Lidocaine and Epinephrine

• If you have an allergy to lidocaine, epinephrine, or any other part of lidocaine and epinephrine.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if you have any side effects that bother you or do not go away.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

(LYE doe kane & ep i NEF rin)

• Local Anesthetic

Dental: ≤2 to 4 minutes

Hypersensitivity to lidocaine, other local anesthetics of the amide type, epinephrine, or any component of the formulation.

Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity to para amino benzoic acid (PABA).

There are no dosage adjustments provided in the manufacturer’s labeling. However, accumulation of metabolites may be increased in renal impairment.

Dialysis: Not dialyzable (0% to 5%) by hemo- or peritoneal dialysis; supplemental dose is not necessary (Aronoff 2007).

There are no dosage adjustments provided in the manufacturer’s labeling; use with caution (hepatically metabolized); patients with severe hepatic impairment are at greater risk of lidocaine toxicity.

Concerns related to adverse effects:

• Cardiovascular effects: Lidocaine can cause cardiac depression (eg, bradycardia, hypotension); patients with hypovolemia may be at increased risk.

• CNS toxicity: Careful and constant monitoring of the patient's state of consciousness should be done following each local anesthetic injection; at such times, restlessness, anxiety, tinnitus, dizziness, blurred vision, tremors, depression, or drowsiness may be early warning signs of CNS toxicity. Treatment is primarily symptomatic and supportive.

• Hypersensitivity: Anaphylactic reactions may occur following administration.

• Intra-articular infusion related chondrolysis: Continuous intra-articular infusion of local anesthetics after arthroscopic or other surgical procedures is not an approved use; chondrolysis (primarily in the shoulder joint) has occurred following infusion, with some cases requiring arthroplasty or shoulder replacement.

• Methemoglobinemia: Local anesthetics may cause methemoglobinemia.

• Respiratory arrest: Local anesthetics have been associated with occurrences of respiratory arrest.

Disease-related concerns:

• Cardiovascular disease: Use with caution in patients with bradycardia, severe shock, heart block, or impaired cardiovascular function; use with caution in areas of the body supplied by end arteries or having otherwise compromised blood supply. Patients with peripheral vascular disease or hypertensive vascular disease may exhibit exaggerated vasoconstrictor response. Ischemic injury (eg, exfoliating, ulcerating lesions) or necrosis may result.

• Diabetes: Use with caution in patients with diabetes.

• Hepatic impairment: Use with caution in patients with hepatic impairment; lidocaine is hepatically metabolized and patients with severe hepatic impairment are at greater risk of lidocaine toxicity.

• Renal impairment: Use with caution in patients with severe renal impairment (lidocaine metabolites may accumulate).

• Thyroid disease: Use with caution in patients with poorly controlled hyperthyroidism.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Special populations:

• Acutely ill patients: Use with caution in acutely ill; reduce dose consistent with age and physical status.

• Debilitated patients: Use with caution in debilitated patients; reduce dose consistent with age and physical status.

• Elderly: Use with caution in the elderly; reduce dose consistent with age and physical status.

• Pediatric: Use with caution in children; reduce dose consistent with age and physical status.

Dosage form specific issues:

• Benzyl alcohol and derivatives: Some dosage forms may contain benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension and cardiovascular collapse (AAP 1997; CDC 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol with caution in neonates See manufacturer’s labeling.

• Sodium metabisulfite: May contain sodium metabisulfite; use caution in patients with a sulfite allergy.

Other warnings/precautions:

• Appropriate use: Avoid intravascular injections. Aspirate the syringe prior to administration; the needle must be repositioned until no return of blood can be elicited by aspiration; however, absence of blood in the syringe does not guarantee that intravascular injection has been avoided. Use with caution when there is inflammation and/or sepsis in the region of the proposed injection. Do not use injections containing preservatives (eg, methylparaben) for epidural or spinal anesthesia, or for any route of administration that would introduce solution into the cerebrospinal fluid.

• Epidural anesthesia: Use lumbar and caudal epidural anesthesia with extreme caution in patients with existing neurological disease, spinal deformities, septicemia, and impaired cardiovascular function (eg, severe hypertension).

• Repeat doses: Repeat doses of lidocaine may cause significant increases in blood levels with each repeated dose due to slow accumulation of the drug or its metabolites. Tolerance to elevated blood levels varies with the status of the patient.

• Trained personnel: Dental practitioners and/or clinicians using local anesthetic agents should be well trained in diagnosis and management of emergencies that may arise from the use of these agents. Resuscitative equipment, oxygen, and other resuscitative drugs should be available for immediate use.