FOR INFILTRATION AND NERVE BLOCK
NOT FOR EPIDURAL OR CAUDAL USE
Lidocaine HCI Injection, USP is a sterile aqueous solution that contains a local anesthetic agent and is administered parenterally. See INDICATIONS for specific uses.
Lidocaine HCI Injections, USP contains lidocaine HCI which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride and has the following structural formula:
Lidocaine HCI 1% — Each mL contains Lidocaine HCI 10 mg, Sodium Chloride 7 mg, Methylparaben 1 mg, Water for Injection q.s.
Lidocaine HCI 2% — Each mL contains Lidocaine HCI 20 mg, Sodium Chloride 4.6 mg, Methylparaben 1 mg, Water for Injection q.s.
The pH (range 5.0-7.0) of both strengths is adjusted with Sodium Hydroxide and/or Hydrochloric Acid, when necessary.
Lidocaine HCI Injection, USP with preservatives is indicated for production of local or regional anesthesia, by infiltration techniques such as percutaneous injection and by peripheral nerve block techniques such as brachial plexus and intercostal, when the accepted procedures for these techniques as described in standard divbooks are observed.
Lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type.
LIDOCAINE HYDROCHLORIDE SOLUTION FOR INFILTRATION AND NERVE BLOCK SHOULD BE EMPLOYED ONLY BY CLINICIANS WHO ARE WELL VERSED IN DIAGNOSIS AND MANAGEMENT OF DOSE-RELATED TOXICITY AND OTHER ACUTE EMERGENCIES THAT MIGHT ARISE FROM THE BLOCK TO BE EMPLOYED AND THEN ONLY AFTER ENSURING THE IMMEDIATE AVAILABILITY OF OXYGEN, OTHER RESUSCITATIVE DRUGS, CARDIOPULMONARY EQUIPMENT, AND THE PERSONNEL NEEDED FOR PROPER MANAGEMENT OF TOXIC REACTIONS AND RELATED EMERGENCIES (See also ADVERSE REACTIONS and PRECAUTIONS).
DELAY IN PROPER MANAGEMENT OF DOSE-RELATED TOXICITY, UNDERVENTILATION FROM ANY CAUSE AND/OR ALTERED SENSITIVITY MAY LEAD TO THE DEVELOPMENT OF ACIDOSIS, CARDIAC ARREST AND, POSSIBLY, DEATH.
To avoid intravascular injection, aspiration should be performed before the local anesthetic solution is injected. The needle must be repositioned until no return of blood can be elicited by aspiration. Note, however, that the absence of blood in the syringe does not guarantee that intravascular injection has been avoided.
Local anesthetic solutions containing antimicrobial preservatives (e.g. methylparaben) should not be used for epidural or spinal anesthesia because the safety of these agents has not been established with regard to intrathecal injection, either intentional or accidental.
Acute emergencies from local anesthetics are generally related to high plasma levels encountered during therapeutic use of local anesthetics or to unintended subarachnoid injection of local anesthetic solution (see ADVERSE REACTIONS, WARNINGS and PRECAUTIONS).
Table 1 (Recommended Dosages) summarizes the recommended volumes and concentrations of Lidocaine HCI Injection, USP for various types of anesthetic procedures. The dosages suggested in this table are for normal healthy adults and refer to the use of epinephrine-free solutions. When larger volumes are required only solutions containing epinephrine should be used except in those cases where vasopressor drugs may be contraindicated.
These recommended doses serve only as a guide to the amount of anesthetic required for most routine procedures. The actual volumes and concentrations to be used depend on a number of factors such as type and extent of surgical procedure, depth of anesthesia, and degree of muscular relaxation required, duration of anesthesia required, and the physical condition of the patient. In all cases the lowest concentration and smallest dose that will produce the desired result should be given. Dosages should be reduced for children and for elderly and debilitated patients and patients with cardiac and/or liver disease.
The onset of anesthesia, the duration of anesthesia, and the degree of muscular relaxation are proportional to the volume and concentration (i.e. total dose) of local anesthetic used. Thus an increase in volume and concentration of Lidocaine HCI Injection, USP will decrease the onset of anesthesia, prolong the duration of anesthesia, provide a greater degree of muscular relaxation and increase the segmental spread of anesthesia. Although the incidence of side effects with lidocaine is quite low, caution should be exercised when employing large volumes and concentrations since the incidence of side effects is directly proportional to the total dose of local anesthetic agent injected.
Lidocaine Hydrochloride Injection, USP.
NDC 0517-0625-25 1% 50 mL Multiple Dose Vials*
packed in boxes of 25
NDC 0517-0626-25 2% 50 mL Multiple Dose Vials*
packed in boxes of 25
*Multiple Dose Vials are preserved with Methylparaben.
Store at controlled room temperature 15°-30°C (59°-86°F) (See USP).
SHIRLEY, NY 11967