Description
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.
