POLOCAINE-MPF
(+1 other brands)
Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED: Single-dose vials and multiple-dose vials of POLOCAINE may be sterilized by autoclaving at 15 pound pressure, 121°C (250°F) for 15 minutes. Solutions of POLOCAINE may be reautoclaved when necessary. Do not administer solutions which are discolored or which contain particulate matter. THESE SOLUTIONS ARE NOT INTENDED FOR SPINAL ANESTHESIA OR DENTAL USE. POLOCAINE ® -MPF (Mepivacaine HCl Injection, USP) without preservatives is available as follows: Product Code Unit of Sale Strength Each 261037 NDC 63323-260-37 Unit of 25 1% 300 mg per 30 mL (10 mg per mL) NDC 63323-260-01 30 mL Single Dose Vial 293037 NDC 63323-293-37 Unit of 25 1.5% 450 mg per 30 mL (15 mg per mL) NDC 63323-293-01 30 mL Single Dose Vial 294027 NDC 63323-294-27 Unit of 25 2% 400 mg per 20 mL (20 mg per mL) NDC 63323-294-01 20 mL Single Dose Vial POLOCAINE ® (Mepivacaine HCl Injection, USP) with preservatives is available as follows: Product Code Unit of Sale Strength Each 283057 NDC 63323-283-57 Unit of 25 1% 500 mg per 50 mL (10 mg per mL) NDC 63323-283-01 50 mL Multiple Dose Vial 296057 NDC 63323-296-57 Unit of 25 2% 1,000 mg per 50 mL (20 mg per mL) NDC 63323-296-01 50 mL Multiple Dose Vial For single-dose vials: Discard unused portion. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]; brief exposure up to 40 ° C (104 ° F) does not adversely affect the product. All trademarks are the property of Fresenius Kabi USA, LLC. Manufactured for: www.fresenius-kabi.com/us 451105D/Revised: April 2019 Fresenius Kabi Logo; PACKAGE LABEL - PRINCIPAL DISPLAY – Polocaine ® –MPF 30 mL Single Dose Vial Label NDC 63323-260-01 261037 Polocaine ® –MPF (mepivacaine HCl Injection, USP) 1% 300 mg per 30 mL (10 mg per mL) For Nerve Block, Caudal, Epidural and Infiltration Anesthesia. Not Intended for Spinal Anesthesia or Dental Use. Methylparaben Free 30 mL Single Dose Vial PACKAGE LABEL - PRINCIPAL DISPLAY – Polocaine®–MPF 30 mL Single Dose Vial Label; PACKAGE LABEL - PRINCIPAL DISPLAY - Polocaine-MPF 30 mL Single Dose Vial Tray Label NDC 63323-260-37 261037 Polocaine ® -MPF (mepivacaine HCl Injection, USP) 1% 300 mg per 30 mL (10 mg per mL) For Nerve Block, Caudal, Epidural and Infiltration Anesthesia. Not Intended for Spinal Anesthesia or Dental Use. Methylparaben Free Rx only 25 Single Dose Vials, 30 mL PACKAGE LABEL - PRINCIPAL DISPLAY - Polocaine-MPF 30 mL Single Dose Vial Tray Label; PACKAGE LABEL - PRINCIPAL DISPLAY - Polocaine ® 50 mL Multiple Dose Vial Label NDC 63323-283-01 283057 Polocaine ® (mepivacaine HCl Injection, USP) 1% 500 mg per 50 mL (10 mg per mL) For Infiltration and Nerve Block Only Not Intended for Spinal Anesthesia or Dental Use. 50 mL Multiple Dose Vial PACKAGE LABEL - PRINCIPAL DISPLAY - Polocaine® 50 mL Multiple Dose Vial Label; PACKAGE LABEL - PRINCIPAL DISPLAY - Polocaine 50 mL Multiple Dose Vial Tray Label NDC 63323-283-57 283057 Polocaine ® (mepivacaine HCl Injection, USP) 1% 500 mg per 50 mL (10 mg per mL) For Infiltration and Nerve Block Only Not Intended for Spinal Anesthesia or Dental Use. Rx only 25 Multiple Dose Vials, 50 mL PACKAGE LABEL - PRINCIPAL DISPLAY - Polocaine 50 mL Multiple Dose Vial Tray Label NDC 63323-283-57; PACKAGE LABEL - PRINCIPAL DISPLAY - Polocaine ® -MPF 30 mL Single Dose Vial Label NDC 63323-293-01 293037 Polocaine ® –MPF (mepivacaine HCl Injection, USP) 1.5% 450 mg per 30 mL (15 mg per mL) For Nerve Block, Caudal, Epidural and Infiltration Anesthesia. Not Intended for Spinal Anesthesia or Dental Use. Methylparaben Free 30 mL Single Dose Vial PACKAGE LABEL - PRINCIPAL DISPLAY - Polocaine®-MPF 30 mL Single Dose Vial Label; PACKAGE LABEL - PRINCIPAL DISPLAY - Polocaine-MPF 30 mL Single Dose Vial Tray Label NDC 63323-293-37 293037 Polocaine ® -MPF (mepivacaine HCl Injection, USP) 1.5% 450 mg per 30 mL (15 mg per mL) For Nerve Block, Caudal, Epidural and Infiltration Anesthesia. Not Intended for Spinal Anesthesia or Dental Use. Methylparaben Free Rx only 25 Single Dose Vials, 30 mL PACKAGE LABEL - PRINCIPAL DISPLAY - Polocaine-MPF 30 mL Single Dose Vial Tray Label; PACKAGE LABEL - PRINCIPAL DISPLAY - Polocaine ® -MPF 20 mL Single Dose Vial Label NDC 63323-294-01 294027 Polocaine ® –MPF (mepivacaine HCl Injection, USP) 2% 400 mg per 20 mL (20 mg per mL) For Nerve Block, Caudal, Epidural and Infiltration Anesthesia. Not Intended for Spinal Anesthesia or Dental Use. Methylparaben Free 20 mL Single Dose Vial PACKAGE LABEL - PRINCIPAL DISPLAY - Polocaine®-MPF 20 mL Single Dose Vial Label; PACKAGE LABEL - PRINCIPAL DISPLAY - Polocaine-MPF 20 mL Single Dose Vial Tray Label NDC 63323-294-27 294027 Polocaine ® -MPF (mepivacaine HCl Injection, USP) 2% 400 mg per 20 mL (20 mg per mL) For Nerve Block, Caudal, Epidural and Infiltration Anesthesia. Not Intended for Spinal Anesthesia or Dental Use. Methylparaben Free Rx only 25 Single Dose Vials, 20 mL PACKAGE LABEL - PRINCIPAL DISPLAY - Polocaine-MPF 20 mL Single Dose Vial Tray Label; PACKAGE LABEL - PRINCIPAL DISPLAY - Polocaine ® 50 mL Multiple Dose Vial Label NDC 63323-296-01 296057 Polocaine ® (mepivacaine HCl Injection, USP) 2% 1,000 mg per 50 mL (20 mg per mL) For Infiltration and Nerve Block Only Not Intended for Spinal Anesthesia or Dental Use. 50 mL Multiple Dose Vial PACKAGE LABEL - PRINCIPAL DISPLAY - Polocaine® 50 mL Multiple Dose Vial Label; PACKAGE LABEL - PRINCIPAL DISPLAY - Polocaine 50 mL Multiple Dose Vial Tray Label NDC 63323-296-57 296057 Polocaine ® (mepivacaine HCl Injection, USP) 2% 1,000 mg per 50 mL (20 mg per mL) For Infiltration and Nerve Block Only Not Intended for Spinal Anesthesia or Dental Use. Rx only 25 Multiple Dose Vials, 50 mL PACKAGE LABEL - PRINCIPAL DISPLAY - Polocaine 50 mL Multiple Dose Vial Tray Label NDC 63323-296-57
- HOW SUPPLIED: Single-dose vials and multiple-dose vials of POLOCAINE may be sterilized by autoclaving at 15 pound pressure, 121°C (250°F) for 15 minutes. Solutions of POLOCAINE may be reautoclaved when necessary. Do not administer solutions which are discolored or which contain particulate matter. THESE SOLUTIONS ARE NOT INTENDED FOR SPINAL ANESTHESIA OR DENTAL USE. POLOCAINE ® -MPF (Mepivacaine HCl Injection, USP) without preservatives is available as follows: Product Code Unit of Sale Strength Each 261037 NDC 63323-260-37 Unit of 25 1% 300 mg per 30 mL (10 mg per mL) NDC 63323-260-01 30 mL Single Dose Vial 293037 NDC 63323-293-37 Unit of 25 1.5% 450 mg per 30 mL (15 mg per mL) NDC 63323-293-01 30 mL Single Dose Vial 294027 NDC 63323-294-27 Unit of 25 2% 400 mg per 20 mL (20 mg per mL) NDC 63323-294-01 20 mL Single Dose Vial POLOCAINE ® (Mepivacaine HCl Injection, USP) with preservatives is available as follows: Product Code Unit of Sale Strength Each 283057 NDC 63323-283-57 Unit of 25 1% 500 mg per 50 mL (10 mg per mL) NDC 63323-283-01 50 mL Multiple Dose Vial 296057 NDC 63323-296-57 Unit of 25 2% 1,000 mg per 50 mL (20 mg per mL) NDC 63323-296-01 50 mL Multiple Dose Vial For single-dose vials: Discard unused portion. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]; brief exposure up to 40 ° C (104 ° F) does not adversely affect the product. All trademarks are the property of Fresenius Kabi USA, LLC. Manufactured for: www.fresenius-kabi.com/us 451105D/Revised: April 2019 Fresenius Kabi Logo
- PACKAGE LABEL - PRINCIPAL DISPLAY – Polocaine ® –MPF 30 mL Single Dose Vial Label NDC 63323-260-01 261037 Polocaine ® –MPF (mepivacaine HCl Injection, USP) 1% 300 mg per 30 mL (10 mg per mL) For Nerve Block, Caudal, Epidural and Infiltration Anesthesia. Not Intended for Spinal Anesthesia or Dental Use. Methylparaben Free 30 mL Single Dose Vial PACKAGE LABEL - PRINCIPAL DISPLAY – Polocaine®–MPF 30 mL Single Dose Vial Label
- PACKAGE LABEL - PRINCIPAL DISPLAY - Polocaine-MPF 30 mL Single Dose Vial Tray Label NDC 63323-260-37 261037 Polocaine ® -MPF (mepivacaine HCl Injection, USP) 1% 300 mg per 30 mL (10 mg per mL) For Nerve Block, Caudal, Epidural and Infiltration Anesthesia. Not Intended for Spinal Anesthesia or Dental Use. Methylparaben Free Rx only 25 Single Dose Vials, 30 mL PACKAGE LABEL - PRINCIPAL DISPLAY - Polocaine-MPF 30 mL Single Dose Vial Tray Label
- PACKAGE LABEL - PRINCIPAL DISPLAY - Polocaine ® 50 mL Multiple Dose Vial Label NDC 63323-283-01 283057 Polocaine ® (mepivacaine HCl Injection, USP) 1% 500 mg per 50 mL (10 mg per mL) For Infiltration and Nerve Block Only Not Intended for Spinal Anesthesia or Dental Use. 50 mL Multiple Dose Vial PACKAGE LABEL - PRINCIPAL DISPLAY - Polocaine® 50 mL Multiple Dose Vial Label
- PACKAGE LABEL - PRINCIPAL DISPLAY - Polocaine 50 mL Multiple Dose Vial Tray Label NDC 63323-283-57 283057 Polocaine ® (mepivacaine HCl Injection, USP) 1% 500 mg per 50 mL (10 mg per mL) For Infiltration and Nerve Block Only Not Intended for Spinal Anesthesia or Dental Use. Rx only 25 Multiple Dose Vials, 50 mL PACKAGE LABEL - PRINCIPAL DISPLAY - Polocaine 50 mL Multiple Dose Vial Tray Label NDC 63323-283-57
- PACKAGE LABEL - PRINCIPAL DISPLAY - Polocaine ® -MPF 30 mL Single Dose Vial Label NDC 63323-293-01 293037 Polocaine ® –MPF (mepivacaine HCl Injection, USP) 1.5% 450 mg per 30 mL (15 mg per mL) For Nerve Block, Caudal, Epidural and Infiltration Anesthesia. Not Intended for Spinal Anesthesia or Dental Use. Methylparaben Free 30 mL Single Dose Vial PACKAGE LABEL - PRINCIPAL DISPLAY - Polocaine®-MPF 30 mL Single Dose Vial Label
- PACKAGE LABEL - PRINCIPAL DISPLAY - Polocaine-MPF 30 mL Single Dose Vial Tray Label NDC 63323-293-37 293037 Polocaine ® -MPF (mepivacaine HCl Injection, USP) 1.5% 450 mg per 30 mL (15 mg per mL) For Nerve Block, Caudal, Epidural and Infiltration Anesthesia. Not Intended for Spinal Anesthesia or Dental Use. Methylparaben Free Rx only 25 Single Dose Vials, 30 mL PACKAGE LABEL - PRINCIPAL DISPLAY - Polocaine-MPF 30 mL Single Dose Vial Tray Label
- PACKAGE LABEL - PRINCIPAL DISPLAY - Polocaine ® -MPF 20 mL Single Dose Vial Label NDC 63323-294-01 294027 Polocaine ® –MPF (mepivacaine HCl Injection, USP) 2% 400 mg per 20 mL (20 mg per mL) For Nerve Block, Caudal, Epidural and Infiltration Anesthesia. Not Intended for Spinal Anesthesia or Dental Use. Methylparaben Free 20 mL Single Dose Vial PACKAGE LABEL - PRINCIPAL DISPLAY - Polocaine®-MPF 20 mL Single Dose Vial Label
- PACKAGE LABEL - PRINCIPAL DISPLAY - Polocaine-MPF 20 mL Single Dose Vial Tray Label NDC 63323-294-27 294027 Polocaine ® -MPF (mepivacaine HCl Injection, USP) 2% 400 mg per 20 mL (20 mg per mL) For Nerve Block, Caudal, Epidural and Infiltration Anesthesia. Not Intended for Spinal Anesthesia or Dental Use. Methylparaben Free Rx only 25 Single Dose Vials, 20 mL PACKAGE LABEL - PRINCIPAL DISPLAY - Polocaine-MPF 20 mL Single Dose Vial Tray Label
- PACKAGE LABEL - PRINCIPAL DISPLAY - Polocaine ® 50 mL Multiple Dose Vial Label NDC 63323-296-01 296057 Polocaine ® (mepivacaine HCl Injection, USP) 2% 1,000 mg per 50 mL (20 mg per mL) For Infiltration and Nerve Block Only Not Intended for Spinal Anesthesia or Dental Use. 50 mL Multiple Dose Vial PACKAGE LABEL - PRINCIPAL DISPLAY - Polocaine® 50 mL Multiple Dose Vial Label
- PACKAGE LABEL - PRINCIPAL DISPLAY - Polocaine 50 mL Multiple Dose Vial Tray Label NDC 63323-296-57 296057 Polocaine ® (mepivacaine HCl Injection, USP) 2% 1,000 mg per 50 mL (20 mg per mL) For Infiltration and Nerve Block Only Not Intended for Spinal Anesthesia or Dental Use. Rx only 25 Multiple Dose Vials, 50 mL PACKAGE LABEL - PRINCIPAL DISPLAY - Polocaine 50 mL Multiple Dose Vial Tray Label NDC 63323-296-57
Overview
Mepivacaine hydrochloride is 2-Piperidinecarboxamide, N-(2, 6-dimethylphenyl)-1-methyl-, monohydrochloride and has the following structural formula: C 15 H 22 N 2 O • HCl It is a white, crystalline, odorless powder, soluble in water, but very resistant to both acid and alkaline hydrolysis. Mepivacaine hydrochloride is a local anesthetic available as sterile isotonic solutions (clear, colorless) in concentrations of 1%, 1.5% and 2% for injection via local infiltration, peripheral nerve block, and caudal and lumbar epidural blocks. Mepivacaine hydrochloride is related chemically and pharmacologically to the amide-type local anesthetics. It contains an amide linkage between the aromatic nucleus and the amino group. Composition of Available Solutions* 1% Single Dose 30 mL Vial mg/mL 1% Multiple Dose 50 mL Vial mg/mL 1.5% Single Dose 30 mL Vial mg/mL 2% Single Dose 20 mL Vial mg/mL 2% Multiple Dose 50 mL Vial mg/mL Mepivacaine hydrochloride 10 10 15 20 20 Sodium chloride 6.6 7 5.6 4.6 5 Potassium chloride 0.3 0.3 0.3 Calcium chloride 0.33 0.33 0.33 Methylparaben 1 1 *In Water For Injection The pH of the solution is adjusted between 4.5 and 6.8 with sodium hydroxide or hydrochloric acid. structure
Indications & Usage
: POLOCAINE (Mepivacaine HCl Injection, USP), is indicated for production of local or regional analgesia and anesthesia by local infiltration, peripheral nerve block techniques, and central neural techniques including epidural and caudal blocks. The routes of administration and indicated concentrations for mepivacaine are: local infiltration 0.5% (via dilution) or 1 % peripheral nerve blocks 1% and 2% epidural block 1%, 1.5%, 2% caudal block 1%, 1.5%, 2% See DOSAGE AND ADMINISTRATION for additional information. Standard textbooks should be consulted to determine the accepted procedures and techniques for the administration of mepivacaine.
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 mepivacaine hydrochloride should be reduced for elderly and 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 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. Polocaine is not approved for this use (see WARNINGS and DOSAGE AND ADMINISTRATION ). The recommended single adult dose (or the total of a series of doses given in one procedure) of mepivacaine hydrochloride for unsedated, healthy, normal-sized individuals should not usually exceed 400 mg. The recommended dosage is based on requirements for the average adult and should be reduced for elderly or debilitated patients. While maximum doses of 7 mg/kg (550 mg) have been administered without adverse effect, these are not recommended, except in exceptional circumstances and under no circumstances should the administration be repeated at intervals of less than 1½ hours. The total dose for any 24-hour period should not exceed 1,000 mg because of a slow accumulation of the anesthetic or its derivatives or slower than normal metabolic degradation or detoxification with repeat administration (see CLINICAL PHARMACOLOGY and PRECAUTIONS ). Pediatric patients tolerate the local anesthetic as well as adults. However, the pediatric dose should be carefully measured as a percentage of the total adult dose based on weight , and should not exceed 5 mg/kg to 6 mg/kg (2.5 mg/lb to 3 mg/lb) in pediatric patients, especially those weighing less than 30 lbs. In pediatric patients under 3 years of age or weighing less than 30 lbs concentrations less than 2% (eg, 0.5% to 1.5%) should be employed. Unused portions of solutions not containing preservatives, ie, those supplied in 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. Recommended Concentrations and Doses of Mepivacaine Hydrochloride Procedure Concentration Total Dose Comments mL mg Cervical, brachial, intercostal, Pudendal nerve block 1% 5 to 40 50 to 400 Pudendal block: one half of total dose injected each side. 2% 5 to 20 100 to 400 Transvaginal block (paracervical plus pudendal) 1% up to 30 (both sides) up to 300 (both sides) One half of total dose injected each side. See PRECAUTIONS . Paracervical block 1% up to 20 (both sides) up to 200 (both sides) One half of total dose injected each side. This is maximum recommended dose per 90-minute period in obstetrical and non-obstetrical patients. Inject slowly, 5 minutes between sides. See PRECAUTIONS . Caudal and Epidural block 1% 15 to 30 150 to 300 *Use only single-dose vials which do not contain a preservative. 1.5% 10 to 25 150 to 375 2% 10 to 20 200 to 400 Infiltration 1% up to 40 up to 400 An equivalent amount of a 0.5% solution (prepared by diluting the 1% solution with Sodium Chloride Injection, USP) may be used for large areas. Therapeutic block (pain management) 1% 1 to 5 10 to 50 2% 1 to 5 20 to 100 Unused portions of solutions not containing preservatives should be discarded. * Dosage forms listed as POLOCAINE-MPF (Mepivacaine HCl Injection, USP) are single-dose solutions which do not contain a preservative.
Warnings & Precautions
WARNINGS: 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 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 CNS and cardiovascular adverse effects, including seizures, coma, arrhythmias, and death. Discontinue Polocaine 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 (ie, 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 inadvertently, 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. Reactions resulting in fatality have occurred on rare occasions with the use of local anesthetics. Mepivacaine with epinephrine or other vasopressors should not be used concomitantly with ergot-type oxytocic drugs, because a severe persistent hypertension may occur. Likewise, solutions of mepivacaine containing a vasoconstrictor, such as epinephrine, should be used with extreme caution in patients receiving monoamine oxidase inhibitors (MAOI) or antidepressants of the triptyline or imipramine types, because severe prolonged hypertension may result. Local anesthetic procedures should be used with caution when there is inflammation and/or sepsis in the region of the proposed injection. Mixing or the prior or intercurrent use of any local anesthetic with mepivacaine cannot be recommended because of insufficient data on the clinical use of such mixtures.
Contraindications
: Mepivacaine 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 solutions of mepivacaine.
Adverse Reactions
To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Reactions to mepivacaine 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, inadvertent intravascular injection, or slow metabolic degradation. Systemic The most commonly encountered acute adverse experiences which demand immediate countermeasures are related to the central nervous system 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. 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. Central Nervous System 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 central nervous system 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 Reactions High doses or, inadvertent intravascular injection, may lead to high plasma levels and related depression of the myocardium, decreased cardiac output, heart block, hypotension (or sometimes hypertension), bradycardia, ventricular arrhythmias, and possibly 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. 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; 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.
Drug Interactions
Clinically Significant Drug Interactions The administration of local anesthetic solutions containing epinephrine or norepinephrine to patients receiving monoamine oxidase inhibitors or tricyclic antidepressants may produce severe, prolonged hypertension. Concurrent use of these agents should generally be avoided. In situations when concurrent therapy is necessary, careful patient monitoring is essential. Concurrent administration of vasopressor drugs and of ergot-type oxytocic drugs may cause severe, persistent hypertension or cerebrovascular accidents. Phenothiazines and butyrophenones may reduce or reverse the pressor effect of epinephrine. Patients who are administered local anesthetics are at increased risk of developing methemoglobinemia when concurrently exposed to the following drugs, which could include other local anesthetics: Examples of Drugs Associated with Methemoglobinemia: Class Examples Nitrates/Nitrites nitroglycerin, nitroprusside, nitric oxide, nitrous oxide Local anesthetics articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, tetracaine Antineoplastic agents cyclophosphamide, flutamide, hydroxyurea, ifosfamide, rasburicase Antibiotics dapsone, nitrofurantoin, para-aminosalicylic acid, sulfonamides Antimalarials chloroquine, primaquine Anticonvulsants phenobarbital, phenytoin, sodium valproate Other drugs acetaminophen, metoclopramide, quinine, sulfasalazine
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