Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING Do not autoclave. Storage : All solutions should be stored at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from light . For single-dose vials and ampules: Discard unused portion. For Epidural test dose, Lidocaine Hydrochloride and Epinephrine Injection, USP 1:200,000 is a clear, colorless to slightly yellow solution available as: Unit of Sale Concentration 1.5% Contains 15 mg lidocaine hydrochloride per mL NDC 0409-1209-01 Tray of 10 single-dose ampuls 75 mg/5 mL (15 mg/mL) NDC 0409-1209-05 Case of 400 single-dose ampuls 75 mg/5 mL (15 mg/mL) NDC 0409-1209-65 Case of 800 single-dose ampuls (Kit Packer) 75 mg/5 mL (15 mg/mL) Lidocaine Hydrochloride and Epinephrine Injection, USP 1:200,000 is a clear, colorless to slightly yellow solution available as: Unit of Sale Concentration 1.5% Contains 15 mg lidocaine hydrochloride per mL NDC 0409-3181-01 Carton of 5 single-dose fliptop vials 450 mg/30 mL (15 mg/mL) 2% Contains 20 mg lidocaine hydrochloride per mL NDC 0409-3183-01 Carton of 5 single-dose fliptop vials 400 mg/20 mL (20 mg/mL) Lidocaine Hydrochloride and Epinephrine Injection 1:200,000, USP is a clear, colorless to slightly yellow solution available as: Unit of Sale Concentration 0.5% Contains 5 mg lidocaine hydrochloride per mL NDC 0409-3177-01 Tray of 25 multiple-dose fliptop vials 250 mg/50 mL (5 mg/mL) Lidocaine Hydrochloride and Epinephrine Injection 1:100,000, USP is a clear, colorless to slightly yellow solution available as: Unit of Sale Concentration 1% Contains 10 mg lidocaine hydrochloride per mL NDC 0409-0007-10 Carton of 10 multiple-dose fliptop vials 200 mg/20 mL (10 mg/mL) NDC 0409-3178-01 Tray of 25 multiple-dose fliptop vials 200 mg/20 mL (10 mg/mL) NDC 0409-3178-02 Tray of 25 multiple-dose fliptop vials 300 mg/30 mL (10 mg/mL) NDC 0409-3178-03 Tray of 25 multiple-dose fliptop vials 500 mg/50 mL (10 mg/mL) 2% Contains 20 mg lidocaine hydrochloride per mL NDC 0409-0147-10 Carton of 10 multiple-dose fliptop vials 400 mg/20 mL (20 mg/mL) NDC 0409-3182-01 Tray of 25 multiple-dose fliptop vials 400 mg/20 mL (20 mg/mL) NDC 0409-3182-02 Tray of 25 multiple-dose fliptop vials 600 mg/30 mL (20 mg/mL) NDC 0409-3182-03 Tray of 25 multiple-dose fliptop vials 1000 mg/50 mL (20 mg/mL); PRINCIPAL DISPLAY PANEL - 5 mL Ampule Label 5 mL Single-dose NDC 0409-1209-10 LIDOCAINE HCl 1.5% 75 mg/5 mL (15 mg/mL) and EPINEPHRINE 1:200,000 Inj., USP Rx only Epidural Test Dose Discard unused portion. Dist. by Hospira, Inc., Lake Forest, IL 60045 USA Hospira RL–7864 LOT ##–###–AA EXP DMMMYYYY Lidocaine 5mL ampule label.PNG; PRINCIPAL DISPLAY PANEL - 5 mL Ampule Tray Label 5 mL Single-dose 10 Ampuls Rx only NDC 0409-1209-01 Contains 10 of NDC 0409-1209-10 Lidocaine HCl 1.5% 75 mg/5 mL (15 mg/mL) and Epinephrine 1:200,000 Injection, USP Epidural Test Dose For Use as a Test Dose During Epidural Anesthesia Protect from light. Keep ampuls in tray until time of use. Each mL contains lidocaine HCl, anhyd. 15 mg; epinephrine 5 mcg; sodium chloride 6.5 mg; sodium metabisulfite 0.5 mg added. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment. pH 4.5 (3.3 to 5.5). Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Do not autoclave (contains epinephrine). NOTE: Inspect ampul and discard if chipped, cracked or underfilled. Do not use the Injection if its color is pinkish or darker than slightly yellow or if it contains a precipitate. Usual dosage : See Insert. During epidural anesthesia, 2 to 3 mL will provide a test dose containing 30 to 45 mg of lidocaine hydrochloride and 10 to 15 mcg of epinephrine. The test dose should be administered and the effects monitored before the full dose is given. Discard unused portion. Distributed by Hospira, Inc., Lake Forest, IL 60045 USA Hospira RL–7863 LOT ##–###–AA EXP DMMMYYYY Lidocaine 5 mL ampule tray label.PNG; PRINCIPAL DISPLAY PANEL - 5 mL Ampule Label - 1209 5 mL Single-dose NDC 0409-1209-70 LIDOCAINE HCl 1.5% 75 mg/5 mL (15 mg/mL) and EPINEPHRINE 1:200,000 Injection, USP Rx only Epidural Test Dose Discard unused portion. Dist. by Hospira, Inc., Lake Forest, IL 60045 USA Hospira RL–7862 LOT ##–###–AA EXP DMMMYYYY Lidocaine 5 mL ampule label.PNG; PRINCIPAL DISPLAY PANEL - 50 mL Vial Label 50 mL MULTIPLE-DOSE Lidocaine HCl 0.5% 250 mg/50 mL (5 mg/mL) and Epinephrine 1:200,000 Injection, USP Rx only For Infiltration and Nerve Block. NOT FOR EPIDURAL OR CAUDAL USE. Distributed by Hospira, Inc., Lake Forest, IL 60045 USA Hospira PRINCIPAL DISPLAY PANEL - 50 mL Vial Label; PRINCIPAL DISPLAY PANEL - 50 mL Vial Tray 50 mL MULTIPLE-DOSE Fliptop Vial Rx only NDC 0409-3177-01 Contains 25 of NDC 0409-3177-16 Lidocaine HCl 0.5% 250 mg/50 mL (5 mg/mL) and Epinephrine 1:200,000 Injection, USP Protect from light. Retain in carton until contents are used. Do not autoclave. For Infiltration and Nerve Block. NOT FOR EPIDURAL OR CAUDAL USE. PRINCIPAL DISPLAY PANEL - 50 mL Vial Tray; PRINCIPAL DISPLAY PANEL - 20 mL Vial Label 20 mL MULTIPLE-DOSE Lidocaine HCl 1% 200 mg/20 mL (10 mg/mL) and Epinephrine 1:100,000 Injection, USP For Infiltration and Nerve Block. Rx only NOT FOR EPIDURAL OR CAUDAL USE. Distributed by Hospira, Inc., Lake Forest, IL 60045 USA Hospira PRINCIPAL DISPLAY PANEL - 20 mL Vial Label; PRINCIPAL DISPLAY PANEL - 20 mL Vial Tray 20 mL MULTIPLE-DOSE Fliptop Vial Rx only NDC 0409-3178-01 Contains 25 of NDC 0409-3178-16 Lidocaine HCl 1% 200 mg/20 mL (10 mg/mL) and Epinephrine 1:100,000 Injection, USP Protect from light. Retain in carton until contents are used. Do not autoclave. For Infiltration and Nerve Block. NOT FOR EPIDURAL OR CAUDAL USE. PRINCIPAL DISPLAY PANEL - 20 mL Vial Tray; PRINCIPAL DISPLAY PANEL - 30 mL Vial Label 30 mL MULTIPLE-DOSE Lidocaine HCl 1% 300 mg/30 mL (10 mg/mL) and Epinephrine 1:100,000 Injection, USP For Infiltration and Nerve Block. NOT FOR EPIDURAL OR CAUDAL USE. PRINCIPAL DISPLAY PANEL - 30 mL Vial Label; PRINCIPAL DISPLAY PANEL - 30 mL Vial Tray 30 mL MULTIPLE-DOSE Fliptop Vial Rx only NDC 0409-3178-02 Contains 25 of NDC 0409-3178-17 Lidocaine HCl 1% 300 mg/30 mL (10 mg/mL) and Epinephrine 1:100,000 Injection, USP Protect from light. Retain in carton until contents are used. Do not autoclave. For Infiltration and Nerve Block. NOT FOR EPIDURAL OR CAUDAL USE. PRINCIPAL DISPLAY PANEL - 30 mL Vial Tray; PRINCIPAL DISPLAY PANEL - 50 mL Vial Label - 3178 50 mL MULTIPLE-DOSE Lidocaine HCl 1% 500 mg/50 mL (10 mg/mL) and Epinephrine 1:100,000 Injection, USP For Infiltration and Nerve Block. Rx only NOT FOR EPIDURAL OR CAUDAL USE. Distributed by Hospira, Inc., Lake Forest, IL 60045 USA Hospira PRINCIPAL DISPLAY PANEL - 50 mL Vial Label - 3178; PRINCIPAL DISPLAY PANEL - 50 mL Vial Tray - 3178 50 mL MULTIPLE-DOSE Fliptop Vial Rx only NDC 0409-3178-03 Contains 25 of NDC 0409-3178-18 Lidocaine HCl 1% 500 mg/50 mL (10 mg/mL) and Epinephrine 1:100,000 Injection, USP Protect from light. Retain in carton until contents are used. Do not autoclave. For Infiltration and Nerve Block. NOT FOR EPIDURAL OR CAUDAL USE. PRINCIPAL DISPLAY PANEL - 50 mL Vial Tray - 3178; PRINCIPAL DISPLAY PANEL - 30 mL Vial Label - 3181 30 mL Single-dose LIDOCAINE HCl 1.5% and 450 mg/30 mL (15 mg/mL) and Epinephrine 1:200,000 Injection, USP Rx only For Infiltration and Nerve Block including Epidural and Caudal. Discard unused portion. Hospira Distributed by Hospira, Inc., Lake Forest, IL 60045 USA PRINCIPAL DISPLAY PANEL - 30 mL Vial Label - 3181; PRINCIPAL DISPLAY PANEL - 30 mL Vial Carton 30 mL Single-dose 5 Fliptop Vials Rx only NDC 0409-3181-01 Contains 5 of NDC 0409-3181-11 Lidocaine Hydrochloride 1.5% 450 mg/30 mL (15 mg/mL) and Epinephrine 1:200,000 Injection, USP Hospira Protect from light. Retain in carton until time of use. Do not autoclave. Discard unused portion. For Infiltration and Nerve Block including Epidural and Caudal. PRINCIPAL DISPLAY PANEL - 30 mL Vial Carton; PRINCIPAL DISPLAY PANEL - 20 mL Vial Label - 3182 20 mL MULTIPLE-DOSE Lidocaine HCl 2% 400 mg/20 mL (20 mg/mL) and Epinephrine 1:100,000 Injection, USP For Infiltration and Nerve Block. NOT FOR EPIDURAL OR CAUDAL USE. Distributed by Hospira Inc., Lake Forest, IL 60045 USA Hospira PRINCIPAL DISPLAY PANEL - 20 mL Vial Label - 3182; PRINCIPAL DISPLAY PANEL - 20 mL Vial Tray - 3182 20 mL MULTIPLE-DOSE Fliptop Vial Rx only NDC 0409-3182-01 Contains 25 of NDC 0409-3182-11 Lidocaine HCl 2% 400 mg/20 mL (20 mg/mL) and Epinephrine 1:100,000 Injection, USP Protect from light. Retain in carton until contents are used. Do not autoclave. For Infiltration and Nerve Block. NOT FOR EPIDURAL OR CAUDAL USE. PRINCIPAL DISPLAY PANEL - 20 mL Vial Tray - 3182; PRINCIPAL DISPLAY PANEL - 30 mL Vial Label - 3182 30 mL MULTIPLE-DOSE Lidocaine HCl 2% 600 mg/30 mL (20 mg/mL) and Epinephrine 1:100,000 Injection, USP For Infiltration and Nerve Block. NOT FOR EPIDURAL OR CAUDAL USE. Rx only Distributed by Hospira Inc., Lake Forest, IL 60045 USA Hospira PRINCIPAL DISPLAY PANEL - 30 mL Vial Label - 3182; PRINCIPAL DISPLAY PANEL - 30 mL Vial Tray - 3182 30 mL MULTIPLE-DOSE Fliptop Vial Rx only NDC 0409-3182-02 Contains 25 of NDC 0409-3182-21 Lidocaine HCl 2% 600 mg/30 mL (20 mg/mL) and Epinephrine 1:100,000 Injection, USP Protect from light. Retain in carton until contents are used. Do not autoclave. For Infiltration and Nerve Block. NOT FOR EPIDURAL OR CAUDAL USE. PRINCIPAL DISPLAY PANEL - 30 mL Vial Tray - 3182; PRINCIPAL DISPLAY PANEL - 50 mL Vial Label - 3182 50 mL MULTIPLE-DOSE Lidocaine HCl 2% 1000 mg/50 mL (20 mg/mL) and Epinephrine 1:100,000 Injection, USP For Infiltration and Nerve Block. Rx only NOT FOR EPIDURAL OR CAUDAL USE. Distributed by Hospira Inc., Lake Forest, IL 60045 USA Hospira PRINCIPAL DISPLAY PANEL - 50 mL Vial Label - 3182; PRINCIPAL DISPLAY PANEL - 50 mL Vial Tray - 3182 50 mL MULTIPLE-DOSE Fliptop Vial Rx only NDC 0409-3182-03 Contains 25 of NDC 0409-3182-31 Lidocaine HCl 2% 1000 mg/50 mL (20 mg/mL) and Epinephrine 1:100,000 Injection, USP Protect from light. Retain in carton until contents are used. Do not autoclave. For Infiltration and Nerve Block. NOT FOR EPIDURAL OR CAUDAL USE. PRINCIPAL DISPLAY PANEL - 50 mL Vial Tray - 3182; PRINCIPAL DISPLAY PANEL - 20 mL Vial Label - 3183 20 mL Single-dose Lidocaine HCl 2% 400 mg/20 mL (20 mg/mL) and Epinephrine 1:200,000 Injection, USP For Infiltration and Nerve Block including Epidural and Caudal. Rx only Distributed by Hospira, Inc., Lake Forest, IL 60045 USA Hospira PRINCIPAL DISPLAY PANEL - 20 mL Vial Label - 3183; PRINCIPAL DISPLAY PANEL - 20 mL Vial Carton 20 mL Single-dose 5 Fliptop Vials Rx only NDC 0409-3183-01 Contains 5 of NDC 0409-3183-11 Lidocaine HCl 2% 400 mg/20 mL (20 mg/mL) and Epinephrine 1:200,000 Injection, USP Protect from light. Retain in carton until time of use. Do not autoclave. Discard unused portion. For Infiltration and Nerve Block including Epidural and Caudal. Hospira PRINCIPAL DISPLAY PANEL - 20 mL Vial Carton; PRINCIPAL DISPLAY PANEL – 20 mL vial Label - 0007 20 mL MULTIPLE-DOSE Lidocaine HCL 1% 200 mg/20 mL (10 mg/mL) and Epinephrine 1:100,000 Injection, USP For Infiltration and Nerve Block. Rx only NOT FOR EPIDURAL OR CAUDAL USE. PRINCIPAL DISPLAY PANEL – 20 mL vial Label - 0007; PRINCIPAL DISPLAY PANEL - 20 mL Vial Carton -0007 20 mL MULTIPLE-DOSE Fliptop Vial Rx only NDC 0409-0007-10 Contains 10 of NDC 0409-0007-01 Lidocaine HCl 1% 200 mg/20 mL (10 mg/mL) and Epinephrine 1:100,000 Injection, USP Protect from light. Retain in carton until contents are used. Do not autoclave. For Infiltration and Nerve Block. NOT FOR EPIDURAL OR CAUDAL USE. PRINCIPAL DISPLAY PANEL – 20 mL vial Carton -0007; PRINCIPAL DISPLAY PANEL – 20 mL vial Label - 0147 20 mL MULTIPLE-DOSE Lidocaine HCl 2% 400 mg/20 mL (20 mg/mL) and Epinephrine 1:100,000 Injection, USP For Infiltration and Nerve Block NOT FOR EPIDURAL OR CAUDAL USE. PRINCIPAL DISPLAY PANEL – 20 mL Label - 0147; PRINCIPAL DISPLAY PANEL – 20 mL vial Carton - 0147 20 mL MULTIPLE-DOSE Fliptop Vial Rx only NDC 0409-0147-10 Contains 10 of NDC 0409-0147-01 Lidocaine HCl 2% 400 mg/20 mL (20 mg/mL) and Epinephrine 1:100,000 Injection, USP Protect from light. Retain in carton until contents are used. Do not autoclave. For Infiltration and Nerve Block. NOT FOR EPIDURAL OR CAUDAL USE. PRINCIPAL DISPLAY PANEL – 20 mL Carton - 0147
- 16 HOW SUPPLIED/STORAGE AND HANDLING Do not autoclave. Storage : All solutions should be stored at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from light . For single-dose vials and ampules: Discard unused portion. For Epidural test dose, Lidocaine Hydrochloride and Epinephrine Injection, USP 1:200,000 is a clear, colorless to slightly yellow solution available as: Unit of Sale Concentration 1.5% Contains 15 mg lidocaine hydrochloride per mL NDC 0409-1209-01 Tray of 10 single-dose ampuls 75 mg/5 mL (15 mg/mL) NDC 0409-1209-05 Case of 400 single-dose ampuls 75 mg/5 mL (15 mg/mL) NDC 0409-1209-65 Case of 800 single-dose ampuls (Kit Packer) 75 mg/5 mL (15 mg/mL) Lidocaine Hydrochloride and Epinephrine Injection, USP 1:200,000 is a clear, colorless to slightly yellow solution available as: Unit of Sale Concentration 1.5% Contains 15 mg lidocaine hydrochloride per mL NDC 0409-3181-01 Carton of 5 single-dose fliptop vials 450 mg/30 mL (15 mg/mL) 2% Contains 20 mg lidocaine hydrochloride per mL NDC 0409-3183-01 Carton of 5 single-dose fliptop vials 400 mg/20 mL (20 mg/mL) Lidocaine Hydrochloride and Epinephrine Injection 1:200,000, USP is a clear, colorless to slightly yellow solution available as: Unit of Sale Concentration 0.5% Contains 5 mg lidocaine hydrochloride per mL NDC 0409-3177-01 Tray of 25 multiple-dose fliptop vials 250 mg/50 mL (5 mg/mL) Lidocaine Hydrochloride and Epinephrine Injection 1:100,000, USP is a clear, colorless to slightly yellow solution available as: Unit of Sale Concentration 1% Contains 10 mg lidocaine hydrochloride per mL NDC 0409-0007-10 Carton of 10 multiple-dose fliptop vials 200 mg/20 mL (10 mg/mL) NDC 0409-3178-01 Tray of 25 multiple-dose fliptop vials 200 mg/20 mL (10 mg/mL) NDC 0409-3178-02 Tray of 25 multiple-dose fliptop vials 300 mg/30 mL (10 mg/mL) NDC 0409-3178-03 Tray of 25 multiple-dose fliptop vials 500 mg/50 mL (10 mg/mL) 2% Contains 20 mg lidocaine hydrochloride per mL NDC 0409-0147-10 Carton of 10 multiple-dose fliptop vials 400 mg/20 mL (20 mg/mL) NDC 0409-3182-01 Tray of 25 multiple-dose fliptop vials 400 mg/20 mL (20 mg/mL) NDC 0409-3182-02 Tray of 25 multiple-dose fliptop vials 600 mg/30 mL (20 mg/mL) NDC 0409-3182-03 Tray of 25 multiple-dose fliptop vials 1000 mg/50 mL (20 mg/mL)
- PRINCIPAL DISPLAY PANEL - 5 mL Ampule Label 5 mL Single-dose NDC 0409-1209-10 LIDOCAINE HCl 1.5% 75 mg/5 mL (15 mg/mL) and EPINEPHRINE 1:200,000 Inj., USP Rx only Epidural Test Dose Discard unused portion. Dist. by Hospira, Inc., Lake Forest, IL 60045 USA Hospira RL–7864 LOT ##–###–AA EXP DMMMYYYY Lidocaine 5mL ampule label.PNG
- PRINCIPAL DISPLAY PANEL - 5 mL Ampule Tray Label 5 mL Single-dose 10 Ampuls Rx only NDC 0409-1209-01 Contains 10 of NDC 0409-1209-10 Lidocaine HCl 1.5% 75 mg/5 mL (15 mg/mL) and Epinephrine 1:200,000 Injection, USP Epidural Test Dose For Use as a Test Dose During Epidural Anesthesia Protect from light. Keep ampuls in tray until time of use. Each mL contains lidocaine HCl, anhyd. 15 mg; epinephrine 5 mcg; sodium chloride 6.5 mg; sodium metabisulfite 0.5 mg added. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment. pH 4.5 (3.3 to 5.5). Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Do not autoclave (contains epinephrine). NOTE: Inspect ampul and discard if chipped, cracked or underfilled. Do not use the Injection if its color is pinkish or darker than slightly yellow or if it contains a precipitate. Usual dosage : See Insert. During epidural anesthesia, 2 to 3 mL will provide a test dose containing 30 to 45 mg of lidocaine hydrochloride and 10 to 15 mcg of epinephrine. The test dose should be administered and the effects monitored before the full dose is given. Discard unused portion. Distributed by Hospira, Inc., Lake Forest, IL 60045 USA Hospira RL–7863 LOT ##–###–AA EXP DMMMYYYY Lidocaine 5 mL ampule tray label.PNG
- PRINCIPAL DISPLAY PANEL - 5 mL Ampule Label - 1209 5 mL Single-dose NDC 0409-1209-70 LIDOCAINE HCl 1.5% 75 mg/5 mL (15 mg/mL) and EPINEPHRINE 1:200,000 Injection, USP Rx only Epidural Test Dose Discard unused portion. Dist. by Hospira, Inc., Lake Forest, IL 60045 USA Hospira RL–7862 LOT ##–###–AA EXP DMMMYYYY Lidocaine 5 mL ampule label.PNG
- PRINCIPAL DISPLAY PANEL - 50 mL Vial Label 50 mL MULTIPLE-DOSE Lidocaine HCl 0.5% 250 mg/50 mL (5 mg/mL) and Epinephrine 1:200,000 Injection, USP Rx only For Infiltration and Nerve Block. NOT FOR EPIDURAL OR CAUDAL USE. Distributed by Hospira, Inc., Lake Forest, IL 60045 USA Hospira PRINCIPAL DISPLAY PANEL - 50 mL Vial Label
- PRINCIPAL DISPLAY PANEL - 50 mL Vial Tray 50 mL MULTIPLE-DOSE Fliptop Vial Rx only NDC 0409-3177-01 Contains 25 of NDC 0409-3177-16 Lidocaine HCl 0.5% 250 mg/50 mL (5 mg/mL) and Epinephrine 1:200,000 Injection, USP Protect from light. Retain in carton until contents are used. Do not autoclave. For Infiltration and Nerve Block. NOT FOR EPIDURAL OR CAUDAL USE. PRINCIPAL DISPLAY PANEL - 50 mL Vial Tray
- PRINCIPAL DISPLAY PANEL - 20 mL Vial Label 20 mL MULTIPLE-DOSE Lidocaine HCl 1% 200 mg/20 mL (10 mg/mL) and Epinephrine 1:100,000 Injection, USP For Infiltration and Nerve Block. Rx only NOT FOR EPIDURAL OR CAUDAL USE. Distributed by Hospira, Inc., Lake Forest, IL 60045 USA Hospira PRINCIPAL DISPLAY PANEL - 20 mL Vial Label
- PRINCIPAL DISPLAY PANEL - 20 mL Vial Tray 20 mL MULTIPLE-DOSE Fliptop Vial Rx only NDC 0409-3178-01 Contains 25 of NDC 0409-3178-16 Lidocaine HCl 1% 200 mg/20 mL (10 mg/mL) and Epinephrine 1:100,000 Injection, USP Protect from light. Retain in carton until contents are used. Do not autoclave. For Infiltration and Nerve Block. NOT FOR EPIDURAL OR CAUDAL USE. PRINCIPAL DISPLAY PANEL - 20 mL Vial Tray
- PRINCIPAL DISPLAY PANEL - 30 mL Vial Label 30 mL MULTIPLE-DOSE Lidocaine HCl 1% 300 mg/30 mL (10 mg/mL) and Epinephrine 1:100,000 Injection, USP For Infiltration and Nerve Block. NOT FOR EPIDURAL OR CAUDAL USE. PRINCIPAL DISPLAY PANEL - 30 mL Vial Label
- PRINCIPAL DISPLAY PANEL - 30 mL Vial Tray 30 mL MULTIPLE-DOSE Fliptop Vial Rx only NDC 0409-3178-02 Contains 25 of NDC 0409-3178-17 Lidocaine HCl 1% 300 mg/30 mL (10 mg/mL) and Epinephrine 1:100,000 Injection, USP Protect from light. Retain in carton until contents are used. Do not autoclave. For Infiltration and Nerve Block. NOT FOR EPIDURAL OR CAUDAL USE. PRINCIPAL DISPLAY PANEL - 30 mL Vial Tray
- PRINCIPAL DISPLAY PANEL - 50 mL Vial Label - 3178 50 mL MULTIPLE-DOSE Lidocaine HCl 1% 500 mg/50 mL (10 mg/mL) and Epinephrine 1:100,000 Injection, USP For Infiltration and Nerve Block. Rx only NOT FOR EPIDURAL OR CAUDAL USE. Distributed by Hospira, Inc., Lake Forest, IL 60045 USA Hospira PRINCIPAL DISPLAY PANEL - 50 mL Vial Label - 3178
- PRINCIPAL DISPLAY PANEL - 50 mL Vial Tray - 3178 50 mL MULTIPLE-DOSE Fliptop Vial Rx only NDC 0409-3178-03 Contains 25 of NDC 0409-3178-18 Lidocaine HCl 1% 500 mg/50 mL (10 mg/mL) and Epinephrine 1:100,000 Injection, USP Protect from light. Retain in carton until contents are used. Do not autoclave. For Infiltration and Nerve Block. NOT FOR EPIDURAL OR CAUDAL USE. PRINCIPAL DISPLAY PANEL - 50 mL Vial Tray - 3178
- PRINCIPAL DISPLAY PANEL - 30 mL Vial Label - 3181 30 mL Single-dose LIDOCAINE HCl 1.5% and 450 mg/30 mL (15 mg/mL) and Epinephrine 1:200,000 Injection, USP Rx only For Infiltration and Nerve Block including Epidural and Caudal. Discard unused portion. Hospira Distributed by Hospira, Inc., Lake Forest, IL 60045 USA PRINCIPAL DISPLAY PANEL - 30 mL Vial Label - 3181
- PRINCIPAL DISPLAY PANEL - 30 mL Vial Carton 30 mL Single-dose 5 Fliptop Vials Rx only NDC 0409-3181-01 Contains 5 of NDC 0409-3181-11 Lidocaine Hydrochloride 1.5% 450 mg/30 mL (15 mg/mL) and Epinephrine 1:200,000 Injection, USP Hospira Protect from light. Retain in carton until time of use. Do not autoclave. Discard unused portion. For Infiltration and Nerve Block including Epidural and Caudal. PRINCIPAL DISPLAY PANEL - 30 mL Vial Carton
- PRINCIPAL DISPLAY PANEL - 20 mL Vial Label - 3182 20 mL MULTIPLE-DOSE Lidocaine HCl 2% 400 mg/20 mL (20 mg/mL) and Epinephrine 1:100,000 Injection, USP For Infiltration and Nerve Block. NOT FOR EPIDURAL OR CAUDAL USE. Distributed by Hospira Inc., Lake Forest, IL 60045 USA Hospira PRINCIPAL DISPLAY PANEL - 20 mL Vial Label - 3182
- PRINCIPAL DISPLAY PANEL - 20 mL Vial Tray - 3182 20 mL MULTIPLE-DOSE Fliptop Vial Rx only NDC 0409-3182-01 Contains 25 of NDC 0409-3182-11 Lidocaine HCl 2% 400 mg/20 mL (20 mg/mL) and Epinephrine 1:100,000 Injection, USP Protect from light. Retain in carton until contents are used. Do not autoclave. For Infiltration and Nerve Block. NOT FOR EPIDURAL OR CAUDAL USE. PRINCIPAL DISPLAY PANEL - 20 mL Vial Tray - 3182
- PRINCIPAL DISPLAY PANEL - 30 mL Vial Label - 3182 30 mL MULTIPLE-DOSE Lidocaine HCl 2% 600 mg/30 mL (20 mg/mL) and Epinephrine 1:100,000 Injection, USP For Infiltration and Nerve Block. NOT FOR EPIDURAL OR CAUDAL USE. Rx only Distributed by Hospira Inc., Lake Forest, IL 60045 USA Hospira PRINCIPAL DISPLAY PANEL - 30 mL Vial Label - 3182
- PRINCIPAL DISPLAY PANEL - 30 mL Vial Tray - 3182 30 mL MULTIPLE-DOSE Fliptop Vial Rx only NDC 0409-3182-02 Contains 25 of NDC 0409-3182-21 Lidocaine HCl 2% 600 mg/30 mL (20 mg/mL) and Epinephrine 1:100,000 Injection, USP Protect from light. Retain in carton until contents are used. Do not autoclave. For Infiltration and Nerve Block. NOT FOR EPIDURAL OR CAUDAL USE. PRINCIPAL DISPLAY PANEL - 30 mL Vial Tray - 3182
- PRINCIPAL DISPLAY PANEL - 50 mL Vial Label - 3182 50 mL MULTIPLE-DOSE Lidocaine HCl 2% 1000 mg/50 mL (20 mg/mL) and Epinephrine 1:100,000 Injection, USP For Infiltration and Nerve Block. Rx only NOT FOR EPIDURAL OR CAUDAL USE. Distributed by Hospira Inc., Lake Forest, IL 60045 USA Hospira PRINCIPAL DISPLAY PANEL - 50 mL Vial Label - 3182
- PRINCIPAL DISPLAY PANEL - 50 mL Vial Tray - 3182 50 mL MULTIPLE-DOSE Fliptop Vial Rx only NDC 0409-3182-03 Contains 25 of NDC 0409-3182-31 Lidocaine HCl 2% 1000 mg/50 mL (20 mg/mL) and Epinephrine 1:100,000 Injection, USP Protect from light. Retain in carton until contents are used. Do not autoclave. For Infiltration and Nerve Block. NOT FOR EPIDURAL OR CAUDAL USE. PRINCIPAL DISPLAY PANEL - 50 mL Vial Tray - 3182
- PRINCIPAL DISPLAY PANEL - 20 mL Vial Label - 3183 20 mL Single-dose Lidocaine HCl 2% 400 mg/20 mL (20 mg/mL) and Epinephrine 1:200,000 Injection, USP For Infiltration and Nerve Block including Epidural and Caudal. Rx only Distributed by Hospira, Inc., Lake Forest, IL 60045 USA Hospira PRINCIPAL DISPLAY PANEL - 20 mL Vial Label - 3183
- PRINCIPAL DISPLAY PANEL - 20 mL Vial Carton 20 mL Single-dose 5 Fliptop Vials Rx only NDC 0409-3183-01 Contains 5 of NDC 0409-3183-11 Lidocaine HCl 2% 400 mg/20 mL (20 mg/mL) and Epinephrine 1:200,000 Injection, USP Protect from light. Retain in carton until time of use. Do not autoclave. Discard unused portion. For Infiltration and Nerve Block including Epidural and Caudal. Hospira PRINCIPAL DISPLAY PANEL - 20 mL Vial Carton
- PRINCIPAL DISPLAY PANEL – 20 mL vial Label - 0007 20 mL MULTIPLE-DOSE Lidocaine HCL 1% 200 mg/20 mL (10 mg/mL) and Epinephrine 1:100,000 Injection, USP For Infiltration and Nerve Block. Rx only NOT FOR EPIDURAL OR CAUDAL USE. PRINCIPAL DISPLAY PANEL – 20 mL vial Label - 0007
- PRINCIPAL DISPLAY PANEL - 20 mL Vial Carton -0007 20 mL MULTIPLE-DOSE Fliptop Vial Rx only NDC 0409-0007-10 Contains 10 of NDC 0409-0007-01 Lidocaine HCl 1% 200 mg/20 mL (10 mg/mL) and Epinephrine 1:100,000 Injection, USP Protect from light. Retain in carton until contents are used. Do not autoclave. For Infiltration and Nerve Block. NOT FOR EPIDURAL OR CAUDAL USE. PRINCIPAL DISPLAY PANEL – 20 mL vial Carton -0007
- PRINCIPAL DISPLAY PANEL – 20 mL vial Label - 0147 20 mL MULTIPLE-DOSE Lidocaine HCl 2% 400 mg/20 mL (20 mg/mL) and Epinephrine 1:100,000 Injection, USP For Infiltration and Nerve Block NOT FOR EPIDURAL OR CAUDAL USE. PRINCIPAL DISPLAY PANEL – 20 mL Label - 0147
- PRINCIPAL DISPLAY PANEL – 20 mL vial Carton - 0147 20 mL MULTIPLE-DOSE Fliptop Vial Rx only NDC 0409-0147-10 Contains 10 of NDC 0409-0147-01 Lidocaine HCl 2% 400 mg/20 mL (20 mg/mL) and Epinephrine 1:100,000 Injection, USP Protect from light. Retain in carton until contents are used. Do not autoclave. For Infiltration and Nerve Block. NOT FOR EPIDURAL OR CAUDAL USE. PRINCIPAL DISPLAY PANEL – 20 mL Carton - 0147
Overview
Lidocaine Hydrochloride and Epinephrine Injection, USP is a sterile, nonpyrogenic solution of lidocaine hydrochloride and epinephrine in water for injection for parenteral administration in various concentrations with characteristics as follows: Concentration Lidocaine hydrochloride Epinephrine Lidocaine hydrochloride (anhyd.) mg/mL Epinephrine mcg/mL Sodium Chloride mg/mL 0.5% 1:200,000 5 5 8 1% 1:200,000 10 5 7 1.5% 1:200,000 15 5 6.5 2% 1:200,000 20 5 6 1% 1:100,000 10 10 7 2% 1:100,000 20 10 6 Sodium metabisulfite 0.5 mg/mL and citric acid, anhydrous 0.2 mg/mL added as stabilizers. The headspace of Lists 1209, 3177, 3178, 3181, 3182 and 3183 are nitrogen gassed. May contain sodium hydroxide and/or hydrochloric acid to adjust pH; pH is 4.5 (3.3 to 5.5). See HOW SUPPLIED section for various sizes and strengths. Multiple-dose vials contain methylparaben 1 mg/mL added as preservative. Single-dose ampuls and vials contain no bacteriostat or antimicrobial agent. Discard unused portion. Lidocaine is a local anesthetic of the amide-type. Lidocaine Hydrochloride, USP is chemically designated 2-(diethyl-amino)-2',6'-acetoxylidide monohydrochloride monohydrate, a white powder freely soluble in water. It has the following structural formula: Epinephrine is a vasoconstrictor. Epinephrine, USP is a sympathomimetic (adrenergic) agent designated chemically as 4-[1-hydroxy-2 (methylamino) ethyl]-1,2 benzenediol, a white, microcrystalline powder. It has the following structural formula: lidocaine-01.jpg lidocaine-02.jpg
Indications & Usage
Lidocaine Hydrochloride and Epinephrine 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 and Epinephrine Injection are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration (2.2) ] . Lidocaine Hydrochloride and Epinephrine Injection is a combination of lidocaine, an amide local anesthetic, and epinephrine, an alpha and beta adrenergic agonist. Lidocaine Hydrochloride and Epinephrine 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. For each type of block indicated to produce local or regional anesthesia or analgesia, specific concentrations and presentations are recommended. ( 1 , 2.2 )
Dosage & Administration
See Full Prescribing Information for recommended dosages and administration information for adult and pediatric patients ( 2 ) 2.1 Important Dosage and Administration Information • Lidocaine Hydrochloride and Epinephrine Injection is not recommended for intrathecal use. • Avoid use of Lidocaine Hydrochloride and Epinephrine 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 and Epinephrine Injections are clear, colorless to slightly yellow 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 and Epinephrine Injection is not recommended because of insufficient data on the clinical use of such mixtures. Administration Precautions • Lidocaine Hydrochloride and Epinephrine 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 and Epinephrine 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 and Epinephrine 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 and Epinephrine 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 and Epinephrine 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 and Epinephrine 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 and Epinephrine 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 [see Warnings and Precautions (5.10) ] . 2.2 Recommended Concentrations and Dosages of Lidocaine Hydrochloride and Epinephrine Injection/Lidocaine Hydrochloride Injection (without Epinephrine) in Adults The dosage of Lidocaine Hydrochloride and Epinephrine 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 (without epinephrine) 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 (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 Dose should not exceed 4 mg/kg. 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 Dose determined by number of dermatomes to be anesthetized (2 to 3 mL/dermatome). 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 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 [see Dosage and Administration (2.5) ] . 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 the administration of epidural anesthesia, it is recommended that a test dose of Lidocaine Hydrochloride and Epinephrine Injection without antimicrobial preservative (1.5% lidocaine with 1:200,000 epinephrine) be administered initially and the effects monitored before the full dose is given. When using a “continuous” catheter technique, test doses should be given prior to both the initial and all supplemental doses, because a catheter in the epidural space can migrate into a blood vessel or through the dura [see Dosage and Administration (2.4) ] . During epidural administration, administer Lidocaine Hydrochloride and Epinephrine Injection, 1.5% (15 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 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. Three mL of Lidocaine Hydrochloride and Epinephrine Injection without antimicrobial preservative (1.5% lidocaine with 1:200,000 epinephrine) is recommended for use as a test dose prior to caudal and lumbar epidural blocks when clinical conditions permit. This test dose may serve as a warning of unintended intravascular or intrathecal injection. Closely monitor for early clinical signs of toxicity following each test dose [see Warnings and Precautions (5.7) ] . Allot adequate time for onset of spinal block to detect possible intrathecal injection. An intravascular or intrathecal injection is still possible even if results of the test dose are negative. The test dose itself may produce a systemic toxic reaction, high spinal, or cardiovascular effects from the epinephrine [see Warnings and Precautions (5.1) , Overdosage (10) ] . 2.5 Maximum Recommended Dosage Adults For normal healthy adults, the individual maximum recommended dose of Lidocaine Hydrochloride and Epinephrine Injection should not exceed 7 mg/kg 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 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 Use in Specific Populations (8.1) ] . Pediatric Patients A maximum dose of Lidocaine Hydrochloride and Epinephrine 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.
Warnings & Precautions
• Dose-Related Toxicity : Monitor cardiovascular and respiratory vital signs and patient’s state of consciousness after injection of Lidocaine Hydrochloride and Epinephrine. ( 5.1 ) • Methemoglobinemia : Cases of methemoglobinemia have been reported in association with local anesthetics use. See full prescribing information for more details on managing these risks. ( 5.2 ) • Chondrolysis with Intra-Articular Infusion : Avoid intra-articular infusions as there have been post-marketing reports of chondrolysis in patients receiving such infusion. ( 5.4 ) • Allergic-Type Reactions to Sulfites in Lidocaine Hydrochloride and Epinephrine Injection and Anaphylactic Reactions : Lidocaine Hydrochloride and Epinephrine Injection contains 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. ( 5.6 ) • Risk of Systemic Toxicities with Unintended Intravascular or Intrathecal Injection : Unintended intravascular or intrathecal injection may be associated with systemic toxicities, including CNS or cardiorespiratory depression and coma, progression ultimately to respiratory arrest. Aspirate for blood or cerebrospinal fluid (where applicable) prior to each dose and consider using a test dose of Lidocaine Hydrochloride and Epinephrine. ( 5.7 ) 5.1 Dose-Related Toxicity The safety and effectiveness of Lidocaine Hydrochloride and Epinephrine Injection depend on proper dosage, correct technique, adequate precautions, and readiness for emergencies. Careful and constant monitoring of cardiovascular and respiratory (adequacy of ventilation) vital signs and the patient's state of consciousness should be performed after injection of Lidocaine Hydrochloride and Epinephrine Injection solutions. Possible early warning signs of central nervous system (CNS) toxicity are restlessness, anxiety, incoherent speech, lightheadedness, numbness and tingling of the mouth and lips, metallic taste, tinnitus, dizziness, blurred vision, tremors, twitching, CNS depression, or drowsiness. 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. 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. Use the lowest dosage of Lidocaine Hydrochloride and Epinephrine Injection that results in effective anesthesia to avoid high plasma levels and serious adverse effects. Avoid rapid injection of a large volume of Lidocaine Hydrochloride and Epinephrine Injection solution and administer fractional (incremental) doses when feasible. Injection of repeated doses of Lidocaine Hydrochloride and Epinephrine Injection may cause significant increases in plasma levels with each repeated dose due to slow accumulation of the drug or its metabolites, or to slow metabolic degradation. Tolerance to elevated blood levels varies with the status of the patient. Debilitated, elderly patients and acutely ill patients should be given reduced doses commensurate with their age and physical status. 5.2 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 [see Drug Interactions (7.5)]. 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 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 Lidocaine Hydrochloride and Epinephrine Injection and any other oxidizing agents. Depending on the severity of the symptoms, patients may respond to supportive care, i.e., oxygen therapy, hydration. More severe symptoms may require treatment with methylene blue, exchange transfusion, or hyperbaric oxygen. 5.3 Antimicrobial Preservatives in Multiple-Dose Vials Avoid use of Lidocaine Hydrochloride and Epinephrine Injection solutions containing antimicrobial preservatives (i.e., those supplied in multiple-dose vials) for epidural or caudal anesthesia because safety has not been established with such use. 5.4 Chondrolysis with Intra-Articular Infusion 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 2 nd 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. 5.5 Risk of Adverse Reactions Due to Drug Interactions with Lidocaine Hydrochloride and Epinephrine Injection Risk of Severe, Persistent Hypertension Due to Drug Interactions Between Lidocaine Hydrochloride and Epinephrine Injection and Monoamine Oxidase Inhibitors and Tricyclic Antidepressants Administration of Lidocaine Hydrochloride and Epinephrine Injection in patients receiving monoamine oxidase inhibitors (MAOI), or tricyclic antidepressants may result in severe, prolonged hypertension. Concurrent use of these agents should generally be avoided. In situations when concurrent therapy is necessary, careful monitoring of the patient's hemodynamic status is essential [see Drug Interactions (7.2) ] . Risk of Severe, Persistent Hypertension or Cerebrovascular Accidents Due to Drug Interactions Between Lidocaine Hydrochloride and Epinephrine Injection and Ergot-Type Oxytocic Drugs Concurrent administration of Lidocaine Hydrochloride and Epinephrine Injection and ergot-type oxytocic drugs may cause severe, persistent hypertension or cerebrovascular accidents. Avoid use of Lidocaine Hydrochloride and Epinephrine Injection concomitantly with ergot-type oxytocic drugs [see Drug Interactions (7.3) ] . Risk of Hypertension and Bradycardia Due to Drug Interactions Between Lidocaine Hydrochloride and Epinephrine Injection and Nonselective Beta-Adrenergic Antagonists Administration of Lidocaine Hydrochloride and Epinephrine Injection in patients receiving nonselective beta-adrenergic antagonists may cause severe hypertension and bradycardia. Concurrent use of these agents should generally be avoided. In situations when concurrent therapy is necessary, careful monitoring of the patient's blood pressure and heart rate is essential [see Drug Interactions (7.4) ] . 5.6 Allergic-Type Reactions to Sulfites in Lidocaine Hydrochloride and Epinephrine Injection and Anaphylactic Reactions Lidocaine Hydrochloride and Epinephrine Injection 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 (6) ] . Lidocaine hydrochloride should be used with caution in persons with known drug sensitivities. Patients allergic to para-aminobenzoic acid derivatives (procaine, tetracaine, benzocaine, etc.) have not shown cross-sensitivity to lidocaine hydrochloride. 5.7 Risk of Systemic Toxicities with Unintended Intravascular or Intrathecal Injection Unintended intravascular or intrathecal injection of Lidocaine Hydrochloride and Epinephrine Injection may be associated with systemic toxicities, including CNS or cardiorespiratory depression and coma, progressing ultimately to respiratory arrest. Unintentional intrathecal injection during the intended performance of caudal or lumbar epidural block or nerve blocks near the vertebral column has resulted in underventilation or apnea ("Total or High Spinal"). A high spinal has been characterized by paralysis of the legs, loss of consciousness, respiratory paralysis, and bradycardia [see Adverse Reactions (6) ] . Aspirate for blood or cerebrospinal fluid (where applicable) before injecting Lidocaine Hydrochloride and Epinephrine 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. Use of Test Dose with Epidural Anesthesia To serve as a warning of unintended intravascular or intrathecal injection, 3 mL of Lidocaine Hydrochloride and Epinephrine Injection without antimicrobial preservative (1.5% lidocaine with 1:200,000 epinephrine) may be used as a test dose prior to administration of the full dose in caudal and lumbar epidural blocks [see Dosage and Administration (2.4) ] . Three mL of Lidocaine Hydrochloride and Epinephrine Injection (1.5% lidocaine with 1:200,000 epinephrine) without antimicrobial preservative contains 45 mg lidocaine and 15 mcg epinephrine. An intravascular or intrathecal injection is still possible even if results of the test dose are negative. Signs/symptoms of unintended intravascular or intrathecal injection of the test dose of Lidocaine Hydrochloride and Epinephrine Injection and monitoring recommendations are described below. • Unintended intravascular injection: Likely to produce a transient “epinephrine response” within 45 seconds, consisting of an increase in heart rate and/or 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. Therefore, following the test dose, the heart rate should be monitored for increases. Patients on beta-blockers may not manifest changes in heart rate, but blood pressure monitoring can detect a transient rise in systolic blood pressure. • Unintended intrathecal injection: Evidenced within a few minutes by signs of spinal block (e.g., decreased sensation of the buttocks, paresis of the legs, or, in the sedated patient, absent knee jerk). The test dose itself may produce a systemic toxic reaction, high spinal or epinephrine-induced cardiovascular effects [see Overdosage (10) ] . 5.8 Risk of Toxicity in Patients with Hepatic Impairment Because amide local anesthetics such as lidocaine are metabolized by the liver, consider reduced dosing and increased monitoring for lidocaine systemic toxicity in patients with moderate to severe hepatic impairment who are treated with lidocaine hydrochloride, especially with repeat doses [see Use in Specific Populations (8.6) ] . 5.9 Risk of Use in Patients with Impaired Cardiovascular Function Lidocaine should also be given in reduced doses in patients with impaired cardiovascular function since they may be less able to compensate for functional changes associated with the prolongation of A-V conduction produced by these drugs. Monitor patients closely for blood pressure, heart rate, and ECG changes. 5.10 Risk of Ischemic Injury or Necrosis in Body Areas with Limited Blood Supply Use Lidocaine Hydrochloride and Epinephrine 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. Patients with peripheral vascular disease and those with hypertensive vascular disease may exhibit exaggerated vasoconstrictor response. Ischemic injury or necrosis may result. 5.11 Risk of Cardiac Arrhythmias with Concomitant Use of Potent Inhalation Anesthetics Serious dose-related cardiac arrhythmias may occur if preparations containing a vasoconstrictor such as epinephrine (e.g., Lidocaine Hydrochloride and Epinephrine Injection) are used in patients during or following the administration of potent inhalation anesthetics [see Drug Interactions (7.6) ] . In deciding whether to concurrently use Lidocaine Hydrochloride and Epinephrine Injection with potent inhalation anesthetics in the same patient, the combined action of both agents upon the myocardium, the concentration and volume of vasoconstrictor used, and the time since injection, when applicable, should be taken into account. 5.12 Risk of Adverse Reactions with Use in the Head and Neck Area Small doses of local anesthetics (e.g., Lidocaine Hydrochloride and Epinephrine Injection) injected into the head and neck area, including retrobulbar, dental and stellate ganglion blocks, may produce adverse reactions similar to systemic toxicity seen with unintentional intravascular injections of larger doses. The injection procedures require the utmost care. Confusion, convulsions, respiratory depression and/or respiratory arrest, and cardiovascular stimulation or depression have been reported. These reactions may be due to intra-arterial injection of the local anesthetic with retrograde flow to the cerebral circulation. They may also be due to puncture of the dural sheath of the optic nerve during retrobulbar block with diffusion of any local anesthetic along the subdural space to the midbrain. Monitor circulation and respiration and constantly observe patients receiving Lidocaine Hydrochloride and Epinephrine Injection blocks. Resuscitative equipment and drugs, and personnel for treating adverse reactions should be immediately available. Dosage recommendations should not be exceeded [see Dosage and Administration (2.2) ] . 5.13 Familial Malignant Hyperthermia Many drugs used during the conduct of anesthesia are considered potential triggering agents for familial malignant hyperthermia. Since it is not known whether amide-type local anesthetics may trigger this reaction and since the need for supplemental general anesthesia cannot be predicted in advance, it is suggested that a standard protocol for the management of malignant hyperthermia should be available. Early unexplained signs of tachycardia, tachypnea, labile blood pressure and metabolic acidosis may precede temperature elevation. Successful outcome is dependent on early diagnosis, prompt discontinuance of the suspect triggering agent(s) and institution of treatment, including oxygen therapy, indicated supportive measures and dantrolene (consult dantrolene sodium intravenous package insert before using). 5.14 Risk of Respiratory Arrest with Use in Ophthalmic Surgery Clinicians who perform retrobulbar blocks should be aware that there have been reports of respiratory arrest following local anesthetic injection. Prior to retrobulbar block (e.g., with Lidocaine Hydrochloride and Epinephrine Injection), as with all other regional procedures, resuscitative equipment and drugs, and personnel to manage respiratory arrest or depression, convulsions, and cardiac stimulation or depression should be immediately available. As with other anesthetic procedures, patients should be constantly monitored following ophthalmic blocks for signs of these adverse reactions, which may occur following relatively low total doses. 5.15 Risk of Inadvertent Trauma to Tongue, Lips, and Buccal Mucosa in Dental Applications Because of the long duration of anesthesia, when Lidocaine Hydrochloride and Epinephrine Injection [0.5% (5 mg/mL) of lidocaine] is used for dental injections, warn patients about the possibility of inadvertent trauma to tongue, lips, and buccal mucosa and advise them not to chew solid foods until sensation returns [see Patient Counseling Information (17) ] . 5.16 Drug/Laboratory Test Interactions The intramuscular injection of lidocaine hydrochloride may result in an increase in creatine phosphokinase levels. Thus, the use of this enzyme determination, without isoenzyme separation, as a diagnostic test for the presence of acute myocardial infarction may be compromised by the intramuscular injection of lidocaine hydrochloride.
Contraindications
Lidocaine Hydrochloride and Epinephrine Injections are 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 and Epinephrine Injections. Known hypersensitivity to any local anesthetic agent of the amide-type or to other components of Lidocaine Hydrochloride and Epinephrine Injection. ( 4 )
Adverse Reactions
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 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 dose-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. Nervous System Disorders Adverse reactions were characterized by excitation and/or depression of the central nervous system and included 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 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 hydrochloride 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. 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. In the practice of caudal or lumbar epidural block, unintentional penetration of the subarachnoid space by the catheter or needle has occurred. Subsequent adverse effects may have depended partially on the amount of drug administered intrathecally and the physiological and physical effects of a dural puncture. A high spinal has been characterized by paralysis of the legs, loss of consciousness, respiratory paralysis, and bradycardia. Neurologic effects following epidural or caudal anesthesia have included spinal block of varying magnitude (including high or total spinal block); hypotension secondary to spinal block; urinary retention; fecal and urinary incontinence; loss of perineal sensation and sexual function; persistent anesthesia, paresthesia, weakness, paralysis of the lower extremities and loss of sphincter control, all of which had slow, incomplete, or no recovery; headache; backache; septic meningitis; meningismus; slowing of labor; increased incidence of forceps delivery; and cranial nerve palsies due to traction on nerves from loss of cerebrospinal fluid. Neurologic effects following other procedures or routes of administration have included persistent anesthesia, paresthesia, weakness, paralysis, all with slow, incomplete, or no recovery. Convulsions : Incidence varied with the procedure used and the total dose administered. In a survey of studies of epidural anesthesia, overt toxicity progressing to convulsions occurred in approximately 0.1% of local anesthetic administrations. The incidences of adverse neurologic 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. Cardiac Disorders High doses or unintentional intravascular injection have led to high plasma levels and related depression of the myocardium, decreased cardiac output, heartblock, hypotension, bradycardia, ventricular arrhythmias, including ventricular tachycardia and ventricular fibrillation, and cardiac arrest [see Warnings and Precautions (5.9) ]. Immune System Disorders 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 [see Warnings and Precautions (5.6) ] . There have been no reports of cross sensitivity between lidocaine hydrochloride and procainamide or between lidocaine hydrochloride and quinidine. Hematologic Methemoglobinemia [see Warnings and Precautions (5.2) ] . Most common adverse reactions are as follows: • Central Nervous System: 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. ( 6 ) • Cardiovascular System: Bradycardia, hypotension, and cardiovascular collapse. ( 6 ) • Allergic: Cutaneous lesions, urticaria, edema or anaphylactoid reactions. ( 6 ) • Neurologic: Positional headaches, hypotension and backache. ( 6 ) • Hematologic: Methemoglobinemia. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc, at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Drug Interactions
• Local Anesthetics : The toxic effects of local anesthetics are additive. Monitor for neurologic and cardiovascular effects when additional local anesthetics are administered. ( 7.1 ) • Monoamine Oxidase Inhibitors and Tricyclic Antidepressants : Administration of Lidocaine Hydrochloride and Epinephrine Injection to patients receiving monoamine oxidase inhibitors or tricyclic antidepressants may produce severe, prolonged hypertension Concurrent use of these agents should generally be avoided. ( 5.5 , 7.2 ) • Ergot-type Oxytocic drugs : Concurrent administration of Lidocaine Hydrochloride and Epinephrine Injection and ergot-type oxytocic drugs may cause severe, persistent hypertension or cerebrovascular accidents. ( 5.5 , 7.3 ) • Nonselective Beta-Adrenergic Antagonists : Administration of Lidocaine Hydrochloride and Epinephrine Injection in patients receiving nonselective beta-adrenergic antagonist may cause severe hypertension and bradycardia. Concurrent use of these agents should generally be avoided. ( 5.5 , 7.4 ) • Drugs Associated with Methemoglobinemia : Patients are at increased risk of developing methemoglobinemia when concurrently exposed to nitrates, nitrites, local anesthetics, antineoplastic agents, antibiotics, antimalarials, anticonvulsants and other drugs. ( 7.5 ) • Potent Inhalation Anesthetics : Serious dose-related cardiac arrhythmias may occur if preparations containing epinephrine are used in patients during or following the administration of potent inhalation anesthetics. ( 5.11 , 7.6 ) 7.1 Local Anesthetics The toxic effects of local anesthetics are additive. If coadministration of other local anesthetics with Lidocaine Hydrochloride and Epinephrine Injection cannot be avoided, monitor patients for neurologic and cardiovascular effects related to local anesthetic systemic toxicity [see Warnings and Precautions (5.1) ] . 7.2 Monoamine Oxidase Inhibitors and Tricyclic Antidepressants The administration of Lidocaine Hydrochloride and Epinephrine Injection to patients receiving monoamine oxidase inhibitors or tricyclic antidepressants may produce severe, prolonged hypertension. Concurrent use of these agents should generally be avoided. In situations when concurrent therapy is necessary, careful monitoring of the patient’s hemodynamic status is essential [see Warnings and Precautions (5.5) ] . 7.3 Ergot-Type Oxytocic Drugs Concurrent administration of vasopressor drugs (for the treatment of hypotension related to obstetric blocks) and ergot-type oxytocic drugs may cause severe, persistent hypertension or cerebrovascular accidents. Avoid use of Lidocaine Hydrochloride and Epinephrine Injection concomitantly with ergot-type oxytocic drugs [see Warnings and Precautions (5.5) ] . 7.4 Nonselective Beta-Adrenergic Antagonists Administration of Lidocaine Hydrochloride and Epinephrine Injection in patients receiving nonselective beta-adrenergic antagonists may cause severe hypertension and bradycardia. Concurrent use of these agents should generally be avoided. In situations when concurrent therapy is necessary, careful monitoring of the patient's blood pressure and heart rate is essential [see Warnings and Precautions (5.5) ] . 7.5 Drugs Associated with Methemoglobinemia Patients that are administered local anesthetics may be at increased risk of developing methemoglobinemia when concurrently exposed to the following oxidizing agents: Class Examples Nitrates/Nitrites nitroglycerin, nitroprusside, nitric oxide, nitrous oxide Local anesthetics articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, tetracaine Antineoplastic agents cyclophosphamide, flutamide, rasburicase, ifosfamide, hydroxyurea Antibiotics dapsone, sulfonamides, nitrofurantoin, para- aminosalicylic acid Antimalarials chloroquine, primaquine Anticonvulsants phenytoin, sodium valproate, phenobarbital Other drugs acetaminophen, metoclopramide, quinine, sulfasalazine 7.6 Potent Inhalation Anesthetics Serious dose-related cardiac arrhythmias may occur if preparations containing epinephrine (e.g., Lidocaine Hydrochloride and Epinephrine Injection) are used in patients during or following the administration of potent inhalation anesthetics [see Warnings and Precautions (5.11) ] . 7.7 Phenothiazines and Butyrophenones Phenothiazines and butyrophenones may reduce or reverse the pressor effect of epinephrine. Concurrent use of Lidocaine Hydrochloride with Epinephrine and these agents should generally be avoided. In situations when concurrent therapy is necessary, careful patient monitoring is essential.
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