MARCAINE
Drug Facts
Composition & Profile
Identifiers & Packaging
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 o f 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 1:200,000 -- 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; HOW SUPPLIED Sodium Chloride Injection, USP, 0.9%, preservative free, is available as follows: Product Code Unit of Sale Strength Each 918602 63323-186-02 Trays of 25 0.9% (18 mg per 2 mL) (9 mg per mL) NDC 63323-186-04 2 mL fill, in a 3 mL Single-Dose vial 918610 63323-186-10 Trays of 25 0.9% (90 mg per 10 mL) (9 mg per mL) NDC 63323-186-01 10 mL Single-Dose vial 918620 63323-186-20 Trays of 25 0.9% (180 mg per 20 mL) (9 mg per mL) NDC 63323-186-03 20 mL Single-Dose vial Preservative Free . Discard unused portion. Use only if solution is clear and seal intact. Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. Fresenius Kabi Logo www.fresenius-kabi.com/us 45764E Revised: October 2018 Fresenius Kabi Logo; PRINCIPAL DISPLAY PANEL: P-Care M NDC 49836-001-18 RX-Only P-Care M Kit Contains: 1 Marcaine ® 0.5% Single Dose Vial (5mg/mL) (10mL) 1 Sodium Chloride Injection, USP 0.9% Single Dose Vial (10 mL) 1 Sterile Povidone-Iodine Swabsticks (3 Swabs) 1 Sterile Pair Nitrile Powder-Free Gloves (Size 7.5) 1 Sterile Towel Drape 1 Sterile Fenestrated Towel Drape 2 Sterile Adhesive Bandage 2 Sterile Adhesive Spot Bandage 3 Sterile Packs of 4x4 Gauze (6 Gauzes) 5 Sterile Isopropyl Alcohol 70% Prep Pad 1 Dose Needles and Syringes Not Included P-Care M DISTRIBUTED BY: SCHMIGS HAUPPAUGE, NY 11788 NDC 49836-001-18 MANUFACTURED BY: Rx Pharma Pack HAUPPAUGE, NY 11788 Questions/Comments 1-844-632-7898 Kit Contents: Marcaine ® ‡ 0.5% (5mg/mL) (Hospira, Inc.)* Bupicacaine 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. Sodium Chloride Injection, USP 0.9% (10 mL) (APP Fresenius Kabi USA, LLC)* Each mL contains sodium chloride, 9 mg. May contain HCI and/or NaOH for pH adjustment. Sterile, nonpyrogenic, preservative free. Sterile Povidone-lodine Swabsticks (Aplicare)* Sterile Nitrile Powder-Free Gloves (Dynarex) - Size 7.5* Sterile Towel Drape (Dynarex)* Sterile Fenestrated Towel Drape (Dynarex)* Sterile Adhesive Bandage (Dynarex)* Sterile Adhesive Spot Bandage (Dynarex)* Sterile 4x4 Gauze (Dynarex)* Sterile Alcohol Prep Pad 70% by Volume (Dynarex)* ‡ Marcaine ® (registered trademark of Hospira, Inc.) * Internal package components remain sterile when stated as long as items are unopened and undamaged. WARNING: KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY. PROTECT FROM LIGHT I AVOID FREEZING STORE AT CONTROLLED ROOM TEMPERATURE 20º-25ºC (68º-77º F) [SEE USP CONTROLLED ROOM TEMPERATURE] DO NOT REFRIGERATE. Directions for Use: See enclosed inserts. SUSTAINABLE Certified Sourcing FORESTRY www.sfiprogram.org INITIATIVE SFI-01376 ORG 04/2017 This product is not eligible for Medicare or Medicaid reimbursement P-Care M Kit P-Care M Kit
- 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 o f 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 1:200,000 -- 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
- HOW SUPPLIED Sodium Chloride Injection, USP, 0.9%, preservative free, is available as follows: Product Code Unit of Sale Strength Each 918602 63323-186-02 Trays of 25 0.9% (18 mg per 2 mL) (9 mg per mL) NDC 63323-186-04 2 mL fill, in a 3 mL Single-Dose vial 918610 63323-186-10 Trays of 25 0.9% (90 mg per 10 mL) (9 mg per mL) NDC 63323-186-01 10 mL Single-Dose vial 918620 63323-186-20 Trays of 25 0.9% (180 mg per 20 mL) (9 mg per mL) NDC 63323-186-03 20 mL Single-Dose vial Preservative Free . Discard unused portion. Use only if solution is clear and seal intact. Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. Fresenius Kabi Logo www.fresenius-kabi.com/us 45764E Revised: October 2018 Fresenius Kabi Logo
- PRINCIPAL DISPLAY PANEL: P-Care M NDC 49836-001-18 RX-Only P-Care M Kit Contains: 1 Marcaine ® 0.5% Single Dose Vial (5mg/mL) (10mL) 1 Sodium Chloride Injection, USP 0.9% Single Dose Vial (10 mL) 1 Sterile Povidone-Iodine Swabsticks (3 Swabs) 1 Sterile Pair Nitrile Powder-Free Gloves (Size 7.5) 1 Sterile Towel Drape 1 Sterile Fenestrated Towel Drape 2 Sterile Adhesive Bandage 2 Sterile Adhesive Spot Bandage 3 Sterile Packs of 4x4 Gauze (6 Gauzes) 5 Sterile Isopropyl Alcohol 70% Prep Pad 1 Dose Needles and Syringes Not Included P-Care M DISTRIBUTED BY: SCHMIGS HAUPPAUGE, NY 11788 NDC 49836-001-18 MANUFACTURED BY: Rx Pharma Pack HAUPPAUGE, NY 11788 Questions/Comments 1-844-632-7898 Kit Contents: Marcaine ® ‡ 0.5% (5mg/mL) (Hospira, Inc.)* Bupicacaine 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. Sodium Chloride Injection, USP 0.9% (10 mL) (APP Fresenius Kabi USA, LLC)* Each mL contains sodium chloride, 9 mg. May contain HCI and/or NaOH for pH adjustment. Sterile, nonpyrogenic, preservative free. Sterile Povidone-lodine Swabsticks (Aplicare)* Sterile Nitrile Powder-Free Gloves (Dynarex) - Size 7.5* Sterile Towel Drape (Dynarex)* Sterile Fenestrated Towel Drape (Dynarex)* Sterile Adhesive Bandage (Dynarex)* Sterile Adhesive Spot Bandage (Dynarex)* Sterile 4x4 Gauze (Dynarex)* Sterile Alcohol Prep Pad 70% by Volume (Dynarex)* ‡ Marcaine ® (registered trademark of Hospira, Inc.) * Internal package components remain sterile when stated as long as items are unopened and undamaged. WARNING: KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY. PROTECT FROM LIGHT I AVOID FREEZING STORE AT CONTROLLED ROOM TEMPERATURE 20º-25ºC (68º-77º F) [SEE USP CONTROLLED ROOM TEMPERATURE] DO NOT REFRIGERATE. Directions for Use: See enclosed inserts. SUSTAINABLE Certified Sourcing FORESTRY www.sfiprogram.org INITIATIVE SFI-01376 ORG 04/2017 This product is not eligible for Medicare or Medicaid reimbursement P-Care M Kit P-Care M Kit
Overview
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 DESCRIPTION Sodium Chloride Injection, USP, 0.9% is a sterile, nonpyrogenic solution. The osmolarity is 300 mOsmol per liter (calculated). Each mL contains: Sodium chloride 9 mg; Water for Injection q.s. It contains no bacteriostat, antimicrobial agent or added buffer and is supplied only in single dose containers. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment (pH 4.5-7.0). Sodium chloride occurs as colorless cubic crystals or white crystalline powder and has a saline taste. Sodium chloride is freely soluble in water. It is soluble in glycerin and slightly soluble in alcohol. The empirical formula for sodium chloride is NaCl and the molecular weight is 58.44.
Indications & Usage
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% retobulbar 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. INDICATIONS AND USAGE Sodium Chloride Injection, USP, 0.9% preparations are indicated for diluting or dissolving drugs for intramuscular, intravenous or subcutaneous injection according to instructions of the manufacturer of the drug to be administered. Sodium Chloride Injection, USP, 0.9% is also indicated for use in flushing of intravenous catheters. USE Antiseptic skin preparation USE For preparation of the skin prior to injection.
Dosage & Administration
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% solution 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 container permit. Solutions which are discolored or which contain particulate matter should not be administered. Table 1. Recommended Concentrations and Doses of MARCAINE Each Dose Type of Block Conc. (mL) (mg) Motor Block 1 Local infiltration 0.25% 4 up to max. up to max. ------- Epidural 0.75% 2,4 10-20 75-150 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 0.5% 2-3 10-15 ------ Test Dose w/epi (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. DOSAGE AND ADMINISTRATION Before Sodium Chloride Injection, USP, 0.9% is used as a vehicle for the administration of a drug, specific references should be checked for any possible incompatibility with sodium chloride. The volume of the preparation to be used for diluting or dissolving any drug for injection is dependent on the vehicle concentration, dose and route of administration as recommended by the manufacturer. Sodium Chloride Injection, USP, 0.9% is also indicated for use in flushing intravenous catheters. Prior to and after administration of the medication, the intravenous catheter should be flushed in its entirety with Sodium Chloride Injection, USP, 0.9%. Use in accord with any warnings or precautions appropriate to the medication being administered. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. DIRECTIONS Apply locally as needed DIRECTIONS Wipe injection site vigorously and discard.
Warnings & Precautions
WARNINGS 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. WARNINGS For use in newborns, when a sodium chloride solution is required for preparation or diluting medications or in flushing intravenous catheters, only preservative free Sodium Chloride Injection, USP, 0.9% should be used. WARNINGS Do not use if allergic to iodine in the eyes For external use only Avoid pooling beneath patient Avoid excessive heat. Store at room temperature. Ask a doctor before use if injuries are deep or puncture wounds serious burns Stop use and ask a doctor if redness, 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 immediately.
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 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 charac erized 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. ADVERSE REACTIONS Reactions which may occur because of this solution, added drugs or the technique of reconstitution or administration include febrile response, local tenderness, abscess, tissue necrosis or infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection and extravasation. If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate countermeasures and, if possible, retrieve and save the remainder of the unused vehicle for examination.
Purpose
PURPOSE Antiseptic PURPOSE Antiseptic
Storage & Handling
OTHER INFORMATION Store at room temperature: 15 deg C to 30 deg C 59 deg F to 86 deg F avoid excessive heat Reorder No. 1113 Made in China Manufactured for: Dynarex Corporation Orangeburg, NY 10962 www.dynarex.com Revised: 11/2019
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