Xylocaine w/ Epinephrine 2% 20mL Injection

NDC: 51662-1506-03

Xylocaine (Lidocaine HCl) 2% with Epinephrine 1:100,000, 20 mL Injection — HealthFirst

Active ingredients	Lidocaine hydrochloride 20 mg/mL (2%), Epinephrine 0.01 mg/mL (1:100,000)
Dosage form	Injection, solution, multiple-dose vial (contains methylparaben 1 mg/mL as preservative)
Route	Perineural, infiltration
Size	20 mL multi-dose vial
Manufacturer	HF Acquisition Co LLC, DBA HealthFirst
NDC	51662-1506-03

Indications and Usage

Indicated for the production of local or regional anesthesia by infiltration techniques and peripheral nerve block techniques, when accepted procedures for these techniques are observed.

Dosage and Administration

Dosage varies by procedure and patient factors. The maximum recommended dose of lidocaine HCl with epinephrine should not exceed 7 mg/kg (3.5 mg/lb) body weight, generally not to exceed 500 mg total. Aspiration should be performed before injection to avoid intravascular administration.

Warnings and Precautions

• Should be employed only by clinicians experienced in the diagnosis and management of dose-related toxicity and related emergencies, with resuscitative equipment immediately available
• Cases of methemoglobinemia have been reported with local anesthetic use; patients with G6PD deficiency, cardiac or pulmonary compromise, infants under 6 months, or concurrent exposure to oxidizing agents are at greater risk. Signs include cyanotic skin discoloration and abnormal blood coloration; seek immediate medical attention if these occur
• Contains sodium metabisulfite, which may cause allergic-type reactions, including anaphylaxis, in susceptible individuals
• Use with caution in patients with hepatic disease, impaired cardiovascular function, or known drug sensitivities

Contraindications

Contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type.

Adverse Reactions

Adverse reactions are generally dose-related and systemic in nature, potentially involving the central nervous system (lightheadedness, dizziness, drowsiness, tremors), cardiovascular system (bradycardia, hypotension), and allergic reactions (cutaneous lesions, urticaria, anaphylactoid reactions).

Storage and Handling

Store at 20°C to 25°C (68°F to 77°F). Protect from light. Do not autoclave (contains epinephrine).

How Supplied

Supplied as a 20 mL multiple-dose glass flip-top vial, red cap.

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.