Lidocaine 4% Topical Solution, 50mL | Lannett

NDC: 0527-6004-80

Lidocaine HCl 4% Topical Solution, 50 mL — Lannett Company, Inc.

Active ingredients	Lidocaine hydrochloride anhydrous 4% (40 mg/mL)
Dosage form	Topical solution
Route	Topical (oral and nasal mucous membranes)
Size	50 mL
Manufacturer	Lannett Company, Inc.
NDC	0527-6004-80

Indications and Usage

Production of topical anesthesia of accessible mucous membranes of the oral and nasal cavities and proximal portions of the digestive tract. Not for injection.

Dosage and Administration

The usual adult dose is 1 to 5 mL (40 to 200 mg) applied by spray, cotton applicator, or instillation. The maximum recommended dose should not exceed 4.5 mg/kg (2 mg/lb) of body weight and is generally kept below 300 mg.

Warnings and Precautions

• Not for injection
• Have resuscitative equipment, oxygen, and resuscitative drugs immediately available
• Risk of methemoglobinemia
• Do not ingest food for 60 minutes following use in the mouth or throat because of the risk of aspiration

Contraindications

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

Adverse Reactions

Systemic reactions include CNS effects (lightheadedness, nervousness, confusion, drowsiness, tremor, convulsions) and cardiovascular effects (bradycardia, hypotension, and cardiovascular collapse); localized reactions may occur on mucous membranes.

Storage and Handling

Store at 20°C to 25°C (68°F to 77°F).

How Supplied

Topical solution supplied in 50 mL screw-cap plastic bottles.

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.