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FIORINAL-C is a brand name for Aspirin (also known as Acetylsalicylic Acid), supplied as a capsule. 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.
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 Misuse FIORINAL®-C 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 FIORINAL®-C and all patients should be monitored regularly for the development of these behaviours or conditions (see WARNINGS AND PRECAUTIONS). FIORINAL®-C 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 FIORINAL®-C. 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 FIORINAL®-C or following a dose increase. FIORINAL®-C must be swallowed whole. Cutting, breaking, crushing, chewing, or dissolving FIORINAL®-C 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 FIORINAL®-C especially by children, can result in a fatal overdose of codeine (see DOSAGE AND ADMINISTRATION, Disposal, for instructions on proper disposal).
Neonatal Opioid Withdrawal Syndrome Prolonged maternal use of FIORINAL®-C 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 FIORINAL®-C 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 47 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).
• Patients who are hypersensitive to the active substances acetylsalicylic acid (ASA), caffeine, codeine or other opioid analgesics, butalbital, or to any ingredient in the formulation. For a complete listing, see the DOSAGE FORMS, COMPOSITION AND PACKAGING section of the Product Monograph.
, 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, and head injury • Patients taking monoamine oxidase (MAO) inhibitors (or within 14 days of such therapy) • Women who are breast-feeding, pregnant or during labour and delivery (see SERIOUS WARNINGS AND PRECAUTIONS, and WARNINGS AND PRECAUTIONS).
, hemophilia, hypoprothrombinemia, von Willebrand’s disease, thrombocytopenia, thrombasthenia and other ill-defined hereditary platelet dysfunctions, severe vitamin K deficiency and severe liver damage) • Patients with the syndrome of nasal polyps, angioedema and bronchospastic reactivity to ASA or other nonsteroidal anti-inflammatory drugs.
, 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 FIORINAL®-C 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 FIORINAL®-C and all patients should be monitored regularly for the development of these behaviours or conditions (see WARNINGS AND PRECAUTIONS). FIORINAL®-C 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 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.
• Reserve concomitant prescribing of FIORINAL®-C 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.
Risk in Pregnancy:
FIORINAL®-C 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 WARNINGS AND PRECAUTIONS).
During the third trimester there is risk of premature closure of the ductus arteriosus and uterine inertia (prolonged parturition) (see also WARNINGS AND PRECAUTIONS, Risk of Death in Ultra- Rapid Metabolizers of Codeine, Neonatal Opioid Withdrawal Syndrome (NOWS), and Special Populations, Pregnant Women).
General Patients should be instructed not to give FIORINAL®-C (acetylsalicylic acid-caffeine- codeine-butalbital) capsules to anyone other than the patient for whom it was prescribed, as such inappropriate use may have severe medical consequences, including death.
FIORINAL®-C should be stored securely to avoid theft or misuse. FIORINAL®-C 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 FIORINAL®-C as it may increase the chance of experiencing serious adverse events, including death. Hyperalgesia that will not respond to a further opioid dose increase can occur at particularly high doses.
If hyperalgesia occurs with FIORINAL®-C use, a change in medication may be required (see WARNINGS AND PRECAUTIONS, Opioid Induced Hyperalgesia). Because of its ASA content, FIORINAL®-C 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 stroke observed in patients treated with ASA as an antiplatelet therapy.
Page 7 of 47 ASA administered pre-operatively may prolong the bleeding time. 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. A possible association between Reye's syndrome and the use of salicylates has been suggested but not established.
Reye's syndrome has also occurred in many patients not exposed to salicylates. However, caution is advised when prescribing salicylate-containing medications for young adults with influenza or chickenpox. Long-term use of preparations containing barbiturates and/or codeine may lead to habituation and physical […]
Life-threatening Respiratory Depression:
OVERDOSE Serious, life-threatening, or fatal respiratory depression may occur with use of FIORINAL®-C. 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 FIORINAL®-C or following a dose increase. FIORINAL®-C must be swallowed whole. Cutting, breaking, crushing, chewing, or dissolving FIORINAL®-C 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 FIORINAL®-C especially by children, can result in a fatal overdose of codeine (see DOSAGE AND ADMINISTRATION, Disposal, for instructions on proper disposal).
Neonatal Opioid Withdrawal Syndrome Prolonged maternal use of FIORINAL®-C 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 FIORINAL®-C 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 47 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 FIORINAL®-C 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.
Risk in Pregnancy:
FIORINAL®-C 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 WARNINGS AND PRECAUTIONS).
During the third trimester there is risk of premature closure of the ductus arteriosus and uterine inertia (prolonged parturition) (see also WARNINGS AND PRECAUTIONS, Risk of Death in Ultra- Rapid Metabolizers of Codeine, Neonatal Opioid Withdrawal Syndrome (NOWS), and Special Populations, Pregnant Women).
General Patients should be instructed not to give FIORINAL®-C (acetylsalicylic acid-caffeine- codeine-butalbital) capsules to anyone other than the patient for whom it […]