Xylocaine 10 mg/mL
Lidocaine Hydrochloride · INJECTION, SOLUTION · Henry Schein, Inc.
Xylocaine is a injection, solution containing lidocaine hydrochloride at 10 mg/mL, taken infiltration. Manufactured by Henry Schein, Inc..
Key Facts
- Brand Name
- Xylocaine
- Generic Name
- Lidocaine Hydrochloride
- NDC Code (Product)
0404-9973- Manufacturer
- Henry Schein, Inc.
- Strength
- 10 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INFILTRATION, PERINEURAL
- Marketing Status
- Application #
- NDA006488
- Marketing Start
- 01/10/2022
Recall History
Fresenius Kabi USA LLC
Low out of specification results for epinephrine assay.
Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Novocol Pharmaceutical of Canada, Inc.
Defective container: cracked/broken cartridges
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full 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 AND 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 give…
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 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 be drowsiness merging into unconsciousness and respiratory arrest. Drowsiness following the administration of lidocaine HCl is usually an …
Frequently Asked Questions
What is Xylocaine used for?
Xylocaine contains Lidocaine Hydrochloride. It is a injection, solution taken infiltration. Consult your doctor for specific uses.
Is Xylocaine a controlled substance?
Xylocaine is not classified as a controlled substance by the DEA.
What is the generic name for Xylocaine?
The generic name for Xylocaine is Lidocaine Hydrochloride. There are 12 other brand versions of Lidocaine Hydrochloride.
What is the NDC code for Xylocaine 10 mg/mL?
The NDC (National Drug Code) for Xylocaine 10 mg/mL is 0404-9973, listed by Henry Schein, Inc..
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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)