Lidocaine Hydrochloride and Epinephrine

Lidocaine Hydrochloride and Epinephrine is an FDA-registered drug product whose active ingredient is LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE. It is labelled by Cardinal Health 107, LLC taken by infiltration and marketed as a human prescription drug product. Identifiers on file: NDC 55154-0132, application ANDA089644, label effective 20260520. It is one of 6 FDA drug label records sharing the active ingredient LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE are most often described in connection with: lidocaine hydrochloride, epinephrine injection, local regional, anesthesia analgesia, indicated adult, pediatric patients, surgery dental, procedures diagnostic. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

1 INDICATIONS AND USAGE Lidocaine Hydrochloride and Epinephrine Injection is indicated in adult and pediatric patients for the production of local or regional anesthesia or analgesia for surgery, dental, and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of Lidocaine Hydrochloride and Epinephrine Injection are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration (2.2) ] . Lidocaine Hydrochloride and Epinephrine Injection is a combination of lidocaine, an amide local anesthetic, and epinephrine, an alpha and beta adrenergic agonist. Lidocaine Hydrochloride and Epinephrine Injection is indicated in adult and pediatric patients for the production of local or regional anesthesia or analgesia for surgery, dental, and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. For each type of block indicated to produce local or regional anesthesia or analgesia, specific concentrations and presentations are recommended. ( 1 , 2.2 )

2 DOSAGE AND ADMINISTRATION See Full Prescribing Information for recommended dosages and administration information for adult and pediatric patients ( 2 ) 2.1 Important Dosage and Administration Information • Lidocaine Hydrochloride and Epinephrine Injection is not recommended for intrathecal use. • Avoid use of Lidocaine Hydrochloride and Epinephrine solutions containing antimicrobial preservatives (i.e., multiple-dose vials) for epidural or caudal anesthesia [see Warnings and Precautions (5.3) ] . • Discard unused portions of solution not containing preservatives, i.e., those supplied in single-dose vials, following initial use. • Visually inspect this product for particulate matter and discoloration prior to administration whenever solution and container permit. Lidocaine Hydrochloride and Epinephrine Injections are clear, colorless to slightly yellow solutions. Do not administer solutions which are discolored or contain particulate matter. • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever the solution and container permit. Solutions which are discolored (e.g., pinkish or darker than slightly yellow) or which contain particulate matter or precipitate should not be administered. • Mixing or the prior or intercurrent use of any other local anesthetic with Lidocaine Hydrochloride and Epinephrine Injection is not recommended because of insufficient data on the clinical use of such mixtures. Administration Precautions • Lidocaine Hydrochloride and Epinephrine Injection is to be administered in carefully adjusted dosages by or under the supervision of experienced clinicians who are well versed in the diagnosis and management of dose-related toxicity and other acute emergencies which might arise from the block to be employed. • Use Lidocaine Hydrochloride and Epinephrine Injection only if the following are immediately available: oxygen, cardiopulmonary resuscitative equipment and drugs, and the personnel resources needed for proper management of toxic reactions and related emergencies [see Warnings and Precautions (5.1) , Adverse Reactions (6) , Overdosage (10) ] . • The toxic effects of local anesthetics are additive. Monitor for neurologic and cardiovascular effects related to local anesthetic systemic toxicity when additional local anesthetics are administered with Lidocaine Hydrochloride and Epinephrine Injection [see Warnings and Precautions (5.1) , Drug Interactions (7.1) , Overdosage (10) ] . • Aspirate for blood or cerebrospinal fluid (where applicable) prior to injecting Lidocaine Hydrochloride and Epinephrine Injection, both the initial dose and all subsequent doses, to avoid intravascular or intrathecal injection. However, a negative aspiration for blood or cerebrospinal fluid does not ensure against an intravascular or intrathecal injection [see Warnings and Precautions (5.7) ] . • Avoid rapid injection of a large volume of Lidocaine Hydrochloride and Epinephrine Injection and use fractional (incremental) doses when feasible. • During major regional nerve blocks, such as those of the brachial plexus or lower extremity, the patient should have an indwelling intravenous catheter to assure adequate intravenous access. The lowest dosage of Lidocaine Hydrochloride and Epinephrine Injection that results in effective anesthesia should be used to avoid high plasma levels and serious adverse reactions. • Perform careful and constant monitoring of cardiovascular and respiratory (adequacy of oxygenation and ventilation) vital signs and the patient’s level of consciousness after each local anesthetic injection. • Use Lidocaine Hydrochloride and Epinephrine Injection in carefully restricted quantities in areas of the body supplied by end arteries or having otherwise compromised blood supply such as digits, nose, external ear, or penis [see Warnings and Precautions (5.10) ] . 2.2 Recommended Concentrations and Dosages of Lidocaine Hydrochloride and Epinephrine Injection/Lidocaine Hydrochloride Injection (without Epinephrine) in Adults The dosage of Lidocaine Hydrochloride and Epinephrine Injection 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. Administer the smallest dosage and concentration required to produce the desired result. The types of block and recommended Lidocaine Hydrochloride Injection (without epinephrine) concentrations are shown in Table 1. The dosages suggested in this table are for normal healthy adults and refer to the use of epinephrine-free solutions. Consider administration of solutions containing epinephrine when large volumes are required. Table 1: Recommended Dosages in Adults Procedure Lidocaine Hydrochloride Injection (without epinephrine) Conc (%) Vol (mL) Total Dose (mg) Infiltration Percutaneous 0.5 or 1 1 to 60 5 to 300 Intravenous regional 0.5 10 to 60 50 to 300 Dose should not exceed 4 mg/kg. Peripheral Nerve Blocks, e.g., Brachial 1.5 15 to 20 225 to 300 Dental 2 1 to 5 20 to 100 Intercostal 1 3 30 Paravertebral 1 3 to 5 30 to 50 Pudendal (each side) 1 10 100 Paracervical Obstetrical analgesia (each side) 1 10 100 Sympathetic Nerve Blocks, e.g., Cervical (stellate ganglion) 1 5 50 Lumbar 1 5 to 10 50 to 100 Central Neural Blocks Epidural Dose determined by number of dermatomes to be anesthetized (2 to 3 mL/dermatome). Thoracic 1 20 to 30 200 to 300 Lumbar Analgesia 1 25 to 30 250 to 300 Anesthesia 1.5 15 to 20 225 to 300 2 10 to 15 200 to 300 Caudal Obstetrical analgesia 1 20 to 30 200 to 300 Surgical anesthesia 1.5 15 to 20 225 to 300 The above suggested concentrations and volumes serve only as a guide. Other volumes and concentrations may be used provided the total maximum recommended dose is not exceeded [see Dosage and Administration (2.6) ] . These recommended doses serve only as a guide to the amount of local anesthetic required for most indicated 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. The maximum dosage limit within the recommended dosage range must be individualized in each case after evaluating the size and physical status of the patient, as well as the anticipated rate of systemic absorption from a particular injection site. 2.3 Use in Epidural Anesthesia During the administration of epidural anesthesia, it is recommended that a test dose of Lidocaine Hydrochloride and Epinephrine Injection without antimicrobial preservative (1.5% lidocaine with 1:200,000 epinephrine) be administered initially and the effects monitored before the full dose is given. When using a “continuous” catheter technique, test doses should be given prior to both the initial and all supplemental doses, because a catheter in the epidural space can migrate into a blood vessel or through the dura [see Dosage and Administration (2.4) ] . During epidural administration, administer Lidocaine Hydrochloride and Epinephrine Injection, 1.5% (15 mg/mL) and 2% (20 mg/mL) solutions in incremental doses of 3 mL to 5 mL with sufficient time between doses to detect toxic manifestations of unintentional intravascular or intrathecal injection. Administer injections slowly, with frequent aspirations before and during the injection to avoid intravascular injection. Perform syringe aspirations before and during each supplemental injection in continuous (intermittent) catheter techniques. Repeat doses of lidocaine should be preceded by a test dose containing epinephrine if not clinically contraindicated. Use only the single-dose vials for caudal or epidural anesthesia; avoid use of the multiple-dose vials for these procedures, which contain a preservative [see Dosage and Administration (2.1 , 2.4) , Warnings and Precautions (5.7) ] . 2.4 Test Dose for Epidural Blocks In the event of the known injection of a large volume of local anesthetic solution into the subarachnoid space, after suitable resuscitation and if the catheter is in place, consider attempting the recovery of drug by draining a moderate amount of cerebrospinal fluid (such as 10 mL) through the epidural catheter. Three mL of Lidocaine Hydrochloride and Epinephrine Injection without antimicrobial preservative (1.5% lidocaine with 1:200,000 epinephrine) is recommended for use as a test dose prior to caudal and lumbar epidural blocks when clinical conditions permit. This test dose may serve as a warning of unintended intravascular or intrathecal injection. Closely monitor for early clinical signs of toxicity following each test dose [see Warnings and Precautions (5.7) ] . Allot adequate time for onset of spinal block to detect possible intrathecal injection. An intravascular or intrathecal injection is still possible even if results of the test dose are negative. The test dose itself may produce a systemic toxic reaction, high spinal, or cardiovascular effects from the epinephrine [see Warnings and Precautions (5.1) , Overdosage (10) ] . 2.6 Maximum Recommended Dosage Adults For normal healthy adults, the individual maximum recommended dose of Lidocaine Hydrochloride and Epinephrine Injection should not exceed 7 mg/kg of body weight, and in general it is recommended that the maximum total dose not exceed 500 mg. When used without epinephrine, the maximum individual dose should not exceed 4.5 mg/kg of body weight, and in general it is recommended that the maximum total dose does not exceed 300 mg. For continuous epidural or caudal anesthesia, the maximum recommended dosage should not be administered at intervals of less than 90 minutes. When continuous lumbar or caudal epidural anesthesia is used for non-obstetrical procedures, a higher total dose may be administered if required to produce adequate anesthesia. The maximum recommended dose per 90 minute period of lidocaine hydrochloride for paracervical block in obstetrical patients and non-obstetrical patients is 200 mg total. One half of the total dose is usually administered to each side. Inject slowly, five minutes between sides [see Use in Specific Populations (8.1) ] . Pediatric Patients A maximum dose of Lidocaine Hydrochloride and Epinephrine Injection for children varies based on age and weight. For children over 3 years of age with a normal lean body mass and normal body development, the maximum dose is determined by the child’s age and weight. For example, in a child of 5 years weighing approximately 23 kg, the dose of lidocaine hydrochloride should not exceed approximately 75 mg to 100 mg (3.3 mg/kg to 4.4 mg/kg). The use of dilute solutions (i.e., 0.25% to 0.5%) and total dosages not to exceed 3 mg/kg are recommended for induction of intravenous regional anesthesia in children. The lowest effective concentration and lowest effective dose should be used. Dilution of available concentrations with 0.9% sodium chloride injection may be required to obtain the required final concentration.

4 CONTRAINDICATIONS Lidocaine Hydrochloride and Epinephrine Injections are contraindicated in patients with a known hypersensitivity to lidocaine or to any local anesthetics of the amide-type or to other components of Lidocaine Hydrochloride and Epinephrine Injections. Known hypersensitivity to any local anesthetic agent of the amide-type or to other components of Lidocaine Hydrochloride and Epinephrine Injection. ( 4 )

6 ADVERSE REACTIONS The following clinically significant adverse reactions have been reported and described in the Warnings and Precautions section of the labeling: • Dose-Related Toxicity [see Warnings and Precautions (5.1) ] • Methemoglobinemia [see Warnings and Precautions (5.2) ] • Chondrolysis with Intra-Articular Infusion [see Warnings and Precautions (5.4) ] • Severe, Persistent Hypertension, Cerebrovascular Accidents, and Bradycardia Due to Drug Interactions [see Warnings and Precautions (5.5) ] • Allergic-Type Reactions [see Warnings and Precautions (5.6) ] • Systemic Toxicities with Unintended Intravascular or Intrathecal Injection [see Warnings and Precautions (5.7) ] • Respiratory Arrest Following Retrobulbar Block [see Warnings and Precautions (5.14) ] The following adverse reactions from voluntary reports or clinical studies have been reported with lidocaine or lidocaine and epinephrine. Because many of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Adverse reactions to Lidocaine Hydrochloride are characteristic of those associated with other amide-type local anesthetic. A major cause of adverse reactions to this group of drugs is excessive plasma levels, which may be due to overdosage, unintentional intravascular injection, or slow metabolic degradation. The most commonly encountered acute adverse reactions that demand immediate counter measures were related to the CNS and the cardiovascular system. These adverse reactions were generally dose-related and due to high plasma levels which may have resulted 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 intrathecal 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) has resulted in underventilation or apnea (“Total or High Spinal”). Also, hypertension due to loss of sympathetic tone and respiratory paralysis or underventilation due to cephalad extension of the motor level of anesthesia have occurred. This has led to secondary cardiac arrest when untreated. When used for dental injections, paresthesia of the lips, tongue, and oral tissues have been reported. Persistent paresthesia lasting weeks to months and, in some instances, lasting greater than one year, have also been reported. Nervous System Disorders Adverse reactions were characterized by excitation and/or depression of the central nervous system and included 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 incidences of adverse reactions associated with the use of local anesthetics may be related to the total dose of local anesthetic administered and are also dependent upon the particular drug used, the route of administration and the physical status of the patient. In a prospective review of 10,440 patients who received lidocaine hydrochloride for spinal anesthesia, the incidences of adverse reactions were reported to be about 3 percent each for positional headaches, hypotension and backache; 2 percent for shivering; and less than 1 percent each for peripheral nerve symptoms, nausea, respiratory inadequacy and double vision. Persistent motor, sensory and/or autonomic (sphincter control) deficit of some lower spinal segments with slow recovery (several months) or incomplete recovery have been reported in rare instances when caudal or lumbar epidural block has been attempted. Backache and headache have also been noted following use of these anesthetic procedures. There have been reported cases of permanent injury to extraocular muscles requiring surgical repair following retrobulbar administration. In the practice of caudal or lumbar epidural block, unintentional penetration of the subarachnoid space by the catheter or needle has occurred. Subsequent adverse effects may have depended partially on the amount of drug administered intrathecally and the physiological and physical effects of a dural puncture. A high spinal has been characterized by paralysis of the legs, loss of consciousness, respiratory paralysis, and bradycardia. Neurologic effects following epidural or caudal anesthesia have included spinal block of varying magnitude (including high or total spinal block); hypotension secondary to spinal block; urinary retention; fecal and urinary incontinence; loss of perineal sensation and sexual function; persistent anesthesia, paresthesia, weakness, paralysis of the lower extremities and loss of sphincter control, all of which had slow, incomplete, or no recovery; headache; backache; septic meningitis; meningismus; slowing of labor; increased incidence of forceps delivery; and cranial nerve palsies due to traction on nerves from loss of cerebrospinal fluid. Neurologic effects following other procedures or routes of administration have included persistent anesthesia, paresthesia, weakness, paralysis, all with slow, incomplete, or no recovery. Convulsions : Incidence varied with the procedure used and the total dose administered. In a survey of studies of epidural anesthesia, overt toxicity progressing to convulsions occurred in approximately 0.1% of local anesthetic administrations. The incidences of adverse neurologic reactions associated with the use of local anesthetics may be related to the total dose of local anesthetic administered and are also dependent upon the particular drug used, the route of administration, and the physical status of the patient. Cardiac Disorders High doses or unintentional intravascular injection have led to high plasma levels and related depression of the myocardium, decreased cardiac output, heartblock, hypotension, bradycardia, ventricular arrhythmias, including ventricular tachycardia and ventricular fibrillation, and cardiac arrest [see Warnings and Precautions (5.9) ]. Immune System Disorders Allergic reactions are characterized by cutaneous lesions, urticaria, edema or anaphylactoid reactions. Allergic reactions may occur as a result of sensitivity either to local anesthetic agents or to the methylparaben used as a preservative in the multiple-dose vials [see Warnings and Precautions (5.6) ] . There have been no reports of cross sensitivity between lidocaine hydrochloride and procainamide or between lidocaine hydrochloride and quinidine. Hematologic Methemoglobinemia [see Warnings and Precautions (5.2) ] . Most common adverse reactions are as follows: • Central Nervous System: 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. ( 6 ) • Cardiovascular System: Bradycardia, hypotension, and cardiovascular collapse. ( 6 ) • Allergic: Cutaneous lesions, urticaria, edema or anaphylactoid reactions. ( 6 ) • Neurologic: Positional headaches, hypotension and backache. ( 6 ) • Hematologic: Methemoglobinemia. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc, at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

FDA lists 6 drug label records with LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

What is Lidocaine Hydrochloride and Epinephrine used for?
1 INDICATIONS AND USAGE Lidocaine Hydrochloride and Epinephrine Injection is indicated in adult and pediatric patients for the production of local or regional anesthesia or analgesia for surgery, dental, and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of Lidocaine Hydrochloride and Epinephrine Injection …

Who makes Lidocaine Hydrochloride and Epinephrine?
Cardinal Health 107, LLC is the labeler of record for Lidocaine Hydrochloride and Epinephrine. 6 FDA label records share the active ingredient LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Lidocaine Hydrochloride and Epinephrine come in?
administered by infiltration. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Lidocaine Hydrochloride and Epinephrine prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE?
Yes. 6 FDA drug label records list LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Lidocaine Hydrochloride and Epinephrine been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.