Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1494
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Aminosyn II in Dextrose (Injection, Solution)
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The total daily dose of Aminosyn II 3.5% in 5% Dextrose Injection
to be infused depends on the daily protein requirements and on the patient's
metabolic and clinical response. Parenteral drug products
should be inspected visually for particulate matter and discoloration prior
to administration whenever solution and container permit. Peripheral Vein Nutritional Maintenance Aminosyn
II 3.5% in 5% Dextrose Injection is suitable for administration by peripheral
vein. The solution is not intended for central vein infusion since it does
not contain adequate amounts of amino acids or electrolytes for administration
with high concentrations of dextrose. For peripheral
intravenous infusion, 1 to 1.5 g/kg/day of total amino acids will reduce protein
catabolism. Infusion or ingestion of carbohydrate or lipid will not reduce
the nitrogen sparing effect of intravenous amino acid infusions at this dose. As
with all intravenous fluid therapy, the primary aim is to provide sufficient
water to compensate for insensible, urinary, and other fluid losses (nasogastric
suction, fistula drainage, and diarrhea). Aminosyn II 3.5% in 5% Dextrose
infused at a rate of 45 mL/kg/day, will meet the fluid and amino acid requirements
of the stable adult patient. As reported in the literature,
the dosage and constant infusion rate of intravenous dextrose must be selected
with caution in pediatric patients, particularly neonates and low birth weight
infants, because of the increased risk of hyperglycemia/hypoglycemia. The
daily requirements of the stable, nonhypermetabolic adult patient in an acceptable
weight range with restricted physical activity are approximately 30 kcal/kg
of body weight, 1 to 1.5 g amino acid/kg, and 2500 to 3000 mL of fluids. Each
gram of infused dextrose provides 3.4 kcal; each gram of infused fat provides
9 kcal. A 10% lipid emulsion contains 1.1 kcal/mL. Lipid emulsion can beadministered
to provide up to 3 g fat/kg/day, infused simultaneously with Aminosyn II 3.5%
in 5% Dextrose Injection by means of a Y-connector located near the infusion
site, using separate flow controls for each solution. Aminosyn II 3.5% in
5% Dextrose Injection should not be premixed with fat emulsion. If it is anticipated
that re-institution of oral feedings cannot occur for a prolonged period of
time, consideration should be given to starting a central venous feeding regimen. Electrolytes
and vitamins must be added to the solution, per the physician's prescription,
to meet individual patient requirements. SERUM ELECTROLYTES
SHOULD BE MONITORED AS INDICATED. Electrolytes may be
added to the nutrient solution as indicated by the patient's clinical
condition and laboratory determinations of plasma values. Major electrolytes
are sodium, chloride, potassium, phosphate, magnesium and calcium. Vitamins,
including folic acid and vitamin K are required additives. The trace element
supplements should be given when long-term parenteral nutrition is undertaken. Pediatric Pediatric requirements
for parenteral nutrition are constrained by the greater relative fluid requirements
of the infant and greater caloric requirements per kilogram. A 3.5% amino
acid solution is too concentrated for use in pediatric patients less than
1 year old, who generally require a 2.5% amino acid solution. However, older
pediatric patients can receive Aminosyn II 3.5% in 5% Dextrose Injection.
The suggested amino acid dosage level for children between 4 and 12 years
of age is 2 g/kg/day; for 13 to 15 years of age, 1.7 g/kg/day; and for 16
years of age and above, 1.5 g/kg/day. Energy requirements for children
between 1 and 7 years of age are approximately 75 to 90 kcal/kg/day; for children
7 to 12 years of age, 60 to 75 kcal/kg/day; and for ages 12 to 18 years,
30 to 60 kcal/kg/day. Energy intake may be supplemented with intravenous fat
emulsion. In cases of malnutrition or stress, these requirements may be increased. Supplemental
electrolytes and vitamin additives should be administered as deemed necessary
by careful monitoring of blood chemistries and nutritional status. Iron supplementation
is more critical in the child than the adult because of the increasing red
cell mass required by the growing child. Serum lipids should be monitored
for evidence of essential fatty acid deficiency in patients maintained on
fat-free TPN. Bicarbonate should not be administered during infusion of the
nutritional solution unless deemed absolutely necessary. To
ensure the precise delivery of the small volumes of fluid necessary for total
parenteral nutrition in children, accurately calibrated and reliable infusion
systems should be used.
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Upper Chamber: Aminosyn
II 7%, an amino acid injection, 500 mL. Aminosyn II
7% is a sterile, nonpyrogenic solution for intravenous infusion. The formulation
is described in the table below. Lower
Chamber: 10% Dextrose Injection, USP, 500 mL. 10%
Dextrose Injection, USP is a sterile, nonpyrogenic, hypertonic solution of
Dextrose, USP in water for injection. The table below indicates the characteristics
of this solution. The container must be used only after
removing the clamp and thoroughly mixing the contents of the two chambers.
The solution resulting from mixing the contents of the upper and the lower
chamber will be 3.5% amino acids with 5% dextrose. Mixing the contents of
the upper and lower chambers yields a concentrated source of amino acids and
carbohydrate calories for intravenous infusion. Headspace contains Nitrogen
gas. The composition of this admixture is described in the table below. *Amount cited is for lysine alone and does not include
acetate salt. The formulas for the individual amino acids are as follows: Includes
sodium from the pH adjustor sodium hydroxide and the antioxidant, sodium hydrosulfite. Includes acetate from lysine acetate. May contain sodium hydroxide for pH adjustment. Dextrose,
USP is chemically designated D-glucose, monohydrate (CHO���H0), a hexose sugar freely soluble in water. The
flexible plastic container is fabricated from a specially formulated nonplasticized
thermoplastic co-polyester (CR3). Water can permeate from inside the container
into the overwrap but not in amounts sufficient to affect the solution significantly.
Solutions inside the plastic container also can leach out certain of its chemical
components in very small amounts before the expiration period is attained.
However, the safety of the plastic has been confirmed by tests in animals
according to USP biological standards for plastic containers.
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The Aminosyn II 3.5% in 5% Dextrose Injection admixture obtained
upon mixing thoroughly the contents of the two chambers, provides carbohydrate
calories and crystalline amino acids to promote protein synthesis and wound
healing, and to reduce the rate of endogenous protein catabolism. This mixture
given by peripheral vein with vitamins and maintenance electrolytes may be
administered with intravenous fat emulsion to provide additional calories
and prevent essential fatty acid deficiency.
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This preparation should not be used in patients with hepatic
coma or metabolic disorders involving impaired nitrogen utilization.
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Aminosyn II 3.5% in 5% Dextrose Injection
is supplied in a 1000 mL volume dual-chamber flexible container (List No.
7701). Aminosyn II 3.5% in 5% Dextrose Injection is obtained by opening the
clamp separating the two chambers and mixing the contents of the upper chamber, 500
mL of Aminosyn II 7% and the lower chamber, 500 mL of 10% Dextrose Injection,
USP. 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. Avoid exposure to light. To prevent breakage, handle cold or refrigerated (2��C
to 8��C) co-polyester (CR3) containers with care. HOSPIRA, INC., LAKE FOREST,
IL 60045 USA
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Special care must be taken when administering glucose solutions
to provide calories in diabetic or prediabetic patients. To control and minimize
possible hyperglycemia and consequent glycosuria, it is desirable to monitor
blood and urine glucose and, if necessary, add insulin. Because
of its antianabolic activity, concurrent administration of tetracycline may
reduce the nitrogen sparing effects of infused amino acids. Feeding
regimens which include amino acids should be used with caution in patients
with history of renal disease, pulmonary disease, or with cardiac insufficiency
so as to avoid excessive fluid accumulation. Nitrogen
intake should be carefully monitored in patients with impaired renal function. Contains
no more than 25 mcg/L of aluminum.<br/>Pregnancy Category C.: Animal reproduction studies have not been conducted with
Aminosyn II 3.5% in 5% Dextrose Injection. It is not known whether this admixture
can cause fetal harm when administered to a pregnant woman or can affect reproductive
capacity. Aminosyn II 3.5% in 5% Dextrose Injection should be given to pregnant
women only if clearly needed.<br/>Geriatric Use: Clinical Studies of Aminosyn II in Dextrose Injection have
not been performed to determine whether patients over 65 years of age respond
differently from younger subjects. Other reported clinical experience has
not identified differences in responses between elderly and younger patients.
In general, dose selection for an elderly patient should be cautious, reflecting
the greater frequency of decreased hepatic, renal, or cardiac function, and
of concomitant disease or other drug therapy. This drug is known to be substantially
excreted by kidney, and the risk for adverse reactions to this drug 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.<br/>Pediatric Usage: Due to their concentration, these solutions are not recommended
for use in pediatric patients less than 1 year old. Frequent monitoring of
serum glucose concentrations is required when dextrose is prescribed to pediatric
patients, particularly neonates and low birth weight infants. CLINICAL
EVALUATION AND LABORATORY DETERMINATIONS, AT THE DISCRETION OF THE ATTENDING
PHYSICIAN, ARE NECESSARY FOR PROPER MONITORING DURING ADMINISTRATION. Do not
withdraw venous blood for blood chemistries through the peripheral infusion
site, as interference with estimations of nitrogen containing substances may
occur. Blood studies should include glucose, urea nitrogen, serum electrolytes,
ammonia, cholesterol, acid-base balance, serum proteins, kidney and liver
function tests, osmolarity and hemogram. White blood count and blood cultures
are to be determined if indicated. Urinary osmolality and glucose should be
determined as necessary. Do not use unless the solutions
are clear and container is undamaged. Discard unused portion. Do
not use if solution in either chamber is discolored or if clamp is open or
missing.
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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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Isoleucine, leucine, lysine, methionine, phenylalanine, threonine, tryptophan, valine, alanine, arginine, Aspartic Acid, Glutamic Acid, histidine, proline, serine, tyrosine, glycine and dextrose
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Aminosyn II in Dextrose (Injection, Solution)
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Aminosyn II 3.5% in 5% Dextrose Injection (without electrolyte
additives) is hypertonic; it can be infused through a peripheral vein paying
great care to the possible occurrence of local reactions. Local reactions
consisting of a warm sensation, erythema, phlebitis and thrombosis at the
infusion site have occurred with peripheral intravenous infusion of amino
acids; in such cases the infusion site should be changed promptly to another
vein. Use of large peripheral veins, inline filters, and slower rates of infusion
may reduce the incidence of local venous irritation. Electrolyte additives
should be spread throughout the day. Irritating additive medications may need
to be injected at another venous site. Generalized
flushing, fever and nausea have been reported during peripheral infusions
of amino acid solutions.
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Parenteral infusion of amino acids, similar to the enteral
ingestion of any protein, may induce a rise in blood urea nitrogen (BUN) especially
in patients with impaired renal function. Appropriate laboratory tests should
be performed periodically and the infusion eventually discontinued if BUN
levels exceed normal postprandial limits and continue to rise. It should be
noted that a modest rise in BUN normally occurs as a result of increased protein
intake. Administration of amino acid solutions to a
patient with hepatic insufficiency may result in serum amino acid imbalances,
metabolic alkalosis, prerenal azotemia, hyperammonemia, stupor and coma. Solutions
containing sodium ion 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 ion 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. Solutions containing
acetate ion 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. Aminosyn II 3.5%
in 5% Dextrose Injection contains sodium hydrosulfite, a sulfite that may
cause allergic-type reactions including anaphylactic symptoms and life-threatening
or less severe asthmatic episodes in certain susceptible people. The overall
prevalence of sulfite sensitivity in the general population is unknown and
probably low. Sulfite sensitivity is seen more frequently in asthmatic than
in nonasthmatic people. Parenteral administration of
amino acids may result in increased plasma ammonia concentration. Instances
of asymptomatic hyperammonemia have been reported in patients without overt
liver dysfunction. The mechanisms of this reaction are not clearly defined,
but may involve genetic defects and immature or subclinically impaired liver
function. Hyperammonemia is of special significance
in infants, as it can result in mental retardation. Therefore, it is essential
that blood ammonia levels be monitored frequently in infants. 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 at levels
associated with central nervous system and bone toxicity. Tissue loading may
occur at even lower rates of administration.
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Aminosyn II 3.5% in 5% Dextrose Injection infused through
a peripheral vein is indicated as a source of nitrogen in the nutritional
support of patients in whom for short periods of time oral nutrition cannot
be tolerated, is undesirable or inadequate. The addition
of supplemental electrolytes will be required in accordance with the prescription
of the attending physician.
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Aminosyn II in Dextrose
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