Lidocaine Hydrochloride


General Injectables & Vaccines, Inc
Human Prescription Drug
NDC 52584-034
Lidocaine Hydrochloride is a human prescription drug labeled by 'General Injectables & Vaccines, Inc'. National Drug Code (NDC) number for Lidocaine Hydrochloride is 52584-034. This drug is available in dosage form of Jelly. The names of the active, medicinal ingredients in Lidocaine Hydrochloride drug includes Lidocaine Hydrochloride - 20 mg/mL . The currest status of Lidocaine Hydrochloride drug is Active.

Drug Information:

Drug NDC: 52584-034
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name: Lidocaine Hydrochloride
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type: Human Prescription Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name: Lidocaine Hydrochloride
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: General Injectables & Vaccines, Inc
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Jelly
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status: Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:LIDOCAINE HYDROCHLORIDE - 20 mg/mL
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:TOPICAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Marketing Category: ANDA
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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.
Marketing Start Date: 30 May, 2012
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 29 Feb, 2024
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number: ANDA086283
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.
Listing Expiration Date: 13 Jan, 2026
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Manufacturer Name:General Injectables & Vaccines, Inc
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:1011852
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
UNII:V13007Z41A
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class:Amide Local Anesthetic [EPC]
Amides [CS]
Antiarrhythmic [EPC]
Local Anesthesia [PE]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
52584-034-051 VIAL, SINGLE-USE in 1 BAG (52584-034-05) / 10 mL in 1 VIAL, SINGLE-USE30 May, 201229 Feb, 2024No
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Product Elements:

Lidocaine hydrochloride lidocaine hydrochloride lidocaine hydrochloride lidocaine lidocaine hydrochloride anhydrous

Indications and Usage:

Indications and usage lidocaine hydrochloride jelly usp, 2% is indicated for prevention and control of pain in procedures involving the male and female urethra for topical treatment of painful urethritis, and as an anesthetic lubricant for endotracheal intubation (oral and nasal).

Warnings:

Warnings excessive dosage, or short intervals between doses, can result in high plasma levels and serious adverse effects. patients should be instructed to strictly adhere to the recommended dosage and administration guidelines as set forth in this package insert. the management of serious adverse reactions may require the use of resuscitative equipment, oxygen, and other resuscitative drugs. lidocaine hydrochloride jelly usp, 2% should be used with extreme caution in the presence of sepsis or severely traumatized mucosa in the area of application, since under such conditions there is the potential for rapid systemic absorption. when used for endotracheal tube lubrication, care should be taken to avoid introducing the product into the lumen of the tube. do not use the jelly to lubricate the endotracheal stylettes. if allowed into the inner lumen, the jelly may dry on the inner surface leaving a residue which tends to clump with flexion, narrowing the lumen. there have been rare reports
in which this residue has caused the lumen to occlude (see adverse reactions and dosage and administration). 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 these patients, close monitoring for symptoms and signs of methemoglobinemia is recommended. signs of methemoglobinemia may occur immediately or may be delayed some hours after exposure, and are characterized by a cyanotic skin discoloration and/or abnormal coloration of the blood. methemoglobin levels may continue to rise; therefore, immediate treatment is required to avert more serious central nervous system and cardiovascular adverse effects, including seizures, coma, arrhythmias, and death. discontinue lidocaine hydrochloride jelly usp, 2% and any other oxidizing agents. depending on the severity of the signs and symptoms, patients may respond to supportive care, i.e., oxygen therapy, hydration. a more severe clinical presentation may require treatment with methylene blue, exchange transfusion, or hyperbaric oxygen.

Dosage and Administration:

Dosage and administration when lidocaine hydrochloride jelly usp, 2% 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 hydrochloride jelly usp, 2% is quite low, caution should be exercised, particularly when employing large amounts, since the incidence of adverse effects is directly proportional to the total dose of local anesthetic agent administered. for surface anesthesia of the male adult urethra: slowly insill 15ml (300 mg of lidocaine hcl) into the urethra or until the patient has a feeling of tension. a penile clamp is then applied for se
veral minutes at the corona. an additional dose of not more than 15 ml (300mg) can be instilled for adequate anesthesia. prior to sounding or cystoscopy, a penile clamp should be applied for 5 to 10 minutes to obtain adequate anesthesia. a total dose of 30 ml (600mg) is usually required to fill and dilate the male urethra. prior to catheterization, smaller volumes 5 to 10 ml (100 to 200mg) are usually adequate for lubrication. for surface anesthesia of the female adult urethra: slowly instill 3 to 5 ml (600 to 100mg of lidocaine hcl) of the jelly into the urethra. if desired, some jelly may be deposited on a cotton swab and introduced into the urethra. in order to obtain adequate anesthesia, several minutes should be allowed prior to performing urological procedures. lubrication for endotracheal intubation: apply a moderate amount of jelly to the external surface of the endotracheal tube shortly before use. care should be taken to avoid introducing the product into the lumen of the tube. do not use the jelly to lubricate endotracheal stylettes. (see warnings and adverse reactions) concerning rare reports of inner lumen occlusion. it is also recommended that use of endotracheal tubes with dried jelly on the external surface be avoided for lack of lubricating effect. maximum dosage: no more than 600 mg of lidocaine hydrochloride should be given in any 12 hour period. 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 less than ten years who have a normal lean body mass and a normal lean 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 lbs., the dose of lidocaine hydrochloride should not exceed 75-100 mg when calculated according to clark's rule. in any case, the maximum amount of lidocaine administered should not exceed 4.5 mg / kg (2 mg / lb) of body weight.

Contraindications:

Contraindications lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type or to other components of lidocaine hydrochloride jelly usp, 2%.

Adverse Reactions:

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: there have been rare reports of endotracheal tube occlusion associated with the presence of dried jelly residue in the inner lumen of the tube. see ( warnings and dosage and administration ). 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, twitch
ing, 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 may occur as a result of sensitivity either to the local anesthetic agent or to other components in the formulation. 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.

Overdosage:

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.) 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 anesthetic administration. 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 intravenously. 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 circulatory depression 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. dialysis is of negligible value in the treatment of acute overdosage with lidocaine. the oral ld50 of lidocaine hydrochloride in non-fasted female rats is 459 (346–773) mg / kg (as the salt) and 214 (159–324) mg / kg (as the salt) in fasted female rats.

Description:

Description lidocaine hydrochloride jelly usp, 2% is a sterile aqueous product that contains a local anesthetic agent and is administered topically. (see indications and usage for specific uses). lidocaine hydrochloride jelly usp, 2% contains lidocaine hydrochloride which is chemically designated as acetamide, 2-(diethylamino)-n-(2,6-dimethylphenyl)-, monohydrochloride and has the following structural formula: lidocaine hydrochloride jelly usp, 2% also contains hypromellose, and the resulting mixture maximizes contact with muscosa and provides lubrication for instrumentation. the unused portion should be discarded after initial use. composition of lidocaine hydrochloride jelly usp, 2%: each ml contains 20 mg of lidocaine hcl. the formulation also contains methylparaben, propylparaben, hypromellose, and sodium hydroxide and/or hydrochloric acid to adjust ph between 6.0 to 7.0. formula1.jpg

Clinical Pharmacology:

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. onset of action: the onset of action is 3-5 minutes. it is ineffective when applied to intact skin. 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. pharmacokinetics and metabolism: lidocaine may be absorbed following topical administration to mucous membranes, its rate and extent of absorption varies 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 admi
nistration. lidocaine is also well-absorbed from the gastrointestinal tract, but little intact drug may appear 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 mono-ethylglycinexylidide 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. the plasma binding of lidocaine is dependent on drug concentration, and the fraction bound decreases with increasing concentration. at concentrations of 1 to 4 ug 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 plasma levels above 6 mcg free base per ml. in the rhesus monkey arterial blood levels of 18-21 mcg/ml have been shown to be the threshold for convulsive activity.

How Supplied:

How supplied lidocaine hydrochloride jelly usp, 2% box of 25 in unit use packages containing one single use vial and a uro-jet vial injector. * caution: improper engaging may cause glass breakage and subsequent injury. store at controlled room temperature 15° to 30°c (59° to 86°f). rx only international medication systems, limited south el monte, ca 91733, u.s.a. an amphastar pharmceuticals company rev. 10-19 image1.jpg image2.jpg

Package Label Principal Display Panel:

Sample package label label1.jpg


Comments/ Reviews:

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