ALFENTANIL HYDROCHLORIDE injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Alfentanil Hydrochloride (UNII: 11S92G0TIW) (Alfentanil - UNII:1N74HM2BS7)

Available from:

Akorn

INN (International Name):

Alfentanil Hydrochloride

Composition:

Alfentanil 500 ug in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Alfentanil HCl 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). Alfentanil HCl Injection is contraindicated in patients with: - Hypersensitivity to alfentanil (e.g., anaphylaxis) [see Adverse Reactions (6)] Risk Summary 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. In animal reproduction studies, alfentanil reduced pup birth weights and increased pup mortality when administered to pregnant rats during gestation and throughout lactation at 9 times the human dose of 335 mcg/kg per procedure. Alfentanil was embryocidal when administered to pregnant rabbits during organogenesis at 72.6 times the human dose of 335 mcg/kg per procedure. No malformations were noted in rats or rabbits treated with alfentanil during organogenesis [see Data]. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Prolonged use of opioid analgesics during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth. Neonatal opioid withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea and failure to gain weight. The onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on the specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination of the drug by the newborn. Observe newborns for symptoms of neonatal opioid withdrawal syndrome and manage accordingly [see Warnings and Precautions (5.3)]. Labor or Delivery Opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates. An opioid antagonist, such as naloxone, must be available for reversal of opioid-induced respiratory depression in the neonate. Alfentanil HCl Injection is not recommended for use in pregnant women during or immediately prior to labor, when other analgesic techniques are more appropriate. Opioid analgesics, including Alfentanil HCl Injection, can prolong labor through actions which temporarily reduce the strength, duration, and frequency of uterine contractions. However, this effect is not consistent and may be offset by an increased rate of cervical dilation, which tends to shorten labor. Monitor neonates exposed to opioid analgesics during labor for signs of excess sedation and respiratory depression. Data Animal Data Pregnant rats were treated with intravenous alfentanil doses of 0.08, 0.31, or 1.25 mg/kg/day (2.3, 9, or 36.6 times the human total dose of 335 mcg/kg based on body surface area, respectively). No malformations or embryotoxic effects were noted despite maternal toxicity (increased mortality in the mid- and high-dose group). Pregnant rabbits were treated with intravenous alfentanil doses of 0.08, 0.31, or 1.25 mg/kg/day (4.6, 18, or 72.6 times the human total dose of 335 mcg/kg based on body surface area, respectively). Decreased live fetuses per litter and decreased litter size in the high dose group were noted in the presence of maternal toxicity (decreased body weight gain and mortality in the high-dose group). No evidence of malformations or adverse effects on the fetus was reported in a published study in which pregnant rats were administered 8 mg/kg/day alfentanil (232 times the human dose of 335 mcg/kg/day based on body surface area) continuously from Gestation Day 5 through Gestation Day 20 via subcutaneously implanted osmotic minipumps. Pregnant rats were treated intravenously with alfentanil 0.08, 0.31, or 1.25 mg/kg/day (2.3, 9, or 36.6 times the human total dose of 335 mcg/day based on body surface area, respectively) during gestation and throughout lactation. Reduced birth weights and decreased pup survival were noted in the mid- and high-dose groups in the presence of maternal toxicity (increased mortality in the mid- and high-dose groups). Risk Summary The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Alfentanil HCl Injection and any potential adverse effects on the breastfed infant from Alfentanil HCl Injection or from the underlying maternal condition. Clinical Considerations Infants exposed to Alfentanil HCl Injection through breast milk should be monitored for excess sedation and respiratory depression. Withdrawal symptoms can occur in breastfed infants when maternal administration of an opioid analgesic is stopped, or when breast- feeding is stopped. Infertility Chronic use of opioids may cause reduced fertility in females and males of reproductive potential. It is not known whether these effects on fertility are reversible [see Adverse Reactions (6.2)]. Adequate data to support the use of Alfentanil HCl Injection in children under the age of 12 years of age are not presently available. 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. The initial dose of Alfentanil HCl Injection should be appropriately reduced in elderly. Patients over the age of 65 have been found to have reduced plasma clearance and extended terminal elimination which may prolong postoperative recovery. Elderly patients (aged 65 years or older) may have increased sensitivity to alfentanil. In general, use caution when selecting a dosage for an elderly patient, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy. Respiratory depression is the chief risk for elderly patients treated with opioids, and has occurred after large initial doses were administered to patients who were not opioid-tolerant or when opioids were co-administered with other agents that depress respiration. Titrate the dosage of Alfentanil HCl Injection slowly in geriatric patients [see Warnings and Precautions (5.6)]. This drug is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. Alfentanil HCl Injection should be administered with caution patients with liver dysfunction because of the extensive hepatic metabolism. Reduce the dosage as needed and monitor closely for signs of respiratory depression, sedation, and hypotension. Alfentanil HCl Injection should be administered with caution to patients with kidney dysfunction because of the renal excretion of alfentanil HCl and its metabolites. Reduce the dosage as needed and monitor for signs of respiratory depression, sedation, and hypotension. Alfentanil HCl Injection 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. Alfentanil HCl Injection contains alfentanil, a Schedule II controlled substance. Alfentanil HCl Injection contains alfentanil, a substance with a high potential for abuse similar to other opioids including morphine, sufentanil etc. Alfentanil HCl Injection can be abused and is subject to misuse, addiction, and criminal diversion [see Warnings and Precautions (5.1)]. Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that develop after repeated substance use and includes: a strong desire to take the drug, difficulties in controlling its use, persisting in its use despite harmful consequences, a higher priority given to drug use than to other activities and obligations, increased tolerance, and sometimes a physical withdrawal. Alfentanil HCl Injection, like other opioids, can be diverted for non-medical use into illicit channels of distribution. Careful record-keeping of prescribing information, including quantity, frequency, and renewal requests, as required by state and federal law, is strongly advised. Proper assessment of the patient, proper prescribing practices, periodic re-evaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs. Risks Specific to Abuse of Sufentanil Citrate Injection Abuse of Sufentanil Citrate Injection poses a risk of overdose and death. The risk is increased with concurrent use of Sufentanil Citrate Injection with alcohol and other central nervous system depressants. Parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and HIV. Both tolerance and physical dependence can develop during chronic opioid therapy. Tolerance is the need for increasing doses of opioids to maintain a defined effect such as analgesia (in the absence of disease progression or other external factors). Tolerance may occur to both the desired and undesired effects of drugs, and may develop at different rates for different effects. Physical dependence results in withdrawal symptoms after abrupt discontinuation or a significant dosage reduction of a drug. Withdrawal also may be precipitated through the administration of drugs with opioid antagonist activity (e.g., naloxone, nalmefene), mixed agonist/ antagonist analgesics (pentazocine, butorphanol, nalbuphine), or partial agonists (buprenorphine). Physical dependence may not occur to a clinically significant degree until after several days to weeks of continued opioid usage. Alfentanil HCl Injection should not be abruptly discontinued [see Dosage and Administration (2.13)] . If Alfentanil HCl Injection is abruptly discontinued in a physically-dependent patient, a withdrawal syndrome may occur. Some or all of the following can characterize this syndrome: restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, and mydriasis. Other signs and symptoms also may develop, including: irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate. Infants born to mothers physically dependent on opioids will also be physically dependent and may exhibit respiratory difficulties and withdrawal signs [see Use in Specific Populations (8.1)].

Product summary:

Alfentanil HCl Injection, USP for intravenous use is a sterile, aqueous, preservative free solution. Each mL contains: Active: Alfentanil base 500 mcg. Inactives: Sodium Chloride 9 mg and WFI q.s. Alfentanil HCl Injection, USP available as: NDC 17478-067-02, 2 mL Ampule in packages of 10 NDC 17478-067-05, 5 mL Ampule in packages of 10 NDC 17478-067-10, 10 mL Ampule in packages of 5 NDC 17478-067-20, 20 mL Ampule in packages of 5 Alfentanil HCl 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. Storage: Store at 20° to 25°C (68 to 77°F). [See USP Controlled Room Temperature]. Protect from light. AKORN Distributed by: Akorn Operating Company LLC Gurnee, IL 60031 AFA0N Rev. 05/22

Authorization status:

New Drug Application

Summary of Product characteristics

ALFENTANIL HYDROCHLORIDE- ALFENTANIL HYDROCHLORIDE INJECTION
AKORN
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ALFENTANIL HCL
INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
ALFENTANIL HCL
INJECTION.
ALFENTANIL HCL INJECTION, FOR INTRAVENOUS USE, CII
INITIAL U.S. APPROVAL: 1986
WARNING: ADDICTION, ABUSE, AND MISUSE
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
ALFENTANIL HCL INJECTION EXPOSES USERS TO RISKS OF ADDICTION, ABUSE,
AND MISUSE,
WHICH CAN LEAD TO OVERDOSE AND DEATH. ASSESS PATIENT'S RISK BEFORE
PRESCRIBING AND
MONITOR CLOSELY FOR THESE BEHAVIORS AND CONDITIONS. (5.1)
RECENT MAJOR CHANGES
Warnings and Precautions (5.2)
10/2019
INDICATIONS AND USAGE
Alfentanil HCl Injection is an opioid 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) (1)
DOSAGE AND 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 (2.1).
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. (2.1)
Doses of Alfentanil HCl Injection vary depending on circumstances (see
dosing chart, 2.2.)
Reduce the dose of Alfentanil HCl Injection in elderly, debilitated
and obese patients. (2.4, 2.5)
Reduce the do