A1542-16 COMBINED SPINAL/EPIDURAL 16G TUOHY/25G WHITACRE - regional anesthesia kit

United States - English - NLM (National Library of Medicine)

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Active ingredient:
LIDOCAINE HYDROCHLORIDE ANHYDROUS (UNII: EC2CNF7XFP) (Lidocaine - UNII:98PI200987)
Available from:
Smiths Medical ASD, Inc.
INN (International Name):
LIDOCAINE HYDROCHLORIDE ANHYDROUS
Composition:
LIDOCAINE HYDROCHLORIDE ANHYDROUS 10 mg in 1 mL
Therapeutic indications:
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. Lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type. INDICATIONS AND USAGE Sodium Chloride Injection is used to flush intravascular catheters or as a sterile, isontonic single dose vehicle, solvent, or diluent for substances to administered intravenously,k 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. MARCAINE Spinal is indicated for the production of subarachnoid bloc
Product summary:
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 HOW SUPPLIED 5 mL ampuls packaged in box of 50 each (NDC-65282-1505-1) 10 mL ampuls packaged in box of 50 each (NDC-65282-1510-1) 30 mL ampuls packaged in box of 30 each (NDC-65282-1530-3) Single-dose ampuls of 2 mL (15 mg bupivacaine hydrochloride with 165 mg dextrose), is supplied as follows: Store at 20 to 25ºC (68 to 77ºF). [See USP Controlled Room Temperature.] MARCAINE Spinal solution may be autoclaved once at 15 pound pressure, 121°C (250°F) for 15 minutes. Do not administer any solution which is discolored or contains particulate matter. Revised: 10/2011
Authorization status:
Premarket Notification
Authorization number:
0409-1761-62, 0409-4713-65, 51688-9778-2, 52380-0001-3, 65282-1510-1

A1542-16 COMBINED SPINAL/EPIDURAL 16G TUOHY/25G WHITACRE - regional

anesthesia kit

Smiths Medical ASD, Inc.

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LIDOCAINE HYDROCHLORIDE (lidocaine hydrochloride anhydrous) injection, solution

AQUEOUS SOLUTIONS FOR INFILTRATION

AND NERVE BLOCK

Ampul

Plastic Multiple-dose Fliptop Vial

Glass Teartop Vial

Rx only

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

mg/mL sodium chloride

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:

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.

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.

INDICATIONS AND 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.

CONTRAINDICATIONS

Lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of

the amide type.

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.

PRECAUTIONSGeneral:

The safety and effectiveness of lidocaine depend on proper dosage, correct technique, adequate

precautions, and readiness for emergencies. Standard textbooks should be consulted for specific

techniques and precautions for various regional anesthetic procedures.

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. Syringe aspirations

should also be performed before and during each supplemental injection when using indwelling catheter

techniques. During the administration of epidural anesthesia, it is recommended that a test dose be

administered initially and that the patient be monitored for central nervous system toxicity and

cardiovascular toxicity, as well as for signs of unintended intrathecal administration before proceeding.

When clinical conditions permit, consideration should be given to employing local anesthetic solutions

that contain epinephrine for the test dose because circulatory changes compatible with epinephrine may

also serve as a warning sign of unintended intravascular injection. An intravascular injection is still

possible even if aspirations for blood are negative. 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 condition. Lidocaine should also be used with caution in patients with severe shock or

heart block. Lumbar and caudal epidural anesthesia should be used with extreme caution in persons with

the following conditions: existing neurological disease, spinal deformities, septicemia and severe

hypertension.

Local anesthetic solutions containing a vasoconstrictor should be used cautiously and in carefully

circumscribed quantities in areas of the body supplied by end arteries or having otherwise

compromised blood supply. Patients with peripheral vascular disease and those with hypertensive

vascular disease may exhibit exaggerated vasoconstrictor response. Ischemic injury or necrosis may

result. Preparations containing a vasoconstrictor should be used with caution in patients during or

following the administration of potent general anesthetic agents, since cardiac arrhythmias may occur

under such conditions.

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 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 greater risk of developing toxic plasma concentrations.

Lidocaine 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 the management of malignant

hyperthermia 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).

Proper tourniquet technique, as described in publications and standard textbooks, is essential in the

performance of intravenous regional anesthesia. Solutions containing epinephrine or other

vasoconstrictors should not be used for this technique.

Lidocaine should be used with caution in persons with known drug sensitivities. Patients allergic to

para-aminobenzoic acid derivatives (procaine, tetracaine, benzocaine, etc.) have not shown cross

sensitivity to lidocaine.

Use in the Head and Neck Area: Small doses of local anesthetics injected into the head and neck area,

including retrobulbar, dental and stellate ganglion blocks, may produce adverse reactions similar to

systemic toxicity seen with unintentional intravascular injections of larger doses. Confusion,

convulsions, respiratory depression and/or respiratory arrest and cardiovascular stimulation or

depression have been reported. These reactions may be due to intra-arterial injections of the local

anesthetic with retrograde flow to the cerebral circulation. Patients receiving these blocks should have

their circulation and respiration monitored and be constantly observed. Resuscitative equipment and

personnel for treating adverse reactions should be immediately available. Dosage recommendations

should not be exceeded. (See DOSAGE AND ADMINISTRATION).

Information for Patients:

When appropriate, patients should be informed in advance that they may experience temporary loss of

sensation and motor activity, usually in the lower half of the body following proper administration of

epidural anesthesia.

Clinically Significant Drug Interactions:

The administration of local anesthetic solutions containing epinephrine or norepinephrine to patients

receiving monoamine oxidase inhibitors or tricyclic antidepressants may produce severe prolonged

hypertension.

Phenothiazines and butyrophenones may reduce or reverse the pressor effect of epinephrine.

Concurrent use of these agents should generally be avoided. In situations when concurrent therapy is

necessary, careful patient monitoring is essential.

Concurrent administration of vasopressor drugs (for the treatment of hypotension related to obstetric

blocks) and ergot-type oxytoxic drugs may cause severe persistent hypertension or cerebrovascular

accidents.

Drug Laboratory Test Interactions:

The intramuscular injection of lidocaine may result in an increase in creatine phosphokinase levels.

Thus, the use of this enzyme determination without isoenzyme separation as a diagnostic test for the

presence of acute myocardial infarction may be compromised by the intramuscular injection of

lidocaine.

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.

Pregnancy:

Teratogenic Effects. Pregnancy Category B. Reproduction 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:

Local anesthetics rapidly cross the placenta and when used for epidural, paracervical, pudendal or

caudal block anesthesia, can cause varying degrees of maternal, fetal and neonatal toxicity (See

CLINICAL PHARMACOLOGY—Pharmacokinetics). The potential for toxicity depends upon the

procedure performed, the type and amount of drug used, and the technique of drug administration.

Adverse reactions in the parturient, fetus and neonate involve alterations of the central nervous system

peripheral vascular tone and cardiac function.

Maternal hypotension has resulted from regional anesthesia. Local anesthetics produce vasodilation by

blocking sympathetic nerves. Elevating the patient’s legs and positioning her on her left side will help

prevent decreases in blood pressure. The fetal heart rate also should be monitored continuously, and

electronic fetal monitoring is highly advisable.

Epidural, spinal, paracervical, or pudendal anesthesia may alter the forces of parturition through

changes in uterine contractility or maternal expulsive efforts. In one study, paracervical block

anesthesia was associated with a decrease in the mean duration of first stage labor and facilitation of

cervical dilation. However, spinal and epidural anesthesia have also been reported to prolong the

second stage of labor by removing the parturient’s reflex urge to bear down or by interfering with

motor function. The use of obstetrical anesthesia may increase the need for forceps assistance.

The use of some local anesthetic drug products during labor and delivery may be followed by

diminished muscle strength and tone for the first day or two of life. The long-term significance of these

observations is unknown. Fetal bradycardia may occur in 20 to 30 percent of patients receiving

paracervical nerve block anesthesia with the amide-type local anesthetics and may be associated with

fetal acidosis. Fetal heart rate should always be monitored during paracervical anesthesia. The

physician should weigh the possible advantages against risks when considering paracervical block in

prematurity, toxemia of pregnancy and fetal distress. Careful adherence to recommended dosage is of

the utmost importance in obstetrical paracervical block. Failure to achieve adequate analgesia with

recommended doses should arouse suspicion of intravascular or fetal intracranial injection. Cases

compatible with unintended fetal intracranial injection of local anesthetic solution have been reported

following intended paracervical or pudendal block or both. Babies so affected present with unexplained

neonatal depression at birth, which correlates with high local anesthetic serum levels, and often

manifest seizures within six hours. Prompt use of supportive measures combined with forced urinary

excretion of the local anesthetic has been used successfully to manage this complication.

Case reports of maternal convulsions and cardiovascular collapse following use of some local

anesthetics for paracervical block in early pregnancy (as anesthesia for elective abortion) suggest that

systemic absorption under these circumstances may be rapid. The recommended maximum dose of each

drug should not be exceeded. Injection should be made slowly and with frequent aspiration. Allow a 5-

minute interval between sides.

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 pediatric patients should be reduced, commensurate with age, body weight and physical

condition. See DOSAGE AND ADMINISTRATION.

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.

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 LD 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.

DOSAGE AND 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

Anes thetic

Procedures in Normal Healthy Adults

Lidocaine Hydrochloride

Injection, USP (without

Epinephrine)

Procedure

Conc. (%)

Vol.

(mL)

Total

Dos e

(mg)

Infiltration

Percutaneous

0.5 or 1.0

1−60

5−300

Intravenous Regional

10−60 50−300

Peripheral Nerve Blocks, e.g.

Brachial

15−20 225−300

Dental

1−5

20−100

Intercostal

Paravertebral

3−5

30−50

Pudendal (each side)

Paracervical

Obstetrical Analgesia

(each side)

Sympathetic Nerve Blocks, e.g.

Cervical (stellate ganglion)

Lumbar

5−10

50−100

Central Neural Blocks

Epidural*

Thoracic

20−30 200−300

Lumbar

Analgesia

25−30 250−300

Anesthesia

15−20 225−300

10−15 200−300

Caudal

Obstetrical Analgesia

20−30 200−300

Surgical Anesthesia

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.

HOW SUPPLIED

Lidocaine Hydrochloride Injection, USP is supplied as follows:

NDC

Container

Concentration

Size

Total (mg)

Single-dos e:

0409-4278-01 Glass Teartop Vial

0.5% (5 mg/mL)

50 mL

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

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

0409-4713-32 Glass Ampul

1% (10 mg/mL)

2 mL

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

0409-4270-01 Sterile Glass Teartop Vial 1% (10 mg/mL)

30 mL

0409-4776-01 Glass Ampul

1.5% (15 mg/mL)20 mL

0409-4056-01 Sterile Glass Ampul

1.5% (15 mg/mL)20 mL

0409-4282-01 Glass Ampul

2% (20 mg/mL)

2 mL

0409-4282-02 Glass Ampul

2% (20 mg/mL)

10 mL

Multiple-dos e:

0409-4275-01 Plastic Fliptop Vial

0.5% (5 mg/mL)

50 mL

0409-4276-01 Plastic Fliptop Vial

1% (10 mg/mL)

20 mL

0409-4276-02 Plastic Fliptop Vial

1% (10 mg/mL)

50 mL

0409-4277-01 Plastic Fliptop Vial

2% (20 mg/mL)

20 mL

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

Lidocaine Pack Label

3/4 Fluid Ounce Povidone Iodine

Povidone-iodine 10%

Antiseptic

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

Stop use and ask a doctor if

redness, irritation, swelling or pain persists or increases

infection occurs

Avoid pooling beneath patient

Keep out of reach of children. In case of accidental ingestion, seek professional assistance or

consult a poison control center immediately.

Spectra Medical Devices, Inc.

SODIUM CHLORIDE

INJECTION, USP, 0.9%

DESCRIPTION

Sodium Chloride Injection, USP is a sterile, nonpyrogenic, isotonic solution of sodium chloride 0.9%

(9mg/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.

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 (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.

INDICATIONS AND USAGE

Sodium Chloride Injection is used to flush intravascular catheters or as a sterile, isontonic single dose

vehicle, solvent, or diluent for substances to administered intravenously,k 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.

WARNING

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 coricos-teroids,

corticotrophin 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.

PRECAUTIONS

GENERAL

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.

PREGNANCY

CATEGORY C-Animal reproduction studies have not been conducted with Sodium Chloride Injection.

It is also not known whether Sodium Chloride Injection can cause fetal harm when administered to a

pregnant woman or can effect reproduction capacity. Sodium Chloride Injection should be given to a

pregnant woman only if clearly needed.

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 extravasations.

If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate

countermeasures and if possible, retrieve and save the remainder of unused vehicle for examination.

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.

DOSAGE AND 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 as recommended by the manufacture. Parental drug

products should be inspected visually for particulate matter and discoloration prior to

administration, whenever solution and container permit.

HOW SUPPLIED

5 mL ampuls packaged in box of 50 each (NDC-65282-1505-1)

10 mL ampuls packaged in box of 50 each (NDC-65282-1510-1)

30 mL ampuls packaged in box of 30 each (NDC-65282-1530-3)

STORAGE

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

Manufactured for:

Spectra Medical Devices, Inc. 260-F Fordham Road, Wilmington, MA 01887

By: KM. Pharm Co., LTD.

MARCAINE SPINAL (bupivacaine hydrochloride) injection, solution

bupivacaine hydrochloride in dextrose injection, USP

STERILE HYPERBARIC SOLUTION

FOR SPINAL ANESTHESIA

Rx only

DESCRIPTION

Bupivacaine hydrochloride is 2-Piperidinecarboxamide, 1-butyl-N-(2,6-dimethylphenyl)-,

monohydrochloride, monohydrate, a white crystalline powder that is freely soluble in 95 percent

ethanol, soluble in water, and slightly soluble in chloroform or acetone. It has the following structural

formula:

Dextrose is D-glucopyranose monohydrate and has the following structural formula:

MARCAINE

Spinal is available in sterile hyperbaric solution for subarachnoid injection (spinal

block).

Bupivacaine hydrochloride is related chemically and pharmacologically to the aminoacyl local

anesthetics. It is a homologue of mepivacaine and is chemically related to lidocaine. All three of these

anesthetics contain an amide linkage between the aromatic nucleus and the amino or piperidine group.

They differ in this respect from the procaine-type local anesthetics, which have an ester linkage.

Each mL of MARCAINE Spinal contains 7.5 mg bupivacaine hydrochloride (anhydrous) and 82.5 mg

dextrose (anhydrous). The pH of this solution is adjusted to between 4.0 and 6.5 with sodium hydroxide

or hydrochloric acid.

The specific gravity of MARCAINE Spinal is between 1.030 and 1.035 at 25°C and 1.03 at 37°C.

MARCAINE Spinal does not contain any preservatives.

CLINICAL PHARMACOLOGY

Local anesthetics block the generation and the conduction of nerve impulses, presumably by increasing

the threshold for electrical excitation in the nerve, by slowing the propagation of the nerve impulse, and

by reducing the rate of rise of the action potential. In general, the progression of anesthesia is related to

the diameter, myelination, and conduction velocity of affected nerve fibers. Clinically, the order of loss

of nerve function is as follows: (1) pain, (2) temperature, (3) touch, (4) proprioception, and (5) skeletal

muscle tone.

Systemic absorption of local anesthetics produces effects on the cardiovascular and central nervous

systems (CNS). At blood concentrations achieved with normal therapeutic doses, changes in cardiac

conduction, excitability, refractoriness, contractility, and peripheral vascular resistance are minimal.

However, toxic blood concentrations depress cardiac conduction and excitability, which may lead to

atrioventricular block, ventricular arrhythmias, and cardiac arrest, sometimes resulting in fatalities. In

addition, myocardial contractility is depressed and peripheral vasodilation occurs, leading to decreased

cardiac output and arterial blood pressure. Recent clinical reports and animal research suggest that

these cardiovascular changes are more likely to occur after unintended direct intravascular injection of

bupivacaine. Therefore, when epidural anesthesia with bupivacaine is considered, incremental dosing is

necessary.

Following systemic absorption, local anesthetics can produce central nervous system stimulation,

depression, or both. Apparent central stimulation is manifested as restlessness, tremors and shivering,

progressing to convulsions, followed by depression and coma progressing ultimately to respiratory

arrest. However, the local anesthetics have a primary depressant effect on the medulla and on higher

centers. The depressed stage may occur without a prior excited stage.

Pharmacokinetics: The rate of systemic absorption of local anesthetics is dependent upon the total

dose and concentration of drug administered, the route of administration, the vascularity of the

administration site, and the presence or absence of epinephrine in the anesthetic solution. A dilute

concentration of epinephrine (1:200,000 or 5 mcg/mL) usually reduces the rate of absorption and peak

plasma concentration of MARCAINE, permitting the use of moderately larger total doses and

sometimes prolonging the duration of action.

The onset of action with MARCAINE is rapid and anesthesia is long lasting. The duration of anesthesia

is significantly longer with MARCAINE than with any other commonly used local anesthetic. It has also

been noted that there is a period of analgesia that persists after the return of sensation, during which

time the need for strong analgesics is reduced.

The onset of sensory blockade following spinal block with MARCAINE Spinal is very rapid (within

one minute); maximum motor blockade and maximum dermatome level are achieved within 15 minutes in

most cases. Duration of sensory blockade (time to return of complete sensation in the operative site or

regression of two dermatomes) following a 12 mg dose averages 2 hours with or without 0.2 mg

epinephrine. The time to return of complete motor ability with 12 mg MARCAINE Spinal averages 3 1/2

hours without the addition of epinephrine and 4 1/2 hours if 0.2 mg epinephrine is added. When

compared to equal milligram doses of hyperbaric tetracaine, the duration of sensory blockade was the

same but the time to complete motor recovery was significantly longer for tetracaine. Addition of 0.2

mg epinephrine significantly prolongs the motor blockade and time to first postoperative narcotic with

MARCAINE Spinal.

Local anesthetics appear to cross the placenta by passive diffusion. The rate and degree of diffusion is

governed by (1) the degree of plasma protein binding, (2) the degree of ionization, and (3) the degree of

lipid solubility. Fetal/maternal ratios of local anesthetics appear to be inversely related to the degree of

plasma protein binding, because only the free, unbound drug is available for placental transfer.

MARCAINE with a high protein binding capacity (95%) has a low fetal/maternal ratio (0.2 to 0.4). The

extent of placental transfer is also determined by the degree of ionization and lipid solubility of the

drug. Lipid soluble, nonionized drugs readily enter the fetal blood from the maternal circulation.

Depending upon the route of administration, local anesthetics are distributed to some extent to all body

tissues, with high concentrations found in highly perfused organs such as the liver, lungs, heart, and

brain.

Pharmacokinetic studies on the plasma profiles of MARCAINE after direct intravenous injection

suggest a three-compartment open model. The first compartment is represented by the rapid

intravascular distribution of the drug. The second compartment represents the equilibration of the drug

throughout the highly perfused organs such as the brain, myocardium, lungs, kidneys, and liver. The

third compartment represents an equilibration of the drug with poorly perfused tissues, such as muscle

and fat. The elimination of drug from tissue distribution depends largely upon the ability of binding sites

in the circulation to carry it to the liver where it is metabolized.

Various pharmacokinetic parameters of the local anesthetics can be significantly altered by the presence

of hepatic or renal disease, addition of epinephrine, factors affecting urinary pH, renal blood flow, the

route of drug administration, and the age of the patient. The half-life of MARCAINE in adults is 2.7

hours and in neonates 8.1 hours. In clinical studies, elderly patients exhibited a greater spread and

higher maximal level of analgesia than younger patients. Elderly patients also reached the maximal level

of analgesia more rapidly than younger patients, and exhibited a faster onset of motor blockade. The

total plasma clearance was decreased and the terminal half-life was lengthened in these patients.

Amide-type local anesthetics such as MARCAINE are metabolized primarily in the liver via

conjugation with glucuronic acid. Patients with hepatic disease, especially those with severe hepatic

disease, may be more susceptible to the potential toxicities of the amide-type local anesthetics.

Pipecolylxylidine is the major metabolite of MARCAINE.

The kidney is the main excretory organ for most local anesthetics and their metabolites. Urinary

excretion is affected by urinary perfusion and factors affecting urinary pH. Only 6% of bupivacaine is

excreted unchanged in the urine.

When administered in recommended doses and concentrations, MARCAINE does not ordinarily produce

irritation or tissue damage and does not cause methemoglobinemia.

INDICATIONS AND USAGE

MARCAINE Spinal is indicated for the production of subarachnoid block (spinal anesthesia).

Standard textbooks should be consulted to determine the accepted procedures and techniques for the

administration of spinal anesthesia.

CONTRAINDICATIONS

MARCAINE Spinal is contraindicated in patients with a known hypersensitivity to it or to any local

anesthetic agent of the amide-type.

The following conditions preclude the use of spinal anesthesia:

1. Severe hemorrhage, severe hypotension or shock and arrhythmias, such as complete heart block,

which severely restrict cardiac output.

2. Local infection at the site of proposed lumbar puncture.

3. Septicemia.

WARNINGS

LOCAL ANESTHETICS SHOULD ONLY BE EMPLOYED BY CLINICIANS WHO ARE WELL

VERSED IN DIAGNOSIS AND MANAGEMENT OF DOSE-RELATED TOXICITY AND OTHER

ACUTE EMERGENCIES WHICH MIGHT ARISE FROM THE BLOCK TO BE EMPLOYED, AND

THEN ONLY AFTER INSURING THE IMMEDIATE AVAILABILITY OF OXYGEN, OTHER

RESUSCITATIVE DRUGS, CARDIOPULMONARY RESUSCITATIVE EQUIPMENT, AND THE

PERSONNEL RESOURCES 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

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.

Spinal anesthetics should not be injected during uterine contractions, because spinal fluid current may

carry the drug further cephalad than desired.

A free flow of cerebrospinal fluid during the performance of spinal anesthesia is indicative of entry

into the subarachnoid space. However, aspiration should be performed before the anesthetic solution is

injected to confirm entry into the subarachnoid space and to avoid intravascular injection.

MARCAINE solutions containing epinephrine or other vasopressors should not be used concomitantly

with ergot-type oxytocic drugs, because a severe persistent hypertension may occur. Likewise,

solutions of MARCAINE containing a vasoconstrictor, such as epinephrine, should be used with

extreme caution in patients receiving monoamine oxidase inhibitors (MAOI) or antidepressants of the

triptyline or imipramine types, because severe prolonged hypertension may result.

Until further experience is gained in patients younger than 18 years, administration of MARCAINE in

this age group is not recommended.

Mixing or the prior or intercurrent use of any other local anesthetic with MARCAINE cannot be

recommended because of insufficient data on the clinical use of such mixtures.

RECAUTIONS

General: The safety and effectiveness of spinal anesthetics 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 patient should have IV fluids running via an indwelling catheter to assure a

functioning intravenous pathway. The lowest dosage of local anesthetic that results in effective

anesthesia should be used. Aspiration for blood should be performed before injection and injection

should be made slowly. Tolerance varies with the status of the patient. Elderly patients and acutely ill

patients may require reduced doses. Reduced doses may also be indicated in patients with increased

intra-abdominal pressure (including obstetrical patients), if otherwise suitable for spinal anesthesia.

There should be careful and constant monitoring of cardiovascular and respiratory (adequacy of

ventilation) vital signs and the patient’s state of consciousness after local anesthetic injection.

Restlessness, anxiety, incoherent speech, lightheadedness, numbness and tingling of the mouth and lips,

metallic taste, tinnitus, dizziness, blurred vision, tremors, depression, or drowsiness may be early

warning signs of central nervous system toxicity.

Spinal anesthetics should be used with caution in patients with severe disturbances of cardiac rhythm,

shock, or heart block.

Sympathetic blockade occurring during spinal anesthesia may result in peripheral vasodilation and

hypotension, the extent depending on the number of dermatomes blocked. Patients over 65 years,

particularly those with hypertension, may be at increased risk for experiencing the hypotensive effects

of MARCAINE Spinal. Blood pressure should, therefore, be carefully monitored especially in the

early phases of anesthesia. Hypotension may be controlled by vasoconstrictors in dosages depending on

the severity of hypotension and response of treatment. The level of anesthesia should be carefully

monitored because it is not always controllable in spinal techniques.

Because amide-type local anesthetics such as MARCAINE are metabolized by the liver, these drugs,

especially repeat doses, should be used cautiously 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. Local anesthetics should also be used with caution in

patients with impaired cardiovascular function because they may be less able to compensate for

functional changes associated with the prolongation of AV conduction produced by these drugs.

However, dosage recommendations for spinal anesthesia are much lower than dosage recommendations

for other major blocks and most experience regarding hepatic and cardiovascular disease dose-related

toxicity is derived from these other major blocks.

Serious dose-related cardiac arrhythmias may occur if preparations containing a vasoconstrictor such

as epinephrine are employed in patients during or following the administration of potent inhalation

agents. In deciding whether to use these products concurrently in the same patient, the combined action

of both agents upon the myocardium, the concentration and volume of vasoconstrictor used, and the time

since injection, when applicable, should be taken into account.

Many drugs used during the conduct of anesthesia are considered potential triggering agents for

familial malignant hyperthermia. Because it is not known whether amide-type local anesthetics may

trigger this reaction and because 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.)

The following conditions may preclude the use of spinal anesthesia, depending upon the physician’s

evaluation of the situation and ability to deal with the complications or complaints which may occur:

Pre-existing diseases of the central nervous system, such as those attributable to pernicious anemia,

poliomyelitis, syphilis, or tumor.

Hematological disorders predisposing to coagulopathies or patients on anticoagulant therapy.

Trauma to a blood vessel during the conduct of spinal anesthesia may, in some instances, result in

uncontrollable central nervous system hemorrhage or soft tissue hemorrhage.

Chronic backache and preoperative headache.

Hypotension and hypertension.

Technical problems (persistent paresthesias, persistent bloody tap).

Arthritis or spinal deformity.

Extremes of age.

Psychosis or other causes of poor cooperation by the patient.

Information for Patients: When appropriate, patients should be informed in advance that they may

experience temporary loss of sensation and motor activity, usually in the lower half of the body,

following proper administration of spinal anesthesia. Also, when appropriate, the physician should

discuss other information including adverse reactions in the MARCAINE Spinal package insert.

Clinically Significant Drug Interactions: The administration of local anesthetic solutions containing

epinephrine or norepinephrine to patients receiving monoamine oxidase inhibitors or tricyclic

antidepressants may produce severe, prolonged hypertension. Concurrent use of these agents should

generally be avoided. In situations when concurrent therapy is necessary, careful patient monitoring is

essential.

Concurrent administration of vasopressor drugs and of ergot-type oxytocic drugs may cause severe

persistent hypertension or cerebrovascular accidents.

Phenothiazines and butyrophenones may reduce or reverse the pressor effect of epinephrine.

Carcinogenesis, Mutagenesis, and Impairment of Fertility: Long-term studies in animals to evaluate

the carcinogenic potential of bupivacaine hydrochloride have not been conducted. The mutagenic

potential and the effect on fertility of bupivacaine hydrochloride have not been determined.

Pregnancy Category C: There are no adequate and well-controlled studies in pregnant

women. MARCAINE Spinal should be used during pregnancy only if the potential benefit justifies the

potential risk to the fetus. Bupivacaine hydrochloride produced developmental toxicity when

administered subcutaneously to pregnant rats and rabbits at clinically relevant doses. This does not

exclude the use of MARCAINE Spinal at term for obstetrical anesthesia or analgesia. (See Labor and

Delivery.)

Bupivacaine hydrochloride was administered subcutaneously to rats at doses of 4.4, 13.3, and 40 mg/kg

and to rabbits at doses of 1.3, 5.8, and 22.2 mg/kg during the period of organogenesis (implantation to

closure of the hard palate). The high doses are approximately 30-times the daily maximum

recommended human dose (MRHD) of 12 mg/day on a mg dose/m body surface area (BSA) basis. No

embryo-fetal effects were observed in rats at the high dose which caused increased maternal lethality.

An increase in embryo-fetal deaths was observed in rabbits at the high dose in the absence of maternal

toxicity with the fetal No Observed Adverse Effect Level being approximately 8-times the MRHD on a

BSA basis.

In a rat pre- and post-natal development study (dosing from implantation through weaning) conducted at

subcutaneous doses of 4.4, 13.3, and 40 mg/kg mg/kg/day, decreased pup survival was observed at the

high dose. The high dose is approximately 30-times the daily MRHD of 12 mg/day on a BSA basis.

Labor and Delivery: Spinal anesthesia has a recognized use during labor and delivery. Bupivacaine

hydrochloride, when administered properly, via the epidural route in doses 10 to 12 times the amount

used in spinal anesthesia has been used for obstetrical analgesia and anesthesia without evidence of

adverse effects on the fetus.

Maternal hypotension has resulted from regional anesthesia. Local anesthetics produce vasodilation by

blocking sympathetic nerves. Elevating the patient’s legs and positioning her on her left side will help

prevent decreases in blood pressure. The fetal heart rate also should be monitored continuously and

electronic fetal monitoring is highly advisable.

It is extremely important to avoid aortocaval compression by the gravid uterus during administrations of

regional block to parturients. To do this, the patient must be maintained in the left lateral decubitus

position or a blanket roll or sandbag may be placed beneath the right hip and the gravid uterus displaced

to the left.

Spinal anesthesia may alter the forces of parturition through changes in uterine contractility or maternal

expulsive efforts. Spinal anesthesia has also been reported to prolong the second stage of labor by

removing the parturient’s reflex urge to bear down or by interfering with motor function. The use of

obstetrical anesthesia may increase the need for forceps assistance.

The use of some local anesthetic drug products during labor and delivery may be followed by

diminished muscle strength and tone for the first day or two of life. This has not been reported with

bupivacaine.

There have been reports of cardiac arrest during use of MARCAINE 0.75% solution for epidural

anesthesia in obstetrical patients. The package insert for MARCAINE hydrochloride for epidural,

nerve block, etc., has a more complete discussion of preparation for, and management of, this problem.

These cases are compatible with systemic toxicity following unintended intravascular injection of the

much larger doses recommended for epidural anesthesia and have not occurred within the dose range of

bupivacaine hydrochloride 0.75% recommended for spinal anesthesia in obstetrics. The 0.75%

concentration of MARCAINE is therefore not recommended for obstetrical epidural anesthesia.

MARCAINE Spinal (bupivacaine hydrochloride in dextrose injection) is recommended for spinal

anesthesia in obstetrics.

Nursing Mothers: Bupivacaine has been reported to be excreted in human milk suggesting that the

nursing infant could be theoretically exposed to a dose of the drug. Because of the potential for serious

adverse reactions in nursing infants from bupivacaine, a decision should be made whether to discontinue

nursing or not administer bupivacaine, taking into account the importance of the drug to the mother.

Pediatric Use: Until further experience is gained in patients younger than 18 years, administration of

MARCAINE Spinal in this age group is not recommended.

Geriatric Use: Patients over 65 years, particularly those with hypertension, may be at increased risk for

developing hypotension while undergoing spinal anesthesia with MARCAINE Spinal. (See

PRECAUTIONS, General and ADVERSE REACTIONS, Cardiovascular System.)

Elderly patients may require lower doses of MARCAINE Spinal. (See PRECAUTIONS, General and

DOSAGE AND ADMINISTRATION.)

In clinical studies, differences in various pharmacokinetic parameters have been observed between

elderly and younger patients. (See CLINICAL PHARMACOLOGY, Pharmacokinetics.)

This product is known to be substantially excreted by the kidney, and the risk of toxic reactions to this

drug may be greater in patients with impaired renal function. Because elderly patients are more likely to

have decreased renal function, care should be taken in dose selection, and it may be useful to monitor

renal function. (See CLINICAL PHARMACOLOGY, Pharmacokinetics.)

ADVERSE REACTIONS

Reactions to bupivacaine are characteristic of those associated with other amide-type local anesthetics.

The most commonly encountered acute adverse experiences which demand immediate countermeasures

following the administration of spinal anesthesia are hypotension due to loss of sympathetic tone and

respiratory paralysis or underventilation due to cephalad extension of the motor level of anesthesia.

These may lead to cardiac arrest if untreated. In addition, dose-related convulsions and cardiovascular

collapse may result from diminished tolerance, rapid absorption from the injection site, or from

unintentional intravascular injection of a local anesthetic solution. Factors influencing plasma protein

binding, such as acidosis, systemic diseases which alter protein production, or competition of other

drugs for protein binding sites, may diminish individual tolerance.

Respiratory System: Respiratory paralysis or underventilation may be noted as a result of upward

extension of the level of spinal anesthesia and may lead to secondary hypoxic cardiac arrest if untreated.

Preanesthetic medication, intraoperative analgesics and sedatives, as well as surgical manipulation, may

contribute to underventilation. This will usually be noted within minutes of the injection of spinal

anesthetic solution, but because of differing maximal onset times, differing intercurrent drug usage and

differing surgical manipulation, it may occur at any time during surgery or the immediate recovery

period.

Cardiovascular System: Hypotension due to loss of sympathetic tone is a commonly encountered

extension of the clinical pharmacology of spinal anesthesia. This is more commonly observed in

elderly patients, particularly those with hypertension, and patients with shrunken blood volume, shrunken

interstitial fluid volume, cephalad spread of the local anesthetic, and/or mechanical obstruction of

venous return. Nausea and vomiting are frequently associated with hypotensive episodes following the

administration of spinal anesthesia. High doses, or inadvertent intravascular injection, may lead to high

plasma levels and related depression of the myocardium, decreased cardiac output, bradycardia, heart

block, ventricular arrhythmias, and, possibly, cardiac arrest. (See WARNINGS, PRECAUTIONS, and

OVERDOSAGE sections.)

Central Nervous System: Respiratory paralysis or underventilation secondary to cephalad spread of the

level of spinal anesthesia (see Respiratory System) and hypotension for the same reason (see

Cardiovascular System) are the two most commonly encountered central nervous system-related adverse

observations which demand immediate countermeasures.

High doses or inadvertent intravascular injection may lead to high plasma levels and related central

nervous system toxicity characterized by excitement and/or depression. Restlessness, anxiety, dizziness,

tinnitus, blurred vision, or tremors may occur, possibly proceeding to convulsions. However,

excitement may be transient or absent, with depression being the first manifestation of an adverse

reaction. This may quickly be followed by drowsiness merging into unconsciousness and respiratory

arrest.

Neurologic: The incidences of adverse neurologic reactions associated with the use of local

anesthetics may be related to the total dose of local anesthetic administered and are also dependent upon

the particular drug used, the route of administration, and the physical status of the patient. Many of these

effects may be related to local anesthetic techniques, with or without a contribution from the drug.

Neurologic effects following spinal anesthesia may include loss of perineal sensation and sexual

function; persistent anesthesia, paresthesia, weakness and paralysis of the lower extremities, and loss of

sphincter control all of which may have slow, incomplete, or no recovery; hypotension, high or total

spinal block; urinary retention; headache; backache; septic meningitis, meningismus; arachnoiditis;

slowing of labor; increased incidence of forceps delivery; shivering; cranial nerve palsies due to

traction on nerves from loss of cerebrospinal fluid; and fecal and urinary incontinence.

Allergic: Allergic-type reactions are rare and may occur as a result of sensitivity to the local anesthetic.

These reactions are characterized by signs such as urticaria, pruritus, erythema, angioneurotic edema

(including laryngeal edema), tachycardia, sneezing, nausea, vomiting, dizziness, syncope, excessive

sweating, elevated temperature, and, possibly, anaphylactoid-like symptomatology (including severe

hypotension). Cross sensitivity among members of the amide-type local anesthetic group has been

reported. The usefulness of screening for sensitivity has not been definitely established.

Other: Nausea and vomiting may occur during spinal anesthesia.

OVERDOSAGE

Acute emergencies from local anesthetics are generally related to high plasma levels encountered

during therapeutic use or to underventilation (and perhaps apnea) secondary to upward extension of

spinal anesthesia. Hypotension is commonly encountered during the conduct of spinal anesthesia due to

relaxation of sympathetic tone, and sometimes, contributory mechanical obstruction of venous return.

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 injection. At the first sign of change, oxygen

should be administered.

The first step in the management of systemic toxic reactions, as well as underventilation or apnea due to a

high or total spinal, consists of immediate attention to the establishment and maintenance of a patent airway

and effective assisted or controlled ventilation with 100% oxygen with a delivery system capable of permitting

immediate positive airway pressure by mask. This may prevent convulsions if they have not already

occurred.

If necessary, use drugs to control the convulsions. A 50 mg to 100 mg bolus IV injection of

succinylcholine will paralyze the patient without depressing the central nervous or cardiovascular

systems and facilitate ventilation. A bolus IV dose of 5 mg to 10 mg of diazepam or 50 mg to 100 mg of

thiopental will permit ventilation and counteract central nervous system stimulation, but these drugs also

depress central nervous system, respiratory and cardiac function, add to postictal depression and may

result in apnea. Intravenous barbiturates, anticonvulsant agents, or muscle relaxants should only be

administered by those familiar with their use. Immediately after the institution of these ventilatory

measures, the adequacy of the circulation should be evaluated. Supportive treatment of circulatory

depression may require administration of intravenous fluids, and, when appropriate, a vasopressor

dictated by the clinical situation (such as ephedrine or epinephrine to enhance myocardial contractile

force).

Hypotension due to sympathetic relaxation may be managed by giving intravenous fluids (such as

isotonic saline or lactated Ringer’s solution), in an attempt to relieve mechanical obstruction of venous

return, or by using vasopressors (such as ephedrine which increases the force of myocardial

contractions) and, if indicated, by giving plasma expanders or whole blood.

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.

Recent clinical data from patients experiencing local anesthetic-induced convulsions demonstrated rapid

development of hypoxia, hypercarbia, and acidosis with bupivacaine within a minute of the onset of

convulsions. These observations suggest that oxygen consumption and carbon dioxide production are

greatly increased during local anesthetic convulsions and emphasize the importance of immediate and

effective ventilation with oxygen which may avoid cardiac arrest.

If not treated immediately, convulsions with simultaneous hypoxia, hypercarbia, and acidosis plus

myocardial depression from the direct effects of the local anesthetic may result in cardiac arrhythmias,

bradycardia, asystole, ventricular fibrillation, or cardiac arrest. Respiratory abnormalities, including

apnea, may occur. Underventilation or apnea due to a high or total spinal 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 and maintained for a prolonged

period if necessary. Recovery has been reported after prolonged resuscitative efforts.

The supine position is dangerous in pregnant women at term because of aortocaval compression by the

gravid uterus. Therefore during treatment of systemic toxicity, maternal hypotension, or fetal

bradycardia following regional block, the parturient should be maintained in the left lateral decubitus

position if possible, or manual displacement of the uterus off the great vessels be accomplished.

The mean seizure dosage of bupivacaine in rhesus monkeys was found to be 4.4 mg/kg with mean

arterial plasma concentration of 4.5 mcg/mL. The intravenous and subcutaneous LD in mice is 6 mg/kg

to 8 mg/kg and 38 mg/kg to 54 mg/kg respectively.

DOSAGE AND ADMINISTRATION

The dose of any local anesthetic administered varies with the anesthetic procedure, the area to be

anesthetized, the vascularity of the tissues, the number of neuronal segments to be blocked, the depth of

anesthesia and degree of muscle relaxation required, the duration of anesthesia desired, individual

tolerance, and the physical condition of the patient. The smallest dose and concentration required to

produce the desired result should be administered. Dosages of MARCAINE Spinal should be reduced

for elderly and debilitated patients and patients with cardiac and/or liver disease.

For specific techniques and procedures, refer to standard textbooks.

There have been adverse event reports of chondrolysis in patients receiving intra-articular infusions of

local anesthetics following arthroscopic and other surgical procedures. MARCAINE Spinal is not

approved for this use (see WARNINGS and DOSAGE AND ADMINISTRATION).

The extent and degree of spinal anesthesia depend upon several factors including dosage, specific

gravity of the anesthetic solution, volume of solution used, force of injection, level of puncture, and

position of the patient during and immediately after injection.

Seven and one-half mg (7.5 mg or 1 mL) MARCAINE Spinal has generally proven satisfactory for

spinal anesthesia for lower extremity and perineal procedures including TURP and vaginal

hysterectomy. Twelve mg (12 mg or 1.6 mL) has been used for lower abdominal procedures such as

abdominal hysterectomy, tubal ligation, and appendectomy. These doses are recommended as a guide

for use in the average adult and may be reduced for the elderly or debilitated patients. Because

experience with MARCAINE Spinal is limited in patients below the age of 18 years, dosage

recommendations in this age group cannot be made.

Obstetrical Use: Doses as low as 6 mg bupivacaine hydrochloride have been used for vaginal delivery

under spinal anesthesia. The dose range of 7.5 mg to 10.5 mg (1 mL to 1.4 mL) bupivacaine

hydrochloride has been used for Cesarean section under spinal anesthesia.

In recommended doses, MARCAINE Spinal produces complete motor and sensory block.

Unused portions of solutions should be discarded following initial use.

MARCAINE Spinal should be inspected visually for discoloration and particulate matter prior to

administration; solutions which are discolored or which contain particulate matter should not be

administered.

HOW SUPPLIED

Single-dose ampuls of 2 mL (15 mg bupivacaine hydrochloride with 165 mg dextrose), is supplied as

follows:

NDC No.

Container

Fill

Quantity

0409-1761-02 Uni-Amp

2 mL package of 10

0409-1761-62 Uni-Amp

2 mL bulk package of 800

Store at 20 to 25ºC (68 to 77ºF). [See USP Controlled Room Temperature.]

MARCAINE Spinal solution may be autoclaved once at 15 pound pressure, 121°C (250°F) for

15 minutes. Do not administer any solution which is discolored or contains particulate matter.

Revised: 10/2011

Package Label Display Panel

Package Label Display Panel

A1542-16 COMBINED SPINAL/EPIDURAL 16G TUOHY/25G WHITACRE

regional anesthesia kit kit

Product Information

Product T ype

MEDICAL DEVICE

Ite m Code (Source )

NHRIC:516 8 8 -9 778

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NHRIC:516 8 8 -9 778 -2

10 in 1 CASE

1

1 in 1 PACKAGE, COMBINATION

Quantity of Parts

Part #

Package Quantity

Total Product Quantity

Pa rt 1

1 AMPULE

5 mL

Pa rt 2

1 PACKET

22.5 mL

Pa rt 3

1 AMPULE

10 mL

Pa rt 4

1 AMPULE

2 mL

Part 1 of 4

LIDOCAINE HYDROCHLORIDE

lidocaine hydrochloride anhydrous injection, solution

Product Information

Ite m Code (Source )

NDC:0 40 9 -4713

Route of Administration

INFILTRATION

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

LIDO CAINE HYDRO CHLO RIDE ANHYDRO US (UNII: EC2CNF7XFP) (Lido caine

- UNII:9 8 PI20 0 9 8 7)

LIDOCAINE HYDROCHLORIDE

ANHYDROUS

10 mg

in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

So dium Chlo ride (UNII: 451W47IQ8 X)

7 mg in 1 mL

Wa ter (UNII: 0 59 QF0 KO0 R)

So dium Hydro xide (UNII: 55X0 4QC32I)

Hydro chlo ric Acid (UNII: QTT1758 2CB)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 40 9 -4713-6 5

5 mL in 1 AMPULE

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 8 0 40 8

0 3/30 /20 10

Part 2 of 4

APLICARE POVIDONE-IODINE

povidone-iodine solution

Product Information

Ite m Code (Source )

NDC:5238 0 -0 0 0 1

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

PO VIDO NE-IO DINE (UNII: 8 5H0 HZU9 9 M) (IODINE - UNII:9 6 79 TC0 7X4)

POVIDONE-IODINE

0 .10 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP)

SO DIUM PHO SPHATE, DIBASIC (UNII: GR6 8 6 LBA74)

SO DIUM HYDRO XIDE (UNII: 55X0 4QC32I)

NO NO XYNO L-9 (UNII: 48 Q18 0 SH9 T)

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:5238 0 -0 0 0 1-3

22.5 mL in 1 PACKET

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt333A

0 3/0 1/19 8 4

Part 3 of 4

SODIUM CHLORIDE

sodium chloride solution

Product Information

Ite m Code (Source )

NDC:6 528 2-1510

Route of Administration

EPIDURAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X) (CHLORIDE ION - UNII:Q32ZN48 6 9 8 )

SODIUM CHLORIDE

9 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 528 2-1510 -1

10 mL in 1 AMPULE

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

unappro ved drug o ther

12/0 1/20 0 0

Part 4 of 4

MARCAINE SPINAL

bupivacaine hydrochloride injection, solution

Product Information

Ite m Code (Source )

NDC:0 40 9 -176 1

Route of Administration

INTRATHECAL, INTRASPINAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

BUPIVACAINE HYDRO CHLO RIDE (UNII: 7TQO7W3VT8 ) (BUPIVACAINE -

UNII:Y8 33539 4RO)

BUPIVACAINE HYDROCHLORIDE

ANHYDROUS

7.5 mg

in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

ANHYDRO US DEXTRO SE (UNII: 5SL0 G7R0 OK)

8 2.5 mg in 1 mL

SO DIUM HYDRO XIDE (UNII: 55X0 4QC32I)

HYDRO CHLO RIC ACID (UNII: QTT1758 2CB)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 40 9 -176 1-6 2

2 mL in 1 AMPULE

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

NDA0 18 6 9 2

0 3/12/20 10

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

premarket no tificatio n

K9 6 50 17

12/14/20 0 5

Labeler -

Smiths Medical ASD, Inc. (137835299)

Smiths Medical ASD, Inc.

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Smiths Medical ASD, Inc.

1378 3529 9

relabel, manufacture

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Ho spira, Inc.

0 30 6 0 6 222

ma nufa c ture

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Aplicare, Inc.

10 72550 0 2

ma nufa c ture

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Kwang Myung Pharm. Co ., Ltd.

6 310 9 9 38 4

ma nufa c ture

Revised: 11/2012

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