Alfenta
Loading...Alfenta Recall
Get an alert when a recall is issued.
Questions & Answers
Side Effects & Adverse Reactions
ALFENTA SHOULD BE ADMINISTERED ONLY BY PERSONS SPECIFICALLY TRAINED IN THE USE OF INTRAVENOUS AND GENERAL ANESTHETIC AGENTS AND IN THE MANAGEMENT OF RESPIRATORY EFFECTS OF POTENT OPIOIDS.
AN OPIOID ANTAGONIST, RESUSCITATIVE AND INTUBATION EQUIPMENT AND OXYGEN SHOULD BE READILY AVAILABLE.
BECAUSE OF THE POSSIBILITY OF DELAYED RESPIRATORY DEPRESSION, MONITORING OF THE PATIENT MUST CONTINUE WELL AFTER SURGERY.
ALFENTA (alfentanil hydrochloride) 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. Administration of ALFENTA at anesthetic induction dosages (above 130 mcg/kg) will consistently produce muscular rigidity with an immediate onset. The onset of muscular rigidity occurs earlier than with other opioids. ALFENTA may produce muscular rigidity that involves all skeletal muscles, including those of the neck and extremities. The incidence may be reduced by: 1) routine methods of administration of neuromuscular blocking agents for balanced opioid anesthesia; 2) administration of up to 1/4 of the full paralyzing dose of a neuromuscular blocking agent just prior to administration of ALFENTA at dosages up to 130 mcg/kg; following loss of consciousness, a full paralyzing dose of a neuromuscular blocking agent should be administered; or 3) simultaneous administration of ALFENTA and a full paralyzing dose of a neuromuscular blocking agent when ALFENTA is used in rapidly administered anesthetic dosages (above 130 mcg/kg).
The neuromuscular blocking agent used should be appropriate for the patient's cardiovascular status. Adequate facilities should be available for postoperative monitoring and ventilation of patients administered ALFENTA. It is essential that these facilities be fully equipped to handle all degrees of respiratory depression.
PATIENTS RECEIVING MONITORED ANESTHESIA CARE (MAC) SHOULD BE CONTINUOUSLY MONITORED BY PERSONS NOT INVOLVED IN THE CONDUCT OF THE SURGICAL OR DIAGNOSTIC PROCEDURE; OXYGEN SUPPLEMENTATION SHOULD BE IMMEDIATELY AVAILABLE AND PROVIDED WHERE CLINICALLY INDICATED; OXYGEN SATURATION SHOULD BE CONTINUOUSLY MONITORED; THE PATIENT SHOULD BE OBSERVED FOR EARLY SIGNS OF HYPOTENSION, APNEA, UPPER AIRWAY OBSTRUCTION AND/OR OXYGEN DESATURATION.
Severe and unpredictable potentiation of monoamine oxidase (MAO) inhibitors has been reported for other opioid analgesics, and rarely with alfentanil. Therefore when alfentanil is administered to patients who have received MAO inhibitors within 14 days, appropriate monitoring and ready availability of vasodilators and beta-blockers for the treatment of hypertension is recommended.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
ALFENTA (alfentanil hydrochloride) 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 ALFENTA.
History
There is currently no drug history available for this drug.
Other Information
ALFENTA (alfentanil hydrochloride) Injection is an opioid analgesic chemically designated as N-[1-[2-(4-ethyl-4,5-dihydro-5-oxo-1H-tetrazol-1-yl)ethyl]-4-(methoxymethyl)-4-piperidinyl]-N-phenylpropanamide monohydrochloride (1:1) with a molecular weight of 452.98 and an n-octanol:water partition coefficient of 128:1 at pH 7.4. The structural formula of ALFENTA is:
ALFENTA is a sterile, non-pyrogenic, preservative free aqueous solution containing alfentanil hydrochloride equivalent to 500 µg per mL of alfentanil base for intravenous injection. The solution, which contains sodium chloride for isotonicity, has a pH range of 4-6. Each mL contains: Active: Alfentanil base 500 mcg. Inactive: Sodium Chloride 9 mg and Water for Injection Q.S.
Sources
Alfenta Manufacturers
-
Taylor Pharmaceuticals
![Alfenta (Alfentanil Hydrochloride) Injection [Taylor Pharmaceuticals]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Alfenta | Taylor Pharmaceuticals
The dosage of ALFENTA (alfentanil hydrochloride) 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 ALFENTA should be determined on the basis of lean body weight. The dose of ALFENTA should be reduced in elderly or debilitated patients (see PRECAUTIONS).
Vital signs should be monitored routinely.
See Dosage Guidelines for the use of ALFENTA: 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 ALFENTA, 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 ALFENTA or a potent inhalation agent should be administered in response to signs of lightening of anesthesia within the last 15 minutes of surgery. ALFENTA infusion should be discontinued at least 10-15 minutes prior to the end of surgery. Usage in ChildrenClinical data to support the use of ALFENTA in patients under 12 years of age are not presently available. Therefore, such use is not recommended.
PremedicationThe selection of preanesthetic medications should be based upon the needs of the individual patient.
Neuromuscular Blocking AgentsThe 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 ALFENTA, 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 ALFENTA accurately, the use of a tuberculin syringe or equivalent is recommended.
The physical and chemical compatibility of ALFENTA have been demonstrated in solution with normal saline, 5% dextrose in normal saline, 5% dextrose in water and Lactated Ringers. Clinical studies of ALFENTA infusion have been conducted with ALFENTA diluted to a concentration range of 25 mcg/mL to 80 mcg/mL.
As an example of the preparation of ALFENTA for infusion, 20 mL of ALFENTA added to 230 mL of diluent provides 40 mcg/mL solution of ALFENTA.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
SAFETY AND HANDLINGALFENTA (alfentanil hydrochloride) is supplied in individually sealed dosage forms which pose no known risk to health-care providers having incidental contact. Accidental dermal exposure to ALFENTA should be treated by rinsing the affected area with water.
Protect from light. Storage: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature].
-
Akorn
Alfenta | Akorn
The dosage of ALFENTA (alfentanil hydrochloride) 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 ALFENTA should be determined on the basis of lean body weight. The dose of ALFENTA should be reduced in elderly or debilitated patients (see PRECAUTIONS).
Vital signs should be monitored routinely.
See Dosage Guidelines for the use of ALFENTA: 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 ALFENTA, 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 ALFENTA or a potent inhalation agent should be administered in response to signs of lightening of anesthesia within the last 15 minutes of surgery. ALFENTA infusion should be discontinued at least 10-15 minutes prior to the end of surgery. Usage in ChildrenClinical data to support the use of ALFENTA in patients under 12 years of age are not presently available. Therefore, such use is not recommended.
PremedicationThe selection of preanesthetic medications should be based upon the needs of the individual patient.
Neuromuscular Blocking AgentsThe 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 ALFENTA, 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 ALFENTA accurately, the use of a tuberculin syringe or equivalent is recommended.
The physical and chemical compatibility of ALFENTA have been demonstrated in solution with normal saline, 5% dextrose in normal saline, 5% dextrose in water and Lactated Ringers. Clinical studies of ALFENTA infusion have been conducted with ALFENTA diluted to a concentration range of 25 mcg/mL to 80 mcg/mL.
As an example of the preparation of ALFENTA for infusion, 20 mL of ALFENTA added to 230 mL of diluent provides 40 mcg/mL solution of ALFENTA.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
SAFETY AND HANDLINGALFENTA (alfentanil hydrochloride) is supplied in individually sealed dosage forms which pose no known risk to health-care providers having incidental contact. Accidental dermal exposure to ALFENTA should be treated by rinsing the affected area with water.
Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light.
![Alfenta (Alfentanil Hydrochloride) Injection [Akorn]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=098af6c6-7400-4b2b-bae6-03d5913ad712&name=alf01-0003-02.jpg)
Login To Your Free Account