A. For Intramuscular Administration When oral therapy
Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED DEPO-MEDROL Sterile Aqueous Suspension is available as single-dose vials in the following strengths and package sizes: 40 mg per mL 80 mg per mL 1 mL vials NDC 0009-3073-01 1 mL vials NDC 0009-3475-01 25 x 1 mL vials NDC 0009-3073-03 25 x 1 mL vials NDC 0009-3475-03 Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP]. This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com . Pfizer Logo and Address LAB-0160-13.0 July 2018 Pfizer Logo and Address; 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 45764E Revised: 10/2019 Fresenius-Kabi Logo; 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 50 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 These solutions are not for spinal anesthesia. Store at 20 to 25°C (68 to 77°F); excursions permitted between 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] MARCAINE―Solutions of MARCAINE that do not contain epinephrine may be autoclaved. Autoclave at 15-pound pressure, 121°C (250°F) for 15 minutes. Unit of Sale Concentration Each 0.25% Contains 2.5 mg bupivacaine hydrochloride per mL. NDC 0409-1559-10 Tray of 10 25 mg/10 mL (2.5 mg/mL) NDC 0409-1559-18 Single-dose vial NDC 0409-1559-30 Carton of 10 75 mg/30 mL (2.5 mg/mL) NDC 0409-1559-19 Single-dose vial NDC 0409-1587-50 Carton of 1 125 mg/50 mL (2.5 mg/mL) NDC 0409-1587-50 Multiple-dose vial 0.5% Contains 5 mg bupivacaine hydrochloride per mL. NDC 0409-1560-10 Tray of 10 50 mg/10 mL (5 mg/mL) NDC 0409-1560-18 Single-dose vial NDC 0409-1560-29 Carton of 10 150 mg/30 mL (5 mg/mL) NDC 0409-1560-19 Single-dose vial NDC 0409-1610-50 Carton of 1 250 mg/50 mL (5 mg/mL) NDC 0409-1610-50 Multiple-dose vial 0.75% Contains 7.5 mg bupivacaine hydrochloride per mL. NDC 0409-1582-10 Tray of 10 75 mg/10 mL (7.5 mg/mL) NDC 0409-1582-18 Single-dose vial NDC 0409-1582-29 Carton of 10 225 mg/30 mL (7.5 mg/mL) NDC 0409-1582-19 Single-dose vial MARCAINE with epinephrine 1:200,000 (as bitartrate)― Solutions of MARCAINE that contain epinephrine should not be autoclaved and should be protected from light. Do not use the solution if its color is pinkish or darker than slightly yellow or if it contains a precipitate . Unit of Sale Concentration Each 0 .25% with epinephrine 1:20 0 ,0 0 0 —Contains 2.5 mg bupivacaine hydrochloride per mL. NDC 0409-1746-10 Carton of 10 25 mg/10 mL (2.5 mg/mL) NDC 0409-1746-70 Single-dose vial NDC 0409-1746-30 Carton of 10 75 mg/30 mL (2.5 mg/mL) NDC 0409-1746-71 Single-dose vial NDC 0409-1752-50 Carton of 1 125 mg/50 mL (2.5 mg/mL) NDC 0409-1752-50 Multiple-dose vial 0.5% with epinephrine 1:200,000—Contains 5 mg bupivacaine hydrochloride per mL. NDC 0409-1749-10 Carton of 10 50 mg/10 mL (5 mg/mL) NDC 0409-1749-70 Single-dose vial NDC 0409-1749-29 Carton of 10 150 mg/30 mL (5 mg/mL) NDC 0409-1749-71 Single-dose vial NDC 0409-1755-50 Carton of 1 250 mg/50 mL (5 mg/mL) NDC 0409-1755-50 Multiple-dose vial For single-dose vials: Discard unused portion. Distributed by Hospira, Inc., Lake Forest, IL 60045 USA Revised: 11/2018; PRINCIPAL DISPLAY PANEL: P-Care D40MX NDC 49836-010-20 RX-Only P-Care D40MX Kit Contains: 1 Depo-Medrol ® Single Dose Vial (40 mg/mL) (1mL) 1 Marcaine ® 0.5% Single Dose Vial (5 mg/mL) (10mL) 1 Xylocaine ® - MPF 1% Single Dose Vial (10 mg/mL) (5 mL) 1 Sodium Chloride Injection, USP 0.9% Single Dose Vial (10mL) 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 Needles and Syringes Not included 1 Dose P-Care D40MX DISTRIBUTED BY: SCHMIGS HAUPPAUGE, NY 11788 NDC 49836-010-20 MANUFACTURED BY: Rx Pharma Pack HAUPPAUGE, NY 11788 Questions/Comments 1-844-632-7898 Kit Contents: Depo-Medrol ® ¥ (40 mg/mL) (Pfizer Inc.)* Methylprednisolone Acetate Injectable Suspension, USP Each mL contains methylprednisolone acetate, 40 mg. Also contains polyethylene glycol 3350, 29 mg; and myristyl-gamma-picolinium chloride, 0.195 mg. Sodium Chloride was added to adjust tonicity. When necessary, pH was adjusted with sodium hydroxide and/or hydrochloric acid. Marcaine ® ‡ 0.5% (5mg/mL) (Hospira, Inc.) * Bupivacaine HCl Injection, USP Each mL contains 5 mg bupivacaine HCl, with NaCl to make isotonic, in water for injection. pH adjusted with NaOH or HCl. Xylocaine ® § - MPF 1% (10mg/mL) (APP 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 HCl and/or NaOH for pH adjustment. Sterile, nonpyrogenic, preservative free. Sterile Povidone-Iodine 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)* ¥ Depo- Medrol ® (registered trademark of Pfizer Inc.) ‡ Marcaine ® (registered trademark of Hospira, Inc.) § 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/AVOID FREEZING STORE AT CONTROLLED ROOM TEMPERATURE 20º-25ºC (68º-77ºF) [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 D40MX P-Care D40MX
- HOW SUPPLIED DEPO-MEDROL Sterile Aqueous Suspension is available as single-dose vials in the following strengths and package sizes: 40 mg per mL 80 mg per mL 1 mL vials NDC 0009-3073-01 1 mL vials NDC 0009-3475-01 25 x 1 mL vials NDC 0009-3073-03 25 x 1 mL vials NDC 0009-3475-03 Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP]. This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com . Pfizer Logo and Address LAB-0160-13.0 July 2018 Pfizer Logo and Address
- 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 45764E Revised: 10/2019 Fresenius-Kabi Logo
- 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 50 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 These solutions are not for spinal anesthesia. Store at 20 to 25°C (68 to 77°F); excursions permitted between 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] MARCAINE―Solutions of MARCAINE that do not contain epinephrine may be autoclaved. Autoclave at 15-pound pressure, 121°C (250°F) for 15 minutes. Unit of Sale Concentration Each 0.25% Contains 2.5 mg bupivacaine hydrochloride per mL. NDC 0409-1559-10 Tray of 10 25 mg/10 mL (2.5 mg/mL) NDC 0409-1559-18 Single-dose vial NDC 0409-1559-30 Carton of 10 75 mg/30 mL (2.5 mg/mL) NDC 0409-1559-19 Single-dose vial NDC 0409-1587-50 Carton of 1 125 mg/50 mL (2.5 mg/mL) NDC 0409-1587-50 Multiple-dose vial 0.5% Contains 5 mg bupivacaine hydrochloride per mL. NDC 0409-1560-10 Tray of 10 50 mg/10 mL (5 mg/mL) NDC 0409-1560-18 Single-dose vial NDC 0409-1560-29 Carton of 10 150 mg/30 mL (5 mg/mL) NDC 0409-1560-19 Single-dose vial NDC 0409-1610-50 Carton of 1 250 mg/50 mL (5 mg/mL) NDC 0409-1610-50 Multiple-dose vial 0.75% Contains 7.5 mg bupivacaine hydrochloride per mL. NDC 0409-1582-10 Tray of 10 75 mg/10 mL (7.5 mg/mL) NDC 0409-1582-18 Single-dose vial NDC 0409-1582-29 Carton of 10 225 mg/30 mL (7.5 mg/mL) NDC 0409-1582-19 Single-dose vial MARCAINE with epinephrine 1:200,000 (as bitartrate)― Solutions of MARCAINE that contain epinephrine should not be autoclaved and should be protected from light. Do not use the solution if its color is pinkish or darker than slightly yellow or if it contains a precipitate . Unit of Sale Concentration Each 0 .25% with epinephrine 1:20 0 ,0 0 0 —Contains 2.5 mg bupivacaine hydrochloride per mL. NDC 0409-1746-10 Carton of 10 25 mg/10 mL (2.5 mg/mL) NDC 0409-1746-70 Single-dose vial NDC 0409-1746-30 Carton of 10 75 mg/30 mL (2.5 mg/mL) NDC 0409-1746-71 Single-dose vial NDC 0409-1752-50 Carton of 1 125 mg/50 mL (2.5 mg/mL) NDC 0409-1752-50 Multiple-dose vial 0.5% with epinephrine 1:200,000—Contains 5 mg bupivacaine hydrochloride per mL. NDC 0409-1749-10 Carton of 10 50 mg/10 mL (5 mg/mL) NDC 0409-1749-70 Single-dose vial NDC 0409-1749-29 Carton of 10 150 mg/30 mL (5 mg/mL) NDC 0409-1749-71 Single-dose vial NDC 0409-1755-50 Carton of 1 250 mg/50 mL (5 mg/mL) NDC 0409-1755-50 Multiple-dose vial For single-dose vials: Discard unused portion. Distributed by Hospira, Inc., Lake Forest, IL 60045 USA Revised: 11/2018
- PRINCIPAL DISPLAY PANEL: P-Care D40MX NDC 49836-010-20 RX-Only P-Care D40MX Kit Contains: 1 Depo-Medrol ® Single Dose Vial (40 mg/mL) (1mL) 1 Marcaine ® 0.5% Single Dose Vial (5 mg/mL) (10mL) 1 Xylocaine ® - MPF 1% Single Dose Vial (10 mg/mL) (5 mL) 1 Sodium Chloride Injection, USP 0.9% Single Dose Vial (10mL) 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 Needles and Syringes Not included 1 Dose P-Care D40MX DISTRIBUTED BY: SCHMIGS HAUPPAUGE, NY 11788 NDC 49836-010-20 MANUFACTURED BY: Rx Pharma Pack HAUPPAUGE, NY 11788 Questions/Comments 1-844-632-7898 Kit Contents: Depo-Medrol ® ¥ (40 mg/mL) (Pfizer Inc.)* Methylprednisolone Acetate Injectable Suspension, USP Each mL contains methylprednisolone acetate, 40 mg. Also contains polyethylene glycol 3350, 29 mg; and myristyl-gamma-picolinium chloride, 0.195 mg. Sodium Chloride was added to adjust tonicity. When necessary, pH was adjusted with sodium hydroxide and/or hydrochloric acid. Marcaine ® ‡ 0.5% (5mg/mL) (Hospira, Inc.) * Bupivacaine HCl Injection, USP Each mL contains 5 mg bupivacaine HCl, with NaCl to make isotonic, in water for injection. pH adjusted with NaOH or HCl. Xylocaine ® § - MPF 1% (10mg/mL) (APP 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 HCl and/or NaOH for pH adjustment. Sterile, nonpyrogenic, preservative free. Sterile Povidone-Iodine 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)* ¥ Depo- Medrol ® (registered trademark of Pfizer Inc.) ‡ Marcaine ® (registered trademark of Hospira, Inc.) § 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/AVOID FREEZING STORE AT CONTROLLED ROOM TEMPERATURE 20º-25ºC (68º-77ºF) [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 D40MX P-Care D40MX
Overview
DEPO-MEDROL is an anti-inflammatory glucocorticoid for intramuscular, intra-articular, soft tissue or intralesional injection. It is available as single-dose vials in two strengths: 40 mg/mL, 80 mg/mL. Each mL of these preparations contains: Methylprednisolone acetate 40 mg 80 mg Polyethylene glycol 3350 29 mg 28 mg Myristyl-gamma-picolinium chloride 0.195 mg 0.189 mg Sodium Chloride was added to adjust tonicity. When necessary, pH was adjusted with sodium hydroxide and/or hydrochloric acid. The pH of the finished product remains within the USP specified range (e.g., 3.0 to 7.0.) The chemical name for methylprednisolone acetate is pregna-1,4-diene-3,20-dione, 21-(acetyloxy)-11,17-dihydroxy-6-methyl-,(6α,11β)- and the molecular weight is 416.51. The structural formula is represented below: Depo-Medrol Structural Formula DEPO-MEDROL Sterile Aqueous Suspension contains methylprednisolone acetate which is the 6-methyl derivative of prednisolone. Methylprednisolone acetate is a white or practically white, odorless, crystalline powder which melts at about 215° with some decomposition. It is soluble in dioxane, sparingly soluble in acetone, alcohol, chloroform, and methanol, and slightly soluble in ether. It is practically insoluble in water. Depo-Medrol 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. DESCRIPTION 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 MPF Structure Epinephrine is (-) -3, 4-Dihydroxy-α-[(methylamino) methyl] ben yl alcohol and has the molecular wt. 183.21. Epinephrine (C 9 H 13 NO 3 ) has the following structural formula: Epinephrine Structure 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 MPF Structure Epinephrine Structure DESCRIPTION Bupivacaine hydrochloride is 2-Piperidinecarboxamide, 1-butyl-N-(2,6-dimethylphenyl)-,monohydrochloride, monohydrate, a white crystalline powder that is freely soluble in 95 percent ethanol, soluble in water, and slightly soluble in chloroform or acetone. It has the following structural formula: Marcaine Structural Formula Epinephrine is (-)-3,4-Dihydroxy-α-[(methylamino)methyl] benzyl alcohol. It has the following structural formula: Epinephrine Structural Formula MARCAINE is available in sterile isotonic solutions with and without epinephrine (as bitartrate) 1:200,000 for injection via local infiltration, peripheral nerve block, and caudal and lumbar epidural blocks. Solutions of MARCAINE may be autoclaved if they do not contain epinephrine. Solutions are clear and colorless. Bupivacaine is related chemically and pharmacologically to the aminoacyl local anesthetics. It is a homologue of mepivacaine and is chemically related to lidocaine. All three of these anesthetics contain an amide linkage between the aromatic nucleus and the amino, or piperidine group. They differ in this respect from the procaine-type local anesthetics, which have an ester linkage. MARCAINE —Sterile isotonic solutions containing sodium chloride. In multiple-dose vials, each mL also contains 1 mg methylparaben as antiseptic preservative. The pH of these solutions is adjusted to between 4 and 6.5 with sodium hydroxide or hydrochloric acid. MARCAINE with epinephrine 1:200,000 (as bitartrate)—Sterile isotonic solutions containing sodium chloride. Each mL contains bupivacaine hydrochloride and 0.0091 mg epinephrine bitartrate, with 0.5 mg sodium metabisulfite, 0.001 mL monothioglycerol, and 2 mg ascorbic acid as antioxidants, 0.0017 mL 60% sodium lactate buffer, and 0.1 mg edetate calcium disodium as stabilizer. In multiple-dose vials, each mL also contains 1 mg methylparaben as antiseptic preservative. The pH of these solutions is adjusted to between 3.4 and 4.5 with sodium hydroxide or hydrochloric acid. The specific gravity of MARCAINE 0.5% with epinephrine 1:200,000 (as bitartrate) at 25°C is 1.008 and at 37°C is 1.008. Marcaine Structural Formula Epinephrine Structural Formula
Indications & Usage
A. For Intramuscular Administration When oral therapy is not feasible and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intramuscular use of DEPO- MEDROL Sterile Aqueous Suspension is indicated as follows: Allergic States : Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, seasonal or perennial allergic rhinitis, serum sickness, transfusion reactions. Dermatologic Diseases : Bullous dermatitis herpetiformis, exfoliative dermatitis, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine Disorders : Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsupportive thyroiditis. Gastrointestinal Diseases : To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis. Hematologic Disorders : Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond Blackfan anemia), pure red cell aplasia, select cases of secondary thrombocytopenia. Miscellaneous : Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Neoplastic Diseases : For palliative management of: leukemias and lymphomas. Nervous System : Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor or craniotomy. Ophthalmic Diseases : Sympathetic opthalmia, temporal arteritis, uveitis, ocular inflammatory conditions unresponsive to topical corticosteroids. Renal Diseases : To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome, or that due to lupus erythematosus. Respiratory Diseases : Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic Disorders : As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus. B. For Intra-articular Or Soft Tissue Administration (See WARNINGS) DEPO-MEDROL is indicated as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute and subacute bursitis, acute nonspecific tenosynovitis, epicondylitis, rheumatoid arthritis, synovitis of osteoarthritis. C. For Intralesional Administration DEPO-MEDROL is indicated for intralesional use in alopecia areata, discoid lupus erythematosus; keloids, localized hypertrophic, infiltrated inflammatory lesions of granuloma annulare, lichen planus, lichen simplex chronicus (neurodermatitis) and psoriatic plaques; necrobiosis lipoidica diabeticorum. DEPO-MEDROL also may be useful in cystic tumors of an aponeurosis or tendon (ganglia). USE Antiseptic skin preparation USE Preparation of the skin prior to injection. 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. INDICATIONS AND 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 MARCAINE is indicated 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. Only the 0.25% and 0.5% concentrations are indicated for obstetrical anesthesia. (See WARNINGS .) Experience with nonobstetrical surgical procedures in pregnant patients is not sufficient to recommend use of 0.75% concentration of MARCAINE in these patients. MARCAINE is not recommended for intravenous regional anesthesia (Bier Block). See WARNINGS . The routes of administration and indicated MARCAINE concentrations are: local infiltration 0.25% peripheral nerve block 0.25% and 0.5% retrobulbar block 0.75% sympathetic block 0.25% lumbar epidural 0.25%, 0.5%, and 0.75% (0.75% not for obstetrical anesthesia) caudal 0.25% and 0.5% epidural test dose 0.5% with epinephrine 1:200,000 dental blocks 0.5% with epinephrine 1:200,000 (See DOSAGE AND ADMINISTRATION for additional information). Standard textbooks should be consulted to determine the accepted procedures and techniques for the administration of MARCAINE.
Dosage & Administration
Because of possible physical incompatibilities, DEPO-MEDROL Sterile Aqueous Suspension should not be diluted or mixed with other solutions. The initial dosage of parenterally administered DEPO-MEDROL will vary from 4 to 120 mg, depending on the specific disease entity being treated. However, in certain overwhelming, acute, life- threatening situations, administration in dosages exceeding the usual dosages may be justified and may be in multiples of the oral dosages. It Should Be Emphasized that Dosage Requirements Are Variable and Must Be Individualized on the Basis of the Disease Under Treatment and the Response of the Patient . After a favorable response is noted the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. Situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient's individual drug responsiveness, and the effect of patient exposure to stressful situations not directly related to the disease entity under treatment. In this latter situation, it may be necessary to increase the dosage of the corticosteroid for a period of time consistent with the patient's condition. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly. A. Administration for Local Effect Therapy with DEPO-MEDROL does not obviate the need for the conventional measures usually employed. Although this method of treatment will ameliorate symptoms, it is in no sense a cure and the hormone has no effect on the cause of the inflammation. 1. Rheumatoid Arthritis and Osteoarthritis . The dose for intra-articular administration depends upon the size of the joint and varies with the severity of the condition in the individual patient. In chronic cases, injections may be repeated at intervals ranging from one to five or more weeks, depending upon the degree of relief obtained from the initial injection. The doses in the following table are given as a general guide: Size of Joint Examples Range of Dosage Large Knees Ankles Shoulders 20 to 80 mg Medium Elbows Wrists 10 to 40 mg Small Metacarpophalangeal Interphalangeal Sternoclavicular Acromioclavicular 4 to 10 mg Procedure : It is recommended that the anatomy of the joint involved be reviewed before attempting intra-articular injection. In order to obtain the full anti-inflammatory effect, it is important that the injection be made into the synovial space. Employing the same sterile technique as for a lumbar puncture, a sterile 20 to 24 gauge needle (on a dry syringe) is quickly inserted into the synovial cavity. Procaine infiltration is elective. The aspiration of only a few drops of joint fluid proves the joint space has been entered by the needle. The injection site for each joint is determined by that location where the synovial cavity is most superficial and most free of large vessels and nerves. With the needle in place, the aspirating syringe is removed and replaced by a second syringe containing the desired amount of DEPO-MEDROL. The plunger is then pulled outward slightly to aspirate synovial fluid and to make sure the needle is still in the synovial space. After injection, the joint is moved gently a few times to aid mixing of the synovial fluid and the suspension. The site is covered with a small sterile dressing. Suitable sites for intra-articular injection are the knee, ankle, wrist, elbow, shoulder, phalangeal, and hip joints. Since difficulty is not infrequently encountered in entering the hip joint, precautions should be taken to avoid any large blood vessels in the area. Joints not suitable for injection are those that are anatomically inaccessible such as the spinal joints and those like the sacroiliac joints that are devoid of synovial space. Treatment failures are most frequently the result of failure to enter the joint space. Little or no benefit follows injection into surrounding tissue. If failures occur when injections into the synovial spaces are certain, as determined by aspiration of fluid, repeated injections are usually futile. If a local anesthetic is used prior to injection of DEPO-MEDROL, the anesthetic package insert should be read carefully and all the precautions observed. 2. Bursitis . The area around the injection site is prepared in a sterile way and a wheal at the site made with 1 percent procaine hydrochloride solution. A 20 to 24 gauge needle attached to a dry syringe is inserted into the bursa and the fluid aspirated. The needle is left in place and the aspirating syringe changed for a small syringe containing the desired dose. After injection, the needle is withdrawn and a small dressing applied. 3. Miscellaneous: Ganglion, Tendinitis, Epicondylitis . In the treatment of conditions such as tendinitis or tenosynovitis, care should be taken following application of a suitable antiseptic to the overlying skin to inject the suspension into the tendon sheath rather than into the substance of the tendon. The tendon may be readily palpated when placed on a stretch. When treating conditions such as epicondylitis, the area of greatest tenderness should be outlined carefully and the suspension infiltrated into the area. For ganglia of the tendon sheaths, the suspension is injected directly into the cyst. In many cases, a single injection causes a marked decrease in the size of the cystic tumor and may effect disappearance. The usual sterile precautions should be observed, of course, with each injection. The dose in the treatment of the various conditions of the tendinous or bursal structures listed above varies with the condition being treated and ranges from 4 to 30 mg. In recurrent or chronic conditions, repeated injections may be necessary. 4. Injections for Local Effect in Dermatologic Conditions . Following cleansing with an appropriate antiseptic such as 70% alcohol, 20 to 60 mg is injected into the lesion. It may be necessary to distribute doses ranging from 20 to 40 mg by repeated local injections in the case of large lesions. Care should be taken to avoid injection of sufficient material to cause blanching since this may be followed by a small slough. One to four injections are usually employed, the intervals between injections varying with the type of lesion being treated and the duration of improvement produced by the initial injection. B. Administration for Systemic Effect The intramuscular dosage will vary with the condition being treated. When employed as a temporary substitute for oral therapy, a single injection during each 24-hour period of a dose of the suspension equal to the total daily oral dose of MEDROL ® Tablets (methylprednisolone tablets, USP) is usually sufficient. When a prolonged effect is desired, the weekly dose may be calculated by multiplying the daily oral dose by 7 and given as a single intramuscular injection. In pediatric patients, the initial dose of methylprednisolone may vary depending on the specific disease entity being treated. Dosage must be individualized according to the severity of the disease and response of the patient. The recommended dosage may be reduced for pediatric patients, but dosage should be governed by he severity of the condition rather than by strict adherence to the ratio indicated by age or body weight. In patients with the adrenogenital syndrome , a single intramuscular injection of 40 mg every two weeks may be adequate. For maintenance of patients with rheumatoid arthritis , the weekly intramuscular dose will vary from 40 to 120 mg. The usual dosage for patients with dermatologic lesions benefited by systemic corticoid therapy is 40 to 120 mg of methylprednisolone acetate administered intramuscularly at weekly intervals for one to four weeks. In acute severe dermatitis due to poison ivy, relief may result within 8 to 12 hours following intramuscular administration of a single dose of 80 to 120 mg. In chronic contact dermatitis, repeated injections at 5 to 10 day intervals may be necessary. In seborrheic dermatitis, a weekly dose of 80 mg may be adequate to control the condition. Following intramuscular administration of 80 to 120 mg to asthmatic patients, relief may result within 6 to 48 hours and persist for several days to two weeks. Similarly, in patients with allergic rhinitis (hay fever), an intramuscular dose of 80 to 120 mg may be followed by relief of coryzal symptoms within six hours persisting for several days to three weeks. If signs of stress are associated with the condition being treated, the dosage of the suspension should be increased. If a rapid hormonal effect of maximum intensity is required, the intravenous administration of highly soluble methylprednisolone sodium succinate is indicated. In treatment of acute exacerbations of multiple sclerosis, daily doses of 160 mg of methylprednisolone for a week followed by 64 mg every other day for 1 month have been shown to be effective. For the purpose of comparison, the following is the equivalent milligram dose of the various glucocorticoids: Cortisone, 25 Triamcinolone, 4 Hydrocortisone, 20 Paramethasone, 2 Prednisolone, 5 Betamethasone, 0.75 Prednisone, 5 Dexamethasone, 0.75 Methylprednisolone, 4 These dose relationships apply only to oral or intravenous administration of these compounds. When these substances or their derivatives are injected intramuscularly or into joint spaces, their relative properties may be greatly altered. DIRECTIONS Apply locally as needed DIRECTIONS Wipe injection site vigorously and discard 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. DOSAGE AND 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 30 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 The dose of any local anesthetic 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. The smallest dose and concentration required to produce the desired result should be administered. Dosages of MARCAINE should be reduced for elderly and/or debilitated patients and patients with cardiac and/or liver disease. The rapid injection of a large volume of local anesthetic solution should be avoided and fractional (incremental) doses should be used when feasible. For specific techniques and procedures, refer to standard textbooks. There have been adverse event reports of chondrolysis in patients receiving intra-articular infusions of local anesthetics following arthroscopic and other surgical procedures. MARCAINE is not approved for this use (see WARNINGS and DOSAGE AND ADMINISTRATION ). In recommended doses, MARCAINE produces complete sensory block, but the effect on motor function differs among the three concentrations. 0.25%—when used for caudal, epidural, or peripheral nerve block, produces incomplete motor block. Should be used for operations in which muscle relaxation is not important, or when another means of providing muscle relaxation is used concurrently. Onset of action may be slower than with the 0.5% or 0.75% solutions. 0.5%— provides motor blockade for caudal, epidural, or nerve block, but muscle relaxation may be inadequate for operations in which complete muscle relaxation is essential. 0.75%—produces complete motor block. Most useful for epidural block in abdominal operations requiring complete muscle relaxation, and for retrobulbar anesthesia. Not for obstetrical anesthesia. The duration of anesthesia with MARCAINE is such that for most indications, a single-dose is sufficient. Maximum dosage limit must be individualized in each case after evaluating the size and physical status of the patient, as well as the usual rate of systemic absorption from a particular injection site. Most experience to date is with single-doses of MARCAINE up to 225 mg with epinephrine 1:200,000 and 175 mg without epinephrine; more or less drug may be used depending on individualization of each case. These doses may be repeated up to once every three hours. In clinical studies to date, total daily doses have been up to 400 mg. Until further experience is gained, this dose should not be exceeded in 24 hours. The duration of anesthetic effect may be prolonged by the addition of epinephrine. The dosages in Table 1 have generally proved satisfactory and are recommended as a guide for use in the average adult. These dosages should be reduced for elderly or debilitated patients. Until further experience is gained, MARCAINE is not recommended for pediatric patients younger than 12 years. MARCAINE is contraindicated for obstetrical paracervical blocks, and is not recommended for intravenous regional anesthesia (Bier Block). Use in Epidural Anesthesia : During epidural administration of MARCAINE, 0.5% and 0.75% solutions should be administered in incremental doses of 3 mL to 5 mL with sufficient time between doses to detect toxic manifestations of unintentional intravascular or intrathecal injection. In obstetrics, only the 0.5% and 0.25% concentrations should be used; incremental doses of 3 mL to 5 mL of the 0.5% solution not exceeding 50 mg to 100 mg at any dosing interval are recommended. Repeat doses should be preceded by a test dose containing epinephrine if not contraindicated. Use only the single-dose ampuls and single-dose vials for caudal or epidural anesthesia; the multiple-dose vials contain a preservative and therefore should not be used for these procedures. Test Dose for Caudal and Lumbar Epidural Blocks : The Test Dose of MARCAINE (0.5% bupivacaine with 1:200,000 epinephrine in a 3 mL ampul) is recommended for use as a test dose when clinical conditions permit prior to caudal and lumbar epidural blocks. This may serve as a warning of unintended intravascular or subarachnoid injection (See PRECAUTIONS ). The pulse rate and other signs should be monitored carefully immediately following each test dose administration to detect possible intravascular injection, and adequate time for onset of spinal block should be allotted to detect possible intrathecal injection. An intravascular or subarachnoid 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 OVERDOSAGE ). Use in Dentistry : The 0.5% concentration with epinephrine is recommended for infiltration and block injection in the maxillary and mandibular area when a longer duration of local anesthetic action is desired, such as for oral surgical procedures generally associated with significant postoperative pain. The average dose of 1.8 mL (9 mg) per injection site will usually suffice; an occasional second dose of 1.8 mL (9 mg) may be used if necessary to produce adequate anesthesia after making allowance for 2 to 10 minutes onset time (See CLINICAL PHARMACOLOGY ). The lowest effective dose should be employed and time should be allowed between injections; it is recommended that the total dose for all injection sites, spread out over a single dental sitting, should not ordinarily exceed 90 mg for a healthy adult patient (ten 1.8 mL injections of 0.5% MARCAINE with epinephrine). Injections should be made slowly and with frequent aspirations. Until further experience is gained, MARCAINE in dentistry is not recommended for pediatric patients younger than 12 years. Unused portions of solution not containing preservatives, i.e., those supplied in single-dose ampuls and single-dose vials, should be discarded following initial use. This product should be inspected visually for particulate matter and discoloration prior to administration whenever solution and contain r permit. Solutions which are discolored or which contain particulate matter should not be administered. Table 1. Recommended Concentrations and Doses of MARCAINE Type of Block Conc. Each Dose Motor Block 1 (mL) (mg) Local Infiltration 0.25% 4 up to max. up to max. ------- Epidural 0.75% 2,4 10-20 75-100 complete 0.5% 4 10-20 50-100 moderate to complete 0.25% 4 10-20 25-50 partial to moderate Caudal 0.5% 4 15-30 75-100 moderate to complete 0.25% 4 15-30 37.5-75 moderate Peripheral nerves 0.5% 4 5 to max. 25 to max. moderate to complete 0.25% 4 5 to max. 12.5 to max moderate to complete Retrobulbar 3 0.75% 4 2-4 15-30 complete Sympathetic 0.25% 20-50 50-125 ------- Dental 3 0.5% w/ epi 1.8-3.6 per site 9-18 per site ------- Epidural 3 Test Dose 0.5% w/ epi 2-3 10-15 (10-15 micrograms epinephrine) ------- 1 With continuous (intermittent) techniques, repeat doses increase the degree of motor block. The first repeat dose of 0.5% may produce complete motor block. Intercostal nerve block with 0.25% may also produce complete motor block for intra-abdominal surgery. 2 For single-dose use, not for intermittent epidural technique. Not for obstetrical anesthesia. 3 See PRECAUTIONS. 4 Solutions with or without epinephrine.
Warnings & Precautions
WARNINGS Serious Neurologic Adverse Reactions with Epidural Administration Serious neurologic events, some resulting in death, have been reported with epidural injection of corticosteroids. Specific events reported include, but are not limited to, spinal cord infarction, paraplegia, quadriplegia, cortical blindness, and stroke. These serious neurologic events have been reported with and without use of fluoroscopy. The safety and effectiveness of epidural administration of corticosteroids have not been established, and corticosteroids are not approved for this use. General This product is not suitable for multi-dose use. Following administration of the desired dose, any remaining suspension should be discarded. Injection of DEPO-MEDROL may result in dermal and/or subdermal changes forming depressions in the skin at the injection site. In order to minimize the incidence of dermal and subdermal atrophy, care must be exercised not to exceed recommended doses in injections. Multiple small injections into the area of the les ion should be made whenever possible. The technique of intra-articular and intramuscular injection should include precautions against injection or leakage into the dermis. Injection into the deltoid muscle should be avoided because of a high incidence of subcutaneous atrophy. It is critical that, during administration of DEPO-MEDROL, appropriate technique be used and care taken to ensure proper placement of drug. Rare instances of anaphylactoid reactions have occurred in patients receiving corticosteroid therapy (see ADVERSE REACTIONS ). Increased dosage of rapidly acting corticosteroids is indicated in patients on corticosteroid therapy subjected to any unusual stress before, during, and after the stressful situation. Results from one multicenter, randomized, placebo-controlled study with methylprednisolone hemisuccinate, an IV corticosteroid, showed an increase in early (at 2 weeks) and late (at 6 months) mortality in patients with cranial trauma who were determined not to have other clear indications for corticosteroid treatment. High doses of systemic corticosteroids, including DEPO-MEDROL, should not be used for the treatment of traumatic brain injury. Cardio-renal Average and large doses of corticosteroids can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium. These effects are less likely to occur with synthetic derivatives when used in large doses. Dietary salt restriction and potassium supplementation may be necessary. All corticosteroids increase calcium excretion. Literature reports suggest an apparent association between use of corticosteroids and left ventricular free wall rupture after a recent myocardial infarction; therefore, therapy with corticosteroids should be used with great caution in these patients. Endocrine Hypothalamic-pituitary adrenal (HPA) axis suppression. Cushing's syndrome, and hyperglycemia: Monitor patients for these conditions with chronic use. Corticosteroids can produce reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Drug induced secondary adrenocortical insufficiency may be minimized by gradual reduction of dosage. This type of relative insufficiency may persist for months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted. Infections General Persons who are on corticosteroids are more susceptible to infections than are healthy individuals. There may be decreased resistance and inability to localize infection when corticosteroids are used. Infections with any pathogen (viral, bacterial, fungal, protozoan, or helminthic) in any location of the body, may be associated with the use of corticosteroids alone or in combination with other immunosuppressive agents. These infections may be mild, but can be severe and at times fatal. With increasing doses of corticosteroids, the rate of occurrence of infectious complications increases. Do not use intra-articularly, intrabursally, or for intratendinous administration for local effect in the presence of an acute infection. Corticosteroids may mask some signs of infection and new infections may appear during their use. Fungal Infections Corticosteroids may exacerbate systemic fungal infections and therefore should not be used in the presence of such infections unless they are needed to control drug interactions. There have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure (see CONTRAINDICATIONS and PRECAUTIONS: Drug Interactions, Amphotericin B injection and potassium-depleting agents ). Special Pathogens Latent disease may be activated or there may be an exacerbation of intercurrent infections due to pathogens, including those caused by Amoeba, Candida, Cryptococcus, Mycobacterium, Nocardia, Pneumocystis, and Toxoplasma . It is recommended that latent amebiasis or active amebiasis be ruled out before initiating corticosteroid therapy in any patient who has spent time in the tropics or in any patient with unexplained diarrhea. Similarly, corticosteroids should be used with great care in patients with known or suspected Strongyloides (threadworm) infestation. In such patients, corticosteroid-induced immunosuppression may lead to Strongyloides hyperinfection and dissemination with widespread larval migration, often accompanied by severe enterocolitis and potentially fatal gram-negative septicemia. Corticosteroids should n t be used in cerebral malaria. There is currently no evidence of benefit from steroids in this condition. Tuberculosis The use of corticosteroids in active tuberculosis should be restricted to those cases of fulminating or disseminated tuberculosis in which the corticosteroid is used for the management of the disease in conjunction with an appropriate antituberculous regimen. If corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, close observation is necessary, as reactivation of the disease may occur. During prolonged corticosteroid therapy, these patients should receive chemoprophylaxis. Vaccinations Administration of live or live, attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids. Killed or inactivated vaccines may be administered. However, the response to such vaccines cannot be predicted. Immunization procedures may be undertaken in patients who are receiving corticosteroids as replacement therapy (e.g., for Addison's disease). Viral Infections Chicken pox and measles can have a more serious or even fatal course in pediatric and adult patients on corticosteroids. In pediatric and adult patients who have not had these diseases, particular care should be taken to avoid exposure. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If exposed to chicken pox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with immunoglobulin (IG) may be indicated (see the respective package inserts for complete VZIG and IG prescribing information). If chicken pox develops, treatment with antiviral agents should be considered. Ophthalmic Use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to bacteria, fungi, or viruses. The use of systemic corticosteroids is not recommended in the treatment of optic neuritis and may lead to an increase in the risk of new episodes. Corticosteroids should be used cautiously in patients with ocular herpes simplex because of corneal perforation. Corticosteroids should not be used in active ocular herpes simplex. 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, irritation, 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. 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 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 THE 0.75% CONCENTRATION OF MARCAINE IS NOT RECOMMENDED FOR OBSTETRICAL ANESTHESIA. THERE HAVE BEEN REPORTS OF CARDIAC ARREST WITH DIFFICULT RESUSCITATION OR DEATH DURING USE OF MARCAINE FOR EPIDURAL ANESTHESIA IN OBSTETRICAL PATIENTS. IN MOST CASES, THIS HAS FOLLOWED USE OF THE 0.75% CONCENTRATION. RESUSCITATION HAS BEEN DIFFICULT OR IMPOSSIBLE DESPITE APPARENTLY ADEQUATE PREPARATION AND APPROPRIATE MANAGEMENT. CARDIAC ARREST HAS OCCURRED AFTER CONVULSIONS RESULTING FROM SYSTEMIC TOXICITY, PRESUMABLY FOLLOWING UNINTENTIONAL INTRAVASCULAR INJECTION. THE 0.75% CONCENTRATION SHOULD BE RESERVED FOR SURGICAL PROCEDURES WHERE A HIGH DEGREE OF MUSCLE RELAXATION AND PROLONGED EFFECT ARE NECESSARY. LOCAL ANESTHETICS SHOULD ONLY BE EMPLOYED BY CLINICIANS WHO ARE WELL VERSED IN DIAGNOSIS AND MANAGEMENT OF DOSE-RELATED TOXICITY AND OTHER ACUTE EMERGENCIES WHICH MIGHT ARISE FROM THE BLOCK TO BE EMPLOYED, AND THEN ONLY AFTER INSURING THE IMMEDIATE AVAILABILITY OF OXYGEN, OTHER RESUSCITATIVE DRUGS, CARDIOPULMONARY RESUSCITATIVE EQUIPMENT, AND THE PERSONNEL RESOURCES NEEDED FOR PROPER MANAGEMENT OF TOXIC REACTIONS AND RELATED EMERGENCIES. (See also ADVERSE REACTIONS, PRECAUTIONS , and OVERDOSAGE .) 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 CNS and cardiovascular adverse effects, including seizures, coma, arrhythmias, and death. Discontinue MARCAINE 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. Local anesthetic solutions containing antimicrobial preservatives, i.e., those supplied in multiple-dose vials, should not be used for epidural or caudal anesthesia because safety has not been established with regard to intrathecal injection, either intentionally or unintentionally, of such preservatives. 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. It is essential that aspiration for blood or cerebrospinal fluid (where applicable) be done prior to injecting any local anesthetic, both the original dose and all subsequent doses, to avoid intravascular or subarachnoid injection. However, a negative aspiration does not ensure against an intravascular or subarachnoid injection. MARCAINE with epinephrine 1:200,000 or other vasopressors should not be used concomitantly with ergot-type oxytocic drugs, because a severe persistent hypertension may occur. Likewise, solutions of MARCAINE containing a vasoconstrictor, such as epinephrine, should be used with extreme caution in patients receiving monoamineoxidase inhibitors (MAOI) or antidepressants of the triptyline or imipramine types, because severe prolonged hypertension may result. Until further experience is gained in pediatric patients younger than 12 years, administration of MARCAINE in this age group is not recommended. Mixing or the prior or intercurrent use of any other local anesthetic with MARCAINE cannot be recommended because of insufficient data on the clinical use of such mixtures. There have been reports of cardiac arrest and death during the use of MARCAINE for intravenous regional anesthesia (Bier Block). Information on safe dosages and techniques of administration of MARCAINE in this procedure is lacking. Therefore, MARCAINE is not recommended for use in this technique. MARCAINE with epinephrine 1:200,000 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. 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 nonasthmatic people. Single-dose ampuls and single-dose vials of MARCAINE without epinephrine do not contain sodium metabisulfite.
Contraindications
DEPO-MEDROL is contraindicated in patients with known hypersensitivity to the product and its constituents. Intramuscular corticosteroid preparations are contraindicated for idiopathic thrombocytopenic purpura. DEPO-MEDROL is contraindicated for intrathecal administration. This formulation of methylprednisolone acetate has been associated with reports of severe medical events when administered by this route. DEPO-MEDROL is contraindicated in systemic fungal infections, except when administered as an intra-articular injection for localized joint conditions (see WARNINGS: Infections, Fungal Infections ). CONTRAINDICATIONS Lidocaine HCl is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type. CONTRAINDICATIONS MARCAINE is contraindicated in obstetrical paracervical block anesthesia. Its use in this technique has resulted in fetal bradycardia and death. MARCAINE is contraindicated in patients with a known hypersensitivity to it or to any local anesthetic agent of the amide-type or to other components of MARCAINE solutions.
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. 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 to MARCAINE are characteristic of those associated with other amide-type local anesthetics. 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 experiences which demand immediate counter-measures are related to the CNS and the cardiovascular system. These adverse experiences are generally dose related and due to high plasma levels which may result 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 subarachnoid 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) may result in underventilation or apnea ("Total or High Spinal"). Also, hypotension due to loss of sympathetic tone and respiratory paralysis or underventilation due to cephalad extension of the motor level of anesthesia may occur. This may lead to secondary cardiac arrest if untreated. Patients over 65 years, particularly those with hypertension, may be at increased risk for experiencing the hypotensive effects of MARCAINE. Factors influencing plasma protein binding, such as acidosis, systemic diseases which alter protein production, or competition of other drugs for protein binding sites, may diminish individual tolerance. CNS Reactions : These are characterized by excitation and/or depression. Restlessness, anxiety, dizziness, tinnitus, blurred vision, or tremors may occur, possibly proceeding to convulsions. However, excitement may be transient or absent, with depression being the first manifestation of an adverse reaction. This may quickly be followed by drowsiness merging into unconsciousness and respiratory arrest. Other CNS effects may be nausea, vomiting, chills, and constriction of the pupils. The incidence of convulsions associated with the use of local anesthetics varies 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. Cardiovascular System Reactions: High doses or unintentional intravascular injection may lead 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, PRECAUTIONS , and OVERDOSAGE ). Allergic : Allergic-type reactions are rare and may occur as a result of sensitivity to the local anesthetic or to other formulation ingredients, such as the antimicrobial preservative methylparaben contained in multiple-dose vials or sulfites in epinephrine-containing solutions. These reactions are characterized by signs such as urticaria, pruritus, erythema, angioneurotic edema (including laryngeal edema), tachycardia, sneezing, nausea, vomiting, dizziness, syncope, excessive sweating, elevated temperature, and possibly, anaphylactoid-like symptomatology (including severe hypotension). Cross sensitivity among members of the amide-type local anesthetic group has been reported. The usefulness of screening for sensitivity has not been definitely established. Neurologic: 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. Many of these effects may be related to local anesthetic techniques, with or without a contribution from the drug. In the practice of caudal or lumbar epidural block, occasional unintentional penetration of the subarachnoid space by the catheter or needle may occur. Subsequent adverse effects may depend partially on the amount of drug administered intrathecally and the physiological and physical effects of a dural puncture. A high spinal is characterized by paralysis of the legs, loss of consciousness, respiratory paralysis, and bradycardia. Neurologic effects following epidural or caudal anesthesia may include 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 may have 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 may include persistent anesthesia, paresthesia, weakness, paralysis, all of which may have slow, incomplete, or no recovery.
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 China Manufactured for: Dynarex Corporation Orangeburg, NY 10962 www.dynarex.com Revised: 11/2019
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