Lidocaine 2% Injection, MDV 50mL 25/Pack

Lidocaine HCl 2% Injection, 25 x 50 mL Multiple-Dose Vials — Camber Pharmaceuticals
Active ingredients Lidocaine hydrochloride 20 mg/mL (2%), 1,000 mg per 50 mL
Dosage form Sterile injectable solution, multiple-dose vial
Route Infiltration and perineural administration for local or regional anesthesia/analgesia
Size 50 mL multiple-dose vial, 25 vials per pack
Manufacturer Camber Pharmaceuticals, Inc.
NDC 31722-217-32
Indications and Usage
Lidocaine hydrochloride injection is indicated in adult and pediatric patients for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and obstetrical procedures.
Dosage and Administration
Dosage varies depending on the procedure, the area to be anesthetized, the depth and duration of anesthesia required, and the patient's individual response. Use the lowest effective dose necessary to produce the desired effect. This 2% formulation is labeled for infiltration and nerve block and is not for caudal or epidural use.
Warnings and Precautions
Dose-related central nervous system and cardiovascular toxicity may occur with excessive systemic exposure.
Avoid inadvertent intravascular administration; aspirate before and periodically during injection.
Risk of methemoglobinemia.
Use caution in patients with hepatic impairment, cardiovascular disease, or other conditions that may increase the risk of systemic toxicity.
This product contains methylparaben as a preservative.
This product is not for caudal or epidural use.
Contraindications
Known hypersensitivity to lidocaine, other amide-type local anesthetics, or any component of the formulation.
Adverse Reactions
Adverse reactions associated with systemic lidocaine exposure may include CNS effects such as lightheadedness, dizziness, drowsiness, nervousness, tremor, tinnitus, confusion, and seizures. Cardiovascular effects may include hypotension, bradycardia, arrhythmias, and cardiovascular collapse. Allergic reactions and methemoglobinemia may also occur.
Storage and Handling
Store at 20°C to 25°C (68°F to 77°F) in accordance with USP Controlled Room Temperature requirements. Protect from light. Do not use if the solution is discolored or contains a precipitate.
How Supplied
Lidocaine HCl Injection, USP 2% is supplied as a sterile, nonpyrogenic solution containing 1,000 mg/50 mL (20 mg/mL) in 50 mL multiple-dose vials, with 25 vials per carton. NDC 31722-217-32.
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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