Alfentanil Hcl Injection

— THERAPEUTIC CATEGORIES —
  • Anesthetics

Alfentanil Hcl Injection Generic Name & Formulations

General Description

Alfentanil (base) 500mcg/mL; soln for IV inj; preservative-free.

Pharmacological Class

Opioid agonist.

How Supplied

Ampules—5, 10

Manufacturer

Mechanism of Action

Alfentanil HCl Injection is an opioid agonist. The principal actions of therapeutic value are analgesia and sedation.

Alfentanil Hcl Injection Indications

Indications

As an analgesic adjunct given in incremental doses in the maintenance of anesthesia with barbiturate/nitrous oxide/oxygen. As an analgesic administered by continuous infusion with nitrous oxide/oxygen in the maintenance of general anesthesia. As a primary anesthetic agent for the induction of anesthesia in patients undergoing general surgery in which endotracheal intubation and mechanical ventilation are required. As an analgesic component for monitored anesthesia care (MAC).

Alfentanil Hcl Injection Dosage and Administration

Adult

See full labeling. Should be administered only by trained persons in IV anesthetics and management of respiratory effects in an adequate facility. Have an opioid antagonist, resuscitative and intubation equipment, and oxygen readily available. Individualize. Choose appropriate neuromuscular blocking agent for patient’s condition. Administer induction doses slowly over 3mins. Spontaneously breathing/assisted ventilation: Induction: 8–20mcg/kg; maintenance: 3–5mcg/kg every 5–20mins or 0.5–1mcg/kg/min; total dose: 8–40mcg/kg. Assisted or controlled ventilation (incremental injection): Induction: 20–50mcg/kg; maintenance: 5–15mcg/kg every 5–20mins; total dose: up to 75mcg/kg. Assisted or controlled ventilation (continuous infusion): Induction 50–75mcg/kg; maintenance: 0.5–3mcg/kg/min; total dose: based on duration of procedure. Primary anesthetic agent: Induction: 130–245mcg/kg; maintenance: 0.5–1.5mcg/kg/min or general anesthetic; total dose: based on duration of procedure; utilize muscle relaxant for truncal rigidity. MAC: Induction: 3–8mcg/kg; maintenance: 3–5mcg/kg every 5–20mins or 0.25–1mcg/kg/min; total dose: 3–40mcg/kg. Guideline for continuous infusion: 0.5–3mcg/kg/min with nitrous oxide/oxygen in patients undergoing general surgery. Discontinue infusions at least 10–15mins prior to the end of surgery during general anesthesia. Infusions for MAC may continue to the end of the procedure. Elderly (>65yrs): reduce dose by up to 40%; titrate slowly. Debilitated: reduce dose. Obese patients: base dose on ideal body weight. Concomitant use or discontinuation of CYP3A4 inhibitors or inducers: monitor closely and consider dose adjustments.

Children

<12yrs: not established.

Alfentanil Hcl Injection Contraindications

Not Applicable

Alfentanil Hcl Injection Boxed Warnings

Boxed Warning

Serious and life-threatening risks from use of Alfentanil HCl Injection: Addiction, abuse, and misuse; Life-threatening respiratory depression; Risks from concomitant use with benzodiazepines or other CNS depressants; CYP3A4 interaction.

Alfentanil Hcl Injection Warnings/Precautions

Warnings/Precautions

Abuse potential (monitor). Life-threatening respiratory depression; monitor during initiation or following a dose increase. COPD, cor pulmonale, decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression; monitor closely. Sleep-related breathing disorders (including central sleep apnea (CSA), sleep-related hypoxemia); consider dose reduction if CSA develops. Opioid-induced hyperalgesia (OIH) and allodynia; consider decreasing dose of current opioid or opioid rotation if OIH is suspected. Head injury. Increased intracranial pressure, brain tumors; monitor. Seizure disorders. CNS depression. Biliary tract disease. Acute pancreatitis. Hypertension. Drug abusers. Monitor vital signs routinely. Avoid abrupt cessation. Renal or hepatic impairment. Elderly. Cachectic. Debilitated. Pregnancy; potential neonatal opioid withdrawal syndrome during prolonged use. Labor & delivery: not recommended. Nursing mothers: monitor infants.

Alfentanil Hcl Injection Pharmacokinetics

Absorption

Onset of the anesthetic action is immediate.

Distribution

Apparent volume of distribution: 0.4–1 L/kg. Plasma protein bound: ~92%.

Metabolism

Hepatic.

Elimination

Renal. Half-life: 90–111 minutes.

Alfentanil Hcl Injection Interactions

Interactions

Increased risk of hypotension, respiratory depression, sedation with benzodiazepines or other CNS depressants (eg, sedatives/hypnotics, anxiolytics, general anesthetics, phenothiazines, tranquilizers, muscle relaxants, antipsychotics, alcohol, other opioids); monitor. During or within 14 days of MAOIs: monitor for hypertension. Risk of serotonin syndrome with serotonergic drugs (eg, SSRIs, SNRIs, TCAs, triptans, 5-HT3 antagonists, mirtazapine, trazodone, tramadol, cyclobenzaprine, metaxalone, MAOIs, linezolid, IV methylene blue); monitor and discontinue if suspected. Avoid concomitant mixed agonist/antagonist opioids (eg, butorphanol, nalbuphine, pentazocine) or partial agonist (eg, buprenorphine); may reduce effects and/or precipitate withdrawal symptoms. Potentiated by CYP3A4 inhibitors (eg, macrolides, azole antifungals, protease inhibitors), cimetidine. Antagonized by CYP3A4 inducers (eg, rifampin, carbamazepine, phenytoin). May antagonize diuretics; monitor. Paralytic ileus may occur with anticholinergics. Cardiovascular depression with nitrous oxide and high-dose alfentanil. May increase serum amylase.

Alfentanil Hcl Injection Adverse Reactions

Adverse Reactions

Apnea, skeletal muscle rigidity, bradycardia (may be severe); respiratory depression, orthostatic hypotension, syncope.

Alfentanil Hcl Injection Clinical Trials

See Literature

Alfentanil Hcl Injection Note

Not Applicable

Alfentanil Hcl Injection Patient Counseling

See Literature