Nutrilyte II

Name: Nutrilyte II

Uses of Nutrilyte II

  • It is used to give electrolytes to the body when more are needed. This product must be mixed in TPN solution before it is given.

How is this medicine (Nutrilyte II) best taken?

Use Nutrilyte II as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • It is given as an infusion into a vein over a period of time.

What do I do if I miss a dose?

  • Call your doctor to find out what to do.

Indications and Usage for Nutrilyte II

Nutrilyte II Concentrate is indicated for use as a supplement to parenteral nutritional solutions containing amino acids, dextrose and/or other calorie sources delivered by central venous or peripheral infusion to facilitate amino acid utilization and maintain electrolyte balance in adults.

Nutrilyte II Concentrate is also indicated as a source of replacement electrolytes for the depleted adult patient during parenteral therapy.

Warnings

  1. Strongly hypertonic solutions. Must be properly diluted and thoroughly mixed before injection.
  2. Contains no phosphate.Patients receiving TPN solutions containing concentrated dextrose may also require phosphate in addition to Nutrilyte II. It is necessary to take into consideration the calcium and magnesium ions in this solution in order to avoid precipitation where phosphate is present in the diluted solution. Phosphate (10-15 mEq/L), calcium (5 mEq/L) and magnesium (5-10 mEq/L) rarely are incompatible when properly mixed. Higher levels must be added cautiously with adequate mixing (avoid layering) and inspection. Additional calcium and phosphate may be added to alternate bottles. If additional phosphate is required, it is essential to consider the salt form because of pre-existing levels of potassium and the final concentration of phosphate in the infusate.
  3. Each 20 mL of Nutrilyte II contains 20 mEq of potassium. Patient requirements should be carefully evaluated prior to the addition of any potassium salt to a solution containing Nutrilyte II.
  4. This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.

    Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.

Adverse Reactions

Symptoms may result from an excess or deficit of one or more of the ions present in Nutrilyte II Multi- Electrolyte Concentrate. Therefore, frequent monitoring of blood electrolyte levels is essential.

Sodium excess can cause edema and subsequent congestive heart failure in patients with cardiovascular insufficiency.

Potassium excess can cause an abnormal electrocardiogram, cardiac arrhythmias leading to cardiac arrest, paresthesias and flaccid paralysis, mental confusion and weakness.

Potassium deficit can impair neuromuscular function and cause intestinal dilatation and ileus.

Magnesium excess can cause muscular weakness, flushing, sweating, hypotension, circulatory collapse and depression of cardiac and central nervous system function. Magnesium deficiency can cause hyperirritability psychotic behavior, tachycardia, hypertension and neuromuscular dysfunction.

Calcium excess can cause depression, headaches, drowsiness, disorientation, syncope, dysphagia, hypotonia of skeletal and smooth muscles, arrhythmias and coma. Calcium deficits can produce neuromuscular hyperexcitability (paresthesias, cramps, tetany and grand mal seizures).

Phosphorus deficiency may lead to impaired tissue oxygenation and acute hemolytic anemia. Relative to calcium, excessive phosphorus intake can precipitate hypocalcemia with ensuing neuromuscular hyperexcitability.

Nutrilyte II Dosage and Administration

For adults, one 20 mL dose of Nutrilyte II should be added to each liter of amino acid/dextrose solution (TPN) or other suitable intravenous solution.

Route: Nutrilyte II Concentrate is for prescription compounding of intravenous admixtures only. The solution is strongly hypertonic. Not for direct patient injection. Dilute to appropriate strength with suitable intravenous fluid prior to administration.

DIRECTIONS FOR DISPENSING FROM 100 mL PHARMACY BULK PACKAGENOT FOR DIRECT INFUSION

The 100 mL Pharmacy Bulk Package is for use in a Pharmacy Admixture Service only. The 100 mL Pharmacy Bulk Package should be suspended (inverted) by its IV hang label in a laminar flow hood or biological safety cabinet. Prior to entering a Pharmacy Bulk Package remove the flip-off seal and cleanse the rubber closure with a suitable antiseptic agent. Entry into the Pharmacy Bulk Package must be made with a sterile transfer set or other sterile dispensing device and the contents dispensed in aliquots using aseptic technique. Use of a syringe needle is not recommended as it may cause leakage. ANY UNUSED PORTION MUST BE DISCARDED WITHIN 4 HOURS AFTER INITIAL ENTRY. The date and the time initially opened should be recorded in the space provided on the Pharmacy Bulk Package label.

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

How is Nutrilyte II Supplied

Nutrilyte II (Multi-Electrolyte Concentrate)

NDC 0517-2020-25 20 mL Single Dose Vial Boxes of 25

For preparing 1 Liter TPN Solution.

NDC 0517-2000-25 100 mL Pharmacy Bulk Package Boxes of 25

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30° C (59° to 86°F) (See USP Controlled Room Temperature).

AMERICAN
REGENT, INC.
SHIRLEY, NY 11967

IN2000
Rev. 1/09

PRINICIPAL DISPLAY PANEL - 100 mL

Container

NDC 0517-2000-25

Nutrilyte II® (Multi-Electrolyte Concentrate)

100 mL PHARMACY BULK PACKAGE
NOT FOR DIRECT INFUSION

FOR IV USE AFTER DILUTION

Rx Only

Each mL provides:
Electrolytes (mEq): Acetate 1.475,
Potassium 1, Chloride 1.75,
Sodium 1.75, Magnesium 0.25,
Calcium 0.225




Carton

NDC 0517-2000-25

Nutrilyte II6212 mOsmol/Liter
(Multi-Electrolyte Concentrate)

100 mL PHARMACY BULK PACKAGE
NOT FOR DIRECT INFUSION

FOR IV USE AFTER DILUTION

Rx Only

Each mL provides:
Electrolytes (mEq): Acetate 1.475, Potassium 1, Chloride 1.75,
Sodium 1.75, Magnesium 0.25, Calcium 0.225

Nutrilyte II 
multi-electrolyte injection, solution, concentrate
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0517-2020
Route of Administration INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POTASSIUM ACETATE (POTASSIUM CATION) POTASSIUM ACETATE 98 mg  in 1 mL
SODIUM CHLORIDE (CHLORIDE ION) SODIUM CHLORIDE 74.5 mg  in 1 mL
SODIUM ACETATE (ACETATE ION) SODIUM ACETATE ANHYDROUS 64.6 mg  in 1 mL
MAGNESIUM CHLORIDE (MAGNESIUM CATION) MAGNESIUM CHLORIDE 25.5 mg  in 1 mL
CALCIUM CHLORIDE (CALCIUM CATION) CALCIUM CHLORIDE 16.55 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
ACETIC ACID  
WATER  
Packaging
# Item Code Package Description
1 NDC:0517-2020-25 25 VIAL, SINGLE-DOSE in 1 TRAY
1 20 mL in 1 VIAL, SINGLE-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 10/01/1990
Nutrilyte II 
multi-electrolyte injection, solution, concentrate
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0517-2000
Route of Administration INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POTASSIUM ACETATE (POTASSIUM CATION) POTASSIUM ACETATE 98 mg  in 1 mL
SODIUM CHLORIDE (CHLORIDE ION) SODIUM CHLORIDE 74.5 mg  in 1 mL
SODIUM ACETATE (ACETATE ION) SODIUM ACETATE 64.6 mg  in 1 mL
MAGNESIUM CHLORIDE (MAGNESIUM CATION) MAGNESIUM CHLORIDE 25.5 mg  in 1 mL
CALCIUM CHLORIDE (CALCIUM CATION) CALCIUM CHLORIDE 16.55 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
ACETIC ACID  
WATER  
Packaging
# Item Code Package Description
1 NDC:0517-2000-25 25 VIAL, PHARMACY BULK PACKAGE in 1 TRAY
1 100 mL in 1 VIAL, PHARMACY BULK PACKAGE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 10/01/1990
Labeler - American Regent, Inc. (622781813)
Establishment
Name Address ID/FEI Operations
Luitpold Pharmaceuticals, Inc. 002033710 ANALYSIS(0517-2020, 0517-2000), MANUFACTURE(0517-2020, 0517-2000), STERILIZE(0517-2020, 0517-2000)
Revised: 09/2014   American Regent, Inc.
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