Bupivacaine, VL PF 0.75% 10mL (25/PK)

NDC: 00409-1165-01

Bupivacaine Hydrochloride Injection USP, 0.75% (7.5 mg/mL), 10 mL Single-Dose Vial (25/Pack) — Pfizer

Active ingredients	Bupivacaine hydrochloride 0.75% (7.5 mg/mL)
Dosage form	Sterile injectable solution, preservative-free
Route	Retrobulbar block, epidural, or local/regional nerve block injection
Size	10 mL single-dose vial, 25 vials per carton
Manufacturer	Pfizer

Indications and Usage

Production of local or regional anesthesia for surgery and other procedures, including retrobulbar block for ophthalmic surgery.

Dosage and Administration

For retrobulbar block, administer 2 to 4 mL (15 to 30 mg). Dose varies with the procedure, tissue vascularity, and patient status; use the lowest effective dose and aspirate before injection to avoid intravascular administration. Do not exceed a total daily dose of 400 mg.

Warnings and Precautions

• The 0.75% concentration has been associated with cardiac arrest and death in obstetrical epidural anesthesia and is not recommended for that use
• Contraindicated for intravenous regional anesthesia (Bier block) due to reports of cardiac arrest
• Respiratory arrest has been reported following retrobulbar block; resuscitative equipment and personnel should be immediately available

Contraindications

Contraindicated for obstetrical paracervical block, intravenous regional anesthesia (Bier block), and in patients hypersensitive to bupivacaine or other amide-type local anesthetics.

Adverse Reactions

CNS effects such as restlessness, dizziness, tremors, and seizures; cardiovascular effects including hypotension, bradycardia, and arrhythmias progressing to cardiac arrest; allergic reactions and methemoglobinemia may also occur.

Storage and Handling

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from light. Discard unused portion after initial use.

How Supplied

Preservative-free, sterile, nonpyrogenic solution in a 10 mL single-dose vial, 25 vials per carton.

Professional use only. Clinical information summarized from FDA-approved prescribing information (Structured Product Labeling); refer to the full prescribing information via DailyMed for complete details.

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