XYLOCAINE-MPF WITH EPI (Page 4 of 4)

MAXIMUM RECOMMENDED DOSAGE

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 to 100 mg (1.5 to 2 mg/lb). The use of even more dilute solutions (i.e., 0.25 to 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.

NOTE: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever the solution and container permit. The Injection is not to be used if its color is pinkish or darker than slightly yellow or if it contains a precipitate.

Table 1: Recommended Dosages

MAX DOSAGE
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*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 incidents of swelling and edema. When chemical disinfection of multi-dose 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).

HOW SUPPLIED

Xylocaine®-MPF (lidocaine HCl and epinephrine Injection, USP) with Epinephrine 1:200,000

NDC 51662-1550-2 XYLOCAINE® -MPF WITH EPINEPHRINE 1:200,000 2% 400mg/20mL (20mg/mL) 20mL VIAL, IN A POUCH

NDC 51662-1550-3 XYLOCAINE® -MPF WITH EPINEPHRINE 1:200,000 2% 400mg/20mL (20mg/mL) 20mL VIAL, 25 POUCHES IN A CASE WITH 1 VIAL PER POUCH.

HF Acquisition Co LLC, DBA HealthFirst
11629 49th Pl W.

Mukilteo, WA 98275

For single-dose vials and ampules: Discard unused portion.

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 USA, LLC.

LOGO
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www.fresenius-kabi.com/us

451175G
Revised: August 2020

PRINCIPAL DISPLAY PANEL — 51662-1550-2 — VIAL AND POUCH LABELING-Updated

VIAL LABELING

UPDATED VIAL LABEL
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POUCH LABELING

POUCH LABELING
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PRINCIPAL DISPLAY PANEL — 51662-1550-3 — SERIALIZED CASE LABELING-Updated

CASE LABEL

UPDATED CASE LABELING
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RFID LABELING

UPDATED RFID LABELINGUPDATED CASE LABELINGUPDATED RFID LABELING
XYLOCAINE-MPF WITH EPI
xylocaine-mpf with epi injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51662-1550(NDC:63323-489)
Route of Administration INFILTRATION, PERINEURAL, INTRACAUDAL, EPIDURAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EPINEPHRINE BITARTRATE (EPINEPHRINE) EPINEPHRINE 0.005 mg in 1 mL
LIDOCAINE HYDROCHLORIDE ANHYDROUS (LIDOCAINE) LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE 0.2 mg in 1 mL
SODIUM METABISULFITE (BISULFITE ION) 0.5 mg in 1 mL
SODIUM HYDROXIDE
SODIUM CHLORIDE 6 mg in 1 mL
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51662-1550-3 25 POUCH in 1 CASE contains a POUCH (51662-1550-2)
1 NDC:51662-1550-2 1 VIAL, SINGLE-DOSE in 1 POUCH This package is contained within the CASE (51662-1550-3) and contains a VIAL, SINGLE-DOSE
1 20 mL in 1 VIAL, SINGLE-DOSE This package is contained within a POUCH (51662-1550-2) and a CASE (51662-1550-3)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA006488 06/28/2021
Labeler — HF Acquisition Co LLC, DBA HealthFirst (045657305)
Registrant — HF Acquisition Co LLC, DBA HealthFirst (045657305)
Establishment
Name Address ID/FEI Operations
HF Acquisition Co LLC, DBA HealthFirst 045657305 relabel (51662-1550)

Revised: 07/2022 HF Acquisition Co LLC, DBA HealthFirst

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