BUPIVACAINE HYDROCHLORIDE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Steriscience Specialties Private Limited

Administration route:

INFILTRATION

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Bupivacaine hydrochloride injection is indicated in adults for the production of local or regional anesthesia or analgesia for surgery and 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) ]. During epidural administration, administer bupivacaine hydrochloride injection slowly, with frequent aspirations before and during the injection to avoid intravascular injection. Perform syringe aspirations before and during each supplemental injection in continuous (inter

Product summary:

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.] Protect from light. This product is clear and colorless. Do not use the solution if it is discolored or if it contains a precipitate.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BUPIVACAINE HYDROCHLORIDE- BUPIVACAINE HYDROCHLORIDE INJECTION,
SOLUTION
STERISCIENCE SPECIALTIES PRIVATE LIMITED
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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
INDICATIONS AND USAGE
Bupivacaine hydrochloride injection contains bupivacaine, an amide
local anesthetic. Bupivacaine
hydrochloride injection is indicated in adults for the production of
local or regional anesthesia or analgesia
for surgery and 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) (1)
Limitations of Use (1)
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) (1)
DOSAGE AND ADMINISTRATION
• Not for intrathecal use. (2.1)
• Avoid use of solutions containing antimicrobial preservatives
(i.e., multiple-dose vials) for epidural or
caudal anesthesia. (2.1, 5.4)
• See full prescribing information for:
- Recommended concentrations and dosages of bupivacaine hydrochloride
injection according to type of
block. (2.2)
- Additional dosage and administration information pertaining to use
in epidural anesthesia and use in
ophthalmic surgery. (2.3, 2.4, 2.5) (2)
DOSAGE FORMS AND STRENGTHS
Bupivacaine hydrochloride injection is available in multiple
concentrations. See full prescribing information
for detailed description of each formulation. (3) (5)
CONTRAINDICATIONS
• Obstetrical paracervical block anesthesia. Its use in this
technique has resulted in fetal bradycardia and
death. (4)
• Intravenous regiona