lidocaine hydrochloride and epinephrine injection, USP Highlights

Lidocaine Hydrochloride and Epinephrine Injection is a combination of lidocaine, an amide local anesthetic, and epinephrine, an alpha and beta adrenergic agonist. Lidocaine Hydrochloride and Epinephrine 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)

•

For epidural test dose, Lidocaine Hydrochloride and Epinephrine 1:200,000 Injection, USP, Single-dose Ampuls: 1.5%

•

Lidocaine Hydrochloride and Epinephrine 1:200,000 Injection, USP, Single-dose Vials: 1.5%, 2%

•

Lidocaine Hydrochloride and Epinephrine 1:200,000 Injection, USP, Multiple-dose Vials: 0.5%

•

Lidocaine Hydrochloride and Epinephrine 1:100,000 Injection, USP, Multiple-dose Vials: 1%, 2%

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

•

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

•

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)

•

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)

•

Allergic-Type Reactions to Sulfites in Lidocaine Hydrochloride and Epinephrine Injection and Anaphylactic Reactions: Lidocaine Hydrochloride and Epinephrine Injection contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. (5.6)

•

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 Lidocaine Hydrochloride and Epinephrine. (5.7)

Most common adverse reactions are as follows:

•

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)

•

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

•

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

•

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

•

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.

•

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

•

Monoamine Oxidase Inhibitors and Tricyclic Antidepressants: Administration of Lidocaine Hydrochloride and Epinephrine Injection 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)

•

Ergot-type Oxytocic drugs: Concurrent administration of Lidocaine Hydrochloride and Epinephrine Injection and ergot-type oxytocic drugs may cause severe, persistent hypertension or cerebrovascular accidents. (5.5, 7.3)

•

Nonselective Beta-Adrenergic Antagonists: Administration of Lidocaine Hydrochloride and Epinephrine Injection 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)

•

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)

•

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

•

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

•

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