Indications for: Alfentanil HCl Injection

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).

Adult Dosage:

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 Dosage:

<12yrs: not established.

Boxed Warning:

Addiction, abuse, and misuse.

Alfentanil HCl Injection 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. 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 Classification:

Opioid agonist.

Alfentanil HCl Injection 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.

Adverse Reactions:

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

How Supplied:

Ampules—5, 10