Lidocaine 2% Jelly 30mL Sterile (JELCAINE)

NDC: 71351-025-30

Lidocaine HCl 2% Jelly, 30 mL — Brookfield Pharmaceuticals

Indications and Usage

Indicated for prevention and control of pain in procedures involving the male and female urethra and as an anesthetic lubricant for endotracheal intubation. Also used topically for the treatment of painful urethritis.

Dosage and Administration

For the male urethra, instill approximately 15 mL (300 mg) slowly into the urethra, with a usual total of 30 mL (600 mg) for filling and dilation. For the female urethra, instill 3 to 5 mL (60 to 100 mg) slowly. No more than 600 mg should be administered in any 12-hour period.

Warnings and Precautions

• Excessive dosage or short dosing intervals can produce high plasma levels and serious adverse effects
• Risk of methemoglobinemia, particularly in infants under 6 months and patients with glucose-6-phosphate dehydrogenase deficiency
• Aspiration hazard; avoid food intake for 60 minutes after oropharyngeal use
• Use with caution in patients with severe shock or heart block

Contraindications

Contraindicated in patients with hypersensitivity to amide-type local anesthetics or any other component of the product.

Adverse Reactions

Adverse reactions include central nervous system effects such as lightheadedness, confusion, convulsions, and respiratory depression, and cardiovascular effects such as bradycardia, hypotension, and cardiac arrest. Allergic reactions including urticaria, edema, and anaphylaxis may occur.

Storage and Handling

Store at controlled room temperature, 15°C to 30°C (59°F to 86°F).

How Supplied

Sterile water-soluble topical anesthetic jelly supplied in single-use tubes.

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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