Complete SPL Sections
1 INDICATIONS AND USAGE
INDICATIONS & USAGE SECTION
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. Specific concentrations and presentations of lidocaine hydrochloride injection are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration ( 2.2 )] .
2 DOSAGE AND ADMINISTRATION
DOSAGE & ADMINISTRATION SECTION
3 DOSAGE FORMS AND STRENGTHS
DOSAGE FORMS & STRENGTHS SECTION
4 CONTRAINDICATIONS
CONTRAINDICATIONS SECTION
Lidocaine hydrochloride injection is contraindicated in patients with a known hypersensitivity to lidocaine or to any local anesthetics of the amide type or to other components of lidocaine hydrochloride injection.
5 WARNINGS AND PRECAUTIONS
WARNINGS AND PRECAUTIONS SECTION
6 ADVERSE REACTIONS
ADVERSE REACTIONS SECTION
The following clinically significant adverse reactions have been reported and described in the Warnings and Precautions section of the labeling: Dose-Related Toxicity [see Warnings and Precautions ( 5.1 )] Methemoglobinemia [see Warnings and Precautions ( 5.2 )] Chondrolysis with Intra-Articular Infusion [see Warnings and Precautions ( 5.4 )] Severe, Persistent Hypertension, Cerebrovascular Accidents, and Bradycardia Due to Drug Interactions [see Warnings and Precautions ( 5.5 )] Allergic-Type Reactions [see Warnings and Precautions ( 5.6 )] Systemic Toxicities with Unintended Intravascular or Intrathecal Injection [see Warnings and Precautions ( 5.7 )] Respiratory Arrest Following Retrobulbar Block [see Warnings and Precautions ( 5.14 )] The following adverse reactions from voluntary reports or clinical studies have been reported with lidocaine or lidocaine and epinephrine. Because many of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Adverse reactions to lidocaine hydrochloride injection are characteristic of those associated with other amide-type local anesthetic. A major cause of adverse reactions to this group of drugs is excessive plasma levels, which may be due to overdosage, unintentional intravascular injection, or slow metabolic degradation. The most commonly encountered acute adverse reactions that demand immediate counter measures were related to the CNS and the cardiovascular system. These adverse reactions were generally dose-related and due to high plasma levels which may have resulted from overdosage, rapid absorption from the injection site, diminished tolerance, or from unintentional intravascular injection of the local anesthetic solution. In addition to systemic does-related toxicity, unintentional intrathecal injection of drug during the intended performance of caudal or lumbar epidural block or nerve blocks near the vertebral column (especially in the head and neck region) has resulted in underventilation or apnea (“Total or High Spinal”). Also, hypertension due to loss of sympathetic tone and respiratory paralysis or underventilation due to cephalad extension of the motor level of anesthesia have occurred. This has led to secondary cardiac arrest when untreated. When used for dental injections, paresthesia of the lips, tongue, and oral tissues have been reported. Persistent paresthesia lasting weeks to months and, in some instances, lasting greater than one year, have also been reported.
7 DRUG INTERACTIONS
DRUG INTERACTIONS SECTION
8 USE IN SPECIFIC POPULATIONS
USE IN SPECIFIC POPULATIONS SECTION
10 OVERDOSAGE
OVERDOSAGE SECTION
11 DESCRIPTION
DESCRIPTION SECTION
Lidocaine hydrochloride injection, USP contains lidocaine hydrochloride, an amide local anesthetic, as the active pharmaceutical ingredient. The route of administration for lidocaine hydrochloride injection, USP is by injection, for infiltration, nerve block, epidural and caudal use. Multiple dose vials contain methylparaben and they should not be used for caudal and lumbar epidural blocks. Dosage forms listed as lidocaine hydrochloride injection, USP – MPF indicate single-dose solutions that are Methylparaben Free (MPF). Lidocaine hydrochloride, is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride monohydrate and has the molecular weight of 288.8 g/mol. Lidocaine hydrochloride molecular formula is C 14 H 22 N 2 O • HCl•H 2 O, and has the following structural formula: Lidocaine hydrochloride injection, USP in multiple dose vials is a sterile, nonpyrogenic, isotonic, clear, colorless solution containing lidocaine hydrochloride and sodium chloride. Each mL contains 1 mg methylparaben as an antiseptic preservative. The pH of these solutions is adjusted to approximately 6.5 (5.0 to 7.0) with sodium hydroxide and hydrochloric acid. £ Quantity is equivalent to 10.7 mg per mL Lidocaine Hydrochloride, USP (Monohydrate). Ingredients Strength 1% Amount (Per mL) Lidocaine Hydrochloride (Anhydrous) 10 mg £ Sodium Chloride 7 mg Methylparaben 1 mg Sodium Hydroxide Added for pH Adjustment to approximately 6.5 (5.0 to 7.0) Hydrochloric Acid Lidocaine hydrochloride injection, USP - MPF is a sterile, nonpyrogenic, isotonic, clear, colorless, and preservative-free solution. The pH of these solutions is adjusted to approximately 6.5 (5.0 to 7.0) with sodium hydroxide and hydrochloric acid. £ Quantity is equivalent to 10.7 mg per mL Lidocaine Hydrochloride, USP (Monohydrate). Ingredients Strength 1% Amount (Per mL) Lidocaine Hydrochloride (Anhydrous) 10 mg £ Sodium Chloride 7 mg Sodium Hydroxide Added for pH Adjustment to approximately 6.5 (5.0 to 7.0) Hydrochloric Acid
12 CLINICAL PHARMACOLOGY
CLINICAL PHARMACOLOGY SECTION
13 NONCLINICAL TOXICOLOGY
NONCLINICAL TOXICOLOGY SECTION
16 HOW SUPPLIED/STORAGE AND HANDLING
HOW SUPPLIED SECTION
Lidocaine hydrochloride injection, USP is a clear, colorless solution supplied as follows: Lidocaine Hydrochloride Injection, USP (1%) NDC (10 mg per mL) Package Factor 83634-651-10 100 mg per 10 mL Multiple-Dose Vial 25 vials per carton 83634-651-20 200 mg per 20 mL Multiple-Dose Vial 25 vials per carton 83634-651-50 500 mg per 50 mL Multiple-Dose Vial 25 vials per carton Lidocaine Hydrochloride Injection, USP (1%) NDC (10 mg per mL) – MPF Package Factor 83634-653-02 20 mg per 2 mL Single-Dose Vial 25 vials per carton 83634-653-05 50 mg per 5 mL Single-Dose Vial 25 vials per carton 83634-653-30 300 mg per 30 mL Single-Dose Vial 25 vials per carton
17 PATIENT COUNSELING INFORMATION
INFORMATION FOR PATIENTS SECTION
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL - PRINCIPAL DISPLAY PANEL – Vial Label NDC 83634-653-41 Lidocaine HCl Injection, USP – 1% 20 mg per 2 mL (10 mg per mL) For Infiltration and Nerve Block Including Caudal and Epidural Use Methylparaben-Free 2 mL Single-Dose Vial Rx only
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL - PRINCIPAL DISPLAY PANEL – Vial Label NDC 83634-653-42 Lidocaine HCl Injection, USP – 1% 50 mg per 5 mL (10 mg per mL) For Infiltration and Nerve Block Including Caudal and Epidural Use Methylparaben-Free 5 mL Single-Dose Vial Rx only
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL - PRINCIPAL DISPLAY PANEL – Vial Label NDC 83634-653-43 Lidocaine HCl Injection, USP – 1% 300 mg per 30 mL (10 mg per mL) For Infiltration and Nerve Block Including Caudal and Epidural Use 30 mL Single-Dose Vial Methylparaben-Free Rx only
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL - PRINCIPAL DISPLAY PANEL – Vial Label NDC 83634-651-41 Lidocaine HCl Injection, USP – 1% 100 mg per 10 mL (10 mg per mL) For Infiltration and Nerve Block Not for Caudal or Epidural Use 10 mL Multiple-Dose Vial Rx only
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL - PRINCIPAL DISPLAY PANEL – Vial Label NDC 83634-651-42 Lidocaine HCl Injection, USP – 1% 200 mg per 20 mL (10 mg per mL) For Infiltration and Nerve Block Not for Caudal or Epidural Use 20 mL Multiple-Dose Vial Rx only
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL - PRINCIPAL DISPLAY PANEL – Vial Label NDC 83634-651-43 Lidocaine HCl Injection, USP – 1% 500 mg per 50 mL (10 mg per mL) For Infiltration and Nerve Block Not for Caudal or Epidural Use 50 mL Multiple-Dose Vial Rx only