Mepivacaine
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Chetan Lokhande, M.B.B.S [2]
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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
There is limited information regarding Mepivacaine Clinical Trials Experience in the drug label.
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
There is limited information regarding Mepivacaine overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
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
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Package and Label Display Panel
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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.