Lidocaine Hydrochloride

2 DOSAGE AND ADMINISTRATION See Full Prescribing Information for recommended dosages and administration information for adult and pediatric patients 2.1 Important Dosage and Administration Information Lidocaine hydrochloride injection is not recommended for intrathecal use. Avoid use of lidocaine hydrochloride injection solutions containing antimicrobial preservatives (i.e., multiple-dose vials) for epidural or caudal anesthesia [see Warnings and Precautions ( 5.3 )]. Discard unused portions of solution not containing preservatives, i.e., those supplied in single-dose vials, following initial use. Visually inspect this product for particulate matter and discoloration prior to administration whenever solution and container permit. Lidocaine hydrochloride injection is a clear, colorless solutions. Do not administer solutions which are discolored or contain particulate matter. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever the solution and container permit. Solutions which are discolored (e.g., pinkish or darker than slightly yellow) or which contain particulate matter or precipitate should not be administered. Mixing or the prior or intercurrent use of any other local anesthetic with Lidocaine hydrochloride injection is not recommended because of insufficient data on the clinical use of such mixtures. Administration Precautions Lidocaine hydrochloride injection is to be administered in carefully adjusted dosages by or under the supervision of experienced clinicians who are well versed in the diagnosis and management of dose-related toxicity and other acute emergencies which might arise from the block to be employed. Use lidocaine hydrochloride injection only if the following are immediately available: oxygen, cardiopulmonary resuscitative equipment and drugs, and the personnel resources needed for proper management of toxic reactions and related emergencies [see Warnings and Precautions ( 5.1 ), Adverse Reactions ( 6 ), Overdosage ( 10 )]. The toxic effects of local anesthetics are additive. Monitor for neurologic and cardiovascular effects related to local anesthetic systemic toxicity when additional local anesthetics are administered with lidocaine hydrochloride injection [see Warnings and Precautions ( 5.1 ), Drug Interactions ( 7.1 ), Overdosage ( 10 )]. Aspirate for blood or cerebrospinal fluid (where applicable) prior to injecting lidocaine hydrochloride injection, both the initial dose and all subsequent doses, to avoid intravascular or intrathecal injection. However, a negative aspiration for blood or cerebrospinal fluid does not ensure against an intravascular or intrathecal injection [see Warnings and Precautions ( 5.7 )]. Avoid rapid injection of a large volume of lidocaine hydrochloride injection and use fractional (incremental) doses when feasible. During major regional nerve blocks, such as those of the brachial plexus or lower extremity, the patient should have an indwelling intravenous catheter to assure adequate intravenous access. The lowest dosage of lidocaine hydrochloride injection that results in effective anesthesia should be used to avoid high plasma levels and serious adverse reactions. Perform careful and constant monitoring of cardiovascular and respiratory (adequacy of oxygenation and ventilation) vital signs and the patient’s level of consciousness after each local anesthetic injection. Use lidocaine hydrochloride injection in carefully restricted quantities in areas of the body supplied by end arteries or having otherwise compromised blood supply such as digits, nose, external ear, or penis. 2.2 Recommended Concentrations and Dosages of lidocaine hydrochloride injection in Adults The dosage of lidocaine hydrochloride injection administered varies with the anesthetic procedure, the area to be anesthetized, the vascularity of the tissues, the number of neuronal segments to be blocked, the depth of anesthesia and degree of muscle relaxation required, the duration of anesthesia desired, individual tolerance, and the physical condition of the patient. Administer the smallest dosage and concentration required to produce the desired result. The types of block and recommended lidocaine hydrochloride injection concentrations are shown in Table 1. The dosages suggested in this table are for normal healthy adults and refer to the use of epinephrine-free solutions. Consider administration of solutions containing epinephrine when large volumes are required. Table 1: Recommended Dosages in Adults Procedure Lidocaine Hydrochloride Injection Conc (%) Vol (mL) Total Dose (mg) Infiltration Percutaneous 0.5 or 1 1 to 60 5 to 300 Intravenous regional 0.5 10 to 60 50 to 300** Peripheral Nerve Blocks, e.g., Brachial 1.5 15 to 20 225 to 300 Dental 2 1 to 5 20 to 100 Intercostal 1 3 30 Paravertebral 1 3 to 5 30 to 50 Pudendal (each side) 1 10 100 Paracervical Obstetrical analgesia (each side) 1 10 100 Sympathetic Nerve Blocks, e.g., Cervical (stellate ganglion) 1 5 50 Lumbar 1 5 to 10 50 to 100 Central Neural Blocks Epidural* Thoracic 1 20 to 30 200 to 300 Lumbar Analgesia 1 25 to 30 250 to 300 Anesthesia 1.5 15 to 20 225 to 300 2 10 to 15 200 to 300 Caudal Obstetrical analgesia 1 20 to 30 200 to 300 Surgical anesthesia 1.5 15 to 20 225 to 300 *Dose determined by number of dermatomes to be anesthetized (2 to 3 mL/dermatome). ** Dose should not exceed 4 mg/kg. The above suggested concentrations and volumes serve only as a guide. Other volumes and concentrations may be used provided the total maximum recommended dose is not exceeded. These recommended doses serve only as a guide to the amount of local anesthetic required for most indicated 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. The maximum dosage limit within the recommended dosage range must be individualized in each case after evaluating the size and physical status of the patient, as well as the anticipated rate of systemic absorption from a particular injection site. 2.3 Use in Epidural Anesthesia During epidural administration, administer lidocaine hydrochloride injection, 1% (10 mg/mL) and 2% (20 mg/mL) solutions in incremental doses of 3 mL to 5 mL with sufficient time between doses to detect toxic manifestations of unintentional intravascular or intrathecal injection. Administer injections slowly, with frequent aspirations before and during the injection to avoid intravascular injection. Perform syringe aspirations before and during each supplemental injection in continuous (intermittent) catheter techniques. Repeat doses of lidocaine hydrochloride injection should be preceded by a test dose containing epinephrine if not clinically contraindicated. Use only the single-dose vials for caudal or epidural anesthesia; avoid use of the multiple-dose vials for these procedures, which contain a preservative [see Dosage and Administration ( 2.1 , 2.4 ), Warnings and Precautions ( 5.7 )]. 2.4 Test Dose for Epidural Blocks In the event of the known injection of a large volume of local anesthetic solution into the subarachnoid space, after suitable resuscitation and if the catheter is in place, consider attempting the recovery of drug by draining a moderate amount of cerebrospinal fluid (such as 10 mL) through the epidural catheter. 2.6 Maximum Recommended Dosage Adults For normal healthy adults, the maximum individual dose should not exceed 4.5 mg/kg of body weight, and in general it is recommended that the maximum total dose does not exceed 300 mg. For continuous epidural or caudal anesthesia, the maximum recommended dosage should not be administered at intervals of less than 90 minutes. When continuous lumbar or caudal epidural anesthesia is used for non-obstetrical procedures, a higher total dose may be administered if required to produce adequate anesthesia. The maximum recommended dose per 90 minute period of lidocaine hydrochloride for paracervical block in obstetrical patients and non-obstetrical patients is 200 mg total. One half of the total dose is usually administered to each side. Inject slowly, five minutes between sides [see Pregnancy ( 8.1 )]. Pediatric Patients A maximum dose of lidocaine hydrochloride injection for children varies based on age and weight. For children over 3 years of age with a normal lean body mass and normal body development, the maximum dose is determined by the child’s age and weight. For example, in a child of 5 years weighing approximately 23 kg, the dose of lidocaine hydrochloride should not exceed approximately 75 mg to 100 mg (3.3 mg/kg to 4.4 mg/kg). The use of dilute solutions (i.e., 0.25% to 0.5%) and total dosages not to exceed 3 mg/kg are recommended for induction of intravenous regional anesthesia in children. The lowest effective concentration and lowest effective dose should be used. Dilution of available concentrations with 0.9% sodium chloride injection may be required to obtain the required final concentration.

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1 INDICATIONS AND USAGE 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.