Lidocaine Hydrochloride Injection contains lidocaine, an amide local anesthetic. Lidocaine Hydrochloride Injection is indicated in adult and pediatric patients for the production of local or regional anesthesia or analgesia for surgery, dental, and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. For each type of block indicated to produce local or regional anesthesia or analgesia, specific concentrations and presentations are recommended. (1, 2.2)

See Full Prescribing Information for recommended dosages and administration information for adult and pediatric patients. (2)

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Lidocaine Hydrochloride Injection, single-dose vials: 0.5%, 1% (3)

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Lidocaine Hydrochloride Injection, single-dose ampuls: 1%, 1.5%, 2% (3)

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Lidocaine Hydrochloride Injection, multiple-dose vials: 0.5%, 1%, 2% (3)

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Known hypersensitivity to any local anesthetic agent of the amide-type or to other components of Lidocaine Hydrochloride Injection. (4)

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Dose-Related Toxicity: Monitor cardiovascular and respiratory vital signs and patient’s state of consciousness after injection of Lidocaine Hydrochloride Injection. (5.1)

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Methemoglobinemia: Cases of methemoglobinemia have been reported in association with local anesthetics use. See full prescribing information for more details on managing these risks. (5.2)

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Chondrolysis with Intra-Articular Infusion: Avoid intra-articular infusions as there have been post-marketing reports of chondrolysis in patients receiving such infusion. (5.4)

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Risk of Systemic Toxicities with Unintended Intravascular or Intrathecal Injection: Unintended intravascular or intrathecal injection may be associated with systemic toxicities, including CNS or cardiorespiratory depression and coma, progression ultimately to respiratory arrest. Aspirate for blood or cerebrospinal fluid (where applicable) prior to each dose and consider using a test dose of a lidocaine solution containing epinephrine. (5.7)

Most common adverse reactions are as follows:

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Central Nervous System: Lightheadedness, 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. (6)

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Cardiovascular System: Bradycardia, hypotension, and cardiovascular collapse. (6)

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Allergic: Cutaneous lesions, urticaria, edema or anaphylactoid reactions. (6)

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Neurologic: Positional headaches, hypotension and backache. (6)

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Hematologic: Methemoglobinemia. (6)

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1‑800‑438‑1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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Local Anesthetics: The toxic effects of local anesthetics are additive. Monitor for neurologic and cardiovascular effects when additional local anesthetics are administered. (7.1)

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Monoamine Oxidase Inhibitors and Tricyclic Antidepressants: Administration of lidocaine solutions containing epinephrine to patients receiving monoamine oxidase inhibitors or tricyclic antidepressants may produce severe, prolonged hypertension. Concurrent use of these agents should generally be avoided. (5.5, 7.2)

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Ergot-type Oxytocic drugs: Concurrent administration of lidocaine solutions containing epinephrine and ergot-type oxytocic drugs may cause severe, persistent hypertension or cerebrovascular accidents. (5.5, 7.3)

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Nonselective Beta-Adrenergic Antagonists: Administration of lidocaine solutions containing epinephrine in patients receiving nonselective beta-adrenergic antagonist may cause severe hypertension and bradycardia. Concurrent use of these agents should generally be avoided. (5.5, 7.4)

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Drugs Associated with Methemoglobinemia: Patients are at increased risk of developing methemoglobinemia when concurrently exposed to nitrates, nitrites, local anesthetics, antineoplastic agents, antibiotics, antimalarials, anticonvulsants and other drugs. (7.5)

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Potent Inhalation Anesthetics: Serious dose-related cardiac arrhythmias may occur if lidocaine solutions containing epinephrine are used in patients during or following the administration of potent inhalation anesthetics. (5.11, 7.6)

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Geriatric Use: Elderly patients should be given reduced doses commensurate with their age and physical condition. (8.5)

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Hepatic Impairment: Consider reduced dosing and increased monitoring for local anesthetic systemic toxicity in patients with hepatic impairment. (8.6)