Mepivacaine

Mepivacaine
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Chetan Lokhande, M.B.B.S [2]

Disclaimer

WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.

Black Box Warning

Black Box warning See full prescribing information for complete Boxed Warning. * These solutions are not intended for spinal anesthesia or dental use

Overview

Mepivacaine is a local anesthetic that is FDA approved for the {{{indicationType}}} of epidural anesthesia, epidural block, injection of anesthetic agent into brachial plexus, injection of anesthetic agent into pudendal nerve, local anesthesia, local anesthesia, by infiltration, local anesthetic intercostal nerve block. local anesthetic nerve block, transvaginal, local anesthetic nerve block in cervical region. pain management, paracervical block anesthesia, regional anesthesia. There is a Black Box Warning for this drug as shown here. Common adverse reactions include cardiovascular: bradyarrhythmia, cardiac arrest, fetal bradycardia, with paracervical block, heart block, hypotension, ventricular arrhythmia, immunologic: bacterial meningitis, septic, immune hypersensitivity reaction (rare ), musculoskeletal: chondrolysis of articular cartilage, neurologic: cranial nerve disorder, seizure, respiratory: respiratory arrest.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

• Dosage varies with anesthetic procedure, area to be anesthetized, vascularity of tissues, number of neuronal segments to be blocked, depth of anesthesia and degree of muscle relaxation required, and duration of anesthesia required.

Epidural anesthesia, epidural block

• 15 to 30 mL (150 to 300 mg) of 1% solution.
• 10 to 25 mL (150 to 375 mg) of 1.5% solution.
• 10 to 20 mL (200 to 400 mg) of 2% solution

Injection of anesthetic agent into brachial plexus

• 5 to 40 mL (50 to 400 mg) of 1% solution
• 5 to 20 mL (100 to 400 mg) of 2% solution
• 5 to 40 mL (50 to 400 mg) of 1% solution; one-half of total dose injected into each side

Injection of anesthetic agent into pudendal nerve

• 5 to 20 mL (100 to 400 mg) of 2% solution; one-half of total dose injected into each side

Local anesthesia

• Doses vary with anesthetic procedure, MAX single adult dose is 400 mg

• Local anesthesia, by infiltration

• 0.5% or 1% solution; MAX dose 400 mg

• Local anesthetic intercostal nerve block

• 5 to 40 mL (50 to 400 mg) of 1% solution
• 5 to 20 mL (100 to 400 mg) of 2% solution

• Local anesthetic nerve block, Transvaginal

• Max 30 mL (300 mg) of 1% solution; one-half of total dose injected into each side

• Local anesthetic nerve block in cervical region

• 5 to 40 mL (50 to 400 mg) of 1% solution
• 5 to 20 mL (100 to 400 mg) of 2% solution

Pain management: therapeutic block

• 1 to 5 mL (10 to 50 mg) of 1% solution
• 1 to 5 mL (20 to 100 mg) of 2% solution

Paracervical block anesthesia

• Max 20 mL (200 mg) of 1% solution every 90 min; one half of total dose injected each side; inject slowly, with 5 min between sides

Regional anesthesia

• Doses vary with anesthetic procedure, MAX single adult dose is 400 mg

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information about Off-Label Guideline-Supported Use of Mepivacaine in adult patients.

Non–Guideline-Supported Use

There is limited information about Off-Label Non–Guideline-Supported Use of Mepivacaine in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Epidural anesthesia, epidural block

• Dose not to exceed 5-6 mg/kg

• Age under 3 yr, weight less than 30 pounds use concentrations of 0.5-1.5%

Injection of anesthetic agent into brachial plexus

• Dose not to exceed 5-6 mg/kg

• Age under 3 yr, weight less than 30 pounds use concentrations of 0.5-1.5%

Injection of anesthetic agent into pudendal nerve

• Dose not to exceed 5-6 mg/kg

• Age under 3 yr, weight less than 30 pounds use concentrations of 0.5-1.5%

Local anesthesia

• Dose not to exceed 5-6 mg/kg

• Age under 3 yr, weight less than 30 pounds use concentrations of 0.5-1.5%

Local anesthesia, by infiltration

• Dose not to exceed 5-6 mg/kg

• Age under 3 yr, weight less than 30 pounds use concentrations of 0.5-1.5%

Local anesthetic intercostal nerve block

• Dose not to exceed 5-6 mg/kg

• Age under 3 yr, weight less than 30 pounds use concentrations of 0.5-1.5%

Local anesthetic nerve block, Transvaginal

• Dose not to exceed 5-6 mg/kg

• Age under 3 yr, weight less than 30 pounds use concentrations of 0.5-1.5%

Local anesthetic nerve block in cervical region

• Dose not to exceed 5-6 mg/kg

• Age under 3 yr, weight less than 30 pounds use concentrations of 0.5-1.5%

Pain management

• Dose not to exceed 5-6 mg/kg

• Age under 3 yr, weight less than 30 pounds use concentrations of 0.5-1.5%

Paracervical block anesthesia

• Dose not to exceed 5-6 mg/kg
• Age under 3 yr, weight less than 30 pounds use concentrations of 0.5-1.5%

Regional anesthesia

• Dose not to exceed 5-6 mg/kg

• Age under 3 yr, weight less than 30 pounds use concentrations of 0.5-1.5%

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information about Off-Label Guideline-Supported Use of Mepivacaine in pediatric patients.

Non–Guideline-Supported Use

There is limited information about Off-Label Non–Guideline-Supported Use of Mepivacaine in pediatric patients.

Contraindications

CARBOCAINE 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 CARBOCAINE.

Warnings

Black Box warning See full prescribing information for complete Boxed Warning. * These solutions are not intended for spinal anesthesia or dental use

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.

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 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. CARBOCAINE 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 CARBOCAINE 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 CARBOCAINE cannot be recommended because of insufficient data on the clinical use of such mixtures.

Adverse Reactions

Clinical Trials Experience

Reactions to CARBOCAINE 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 counter-measures 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 sections.)

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.

Postmarketing Experience

There is limited information regarding Mepivacaine Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Mepivacaine Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Mepivacaine in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Mepivacaine in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Mepivacaine during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Mepivacaine in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Mepivacaine in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Mepivacaine in geriatric settings.

Gender

There is no FDA guidance on the use of Mepivacaine with respect to specific gender populations.

Race

There is no FDA guidance on the use of Mepivacaine with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Mepivacaine in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Mepivacaine in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Mepivacaine in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Mepivacaine in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Mepivacaine Administration in the drug label.

Monitoring

There is limited information regarding Mepivacaine Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Mepivacaine and IV administrations.

Overdosage

Acute emergencies from local anesthetics are generally related to high plasma levels encountered during therapeutic use of local anesthetics or to unintended subarachnoid injection of local anesthetic solution. (See ADVERSE REACTIONS, WARNINGS, and PRECAUTIONS.)

Management of Local Anesthetic Emergencies

The first consideration is prevention, best accomplished by careful and constant monitoring of cardiovascular and respiratory vital signs and the patient’s state of consciousness after each local anesthetic injection. At the first sign of change, oxygen should be administered.

The first step in the management of systemic toxic reactions, as well as underventilation or apnea due to unintentional subarachnoid injection of drug solution, consists of immediate attention to the establishment and maintenance of a patent airway and effective assisted or controlled ventilation with 100% oxygen with a delivery system capable of permitting immediate positive airway pressure by mask. This may prevent convulsions if they have not already occurred.

If necessary, use drugs to control the convulsions. A 50 mg to 100 mg bolus IV injection of succinylcholine will paralyze the patient without depressing the central nervous or cardiovascular systems and facilitate ventilation. A bolus IV dose of 5 mg to 10 mg of diazepam or 50 mg to 100 mg of thiopental will permit ventilation and counteract central nervous system stimulation, but these drugs also depress central nervous system, respiratory, and cardiac function, add to postictal depression and may result in apnea. Intravenous barbiturates, anticonvulsant agents, or muscle relaxants should only be administered by those familiar with their use. Immediately after the institution of these ventilatory measures, the adequacy of the circulation should be evaluated. Supportive treatment of circulatory depression may require administration of intravenous fluids, and when appropriate, a vasopressor dictated by the clinical situation (such as ephedrine or epinephrine to enhance myocardial contractile force).

Endotracheal intubation, employing drugs and techniques familiar to the clinician may be indicated after initial administration of oxygen by mask, if difficulty is encountered in the maintenance of a patent airway or if prolonged ventilatory support (assisted or controlled) is indicated.

Recent clinical data from patients experiencing local anesthetic induced convulsions demonstrated rapid development of hypoxia, hypercarbia, and acidosis within a minute of the onset of convulsions. These observations suggest that oxygen consumption and carbon dioxide production are greatly increased during local anesthetic convulsions and emphasize the importance of immediate and effective ventilation with oxygen which may avoid cardiac arrest.

If not treated immediately, convulsions with simultaneous hypoxia, hypercarbia, and acidosis, plus myocardial depression from the direct effects of the local anesthetic may result in cardiac arrhythmias, bradycardia, asystole, ventricular fibrillation, or cardiac arrest. Respiratory abnormalities, including apnea, may occur. Underventilation or apnea due to unintentional subarachnoid injection of local anesthetic solution may produce these same signs and also lead to cardiac arrest if ventilatory support is not instituted. If cardiac arrest should occur, standard cardiopulmonary resuscitative measures should be instituted and maintained for a prolonged period if necessary. Recovery has been reported after prolonged resuscitative efforts.

The supine position is dangerous in pregnant women at term because of aortocaval compression by the gravid uterus. Therefore during treatment of systemic toxicity, maternal hypotension, or fetal bradycardia following regional block, the parturient should be maintained in the left lateral decubitus position if possible, or manual displacement of the uterus off the great vessels be accomplished.

The mean seizure dosage of mepivacaine in rhesus monkeys was found to be 18.8 mg/kg with mean arterial plasma concentration of 24.4 mcg/mL. The intravenous and subcutaneous LD50 in mice is 23 mg/kg to 35 mg/kg and 280 mg/kg respectively.

Pharmacology

There is limited information regarding Mepivacaine Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Mepivacaine Mechanism of Action in the drug label.

Structure

There is limited information regarding Mepivacaine Structure in the drug label.

Pharmacodynamics

There is limited information regarding Mepivacaine Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Mepivacaine Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Mepivacaine Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Mepivacaine Clinical Studies in the drug label.

How Supplied

There is limited information regarding Mepivacaine How Supplied in the drug label.

Storage

There is limited information regarding Mepivacaine Storage in the drug label.

Images

Drug Images

{{#ask: Page Name::Mepivacaine |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

{{#ask: Label Page::Mepivacaine |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Mepivacaine Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Mepivacaine interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Mepivacaine Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Mepivacaine Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.