Download Prescribing Info - American Regent

NUTRILYTE®
NUTRILYTE®
(Multi-Electrolyte Concentrate)
(Multi-Electrolyte Concentrate)
Rx Only
Rx Only
Not for direct infusion. For prescription compounding of intravenous admixtures only. Concentrated
solution. Dilute to appropriate strength with suitable intravenous fluid prior to administration.
DESCRIPTION:
Nutrilyte (Multi-EIectrolyte 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
2.03
40.6
Potassium
2.03
40.6
Chloride
1.68
33.6
Sodium
1.25
25
Magnesium
0.40
8
Calcium
0.25
5
Gluconate
0.25
5
Nutrilyte Contains
per mL
per 20 mL
Sodium Acetate •3H2O, USP
135 mg
2.7 grams
Potassium Chloride, USP
125 mg
2.5 grams
Sodium Gluconate
55 mg
1.1 grams
Magnesium Acetate •4H2O
43 mg
0.86 gram
Potassium Acetate, USP
34.5 mg
0.69 gram
22 mg
0.44 gram
Calcium Acetate •H2O
Water for Injection, USP
q.s.
q.s.
pH (6.3 to 7.0) adjusted with Glacial Acetic Acid when necessary.
Calculated Osmolarity: Approximately 7562 mOsmol/Liter; 7.562 mOsmol/ mL.
CLINICAL PHARMACOLOGY
Nutrilyte Concentrate provides a source of intra- and extracellular electrolytes in suitable amounts, to help
maintain normal cellular metabolism during total parenteral nutrition (TPN) and other parenteral therapy in
adults. Use of properly diluted Nutrilyte meets most adult daily electrolyte requirements and provides
adjunctive therapy for replenishment of depleted electrolyte stores.
Intracellular: Potassium, the principal intracellular cation, maintains the integrity of the cellular membrane,
helps transport dextrose across the cell membrane and contributes to normal renal function: Magnesium, the
second most concentrated intracellular cation, acts as an important cofactor in enzymatic reactions and helps
to maintain normal central nervous system activity and amino acid utilization. Calcium participates in the
maintenance of normal neuromuscular functions and blood coagulation.
Extracellular: Chloride, the primary extracellular anion, contributes to the maintenance of acid-base balance.
Sodium, the principal extracellular cation, acts in conjunction with potassium to maintain integrity of the cell
membrane. Sodium also helps to maintain motor nerve depolarization, normal renal metabolism and fluid
balance. Acetate is a bicarbonate alternate and an important intermediate in the tricarboxylic acid cycle.
INDICATIONS AND USAGE
Nutrilyte 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 Concentrate is also indicated as a source of replacement electrolytes for the depleted adult patient
during parenteral therapy.
CONTRAINDICATIONS
Nutrilyte Concentrate is contraindicated in clinical conditions where additives of potassium, sodium, calcium,
magnesium or chloride could be clinically detrimental. Such conditions include anuria, hyperkalemia, heart
block or myocardial damage and edema due to cardiovascular, renal or hepatic failure.
Nutrilyte Concentrate is not intended for pediatric use.
Use only if solution is clear and seal intact.
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. 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 contains 40.5 mEq of potassium. Patient requirements should be carefully
evaluated prior to the addition of any potassium salt to a solution containing Nutrilyte.
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.
NUTRILYTE®
NUTRILYTE®
(Multi-Electrolyte Concentrate)
(Multi-Electrolyte Concentrate)
Rx Only
Rx Only
PRECAUTIONS
1. To minimize the risk of possible incompatibilities arising from mixing this solution with other additives that
may be prescribed, the final infusate should be inspected for cloudiness or precipitation immediately after
mixing, prior to administration and periodically during administration.
2. Blood levels of sodium, potassium, calcium, magnesium, phosphorus and chloride should be monitored
frequently during parenteral nutrition or intravenous therapy, and the daily dosage of electrolytes may
require tailoring to meet individual needs. In tissue electrolyte depletion, addition of certain electrolytes
may be required to meet individual patient needs.
3. Care must be exercised administering solutions containing up to 30 mEq of sodium and 40 mEq of
potassium per liter to patients with renal or cardiovascular insufficiency, particularly if they are
postoperative or elderly. Sodium-containing solutions should be administered with caution to patients
receiving corticosteroids or corticotropin or to other salt-retaining patients. Potassium replacement
therapy may be guided by serial electrocardiograms since plasma levels are not necessarily indicative of
tissue potassium levels.
4. Administration of barbiturates, narcotics or hypnotics should be adjusted with caution in patients also
receiving magnesium-containing solutions because of an additive central depressive effect.
5. Parenteral magnesium and/or calcium and/or potassium should be administered with extreme caution to
patients receiving digitalis preparations.
6. Extraordinary electrolyte and fluid losses are not necessarily corrected by infusion of solutions containing
Nutrilyte. In order to avoid deficits, special consideration must be given to replacement of excessive fluid
and electrolyte losses in such conditions as protracted vomiting or diarrhea, nasogastric suction or fistula
drainage.
7. If both phosphate and a Nutrilyte Concentrate are to be added to the solution for TPN administration, add
the Nutrilyte Concentrate to one container (either to the amino acids or the concentrated dextrose) and add
the phosphate to the other to avoid physical incompatibilities between calcium and phosphorus.
ADVERSE REACTIONS
Symptoms may result from an excess or deficit of one or more of the ions present in Nutrilyte 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
hyperexcitabilty (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
hyperexcitabilty.
DOSAGE AND ADMINISTRATION
For adults, one 20 mL dose of Nutrilyte should be added to each liter of amino acid/dextrose solution (TPN)
or other suitable intravenous solution.
Route: Nutrilyte 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.
HOW SUPPLIED: Nutrilyte® (Multi-Electrolyte Concentrate)
NDC 0517-3120-25
20 mL Single Dose Vial
For preparing 1 Liter TPN Solution.
Boxes of 25
NDC 0517-3100-25
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).
IN3100
Rev. 1/09
MG #15000
AMERICAN
REGENT, INC.
SHIRLEY, NY 11967