alfenta- 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:

TAYLOR PHARMACEUTICALS

INN (International Name):

Alfentanil Hydrochloride

Pharmaceutical form:

INJECTION

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

ALFENTA (alfentanil hydrochloride) is indicated: SEE DOSAGE CHART FOR MORE COMPLETE INFORMATION ON THE USE OF ALFENTA. ALFENTA (alfentanil hydrochloride) is contraindicated in patients with known hypersensitivity to the drug or known intolerance to other opioid agonists. ALFENTA (alfentanil hydrochloride) 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. ALFENTA should be handled accordingly.

Product summary:

ALFENTA (alfentanil hydrochloride) Injection for intravenous use. Each mL Contains: Active: Alfentanil base 500 mcg. Inactives: Sodium Chloride 9 mg and WFI Q.S ALFENTA Injection is available as: NDC 11098-060-02, 2 mL Ampule in packages of 10 NDC 11098-060-05, 5 mL Ampule in packages of 10 NDC 11098-060-10, 10 mL Ampule in packages of 5 NDC 11098-060-20, 20 mL Ampule in packages of 5

Summary of Product characteristics

ALFENTA- ALFENTANIL HYDROCHLORIDE INJECTION
TAYLOR PHARMACEUTICALS
----------
ALFENTA
CII
RX ONLY
DESCRIPTION
ALFENTA (alfentanil hydrochloride) 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 and an n-octanol:water
partition coefficient of 128:1 at pH 7.4. The structural formula of
ALFENTA is:
ALFENTA 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 4-6.
Each mL contains: ACTIVE:
Alfentanil base 500 mcg. INACTIVE: Sodium Chloride 9 mg and Water for
Injection Q.S.
CLINICAL PHARMACOLOGY
ALFENTA (alfentanil hydrochloride) is an opioid analgesic with a rapid
onset of action.
At doses of 8-40 mcg/kg for surgical procedures lasting up to 30
minutes, ALFENTA 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 50-75 mcg/kg followed
by a continuous infusion of 0.5-3 mcg/kg/min, ALFENTA 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, ALFENTA 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 ALFENTA has been reported.
The pharmacokinetics of ALFENTA can be described as a
three-compartment model with sequential
d