(lidocaine HCl Injection, USP)

Xylocaine®
(lidocaine HCl and epinephrine Injection, USP)

 For Infiltration and Nerve Block                                  Rx Only         

Xylocaine (lidocaine HCl) Injections are sterile, nonpyrogenic, aqueous solutions that contain a local anesthetic agent with or without epinephrine and are administered parenterally by injection. See INDICATIONS for specific uses.

Xylocaine solutions contain lidocaine HCl, which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride and has the molecular wt. 270.8.  Lidocaine HCl (C14H22N2O • HCl) has the following structural formula:

Xylocaine Structure

Epinephrine is (-) -3, 4-Dihydroxy-α-[(methylamino) methyl] benzyl alcohol and has the molecular wt. 183.21.  Epinephrine (C9H13NO3) has the following structural formula:

Epinephrine Structure

Dosage forms listed as Xylocaine-MPF indicate single dose solutions that are Methyl Paraben Free (MPF).

Xylocaine MPF is a sterile, nonpyrogenic, isotonic solution containing sodium chloride. Xylocaine in multiple dose vials: Each mL also contains 1 mg methyl­paraben as antiseptic preservative. The pH of these solutions is adjusted to approximately 6.5 (5.0 to 7.0) with sodium hydroxide and/or hydrochloric acid.

Xylocaine MPF with Epinephrine is a sterile, nonpyrogenic, isotonic solution containing sodium chloride. Each mL contains lidocaine hydrochloride and epinephrine, with 0.5 mg sodium metabisulfite as an antioxidant and 0.2 mg citric acid as a stabilizer.Xylocaine with Epinephrine in multiple dose vials: Each mL also contains 1 mg methylparaben as antiseptic preservative. The pH of these solutions is adjusted to approximately 4.5 (3.3 to 5.5) with sodium hydroxide and/or hydrochloric acid. Filled under nitrogen.

Xylocaine (lidocaine HCl) Injections are 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 HCl is contraindicated in patients with a known history of hyper sensitivity to local anesthetics of the amide type.

XYLOCAINE INJECTIONS FOR INFILTRATION AND NERVE BLOCK SHOULD BE EMPLOYED ONLY BY CLINICIANS WHO ARE WELL VERSED IN DIAGNOSIS AND MANAGEMENT OF DOSE-RELATED TOXICITY AND OTHER ACUTE EMERGENCIES THAT MIGHT ARISE FROM THE BLOCK TO BE EMPLOYED AND THEN ONLY AFTER ENSURING THE 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 addtional 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 (eg, methylparaben) should not be used for epidural or spinal anesthesia because the safety of these agents has not been established with regard to intrathecal injection, either intentional or accidental.

Xylocaine with epinephrine solutions contain sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people.

Anaphylactic reactions may occur following administration of lidocaine hydrochloride (see ADVERSE REACTIONS).

In the case of severe reaction, discontinue the use of the drug.

Systemic

Adverse experiences following the administration of lidocaine HCl 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 HCl 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 the multiple dose vials.  Allergic reactions, including anaphylactic reactions, may occur as a result of sensitivity to lidocaine, but are infrequent.  If allergic reactions do occur, they should be managed by conventional means.  The detection of sensitivity by skin testing is of doubtful value.

There have been no reports of cross sensitivity between lidocaine hydrochloride and procainamide or between lidocaine hydrochloride and quinidine.

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 HCl 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.

Hematologic
Methemoglobinemia

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 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 convulsions, as well as underventilation or apnea due to unintended subarachnoid injection of drug solution, consists of immediate attention to the maintenance of a patent airway and assisted or controlled ventilation with oxygen and a delivery system capable of permitting immediate positive airway pressure by mask.  Immediately after the institution of these ventilatory measures, the adequacy of the circulation should be evaluated, keeping in mind that drugs used to treat convulsions sometimes depress the circulation when administered intravenously.  Should convulsions persist despite adequate respiratory support, and if the status of the circulation permits, small increments of an ultra-short acting barbiturate (such as thiopental or thiamylal) or a benzodiazepine (such as diazepam) may be administered intravenously.  The clinician should be familiar, prior to the use of local anesthetics, with these anticonvulsant drugs.  Supportive treatment of circulatory depression may require administration of intravenous fluids and, when appropriate, a vasopressor as directed by the clinical situation (eg, ephedrine).

If not treated immediately, both convulsions and cardiovascular depression can result in hypoxia, acidosis, bradycardia, arrhythmias and cardiac arrest.  Underventilation or apnea due to unintentional subarachnoid injection of local anesthetic solution may produce these same signs and also lead to cardiac arrest if ventilatory support is not instituted.  If cardiac arrest should occur, standard cardiopulmonary resuscitative measures should be instituted.

Endotracheal intubation, employing drugs and techniques familiar to the clinician, may be indicated, after initial administration of oxygen by mask, if difficulty is encountered in the maintenance of a patent airway or if prolonged ventilatory support (assisted or controlled) is indicated.

Dialysis is of negligible value in the treatment of acute overdosage with lidocaine HCl.

The oral LD50 of lidocaine HCl in non-fasted female rats is 459 (346 to 773) mg/kg (as the salt) and 214 (159 to 324) mg/kg (as the salt) in fasted female rats.

Table 1 (Recommended Dosages) summarizes the recommended volumes and concentrations of Xylocaine Injection for various types of anesthetic procedures.  The dosages suggested in this table are for normal healthy adults and refer to the use of epinephrine-free solutions.  When larger volumes are required, only solutions containing epinephrine should be used except in those cases where vasopressor drugs may be contraindicated.

There have been adverse event reports of chondrolysis in patients receiving intra-articular infusions of local anesthetics following arthroscopic and other surgical procedures.  Xylocaine 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 the elderly and debilitated patients and patients with cardiac and/or liver disease.

The onset of anesthesia, the duration of anesthesia and the degree of muscular relaxation are proportional to the volume and concentration (ie, total dose) of local anesthetic used.  Thus, an increase in volume and concentration of Xylocaine 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 Xylocaine Injection may result in a more profound fall in blood pressure when used in epidural anesthesia.  Although the incidence of side effects with lidocaine HCl is quite low, caution should be exercised when employing large volumes and concentrations, since the incidence of side effects is directly proportional to the total dose of local anesthetic agent injected.

For intravenous regional anesthesia, only the 50 mL single dose vial containing Xylocaine (lidocaine HCl) 0.5% Injection should be used.

Epidural Anesthesia

1% without epinephrine                        10 mL Plastic Ampule

1% without epinephrine                        30 mL single dose solutions

1% with epinephrine                             30 mL single dose solutions
  1:200,000

1.5% without epinephrine                     10 mL Plastic Ampule

1.5% without epinephrine                     20 mL Plastic Ampule

1.5% with epinephrine                          30 mL ampules, 30 mL single dose 
   1:200,000                                                 solutions

2% without epinephrine                        10 mL Plastic Ampule

2% with epinephrine                             20 mL ampules, 20 mL single dose 
   1:200,000                                                solutions

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 to 3 mL of the indicated concentration per dermatome).

Caudal and Lumbar Epidural Block

As a precaution against the adverse experience sometimes observed following unintentional penetration of the subarachnoid space, a test dose such as 2 to 3 mL of 1.5% lidocaine HCl 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 to 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 Xylocaine 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 solution 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.

Disinfecting agents containing heavy metals, which cause release of respective ions (mercury, zinc, copper, etc) should not be used for skin or mucous membrane disinfection as they have been related to incidents of swelling and edema. When chemical disinfection of multidose vials is desired, either isopropyl alcohol (91%) or ethyl alcohol (70%) 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.

Dosage forms listed as Xylocaine-MPF indicate single dose solutions that are Methyl Paraben Free (MPF).

All solutions should be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Protect from light.

All trademarks are the property of Fresenius Kabi, LLC.

451175D
Revised: November 2014

Injection, USP

0.9%

Sodium Chloride Injection, USP, 0.9% is a sterile, nonpyrogenic solution. The osmolarity is 300 mOsmol per liter (calculated).

Each mL contains: Sodium chloride 9 mg; Water for Injection q.s. It contains no bacteriostat, antimicrobial agent or added buffer and is supplied only in single dose containers. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment (pH 4.5-7.0).

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 choride is NaCl and the molecular weight is 58.44.

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 distribution and excretion of sodium (Na+) and chloride (Cl—)are largely under the control of the kidney which maintains a balance between intake and output.

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.

Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. Average normal adult daily requirement ranges from two to three liters (1 to 1.5 liters each for insensible water loss by perspiration and urine production).

Water balance is maintained by various regulatory mechanisms. Water distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (Na+) plays a major role in maintaining physiologic equilibrium.

Sodium Chloride Injection, USP, 0.9% preparations are indicated for diluting or dissolving drugs for intramuscular, intravenous or subcutaneous injection according to instructions of the manufacturer of the drug to be administered.

Sodium Chloride Injection, USP, 0.9% is also indicated for use in flushing of intravenous catheters.

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.

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.

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

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 manufacturer.

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.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Sodium Chloride Injection, USP, 0.9%, preservative free, is available as follows:

Single dose vials, packaged 25 vials per tray.

Preservative Free.  Discard unused portion.

Use only if solution is clear and seal intact.

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

*Vial stoppers do not contain natural rubber latex.

45764D
Revised: January 2008

 Povidone-iodine USP 10%

Antiseptic

antiseptic skin preparation

apply locally as needed

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

citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, water

For questions, comments, or to report
serious side effects: 
800-760-3236

Monday- Friday 8:30 a.m.-5:00 p.m.EST
APLICARE, INC.
MERIDEN, CT 06450 U.S.A
BRAMPTON, ON L6W 4V3 CANADA

www.aplicare.com

0915

Isopropyl Alcohol, 70 % v/v

Antiseptic

• Antiseptic cleanser
• Kills harmful bacteria and germs
• First aid to help prevent infection

• For External Use Only
• Avoid contact with the eyes. If contact  occurs, flush eyes with water

          Flammable, keep away from fire or flame.

• Use as part of your daily cleansing routine
• May be covered with a sterile bandage

• Store at room temperature: 15º-30ºC (59º-86ºF)
• Avoid excessive heat
  

• Water

January 2014

NDC 49836-003-18

RX-Only

P-Care X

Kit Contains:
1 Xylocaine® - MPF 1% Single Dose Vial (10 mg/mL) (5mL)
1 Sodium Chloride Injection, USP 0.9% Single Dose Vial (10 mL)
1 Sterile Povidone-Iodine Swabsticks (3 Swabs)
1 Sterile Pair Nitrile Powder-Free Gloves (Size 7.5)
1 Sterile Towel Drape
1 Sterile Fenestrated Towel Drape
2 Sterile Adhesive Bandage
2 Sterile Adhesive Spot Bandage
3 Sterile Packs of 4x4 Gauze (6 Gauzes)
5 Sterile Isopropyl Alcohol 70% Prep Pad

1 Dose

Needles and Syringes Not Included

P-Care x

DISTRIBUTED BY:
SCHMIGS
HAUPPAUGE, NY 11788
NDC 49836-003-18

MANUFACTURED BY:
Rx Pharma Pack
HAUPPAUGE, NY 11788

Questions/Comments 1-844-632-7898

Kit Contents:

Xylocaine® §- MPF 1% (10 mg/mL) (Fresenius Kabi USA, LLC)*
Lidocaine HCl Injection, USP
Sterile, nonpyrogenic, isotonic solution containing sodium chloride and a local anesthetic agent.

Sodium Chloride Injection, USP 0.9% (10 mL) (APP Fresenius Kabi USA, LLC)*
Each mL contains sodium chloride, 9 mg. May contain HCI and/or NaOH for pH adjustment. Sterile, nonpyrogenic, preservative free.

Sterile Povidone-lodine Swabsticks (Aplicare)*

Sterile Nitrile Powder-Free Gloves (Dynarex) - Size 7.5*

Sterile Towel Drape (Dynarex)*

Sterile Fenestrated Towel Drape (Dynarex)*

Sterile Adhesive Bandage (Dynarex)*

Sterile Adhesive Spot Bandage (Dynarex)*

Sterile 4x4 Gauze (Dynarex)*

Sterile Alcohol Prep Pad 70% by Volume (Dynarex)*

§ Xylocaine® (registered trademark of APP Fresenius Kabi, LLC)
* Internal package components remain sterile when stated as long as items are unopened and undamaged.

WARNING: KEEP THIS AND ALL MEDICATION
OUT OF THE REACH OF CHILDREN. IN CASE OF
ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL
ASSISTANCE OR CONTACT A POISON CONTROL
CENTER IMMEDIATELY.

PROTECT FROM LIGHT I AVOID FREEZING

STORE AT CONTROLLED ROOM TEMPERATURE
20º-25ºC (68º-77º F) [SEE USP CONTROLLED
ROOM TEMPERATURE]

DO NOT REFRIGERATE.

Directions for Use: See enclosed inserts.

ORG 04/2017

This product is not eligible for Medicare or Medicaid reimbursement.

P-Care X

NDC63323-492-57                        491257

Xylocaine® - MPF
(lidocaine HCl injection, USP)

1% 50mg/5mL
(10 mg/mL)

For Infiltration and Nerve Block
Including Caudal and Epidural Use.

Methylparaben Free

5 mL Single Dose Vial                   Rx only

Xylocaine®-MPF

NDC 63323-186-10                     918610

SODIUM
CHLORIDE
INJECTION, USP

0.9%

FOR DRUG DILUENT USE
Rx only

10 mL  Single Dose Vial

Sodium Chloride

NDC 52380-3101-5
NPN 02076101

                                                APLICARE®

Tear Here        Hold Upright          Tear Here

                      THREE
            POVIDONE-IODINE
                SWABSTICKS
                  ANTISEPTIC
             STERILE Solution
    Applicator is STERILE if Package
                     is Intact

    Three 4-inch Saturated Swabsticks

            STERILE SOLUTION

Reorder No. S-3101

Povidone-Iodine Swabsticks

     NDC# 67777-121-13
Made in India 

                   Sterile Alcohol
                            Prep Pad

       For External Use Only
Apply topically as needed
   Discard after single use
                 Sterile Solution                        dynarex
      Sterile unless pouch is
          opened or damaged

                                                       Not made with natural
                                                                       rubber latex

1
Pad    Medium

                                                             Reorder No. 1113

Sterile Alcohol Prep Pad