FDA records indicate that there are no current recalls for this drug.
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Questions & Answers
Side Effects & Adverse Reactions
- Strongly hypertonic solutions. Must be properly diluted and thoroughly mixed before injection.
- 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.
- 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.
- 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.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
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.
History
There is currently no drug history available for this drug.
Other Information
Nutrilyte II (Multi-Electrolyte Concentrate) is a sterile, nonpyrogenic, concentrated solution of intra- and extracellular electrolytes, excluding phosphate. No antimicrobial agent has been added.
It is available in a 20 mL single dose preparation and a 100 mL Pharmacy Bulk Package.
The 100 mL Pharmacy Bulk Package contains many doses for use in a pharmacy admixture program in the preparation of parenteral fluids. See directions for dispensing from the 100 mL Pharmacy Bulk Package.
Electrolytes (mEq): | per mL | Per 20 mL |
Acetate | 1.475 | 29.5 |
Potassium | 1 | 20 |
Chloride | 1.75 | 35 |
Sodium | 1.75 | 35 |
Magnesium | 0.25 | 5 |
Calcium | 0.225 | 4.5 |
Nutrilyte II contains: | per mL | per 20 mL |
Potassium Acetate, USP | 98 mg | 1.96 grams |
Sodium Chloride, USP | 74.5 mg | 1.49 grams |
Sodium Acetate 3H2O, USP | 64.6 mg | 1.292 grams |
Magnesium Chloride 6H2O, USP | 25.5 mg | 0.51 gram |
Calcium Chloride 2H2O, USP | 16.55 mg | 0.331 gram |
Water for Injection, USP | q.s. | q.s. |
pH (6.3 to 7.0) adjusted with Glacial Acetic Acid when necessary. |
Calculated Osmolarity:Approximately 6212 mOsmol/Liter; 6.2 mOsmol/mL.
Sources
Nutrilyte Ii Manufacturers
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American Regent, Inc.
Nutrilyte Ii | American Regent, Inc.
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 PACKAGE—NOT 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.
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