Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/3301
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TPN Electrolytes (Injection, Solution, Concentrate)
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One 20 mL volume of TPN Electrolytes (multiple electrolyte
additive) is added to each liter of amino acid/dextrose solution. Alternatively,
the TPN Electrolytes can be added to the bottle of amino acids or concentrated
dextrose, to permit addition of the necessary phosphate additive to the remaining
bottle. This latter technique helps avoid physical incompatibilities between
calcium and phosphorus. A potassium phosphate additive is recommended for
addition to nutritional solutions containing TPN Electrolytes. Between 10
and 30 mEq of potassium (as phosphate) should be added per liter of TPN solution,
to augment the 20 mEq of potassium provided by TPN Electrolytes. Between
two and three liters of TPN solution with added TPN Electrolytes are usually
administered daily to adults. Solutions are given continuously over the entire
24-hour period at a constant rate, ranging from 83 to 125 mL/hour. TPN solutions
containing TPN Electrolytes and concentrated dextrose are administered intravenously,
through a central venous catheter. Parenteral drug products
should be inspected visually for particulate matter and discoloration prior
to administration, whenever solution and container permit. See PRECAUTIONS.
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| dailymed-instance:descripti... |
TPN Electrolytes (multiple electrolyte additive) is a sterile,
nonpyrogenic, concentrated solution of intra- and extracellular ions for intravenous
infusion after dilution as a maintenance electrolyte replenisher only. It
contains no phosphate and no bacteriostat, antimicrobial agent or added buffer.
The pH is 6.6 (6.0 to 7.5). May contain hydrochloric acid for pH adjustment.
The osmolar concentration is 6.2 mOsmol/mL (calc.). __________________________ *Total
Parenteral Nutrition Ingredients and ion constituents
of the solution are as follows: Sodium Chloride, USP is chemically designated NaCl, a white
crystalline compound freely soluble in water. Calcium
Chloride, USP dihydrate is chemically designated CaCl���2HO, white, odorless fragments or granules, freely soluble in
water. Potassium Chloride, USP is chemically designated
KCl, a white granular powder freely soluble in water. Magnesium
Chloride, USP hexahydrate is chemically designated MgCl���6HO, deliquescent crystals very soluble in water. Sodium
Acetate, USP anhydrous is chemically designated CHNaO,
a hygroscopic powder very soluble in water. Water for
Injection, USP is chemically designated HO. The
semi-rigid container is fabricated from a specially formulated polyolefin.
It is a copolymer of ethylene and propylene. The safety of the plastic has
been confirmed by tests in animals according to USP biological standards for
plastic containers. The container requires no vapor barrier to maintain the
proper drug concentration.
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TPN Electrolytes (multiple electrolyte additive) helps to
maintain normal cellular metabolism during TPN (total parenteral nutrition).
Providing electrolytes in appropriate amounts prevents deficiency symptoms
which otherwise would occur in their absence. Cations: Sodium is the principal extracellular
cation; it helps maintain motor nerve depolarization, proper fluid balance
and normal renal metabolism. Potassium is the principal intracellular cation;
it helps transport dextrose across the cell membrane and contributes to normal
renal function. Magnesium is an important cofactor for enzymatic reactions
and helps to maintain normal CNS (central nervous system) activity and amino
acid utilization. Calcium participates in muscle contraction, blood coagulation
and helps maintain normal neuromuscular function. Anions: Chloride is the principal extracellular
anion which, along with bicarbonate, is involved in maintaining proper anion
balance. Acetate is an important metabolic intermediate in the tricarboxylic
acid cycle and is a bicarbonate alternate. The distribution
and excretion of sodium (Na) and chloride (Cl)
are largely under the control of the kidney which maintains a balance between
intake and output. Approximately 80% of body calcium
(Ca) is excreted in the feces as insoluble salts; urinary excretion
accounts for the remaining 20%. Potassium (K)
is found in low concentration in the plasma and extracellular fluids (3.5 to
5.0 mEq/liter in a healthy adult). Normally about 80% to 90% of the potassium
intake is excreted in the urine, the remainder in the stools and to a small
extent, in the perspiration. The kidney does not conserve potassium well so
that during fasting or in patients on a potassium-free diet, potassium loss
from the body continues resulting in potassium depletion. Magnesium
(Mg) is the second most plentiful intracellular cation. Normal
plasma concentration ranges from 1.5 to 2.5 or 3.0 mEq per liter. Magnesium
is excreted solely by the kidney at a rate proportional to the plasma concentration
and glomerular filtration. Acetate (CHCOO)
provides bicarbonate (HCO) by metabolic conversion
in the liver. This has been shown to proceed readily even in the presence
of severe liver disease.
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TPN Electrolytes (multiple electrolyte additive) is contraindicated
in pathological conditions where additives of potassium, sodium, calcium,
magnesium or chloride could be clinically deleterious, e.g., anuria, hyperkalemia,
heart block or myocardial damage and severe edema due to cardiovascular, renal
or hepatic failure.
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TPN Electrolytes (multiple electrolyte additive) is supplied
in the following single-dose delivery systems: Exposure of pharmaceutical products to heat should be minimized.
Avoid excessive heat. Protect from freezing. It is recommended that the product
be stored at room temperature (25��C); however, brief exposure up to
40��C does not adversely affect the product. Store
at controlled room temperature 15��to 30��C (59��to 86��F).
[See USP.] HOSPIRA, INC., LAKE FOREST,
IL 60045 USA
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Do not administer unless solution is clear and seal is intact.
Discard unused portion. Blood levels of sodium, potassium,
calcium, magnesium, phosphorus and chloride should be monitored frequently
during TPN (total parenteral nutrition). Significant deviations from normal
may justify further supplementation or substitution of individual electrolyte
additives (in place of TPN Electrolytes) to tailor the electrolyte supplement
to meet individual patient requirements. In patients
with renal dysfunction or cardiovascular insufficiency, especially in elderly
or postsurgical patients, consider the potential effects of sodium (35 mEq)
and potassium (20 mEq) present in TPN Electrolytes. Extraordinary
electrolyte losses are not necessarily corrected by TPN Electrolytes. In protracted
vomiting or diarrhea or in patients with fistula drainage or nasogastric suction,
separate replacement therapy may be necessary, based upon analysis of losses
sustained. Caution must be exercised in the administration
of parenteral fluids, especially those containing sodium ions, to patients
receiving corticosteroids or corticotropin. Solutions
containing acetate ions should be used with caution as excess administration
may result in metabolic alkalosis.<br/>Pregnancy Category C.: Animal reproduction studies have not been conducted with
TPN Electrolytes. It is also not known whether TPN Electrolytes can cause
fetal harm when administered to a pregnant woman or can affect reproduction
capacity. TPN Electrolytes should be given to a pregnant woman only if clearly
needed.<br/>GERIATRIC USE: An evaluation of current literature revealed no clinical
experience identifying differences in response between elderly and younger
patients. In general, dose selection for an elderly patient should be cautious,
usually starting at the low end of the dosing range, reflecting the greater
frequency of decreased hepatic, renal, or cardiac function, and of concomitant
disease or other drug therapy. Sodium ions and phosphorus
are known to be substantially secreted by the kidney, and the risk of toxic
reactions may be greater in patients with impaired renal function. Because
elderly patients are more likely to have decreased renal function, care should
be taken in dose selection, and it may be useful to monitor renal function.
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In the event of overhydration or solute overload, re-evaluate
the patient and institute appropriate corrective measures. See WARNINGS and
PRECAUTIONS.
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Sodium chloride, calcium chloride, potassium chloride, magnesium chloride and sodium acetate
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TPN Electrolytes (Injection, Solution, Concentrate)
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Symptoms may result from an excess or deficit of one or more
of the ions present in TPN Electrolytes. Therefore, frequent monitoring of
electrolyte blood levels is recommended. Sodium excess can cause edema and
exacerbation of congestive heart failure. Excess potassium can cause deviations
from the normal ECG (electrocardiogram). Potassium deficits can impair neuromuscular
function, causing muscle weakness or frank paralysis, intestinal dilatation
and ileus. Calcium deficits can produce neuromuscular hyperexcitability, ranging
from paresthesias,cramps and laryngospasm to tetany and grand mal seizures.
Depressed calcium levels can accompany administration of parenteral phosphorus
or large amounts of albumin. Magnesium deficiency can precipitate neuromuscular
dysfunction, hyperirritability, psychotic behavior, tachycardia and hypertension.
Magnesium excess can cause muscle weakness, ECG changes, sedation and mental
confusion.
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CONCENTRATED, HYPERTONIC, ADDITIVE SOLUTION. Must
be diluted in TPN solution prior to administration. CONTAINS
NO PHOSPHATE. Patients receiving TPN solutions containing concentrated dextrose
require additive phosphate, in addition to TPN Electrolytes. Between 10 and
15 mM (310 to 465 mg) phosphorus are physically compatible with
as much as 10 to 12 mEq calcium in the same admixture. The phosphate supplement
should first be added to the amino acid or dextrose bottle and diluted well
to avoid precipitation with calcium. CONTAINS 20 mEq
of POTASSIUM. The potassium content of other additives, such as potassium
phosphate or potassium-containing antibiotics, must be considered in the context
of total potassium delivered. TPN patients usually require 30 to 50 mEq of
potassium per liter of TPN solution containing concentrated (20���25%)
dextrose. NOT INTENDED FOR PEDIATRIC USE. Solutions
containing sodium ions should be used with great care, if at all, in patients
with congestive heart failure, severe renal insufficiency and in clinical
states in which there exists edema with sodium retention. Solutions
which contain potassium ions should be used with great care, if at all, in
patients with hyperkalemia, severe renal failure and in conditions in which
potassium retention is present. In patients with diminished
renal function, administration of solutions containing sodium or potassium
ions may result in sodium or potassium retention. Solutions
containing acetate ions should be used with great care in patients with metabolic
or respiratory alkalosis. Acetate should be administered with great care in
those conditions in which there is an increased level or an impaired utilization
of this ion, such as severe hepatic insufficiency. WARNING:
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 levels associated
with central nervous system and bone toxicity. Tissue loading may occur at
even lower rates of administration.
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TPN Electrolytes (multiple electrolyte additive) is indicated
for use as a supplement to nutritional solutions containing concentrated dextrose
and amino acids delivered by central venous infusion, to help maintain electrolyte
homeostasis in adult patients.
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TPN Electrolytes
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