BUPRENORPHINE HYDROCHLORIDE injection, solution

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

BUPRENORPHINE HYDROCHLORIDE (UNII: 56W8MW3EN1) (Buprenorphine - UNII:40D3SCR4GZ)

थमां उपलब्ध:

Rebel Distributors Corp

INN (इंटरनेशनल नाम):

BUPRENORPHINE HYDROCHLORIDE

रचना:

Buprenorphine 0.3 mg in 1 mL

प्रशासन का मार्ग:

INTRAMUSCULAR

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

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.

उत्पाद समीक्षा:

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

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

उत्पाद विशेषताएं

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