Pajjiż: Stati Uniti
Lingwa: Ingliż
Sors: NLM (National Library of Medicine)
BUPRENORPHINE HYDROCHLORIDE (UNII: 56W8MW3EN1) (Buprenorphine - UNII:40D3SCR4GZ)
Rebel Distributors Corp
BUPRENORPHINE HYDROCHLORIDE
Buprenorphine 0.3 mg in 1 mL
INTRAMUSCULAR
PRESCRIPTION DRUG
Buprenorphine hydrochloride injection is indicated for the relief of moderate to severe pain. Buprenorphine hydrochloride is a partial agonist of the morphine type: i.e., it has certain opioid properties which may lead to psychic dependence of the morphine type due to an opiate-like euphoric component of the drug. Direct dependence studies have shown little physical dependence upon withdrawal of the drug. However, caution should be used in prescribing to individuals who are known to be drug abusers or ex-narcotic addicts. The drug may not substitute in acutely dependent narcotic addicts due to its antagonist component and may induce withdrawal symptoms.
List Container Concentration Fill Quantity 2012 Carpuject® 0.3 mg base/mL 1 mL 10 (22-Gauge, 1¼" Needle) 2012 Carpuject® 0.3 mg base/mL 1 mL 10 with Luer Lock Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature.] Protect from prolonged exposure to light. Retain in carton until time of use. Do not freeze. Revised: June, 2009 Printed in USA EN-2088 Hospira, Inc., Lake Forest, IL 60045, USA Repackaged by: Rebel Distributors Corp, Thousand Oaks, CA 91320
Abbreviated New Drug Application
BUPRENORPHINE HYDROCHLORIDE- BUPRENORPHINE HYDROCHLORIDE INJECTION, SOLUTION REBEL DISTRIBUTORS CORP ---------- BUPRENORPHINE HYDROCHLORIDE INJECTION CIII R only DESCRIPTION Buprenorphine hydrochloride is a narcotic under the Controlled Substances Act due to its chemical derivation from thebaine. Chemically, it is 17-(cyclopropylmethyl)-α-(1,1-dimethylethyl)-4,5-epoxy- 18,19-dihydro-3-hydroxy-6-methoxy-α-methyl-6,14-ethenomorphinan-7-methanol, hydrochloride [5α, 7α(S)]. Buprenorphine hydrochloride is a white powder, weakly acidic and with limited solubility in water. Buprenorphine hydrochloride injection is a clear, sterile, injectable agonist-antagonist analgesic intended for intravenous or intramuscular administration. Each mL of buprenorphine hydrochloride injection contains 0.324 mg buprenorphine hydrochloride (equivalent to 0.3 mg buprenorphine), 50 mg anhydrous dextrose, water for injection, and HCl to adjust pH to 3.5 to 5.5. Buprenorphine hydrochloride has the molecular formula, C H NO ·HCl and the molecular weight of 504.09. It has the following structural formula: CLINICAL PHARMACOLOGY Buprenorphine hydrochloride is a parenteral opioid analgesic with 0.3 mg buprenorphine being approximately equivalent to 10 mg morphine sulfate in analgesic and respiratory depressant effects in adults. Pharmacological effects occur as soon as 15 minutes after intramuscular injection and persist for 6 hours or longer. Peak pharmacologic effects usually are observed at 1 hour. When used intravenously, the times to onset and peak effect are shortened. The limits of sensitivity of available analytical methodology precluded demonstration of bioequivalence between intramuscular and intravenous routes of administration. In postoperative adults, pharmacokinetic studies have shown elimination half-lives ranging from 1.2 to 7.2 hours (mean 2.2 x 29 41 4 hours) after intravenous administration of 0.3 mg of buprenorphine. A single, ten-patient, pharmacokinetic study of doses of 3 mcg/kg in children (age 5 to 7 years) showed a h Aqra d-dokument sħiħ