XYLOCAINE-MPF WITH EPI .005 mg/mL
XYLOCAINE-MPF WITH EPI · INJECTION, SOLUTION · HF Acquisition Co LLC, DBA HealthFirst
XYLOCAINE-MPF WITH EPI is a injection, solution containing xylocaine-mpf with epi at .005 mg/mL, taken epidural. Manufactured by HF Acquisition Co LLC, DBA HealthFirst.
Key Facts
- Brand Name
- XYLOCAINE-MPF WITH EPI
- Generic Name
- XYLOCAINE-MPF WITH EPI
- NDC Code (Product)
51662-1550- Manufacturer
- HF Acquisition Co LLC, DBA HealthFirst
- Strength
- .005 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- EPIDURAL, INFILTRATION, INTRACAUDAL, PERINEURAL
- Marketing Status
- Application #
- NDA006488
- Marketing Start
- 06/28/2021
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
INDICATIONS & USAGE Xylocaine (lidocaine HCl) Injections are indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection and intravenous regional anesthesia by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed.
Dosage & Administration
DOSAGE & ADMINISTRATION Table 1 (Recommended Dosages) summarizes the recommended volumes and concentrations of Xylocaine Injection for various types of anesthetic procedures. The dosages suggested in this table are for normal healthy adults and refer to the use of epinephrine-free solutions. When larger volumes are required, only solutions containing epinephrine should be used except in those cases where vasopressor drugs may be contraindicated. There have been adverse event reports of chondrolysis in patients receiving intra-articular infusions of local anesthetics following arthroscopic and other surgical procedures. Xylocaine is not approved for this use (see WARNINGS and DOSAGE AND ADMINISTRATION ). These recommended doses serve only as a guide to the amount of anesthetic required for most routine procedures. The actual volumes and concentrations to be used depend on a number of factors such as type and extent of surgical procedure, depth of anesthesia and degree of muscular relaxation required, duration of anesthesia required, and the physical condition of the patient. In all cases the lowest concentration and smallest dose that will produce the desired result should be given.…
Warnings
WARNINGS XYLOCAINE INJECTIONS FOR INFILTRATION AND NERVE BLOCK SHOULD BE EMPLOYED ONLY BY CLINICIANS WHO ARE WELL VERSED IN DIAGNOSIS AND MANAGEMENT OF DOSE-RELATED TOXICITY AND OTHER ACUTE EMERGENCIES THAT MIGHT ARISE FROM THE BLOCK TO BE EMPLOYED AND THEN ONLY AFTER ENSURING THE IMMEDIATE AVAILABILITY OF OXYGEN, OTHER RESUSCITATIVE DRUGS, CARDIOPULMONARY EQUIPMENT AND THE PERSONNEL 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 us…
Contraindications
CONTRAINDICATIONS Lidocaine HCl is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type.
Adverse Reactions
ADVERSE REACTIONS o 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. Systemic Adverse experiences following the administration of lidocaine HCl are similar in nature to those observed with other amide local anesthetic agents. These adverse experiences are, in general, dose-related and may result from high plasma levels caused by excessive dosage, rapid absorption or inadvertent intravascular injection, or may result from a hypersensitivity, idiosyncrasy or diminished tolerance on the part of the patient. Serious adverse experiences are generally systemic in nature. The following types are those most commonly reported: Central Nervous System CNS manifestations are excitatory and/or depressant and may be characterized by lightheadedness, nervousness, apprehension, euphoria, confusion, dizziness, drowsiness, tinnitus, blurred or double vision, vomiting, sensations of heat, cold or numbness, twitching, tremors, convulsions, unconsciousness, respiratory depression and arrest. The excitatory manifestations may be very brief or may not occur at all, in which case the first manifestation of toxicity may …
Frequently Asked Questions
What is XYLOCAINE-MPF WITH EPI used for?
XYLOCAINE-MPF WITH EPI contains XYLOCAINE-MPF WITH EPI. It is a injection, solution taken epidural. Consult your doctor for specific uses.
Is XYLOCAINE-MPF WITH EPI a controlled substance?
XYLOCAINE-MPF WITH EPI is not classified as a controlled substance by the DEA.
What is the generic name for XYLOCAINE-MPF WITH EPI?
The generic name for XYLOCAINE-MPF WITH EPI is XYLOCAINE-MPF WITH EPI. There are no other listed brand versions of XYLOCAINE-MPF WITH EPI.
What is the NDC code for XYLOCAINE-MPF WITH EPI .005 mg/mL?
The NDC (National Drug Code) for XYLOCAINE-MPF WITH EPI .005 mg/mL is 51662-1550, listed by HF Acquisition Co LLC, DBA HealthFirst.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)