Xylocaine (lidocaine HCl) Injections
Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Xylocaine ® (lidocaine HCl Injection, USP) Product Code Unit of Sale Strength Each 480457 NDC 63323-484-57 Unit of 25 0.5% (250 mg per 50 mL) (5 mg per mL) NDC 63323-484-57 50 mL Multiple Dose Vial 480527 NDC 63323-485-27 Unit of 25 1% (200 mg per 20 mL) (10 mg per mL) NDC 63323-485-01 20 mL Multiple Dose Vial 480557 NDC 63323-485-57 Unit of 25 1% (500 mg per 50 mL) (10 mg per mL) NDC 63323-485-03 50 mL Multiple Dose Vial 480617 NDC 63323-486-17 Unit of 25 2% (200 mg per 10 mL) (20 mg per mL) NDC 63323-486-01 10 mL Multiple Dose Vial 480627 NDC 63323-486-27 Unit of 25 2% (400 mg per 20 mL) (20 mg per mL) NDC 63323-486-02 20 mL Multiple Dose Vial 480657 NDC 63323-486-57 Unit of 25 2% (1,000 mg per 50 mL) (20 mg per mL) NDC 63323-486-05 50 mL Multiple Dose Vial Xylocaine ® -MPF (lidocaine HCl Injection, USP) Product Code Unit of Sale Strength Each 491157 NDC 63323-491-57 Unit of 25 0.5% (250 mg per 50 mL) (5 mg per mL) NDC 63323-491-01 50 mL Single Dose Vial 491227 NDC 63323-492-27 Unit of 25 1% (20 mg per 2 mL) (10 mg per mL) NDC 63323-492-04 2 mL Single Dose Vial 491257 NDC 63323-492-57 Unit of 25 1% (50 mg per 5 mL) (10 mg per mL) NDC 63323-492-09 5 mL Single Dose Vial 491297 NDC 63323-492-97 Unit of 5 1% (100 mg per 10 mL) (10 mg per mL) NDC 63323-492-08 10 mL Plastic Ampule 491237 NDC 63323-492-37 Unit of 25 1% (300 mg per 30 mL) (10 mg per mL) NDC 63323-492-07 30 mL Single Dose Vial 491231 NDC 63323-492-31 Unit of 5 1% (300 mg per 30 mL) (10 mg per mL) NDC 63323-492-03 30 mL Single Dose Vial 491397 NDC 63323-493-97 Unit of 5 1.5% (150 mg per 10 mL) (15 mg per mL) NDC 63323-493-03 10 mL Plastic Ampule 491391 NDC 63323-493-91 Unit of 5 1.5% (300 mg per 20 mL) (15 mg per mL) NDC 63323-493-01 20 mL Plastic Ampule 491527 NDC 63323-495-27 Unit of 25 2% (40 mg per 2 mL) (20 mg per mL) NDC 63323-495-09 2 mL Single Dose Vial 491507 NDC 63323-495-07 Unit of 25 2% (100 mg per 5 mL) (20 mg per mL) NDC 63323-495-04 5 mL Single Dose Vial 491697 NDC 63323-496-97 Unit of 5 2% (200 mg per 10 mL) (20 mg per mL) NDC 63323-496-03 10 mL Plastic Ampule Xylocaine ® (lidocaine HCl and epinephrine Injection, USP) with Epinephrine 1:100,000 Product Code Unit of Sale Strength Each 480217 NDC 63323-482-17 Unit of 25 1% (100 mg per 10 mL) (10 mg per mL) NDC 63323-482-01 10 mL Multiple Dose Vial 480227 NDC 63323-482-27 Unit of 25 1% (200 mg per 20 mL) (10 mg per mL) NDC 63323-482-03 20 mL Multiple Dose Vial 480257 NDC 63323-482-57 Unit of 25 1% (500 mg per 50 mL) (10 mg per mL) NDC 63323-482-05 50 mL Multiple Dose Vial 480327 NDC 63323-483-27 Unit of 25 2% (400 mg per 20 mL) (20 mg per mL) NDC 63323-483-03 20 mL Multiple Dose Vial 480357 NDC 63323-483-57 Unit of 25 2% (1,000 mg per 5 mL) (20 mg per mL) NDC 63323-483-01 50 mL Multiple Dose Vial Xylocaine ® (lidocaine HCl and epinephrine Injection, USP) with Epinephrine 1:200,000 Product Code Unit of Sale Strength Each 480157 NDC 63323-481-57 Unit of 25 0.5% (250 mg per 50 mL) (5 mg per mL) NDC 63323-481-01 50 mL Multiple Dose Vial Xylocaine ® -MPF (lidocaine HCl and epinephrine Injection, USP) with Epinephrine 1:200,000 Product Code Unit of Sale Strength Each 480717 NDC 63323-487-17 Unit of 25 1% (100 mg per 10 mL) (10 mg per mL) NDC 63323-487-01 10 mL Single Dose Vial 480737 NDC 63323-487-37 Unit of 25 1% (300 mg per 30 mL) (10 mg per mL) NDC 63323-487-07 30 mL Single Dose Vial 480731 NDC 63323-487-31 Unit of 5 1% (300 mg per 30 mL) (10 mg per mL) NDC 63323-487-03 30 mL Single Dose Vial 480817 NDC 63323-488-17 Unit of 25 1.5% (150 mg per 10 mL) (15 mg per mL) NDC 63323-488-01 10 mL Single Dose Vial 480837 NDC 63323-488-37 Unit of 25 1.5% (450 mg per 30 mL) (15 mg per mL) NDC 63323-488-07 30 mL Single Dose Vial 480831 NDC 63323-488-31 Unit of 5 1.5% (450 mg per 30 mL) (15 mg per mL) NDC 63323-488-03 30 mL Single Dose Vial 480917 NDC 63323-489-17 Unit of 25 2% (200 mg per 10 mL) (20 mg per mL) NDC 63323-489-01 10 mL Single Dose Vial 480927 NDC 63323-489-27 Unit of 25 2% (400 mg per 20 mL) (20 mg per mL) NDC 63323-489-02 20 mL Single Dose Vial 480921 NDC 63323-489-21 Unit of 5 2% (400 mg per 20 mL) (20 mg per mL) NDC 63323-489-03 20 mL Single Dose Vial For single-dose vials and ampules: Discard unused portion. All solutions should be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. All trademarks are the property of Fresenius Kabi USA, LLC. Fresenius Kabi Logo www.fresenius-kabi.com/us 4 5 1 1 7 5 F Revised: March 2019 Fresenius Kabi Logo; HOW SUPPLIED Sodium Chloride Injection, USP, 0.9%, preservative free, is available as follows: Product Code Unit of Sale Strength Each 918602 63323-186-02 Trays of 25 0.9% (18 mg per 2 mL) (9 mg per ml) NDC 63323-186-04 2 mL fill, in a 3 mL Single-Dose Vial 918610 63323-186-10 Trays of 25 0.9% (90 mg per 10 mL) (9 mg per mL) NDC 63323-186-01 10 mL Single-Dose vial 918620 63323-186 20 Trays of 25 0.9% (180 mg per 20 mL) (9 mg per mL) NDC 63323-186-03 20 mL Single-Dose vial Preservative Free. Discard unused portion. Use only if solution is clear and seal intact. Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. Fresenius Kabi Logo www.fresenius-kabi.com/us 45764E Revised: October 2018 Fresenius Kabi Logo; PRINCIPAL DISPLAY PANEL: P-Care X NDC 49836-003-18 RX-Only P-Care X Kit Contains: 1 Xylocaine ® - MPF 1% Single Dose Vial (10 mg/mL) (5mL) 1 Sodium Chloride Injection, USP 0.9% Single Dose Vial (10 mL) 1 Sterile Povidone-Iodine Swabsticks (3 Swabs) 1 Sterile Pair Nitrile Powder-Free Gloves (Size 7.5) 1 Sterile Towel Drape 1 Sterile Fenestrated Towel Drape 2 Sterile Adhesive Bandage 2 Sterile Adhesive Spot Bandage 3 Sterile Packs of 4x4 Gauze (6 Gauzes) 5 Sterile Isopropyl Alcohol 70% Prep Pad 1 Dose Needles and Syringes Not Included P-Care x DISTRIBUTED BY: SCHMIGS HAUPPAUGE, NY 11788 NDC 49836-003-18 MANUFACTURED BY: Rx Pharma Pack HAUPPAUGE, NY 11788 Questions/Comments 1-844-632-7898 Kit Contents: Xylocaine ® §- MPF 1% (10 mg/mL) (Fresenius Kabi USA, LLC)* Lidocaine HCl Injection, USP Sterile, nonpyrogenic, isotonic solution containing sodium chloride and a local anesthetic agent. Sodium Chloride Injection, USP 0.9% (10 mL) (APP Fresenius Kabi USA, LLC)* Each mL contains sodium chloride, 9 mg. May contain HCI and/or NaOH for pH adjustment. Sterile, nonpyrogenic, preservative free. Sterile Povidone-lodine Swabsticks (Aplicare)* Sterile Nitrile Powder-Free Gloves (Dynarex) - Size 7.5* Sterile Towel Drape (Dynarex)* Sterile Fenestrated Towel Drape (Dynarex)* Sterile Adhesive Bandage (Dynarex)* Sterile Adhesive Spot Bandage (Dynarex)* Sterile 4x4 Gauze (Dynarex)* Sterile Alcohol Prep Pad 70% by Volume (Dynarex)* § Xylocaine ® (registered trademark of APP Fresenius Kabi, LLC) * Internal package components remain sterile when stated as long as items are unopened and undamaged. WARNING: KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY. PROTECT FROM LIGHT I AVOID FREEZING STORE AT CONTROLLED ROOM TEMPERATURE 20º-25ºC (68º-77º F) [SEE USP CONTROLLED ROOM TEMPERATURE] DO NOT REFRIGERATE. Directions for Use: See enclosed inserts. SUSTAINABLE Certified Sourcing FORESTRY www.sfiprogram.org INITIATIVE SFI-01376 ORG 04/2017 This product is not eligible for Medicare or Medicaid reimbursement. P-Care X P-Care X
- HOW SUPPLIED Xylocaine ® (lidocaine HCl Injection, USP) Product Code Unit of Sale Strength Each 480457 NDC 63323-484-57 Unit of 25 0.5% (250 mg per 50 mL) (5 mg per mL) NDC 63323-484-57 50 mL Multiple Dose Vial 480527 NDC 63323-485-27 Unit of 25 1% (200 mg per 20 mL) (10 mg per mL) NDC 63323-485-01 20 mL Multiple Dose Vial 480557 NDC 63323-485-57 Unit of 25 1% (500 mg per 50 mL) (10 mg per mL) NDC 63323-485-03 50 mL Multiple Dose Vial 480617 NDC 63323-486-17 Unit of 25 2% (200 mg per 10 mL) (20 mg per mL) NDC 63323-486-01 10 mL Multiple Dose Vial 480627 NDC 63323-486-27 Unit of 25 2% (400 mg per 20 mL) (20 mg per mL) NDC 63323-486-02 20 mL Multiple Dose Vial 480657 NDC 63323-486-57 Unit of 25 2% (1,000 mg per 50 mL) (20 mg per mL) NDC 63323-486-05 50 mL Multiple Dose Vial Xylocaine ® -MPF (lidocaine HCl Injection, USP) Product Code Unit of Sale Strength Each 491157 NDC 63323-491-57 Unit of 25 0.5% (250 mg per 50 mL) (5 mg per mL) NDC 63323-491-01 50 mL Single Dose Vial 491227 NDC 63323-492-27 Unit of 25 1% (20 mg per 2 mL) (10 mg per mL) NDC 63323-492-04 2 mL Single Dose Vial 491257 NDC 63323-492-57 Unit of 25 1% (50 mg per 5 mL) (10 mg per mL) NDC 63323-492-09 5 mL Single Dose Vial 491297 NDC 63323-492-97 Unit of 5 1% (100 mg per 10 mL) (10 mg per mL) NDC 63323-492-08 10 mL Plastic Ampule 491237 NDC 63323-492-37 Unit of 25 1% (300 mg per 30 mL) (10 mg per mL) NDC 63323-492-07 30 mL Single Dose Vial 491231 NDC 63323-492-31 Unit of 5 1% (300 mg per 30 mL) (10 mg per mL) NDC 63323-492-03 30 mL Single Dose Vial 491397 NDC 63323-493-97 Unit of 5 1.5% (150 mg per 10 mL) (15 mg per mL) NDC 63323-493-03 10 mL Plastic Ampule 491391 NDC 63323-493-91 Unit of 5 1.5% (300 mg per 20 mL) (15 mg per mL) NDC 63323-493-01 20 mL Plastic Ampule 491527 NDC 63323-495-27 Unit of 25 2% (40 mg per 2 mL) (20 mg per mL) NDC 63323-495-09 2 mL Single Dose Vial 491507 NDC 63323-495-07 Unit of 25 2% (100 mg per 5 mL) (20 mg per mL) NDC 63323-495-04 5 mL Single Dose Vial 491697 NDC 63323-496-97 Unit of 5 2% (200 mg per 10 mL) (20 mg per mL) NDC 63323-496-03 10 mL Plastic Ampule Xylocaine ® (lidocaine HCl and epinephrine Injection, USP) with Epinephrine 1:100,000 Product Code Unit of Sale Strength Each 480217 NDC 63323-482-17 Unit of 25 1% (100 mg per 10 mL) (10 mg per mL) NDC 63323-482-01 10 mL Multiple Dose Vial 480227 NDC 63323-482-27 Unit of 25 1% (200 mg per 20 mL) (10 mg per mL) NDC 63323-482-03 20 mL Multiple Dose Vial 480257 NDC 63323-482-57 Unit of 25 1% (500 mg per 50 mL) (10 mg per mL) NDC 63323-482-05 50 mL Multiple Dose Vial 480327 NDC 63323-483-27 Unit of 25 2% (400 mg per 20 mL) (20 mg per mL) NDC 63323-483-03 20 mL Multiple Dose Vial 480357 NDC 63323-483-57 Unit of 25 2% (1,000 mg per 5 mL) (20 mg per mL) NDC 63323-483-01 50 mL Multiple Dose Vial Xylocaine ® (lidocaine HCl and epinephrine Injection, USP) with Epinephrine 1:200,000 Product Code Unit of Sale Strength Each 480157 NDC 63323-481-57 Unit of 25 0.5% (250 mg per 50 mL) (5 mg per mL) NDC 63323-481-01 50 mL Multiple Dose Vial Xylocaine ® -MPF (lidocaine HCl and epinephrine Injection, USP) with Epinephrine 1:200,000 Product Code Unit of Sale Strength Each 480717 NDC 63323-487-17 Unit of 25 1% (100 mg per 10 mL) (10 mg per mL) NDC 63323-487-01 10 mL Single Dose Vial 480737 NDC 63323-487-37 Unit of 25 1% (300 mg per 30 mL) (10 mg per mL) NDC 63323-487-07 30 mL Single Dose Vial 480731 NDC 63323-487-31 Unit of 5 1% (300 mg per 30 mL) (10 mg per mL) NDC 63323-487-03 30 mL Single Dose Vial 480817 NDC 63323-488-17 Unit of 25 1.5% (150 mg per 10 mL) (15 mg per mL) NDC 63323-488-01 10 mL Single Dose Vial 480837 NDC 63323-488-37 Unit of 25 1.5% (450 mg per 30 mL) (15 mg per mL) NDC 63323-488-07 30 mL Single Dose Vial 480831 NDC 63323-488-31 Unit of 5 1.5% (450 mg per 30 mL) (15 mg per mL) NDC 63323-488-03 30 mL Single Dose Vial 480917 NDC 63323-489-17 Unit of 25 2% (200 mg per 10 mL) (20 mg per mL) NDC 63323-489-01 10 mL Single Dose Vial 480927 NDC 63323-489-27 Unit of 25 2% (400 mg per 20 mL) (20 mg per mL) NDC 63323-489-02 20 mL Single Dose Vial 480921 NDC 63323-489-21 Unit of 5 2% (400 mg per 20 mL) (20 mg per mL) NDC 63323-489-03 20 mL Single Dose Vial For single-dose vials and ampules: Discard unused portion. All solutions should be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. All trademarks are the property of Fresenius Kabi USA, LLC. Fresenius Kabi Logo www.fresenius-kabi.com/us 4 5 1 1 7 5 F Revised: March 2019 Fresenius Kabi Logo
- HOW SUPPLIED Sodium Chloride Injection, USP, 0.9%, preservative free, is available as follows: Product Code Unit of Sale Strength Each 918602 63323-186-02 Trays of 25 0.9% (18 mg per 2 mL) (9 mg per ml) NDC 63323-186-04 2 mL fill, in a 3 mL Single-Dose Vial 918610 63323-186-10 Trays of 25 0.9% (90 mg per 10 mL) (9 mg per mL) NDC 63323-186-01 10 mL Single-Dose vial 918620 63323-186 20 Trays of 25 0.9% (180 mg per 20 mL) (9 mg per mL) NDC 63323-186-03 20 mL Single-Dose vial Preservative Free. Discard unused portion. Use only if solution is clear and seal intact. Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. Fresenius Kabi Logo www.fresenius-kabi.com/us 45764E Revised: October 2018 Fresenius Kabi Logo
- PRINCIPAL DISPLAY PANEL: P-Care X NDC 49836-003-18 RX-Only P-Care X Kit Contains: 1 Xylocaine ® - MPF 1% Single Dose Vial (10 mg/mL) (5mL) 1 Sodium Chloride Injection, USP 0.9% Single Dose Vial (10 mL) 1 Sterile Povidone-Iodine Swabsticks (3 Swabs) 1 Sterile Pair Nitrile Powder-Free Gloves (Size 7.5) 1 Sterile Towel Drape 1 Sterile Fenestrated Towel Drape 2 Sterile Adhesive Bandage 2 Sterile Adhesive Spot Bandage 3 Sterile Packs of 4x4 Gauze (6 Gauzes) 5 Sterile Isopropyl Alcohol 70% Prep Pad 1 Dose Needles and Syringes Not Included P-Care x DISTRIBUTED BY: SCHMIGS HAUPPAUGE, NY 11788 NDC 49836-003-18 MANUFACTURED BY: Rx Pharma Pack HAUPPAUGE, NY 11788 Questions/Comments 1-844-632-7898 Kit Contents: Xylocaine ® §- MPF 1% (10 mg/mL) (Fresenius Kabi USA, LLC)* Lidocaine HCl Injection, USP Sterile, nonpyrogenic, isotonic solution containing sodium chloride and a local anesthetic agent. Sodium Chloride Injection, USP 0.9% (10 mL) (APP Fresenius Kabi USA, LLC)* Each mL contains sodium chloride, 9 mg. May contain HCI and/or NaOH for pH adjustment. Sterile, nonpyrogenic, preservative free. Sterile Povidone-lodine Swabsticks (Aplicare)* Sterile Nitrile Powder-Free Gloves (Dynarex) - Size 7.5* Sterile Towel Drape (Dynarex)* Sterile Fenestrated Towel Drape (Dynarex)* Sterile Adhesive Bandage (Dynarex)* Sterile Adhesive Spot Bandage (Dynarex)* Sterile 4x4 Gauze (Dynarex)* Sterile Alcohol Prep Pad 70% by Volume (Dynarex)* § Xylocaine ® (registered trademark of APP Fresenius Kabi, LLC) * Internal package components remain sterile when stated as long as items are unopened and undamaged. WARNING: KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY. PROTECT FROM LIGHT I AVOID FREEZING STORE AT CONTROLLED ROOM TEMPERATURE 20º-25ºC (68º-77º F) [SEE USP CONTROLLED ROOM TEMPERATURE] DO NOT REFRIGERATE. Directions for Use: See enclosed inserts. SUSTAINABLE Certified Sourcing FORESTRY www.sfiprogram.org INITIATIVE SFI-01376 ORG 04/2017 This product is not eligible for Medicare or Medicaid reimbursement. P-Care X P-Care X
Overview
Xylocaine (lidocaine HCl) Injections are sterile, nonpyrogenic, aqueous solutions that contain a local anesthetic agent with or without epinephrine and are administered parenterally by injection. See INDICATIONS AND USAGE section for specific uses. Xylocaine solutions contain lidocaine HCl, which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride and has the molecular wt. 270.8. Lidocaine HCl (C 14 H 22 N 2O • HCl) has the following structural formula: : Xylocaine Structural Formula Epinephrine is (-) -3, 4-Dihydroxy-α-[(methylamino) methyl] benzyl alcohol and has the molecular wt. 183.21. Epinephrine (C 9 H 13 NO 3 ) has the following structural formula: Epinephrine Structural Formula Dosage forms listed as Xylocaine-MPF indicate single dose solutions that are M ethyl P araben F ree (MPF). Xylocaine MPF is a sterile, nonpyrogenic, isotonic solution containing sodium chloride. Xylocaine in multiple dose vials : Each mL also contains 1 mg methylparaben as antiseptic preservative. The pH of these solutions is adjusted to approximately 6.5 (5.0 to 7.0) with sodium hydroxide and/or hydrochloric acid. Xylocaine MPF with Epinephrine is a sterile, nonpyrogenic, isotonic solution containing sodium chloride. Each mL contains lidocaine hydrochloride and epinephrine, with 0.5 mg sodium metabisulfite as an antioxidant and 0.2 mg citric acid as a stabilizer. Xylocaine with Epinephrine in multiple dose vials: Each mL also contains 1 mg methylparaben as antiseptic preservative. The pH of these solutions is adjusted to approximately 4.5 (3.3 to 5.5) with sodium hydroxide and/or hydrochloric acid. Filled under nitrogen. Xylocaine Structural Formula Epinephrine Structural Formula DESCRIPTION Sodium Chloride Injection, USP, 0.9% is a sterile, nonpyrogenic solution. The osmolarity is 300 mOsmol per liter (calculated). Each mL contains: Sodium chloride 9 mg; Water for Injection q.s. It contains no bacteriostat, antimicrobial agent or added buffer and is supplied only in single dose containers. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment (pH 4.5-7.0). Sodium chloride occurs as colorless cubic crystals or white crystalline powder and has a saline taste. Sodium chloride is freely soluble in water. It is soluble in glycerin and slightly soluble in alcohol. The empirical formula for sodium chloride is NaCl and the molecular weight is 58.44.
Indications & Usage
Xylocaine (lidocaine HCl) Injections are indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection and intravenous regional anesthesia by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed. INDICATIONS AND USAGE Sodium Chloride Injection, USP, 0.9% preparations are indicated for diluting or dissolving drugs for intramuscular, intravenous or subcutaneous injection according to instructions of the manufacturer of the drug to be administered. Sodium Chloride Injection, USP, 0.9% is also indicated for use in flushing of intravenous catheters. USE Antiseptic skin preparation USE For preparation of the skin prior to injection.
Dosage & Administration
Table 1 (Recommended Dosages) summarizes the recommended volumes and concentrations of Xylocaine Injection 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. There have been adverse event reports of chondrolysis in patients receiving intra-articular infusions of local anesthetics following arthroscopic and other surgical procedures. Xylocaine is not approved for this use (see WARNINGS and DOSAGE AND ADMINISTRATION ). 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 the 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 Xylocaine Injection 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. However, increasing the volume and concentration of Xylocaine Injection may result in a more profound fall in blood pressure when used in epidural anesthesia. Although the incidence of side effects with lidocaine HCl 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. For intravenous regional anesthesia, only the 50 mL single dose vial containing Xylocaine (lidocaine HCl) 0.5% Injection should be used. Epidural Anesthesia For epidural anesthesia, only the following dosage forms Xylocaine Injection are recommended: 1% without epinephrine 10 mL Plastic Ampule 1% without epinephrine 30 mL single dose solutions 1% with epinephrine 1:200,000 30 mL single dose solutions 1.5% without epinephrine 10 mL Plastic Ampule 1.5% without epinephrine 20 mL Plastic Ampule 1.5% with epinephrine 1:200,000 30 mL ampules, 30 mL single dose solutions 2% without epinephrine 10 mL Plastic Ampule 2% with epinephrine 1:200,000 20 mL ampules, 20 mL single dose solutions Although these solutions are intended specifically for epidural anesthesia, they may also be used for infiltration and peripheral nerve block, provided they are employed as single dose units. These solutions contain no bacteriostatic agent. In epidural anesthesia, the dosage varies with the numb r of dermatomes to be anesthetized (generally 2 to 3 mL of the indicated concentration per dermatome). Caudal and Lumbar Epidural Block As a precaution against the adverse experience sometimes observed following unintentional penetration of the subarachnoid space, a test dose such as 2 to 3 mL of 1.5% lidocaine HCl should be administered at least 5 minutes prior to injecting the total volume required for a lumbar or caudal epidural block. The test dose should be repeated if the patient is moved in a manner that may have displaced the catheter. Epinephrine, if contained in the test dose (10 to 15 mcg have been suggested), may serve as a warning of unintentional intravascular injection. If injected into a blood vessel, this amount of epinephrine is likely to produce a transient “epinephrine response” within 45 seconds, consisting of an increase in heart rate and systolic blood pressure, circumoral pallor, palpitations and nervousness in the unsedated patient. The sedated patient may exhibit only a pulse rate increase of 20 or more beats per minute for 15 or more seconds. Patients on beta blockers may not manifest changes in heart rate, but blood pressure monitoring can detect an evanescent rise in systolic blood pressure. Adequate time should be allowed for onset of anesthesia after administration of each test dose. The rapid injection of a large volume of Xylocaine Injection through the catheter should be avoided, and, when feasible, fractional doses should be administered. 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. MAXIMUM RECOMMENDED DOSAGES Adults For normal healthy adults, the individual maximum recommended dose of lidocaine HCl with epinephrine should not exceed 7 mg/kg (3.5 mg/lb) of body weight, and in general it is recommended that the maximum total dose not exceed 500 mg. When used without epinephrine the maximum individual dose should not exceed 4.5 mg/kg (2 mg/lb) 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, more drug 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 also discussion of paracervical block in PRECAUTIONS ). For intravenous regional anesthesia, the dose administered should not exceed 4 mg/kg in adults. Children It is difficult to recommend a maximum dose of any drug for children, since this varies as a function of age and weight. For children over 3 years of age who have 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 50 lbs the dose of lidocaine HCl should not exceed 75 to 100 mg (1.5 to 2 mg/lb). The use of even more dilute solutions (i.e., 0.25 to 0.5%) and total dosages not to exceed 3 mg/kg (1.4 mg/lb) are recommended for induction of intravenous regional anesthesia in children. In order to guard against systemic toxicity, the lowest effective concentration and lowest effective dose should be used at all times. In some cases it will be necessary to dilute available concentrations with 0.9% sodium chloride injection in order to obtain the required final concentration. NOTE: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever the solution and container permit. The Injection is not to be used if its color is pinkish or darker than slightly yellow or if it contains a precipitate. Table 1: Recommended Dosages Procedure Xylocaine (lidocaine hydrochloride) Injection (without epinephrine) 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 Pundendal (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). 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. DOSAGE AND ADMINISTRATION Before Sodium Chloride Injection, USP, 0.9% is used as a vehicle for the administration of a drug, specific references should be checked for any possible incompatibility with sodium chloride. The volume of the preparation to be used for diluting or dissolving any drug for injection is dependent on the vehicle concentration, dose and route of administration as recommended by the manufacturer. Sodium Chloride Injection, USP, 0.9% is also indicated for use in flushing intravenous catheters. Prior to and after administration of the medication, the intravenous catheter should be flushed in its entirety with Sodium Chloride Injection, USP, 0.9%. Use in accord with any warnings or precautions appropriate to the medication being administered. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. DIRECTIONS Apply locally as needed DIRECTIONS Wipe injection site vigorously and discard.
Warnings & Precautions
WARNINGS XYLOCAINE INJECTIONS 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. Methemoglobinemia Cases of methemoglobinemia have been reported in association with local anesthetic use. Although all patients are at risk for methemoglobinemia, patients with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, infants under 6 months of age, and concurrent exposure to oxidizing agents or their metabolites are more susceptible to developing clinical manifestations of the condition. If local anesthetics must be used in these patients, close monitoring for symptoms and signs of methemoglobinemia is recommended. Signs of methemoglobinemia may occur immediately or may be delayed some hours after exposure, and are characterized by a cyanotic skin discoloration and/or abnormal coloration of the blood. Methemoglobin levels may continue to rise; therefore, immediate treatment is required to avert more serious central nervous system and cardiovascular adverse effects, including seizures, coma, arrhythmias, and death. Discontinue Xylocaine and any other oxidizing agents. Depending on the severity of the signs and symptoms, patients may respond to supportive care, i.e., oxygen therapy, hydration. A more severe clinical presentation may require treatment with methylene blue, exchange transfusion, or hyperbaric oxygen. Intra-articular infusions of local anesthetics following arthroscopic and other surgical procedures is an unapproved use, and there have been post-marketing reports of chondrolysis in patients receiving such infusions. The majority of reported cases of chondrolysis have involved the shoulder joint; cases of gleno-humeral chondrolysis have been described in pediatric and adult patients following intra-articular infusions of local anesthetics with and without epinephrine for periods of 48 to 72 hours. There is insufficient information to determine whether shorter infusion periods are not associated with these findings. The time of onset of symptoms, such as joint pain, stiffness and loss of motion can be variable, but may begin as early as the 2nd month after surgery. Currently, there is no effective treatment for chondrolysis; patients who experienced chondrolysis have required additional diagnostic and therapeutic procedures and some required arthroplasty or shoulder replacement. 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 he 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. Xylocaine with epinephrine solutions contain 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. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people. Anaphylactic reactions may occur following administration of lidocaine hydrochloride (see ADVERSE REACTIONS ). In the case of severe reaction, discontinue the use of the drug. WARNINGS For use in newborns, when a sodium chloride solution is required for preparation or diluting medications or in flushing intravenous catheters, only preservative free Sodium Chloride Injection, USP, 0.9% should be used. WARNINGS Do not use if allergic to iodine in the eyes For external use only Avoid pooling beneath patient Avoid excessive heat. Store at room temperature. Ask a doctor before use if injuries are deep or puncture wounds serious burns Stop use and ask a doctor if redness, irritations, swelling or pain persists or increases infection occurs Keep out of reach of children. In case of accidental ingestion, seek professional assistance or consult a poison control center immediately. WARNINGS For external use only Flammable, keep away from flame or fire Not for use with electrocautinary devices or procedures Do not use in eyes Sterile unless package is damaged or open. Stop use and ask a doctor if: Irritation or redness develops Condition persists for more than 72 hours Cleansing of an injection site Keep out of reach of children. In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.
Contraindications
Lidocaine HCl is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type.
Adverse Reactions
Systemic Adverse experiences following the administration of lidocaine HCl are similar in nature to those observed with other amide local anesthetic agents. These adverse experiences are, in general, dose- related and may result from high plasma levels caused by excessive dosage, rapid absorption or inadvertent intravascular injection, or may result from a hypersensitivity, idiosyncrasy or diminished tolerance on the part of the patient. Serious adverse experiences are generally systemic in nature. The following types are those most commonly reported: Central Nervous System CNS manifestations are excitatory and/or depressant and may be characterized by 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. The excitatory manifestations may be very brief or may not occur at all, in which case the first manifestation of toxicity may be drowsiness merging into unconsciousness and respiratory arrest. Drowsiness following the administration of lidocaine HCl is usually an early sign of a high blood level of the drug and may occur as a consequence of rapid absorption. Cardiovascular System Cardiovascular manifestations are usually depressant and are characterized by bradycardia, hypotension, and cardiovascular collapse, which may lead to cardiac arrest. Allergic Allergic reactions are characterized by cutaneous lesions, urticaria, edema or anaphylactoid reactions. Allergic reactions may occur as a result of sensitivity either to local anesthetic agents or to the methylparaben used as a preservative in the multiple dose vials. Allergic reactions, including anaphylactic reactions, may occur as a result of sensitivity to lidocaine, but are infrequent. If allergic reactions do occur, they should be managed by conventional means. The detection of sensitivity by skin testing is of doubtful value. There have been no reports of cross sensitivity between lidocaine hydrochloride and procainamide or between lidocaine hydrochloride and quinidine. Neurologic The incidences of adverse reactions associated with the use of local anesthetics may be related to the total dose of local anesthetic administered and are also dependent upon the particular drug used, the route of administration and the physical status of the patient. In a prospective review of 10,440 patients who received lidocaine HCl for spinal anesthesia, the incidences of adverse reactions were reported to be about 3 percent each for positional headaches, hypotension and backache; 2 percent for shivering; and less than 1 percent each for peripheral nerve symptoms, nausea, respiratory inadequacy and double vision. Many of these observations may be related to local anesthetic techniques, with or without a contribution from the local anesthetic. In the practice of caudal or lumbar epidural block, occasional unintentional penetration of the subarachnoid space by the catheter may occur. Subsequent adverse effects may depend partially on the amount of drug administered subdurally. These may include spinal block of varying magnitude (including total spinal block), hypotension secondary to spinal block, loss of bladder and bowel control, and loss of perineal sensation and sexual function. Persistent motor, sensory and/or autonomic (sphincter control) deficit of some lower spinal segments with slow recovery (several months) or incomplete recovery have been reported in rare instances when caudal or lumbar epidural block has been attempted. Backache and headache have also been noted following use of these anesthetic procedures. There have been reported cases of permanent injury to extraocular muscles requiring surgical repair following retrobulbar administration. Hematologic Methemoglobinemia. ADVERSE REACTIONS Reactions which may occur because of this solution, added drugs or the technique of reconstitution or administration include febrile response, local tenderness, abscess, tissue necrosis or infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection and extravasation. If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate countermeasures and, if possible, retrieve and save the remainder of the unused vehicle for examination.
Purpose
PURPOSE Antiseptic PURPOSE Antiseptic
Storage & Handling
OTHER INFORMATION Store at room temperature: 15 deg C to 30 deg C 59 deg F to 86 deg F avoid excessive heat Reorder No. 1113 Made in Chine Manufactured for: Dynarex Corporation Orangeburg, NY 10962 www.dynarex.com Revised: 11/2019
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