ALFENTANIL HYDROCHLORIDE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ALFENTANIL HYDROCHLORIDE (UNII: 11S92G0TIW) (ALFENTANIL - UNII:1N74HM2BS7)

Available from:

Hospira, Inc.

INN (International Name):

ALFENTANIL HYDROCHLORIDE

Composition:

ALFENTANIL 500 ug in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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). Alfentanil 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 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 w

Product summary:

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

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ALFENTANIL HYDROCHLORIDE- ALFENTANIL HYDROCHLORIDE INJECTION, SOLUTION
HOSPIRA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ALFENTANIL INJECTION SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ALFENTANIL
INJECTION.
ALFENTANIL INJECTION, USP (ALFENTANIL HYDROCHLORIDE) FOR INTRAVENOUS
USE, CII
INITIAL U.S. APPROVAL: 1986
WARNING: ADDICTION, ABUSE, AND MISUSE
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
ALFENTANIL 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)
INDICATIONS AND USAGE
Alfentanil injection is an opioid indicated:
as an analgesic adjunct given in incremental doses in the maintenance
of anesthesia with barbiturate/nitrous
oxide /oxyge n.
as an analgesic administered by continuous infusion with nitrous
oxide/oxygen in the maintenance of general
ane sthe sia.
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 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 injection vary depending on circumstances .(see
dosing chart 2.2)
Reduce the dose of alfentanil injection in elderly, debilitated and
obese patients. (2.4, 2.5)
Reduce the dose of alfentanil injection when admin