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SANDOZ FENTANYL is a brand name for Fentanyl, supplied as a patch. 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
, immediate-release opioids) (see DOSAGE AND ADMINISTRATION). Addiction, Abuse, and Misuse Sandoz Fentanyl Patch 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 Sandoz Fentanyl Patch, and all patients should be monitored regularly for the development of these behaviours or conditions (see WARNINGS AND PRECAUTIONS).
Sandoz Fentanyl Patch 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 Sandoz Fentanyl Patch. 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 Sandoz Fentanyl Patch or following a dose increase. Placing Sandoz Fentanyl Patch in the mouth, chewing it, swallowing it or using it in any way other than indicated may cause choking or overdose that could result in death (see WARNINGS AND PRECAUTIONS).
Further, instruct patients of the hazards related to taking opioids: addiction, tolerance and fatal overdose. Accidental Exposure Serious medical consequences, including death, may occur if people, especially children, are accidentally exposed to Sandoz Fentanyl Patch.
Examples of accidental exposure include transfer of Sandoz Fentanyl Patch while hugging, sharing a bed, or moving a patient (see DOSAGE AND ADMINISTRATION subsection Disposal of Sandoz Fentanyl Patch, for instructions on proper disposal).
Neonatal Opioid Withdrawal Syndrome Prolonged maternal use of Sandoz Fentanyl Patch during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening (see WARNINGS AND PRECAUTIONS). Interactions with Alcohol The co-ingestion of alcohol with Sandoz Fentanyl Patch should be avoided as it may result in dangerous additive effects, causing serious injury or death (see WARNINGS AND PRECAUTIONS and DRUG INTERACTIONS).
Sandoz Fentanyl Patch Page 6 of 55 Risks From Concomitant Use with Benzodiazepines or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death (see WARNINGS AND PRECAUTIONS, Neurologic and DRUG INTERACTIONS).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Fentanyl 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 Sandoz Fentanyl Patch 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 Use in non-opioid-tolerant patients, or use of an initiating dose which is higher than the opioid equivalent to which the patient is tolerant at the time of the switch, may lead to fatal respiratory depression.
The following contraindications reduce the potential risk of serious or life-threatening hypoventilation: Sandoz Fentanyl Patch should not be used in the management of acute or postoperative pain since there is no opportunity for dose titration during short-term use and serious or life-threatening hypoventilation could result.
Similarly, Sandoz Fentanyl Patch should not be administered to patients who do not have some degree of tolerance to opioid- induced side effects. Sandoz Fentanyl Patch should ONLY be prescribed to patients who require continuous opioids for pain management, and who are tolerant to at least the morphine equivalent of the lowest initiating Sandoz Fentanyl Patch dose.
The initial dose of Sandoz Fentanyl Patch should be obtained from the conversion tables in DOSAGE AND ADMINISTRATION, and must not be higher than that dose which is equivalent to the total dose of opioids the patient is receiving at the time of the switch to the patch.
It may be appropriate, according to clinical judgment, to initiate some patients on a lower Sandoz Fentanyl Patch dose than that which the conversion tables recommend, which may include use of the 12 mcg/h dose. Opioid-naive patients should not be given Sandoz Fentanyl Patch at any dose, inclusive of 12 mcg/h (see CONTRAINDICATIONS).
In general, the 12 mcg/h dose, which allows for smaller dose increases than does the 25 mcg/h patch, is to be used for titration/adjustments of dosage (see DOSAGE AND ADMINISTRATION). Sandoz Fentanyl Patch should only be prescribed by persons knowledgeable in the continuous administration of potent opioids, in the management of patients receiving potent opioids for treatment of pain, and in the detection and management of respiratory depression including the use of opioid antagonists.
PATIENTS WHO HAVE EXPERIENCED SERIOUS ADVERSE EVENTS SHOULD BE MONITORED FOR AT LEAST 24 HOURS AFTER SANDOZ FENTANYL PATCH REMOVAL, OR MORE, AS CLINICAL SYMPTOMS DICTATE, BECAUSE SERUM Sandoz Fentanyl Patch Page 7 of 55 FENTANYL CONCENTRATIONS DECLINE GRADUALLY AND ARE REDUCED BY ABOUT 50% 20 TO 27 HOURS LATER.
Due to the formation of a subcutaneous depot of fentanyl, not only does continued exposure occur after system removal but, in the case of removal prior to attainment of peak fentanyl exposure, fentanyl plasma levels may, in fact, continue to increase after removal of Sandoz Fentanyl Patch.
Sandoz Fentanyl Patch is intended for transdermal use on intact skin only; use on compromised skin can lead to increased exposure to fentanyl. Risk of Unintentional […]