Feniject®

Therapeutic Area:

Generic Name:

Fentanyl

Dosage Form:

Ampoule

Drug Dose

Therapeutic Indications:

Pain management, acute and chronic pain:

Injection: Surgery: Adjunct to general or regional anesthesia; preoperative medication; analgesic during anesthesia and in the immediate postoperative period

Mechanism of Action:

Binds with stereospecific receptors at many sites within the CNS, increases pain threshold, alters pain reception, inhibits ascending pain pathways

Method of Administration:

Administer IM or IV slowly over 1 to 2 minutes; rapid IV infusion may result in skeletal muscle and chest wall rigidity, impaired ventilation, or respiratory distress/arrest.

Notes

Hypersensitivity (eg, anaphylaxis, hypersensitivity) to fentanyl or any component of the formulation.

Interactions:

Monitor patients who begin or end therapy with potent inhibitors of CYP450 3A4 for signs of opioid toxicity.

Pregnancy and Lactation:

Pregnancy Category C

Fentanyl is excreted in human milk; therefore, do not use in nursing women because of the possibility of sedation and/or respiratory depression in their infants.

Warning and Precaution:

  • CNS depression: May cause CNS depression, which may impair physical or mental abilities; patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving).
  • Hypotension: May cause severe hypotension (including orthostatic hypotension and syncope); use with caution in patients with hypovolemia, cardiovascular disease (including acute MI), or drugs which may exaggerate hypotensive effects (including phenothiazines or general anesthetics). Monitor for symptoms of hypotension following initiation or dose titration. Avoid use in patients with circulatory shock.
  • Respiratory depression: Serious, life-threatening, or fatal respiratory depression may occur, including following use in opioid non-tolerant patients and improper dosing. Monitor closely for respiratory depression, especially during initiation or dose escalation. 
  • Serotonin syndrome: May occur with concomitant use of serotonergic agents (eg, SSRIs, SNRIs, triptans, TCAs), lithium, St John’s wort, agents that impair metabolism of serotonin (eg, MAO inhibitors), or agents that impair metabolism of tramadol (eg, CYP2D6 and 3A4 inhibitors). Monitor patients for symptoms of serotonin syndrome such as mental status changes (eg, agitation, hallucinations, coma); autonomic instability (eg, tachycardia, labile blood pressure, hyperthermia); neuromuscular changes (eg, hyperreflexia, incoordination); and/or GI symptoms (eg, nausea, vomiting, diarrhea).

Adverse Reactions:

Cardiovascular: Peripheral edema (5% to 32%)

Dermatologic: Hyperhidrosis (1% to 14%)

Endocrine & metabolic: Dehydration (9% to 21%), hypokalemia (2% to 15%), weight loss (3% to 11%)

Gastrointestinal: Abdominal pain (3% to 15%), anorexia (5% to 11%), constipation (1% to 26%), diarrhea (6% to 16%), dysgeusia (1% to 14%), nausea (2% to 42%), vomiting (1% to 37%)

Hematologic & oncologic: Anemia (3% to 32%), cancer pain (2% to 16%)

Local: Application site erythema (transdermal device: 14%)

Nervous system: Confusion (1% to 16%), depression (1% to 11%), dizziness (1% to 32%), drowsiness (3% to 20%), fatigue (2% to 20%), headache (1% to 17%), insomnia (1% to 11%)

Neuromuscular & skeletal: Asthenia (2% to 30%), back pain (4% to 11%)

Respiratory: Dyspnea (2% to 19%), pneumonia (2% to 16%)

Storage:

Store below 30ºC and protect from freezing.