sufenta- sufentanil citrate solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

sufentanil citrate (UNII: S9ZFX8403R) (sufentanil - UNII:AFE2YW0IIZ)

Available from:

Taylor Pharmaceuticals

INN (International Name):

sufentanil citrate

Pharmaceutical form:

SOLUTION

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

SUFENTA (sufentanil citrate) is indicated for intravenous administration in adults and pediatric patients: as an analgesic adjunct in the maintenance of balanced general anesthesia in patients who are intubated and ventilated. as a primary anesthetic agent for the induction and maintenance of anesthesia with 100% oxygen in patients undergoing major surgical procedures, in patients who are intubated and ventilated, such as cardiovascular surgery or neurosurgical procedures in the sitting position, to provide favorable myocardial and cerebral oxygen balance or when extended postoperative ventilation is anticipated. SUFENTA (sufentanil citrate) is indicated for epidural administration as an analgesic combined with low dose bupivacaine, usually 12.5 mg per administration, during labor and vaginal delivery. SEE DOSAGE AND ADMINISTRATION SECTION FOR MORE COMPLETE INFORMATION ON THE USE OF SUFENTA. SUFENTA is contraindicated in patients with known hypersensitivity to the drug or known intolerance to other opioid ago

Product summary:

SUFENTA (Sufentanil Citrate Injection, USP) is supplied as a sterile aqueous preservative-free solution for intravenous and epidural use as: NDC 11098-050-01 50 mcg/mL sufentanil base, 1 mL ampules in packages of 10 NDC 11098-050-02 50 mcg/mL sufentanil base, 2 mL ampules in packages of 10 NDC 11098-050-05 50 mcg/mL sufentanil base, 5 mL ampules in packages of 10 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. PROTECT FROM LIGHT.

Summary of Product characteristics

SUFENTA- SUFENTANIL CITRATE SOLUTION
TAYLOR PHARMACEUTICALS
----------
SUFENTA® (SUFENTANIL CITRATE INJECTION, USP)
CII
50 mcg/mL Sufentanil base
RX ONLY
DESCRIPTION
SUFENTA (sufentanil citrate) is a potent opioid analgesic chemically
designated as N-[4-
(methyoxymethyl)-1-[2-(2-thienyl)ethyl]-4-piperidinyl]-N-phenylpropanamide:2-hydroxy-1,2,3-
propanetricarboxylate (1:1) with a molecular weight of 578.68. The
structural formula of SUFENTA is:
SUFENTA is a sterile, preservative free, aqueous solution containing
sufentanil citrate equivalent to 50
mcg per mL of sufentanil base for intravenous and epidural injection.
The solution has a pH range of 3.5
to 6.0.
CLINICAL PHARMACOLOGY
PHARMACOLOGY
SUFENTA is an opioid analgesic. When used in balanced general
anesthesia, SUFENTA has been
reported to be as much as 10 times as potent as fentanyl. When
administered intravenously as a primary
anesthetic agent with 100% oxygen, SUFENTA is approximately 5 to 7
times as potent as fentanyl.
Assays of histamine in patients administered SUFENTA have shown no
elevation in plasma histamine
levels and no indication of histamine release.
(See dosage chart for more complete information on the intravenous use
of SUFENTA.)
PHARMACODYNAMICS
Intravenous use
At intravenous doses of up to 8 mcg/kg, SUFENTA is an analgesic
component of general anesthesia; at
intravenous doses ≥8 mcg/kg, SUFENTA produces a deep level of
anesthesia. SUFENTA produces a
dose related attenuation of catecholamine release, particularly
norepinephrine.
At intravenous dosages of ≥8 mcg/kg, SUFENTA produces hypnosis and
anesthesia without the use of
additional anesthetic agents. A deep level of anesthesia is maintained
at these dosages, as demonstrated
®
additional anesthetic agents. A deep level of anesthesia is maintained
at these dosages, as demonstrated
by EEG patterns. Dosages of up to 25 mcg/kg attenuate the sympathetic
response to surgical stress. The
catecholamine response, particularly norepinephrine, is further
attenuated at doses of SUFENTA of 25
to 3