Label: A3215-18/22 REGIONAL ANESTHESIA 18G HUSTEAD/22G QUINCKE - regional anesthesia kit

  • NDC Code(s): 0409-4713-65, 51688-9759-2, 52380-0001-3, 65282-1510-1
  • Packager: Smiths Medical ASD, Inc.
  • Category: MEDICAL DEVICE
  • DEA Schedule: None
  • Marketing Status: Premarket Notification

Drug Label Information

Updated 02/15

If you are a consumer or patient please visit this version.

  • Drug Facts

    Povidone-iodine

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  • PURPOSE

    Antiseptic

    Antispetic skin preparation

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  • WARNINGS

    Do not use

    -if allergic to iodine.

    -in the eyes

    For external use only.

    Ask a doctor before use if injuries are

    -deep or puncture wounds

    -serious burns

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  • STOP USE

    Stop use and ask a doctor if

    -redness, irritation, swelling or pain persists or increases

    -infection occurs

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

    In case of accidental ingestion, seek professional help or consult a poison control center immediately.

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  • INSTRUCTIONS FOR USE

    Apply locally as needed.

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  • OTHER SAFETY INFORMATION

    1% titratable iodine latex free for hospital or professional use only

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  • QUESTIONS

    1 800 760-3236 (Mon to Fri 8:30 AM-5:00 PM EST)

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  • SPL UNCLASSIFIED SECTION

    AQUEOUS SOLUTIONS FOR INFILTRATION

    AND NERVE BLOCK

    Ampul

    Plastic Multiple-dose Fliptop Vial

    Glass Teartop Vial

    Rx only

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  • DESCRIPTION

    Lidocaine Hydrochloride Injection, USP is a sterile, nonpyrogenic solution of lidocaine hydrochloride in water for injection for parenteral administration in various concentrations with characteristics as follows:

    Concentration

    0.5%

    1%

    1.5%

    2%

    mg/mL lidocaine HCl (anhyd.)

    5

    10

    15

    20

    mg/mL sodium chloride

    8

    7

    6.5

    6

    Multiple-dose vials contain 0.1% of methylparaben added as preservative. May contain sodium hydroxide and/or hydrochloric acid for pH adjustment. The pH is 6.5 (5.0 to 7.0). See HOW SUPPLIED section for various sizes and strengths.

    Lidocaine is a local anesthetic of the amide type.

    Lidocaine Hydrochloride, USP is chemically designated 2-(diethylamino)-N-(2,6-dimethylphenyl)-acetamide monohydrochloride monohydrate, a white powder freely soluble in water. The molecular weight is 288.82. It has the following structural formula:

    lidocaine hydrochloride injection figure 1

    The semi-rigid vial used for the plastic vials is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. The container requires no vapor barrier to maintain the proper drug concentration.

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  • 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.

    Hemodynamics: Excessive blood levels may cause changes in cardiac output, total peripheral resistance, and mean arterial pressure. With central neural blockade these changes may be attributable to block of autonomic fibers, a direct depressant effect of the local anesthetic agent on various components of the cardiovascular system and/or the beta-adrenergic receptor stimulating action of epinephrine when present. The net effect is normally a modest hypotension when the recommended dosages are not exceeded.

    Pharmacokinetics and metabolism: Information derived from diverse formulations, concentrations and usages reveals that lidocaine is completely absorbed following parenteral administration, its rate of absorption depending, for example, upon various factors such as the site of administration and the presence or absence of a vasoconstrictor agent. Except for intravascular administration, the highest blood levels are obtained following intercostal nerve block and the lowest after subcutaneous administration.

    The plasma binding of lidocaine is dependent on drug concentration, and the fraction bound decreases with increasing concentration. At concentrations of 1 to 4 mcg 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.

    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.

    The elimination half-life of lidocaine following an intravenous bolus injection is typically 1.5 to 2.0 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 6.0 mcg free base per mL. In the rhesus monkey arterial blood levels of 18-21 mcg/mL have been shown to be threshold for convulsive activity.

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  • INDICATIONS & USAGE

    Lidocaine Hydrochloride Injection, USP is 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.

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  • CONTRAINDICATIONS

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

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  • WARNINGS

    LIDOCAINE HYDROCHLORIDE INJECTION, 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.

    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. 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. There is insufficient information to determine whether shorter infusion periods are not associated with these findings. 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. 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. The needle must be repositioned until no return of blood can be elicited by aspiration. 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 (e.g., 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.

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  • ADVERSE REACTIONS

    Systemic: 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, 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 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 local anesthetic agents or to the methylparaben used as a preservative in multiple dose vials. 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 physical status of the patient. In a prospective review of 10,440 patients who received lidocaine 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. Many of these observations may be related to local anesthetic techniques, with or without a contribution from the local anesthetic.

    In the practice of caudal or lumbar epidural block, occasional unintentional penetration of the subarachnoid space by the catheter may occur. Subsequent adverse effects may depend partially on the amount of drug administered subdurally.

    These may include spinal block of varying magnitude (including total spinal block), hypotension secondary to spinal block, loss of bladder and bowel control, and loss of perineal sensation and sexual function. 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.

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  • OVERDOSAGE

    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 ADVERSE REACTIONS, WARNINGS and PRECAUTIONS).

    Management of Local Anesthetic Emergencies: The first consideration is prevention, best accomplished by careful monitoring of cardiovascular and respiratory vital signs and the patient’s 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 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. 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. 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.

    The oral LD50 of lidocaine HCl 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.

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  • DOSAGE & ADMINISTRATION

    Table 1 (Recommended Dosages) summarizes the recommended volumes and concentrations of Lidocaine Hydrochloride Injection, USP 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 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 given. Dosages should be reduced for children and for 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 (i.e., total dose) of local anesthetic used. Thus, an increase in volume and concentration of Lidocaine Hydrochloride 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 Hydrochloride Injection may result in a more profound fall in blood pressure when used in epidural anesthesia. Although the incidence of side effects with lidocaine 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.

    For intravenous regional anesthesia, only the 50 mL single-dose vial containing 0.5% Lidocaine Hydrochloride Injection, USP should be used.

    Epidural Anesthesia

    For epidural anesthesia, only the following available specific products of Lidocaine Hydrochloride Injection by Hospira are recommended:

    1%. . . . . . . . . . . . . . . . . . . . 30 mL single-dose teartop vials

    1.5%. . . . . . . . . . . . . . . . . . . . . . . 20 mL single-dose ampuls

    2%. . . . . . . . . . . . . . . . . . . . . . . . . 10 mL single-dose ampuls

    Although these solutions are intended specifically for epidural anesthesia, they may also be used for infiltration and peripheral nerve block provided they are employed as single dose units. These solutions contain no bacteriostatic agent. In epidural anesthesia, the dosage varies with the number of dermatomes to be anesthetized (generally 2−3 mL of the indicated concentration per dermatome).

    Caudal and Lumbar Epidural Block: As a precaution against the adverse experiences sometimes observed following unintentional penetration of the subarachnoid space, a test dose such as 2−3 mL of 1.5% lidocaine hydrochloride should be administered at least 5 minutes prior to injecting the total volume required for a lumbar or caudal epidural block. The test dose should be repeated if the patient is moved in a manner that may have displaced the catheter. Epinephrine, if contained in the test dose (10−15 mcg have been suggested), may serve as a warning of unintentional intravascular injection. If injected into a blood vessel, this amount of epinephrine is likely to produce a transient "epinephrine response" within 45 seconds, consisting of an increase in heart rate and systolic blood pressure, circumoral pallor, palpitations and nervousness in the unsedated patient. The sedated patient may exhibit only a pulse rate increase of 20 or more beats per minute for 15 or more seconds. Patients on beta-blockers may not manifest changes in heart rate, but blood pressure monitoring can detect an evanescent rise in systolic blood pressure. Adequate time should be allowed for onset of anesthesia after administration of each test dose. The rapid injection of a large volume of Lidocaine Hydrochloride Injection through the catheter should be avoided, and, when feasible, fractional doses should be administered.

    In the event of the known injection of a large volume of local anesthetic solutions 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.

    Maximum Recommended Dosages

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

    Adults: For normal healthy adults, the individual maximum recommended dose of lidocaine HCl with epinephrine should not exceed 7 mg/kg (3.5 mg/lb) 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 (2 mg/lb) 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, more drug 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 also discussion of paracervical block in PRECAUTIONS).

    For intravenous regional anesthesia, the dose administered should not exceed 4 mg/kg in adults.

    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 over 3 years of age who have 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 50 lbs., the dose of lidocaine HCl should not exceed 75 — 100 mg (1.5 — 2 mg/lb). The use of even more dilute solutions (i.e., 0.25 — 0.5%) and total dosages not to exceed 3 mg/kg (1.4 mg/lb) are recommended for induction of intravenous regional anesthesia in children.

    In order to guard against systemic toxicity, the lowest effective concentration and lowest effective dose should be used at all times. In some cases it will be necessary to dilute available concentrations with 0.9% sodium chloride injection in order to obtain the required final concentration.

    Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever the solution and container permit. Solutions that are discolored and/or contain particulate matter should not be used.

    Table 1

    Recommended Dosages of Lidocaine Hydrochloride Injection, USP for Various Anesthetic

    Procedures in Normal Healthy Adults

    Lidocaine Hydrochloride Injection, USP (without Epinephrine)

    Procedure

    Conc. (%)

    Vol. (mL)

    Total Dose (mg)

    Infiltration

    Percutaneous

    0.5 or 1.0

    1−60

    5−300

    Intravenous Regional

    0.5

    10−60

    50−300

    Peripheral Nerve Blocks, e.g.

    Brachial

    1.5

    15−20

    225−300

    Dental

    2.0

    1−5

    20−100

    Intercostal

    1.0

    3

    30

    Paravertebral

    1.0

    3−5

    30−50

    Pudendal (each side)

    1.0

    10

    100

    Paracervical

    Obstetrical Analgesia

    (each side)

    1.0

    10

    100

    Sympathetic Nerve Blocks, e.g.

    Cervical (stellate ganglion)

    1.0

    5

    50

    Lumbar

    1.0

    5−10

    50−100

    Central Neural Blocks

    Epidural*

    Thoracic

    1.0

    20−30

    200−300

    Lumbar

    Analgesia

    1.0

    25−30

    250−300

    Anesthesia

    1.5

    15−20

    225−300

    2.0

    10−15

    200−300

    Caudal

    Obstetrical Analgesia

    1.0

    20−30

    200−300

    Surgical Anesthesia

    1.5

    15−20

    225−300

    *Dose determined by number of dermatomes to be anesthetized (2 to 3 mL/dermatome).

    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.

    Sterilization, Storage and Technical Procedures: 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 incidence of swelling and edema. When chemical disinfection of multi-dose vials is desired, either isopropyl alcohol (91%) or 70% ethyl alcohol is recommended. 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. It is recommended that chemical disinfection be accomplished by wiping the vial stopper thoroughly with cotton or gauze that has been moistened with the recommended alcohol just prior to use.

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  • HOW SUPPLIED

    Lidocaine Hydrochloride Injection, USP is supplied as follows:

    NDC

    Container

    Concentration

    Size

    Total (mg)

    Single-dose:

    0409-4278-01

    Glass Teartop Vial

    0.5% (5 mg/mL)

    50 mL

    250

    0409-4713-01

    Glass Ampul

    1% (10 mg/mL)

    2 mL (bulk – 400 units)

    20

    0409-4713-02

    Glass Ampul

    1% (10 mg/mL)

    5 mL

    50

    0409-4713-05

    Glass Ampul

    1% (10 mg/mL)

    5 mL (bulk – 400 units)

    50

    0409-4713-20

    Glass Ampul

    1% (10 mg/mL)

    20 mL

    200

    0409-4713-32

    Glass Ampul

    1% (10 mg/mL)

    2 mL

    20

    0409-4713-62

    Glass Ampul

    1% (10 mg/mL)

    2 mL (bulk – 800 units)

    20

    0409-4713-65

    Glass Ampul

    1% (10 mg/mL)

    5 mL (bulk – 800 units)

    50

    0409-4279-02

    Glass Teartop Vial

    1% (10 mg/mL)

    30 mL

    300

    0409-4270-01

    Sterile Glass Teartop Vial

    1% (10 mg/mL)

    30 mL

    300

    0409-4776-01

    Glass Ampul

    1.5% (15 mg/mL)

    20 mL

    300

    0409-4056-01

    Sterile Glass Ampul

    1.5% (15 mg/mL)

    20 mL

    300

    0409-4282-01

    Glass Ampul

    2% (20 mg/mL)

    2 mL

    40

    0409-4282-02

    Glass Ampul

    2% (20 mg/mL)

    10 mL

    200

    Multiple-dose:

    0409-4275-01

    Plastic Fliptop Vial

    0.5% (5 mg/mL)

    50 mL

    250

    0409-4276-01

    Plastic Fliptop Vial

    1% (10 mg/mL)

    20 mL

    200

    0409-4276-02

    Plastic Fliptop Vial

    1% (10 mg/mL)

    50 mL

    500

    0409-4277-01

    Plastic Fliptop Vial

    2% (20 mg/mL)

    20 mL

    400

    0409-4277-02

    Plastic Fliptop Vial

    2% (20 mg/mL)

    50 mL

    1000

    Single-dose products are preservative-free.

    Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]

    Lidocaine Hydrochloride Injection, USP solutions packaged in ampuls and glass teartop vials may be autoclaved one time only. Autoclave at 15 pounds pressure, 121°C (250°F) for 15 minutes. DO NOT AUTOCLAVE PRODUCT IN PLASTIC VIALS.

    Revised: February, 2010

    Printed in USA EN-2421

    Hospira, Inc., Lake Forest, IL 60045 USA

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  • PRINCIPAL DISPLAY PANEL

    Package Label Display Panel

    Lidocaine Pack Label

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  • DESCRIPTION

    Sodium Chloride Injection, USP is a sterile, nonpyrogenic, isotonic solution of sodium chloride 0.9% (9 mg/mL) in Water for Injection containing no antimicrobial agent or other added substance. The pH is between 4.5 and 7.0. Its chloride and sodium ion concentrates are approximately 0.154 mEq of each per milliliter and its calculated osmolality is 0.308 milliosmols per mL.

    Sodium chloride occurs as colorless cubic crystals or white crystalline powder and has a saline taste. Sodium Chloride is freely soluble in water. It is soluble in glycerin and slightly soluble in alcohol. The empirical formula for sodium chloride is NaCl, and the molecular weight is 58.44.

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  • CLINICAL PHARMACOLOGY

    Sodium chloride comprises over 90% of the inorganic constituents of the blood serum. Sodium chloride in water dissociates to provide sodium (Na+) and chloride (Cl-) ions. These ions are normal constituents of the body fluids (principally extracellular) and are essential for maintaining electrolyte balance. The small volume of Fluid and amount of sodium chloride provided by Sodium Chloride Injection, USP, 0.9% when used only as a vehicle for parenteral injection of drugs, is unlikely to exert a significant effect on fluid and electrolyte balance except possibly in very small infants.

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  • INDICATIONS & USAGE

    Sodium Chloride Injection is used to flush intravascular catheters or as a sterile, isotonic single dose vehicle, solvent, or diluent for substances to be administered intravenously, intramuscularly or sub-cutaneously and for other extemporaneously prepared single dose sterile solutions according to instructions of the manufacture of the drug to be administered.

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  • WARNINGS

    Sodium Chloride must be used with caution in the presence of congestive heart failure, circulatory insufficiency, kidney dysfunction or hypoproteinemia. Excessive amounts of sodium chloride by any route may cause hypokalemia and acidosis.

    Excessive amounts by parental routes may precipitate congestive heart failure and acute pulmonary edema, especially seen in patients with preexisting cardiovascular disease and those receiving corticos-teroids, corticotropin or other drugs that may give rise to sodium retention. For use in newborns, when a Sodium Chloride solution is required for preparation or diluting medications, or in flushing intravenous catheters, only preservative-free Sodium Chloride Injection, USP, 0.9% should be used.

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  • PRECAUTIONS

    Since Sodium Chloride Injection does not contain antimicrobial agents and is intended for single use, any unused amount must be discarded immediately following withdrawal of any portion of the contents of the vial or ampul. Do not open ampul until it is to be used.

    Consult the manufactures instructions for choice of vehicle, appropriate dilution or volume for dissolving the drug to be injected, including the route and rate of injection.

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  • PREGNANCY

    Pregnancy Category C: Animal reproductive studies have not been conducted with Sodium Chloride Injection USP 0.9%. It is also not known whether Sodium Chloride Injection USP 0.9% can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Chloride Injection USP 0.9% should be given to a pregnant woman only if clearly needed.

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  • ADVERSE REACTIONS

    Reactions which may occur because of this solution, added drugs or the technique of reconstitution or administration include febrile response, local tenderness, abscess, tissue necrosis or infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection and extravasation.

    If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate countermeasures, and if possible, retrieve and save the remainder of the unused vehicle for examination.

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  • OVERDOSAGE

    When used as a diluent, solvent or intravascular flushing solution, this parental preparation is unlikely to pose a threat of sodium chloride or fluid overload except possible in very small infants. In the event these should occur, reevaluate the patient and institute appropriate corrective measures.

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  • DOSAGE & ADMINISTRATION

    Before Sodium Chloride Injection, USP, 0.9% is used as a vehicle for the administration of a drug, specific references should be checked for any possible incompatibility with sodium chloride. The volume of the preparation to be used for diluting or dissolving any drug for injection is dependent on the vehicle concentration, dose and route of administration as recommended by the manufacture.

    Sodium Chloride Injection, USP, 0.9% is also indicated for use in flushing intravenous catheters. Prior to and after administration of the medication, the intravenous catheter should be flushed in its entirety with Sodium Chloride Injection, USP, 0.9%. Use in accord with any warnings or precautions appropriate to the medication being administered. Parental drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

    INSTRUCTIONS FOR USE

    To open ampuls, using gauze, place thumb and forefinger on color line, break at constriction.

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  • HOW SUPPLIED

    5 mL ampuls packaged in box of 25 each (NDC-65282-1505-1)
    10 mL ampuls packaged in box of 25 each (NDC-65282-1510-1)

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  • STORAGE AND HANDLING

    Store at controlled room temperature 15-30 C (59-86 F). Avoid freezing.

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  • SPL UNCLASSIFIED SECTION

    Manufactured for:
    Spectra Medical Devices, Inc. 260-F Fordham Road, Wilmington, MA 01887
    By: KM. Pharm. Co., LTD.
    SM1500 Rev. B 12/00

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  • PRINCIPAL DISPLAY PANEL

    Package Label Display Panel

    Sodium Chloride 10mL

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  • PRINCIPAL DISPLAY PANEL

    Package Label Display Panel

    A3215-18-22

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  • INGREDIENTS AND APPEARANCE
    A3215-18/22 REGIONAL ANESTHESIA 18G HUSTEAD/22G QUINCKE 
    regional anesthesia kit kit
    Product Information
    Product Type MEDICAL DEVICE Item Code (Source) NHRIC:51688-9759
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NHRIC:51688-9759-2 10 in 1 CASE
    1 1 in 1 PACKAGE, COMBINATION
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 1 AMPULE 10 mL
    Part 2 1 AMPULE 5 mL
    Part 3 1 PACKET 22.5 mL
    Part 1 of 3
    SODIUM CHLORIDE 
    sodium chloride solution
    Product Information
    Item Code (Source) NDC:65282-1510
    Route of Administration EPIDURAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 9 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:65282-1510-1 10 mL in 1 AMPULE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 12/01/2000
    Part 2 of 3
    LIDOCAINE HYDROCHLORIDE 
    lidocaine hydrochloride injection, solution
    Product Information
    Item Code (Source) NDC:0409-4713
    Route of Administration SUBCUTANEOUS, INFILTRATION DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 10 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) 7 mg  in 1 mL
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0409-4713-65 5 mL in 1 AMPULE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA080408 03/30/2010
    Part 3 of 3
    APLICARE POVIDONE-IODINE 
    povidone-iodine solution
    Product Information
    Item Code (Source) NDC:52380-0001
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE 10 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    NONOXYNOL-9 (UNII: 48Q180SH9T)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52380-0001-3 22.5 mL in 1 PACKET
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 03/01/1984
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    premarket notification K965017 12/14/2005
    Labeler - Smiths Medical ASD, Inc. (137835299)
    Establishment
    Name Address ID/FEI Business Operations
    Smiths Medical ASD, Inc. 137835299 manufacture
    Establishment
    Name Address ID/FEI Business Operations
    Hospira, Inc. 030606222 manufacture
    Establishment
    Name Address ID/FEI Business Operations
    Hospira, Inc. 093132819 manufacture
    Establishment
    Name Address ID/FEI Business Operations
    Kwang Myung Pharm. Co., Ltd. 631099384 manufacture
    Establishment
    Name Address ID/FEI Business Operations
    Aplicare, Inc. 107255002 manufacture
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