P-Care X

Mechanism of Action

Lidocaine HCl 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 HCl 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 HCl 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 HCl is protein bound. Binding is also dependent on the plasma concentration of the alpha-1-acid glycoprotein.

Lidocaine HCl crosses the blood-brain and placental barriers, presumably by passive diffusion.

Lidocaine HCl 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 HCl. Approximately 90% of lidocaine HCl 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 HCl following an intravenous bolus injection is typically 1.5 to 2 hours. Because of the rapid rate at which lidocaine HCl is metabolized, any condition that affects liver function may alter lidocaine HCl kinetics. The half-life may be prolonged two-fold or more in patients with liver dysfunction. Renal dysfunction does not affect lidocaine HCl 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 HCl required to produce overt systemic effects. Objective adverse manifestations become increasingly apparent with increasing venous plasma levels above 6 mcg free base per mL. In the rhesus monkey arterial blood levels of 18 to 21 mcg/mL have been shown to be threshold for convulsive activity.

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(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 HCl.

The oral LD50 of lidocaine 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.

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

Protect from light.

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.

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%

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

DISTRIBUTED BY:

SCHMIGS
HAUPPAUGE, NY 11788

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.

This product is not eligible for Medicare or Medicaid reimbursement.

ORG 04/2017

P-Care X

NDC 63323-186-10                     918610

SODIUM
CHLORIDE
INJECTION, USP

0.9%

FOR DRUG DILUENT USE

Rx only

10 mL  Single Dose Vial

Sterile, Nonpyrogenic

Preservative Free

Discard unused portion.
Each mL contains:
Sodium chloride 9 mg; Water for injection q.s. HCl and/or NaOH may have been added for pH adjustment.

300 mOsmol/L

Usual Dosage: See insert.
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.

APP Pharmaceuticals, LLC
Schaumburg, IL 60173

42569E

Sodium Chloride