DailyMed Label: Polocaine

DailyMed Label: Polocaine

2022

DailyMed Prescription

Polocaine

MEPIVACAINE HYDROCHLORIDE

Fresenius Kabi USA, LLC

NDC: 63323-260

NDC: 63323-283

NDC: 63323-293

NDC: 63323-294

NDC: 63323-296

NDC: 63323-283

NDC: 63323-283

NDC: 63323-296

NDC: 63323-296

NDC: 63323-260

NDC: 63323-260

NDC: 63323-293

NDC: 63323-293

NDC: 63323-294

NDC: 63323-294

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

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.

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.

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.

The safety and effectiveness of local anesthetics depend on proper dosage, correct technique, adequate precautions, and readiness for emergencies.  Resuscitative equipment, oxygen, and other resuscitative drugs should be available for immediate use (see  WARNINGS   and ADVERSE REACTIONS ).  During major regional nerve blocks, the patient should have IV fluids running via an indwelling catheter to assure a functioning intravenous pathway.  The lowest dosage of local anesthetic that results in effective anesthesia should be used to avoid high plasma levels and serious adverse effects.  Injections should be made slowly, with frequent aspirations before and during the injection to avoid intravascular injection.  Current opinion favors fractional administration with constant attention to the patient, rather than rapid bolus injection. Syringe aspirations should also be performed before and during each supplemental injection in continuous (intermittent) catheter techniques.  An intravascular injection is still possible even if aspirations for blood are negative. During the administration of epidural anesthesia, it is recommended that a test dose be administered initially and the effects monitored before the full dose is given. When using a “continuous” catheter technique, test doses should be given prior to both the original and all reinforcing doses, because plastic tubing in the epidural space can migrate into a blood vessel or through the dura.  When the clinical conditions permit, an effective test dose should contain epinephrine (10 mcg to 15 mcg have been suggested) to serve as a warning of unintended intravascular injection.  If injected into a blood vessel, this amount of epinephrine is likely to produce an “epinephrine response” within 45 seconds, consisting of an increase of pulse and blood pressure, circumoral pallor, palpitations, and nervousness in the unsedated patient.  The sedated patient may exhibit only a pulse rate increase of 20 or more beats per minute for 15 or more seconds. Therefore, following the test dose, the heart rate should be monitored for a heart rate increase.  The test dose should also contain 45 mg to 50 mg of mepivacaine hydrochloride to detect an unintended intrathecal administration.  This will be evidenced within a few minutes by signs of spinal block (eg, decreased sensation of the buttocks, paresis of the legs, or, in the sedated patient, absent knee jerk). Injection of repeated doses of local anesthetics may cause significant increases in plasma levels with each repeated dose due to slow accumulation of the drug or its metabolites or to slow metabolic degradation.  Tolerance to elevated blood levels varies with the status of the patient.  Debilitated, elderly patients, and acutely ill patients should be given reduced doses commensurate with their age and physical status.  Local anesthetics should also be used with caution in patients with severe disturbances of cardiac rhythm, shock, heart block, or hypotension. Careful and constant monitoring of cardiovascular and respiratory (adequacy of ventilation) vital signs, and the patient’s state of consciousness should be performed after each local anesthetic injection.  It should be kept in mind at such times that restlessness, anxiety, incoherent speech, lightheadedness, numbness and tingling of the mouth and lips, metallic taste, tinnitus, dizziness, blurred vision, tremors, twitching, depression, or drowsiness may be early warning signs of central nervous system toxicity. Local anesthetic solutions containing a vasoconstrictor should be used cautiously and in carefully restricted quantities in areas of the body supplied by end arteries or having otherwise compromised blood supply such as digits, nose, external ear, penis. Patients with hypertensive vascular disease may exhibit exaggerated vasoconstrictor response.  Ischemic injury or necrosis may result. Mepivacaine should be used with caution in patients with known allergies and sensitivities. Because amide-type local anesthetics such as mepivacaine are metabolized by the liver and excreted by the kidneys, these drugs, especially repeat doses, should be used cautiously in patients with hepatic and renal disease.  Patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at greater risk of developing toxic plasma concentrations.  Local anesthetics should also be used with caution in patients with impaired cardiovascular function because they may be less able to compensate for functional changes associated with the prolongation of AV conduction produced by these drugs. Serious dose-related cardiac arrhythmias may occur if preparations containing a vasoconstrictor such as epinephrine are employed in patients during or following the administration of potent inhalation anesthetics.  In deciding whether to use these products concurrently in the same patient, the combined action of both agents upon the myocardium, the concentration and volume of vasoconstrictor used, and the time since injection, when applicable, should be taken into account.   Many drugs used during the conduct of anesthesia are considered potential triggering agents for familial malignant hyperthermia.  Because it is not known whether amide-type local anesthetics may trigger this reaction and because the need for supplemental general anesthesia cannot be predicted in advance, it is suggested that a standard protocol for management should be available.  Early unexplained signs of tachycardia, tachypnea, labile blood pressure, and metabolic acidosis may precede temperature elevation.  Successful outcome is dependent on early diagnosis, prompt discontinuance of the suspect triggering agent(s), and institution of treatment, including oxygen therapy, indicated supportive measures, and dantrolene.  (Consult dantrolene sodium intravenous package insert before using.) Small doses of local anesthetics injected into the head and neck area may produce adverse reactions similar to systemic toxicity seen with unintentional intravascular injections of larger doses.  The injection procedures require the utmost care. Confusion, convulsions, respiratory depression, and/or respiratory arrest, and cardiovascular stimulation or depression have been reported.  These reactions may be due to intra-arterial injection of the local anesthetic with retrograde flow to the cerebral circulation.  Patients receiving these blocks should have their circulation and respiration monitored and be constantly observed.  Resuscitative equipment and personnel for treating adverse reactions should be immediately available.  Dosage recommendations should not be exceeded. When appropriate, patients should be informed in advance that they may experience temporary loss of sensation and motor activity, usually in the lower half of the body, following proper administration of caudal or epidural anesthesia. Also, when appropriate, the physician should discuss other information including adverse reactions listed in this package insert. Inform patients that use of local anesthetics may cause methemoglobinemia, a serious condition that must be treated promptly. Advise patients or caregivers to seek immediate medical attention if they or someone in their care experience the following signs or symptoms: pale, gray, or blue colored skin (cyanosis); headache; rapid heart rate; shortness of breath; lightheadedness; or fatigue. 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 Long-term studies in animals of most local anesthetics including mepivacaine to evaluate the carcinogenic potential have not been conducted.  Mutagenic potential or the effect on fertility have not been determined.  There is no evidence from human data that mepivacaine may be carcinogenic or mutagenic or that it impairs fertility. Animal reproduction studies have not been conducted with mepivacaine.  There are no adequate and well-controlled studies in pregnant women of the effect of mepivacaine on the developing fetus.  Mepivacaine hydrochloride should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.  This does not preclude the use of mepivacaine at term for obstetrical anesthesia or analgesia (see Labor and Delivery ). Mepivacaine has been used for obstetrical analgesia by the epidural, caudal, and paracervical routes without evidence of adverse effects on the fetus when no more than the maximum safe dosages are used and strict adherence to technique is followed. Local anesthetics rapidly cross the placenta, and when used for epidural, paracervical, caudal, or pudendal block anesthesia, can cause varying degrees of maternal, fetal, and neonatal toxicity (see CLINICAL PHARMACOLOGY ,   Pharmacokinetics ).  The incidence and degree of toxicity depend upon the procedure performed, the type and amount of drug used, and the technique of drug administration.  Adverse reactions in the parturient, fetus, and neonate involve alterations of the central nervous system, peripheral vascular tone, and cardiac function. Maternal hypotension has resulted from regional anesthesia.  Local anesthetics produce vasodilation by blocking sympathetic nerves.  Elevating the patient’s legs and positioning her on her left side will help prevent decreases in blood pressure.  The fetal heart rate also should be monitored continuously and electronic fetal monitoring is highly advisable. Epidural, paracervical, caudal, or pudendal anesthesia may alter the forces of parturition through changes in uterine contractility or maternal expulsive efforts.  In one study, paracervical block anesthesia was associated with a decrease in the mean duration of first stage labor and facilitation of cervical dilation.  Epidural anesthesia has been reported to prolong the second stage of labor by removing the parturient’s reflex urge to bear down or by interfering with motor function.  The use of obstetrical anesthesia may increase the need for forceps assistance. The use of some local anesthetic drug products during labor and delivery may be followed by diminished muscle strength and tone for the first day or two of life.  The long-term significance of these observations is unknown. Fetal bradycardia may occur in 20 to 30 percent of patients receiving para-cervical block anesthesia with the amide-type local anesthetics and may be associated with fetal acidosis.  Fetal heart rate should always be monitored during paracervical anesthesia.  Added risk appears to be present in prematurity, postmaturity, toxemia of pregnancy, and fetal distress.  The physician should weigh the possible advantages against dangers when considering paracervical block in these conditions.  Careful adherence to recommended dosage is of the utmost importance in obstetrical paracervical block.  Failure to achieve adequate analgesia with recommended doses should arouse suspicion of intravascular or fetal intracranial injection. Cases compatible with unintended fetal intracranial injection of local anesthetic solution have been reported following intended paracervical or pudendal block or both. Babies so affected present with unexplained neonatal depression at birth which correlates with high local anesthetic serum levels and usually manifest seizures within six hours. Prompt use of supportive measures combined with forced urinary excretion of the local anesthetic has been used successfully to manage this complication. Case reports of maternal convulsions and cardiovascular collapse following use of some local anesthetics for paracervical block in early pregnancy (as anesthesia for elective abortion) suggest that systemic absorption under these circumstances may be rapid.  The recommended maximum dose of the local anesthetic should not be exceeded. Injection should be made slowly and with frequent aspiration.  Allow a five-minute interval between sides. It is extremely important to avoid aortocaval compression by the gravid uterus during administration of regional block to parturients.  To do this, the patient must be maintained in the left lateral decubitus position or a blanket roll or sandbag may be placed beneath the right hip and the gravid uterus displaced to the left. It is not known whether local anesthetic drugs are excreted in human milk.  Because many drugs are excreted in human milk, caution should be exercised when local anesthetics are administered to a nursing woman. Guidelines for the administration of mepivacaine to pediatric patients are presented in DOSAGE AND ADMINISTRATION . Clinical studies and other reported clinical experience indicates that use of the drug in elderly patients requires a decreased dosage (see CLINICAL PHARMACOLOGY , PRECAUTIONS ,   General , and DOSAGE AND ADMINISTRATION ). Mepivacaine and mepivacaine metabolites are known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function.  Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

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

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

Local anesthetics block the generation and the conduction of nerve impulses, presumably by increasing the threshold for electrical excitation in the nerve, by slowing the propagation of the nerve impulse, and by reducing the rate of rise of the action potential. In general, the progression of anesthesia is related to the diameter, myelination, and conduction velocity of affected nerve fibers.  Clinically, the order of loss of nerve function is as follows: pain, temperature, touch, proprioception, and skeletal muscle tone. Systemic absorption of local anesthetics produces effects on the cardiovascular and central nervous systems.  At blood concentrations achieved with normal therapeutic doses, changes in cardiac conduction, excitability, refractoriness, contractility, and peripheral vascular resistance are minimal.  However, toxic blood concentrations depress cardiac conduction and excitability, which may lead to atrioventricular block and ultimately to cardiac arrest.  In addition, myocardial contractility is depressed and peripheral vasodilation occurs, leading to decreased cardiac output and arterial blood pressure. Following systemic absorption, local anesthetics can produce central nervous system stimulation, depression, or both.  Apparent central stimulation is manifested as restlessness, tremors, and shivering, progressing to convulsions, followed by depression and coma progressing ultimately to respiratory arrest.  However, the local anesthetics have a primary depressant effect on the medulla and on higher centers.  The depressed stage may occur without a prior excited stage. A clinical study using 15 mL of 2% epidural mepivacaine at the T 9-10 interspace in 62 patients, 20 to 79 years of age, demonstrated a 40% decrease in the amount of mepivacaine required to block a given number of dermatomes in the elderly (60 to 79 years, N=13) as compared to young adults 20 to 39 years.  Another study using 10 mL of 2% lumbar epidural mepivacaine in 161 patients, 19 to 75 years of age, demonstrated a strong inverse relationship between patient age and the number of dermatomes blocked per cc of mepivacaine injected. The rate of systemic absorption of local anesthetics is dependent upon the total dose and concentration of drug administered, the route of administration, the vascularity of the administration site, and the presence or absence of epinephrine in the anesthetic solution. A dilute concentration of epinephrine (1:200,000 or 5 mcg/mL) usually reduces the rate of absorption and plasma concentration of mepivacaine, however, it has been reported that vasoconstrictors do not significantly prolong anesthesia with mepivacaine. Onset of anesthesia with mepivacaine is rapid, the time of onset for sensory block ranging from about 3 to 20 minutes depending upon such factors as the anesthetic technique, the type of block, the concentration of the solution, and the individual patient. The degree of motor blockade produced is dependent on the concentration of the solution. A 0.5% solution will be effective in small superficial nerve blocks while the 1% concentration will block sensory and sympathetic conduction without loss of motor function.  The 1.5% solution will provide extensive and often complete motor block and the 2% concentration of mepivacaine hydrochloride will produce complete sensory and motor block of any nerve group. The duration of anesthesia also varies depending upon the technique and type of block, the concentration, and the individual.  Mepivacaine will normally provide anesthesia which is adequate for 2 to 2½ hours of surgery. Local anesthetics are bound to plasma proteins in varying degrees.  Generally, the lower the plasma concentration of drug, the higher the percentage of drug bound to plasma. Local anesthetics appear to cross the placenta by passive diffusion.  The rate and degree of diffusion is governed by the degree of plasma protein binding, the degree of ionization, and the degree of lipid solubility.  Fetal/maternal ratios of local anesthetics appear to be inversely related to the degree of plasma protein binding, because only the free, unbound drug is available for placental transfer.  Mepivacaine is approximately 75% bound to plasma proteins.  The extent of placental transfer is also determined by the degree of ionization and lipid solubility of the drug.  Lipid soluble, nonionized drugs readily enter the fetal blood from the maternal circulation. Depending upon the route of administration, local anesthetics are distributed to some extent to all body tissues, with high concentrations found in highly perfused organs such as the liver, lungs, heart, and brain. Various pharmacokinetic parameters of the local anesthetics can be significantly altered by the presence of hepatic or renal disease, addition of epinephrine, factors affecting urinary pH, renal blood flow, the route of drug administration, and the age of the patient.  The half-life of mepivacaine in adults is 1.9 to 3.2 hours and in neonates 8.7 to 9 hours. Mepivacaine, because of its amide structure, is not detoxified by the circulating plasma esterases.  It is rapidly metabolized, with only a small percentage of the anesthetic (5 percent to 10 percent) being excreted unchanged in the urine.  The liver is the principal site of metabolism, with over 50% of the administered dose being excreted into the bile as metabolites.  Most of the metabolized mepivacaine is probably resorbed in the intestine and then excreted into the urine since only a small percentage is found in the feces.  The principal route of excretion is via the kidney.  Most of the anesthetic and its metabolites are eliminated within 30 hours.  It has been shown that hydroxylation and N-demethylation, which are detoxification reactions, play important roles in the metabolism of the anesthetic.  Three metabolites of mepivacaine have been identified from human adults: two phenols, which are excreted almost exclusively as their glucuronide conjugates, and the N-demethylated compound (2’, 6’-pipecoloxylidide).

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