Alfentanil

What is Alfentanil?

• Alfentanil (Alfenta) is an opioid used for anaesthesia in surgery.

Alfentanil

Alfentanil 3D BS

Alfentanil-2D-skeletal

What are the uses of this medicine?

• Alfentanil (Alfenta) is used:
• 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 the analgesic component for monitored anesthesia care (MAC).

How does this medicine work?

• Alfentanil, a synthetic short-acting opioid with analgesic and local anesthesia enhancing activity.
• Alfentanil primarily binds to mu-opioid receptor, a G-protein-coupled receptor, thereby mimicking the actions of morphine, the prototypical mu receptor agonist.
• This agent induces anti-nociception responses mediated through inhibiting the release of various neurotransmitters such as substance P, GABA, dopamine, acetylcholine and noradrenaline; in addition, the release of vasopressin, somatostatin, insulin and glucagon are also inhibited.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• Hypersensitivity to alfentanil

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Be sure to mention the medications listed below:

• Macrolide antibiotics (e.g., erythromycin)
• azole-antifungal agents (e.g. ketoconazole)
• protease inhibitors (e.g., ritonavir)
• Rifampin
• carbamazepine
• phenytoin
• Benzodiazepines and other sedatives/hypnotics
• anxiolytics
• tranquilizers
• muscle relaxants
• general anesthetics
• antipsychotics
• other opioids
• alcohol
• Selective serotonin reuptake inhibitors (SSRIs)
• serotonin and norepinephrine reuptake inhibitors (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)
• phenelzine
• tranylcypromine
• linezolid
• butorphanol
• nalbuphine
• pentazocine
• buprenorphine
• Muscle Relaxants
• Diuretics
• Anticholinergic Drugs
• Cimetidine
• Nitrous oxide

Is this medicine FDA approved?

• Discovered at Janssen Pharmaceutica in 1976, alfentanil is classified as a Schedule II drug in the United States.

How should this medicine be used?

Recommended dosage:

• Individualize dosing based on factors such as age, body weight, physical status, underlying pathological condition, use of other drugs, type of anesthesia to be used, and the surgical procedure involved.
• Doses of Alfentanil HCl Injection vary depending on circumstances.
• Reduce the dose of Alfentanil HCl Injection in elderly, debilitated and obese patients.
• Reduce the dose of Alfentanil HCl Injection when administered with CNS depressants.

Spontaneously Breathing/Assisted Ventilation

• Induction of Analgesia: 8 to 20 mcg/kg
• Maintenance of Analgesia: 3 to 5 mcg/kg q 5 to 20 min or 0.5 to 1 mcg/kg/min
• Total dose: 8 to 40 mcg/kg

Assisted or Controlled Ventilation

• Induction of Analgesia: 20 to 50 mcg/kg
• Maintenance of Analgesia: 5 to 15 mcg/kg q 5 to 20 min
• Total dose: Up to 75 mcg/kg

Assisted or Controlled Ventilation- Continuous Infusion

• Induction of Analgesia: 50 to 75 mcg/kg
• Maintenance of Analgesia: 0.5 to 3 mcg/kg/min (Average rate 1 to 1.5 mcg/kg/min) Infusion rates are variable and should be titrated to the desired clinical effect.
• Total dose: Dependent on duration of procedure

Anesthetic Induction:

• Induction of Anesthesia: 130 to 245 mcg/kg Administer slowly (over 3 minutes).
• Maintenance of Anesthesia: 0.5 to 1.5 mcg/kg/min or general anesthetic.

MONITORED ANESTHESIA CARE (MAC):

• Induction of MAC: 3 to 8 mcg/kg
• Maintenance of MAC: 3 to 5 mcg/kg q 5 to 20 min or 0.25 to 1 mcg/kg/min
• Infusion rates are variable and should be titrated to the desired clinical effect. See Infusion Dosage Guidelines Below
• Total dose: 3 to 40 mcg/kg

Infusion Dosage Guidelines For Continuous Infusion:

• 0.5 to 3 mcg/kg/min administered with nitrous oxide/oxygen in patients undergoing general surgery.

Administration:

• Alfentanil HCl Injection should be administered only by persons specifically trained in the use of intravenous anesthetics and management of the respiratory effects of potent opioids.
• Ensure that an opioid antagonist, resuscitative and intubation equipment, and oxygen are readily available.
• Administer the dose slowly (over three minutes) as intravenous infusion.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As injection (sterile): eq. to 500 mcg/mL alfentanil base; 2 mL, 5 mL, 10 mL and 20 mL ampules.

This medicine is available in fallowing brand namesː

• Alfenta

What side effects can this medication cause?

The most common side effects of this medicine include:

• apnea
• rigidity
• bradycardia
• Bronchospasm
• hypercarbia
• laryngospasm
• Skeletal muscle rigidity of neck and extremities
• Pain
• Itching
• urticaria
• Headache
• myoclonic movements
• postoperative confusion
• postoperative euphoria
• shivering
• Anaphylaxis
• Arrhythmia
• hypertension
• hypotension
• tachycardia
• Apnea*
• postoperative respiratory depression
• Blurred vision
• dizziness
• sleepiness/postoperative sedation

What special precautions should I follow?

• As an opioid, Alfentanil HCl Injection exposes users to the risks of addiction, abuse, and misuse. Contact local and state professional licensing board or state controlled substances authority for information on how to prevent and detect abuse or diversion of this product.
• Serious, life-threatening, or fatal respiratory depression has been reported with the use of opioids, even when used as recommended. Monitor such patients closely including vital signs, particularly when initiating and titrating Alfentanil HCl Injection and when Alfentanil HCl Injection is given concomitantly with other drugs that depress respiration. To reduce the risk of respiratory depression, proper dosing and titration of Alfentanil HCl Injection are essential.
• Opioids can cause sleep-related breathing disorders including central sleep apnea (CSA) and sleep-related hypoxemia. In patients who present with CSA, consider decreasing the opioid dosage using best practices for opioid taper
• Concomitant use of Alfentanil HCl Injection with a CYP3A4 inhibitor, such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), and protease inhibitors (e.g., ritonavir), may increase plasma concentrations of Alfentanil HCl Injection and prolong opioid adverse reactions, which may exacerbate fatal respiratory depression. When using Alfentanil HCl Injection with CYP3A4 inducers or discontinuing CYP3A4 inhibitors, monitor patients closely at frequent intervals and consider increasing Alfentanil HCl Injection dosage.
• Alfentanil HCl Injection administered in initial dosages up to 20 mcg/kg may cause skeletal muscle rigidity, particularly of the truncal muscles. The incidence and severity of muscle rigidity is usually dose-related.
• Adequate facilities should be available for postoperative monitoring and ventilation of patients administered Alfentanil HCl Injection. It is essential that these facilities be fully equipped to handle all degrees of respiratory depression.
• When Alfentanil HCl Injection is used with CNS depressants, hypotension can occur. If it occurs, consider the possibility of hypovolemia and manage with appropriate parenteral fluid therapy. If volume expansion with fluids plus other countermeasures do not correct hypotension, consider administration of pressor agents other than epinephrine.
• Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of Alfentanil HCl Injection with serotonergic drugs. Discontinue Alfentanil HCl Injection if serotonin syndrome is suspected.
• Alfentanil can cause bradycardia. Monitor patients closely while receiving Alfentanil HCl Injection had have atropine and other resuscitative equipment present.
• Alfentanil HCl Injection may reduce respiratory drive, and the resultant CO2 retention can further increase intracranial pressure. Monitor such patients for signs of increasing intracranial pressure.
• Alfentanil may cause spasm of the sphincter of Oddi. Monitor patients with biliary tract disease, including acute pancreatitis for worsening symptoms.
• Alfentanil may increase the frequency of seizures in patients with seizure disorders. Monitor patients with a history of seizure disorders for worsened seizure control during Alfentanil HCl Injection therapy.
• Alfentanil HCl Injection may cause anaphylaxis reactions. Care should be exercised when administering to patients with known hypersensitivity to alfentanil or other opioid analgesics.

What to do in case of emergency/overdose?

Symptoms of overdose may include:

• respiratory depression
• somnolence progressing to stupor or coma
• skeletal muscle flaccidity
• cold and clammy skin
• constricted pupils
• pulmonary edema
• bradycardia
• hypotension
• partial or complete airway obstruction
• atypical snoring
• death
• mydriasis rather than miosis may be seen with hypoxia

Management of overdosage:

• In case of overdose, priorities are the reestablishment of a patent and protected airway and institution of assisted or controlled ventilation, if needed.
• Employ other supportive measures (including oxygen and vasopressors) in the management of circulatory shock and pulmonary edema as indicated.
• Cardiac arrest or arrhythmias will require advanced life-support techniques.
• If respiratory depression is associated with muscular rigidity, a neuromuscular blocking agent may be required to facilitate assisted or controlled ventilation.
• Intravenous fluids and vasoactive agents may be required to manage hemodynamic instability.
• The opioid antagonists, naloxone or nalmefene, are specific antidotes to respiratory depression resulting from opioid overdose.

Can this medicine be used in pregnancy?

• Prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome.
• Available data with Alfentanil HCl Injection in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage.

Can this medicine be used in children?

• Adequate data to support the use of Alfentanil HCl Injection in children under the age of 12 years of age are not presently available.

What are the active and inactive ingredients in this medicine?

Active ingredients:

• Alfentanil Hydrochloride

Inactive Ingredients:

• Sodium Chloride
• Water

Who manufactures and distributes this medicine?

Distributed by:

• Akorn Operating Company LLC
• Gurnee, IL

What should I know about storage and disposal of this medication?

• Store at 20° to 25°C (68 to 77°F).
• Protect from light.

Full and partial opiod agonists:

• Alfentanil
• Butorphanol
• Codeine
• Diphenoxylate
• Fentanyl
• Heroin
• Hydrocodone
• Hydromorphone
• Levorphanol
• Loperamide
• Meperidine
• Methadone
• Morphine
• Opium
• Oxycodone
• Oxymorphone
• Pentazocine
• Remifentanil
• Sufentanil
• Tramadol

Opiate antagonists:

• Nalmefene
• Naloxegol
• Naloxone
• Naltrexone

• Dailymed label info on Alfentanil
• FDA Alfentanil

Alfentanil Resources
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