sublimaze- fentanyl citrate injection, solution

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

fentanyl citrate (UNII: MUN5LYG46H) (fentanyl - UNII:UF599785JZ)

Dostupné z:

Taylor Pharmaceuticals

INN (Medzinárodný Name):

fentanyl citrate

Forma lieku:

INJECTION, SOLUTION

Spôsob podávania:

INTRAVENOUS

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

SUBLIMAZE (fentanyl citrate) is indicated: SUBLIMAZE (fentanyl citrate) is contraindicated in patients with known intolerance to the drug or other opioid agonists. SUBLIMAZE (fentanyl citrate) is a Schedule II controlled drug substance that can produce drug dependence of the morphine type and therefore has the potential for being abused.

Prehľad produktov:

SUBLIMAZE (fentanyl citrate) Injection is available as: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. PROTECT FROM LIGHT.

Súhrn charakteristických

SUBLIMAZE- FENTANYL CITRATE INJECTION, SOLUTION
TAYLOR PHARMACEUTICALS
----------
SUBLIMAZE INJECTION CII
CII
RX ONLY
DESCRIPTION
SUBLIMAZE (fentanyl citrate) Injection is a potent narcotic analgesic.
Each milliliter of solution
contains fentanyl citrate equivalent to 50 mcg of fentanyl base,
adjusted to pH 4.0 to 7.5 with sodium
hydroxide. SUBLIMAZE is chemically identified as
N-(1-phenethyl-4-piperidyl) propionanilide citrate
(1:1) with a molecular weight of 528.60. The empirical formula is C
H N O • C H O . The
structural formula of SUBLIMAZE is:
SUBLIMAZE is a sterile, non-pyrogenic, preservative free aqueous
solution for intravenous or
intramuscular injection.
CLINICAL PHARMACOLOGY
SUBLIMAZE (fentanyl citrate) is a narcotic analgesic. A dose of 100
mcg (0.1 mg) (2.0 ml) is
approximately equivalent in analgesic activity to 10 mg of morphine or
75 mg of meperidine. The
principal actions of therapeutic value are analgesia and sedation.
Alterations in respiratory rate and
alveolar ventilation, associated with narcotic analgesics, may last
longer than the analgesic effect. As
the dose of narcotic is increased, the decrease in pulmonary exchange
becomes greater. Large doses
may produce apnea. SUBLIMAZE appears to have less emetic activity than
either morphine or
meperidine. Histamine assays and skin wheal testing in man indicate
that clinically significant histamine
release rarely occurs with SUBLIMAZE. Recent assays in man show no
clinically significant histamine
release in dosages up to 50 mcg/kg (0.05 mg/kg) (1 ml/kg). SUBLIMAZE
preserves cardiac stability,
and blunts stress-related hormonal changes at higher doses.
The pharmacokinetics of SUBLIMAZE can be described as a
three-compartment model, with a
distribution time of 1.7 minutes, redistribution of 13 minutes and a
terminal elimination half-life of 219
minutes. The volume of distribution for SUBLIMAZE is 4 L/kg.
SUBLIMAZE plasma protein binding capacity decreases with increasing
ionization of the drug.
Alterations in pH may affect its distribution betwee