INDICATIONS AND USAGE Lidocaine HCl 2% Jelly is indicated for 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 (oral and nasal).

WARNINGS EXCESSIVE DOSAGE, OR SHORT INTERVALS BETWEEN DOSES, CAN RESULT IN HIGH PLASMA LEVELS AND SERIOUS ADVERSE EFFECTS.

PATIENTS SHOULD BE INSTRUCTED TO STRICTLY ADHERE TO THE RECOMMENDED DOSAGE AND ADMINISTRATION GUIDELINES AS SET FORTH IN THIS PACKAGE INSERT.

THE MANAGEMENT OF SERIOUS ADVERSE REACTIONS MAY REQUIRE THE USE OF RESUSCITATIVE EQUIPMENT, OXYGEN AND OTHER RESUSCITATIVE DRUGS.

Lidocaine HCl 2% Jelly should be used with extreme caution in the presence of sepsis or severely traumatized mucosa in the area of application, since under such conditions there is the potential for rapid systemic absorption.

When used for endotracheal tube lubrication care should be taken to avoid introducing the product into the lumen of the tube.

Do not use the jelly to lubricate the endotracheal stylettes.

If allowed into the inner lumen, the jelly may dry on the inner surface leaving a residue which tends to clump with flexion, narrowing the lumen.

There have been rare reports in which this residue has caused the lumen to occlude (see ADVERSE REACTIONS and DOSAGE AND ADMINISTRATION ).

Methemoglobinemia Cases of methemoglobinemia have been reported in association with local anesthetic use.

Although all patients are at risk for methemoglobinemia, patients with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, infants under 6 months of age, and concurrent exposure to oxidizing agents or their metabolites are more susceptible to developing clinical manifestations of the condition.

If local anesthetics must be used in these patients, close monitoring for symptoms and signs of methemoglobinemia is recommended.

Signs of methemoglobinemia may occur immediately or may be delayed some hours after exposure, and are characterized by a cyanotic skin discoloration and/or abnormal coloration of the blood.

Methemoglobin levels may continue to rise; therefore, immediate treatment is required to avert more serious central nervous system and cardiovascular adverse effects, including seizures, coma, arrhythmias, and death.

Discontinue Lidocaine HCl 2% Jelly and any other oxidizing agents.

Depending on the severity of the signs and symptoms, patients may respond to supportive care, i.e., oxygen therapy, hydration.

A more severe clinical presentation may require treatment with methylene blue, exchange transfusion, or hyperbaric oxygen.

ADVERSE REACTIONS Adverse experiences following the administration of lidocaine are similar in nature to those observed in other amide local anesthetic agents.

These adverse experiences are, in general, dose-related and may result from high plasma levels caused by excessive dosage or rapid absorption, or may result from a hypersensitivity, idiosyncrasy, or diminished tolerance on the part of the patient.

Serious adverse experiences are generally systemic in nature.

The following types are those most commonly reported: There have been rare reports of endotracheal tube occlusion associated with the presence of dried jelly residue in the inner lumen of the tube (see WARNINGS and DOSAGE AND ADMINISTRATION ).

Central Nervous System: CNS manifestations are excitatory and/or depressant and may be characterized by light headedness: nervousness, apprehension, euphoria, confusion, dizziness, drowsiness, tinnitus, blurred or double vision, vomiting, sensations of heat, cold or numbness, twitching, tremors, convulsions, unconsciousness, respiratory depression, and arrest.

The excitatory manifestations may be very brief or may not occur at all, in which case the first manifestation of toxicity may be drowsiness merging into unconsciousness and respiratory arrest.

Drowsiness following the administration of lidocaine is usually an early sign of a high blood level of the drug and may occur as a consequence of rapid absorption.

Cardiovascular System: Cardiovascular manifestations are usually depressant and are characterized by bradycardia, hypotension, and cardiovascular collapse which may lead to cardiac arrest.

Allergic: Allergic reactions are characterized by cutaneous lesions, urticaria, edema, or anaphylactoid reactions.

Allergic reactions may occur as a result of sensitivity either to the local anesthetic agent or other components in the formulation.

Allergic reactions as a result of sensitivity to lidocaine are extremely rare and, if they occur, should be managed by conventional means.

The detection of sensitivity by skin testing is of doubtful value.

To report SUSPECTED ADVERSE REACTIONS, contact Sentiss at 1-855-473-6847 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.