Drugplain

Polocaine-MPF 20 mg/mL

MEPIVACAINE HYDROCHLORIDE · INJECTION, SOLUTION · Fresenius Kabi USA, LLC

No Recall History
Plain English

Polocaine-MPF is a injection, solution containing mepivacaine hydrochloride at 20 mg/mL, taken epidural. Manufactured by Fresenius Kabi USA, LLC.

Key Facts

Brand Name
Polocaine-MPF
Generic Name
MEPIVACAINE HYDROCHLORIDE
NDC Code (Product)
63323-294
Manufacturer
Fresenius Kabi USA, LLC
Strength
20 mg/mL
Dosage Form
INJECTION, SOLUTION
Route
EPIDURAL, INFILTRATION
Marketing Status
Application #
ANDA089409
Marketing Start
07/21/2009

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective30 reports
off label use24 reports
hypotension23 reports
dyspnoea21 reports
dizziness18 reports
nausea18 reports
monoplegia17 reports
pruritus16 reports
dyspnoea exertional12 reports
gout12 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND 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

DOSAGE AND 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 …

Warnings

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 t…

Contraindications

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.

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, rasburic…

Adverse Reactions

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,…

Frequently Asked Questions

What is Polocaine-MPF used for?

Polocaine-MPF contains MEPIVACAINE HYDROCHLORIDE. It is a injection, solution taken epidural. Consult your doctor for specific uses.

Is Polocaine-MPF a controlled substance?

Polocaine-MPF is not classified as a controlled substance by the DEA.

What is the generic name for Polocaine-MPF?

The generic name for Polocaine-MPF is MEPIVACAINE HYDROCHLORIDE. There are 11 other brand versions of MEPIVACAINE HYDROCHLORIDE.

What is the NDC code for Polocaine-MPF 20 mg/mL?

The NDC (National Drug Code) for Polocaine-MPF 20 mg/mL is 63323-294, listed by Fresenius Kabi USA, LLC.

Product NDC

63323-294

Package NDC

63323-294-27

Other Polocaine-MPF Dosages

Other Mepivacaine Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)