Fentanyl-Piramal Special Precautions



Piramal Critical Care


Evercare Pharma
Full Prescribing Info
Special Precautions
Respiratory depression: As with all potent opioids, respiratory depression is dose related and can be reversed by a specific opioid antagonist, but additional doses may be necessary because the respiratory depression may last longer than the duration of action of the opioid antagonist. Profound analgesia is accompanied by marked respiratory depression, which can persist or recur in the postoperative period. Therefore, patients should remain under appropriate surveillance. Resuscitation equipment and opioid antagonists should be readily available. Hyperventilation during anesthesia may alter the patient's responses to CO2, thus affecting respiration postoperatively.
Risk from concomitant use of central nervous system (CNS) depressants, especially benzodiazepines or related drugs: Concomitant use of FENTANYL and CNS depressants especially benzodiazepines or related drugs in spontaneous breathing patients, may increase the risk of profound sedation, respiratory depression, coma and death. If a decision is made to administer FENTANYL concomitantly with a CNS depressant, especially a benzodiazepine or a related drug, the lowest effective dose of both drugs should be administered, for the shortest period of concomitant use. Patients should be carefully monitored for signs and symptoms of respiratory depression and profound sedation. In this respect, it is strongly recommended to inform patients and their caregivers to be aware of these symptoms (see Interactions).
Muscle rigidity: Induction of muscle rigidity, which may also involve the thoracic muscles, can occur, but can be avoided by the following measures: slow IV injection (ordinarily sufficient for lower doses), premedication with benzodiazepines, and the use of muscle relaxants.
Non-epileptic (myo)clonic movements can occur.
Cardiac disease: Bradycardia, and possibly cardiac arrest, can occur if the patient has received an insufficient amount of anticholinergic, or when FENTANYL is combined with non-vagolytic muscle relaxants. Bradycardia can be treated with atropine.
Opioids may induce hypotension, especially in hypovolemic patients. Appropriate measures to maintain a stable arterial pressure should be taken.
Special dosing conditions: The use of rapid bolus injections of opioids should be avoided in patients with compromised intracerebral compliance; in such patients the transient decrease in the mean arterial pressure has occasionally been accompanied by a short-lasting reduction of the cerebral perfusion pressure.
Patients on chronic opioid therapy or with a history of opioid abuse may require higher doses.
It is recommended to reduce the dosage in the elderly and in debilitated patients. Opioids should be titrated with caution in patients with any of the following conditions: uncontrolled hypothyroidism, pulmonary disease, decreased respiratory reserve, alcoholism, or impaired hepatic or renal function. Such patients also require prolonged post-operative monitoring.
Interaction with neuroleptics: If FENTANYL is administered with a neuroleptic, the user should be familiar with the special properties of each drug, particularly the difference in duration of action. When such a combination is used, there is a higher incidence of hypotension. Neuroleptics can induce extrapyramidal symptoms that can be controlled with anti-Parkinson agents.
Serotonin syndrome: Caution is advised when FENTANYL is coadministered with drugs that affect the serotonergic neurotransmitter systems.
The development of a potentially life-threatening serotonin syndrome may occur with the concomitant use of serotonergic drugs such as Selective Serotonin Reuptake Inhibitors (SSRIs) and Serotonin Norepinephrine Reuptake Inhibitors (SNRIs), and with drugs which impair metabolism of serotonin (including Monoamine Oxidase Inhibitors [MAOIs]). This may occur within the recommended dose.
Serotonin syndrome may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular abnormalities (e.g., hyperreflexia, incoordination, rigidity), and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea).
If serotonin syndrome is suspected, rapid discontinuation of FENTANYL should be considered.
Effects on Ability to Drive and Use Machines: Patients should only drive or operate a machine if sufficient time has elapsed (at least 24 hours) after the administration of FENTANYL.
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