Lidocaine Hydrochloride (Lidocaine)

Trade Name : Lidocaine

West-Ward Pharmaceuticals Corp

INJECTION, SOLUTION

Strength 20 mg/mL

LIDOCAINE HYDROCHLORIDE Amide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Lidocaine Hydrochloride (Lidocaine) which is also known as Lidocaine and Manufactured by West-Ward Pharmaceuticals Corp. It is available in strength of 20 mg/mL per ml. Read more

Lidocaine Hydrochloride (Lidocaine) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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Preservedu00a0
Local Anesthetic for Infiltration and Nerve Block
Not for Spinal or Epidural Anesthesia
Rx only

Lidocaine Hydrochloride Injection, USPu00a0is au00a0sterile, nonpyrogenic, aqueous, isotonic solution that contains a local anesthetic agent and is administered parenterally by injection.u00a0 See for specific uses.
Lidocaine Hydrochloride Injection solutions contain lidocaine hydrochloride which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride and has the molecular wt. 270.8. Lidocaine HCl (CHNO u2022 HCl) has the following structural formula:
Each mL of the 1% solution contains lidocaine hydrochloride 10 mg, sodium chloride 7 mg and 1 mg methylparaben as antiseptic preservative. Each mL of the 2% solution contains lidocaine hydrochloride 20 mg, sodium chloride 6 mg and 1 mg methylparaben as antiseptic preservative. The pH of these solutions is adjusted to approximately 5.0 to 7.0 with sodium hydroxide and/or hydrochloric acid.

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Lidocaine HCl Injections are indicated for production of local anesthesia by infiltration techniques such as percutaneous injection by peripheral nerve block techniques such as brachial plexus and intercostal, when the accepted procedures for these techniques as described in standard textbooks are observed.

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

LIDOCAINE HCl 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 AVAILABILITY OF OXYGEN, OTHER RESUSCITATIVE DRUGS, CARDIOPULMONARY EQUIPMENT AND THE PERSONNEL NEEDED FOR PROPER MANAGEMENT OF TOXIC REACTIONS AND RELATED EMERGENCIES (see alsou00a0u00a0and ).u00a0 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 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 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.n
Intra-articular infusions of local anesthetics following arthroscopic and other surgical procedures is an unapproved use, and there have been post-marketing reports of chondrolysis in patients receiving such infusions.u00a0 The majority of reported cases of chondrolysis have involved the shoulder joint; cases of gleno-humeral chondrolysis have been described in pediatric and adult patients following intra-articular infusions of local anesthetics with and without epinephrine for periods of 48 to 72 hours.u00a0 There is insufficient information to determine whether shorter infusion periods are not associated with these findings.u00a0 The time of onset of symptoms, such as joint pain, stiffness and loss of motion can be variable, but may begin as early as the 2nd month after surgery.u00a0 Currently, there is no effective treatment for chondrolysis; patients who experienced chondrolysis have required additional diagnostic and therapeutic procedures and some required arthroplasty or shoulder replacement.
To avoid intravascular injection, aspiration should be performed before the local anesthetic solution is injected.u00a0 The needle must be repositioned until no return of blood can be elicited by aspiration.u00a0 Note, however, that the absence of blood in the syringe does not guarantee that intravascular injection has been avoided.
Local anesthetic solutions containing antimicrobial preservatives (eg, methylparaben) should not be used for epidural or spinal anesthesia because the safety of these agents has not been established with regard to intrathecal injection, either intentional or accidental.
Anaphylactic reactions may occur following administration of lidocaine hydrochloride (see ).n In the case of severe reaction, discontinue the use of the drug.

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Acute emergencies from local anesthetics are generally related to high plasma levels encountered during therapeutic use of local anesthetics or to unintended subarachnoid injection of local anesthetic solution (see n and ).
The first consideration is prevention, best accomplished by careful and constant monitoring of cardiovascular and respiratory vital signs and the patientu2019s state of consciousness after each local anesthetic injection. At the first sign of change, oxygen should be administered.
The first step in the management of convulsions, as well as underventilation or apnea due to unintended subarachnoid injection of drug solution, 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 the 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 (eg, ephedrine).
If not treated immediately, both convulsions and cardiovascular depression can result in hypoxia, acidosis, bradycardia, arrhythmias and cardiac arrest. Underventilation or apnea due to unintentional subarachnoid injection of local anesthetic solution may produce these same signs and also lead to cardiac arrest if ventilatory support is not instituted.u00a0 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 HCl.
The oral LD of lidocaine HCl in non-fasted female rats is 459 (346 to 773) mg/kg (as the salt) and 214 (159 to 324) mg/kg (as the salt) in fasted female rats.

Table 1 (Recommended Dosages) summarizes the recommended volumes and concentrations of Lidocaine HCl 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. Lidocaine HCl Injection is not approved for this use (seeu00a0u00a0and ).
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. Dosages should be reduced for children and for the elderly and debilitated patients and patients with cardiac and/or liver disease.
The onset of anesthesia, the duration of anesthesia and the degree of muscular relaxation are proportional to the volume and concentration (ie, total dose) of local anesthetic used. Thus, an increase in volume and concentration of Lidocaine HCl Injection will decrease the onset of anesthesia, prolong the duration of anesthesia, provide a greater degree of muscular relaxation and increase the segmental spread of anesthesia. However, increasing the volume and concentration of Lidocaine HCl Injection may result in a more profound fall in blood pressure when used in epidural anesthesia. Although the incidence of side effects with lidocaine HCl is quite low, caution should be exercised when employing large volumes and concentrations, since the incidence of side effects is directly proportional to the total dose of local anesthetic agent injected.n

NOTE:u00a0The products accompanying this insert do not contain epinephrine.

Disinfecting agents containing heavy metals, which cause release of respective ions (mercury, zinc, copper, etc) should not be used for skin or mucous membrane disinfection as they have been related to incidents of swelling and edema. When chemical disinfection of multiple dose vials is desired, either isopropyl alcohol (91%) or ethyl alcohol (70 %) is recommended.u00a0 Many commercially available brands of rubbing alcohol, as well as solutions of ethyl alcohol not of USP grade, contain denaturants which are injurious to rubber and therefore are not to be used.

Lidocaine Hydrochloride Injection, USP is preserved with 0.1% methylparaben and is available in the following concentrationsn
1% (10 mgmL)
u00a0 u00a02 mL Multiple Dose Vials packaged in 25s (0143-9579-25)
u00a0 u00a030 mL Multiple Dose Vials packaged in 10s (0143-9578-10)
u00a0 u00a050 mL Multiple Dose Vials packaged in 10s (0143-9577-10)
2% (20 mgmL)
u00a0 u00a02 mL Multiple Dose Vials packaged in 25s (0143-9576-25)
u00a0u00a0 50 mL Multiple Dose Vials packaged in 10s ( 0143-9575-10)
Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [see USP Controlled Room Temperature].u00a0
To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceutical Corp. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or .
For Product Inquiry call 1-877-845-0689.

Manufactured by:
Distributed by:
Arrayn- Array
WEST-WARD PHARMACEUTICALSEatontown, NJ 07724 USA
January 2019u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0u00a0
PIN371u2013WES/2

NDC 0143--01u00a0u00a0n n n n n n n n n n 2 mL Multiple Dose Vial
NDC 0143--25u00a0u00a0u00a0 n n n n n 25 x 2 mL Multiple Dose Vials

NDC 0143--01u00a0u00a0n n n n 30 mL Multiple Dose Vial
u00a0n
NDC 0143--10u00a0u00a0n n n n 10 x 30 mL Multiple Dose Vials
u00a0n

NDC 0143--01u00a0u00a0 n n n 50 mL Multiple Dose Vial
u00a0u00a0n
NDC 0143--10u00a0u00a0u00a0n n n n n n 10 x 50 mL Multiple Dose Vials

NDC 0143--01u00a0n n n n n n n n n n 2 mL Multiple Dose Vial
u00a0n
NDC 0143--25u00a0u00a0u00a0 n n n n n 25 x 2 mL Multiple Dose Vials

NDC 0143--01u00a0u00a0 n n n 50 mL Multiple Dose Vial
u00a0n
NDC 0143--10u00a0u00a0u00a0n n n n n 10 x 50 mL Multiple Dose Vialsn
u00a0n

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Lidocaine Hydrochloride (Lidocaine)

Trade Name : Lidocaine

INJECTION, SOLUTION

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Lidocaine Hydrochloride (Lidocaine)

Trade Name : Lidocaine

INJECTION, SOLUTION

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

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Losartan Potassium (Losartan Potassium)

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