Země: Spojené státy
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
fentanyl citrate (UNII: MUN5LYG46H) (fentanyl - UNII:UF599785JZ)
Taylor Pharmaceuticals
fentanyl citrate
INJECTION, SOLUTION
INTRAVENOUS
PRESCRIPTION DRUG
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.
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.
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 Přečtěte si celý dokument