Lidocaine 1% Injection MDV 20mL 10/Pack

Lidocaine HCl 1% Injection, 10 x 20 mL Multiple-Dose Vials — Camber Pharmaceuticals

NDC: 31722-116-32

Product Details

Active Ingredient	Lidocaine hydrochloride 10 mg/mL (1%); 200 mg per 20 mL vial
Dosage Form	Sterile injectable solution, multiple-dose vial
Route	Infiltration and perineural administration for local or regional anesthesia/analgesia, as directed by the prescribing information
Package Size	20 mL per vial; 10 vials per pack
Manufacturer	Camber Pharmaceuticals, Inc.
NDC	31722-116-32

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.

Dosage and Administration

Dosage varies according to the procedure, area to be anesthetized, depth and duration of anesthesia required, and the patient's individual response. Use the lowest effective dose necessary to achieve the desired effect. Refer to the full prescribing information for specific dosing recommendations and maximum dosage limits.

Warnings and Precautions

• Administer only by clinicians experienced in local anesthetic use and the management of local anesthetic toxicity.
• Avoid inadvertent intravascular administration. Perform aspiration before and periodically during injection, as appropriate.
• Toxic blood concentrations may cause central nervous system and cardiovascular effects.
• Lidocaine may cause methemoglobinemia.
• Multiple-dose vials contain methylparaben as an antimicrobial preservative.

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 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. 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.

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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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