POLOCAINE (MEPIVACAINE HCl) 10 mg/mL
POLOCAINE (MEPIVACAINE HCl) · INJECTION, SOLUTION · HF Acquisition Co LLC, DBA HealthFirst
POLOCAINE (MEPIVACAINE HCl) is a injection, solution containing polocaine (mepivacaine hcl) at 10 mg/mL, taken infiltration. Manufactured by HF Acquisition Co LLC, DBA HealthFirst.
Key Facts
- Brand Name
- POLOCAINE (MEPIVACAINE HCl)
- Generic Name
- POLOCAINE (MEPIVACAINE HCl)
- NDC Code (Product)
51662-1534- Manufacturer
- HF Acquisition Co LLC, DBA HealthFirst
- Strength
- 10 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INFILTRATION
- Marketing Status
- Application #
- ANDA089407
- Marketing Start
- 05/11/2021
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
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: See DOSAGE AND ADMINISTRATION for additional information. Standard textbooks should be consulted to determine the accepted procedures and techniques for the administration of mepivacaine. INDICATIONS
Dosage & Administration
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 hydr…
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 th…
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.
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 (MEPIVACAINE HCl) used for?
POLOCAINE (MEPIVACAINE HCl) contains POLOCAINE (MEPIVACAINE HCl). It is a injection, solution taken infiltration. Consult your doctor for specific uses.
Is POLOCAINE (MEPIVACAINE HCl) a controlled substance?
POLOCAINE (MEPIVACAINE HCl) is not classified as a controlled substance by the DEA.
What is the generic name for POLOCAINE (MEPIVACAINE HCl)?
The generic name for POLOCAINE (MEPIVACAINE HCl) is POLOCAINE (MEPIVACAINE HCl). There are no other listed brand versions of POLOCAINE (MEPIVACAINE HCl).
What is the NDC code for POLOCAINE (MEPIVACAINE HCl) 10 mg/mL?
The NDC (National Drug Code) for POLOCAINE (MEPIVACAINE HCl) 10 mg/mL is 51662-1534, listed by HF Acquisition Co LLC, DBA HealthFirst.
Other POLOCAINE (MEPIVACAINE HCl) Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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