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Alfentanil
Overview
What is Alfentanil?
Alfentanil HCl Injection, USP 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 Alfentanil hydrochloride is:
Alfentanil HCl Injection, USP 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 to 6. Each mL contains: Alfentanil base 500 mcg. Sodium Chloride 9 mg and Water for Injection q.s.
What does Alfentanil look like?
What are the available doses of Alfentanil?
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What should I talk to my health care provider before I take Alfentanil?
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How should I use Alfentanil?
Alfentanil HCl injection is indicated:
SEE FOR MORE COMPLETE INFORMATION ON THE USE OF ALFENTANIL HCl INJECTION.
The dosage of Alfentanil HCl 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 HCl injection should be determined on the basis of lean body weight. The dose of Alfentanil HCl injection should be reduced in elderly or debilitated patients (see ).
Vital signs should be monitored routinely.
See for the use of Alfentanil HCl 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
What interacts with Alfentanil?
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What are the warnings of Alfentanil?
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What are the precautions of Alfentanil?
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What are the side effects of Alfentanil?
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What should I look out for while using Alfentanil?
Alfentanil is contraindicated in patients with known hypersensitivity to the drug or known intolerance to other opioid agonists.
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 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 alfentanil 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. 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 mcg/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 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 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 betablockers for the treatment of hypertension is recommended.
What might happen if I take too much Alfentanil?
Overdosage would be manifested by extension of the pharmacological actions of alfentanil (see ) as with other potent opioid analgesics. No experience of overdosage with alfentanil was reported during clinical trials. The intravenous LD50 of alfentanil is 43 to 51 mg/kg in rats, 72 to 74 mg/kg in mice, 72 to 82 mg/kg in guinea pigs and 60 to 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.
How should I store and handle Alfentanil?
Alfentanil HCl Injection, USP for intravenous use. Alfentanil base 500 mcg. Sodium Chloride 9 mg and WFI q.s. Alfentanil HCl Injection, USP is available as: NDC 17478-841-02, 2 mL Ampule in packages of 10NDC 17478-841-05, 5 mL Ampule in packages of 10NDC 17478-841-10, 10 mL Ampule in packages of 5NDC 17478-841-20, 20 mL Ampule in packages of 5 U.S. Patent No. 4,167,574May 1995, November 1995 PREMIERProRx Manufactured by: Lake Forest, IL 60045PremierProRx is a registered trademark of Premier Inc., used under license. PAFA0N Rev. 10/15 Alfentanil HCl Injection, USP for intravenous use. Alfentanil base 500 mcg. Sodium Chloride 9 mg and WFI q.s. Alfentanil HCl Injection, USP is available as: NDC 17478-841-02, 2 mL Ampule in packages of 10NDC 17478-841-05, 5 mL Ampule in packages of 10NDC 17478-841-10, 10 mL Ampule in packages of 5NDC 17478-841-20, 20 mL Ampule in packages of 5 U.S. Patent No. 4,167,574May 1995, November 1995 PREMIERProRx Manufactured by: Lake Forest, IL 60045PremierProRx is a registered trademark of Premier Inc., used under license. PAFA0N Rev. 10/15 Alfentanil HCl Injection, USP for intravenous use. Alfentanil base 500 mcg. Sodium Chloride 9 mg and WFI q.s. Alfentanil HCl Injection, USP is available as: NDC 17478-841-02, 2 mL Ampule in packages of 10NDC 17478-841-05, 5 mL Ampule in packages of 10NDC 17478-841-10, 10 mL Ampule in packages of 5NDC 17478-841-20, 20 mL Ampule in packages of 5 U.S. Patent No. 4,167,574May 1995, November 1995 PREMIERProRx Manufactured by: Lake Forest, IL 60045PremierProRx is a registered trademark of Premier Inc., used under license. PAFA0N Rev. 10/15 Alfentanil HCl Injection, USP for intravenous use. Alfentanil base 500 mcg. Sodium Chloride 9 mg and WFI q.s. Alfentanil HCl Injection, USP is available as: NDC 17478-841-02, 2 mL Ampule in packages of 10NDC 17478-841-05, 5 mL Ampule in packages of 10NDC 17478-841-10, 10 mL Ampule in packages of 5NDC 17478-841-20, 20 mL Ampule in packages of 5 U.S. Patent No. 4,167,574May 1995, November 1995 PREMIERProRx Manufactured by: Lake Forest, IL 60045PremierProRx is a registered trademark of Premier Inc., used under license. PAFA0N Rev. 10/15 Alfentanil HCl Injection, USP for intravenous use. Alfentanil base 500 mcg. Sodium Chloride 9 mg and WFI q.s. Alfentanil HCl Injection, USP is available as: NDC 17478-841-02, 2 mL Ampule in packages of 10NDC 17478-841-05, 5 mL Ampule in packages of 10NDC 17478-841-10, 10 mL Ampule in packages of 5NDC 17478-841-20, 20 mL Ampule in packages of 5 U.S. Patent No. 4,167,574May 1995, November 1995 PREMIERProRx Manufactured by: Lake Forest, IL 60045PremierProRx is a registered trademark of Premier Inc., used under license. PAFA0N Rev. 10/15 Alfentanil HCl Injection, USP for intravenous use. Alfentanil base 500 mcg. Sodium Chloride 9 mg and WFI q.s. Alfentanil HCl Injection, USP is available as: NDC 17478-841-02, 2 mL Ampule in packages of 10NDC 17478-841-05, 5 mL Ampule in packages of 10NDC 17478-841-10, 10 mL Ampule in packages of 5NDC 17478-841-20, 20 mL Ampule in packages of 5 U.S. Patent No. 4,167,574May 1995, November 1995 PREMIERProRx Manufactured by: Lake Forest, IL 60045PremierProRx is a registered trademark of Premier Inc., used under license. PAFA0N Rev. 10/15
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Alfentanil is an opioid analgesic with a rapid onset of action.
At doses of 8 to 40 mcg/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 mcg/kg attenuate hemodynamic responses to laryngoscopy, intubation and incision, with recovery time comparable to fentanyl. At doses of 50 to 75 mcg/kg followed by a continuous infusion of 0.5 to 3 mcg/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 mcg/kg, alfentanil provides analgesia for the conscious but sedated patient. Based on patient response, doses higher than 5 mcg/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 to 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 mcg). The liver is the major site of biotransformation.
Alfentanil has an apparent volume of distribution of 0.4 to 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% 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 to 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 to 200 ng/mL provided adequate anesthesia for superficial surgery.
Alfentanil has an immediate onset of action. At dosages of approximately 105 mcg/kg, alfentanil produces hypnosis as determined by EEG patterns; an anesthetic ED90 of 182 mcg/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 to 245 mcg/kg. For procedures lasting 30 to 60 minutes, loading dosages of up to 50 mcg/kg produce the hemodynamic response to endotracheal intubation and skin incision as comparable to those from fentanyl. A pre-intubation loading dose of 50 to 75 mcg/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 to 3 mcg/kg/min with nitrous oxide/oxygen attenuates sympathetic responses to surgical stress with more rapid recovery than enflurane.
Requirements for volatile inhalation anesthetics were reduced by thirty to fifty percent during the first 60 minutes of maintenance in patients administered anesthetic doses (above 130 mcg/kg) of alfentanil as compared to patients given doses of 4 to 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 induction 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 for 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 mcg/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 ) 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. Decreased oxygen saturation, apnea, decreased respiratory rate, and upper airway obstruction can occur. (See )
Non-Clinical Toxicology
Alfentanil is contraindicated in patients with known hypersensitivity to the drug or known intolerance to other opioid agonists.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 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 alfentanil 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. 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 mcg/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 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 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 betablockers for the treatment of hypertension is recommended.
Drug Interactions:
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.
DELAYED RESPIRATORY DEPRESSION, RESPIRATORY ARREST, BRADYCARDIA, ASYSTOLE, ARRHYTHMIAS AND HYPOTENSION HAVE ALSO BEEN REPORTED. THEREFORE, VITAL SIGNS MUST BE MONITORED CONTINUOUSLY.
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 , , and 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 trials 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.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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