Lidocaine 2% Injection, MDV 50mL 25/Pack

Lidocaine HCl 2% Injection, 25 x 50 mL Multiple-Dose Vials — Camber Pharmaceuticals

NDC: 31722-217-32

Product Details

Active Ingredient	Lidocaine hydrochloride 20 mg/mL (2%); 1,000 mg per 50 mL vial
Dosage Form	Sterile injectable solution, multiple-dose vial
Route	Infiltration and perineural administration for local or regional anesthesia/analgesia
Package Size	50 mL per vial; 25 vials per pack
Manufacturer	Camber Pharmaceuticals, Inc.
NDC	31722-217-32

Indications and Usage

Lidocaine hydrochloride injection is indicated in adults 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, in accordance with the approved product labeling.

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. Refer to the full prescribing information for specific dosing recommendations and maximum dosage limits.

Warnings and Precautions

• Systemic toxicity: Excessive systemic exposure may cause dose-related central nervous system and cardiovascular toxicity.
• Intravascular injection: Avoid inadvertent intravascular administration. Aspirate before and periodically during injection, as appropriate.
• Methemoglobinemia: Lidocaine may cause methemoglobinemia.
• Use in at-risk patients: Exercise caution in patients with hepatic impairment, cardiovascular disease, or other conditions that may increase the risk of systemic toxicity.
• Preservative: This product contains methylparaben.
• Administration restriction: This product is not for caudal or epidural use.

Contraindications

Contraindicated in patients with 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 central nervous system 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

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Professional use only.

Clinical information is summarized from FDA-approved prescribing information (Structured Product Labeling). Refer to the full prescribing information via DailyMed for complete details.

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