Alfentanil Hydrochloride (0122)
[ al-fen'-ta-nil hye-droe-klor'-ide ]
| Ingredients: |
Alfentanil Hydrochloride |
| Indications: |
Anesthesia, adjunct; Anesthesia, general |
| Pregnancy Category: |
C |
| FDA Approved: |
1986- 12- 01 |
| Classes: |
Analgesics, narcotic |
| Brand Names: |
Alfenil
-
Korea
;
Alfenta
-
US; Brazil, Canada
;
Brevafen
-
Argentina
;
Fanaxal
-
Spain
;
Fentalim
-
Italy
;
Rapifen
-
AUSTRALIA, EUROPE(Except
Bulgaria, Ireland, Poland, Slovenia, Spain, Turkey
); Brazil, Chile, Costa-rica, Dominican-republic, El-salvador, Guatemala, Honduras, Hong-kong, Israel, Mexico, Nicaragua, Panama, Paraguay, South-africa, Taiwan, Uruguay, Venezuela
;
|
| DEA schedules: |
Schedule II |
DESCRIPTION
|
| |
Alfentanil HCl 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.
Alfenta is a sterile, non- pyrogenic, preservative free aqueous solution containing alfentanil HCl equivalent to 500 μg/ ml
of alfentanil base for intravenous injection. The solution, which contains sodium chloride for isotonicity, has a pH range
of 4.0- 6.0.
|
CLINICAL PHARMACOLOGY
|
| |
Alfentanil HCl is an opioid analgesic with a rapid onset of action.
At doses of 8- 40 μg/ kg for surgical procedures lasting up to 30 minutes, alfentanil provides analgesic protection against
hemodynamic responses to surgical stress with recovery times generally comparable to those seen with equipotent fentanyl dosages.
For longer procedures, doses of up to 75 μg/ kg attenuate hemodynamic responses to laryngoscopy, intubation and incision,
with recovery time comparable to fentanyl. At doses of 50- 75 μg/ kg followed by a continuous infusion of 0.5- 3.0 μg/ kg/
min, alfentanil attenuates the catecholamine response with more rapid recovery and reduced need for postoperative analgesics
as compared to patients administered enflurane. At doses of 5 μg/ kg, alfentanil provides analgesia for the conscious but
sedated patient. Based on patient response, doses higher than 5 μg/ kg may be needed. Elderly or debilitated patients may
require lower doses. High intrasubject and intersubject variability in the pharmacokinetic disposition of alfentanil has been
reported.
The pharmacokinetics of alfentanil can be described as a three- compartment model with sequential distribution half- lives
of 1 and 14 minutes; and a terminal elimination half- life of 90- 111 minutes (as compared to a terminal elimination half-
life of approximately 475 minutes for fentanyl and approximately 265 minutes for sufentanil at doses of 250 μg). The liver
is the major site of biotransformation.
Alfentanil has an apparent volume of distribution of 0.4- 1 L/ kg, which is approximately one- fourth to one- tenth that of
fentanyl, with an average plasma clearance of 5 ml/ kg/ min as compared to approximately 8 ml/ kg/ min for fentanyl.
Only 1.0% of the dose is excreted as unchanged drug; urinary excretion is the major route of elimination of metabolites. Plasma
protein binding of alfentanil is approximately 92%.
In one study involving 15 patients administered alfentanil with nitrous oxide/ oxygen, a narrow range of plasma alfentanil
concentrations, approximately 310- 340 ng/ ml, was shown to provide adequate anesthesia for intra- abdominal surgery, while
lower concentrations, approximately 190 ng/ ml, blocked responses to skin closure. Plasma concentrations between 100- 200
ng/ ml provided adequate anesthesia for superficial surgery.
Alfentanil has an immediate onset of action. At dosages of approximately 105 μg/ kg, alfentanil produces hypnosis as determined
by EEG patterns; an aesthetic ED90 of 182 μg/ kg for alfentanil in unpremedicated patients has been determined, based upon the ability to block response to placement
of a nasopharyngeal airway. Based on clinical trials, induction dosage requirements range from 130- 245 μg/ kg. For procedures
lasting 30- 60 minutes, loading dosages of up to 50 μg/ kg produce the hemodynamic responses to endotracheal intubation and
skin incision comparable to those from fentanyl. A pre- intubation loading dose of 50- 75 μg/ kg prior to a continuous infusion
attenuates the response to laryngoscopy, intubation and incision. Subsequent administration of alfentanil infusion administered
at a rate of 0.5- 3 μg/ kg/ min with nitrous oxide/ oxygen attenuates sympathetic responses to surgical stress with more rapid
recovery than enflurane.
Requirements for volatile inhalation anesthetics were reduce by 30 to 50%during the first 60 minutes of maintenance in patients
administered anesthetic doses (above 130 μg/ kg) of alfentanil as compared to patients given doses of 4- 5 mg/ kg thiopental
for anesthetic induction. At anesthetic induction dosages, alfentanil provides a deep level of anesthesia during the first
hour of anesthetic maintenance and provides attenuation of the hemodynamic response during intubation and incision.
Following an anesthetic dose of alfentanil, requirements for alfentanil infusion are reduced by 30 to 50% for the first hour
of maintenance.
Patients with compromised liver function and those over 65 years of age have been found to have reduced plasma clearance and
extended terminal elimination of alfentanil, which may prolong postoperative recovery.
Repeated or continuous administration of alfentanil produces increasing plasma concentrations and an accumulation of the drug,
particularly in patients with reduced plasma clearance.
Bradycardia may be seen in patients administered alfentanil. The incidence and degree of bradycardia may be more pronounced
when alfentanil is administered in conjunction with non- vagolytic neuromuscular blocking agents or in the absence of anticholinergic
agents such as atropine.
Administration of intravenous diazepam immediately prior to or following high doses of alfentanil has been shown to produce
decreases in blood pressure that may be secondary to vasodilation; recovery may also be prolonged.
Patients administered doses up to 200 μg/ kg of alfentanil have shown no significant increase in histamine levels and no clinical
evidence of histamine release.
Skeletal muscle rigidity is related to the dose and speed of administration of alfentanil. Muscular rigidity will occur with
an immediate onset following anesthetic induction dosages. Preventative measures (see WARNINGS ) may reduce the rate and severity.
The duration and degree of respiratory depression and increased airway resistance usually increase with dose, but have also
been observed at lower doses. Although higher doses may produce apnea and a longer duration of respiratory depression, apnea
may also occur at low doses.
During monitored anesthesia care (MAC), attention must be given to the respiratory effects of alfentanil injection. Decreased
oxygen saturation, apnea, decreased respiratory rate, and upper airway obstruction can occur. (See WARNINGS )
|
INDICATIONS AND USAGE
|
| |
Alfentanil HCl 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 TABLE 1 FOR MORE COMPLETE INFORMATION ON THE USE OF ALFENTANIL.
|
CONTRAINDICATIONS
|
| |
Alfentanil HCl is contraindicated in patients with known hypersensitivity to the drug.
|
WARNINGS
|
| |
ALFENTANIL 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.
Alfentanil HCl administered in initial dosages up to 20 μg/ kg may cause skeletal muscle rigidity, particularly of the truncal
muscles. The incidence and severity of muscle rigidity is usually dose- related. Administration of alfentanil at anesthetic
induction dosages (above 130 μg/ kg) will consistently produce muscular rigidity with an immediate onset. The onset of muscular
rigidity occurs earlier than with other opioids. Alfentanil 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 alfentanil at dosages up to 130 μg/ kg; following loss of consciousness, a
full paralyzing dose of a neuromuscular blocking agent should be administered; or 3) simultaneous administration of alfentanil
and a full paralyzing dose of a neuromuscular blocking agent when alfentanil is used in rapidly administered anesthetic dosages
(above 130 μg/ 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 alfentanil. 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.
|
PRECAUTIONS
|
| |
DELAYED RESPIRATORY DEPRESSION, RESPIRATORY ARREST, BRADYCARDIA, ASYSTOLE, ARRHYTHMIAS AND HYPOTENSION HAVE ALSO BEEN REPORTED.
THEREFORE, VITAL SIGNS MUST BE MONITORED CONTINUOUSLY.
General
|
| |
The initial dose of alfentanil should be appropriately reduced in elderly and debilitated patients. The effect of the initial
dose should be considered in determining supplemental doses. In obese patients (more then 20% above ideal total body weight),
the dosage of alfentanil should be determined on the basis of lean body weight. In one clinical trial, the dose of alfentanil
required to produce anesthesia, as determined by appearance of delta waves in EEG, was 40% lower in geriatric patients than
that needed in healthy young patients.
In patients with compromised liver function and in geriatric patients, the plasma clearance of alfentanil may be reduced and
postoperative recovery may be prolonged.
Induction doses of alfentanil should be administered slowly (over three minutes). Administration may produce loss of vascular
tone and hypotension. Consideration should be given to fluid replacement prior to induction.
Diazepam administered immediately prior to or in conjunction with high doses of alfentanil may produce vasodilation, hypotension
and result in delayed recovery.
Bradycardia produced by alfentanil may be treated with atropine. Severe bradycardia and asystole have been successfully treated
with atropine and conventional resuscitative methods.
The hemodynamic effects of a particular muscle relaxant and the degree of skeletal muscle relaxation required should be considered
in the selection of a neuromuscular blocking agent.
Following an anesthetic induction dose of alfentanil, requirements for volatile inhalation anesthetics of alfentanil infusion
are reduced by 30 to 50% for the first hour of maintenance.
Alfentanil infusions should be discontinued at least 10- 15 minutes prior to the end of surgery during general anesthesia.
During administration of alfentanil for Monitored Anesthesia Care (MAC), infusions may be continued to the end of the procedure.
Respiratory depression caused by opioid analgesics can be reversed by opioid antagonists such as naloxone. Because the duration
of respiratory depression produced by alfentanil may last longer than the duration of the opioid antagonist action, appropriate
surveillance should be maintained. As with all potent opioids, profound analgesia is accompanied by respiratory depression
and diminished sensitivity to CO2 stimulation which may persist into or recur in the postoperative period.
Intraoperative hyperventilation may further after postoperative response to CO2 . Appropriate postoperative monitoring should be employed, particularly after infusions and large doses of alfentanil, to
ensure that adequate spontaneous breathing is established and maintained in the absence of stimulation prior to discharging
the patient from the recovery area.
|
Head Injuries
|
| |
Alfentanil may obscure the clinical course of patients with head injuries.
|
Impaired Respiration
|
| |
Alfentanil should be used with caution in patients with pulmonary disease, decreased respiratory reserve or potentially compromised
respiration. In such patients, opioids may additionally decrease respiratory drive and increase airway resistance. During
anesthesia, this can be managed by assisted or controlled respiration.
|
Impaired Hepatic or Renal Function
|
| |
In patients with liver or kidney dysfunction, alfentanil should be administered with caution due to the importance of these
organs in the metabolism and excretion of alfentanil.
|
Carcinogenesis, Mutagenesis, and Impairment of Fertility
|
| |
No long- term animal studies of alfentanil have been performed to evaluate carcinogenic potential. No structural chromosome
mutations were produced in the in vivo micronucleus test in female rats at single intravenous doses of alfentanil as high as 20 mg/ kg body weight(approximately
40 times the upper human dose), equivalent to a dose of 103 mg/ m2body surface area. No dominant lethal mutations were produced in the in vivo dominant lethal test in male and female mice at the maximum intravenous dose of 20 mg/ kg(60 mg/ m2). No mutagenic activity was revealed in the in vitro Ames Salmonella typhimurium test, with and without metabolic activation.
|
Pregnancy Category C
|
| |
Alfentanil has been shown to have an embryocidal effect in rats and rabbits when given in doses 2.5 times the upper human
dose for a period of 10 days to over 30 days. These effects could have been due to maternal toxicity (decreased food consumption
with increased mortality) following prolonged administration of the drug.
No evidence of teratogenic effects has been observed after administration for alfentanil in rats or rabbits.
There are no adequate and well- controlled studies in pregnant women. Alfentanil should be used during pregnancy only if the
potential benefit justifies the potential risk to the fetus.
|
Labor and Delivery
|
| |
There are insufficient data to support the use of alfentanil in labor and delivery. Placental transfer of the drug has been
reported: therefore, use in labor and delivery is not recommended.
|
Nursing Mothers
|
| |
In one study of nine women undergoing postpartum tubal ligation, significant levels of alfentanil were detected in colostrum
four hours after administration of 60 μg/ kg of alfentanil, with no detectable levels present after 28 hours. Caution should
be exercised when alfentanil is administered to a nursing woman.
|
Pediatric Use
|
| |
Adequate data to support the use of alfentanil in children under 12 years of age are not presently available.
|
|
DRUG INTERACTIONS
|
| |
Both the magnitude and duration of central nervous system and cardiovascular effects may be enhanced when alfentanil is administered
in combination with other CNS depressants such as barbiturates, tranquilizers, opioids, or inhalation general anesthetics.
Postoperative respiratory depression may be enhanced or prolonged by these agents. In such cases of combined treatment, the
dose of one or both agents should be reduced. Limited clinical experience indicates that requirements for volatile inhalation
anesthetics are reduced by 30 to 50% for the first sixty (60) minutes following alfentanil induction.
The concomitant use of erythromycin with alfentanil can significantly inhibit alfentanil clearance and may increase the risk
of prolonged or delayed respiratory depression. Cimetidine reduces the clearance of alfentanil. Therefore smaller alfentanil
doses will be required with prolonged administration and the duration of action of alfentanil may be extended.
Perioperative administration of drugs affecting hepatic blood flow or enzyme function may reduce plasma clearance and prolong
recovery.
|
ADVERSE REACTIONS
|
| |
The most common adverse reactions of opioids are respiratory depression and skeletal muscle rigidity, particularly of the
truncal muscles. Alfentanil may produce muscular rigidity that involves the skeletal muscles of the neck and extremities.
(See CLINICAL PHARMACOLOGY , WARNINGS , and PRECAUTIONS ) on the management of respiratory depression and skeletal muscle rigidity.
The adverse experience profile from 696 patients receiving alfentanil for Monitored Anesthesia Care (MAC) is similar to the
profile established with alfentanil during general anesthesia. Respiratory events reported during MAC included hypoxia, apnea,
and bradypnea. Other adverse events reported by patients receiving alfentanil for MAC, in order of decreasing frequency, were
nausea, hypotension, vomiting, pruritus, confusion, somnolence and agitation.
The following adverse reaction information is derived from controlled and open clinical trials in 785 patients who received
intravenous alfentanil during induction and maintenance of general anesthesia. The controlled trial included treatment comparisons
with fentanyl, thiopental sodium, enflurane, saline placebo and halothane. The incidence of certain side effects is influenced
by the type of use ( e.g. , chest wall rigidity has a higher reported incidence in clinical trials of alfentanil induction) and by the type of surgery,
( e.g., nausea and vomiting have a higher reported incidence in patients undergoing gynecologic surgery). The overall reports of nausea
and vomiting with alfentanil were comparable to fentanyl.
Incidence Greater than 1%—Probably Causally Related (Derived from Clinical Trials):
- Gastrointestinal: Nausea (28%); vomiting (18%).
- Cardiovascular: Arrhythmia, bradycardia (14%); hypertension (18%); hypotension (10%); tachycardia (12%).
- Musculoskeletal: Chest wall rigidity (17%); skeletal muscle movements*.
- Respiratory: Apnea*, postoperative respiratory depression.
- Central Nervous System: Blurred vision, dizziness*, sleepiness/ postoperative sedation.
- * Incidence 3- 9%.
- All others 1- 3%.
Incidence Less than 1%—Probably Causally Related (Derived from Clinical Trials):
- Adverse events reported in post- marketing surveillance, not seen in clinical trials, are italicized.
- Central Nervous System: Headache*, myoclonic movements, postoperative confusion*, postoperative euphoria*, shivering*.
- Dermatological: Itching*, urticaria*.
- Injection Site: Pain*.
- Musculoskeletal: Skeletal muscle rigidity of neck and extremities
- Respiratory: Bronchospasm, hypercarbia*, laryngospasm*.
- * Incidence 0.3- 1%
|
DRUG ABUSE AND DEPENDENCE
|
| |
Alfentanil HCl is a Schedule II controlled drug substance that can produce drug dependence of the morphine type and therefore
has the potential for being abused.
Opioid analgesics have been associated with abuse and dependence in health care providers and others with ready access to
such drugs. Alfentanil should be handled accordingly.
|
OVERDOSAGE
|
| |
Overdosage would be manifested by extension of the pharmacological actions of alfentanil HCl (see CLINICAL PHARMACOLOGY ) as with other potent opioid analgesics. No experience of overdosage with alfentanil was reported during clinical trials.
The intravenous LD50 of alfentanil is 43- 51 mg/ kg in rats, 72- 74 mg/ kg in mice, 72- 82 mg/ kg in guinea pigs and 60- 88 mg/ kg in dogs. Intravenous
administration of an opioid antagonist such as naloxone should be employed as a specific antidote to manage respiratory depression.
The duration of respiratory depression following overdosage with alfentanil may be longer than the duration of action of the
opioid antagonist. Administration of an opioid antagonist should not preclude immediate establishment of a patent airway,
administration of oxygen, and assisted or controlled ventilation as indicated for hypoventilation or apnea. 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.
|
DOSAGE AND ADMINISTRATION
|
| |
The dosage of alfentanil HCl should be individualized 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 should be determined on the basis of lean body weight.
The dose of alfentanil should be reduced in elderly or debilitated patients (see PRECAUTIONS ).
Vital signs should be monitored routinely.
See Dosage Guidelines in TABLE 1 for the use of alfentanil: (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).
| TABLE 1
Dosage Guidelines Dosage should be individualized And titrated for use during general anesthesia
|
| Spontaneous Breathing/ Assisted Ventilation |
| |
Induction of Analgesia: 8- 20 μg/ kg |
| |
Maintenance of Analgesia: 3- 5 μg/ kg q 5- 20 min or 0.5 to 1 μg/ kg/ min |
| |
Total dose: 8- 40 μg/ kg |
| Assisted or Controlled Ventilation |
| Incremental Injection |
Induction of Analgesia: 20- 50 μg/ kg |
| (To attenuate response to laryngoscopy and intubation) |
Maintenance of Analgesia: 5- 15 μg/ kg q 5- 20 min |
| |
Total dose: Up to 75 μg/ kg |
| Continuous Infusion |
Infusion rates are variable and should be titrated to the desired clinical effect. |
| (To provide attenuation of response to intubation and incision) |
See Infusion Dosage Guidelines Below. |
| |
Induction of Analgesia: 50- 75 μg/ kg |
| |
Maintenance of Analgesia: 0.5 to 3 μg/ kg/ min (Average rate 1 to 1.5 μg/ kg/ min) |
| |
Total dose: Dependent on duration of procedure |
| Anesthetic Induction |
Induction of Anesthesia: 130- 245 μg/ kg |
| |
Maintenance of Anesthesia: 0.5 to 1.5 μg/ 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) |
Induction of MAC: 3- 8 μg/ kg |
| (For sedated and responsive, spontaneously breathing patients) |
Maintenance of MAC: 3- 5 μg/ kg q 5- 20 min or 0.25 to 1 μg/ kg/ min |
| |
Total dose: 3- 40 μg/ kg |
|
Infusion Dosage
|
| |
Continuous Infusion
|
| |
0.5- 3.0 μg/ kg/ min administered with nitrous oxide/ oxygen in patients undergoing general surgery. Following an anesthetic
induction dose of alfentanil, 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 rate up to a maximum of 4.0 μg/ kg/ min and/ or administration of bolus doses of 7 μg/ kg. If changes are not controlled
after three bolus doses given over a 5 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 μg/ kg bolus doses of alfentanil or a potent inhalation agent should be administered
in response to signs of lightening of anesthesia within the last 15 minutes of surgery. Administration of alfentanil 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 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 ).
In patients administered anesthetic (induction) dosages of alfentanil, 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 .
For purposes of administering small volumes of alfentanil accurately, the use of a tuberculin syringe or equivalent is recommended.
The physical and chemical compatibility of alfentanil have been demonstrated in solution with normal saline, 5% dextrose in
normal saline, 5% dextrose in water and lactated Ringer's. Clinical studies of alfentanil infusion have been conducted with
alfentanil diluted to a concentration range of 25- 80 μg/ ml.
As an example of the preparation of alfentanil for infusion, 20 ml of alfentanil added to 230 ml of diluent provides a 40
μg/ ml solution of alfentanil.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever
solution and container permit.
Safety And Handling
|
| |
Alfentanil HCl 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.
|
|
HOW SUPPLIED
|
| |
Each ml of Alfenta injection for intravenous use contains alfentanil HCl equivalent to 500 μg of alfentanil base.
Storage: Protect from light. Store at room temperature 15- 30°C (59- 86°F).
|
PRODUCT IDENTIFICATION
|
| |
None Available |
PRODUCT LISTING - RATED THERAPEUTICALLY EQUIVALENT
|
| |
| solution - injectable - 0.5 mg/ ml -
|
| 2.0 ml x 10.0 |
$73.68 |
GENERIC
Baxter Healthcare Corporation
|
10019006001 |
| 2.0 ml x 10.0 |
$84.00 |
Alfenta
Taylor Pharmaceuticals
|
11098006002 |
| 2.0 ml x 10.0 |
$87.28 |
GENERIC
Abbott Pharmaceutical
|
00074226602 |
| 2.0 ml x 10.0 |
$87.28 |
GENERIC
Novation
|
00074226649 |
| 5.0 ml x 10.0 |
$132.00 |
GENERIC
Baxter Healthcare Corporation
|
10019006002 |
| 5.0 ml x 10.0 |
$145.19 |
Alfenta
Taylor Pharmaceuticals
|
11098006005 |
| 5.0 ml x 10.0 |
$156.51 |
GENERIC
Abbott Pharmaceutical
|
00074226605 |
| 5.0 ml x 10.0 |
$156.51 |
GENERIC
Novation
|
00074226651 |
| 10.0 ml x 5.0 |
$120.71 |
GENERIC
Novation
|
00074226652 |
| 10.0 ml x 5.0 |
$152.25 |
Alfenta
Taylor Pharmaceuticals
|
11098006010 |
| 20.0 ml x 5.0 |
$266.50 |
Alfenta
Taylor Pharmaceuticals
|
11098006020 |
|
|