ALFENTANIL- 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: SEE DOSAGE CHART FOR MORE COMPLETE INFORMATION ON THE USE OF ALFENTANIL HCl INJECTION. Alfentanil is contraindicated in patients with known hypersensitivity to the drug or known intolerance to other opioid agonists. Alfentanil 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.

Product summary:

Alfentanil HCl Injection, USP for intravenous use. Each mL contains: Active: Alfentanil base 500 mcg. Inactives: 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 10 NDC 17478-841-05, 5 mL Ampule in packages of 10 NDC 17478-841-10, 10 mL Ampule in packages of 5 NDC 17478-841-20, 20 mL Ampule in packages of 5 U.S. Patent No. 4,167,574 May 1995, November 1995 PREMIERProRx® Manufactured by: Akorn, Inc. Lake Forest, IL 60045 PremierProRx® is a registered trademark of Premier Inc., used under license. PAFA0N     Rev. 10/15

Authorization status:

New Drug Application

Summary of Product characteristics

ALFENTANIL- ALFENTANIL HYDROCHLORIDE INJECTION
AKORN, INC.
----------
ALFENTANIL HCL
INJECTION, USP
CII
RX ONLY
DESCRIPTION
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:
ACTIVE: Alfentanil base 500 mcg. INACTIVES: Sodium Chloride 9 mg and
Water for Injection q.s.
CLINICAL 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