BUPIVACAINE HYDROCHLORIDE injection, solution

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

BUPIVACAINE HYDROCHLORIDE (UNII: 7TQO7W3VT8) (BUPIVACAINE - UNII:Y8335394RO)

Beszerezhető a:

Eugia US LLC

Az alkalmazás módja:

INFILTRATION

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

Bupivacaine hydrochloride injection is indicated in adults for the production of local or regional anesthesia or analgesia for surgery, oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of bupivacaine hydrochloride injection are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration (2.2) ]. Limitations of Use Not all blocks are indicated for use with bupivacaine hydrochloride injection given clinically significant risks associated with use [see Dosage and Administration (2.2) , Contraindications (4) , Warnings and Precautions (5.1 , 5.4 , 5.5 , 5.7 , 5.9 )] . Bupivacaine hydrochloride is contraindicated in: - obstetrical paracervical block anesthesia. Its use in this technique has resulted in fetal bradycardia and death. - intravenous regional anesthesia (Bier Block) [see Warnings and Precautions (5.7)] . - patients with

Termék összefoglaló:

Bupivacaine hydrochloride injection, USP is a clear, colorless, sterile isotonic solution and is available as follows: Solutions of bupivacaine hydrochloride injection, USP may be autoclaved. Autoclave at 15-pound pressure, 121°C (250°F) for 15 minutes. Protect from light. This product is clear and colorless. Do not use the solution if it is discolored or if it contains a precipitate. 0.25% (2.5 mg/mL): 10 mL Single-Dose Vials in a Carton of 25                                                                                             NDC 55150-167-10 30 mL Single-Dose Vials in a Carton of 25                                                                                             NDC 55150-168-30 0.5% (5 mg/mL): 10 mL Single-Dose Vials in a Carton of 25                                                                                             NDC 55150-169-10                                                                30 mL Single-Dose Vials in a Carton of 25                                                                                             NDC 55150-170-30 0.75% (7.5 mg/mL): 10 mL Single-Dose Vials in a Carton of 25                                                                                             NDC 55150-171-10 30 mL Single-Dose Vials in a Carton of 25                                                                                             NDC 55150-172-30 For single-dose vials: Discard unused portion. 0.25% (2.5 mg/mL):   50 mL Multiple-Dose Vials in a Carton of 25                                                                                             NDC 55150-249-50 0.5% (5 mg/mL): 50 mL Multiple-Dose Vials in a Carton of 25                                                                                             NDC 55150-250-50 Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. The vial stopper is not made with natural rubber latex.

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

BUPIVACAINE HYDROCHLORIDE - BUPIVACAINE HYDROCHLORIDE INJECTION,
SOLUTION
EUGIA US LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BUPIVACAINE
HYDROCHLORIDE INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
BUPIVACAINE HYDROCHLORIDE INJECTION.
BUPIVACAINE HYDROCHLORIDE INJECTION, FOR INFILTRATION, PERINEURAL,
CAUDAL, EPIDURAL, OR
RETROBULBAR USE
INITIAL U.S. APPROVAL: 1972
WARNING: RISK OF CARDIAC ARREST WITH USE OF BUPIVACAINE HYDROCHLORIDE
IN
OBSTETRICAL ANESTHESIA
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
THERE HAVE BEEN REPORTS OF CARDIAC ARREST WITH DIFFICULT RESUSCITATION
OR DEATH DURING
USE OF BUPIVACAINE HYDROCHLORIDE FOR EPIDURAL ANESTHESIA IN
OBSTETRICAL PATIENTS. IN
MOST CASES, THIS HAS FOLLOWED USE OF THE 0.75% (7.5 MG/ML)
CONCENTRATION.
RESUSCITATION HAS BEEN DIFFICULT OR IMPOSSIBLE DESPITE APPARENTLY
ADEQUATE
PREPARATION AND APPROPRIATE MANAGEMENT.
CARDIAC ARREST HAS OCCURRED AFTER CONVULSIONS RESULTING FROM SYSTEMIC
TOXICITY,
PRESUMABLY FOLLOWING UNINTENTIONAL INTRAVASCULAR INJECTION. THE 0.75%
(7.5 MG/ML)
CONCENTRATION OF BUPIVACAINE HYDROCHLORIDE IS NOT RECOMMENDED FOR
OBSTETRICAL
ANESTHESIA AND SHOULD BE RESERVED FOR SURGICAL PROCEDURES WHERE A HIGH
DEGREE OF
MUSCLE RELAXATION AND PROLONGED EFFECT ARE NECESSARY (5.1).
INDICATIONS AND USAGE
Bupivacaine hydrochloride injection contains bupivacaine
hydrochloride, an amide local anesthetic
indicated in adults for the production of local or regional anesthesia
or analgesia for surgery, oral surgery
procedures, diagnostic and therapeutic procedures, and for obstetrical
procedures. For each type of block
indicated to produce local or regional anesthesia or analgesia,
specific concentrations and presentations
are recommended. (1, 2.2)
Limitations of Use
Not all blocks are indicated for use with bupivacaine hydrochloride
injection given clinically significant risks
associated with use. (1, 2.2, 4, 5.1, 5.4, 5.5, 5.7, 5.9)
DOSAGE AND ADMINISTRA