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Alfentanil (Alfentanil Hydrochloride) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Alfentanil Injection is indicated:

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).

SEE DOSAGE CHART FOR MORE COMPLETE INFORMATION ON THE USE OF ALFENTANIL INJECTION.

DOSAGE AND ADMINISTRATION

The dosage of alfentanil injection should be individualized and titrated to the desired effect in each patient according to body weight, physical status, underlying pathological condition, use of other drugs, and type and duration of surgical procedure and anesthesia. In obese patients (more than 20% above ideal total body weight), the dosage of alfentanil injection should be determined on the basis of lean body weight. The dose of alfentanil injection should be reduced in elderly or debilitated patients (see PRECAUTIONS).

Vital signs should be monitored routinely.

See Dosage Guidelines for the use of alfentanil injection: 1) by incremental injection as an analgesic adjunct to anesthesia with barbiturate/nitrous oxide/oxygen for short surgical procedures (expected duration of less than one hour); 2) by continuous infusion as a maintenance analgesic with nitrous oxide/oxygen for general surgical procedures; and 3) by intravenous injection in anesthetic doses for the induction of anesthesia for general surgical procedures with a minimum expected duration of 45 minutes; and 4) by intravenous injection as the analgesic component for monitored anesthesia care (MAC).  

DOSAGE GUIDELINES
DOSAGE SHOULD BE INDIVIDUALIZED AND TITRATED
FOR USE DURING GENERAL ANESTHESIA

SPONTANEOUSLY BREATHING/ ASSISTED VENTILATION

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

ASSISTED OR CONTROLLED VENTILATION

Incremental Injection
(To attenuate response to laryngoscopy and intubation)  

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

Continuous Infusion
(To provide attenuation of response to intubation and incision)

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

Anesthetic Induction

Induction of Anesthesia: 130-245 mcg/kg
Maintenance of Anesthesia: 0.5 to 1.5 mcg/kg/min or general anesthetic
Total dose: Dependent on duration of procedure
At these doses, truncal rigidity should be expected and a muscle relaxant should be utilized.
Administer slowly (over 3 minutes).

Concentration of inhalation agents reduced by 30-50% for initial hour.

MONITORED ANESTHESIA CARE (MAC)

For sedated and responsive, spontaneously breathing patients)

Induction of MAC : 3-8 mcg/kg
Maintenance of MAC : 3-5 mcg/kg q 5-20 min or 0.25 to 1 mcg/kg/min
Total dose : 3-40 mcg/kg

INFUSION DOSAGE

Continuous Infusion: 0.5-3 mcg/kg/min administered with nitrous oxide/oxygen in patients undergoing general surgery. Following an anesthetic induction dose of alfentanil injection, infusion rate requirements are reduced by 30-50% for the first hour of maintenance.
Changes in vital signs that indicate a response to surgical stress or lightening of anesthesia may be controlled by increasing the alfentanil to a maximum of 4 mcg/kg/min and/or administration of bolus doses of 7 mcg/kg. If changes are not controlled after three bolus doses given over a five minute period, a barbiturate, vasodilator, and/or inhalation agent should be used. Infusion rates should always be adjusted downward in the absence of these signs until there is some response to surgical stimulation.
Rather than an increase in infusion rate, 7 mcg/kg bolus doses of alfentanil injection or a potent inhalation agent should be administered in response to signs of lightening of anesthesia within the last 15 minutes of surgery. Alfentanil injection infusion should be discontinued at least 10‑15 minutes prior to the end of surgery.

Usage in Children: Clinical data to support the use of alfentanil injection in patients under 12 years of age are not presently available. Therefore, such use is not recommended.

Premedication: The selection of preanesthetic medications should be based upon the needs of the individual patient.

Neuromuscular Blocking Agents: The neuromuscular blocking agent selected should be compatible with the patient’s condition, taking into account the hemodynamic effects of a particular muscle relaxant and the degree of skeletal muscle relaxation required (see CLINICAL PHARMACOLOGY, WARNINGS and PRECAUTIONS sections).

In patients administered anesthetic (induction) dosages of alfentanil injection, it is essential that qualified personnel and adequate facilities are available for the management of intraoperative and postoperative respiratory depression.

Also see WARNINGS and PRECAUTIONS sections.

For purposes of administering small volumes of alfentanil injection accurately, the use of a tuberculin syringe or equivalent is recommended.

The physical and chemical compatibility of alfentanil injection have been demonstrated in solution with normal saline, 5% dextrose in normal saline, 5% dextrose in water and Lactated Ringers. Clinical studies of alfentanil injection infusion have been conducted with alfentanil injection diluted to a concentration range of 25 mcg/mL to 80 mcg/mL.

As an example of the preparation of alfentanil injection for infusion, 20 mL of alfentanil injection added to 230 mL of diluent provides 40 mcg/mL solution of alfentanil injection.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

SAFETY AND HANDLING

Alfentanil Injection, USP is supplied in individually sealed dosage forms which pose no known risk to health care providers having incidental contact. Accidental dermal exposure to alfentanil should be treated by rinsing the affected area with water.

Protect from light. Retain in carton until time of use. Store at 20° to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]

HOW SUPPLIED

Alfentanil Injection, USP for intravenous use contains alfentanil hydrochloride equivalent to 500 mcg of alfentanil base and is available as: 

List

Size

Container

2266

2 mL

ampul

2266

5 mL

ampul

2266

10 mL

ampul

 Revised: October, 2004 

©Hospira 2004                                                 EN-0637                                               Printed in USA

 

Manufactured by Hospira, Inc. Lake Forest, IL 60045 USA

Novation, the supply company of VHA and UHC, and NOVAPLUS are trademarks of Novation, LLC.

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