NDC 51662-1553 Lidocaine Hcl

Lidocaine Hcl

NDC Product Code 51662-1553

NDC CODE: 51662-1553

Proprietary Name: Lidocaine Hcl What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Lidocaine Hcl What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used to prevent and relieve pain during certain medical procedures (such as inserting a tube into the urinary tract). It is also used to numb the lining of the mouth, throat, or nose before certain medical procedures (such as intubation). Lidocaine jelly is also used to relieve pain caused by swelling of the urinary tract (urethritis). It works by numbing certain areas of the body that are moist. Lidocaine belongs to a class of drugs known as local anesthetics.

NDC Code Structure

  • 51662 - Hf Acquisition Co Llc, Dba Healthfirst

NDC 51662-1553-3

Package Description: 25 POUCH in 1 CASE > 1 VIAL in 1 POUCH (51662-1553-2) > 4 mL in 1 VIAL

NDC Product Information

Lidocaine Hcl with NDC 51662-1553 is a a human prescription drug product labeled by Hf Acquisition Co Llc, Dba Healthfirst. The generic name of Lidocaine Hcl is lidocaine hcl. The product's dosage form is solution and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1987647.

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Lidocaine Hcl Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.


Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • HYDROCHLORIC ACID (UNII: QTT17582CB)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Amide Local Anesthetic - [EPC] (Established Pharmacologic Class)
  • Amides - [CS]
  • Antiarrhythmic - [EPC] (Established Pharmacologic Class)
  • Local Anesthesia - [PE] (Physiologic Effect)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Hf Acquisition Co Llc, Dba Healthfirst
Labeler Code: 51662
FDA Application Number: ANDA086364 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 06-14-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Lidocaine Hcl Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Description

Lidocaine HCI Topical Solution USP, 4% is a sterile, aqueous solution containing a local anesthetic agent and is administered topically.Lidocaine hydrochloride is designated chemically as acetamide, 2-(diethylamino)-N-(2, 6-dimethylphenyl)-monohydrochloride, with the following structural formula:Composition of Lidocaine HCI 4% Topical Solution: Each mL of aqueous solution contains lidocaine HCI, 40 mg, and sodium hydroxide and/or hydrochloric acid to adjust pH to 5.0 to 7.0. No preservative is added since all or part of the contents of the syringe unit is administered as a single dose and the unit should not be re-used.

Clinical Pharmacology

Mechanism of Action: Lidocaine stabilizes the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby effecting local anesthetic action. The onset of action is rapid.Hemodynamics: Excessive blood levels may cause changes in cardiac output, total peripheral resistance, and mean arterial pressure. These changes may be attributable to a direct depressant effect of the local anesthetic agent on various components of the cardiovascular system. The net effect is normally a modest hypotension when the recommended dosages are not exceeded.Pharmacokinetics and Metabolism: Lidocaine may be absorbed following topical administration to mucous membranes, its rate and extent of absorption depending upon concentration and total dose administered, the specific site of application, and duration of exposure. In general, the rate of absorption of local anesthetic agents following topical application occurs most rapidly after intratracheal administration. Lidocaine is also well-absorbed from the gastrointestinal tract, but little intact drug appears in the circulation because of biotransformation in the liver.Lidocaine is metabolized rapidly by the liver, and metabolites and unchanged drug are excreted by the kidneys. Biotransformation includes oxidative N-dealkylation, ring hydroxylation, cleavage of the amide linkage, and conjugation. N-dealkylation,a major pathway of biotransformation, yields the metabolites monoethylglycinexylidide and glycinexylidide. The pharmacological/toxicological actions of these metabolites are similar to, but less potent than those of lidocaine. Approximately 90% of lidocaine administered is excreted in the form of various metabolites, and less than 10% is excreted unchanged. The primary metabolite in urine is a conjugate of 4-hydroxy-2,6-dimethylaniline.Studies have shown that peak blood levels of lidocaine may occur as early as 5 and as late as 30 minutes after endotracheal administration of a 4% lidocaine HCI solution.The plasma binding of lidocaine is dependent on drug concentration, and the fraction bound decreases with increasing concentration. At concentrations of 1 to 4 μg of free base per mL, 60 to 80 percent of lidocaine is protein bound. Binding is also dependent on the plasma concentration of the alpha-1-acid glycoprotein.Lidocaine crosses the blood-brain and placental barriers, presumably by passive diffusion.Studies of lidocaine metabolism following intravenous bolus injections have shown that the elimination half-life of this agent is typically 1.5 to 2 hours. Because of the rapid rate at which lidocaine is metabolized, any condition that affects liver function may alter lidocaine kinetics. The half-life may be prolonged two-fold or more in patients with liver dysfunction. Renal dysfunction does not affect lidocaine kinetics but may increase the accumulation of metabolites.Factors such as acidosis and the use of CNS stimulants and depressants affect the CNS levels of lidocaine required to produce overt systemic effects. Objective adverse manifestations become increasingly apparent with increasing venous plasmalevels above 6 μg free base per mL. In the rhesus monkey arterial blood levels of 18-21μg/mL have been shown to be threshold for convulsive activity.

Indications & Usage

Lidocaine HCI Topical Solution, 4% is indicated for the production of topical anesthesia of the mucous membranes of the respiratory tract.

Contraindications

Lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type.

Warnings

LIDOCAINE HCI TOPICAL SOLUTION 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 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.
Lidocaine HCI Topical Solution should be used with extreme caution if there is sepsis or severely traumatized mucosa in the area of application, since under such conditions there is the potential for rapid systemic absorption.

Precautions

General: The pre-attached curved cannula is flexible but not unbreakable. Do not bend or manipulate prior to or during use, or use in conjunction with any device other than a laryngoscope. Cannula tip breakage during intratracheal anesthesia requires the tip be manually removed, prolonging anesthesia and adding additional procedural risks.The safety and effectiveness of lidocaine depend on proper dosage, correct technique, adequate precautions, and readiness for emergencies. Resuscitative equipment, oxygen and other resuscitative drugs should be available for immediate use. (See “
WARNINGS” and “
ADVERSE REACTIONS”.) The lowest dosage that results in effective anesthesia should be used to avoid high plasma levels and serious adverse effects. Repeated doses of lidocaine may cause significant increases in blood levels with each repeated dose because of slow accumulation of the drug or its metabolites. Tolerance to elevated blood levels varies with the status of the patient. Debilitated, elderly patients, acutely ill patients, and children should be given reduced doses commensurate with their age and physical status. Lidocaine should also be used with caution in patients with severe shock or heart block.
Careful and constant monitoring of cardiovascular and respiratory (adequacy of ventilation) vital signs and the patient’s state of consciousness should be accomplished after each local anesthetic injection. It should be kept in mind at such times that restlessness, anxiety, tinnitus, dizziness, blurred vision, tremors, depression or drowsiness may be early warning signs of central nervous system toxicity.Since amide-type local anesthetics are metabolized by the liver, Lidocaine HCI Topical Solution should be used with caution in patients with hepatic disease. Patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at a greater risk of developing toxic plasma concentrations. Lidocaine HCI Topical Solution should also be used with caution in patients with impaired cardiovascular function since they may be less able to compensate for functional changes associated with the prolongation of A-V conduction produced by these drugs.Many drugs used during the conduct of anesthesia are considered potential triggering agents for familial malignant hyperthermia. Since it is not known whether amide-type local anesthetics may trigger this reaction and since the need for supplemental general anesthesia cannot be predicted in advance, it is suggested that a standard protocol for management should be available. Early unexplained signs of tachycardia, tachypnea, labile blood pressure and metabolic acidosis may precede temperature elevation. Successful outcome is dependent on early diagnosis, prompt discontinuance of the suspect triggering agent(s) and institution of treatment, including oxygen therapy, indicated supportive measures and dantrolene (consult dantrolene sodium intravenous package insert before using).Lidocaine should be used with caution in persons with known drug sensitivities. Patients allergic to para-amino-benzoic acid derivatives (procaine, tetracaine, benzocaine, etc.) have not shown cross sensitivity to lidocaine.Information for Patients: When topical anesthetics are used in the mouth, the patient should be aware that the production of topical anesthesia may impair swallowing and thus enhance the danger of aspiration. For this reason, food should not be ingestedfor 60 minutes following use of local anesthetic preparations in the mouth or throat area. This is particularly important in children because of their frequency of eating.Numbness of the tongue or buccal mucosa may enhance the danger of unintentional biting trauma. Food and chewing gum should not be used while the mouth or throat area is anesthetized.Carcinogenesis, Mutagenesis, Impairment of Fertility: Studies of lidocaine in animals to evaluate the carcinogenic and mutagenic potential or the effect on fertility have not been conducted.Use in Pregnancy: Teratogenic Effects: Pregnancy Category BReproduction studies have been performed in rats at doses up to 6.6 times the human dose and have revealed no evidence of harm to the fetus caused by lidocaine. There are, however, no adequate and well-controlled studies in pregnant women. Animal reproduction studies are not always predictive of human response. General consideration should be given to this fact before administering lidocaine to women of childbearing potential, especially during early pregnancy when maximum organogenesis takes place.Labor and delivery: Lidocaine is not contraindicated in labor and delivery. Should Lidocaine HCI Topical Solution be used concomitantly with other products containing lidocaine, the total dose contributed by all formulations must be kept in mind.Nursing mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when lidocaine is administered to a nursing woman.Pediatric use: Dosages in children should be reduced, commensurate with age and body weight. See “
DOSAGE AND ADMINISTRATION.”

Adverse Reactions

Adverse experiences following the administration of lidocaine 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 or rapid absorption, 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 is usually an early sign of a high blood level of the drug and may occur as a consequence of rapid absorption.Cardiovascular System: Cardiovascular manifestations are usually depressant and are characterized by bradycardia, hypotension, and cardiovascular collapse, which may lead to cardiac arrest.Allergic: Allergic reactions are characterized by cutaneous lesions, urticaria, edema or anaphylactoid reactions. Allergic reactions as a result of sensitivity to lidocaine are extremely rare and, if they occur, should be managed by conventional means. The detection of sensitivity by skin testing is of doubtful value.Neurologic: 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 physicalstatus of the patient.

Overdosage

Acute emergencies from local anesthetics are generally related to high plasma levels encountered during therapeutic use of local anesthetics. See “
ADVERSE REACTIONS”, “
WARNINGS” and “
PRECAUTIONS.”
The intravenous LD50 of lidocaine HCl in female mice is 26 (21-31) mg/kg and the subcutaneous LD50 is 264 (203-304) mg/kg.

Management of Local Anesthetic Emergencies: The first consideration is prevention, best accomplished by careful and constant monitoring of cardiovascular and respiratory vital signs and the patient’s state of consciousness after each local anestheticadministration. At the first sign of change, oxygen should be administered.
The first step in the management of convulsions consists of immediate attention to the maintenance of a patent airway and assisted or controlled ventilation with oxygen and a delivery system capable of permitting immediate positive airway pressure by mask. Immediately after the institution of these ventilatory measures, the adequacy of the circulation should be evaluated, keeping in mind that drugs used to treat convulsions sometimes depress the circulation when administered. Should convulsions persist despite adequate respiratory support, and if the status of the circulation permits, small increments of an ultra-short acting barbiturate (such as thiopental or thiamylal) or a benzodiazepine (such as diazepam) may be administered intravenously. The clinician should be familiar, prior to use of local anesthetics, with these anticonvulsant drugs. Supportive treatment of circulatorydepression may require administration of intravenous fluids and, when appropriate, a vasopressor as directed by the clinical situation (e.g., ephedrine).If not treated immediately, both convulsions and cardiovascular depression can result in hypoxia, acidosis, bradycardia, arrhythmias and cardiac arrest. If cardiac arrest should occur, standard cardiopulmonary resuscitative measures should be instituted.Endotracheal intubation, employing drugs and techniques familiar to the clinician, may be indicated, after initial administration of oxygen by mask, if difficulty is encountered in the maintenance of a patent airway or if prolonged ventilatory support (assisted or controlled) is indicated.Dialysis is of negligible value in the treatment of acute overdosage with lidocaine.

Dosage & Administration

When Lidocaine HCI Topical Solution is used concomitantly with other products containing lidocaine, the total dose contributed by all formulations must be kept in mind.The dosage varies and depends upon the area to be anesthetized, vascularity of the tissues, individual tolerance and the technique of anesthesia. The lowest dosage needed to provide effective anesthesia should be administered. Dosages should be reduced for children and for elderly and debilitated patients.Although the incidence of adverse effects with Lidocaine HCI Topical Solution is quite low, caution should be exercised, particularly when employing large volumes and concentrations of Lidocaine HCI Topical Solution since the incidence of adverse effects is directly proportional to the total dose of local anesthetic agent administered. For specific techniques and procedures refer to standard textbooks. The dosages below are for normal, healthy adults.Topical Application: For laryngoscopy, bronchoscopy and endotracheal intubation, the pharynx may be sprayed with 1-5 mL (40-200 mg lidocaine HCI), i.e., 0.6-3 mg/kg or 0.3-1.5 mg/lb body weight. For local anesthesia by the transtracheal route, it may be occasionally necessary to spray the pharynx by oropharyngeal spray to achieve complete analgesia.Maximum Recommended Dosages:Normal Healthy Adults:The maximum recommended dose of Lidocaine HCI Topical Solution, should be such that the dose of lidocaine HCI is kept below 300 mg and in any case should not exceed 4.5 mg/kg (2 mg/lb) body weight.Children: It is difficult to recommend a maximum dose of any drug for children since this varies as a function of age and weight. For children of less than ten years who have a normal lean body mass and normal body development, the maximum dose may be determined by the application of one of the standard pediatric drug formulas (e.g. Clark’s rule). For example, in a child of five years weighing 50 Ibs., the dose of lidocaine HCI should not exceed 75-100 mg when calculated according to Clark’s rule. The amount of Lidocaine HCI Topical Solution administered should be such that the dose of lidocaine is kept below 300 mg and in any case should not exceed 4.5 mg/kg (2.0 mg/lb) of body weight.Directions for UseDESCRIPTIONThe LARYNG-O-JET® is a disposable kit for producing rapid, effective topical anesthesia of the interior of the larynx and trachea. The kit contains (1) a sterile, anatomically-curved plastic cannula with attached vial injector, and (2) a single-dose vial prefilled with 4 mL of a 4% sterile aqueous solution of lidocaine hydrochloride. Medication, cannula and fluid pathway are sterile in original, unopened package. The kit is designed for one-time use only. After use, it may be discarded without disassembly.USEThe LARYNG-O-JET® Kit is used to instill a jet spray of lidocaine hydrochloride topical solution into the interior of the larynx and trachea for local anesthesia in the unconscious patient just prior to endotracheal intubation. This form of application also is effective as a final stage of topical anesthesia in the conscious patient (after initial use of an atomizer spray or other appropriate technique for applying topical anesthetic to the pharynx and epiglottis) prior to laryngeal or tracheobronchial endoscopic procedures.DIRECTIONSUse Aseptic TechniqueDO NOT ASSEMBLE UNTIL READY TO USEIMPORTANT:Cannula can break if bent. DO NOT BEND the cannula and use caution with laryngoscope to avoid possible cannula breakage.

Cases of cannula tip breakage during or immediately prior to use have been reported. Cannula tip breakage is thought to be related to user

manipulation prior to or during use, or with concomitant use with other intubation devices. (see PRECAUTIONS).

Use of the LARYNG-O-JET® Kit requires strict observance of precautions appropriate to use of topical anesthesia in the respiratory tract.
For Use Prior to Intubation During Anesthesia Induction (Unconscious Patient):1. Open kit following peel pouch directions.

2. Remove vial and vial injector from bag.

3. Aseptically remove vial and vial injector caps and insert vial into injector.

4. Rotate vial about three turns clockwise or until resistance is felt. DO NOT PUSH VIAL INTO INJECTOR; THIS MAY CAUSE MISALIGNMENT. Needle will then be in contact with medication (Fig. 1). Assembled unit should remain sterile in field until laryngoscopy has been completed.

*The pre-attached curved cannula is flexible but not unbreakable. Cannula can break if bent. DO NOT BEND OR MANIPULATE PRIOR TO USE to avoid possible cannula breakage.

5. Before instillation, manually ventilate the patient with 5 or 6 deep breaths of 100% oxygen (denitrogenate with at least 5 minutes of high flow semi-closed 100% oxygen administration in patients with low cardio-respiratory, circulatory, or hematologic reserve).

6. Predetermine dose (volume) of anesthetic to be instilled and expel excess solution.

7. After hypnosis and muscle relaxation have developed fully and oxygenation has been accomplished as above, perform laryngoscopy in conventional manner. See Fig. 2.
Figure 2. Laryngoscopist's view showing cannula in place in adult larynx and trachea, with black guide mark just proximal to cords.8. Hold injector in manner of holding a pen, and insert tip of cannula between vocal cords and into trachea to the proper depth for instillation of local anesthetic. The black guide mark is positioned just proximal to vocal cords. At this depth, interior of larynx will be bathed with anesthetic solution from upper jet orifices and entire tracheal wall by lower jet openings. (NOTE: Black mark on cannula shaft indicates approximate depth for insertion in most normal patients without touching carina with distal tip.) Caution and gentleness during insertion should be observed and the cannula advanced a proportionately shorter distance in those persons suspected of having a high tracheal bifurcation or tracheobronchial anomaly. USE CAUTION WITH LARYNGOSCOPE TO A VOID POSSIBLE CANNULA BREAKAGE.

9. With cannula at proper depth, depress syringe plunger rapidly to produce a jet-like instillation for bathing walls of larynx and trachea. NOTE: Depression of syringe plunger too slowly may fail to eject solution with sufficient velocity to reach all parts of the larynx and trachea.

10. Withdraw unit and discard.

11. Proceed with intubation.
For Use in Endoscopic Procedures to Supplement Initial Atomizer Spray of Local Anesthetic (Conscious Patient):1. Predetermine dose and assemble unit as in steps 1, 2, 3, 4 and 6 (above).

2. Before instillation apply an initial local anesthetic to the pharynx and epiglottis using an atomizer spray or other appropriate technique.

3. Follow steps 8, 9 and 10 (above) for instillation.

4. Proceed with desired laryngeal or tracheobronchial endoscopy.

How Supplied

In unit use packages containing one sterile disposable laryngotracheal cannula with attached vial injector, and one disposable single dose vial prefilled with sterile, aqueous solution of lidocaine hydrochloride.STOCK NO. 6300 4 mL 4% LARYNG-O-JET® 76329-6300-5Twenty-five unit use packages per carton.Manufactured under LARYNG-O-JET® System.Store at 20° to 25°C (68° to 77°F)[see USP Controlled Room Tempertaure].INTERNATIONAL MEDICATION SYSTEMS, LIMITED

SOUTH EL MONTE, CA 91733, U.S.A.

An Amphastar Pharmaceuticals Company REV. 4-15

* Please review the disclaimer below.