Lidocaine Urojet HCl Topical Jelly 2% PF Prefilled Syringe 10mL 25/Package

NDC: 76329-3013-5

Uro-Jet Lidocaine HCl 2% Topical Jelly, 10 mL Prefilled Syringe — International Medication Systems

Active ingredients	Lidocaine hydrochloride 2% (20 mg/mL)
Dosage form	Sterile jelly (preservative-free), prefilled syringe
Route	Topical (mucous membrane; urethral)
Size	10 mL prefilled single-use syringe
Manufacturer	International Medication Systems
NDC	76329-3013-5

Indications and Usage

Prevention and control of pain in procedures involving the male and female urethra, for topical treatment of painful urethritis, and as an anesthetic lubricant for endotracheal intubation.

Dosage and Administration

In the adult male, instill approximately 15 mL (300 mg lidocaine HCl) into the urethra; in the female, 3 to 5 mL is usually adequate. No more than 600 mg of lidocaine hydrochloride should be administered in any 12-hour period.

Warnings and Precautions

• Excessive dosage or rapid absorption can cause high plasma levels with serious CNS and cardiovascular effects
• Use with caution when mucosa is traumatized or sepsis is present, as absorption increases
• Have resuscitative equipment and drugs immediately available
• Risk of methemoglobinemia

Contraindications

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

Adverse Reactions

Reactions are largely dose-related and may include CNS effects (lightheadedness, nervousness, tremor, drowsiness, convulsions) and cardiovascular effects (bradycardia, hypotension, cardiovascular collapse), as well as allergic reactions.

Storage and Handling

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

How Supplied

Sterile, preservative-free 2% jelly (20 mg/mL) in single-use prefilled syringes, including a 10 mL fill.

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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