Lidocaine 1% Injection MDV 20mL 10/Pack

Lidocaine HCl 1% Injection, 10 x 20 mL Multiple-Dose Vials — Camber Pharmaceuticals
Active ingredients Lidocaine hydrochloride 10 mg/mL (1%), 200 mg per 20 mL
Dosage form Sterile injectable solution, multiple-dose vial
Route Infiltration and perineural administration for local or regional anesthesia/analgesia
Size 20 mL multiple-dose vial, 10 vials per pack
Manufacturer Camber Pharmaceuticals, Inc.
NDC 31722-116-32
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. For specific dosing recommendations and maximum dosage limits, refer to the full prescribing information.
Warnings and Precautions
Should be administered by clinicians experienced in the use of local anesthetics and management of local anesthetic toxicity.
Avoid inadvertent intravascular administration; aspiration should be performed before and periodically during injection.
Toxic blood concentrations can cause central nervous system and cardiovascular effects.
Risk of methemoglobinemia.
Multiple-dose vials contain methylparaben as an antimicrobial preservative.
Contraindications
Known hypersensitivity to lidocaine or other amide-type local anesthetics, or to any component of the formulation.
Adverse Reactions
Adverse reactions associated with systemic lidocaine exposure may include CNS effects such as dizziness, tremor, drowsiness, confusion, seizures, and respiratory depression. Cardiovascular effects may include hypotension, bradycardia, arrhythmias, and cardiovascular collapse. Allergic-type reactions are uncommon but may occur.
Storage and Handling
Store at 20°C to 25°C (68°F to 77°F), with permitted excursions in accordance with USP Controlled Room Temperature requirements. Protect from excessive heat. Inspect the solution before use and do not use if discolored or if a precipitate is present.
How Supplied
Sterile, nonpyrogenic Lidocaine HCl Injection, USP 200 mg/20 mL (10 mg/mL) supplied in 20 mL multiple-dose vials, with 10 vials per carton. NDC 31722-116-32.
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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