Fentanyl Citrate (Page 4 of 8)

7 DRUG INTERACTIONS

Table 2 includes clinically significant drug interactions with Fentanyl Citrate Injection.

Table 2: Clinically Significant Drug Interactions with Fentanyl Citrate Injection
Inhibitors of CYP3A4
Clinical Impact: The concomitant use of Fentanyl Citrate Injection and CYP3A4 inhibitors can increase theplasma concentration of fentanyl, resulting in increased or prolonged opioid effects, particularly when an inhibitor is added after a stable dose of Fentanyl Citrate Injection is achieved [see Warnings and Precautions (5.3)].After stopping a CYP3A4 inhibitor, as the effects of the inhibitor decline, the fentanyl plasma concentration will decrease [see Clinical Pharmacology (12.3)] , resulting in decreased opioid efficacy or a withdrawal syndrome in patients who had developed physical dependence to fentanyl.
Intervention: If concomitant use is necessary, consider dosage reduction of Fentanyl Citrate Injection untilstable drug effects are achieved [see Dosage and Administration (2.1)]. Monitor patients for respiratory depression and sedation at frequent intervals.If a CYP3A4 inhibitor is discontinued, consider increasing the Fentanyl Citrate Injection dosage until stable drug effects are achieved. Monitor for signs of opioid withdrawal.
Examples: Macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g. ketoconazole),protease inhibitors (e.g., ritonavir), grapefruit juice
CYP3A4 Inducers
Clinical Impact: The concomitant use of Fentanyl Citrate Injection and CYP3A4 inducers can decrease theplasma concentration of fentanyl [see Clinical Pharmacology (12.3)] , resulting in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence to fentanyl [see Warnings and Precautions (5.3)].After stopping a CYP3A4 inducer, as the effects of the inducer decline, the fentanyl plasma concentration will increase [see Clinical Pharmacology (12.3)] , which could increase or prolong both the therapeutic effects and adverse reactions, and may cause serious respiratory depression.
Intervention: If concomitant use is necessary, consider increasing the Fentanyl Citrate Injection dosageuntil stable drug effects are achieved. Monitor for signs of opioid withdrawal. If a CYP3A4 inducer is discontinued, consider Fentanyl Citrate Injection dosage reduction and monitor for signs of respiratory depression.
Examples: Rifampin, carbamazepine, phenytoin
Benzodiazepines and Other Central Nervous System (CNS) Depressants
Clinical Impact: The concomitant use of Fentanyl Citrate Injection with CNS depressants my result indecreased pulmonary artery pressure and may cause hypotension. Even small dosages of diazepam may cause cardiovascular depression when added to high dose or anesthetic dosages of Fentanyl Citrate Injection. As postoperative analgesia, concomitant use of Fentanyl Citrate Injection can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death.
Intervention: As postoperative analgesia, start with a lower dose of Fentanyl Citrate Injection and monitorpatients for signs of respiratory depression, sedation, and hypotension. Fluids or other measures to counter hypotension should be available [see Warnings and Precautions (5.4)].
Examples: Benzodiazepines and other sedatives/hypnotics, anxiolytics, barbiturates, tranquilizers,muscle relaxants, general anesthetics, antipsychotics, other opioids, alcohol.
Serotonergic Drugs
Clinical Impact: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmittersystem has resulted in serotonin syndrome [see Warnings and Precautions (5.7)].
Intervention: If concomitant use is warranted, carefully observe the patient, particularly during treatmentinitiation and dose adjustment. Discontinue Fentanyl Citrate Injection if serotonin syndrome is suspected.
Examples: Selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptakeinhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, drugs that effect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue).
Monoamine Oxidase Inhibitors
Clinical Impact: MAOI interactions with opioids may manifest as serotonin syndrome [see Warnings and Precautions (5.7)] or opioid toxicity (e.g., respiratory depression, coma) [see Warnings and Precautions (5.2)]
Intervention: The use of Fentanyl Citrate Injection is not recommended for patients taking MAOIs orwithin 14 days of stopping such treatment.
Examples: Phenelzine, tranylcypromine, linezolid
Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics
Clinical Impact: May reduce the analgesic effect of Fentanyl Citrate Injection and/or precipitate withdrawalsymptoms.
Intervention: Avoid concomitant use.
Examples: Butorphanol, nalbuphine, pentazocine, buprenorphine.
Muscle Relaxants
Clinical Impact: Fentanyl may enhance the neuromuscular blocking action of skeletal muscle relaxants andproduce an increased degree of respiratory depression.
Intervention: Monitor patients for signs of respiratory depression that may be greater than otherwiseexpected and decrease the dosage of Fentanyl Citrate Injection and/or the muscle relaxant as necessary.
Diuretics
Clinical Impact: Opioids can reduce the efficacy of diuretics by inducing the release of antidiuretic hormone.
Intervention: Monitor patients for signs of diminished diuresis and/or effects on blood pressure andincrease the dosage of the diuretic as needed.
Anticholinergic Drugs
Clinical Impact: The concomitant use of anticholinergic drugs may increase risk of urinary retention and/orsevere constipation, which may lead to paralytic ileus.
Intervention: Monitor patients for signs of urinary retention or reduced gastric motility when FentanylCitrate Injection is used concomitantly with anticholinergic drugs.
Neuroleptics
Clinical Impact: Elevated blood pressure, with and without pre-existing hypertension, has been reportedfollowing administration of Fentanyl Citrate Injection combined with a neuroleptic see Warnings and Precautions (5.13)].
Intervention: ECG monitoring is indicated when a neuroleptic agent is used in conjunction with FentanylCitrate Injection as an anesthetic premedication, for the induction of anesthesia, or as an adjunct in the maintenance of general or regional anesthesia.
Nitrous oxide
Clinical Impact: Nitrous oxide has been reported to produce cardiovascular depression when given withhigher doses of Fentanyl Citrate Injection.
Intervention: Monitor patients for signs of cardiovascular depression that may be greater than otherwise expected.

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