management of chronic non-cancer, non-palliative pain, it is recommended that 60 mg (90 morphine milligram equivalent) of TEVA-OXYCODAN not be exceeded. Each patient should be assessed for their risk prior to prescribing TEVA-OXYCODAN, 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.
and 6 DOSAGE AND ADMINISTRATION, Adjustment or Reduction of Dosage).
Neonatal Opioid Withdrawal Syndrome (NOWS):
Prolonged maternal use of opioids during pregnancy can result in withdrawal signs in the neonate. Neonatal opioid withdrawal syndrome, unlike opioid withdrawal syndrome in adults, may be life-threatening. Neonatal opioid withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea and failure to gain weight.
The onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on the specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination of the drug by the newborn. Use of TEVA-OXYCODAN is contraindicated in pregnant women (see 2 CONTRAINDICATIONS).
TEVA-OXYCODAN (Page 13 of 42) Use in Drug and Alcohol Addiction TEVA-OXYCODAN is an opioid with no approved use in the management of addictive disorders. Its proper usage in individuals with drug or alcohol dependence, either active or in remission is for the management of pain requiring opioid analgesia.
Patients with a history of addiction to drugs or alcohol may be at higher risk of becoming addicted to TEVA-OXYCODAN; extreme caution and awareness is warranted to mitigate the risk. Driving and Operating Machinery TEVA-OXYCODAN may impair the mental and/or physical abilities needed for certain potentially hazardous activities such as driving a car or operating machinery.
Patients should be cautioned accordingly. Patients should also be cautioned about the combined effects of TEVA-OXYCODAN (oxycodone hydrochloride and ASA) with other CNS depressants, including other opioids, phenothiazine, sedative/hypnotics and alcohol.
Endocrine Adrenal Insufficiency:
1 Pediatrics (< 18 years of age)........................................................................................ 2 Geriatrics (> 65 years of age) ........................................................................................
2 Recommended Dose and Dosage Adjustment ............................................................. 5 Missed Dose.................................................................................................................. 9 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .......................................
10 7 WARNINGS AND PRECAUTIONS ........................................................................................ 1Special Populations ......................................................................................................
1 Pregnant Women..................................................................................................... 2 Breast-feeding .........................................................................................................
3 Pediatrics (< 18 years of age): .................................................................................. 4 Geriatrics (> 65 years of age): ..................................................................................
20 8 ADVERSE REACTIONS ........................................................................................................ 1 Adverse Drug Reaction Overview ...............................................................................
5 Post-Market Adverse Reactions ................................................................................. 21 9 DRUG INTERACTIONS .......................................................................................................
2 Drug Interactions Overview ........................................................................................ 3 Drug-Behavioural Interactions ...................................................................................
TEVA-OXYCODAN is contraindicated in: • Patients who are hypersensitive to the active substance or other opioid analgesics or to any ingredient in the formulation. For a complete listing, see the 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING section of the Product Monograph.
, ileus of any type). , acute appendicitis or pancreatitis). • 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, TEVA-OXYCODAN (Page 5 of 42) and head injury.
• Patients taking monoamine oxidase (MAO) inhibitors (or within 14 days of such therapy). • Patients with the syndrome of nasal polyps, angioedema and bronchospastic reactivity to ASA or other nonsteroidal anti-inflammatory drugs. Anaphylactoid reactions have occurred in such patients.
• Peptic ulcer or other serious gastrointestinal lesions. , hemophilia, hypoprothrombinemia, von Willebrand’s disease, thrombocytopenia, thrombasthenia and other ill-defined hereditary platelet dysfunctions, severe vitamin K deficiency and severe liver damage) • Women who are breast-feeding, and during pregnancy, or during labour and delivery (see
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Aspirin 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.
In addition, the level of pain should be assessed routinely to confirm the most appropriate dose and the need for further use of TEVA-OXYCODAN (see 6 DOSAGE AND ADMINISTRATION, Adjustment or Reduction of Dosage). , non-opioid analgesics).
TEVA-OXYCODAN must be swallowed whole. Cutting, breaking, crushing, chewing, or dissolving TEVA-OXYCODAN can lead to dangerous adverse events including death (see 7 WARNINGS AND PRECAUTIONS). TEVA-OXYCODAN should be used with caution within 12 hours pre-operatively and within the first 12-24 hours post-operatively (see 7 WARNINGS AND PRECAUTIONS, Peri-operative Considerations).
TEVA-OXYCODAN is not indicated for rectal administration. 2 Recommended Dose and Dosage Adjustment Adults (≥18 years of age): 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 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 or as directed by a physician. Patients Not Receiving Opioids at the Time of Initiation of Oxycodone Hydrochloride and ASA Treatment: The usual initial adult dose of TEVA-OXYCODAN for patients 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 1 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 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-OXYCODAN should be initiated at a low dose and slowly titrated to effect (see 7 WARNINGS AND PRECAUTIONS and 1 0 CLINICAL PHARMACOLOGY). 1Pediatrics) Patients with Hepatic and Renal Impairment: Caution should be exercised when prescribing TEVA-OXYCODAN to patients with any degree of hepatic or renal impairment.
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 […]
Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use. Presentation of adrenal insufficiency may include non-specific symptoms and signs including nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure.
If adrenal insufficiency is suspected, confirm the diagnosis with diagnostic testing as soon as possible. If adrenal insufficiency is diagnosed, treat with physiologic replacement doses of corticosteroids. Wean the patient off of the opioid to allow adrenal function to recover and continue corticosteroid treatment until adrenal function recovers.
Other opioids may be tried as some cases reported use of a different opioid without recurrence of adrenal insufficiency. The information available does not identify any particular opioids as being more likely to be associated with adrenal insufficiency.
Gastrointestinal TEVA-OXYCODAN (Oxycodone hydrochloride and ASA) and other morphine-like opioids have been shown to decrease bowel motility. TEVA-OXYCODAN (Oxycodone hydrochloride and ASA) may obscure the diagnosis or clinical course of patients with acute abdominal conditions (see 2 CONTRAINDICATIONS).
Hematologic Because of its ASA content, TEVA-OXYCODAN should be used with caution in patients with a history of bleeding tendencies, in patients on anticoagulant therapy and in patients with underlying hemostatic defects and with extreme caution in patients with peptic ulceration.
Thrombocytopenia has been reported in association with the use of ASA, and may be the underlying cause of the increased risk of bleeding, intracerebral hemorrhage and hemorrhagic TEVA-OXYCODAN (Page 14 of 42) stroke observed in patients treated with ASA as an antiplatelet therapy.
ASA administered pre-operatively may prolong the bleeding time. Hepatic/Biliary/Pancreatic Caution should be exercised when prescribing TEVA-OXYCODAN to patients with any degree of hepatic impairment. Immune Therapeutic doses of ASA can cause anaphylactic shock and other severe allergic reactions.
It should be ascertained if the patient is allergic to ASA, although a specific history of allergy may be lacking. Precautions should be taken when administering salicylates to persons with known allergies. Hypersensitivity to ASA is particularly likely in patients with nasal polyps and relatively common in those with asthma.
Neurologic Interactions with Central Nervous System Depressants (including benzodiazepines and alcohol): TEVA-OXYCODAN should be used with caution and in a reduced dosage during concomitant administration of other opioid analgesics, general anesthetics, phenothiazines and other tranquilizers, sedatives, hypnotics, tricyclic antidepressants, antipsychotics, antihistamines, benzodiazepines, gabapentinoids, baclofen, centrally active anti-emetics, and other CNS depressants.
Respiratory depression, hypotension and profound sedation, coma or death may result. Respiratory depression, hypotension and profound sedation, coma or death may result. Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioid analgesics alone.
Because of similar pharmacological properties, it is reasonable to expect similar risk with the concomitant use of other CNS depressant drugs with opioid analgesics (see
4 Drug-Drug Interactions ............................................................................................... 6 Drug-Laboratory Test Interactions .............................................................................
25 10 CLINICAL PHARMACOLOGY ............................................................................................. 1 Mechanism of Action ................................................................................................
2 Pharmacodynamics ................................................................................................... 3 Pharmacokinetics ......................................................................................................
26 11 STORAGE, STABILITY AND DISPOSAL ............................................................................... 28 12 SPECIAL HANDLING INSTRUCTIONS .................................................................................
28 PART II: SCIENTIFIC INFORMATION....................................................................................... 29 13 PHARMACEUTICAL INFORMATION ..................................................................................
29 14 CLINICAL TRIALS ............................................................................................................. 30 15 MICROBIOLOGY ..............................................................................................................
30 16 NON-CLINICAL TOXICOLOGY ........................................................................................... 30 PATIENT MEDICATION INFORMATION..................................................................................
31 TEVA-OXYCODAN (Page 4 of 42) PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS Adults TEVA-OXYCODAN (oxycodone hydrochloride and acetylsalicylic acid (ASA)) is indicated for: • the relief of mild to moderately severe pain, including conditions accompanied by fever and/or inflammation.
TEVA-OXYCODAN is not indicated as an as-needed (prn) analgesic. 1 Pediatrics (< 18 years of age) The safety and efficacy of TEVA-OXYCODAN has not been studied in the pediatric population. Therefore Health Canada has not authorized an indication for pediatric use.
2 Geriatrics (> 65 years of age) In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, concomitant disease or other drug therapy (see 10 CLINICAL, Special Populations and Conditions, Geriatrics).
2 CONTRAINDICATIONS TEVA-OXYCODAN is contraindicated in: • Patients who are hypersensitive to the active substance or other […]