Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/3919
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Aminosyn-PF (Injection, Solution)
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dailymed-instance:dosage |
Aminosyn-PF 10%, Sulfite-Free, is an amino acid injection-pediatric
formula not intended for direct infusion. Admixtures should be made by or
under the direction of a pharmacist using strict aseptic technique under a
laminar flow hood. Admixtures must be stored under refrigeration and used
within 24 hours of admixing. The total daily dose of
the solution depends on the daily protein requirements and on the patient's
metabolic and clinical response. Pediatric requirements
for parenteral nutrition are constrained by the greater relative fluid requirements
of the infant and greater caloric requirements per kilogram than in the adult. The
recommended intravenous dose of Aminosyn-PF 10% is up to 2.5 g amino acid/kg/day
for infants up to 10 kg. For infants and children larger than 10 kg, the total
daily dose of amino acids should be up to 25 g amino acids/day for the first
10 kg of body weight plus 1.0 to 1.25 g amino acid for each kg of body weight
over 10 kg. Initial amino acid dosage levels of 1.0 g/kg/day may be increased
gradually in increments of 0.5 g/kg/day to approximate desired intake levels. Aminosyn-PF
10% should be diluted with dextrose prior to use. Nonprotein calories should
constitute approximately 100 to 130 kcal/kg/day. Part of the nonprotein caloric
requirement may be provided as lipid emulsion administered concurrently to
provide up to 60% of daily calories at a dose not to exceed 4 g fat/kg/day.Fluid intake for the infant receiving central venous TPN should be approximately
125 mL/kg/day (range: 100 to 175 mL/kg/day), depending on the clinical condition
of the patient. Fat emulsion coadministration should be considered when prolonged
(more than 5 days) parenteral nutrition is required in order to prevent essential
fatty acid deficiency (EFAD). Serum lipids should be monitored for evidence
of EFAD in patients maintained on fat-free TPN. Premature infants with respiratory
distress syndrome suspected of having a patent ductus arteriosus should be
given fluids more cautiously. Cysteine is considered
to be an essential amino acid for infants, especially preterm infants with
potentially immature enzyme pathways. Therefore, addition of a cysteine supplement
to the TPN admixture is recommended. The intake of cysteine by the preterm
infant ingesting maternal milk is approximately 78 mg/kg/day. The suggested
intravenous dosage level for Cysteine Hydrochloride Injection, USP is 500
mg (10 mL) for every 12.5 g (125 mL) of Aminosyn-PF 10% administered (see
package insert for Cysteine Hydrochloride Injection, USP). In order to avoid
potential insolubility of cysteine hydrochloride in admixtures, the foregoing
concentration should not be exceeded. In many patients,
provision of adequate calories in the form of hypertonic dextrose may require
the administration of exogenous insulin to prevent hyperglycemia and glycosuria.
To prevent rebound hypoglycemia, a solution containing 5% dextrose should
be administered when hypertonic dextrose solutions are abruptly discontinued. SERUM
ELECTROLYTES SHOULD BE MONITORED FREQUENTLY. 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. Daily administration
of intravenous vitamin supplements including a complete complement of fat
and water-soluble vitamins is required. Trace metal additives including zinc,
copper, manganese, and chromium should also be provided, especially when long-term
parenteral therapy is anticipated. Calcium and phosphorus
are added to the solution as indicated. Potentially
incompatible ions such as calcium and phosphate may be added to alternate
infusate bottles to avoid precipitation. In patients with hyperchloremic or
other metabolic acidosis, sodium and potassium may be added as the acetate
or lactate salts to provide bicarbonate alternates. Bicarbonate should not
be administered during infusion of the nutritional solution unless deemed
absolutely necessary. Additives may be incompatible.
Consult with pharmacist, if available. When introducing additives, use aseptic
technique, mix thoroughly and do not store. To ensure
the precise delivery of the small volumes of fluid necessary for total parenteral
nutrition in infants, accurately calibrated and reliable infusion systems
should be used. Central Venous
Nutrition Hypertonic mixtures of amino acids
and dextrose may be safely administered by continuous infusion through a central
venous catheter with the tip located in the superior vena cava. Initial infusion
rates should be slow, and gradually increased to the recommended 60-125 mL
per kilogram body weight per day. If administration rate should fall behind
schedule, no attempt to���catch up���to planned intake should
be made. In addition to meeting protein needs, the rate of administration,
particularly during the first few days of therapy, is governed by the patient's
glucose tolerance. Daily intake of amino acids and dextrose should be increased
gradually to the maximum required dose as indicated by frequent determinations
of glucose levels in blood and urine. Peripheral
Parenteral Nutrition For patients in whom
the central venous route is not indicated and who can consume adequate calories
enterally, Aminosyn-PF 10% may be administered by peripheral vein with parenteral
nonprotein calories. The concentration of dextrose in the final admixture
is 5 to 10%, and simultaneous administration of lipid emulsion is recommended
both as a calorie source and to attenuate the potentially irritating effects
of the hypertonic nutritional admixture. Fat emulsion may comprise up to 60%
of the dailycaloric intake at a dosage level not to exceed 4 g fat/kg/day.
It is essential that peripheral infusion be accompanied by adequate caloric
intake. Parenteral drug products should be inspected
visually for particulate matter and discoloration prior to administration,
whenever solution and container permit. Recommended
Directions for Use of the Pharmacy Bulk Package Use Aseptic Technique WARNING: Do not use
flexible container in series connections.
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dailymed-instance:descripti... |
Aminosyn-PF 10%, Sulfite-Free, (an amino
acid injection���pediatric formula) is a sterile, nonpyrogenic solution
for intravenous infusion. Aminosyn-PF 10% is oxygen sensitive. The Pharmacy
Bulk Package is a sterile dosage form which contains multiple single doses
for use only in a pharmacy bulk admixture program. The formulation is described
below: The formulas for the individual amino acids present in
Aminosyn-PF 10% are as follows: The flexible plastic container is fabricated from a specially
formulated polyvinylchloride. Water can permeate from inside the container
into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions
in contact with the plastic container may leach out certain chemical components
from the plastic in very small amounts; however, biological testing was supportive
of the safety of the plastic container materials. Exposure
to temperatures above 25��C/77��F during transport and storage will
lead to minor losses in moisture content. Higher temperatures lead to greater
losses. It is unlikely that these minor losses will lead to clinically significant
changes within the expiration period. The Pharmacy Bulk
Package is designed for use with manual, gravity flow operations and automated
compounding devices for preparing sterile parenteral nutrient admixtures;
it contains no bacteriostat. Multiple single doses may be dispensed during
continual aliquoting operations. Withdrawal of container contents should be
promptly completed within 4 hours after initial closure puncture.
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dailymed-instance:clinicalP... |
Aminosyn-PF 10%, Sulfite-Free, (an amino acid injection���pediatric formula) contains a mixture of essential and nonessential amino
acids as well as taurine. The amino acid composition has been specifically
formulated to provide a well-tolerated nitrogen source for nutritional support
and therapy for infants and young children. When administered in conjunction
with a cysteine hydrochloride additive, Aminosyn-PF 10% results in plasma
amino acid concentrations approximating a profile consistent with that of
a breast-fed infant. The rationale for Aminosyn-PF 10%
is based on the observation of inadequate levels of essential amino acids
in the plasma of infants receiving total parenteral nutrition (TPN) using
conventional amino acid solutions. Clinical studies
in infants who required TPN therapy showed that infusion of Aminosyn-PF 10%
resulted in plasma amino acid concentrations approximating those of normal
breast or formula fed infants. In addition, weight gains, nitrogen balance,
and serum protein concentrations were consistent with an improving nutritional
status. When infused with hypertonic dextrose as a calorie
source, supplemented with cysteine hydrochloride, electrolytes, vitamins,
and minerals, Aminosyn-PF 10% provides TPN for infants and young children,
with the exception of essential fatty acids. It is thought
that the acetate from lysine acetate under the conditions of parenteral nutrition,
does not impact net acid-base balance when renal and respiratory functions
are normal. Clinical evidence seems to support this thinking; however, confirmatory
experimental evidence is not available. The amounts of sodium and acetate
in Aminosyn-PF 10% are not of clinical significance. The
addition of a cysteine hydrochloride additive will contribute to the chloride
load. The electrolyte content of any additives that
are introduced should be carefully considered and included in input computations. The
human newborn conjugates bile with taurine which becomes the primary method
of biliary excretion. Taurine deficiency because of its effect on bile salt
conjugation and, therefore, on bile salt flow may be of major importance in
the genesis of cholestasis. Taurine has also been shown to play a role in
central nervous system development.
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Aminosyn-PF 10%, Sulfite-Free, (an amino acid injection���pediatric formula) is contraindicated in patients with untreated anuria, hepatic
coma, inborn errors of amino acid metabolism (including those involving branched
chain amino acid metabolism such as maple syrup urine disease and isovaleric
acidemia), or hypersensitivity to one or more amino acids present inthe solution.
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dailymed-instance:supply |
Aminosyn -PF 10%, Sulfite-Free, (an amino acid injection���pediatric formula) is supplied as a Pharmacy Bulk Package in 1000
mL flexible plastic containers List 4179. 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). Avoid exposure to light. HOSPIRA, INC., LAKE FOREST,
IL 60045 USA
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SPECIAL PRECAUTIONS FOR CENTRAL INFUSIONS ADMINISTRATION
BY CENTRAL VENOUS CATHETER SHOULD BE USED ONLY BY THOSE
FAMILIAR WITH THIS TECHNIQUE AND ITS COMPLICATIONS.
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dailymed-instance:precautio... |
Clinical evaluation and periodic laboratory determinations
are necessary to monitor changes in fluid balance, electrolyte concentrations,
and acid-base balance during prolonged parenteral therapy or whenever the
condition of the patient warrants such evaluation. Significant deviations
from normal concentrations may require the use of additional electrolyte supplements. Strongly
hypertonic nutrient solutions should be administered via an intravenous catheter
placed in a central vein, preferably the superior vena cava. Care
should be taken to avoid circulatory overload, particularly in patients with
cardiac insufficiency. Special care must be taken when
giving hypertonic dextrose to a diabetic or pre-diabetic patient. To prevent
severe hyperglycemia in such patients, insulin may be required. Administration
of glucose at a rate exceeding the patient's utilization rate may lead
to hyperglycemia, coma, and death. The effect of infusion
of amino acids, without dextrose, upon carbohydrate metabolism of children
is not known at this time. It is essential to provide adequate exogenous dextrose
calories concurrently with amino acids. Administration of amino acids without
carbohydrates may result in the accumulation of ketone bodies in the blood.
Correction of this ketonemia may be achieved by the administration of carbohydrate. Essential
fatty acid deficiency (EFAD) is becoming increasingly recognized in patients
on long term TPN (more than 5 days). The use of fat emulsion to provide 4���10% of total caloric intake as linoleic acid may prevent EFAD. Peripheral
administration of Aminosyn-PF 10%, Sulfite-Free, (an amino acid injection���pediatric formula) requires appropriate dilution and provision of
adequate calories. Care should be taken to assure proper placement of the
needle within the lumen of the vein. The venipuncture site should be inspected
frequently for signs of infiltration. If venous thrombosis or phlebitis occurs,
discontinue infusion or change infusion site and initiate appropriate treatment. Extraordinary
electrolyte losses such as may occur during protracted nasogastric suction,
vomiting, diarrhea, or gastrointestinal fistula drainage may necessitate additional
electrolyte supplementation. Metabolic acidosis can
be prevented or readily controlled by adding a portion of the cations in the
electrolyte mixture as acetate salts and in the case of hyperchloremic acidosis,
by keeping the total chloride content of the infusate to a minimum. Aminosyn-PF
10% contains no chloride. Aminosyn-PF 10% contains no
added phosphorus. Patients, especially those with hypophosphatemia, may require
the addition of phosphate. To prevent hypocalcemia, calcium supplementation
should always accompany phosphate administration. To assure adequate intake,
serum levels should be monitored frequently. Aminosyn-PF
10% contains no more than 25 mcg/L of aluminum. 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. SPECIAL PRECAUTIONS FOR CENTRAL INFUSIONS ADMINISTRATION
BY CENTRAL VENOUS CATHETER SHOULD BE USED ONLY BY THOSE
FAMILIAR WITH THIS TECHNIQUE AND ITS COMPLICATIONS. Central vein infusion (with added concentrated carbohydrate
solutions) of amino acid solutions requires a knowledge of nutrition as well
as clinical expertise in recognition and treatment of complications. Attention
must be given to solution preparation, administration and patient monitoring.
IT IS ESSENTIAL THAT A CAREFULLY PREPARED PROTOCOL, BASED ON CURRENT MEDICAL
PRACTICES, BE FOLLOWED, PREFERABLY BY AN EXPERIENCED TEAM. SUMMARY
HIGHLIGHTS OF COMPLICATIONS (See also Current Medical Literature).<br/>Pregnancy Category C: Animal reproduction studies have not been conducted with
Aminosyn-PF 10%. It is also not known whether Aminosyn-PF 10% can cause fetal
harm when administered to a pregnant woman or can affect reproduction capacity.
Aminosyn-PF 10% should be given to a pregnant woman only if clearly needed.
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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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dailymed-instance:genericMe... |
Isoleucine, leucine, lysine, methionine, phenylalanine, threonine, tryptophan, valine, alanine, arginine, aspartic acid, glutamic acid, histidine, proline, serine, tyrosine, taurine and glycine
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Aminosyn-PF (Injection, Solution)
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dailymed-instance:adverseRe... |
Local reactions consisting of erythema, phlebitis and thrombosis
at the infusion site have occurred with peripheral intravenous infusion of
amino acids particularly if other substances, such as antibiotics, are also
administered through the same site. In such cases the infusion site should
be changed promptly to another vein. Use of large peripheral veins, inline
filters, and slowing the rate 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 also have
been reported during peripheral infusions of amino acid solutions. If
an adverse reaction does occur, discontinue the infusion, evaluate the patient,
institute appropriate therapeutic countermeasures and save the remainder of
the fluid for examination if deemed necessary.
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dailymed-instance:warning |
Safe, effective use of parenteral nutrition requires a knowledge
of nutrition as well as clinical expertise in recognition and treatment of
the complications which can occur. FREQUENT EVALUATION AND LABORATORY DETERMINATIONS
ARE NECESSARY FOR PROPER MONITORING OF PARENTERAL NUTRITION. Studies should
include blood sugar, serum proteins, kidney and liver function tests, electrolytes,
hemogram, carbon dioxide content, serum osmolalities, blood cultures, and
blood ammonia levels. Administration of amino acids
in the presence of impaired renal function or gastrointestinal bleeding may
augment an already elevated blood urea nitrogen. Patients with azotemia from
any cause should not be infused with amino acids without regard to total nitrogen
intake. Administration of intravenous solutions can
cause fluid and/or solute overload resulting in dilution of serum electrolyte
concentrations, overhydration, congested states, or pulmonary edema. The risk
of dilutional states is inversely proportional to the electrolyte concentrations
of the solutions. Administration of amino acid solutions
to a patient with hepatic insufficiency may result in plasma amino acid imbalances,
hyperammonemia, prerenal azotemia, stupor and coma. Hyperammonemia
is of special significance in infants,
as its occurrence in the syndrome caused by genetic metabolic defects is sometimes
associated, although not necessarily in a causal relationship, with mental
retardation. This reaction appears to be dose-related and is more likely to
develop during prolonged therapy. It is essential that blood ammonia levels
be measured frequently in infants. Conservative doses
of amino acids should be given, dictated by the nutritional status of the
patient. Should symptoms of hyperammonemia develop, amino acid dosage levels
should be reduced and titrated against serum ammonia levels. 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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dailymed-instance:indicatio... |
Aminosyn-PF 10%, Sulfite-Free, (an amino acid injection���pediatric formula) is indicated for the nutritional support of infants (including
those of low birth weight) and young children requiring TPN via either central
or peripheral infusion routes. Parenteral nutrition with Aminosyn-PF 10% is
indicated to prevent nitrogen and weight loss or treat negative nitrogen balance
in infants and young children where (1) the alimentary tract by the oral gastrostomy,
or jejunostomy route, cannot or should not be used or adequate protein intake
is not feasible by these routes; (2) gastrointestinal absorption of protein
is impaired; or (3) protein requirements are substantially increased as with
extensive burns. Dosage, route of administration, and concomitant infusion
of non-protein calories are dependent on various factors, such as nutritional
and metabolic status of the patient, anticipated duration of parenteral nutrition
support, and vein tolerance. See DOSAGE AND ADMINISTRATION for additional
information. Central Venous
Infusion Central venous infusion should be
considered when amino acid solutions are to be admixed with hypertonic dextrose
to promote protein synthesis in hypercatabolic or severely depleted infants
or those requiring long-term parenteral nutrition. Peripheral Parenteral Nutrition For
moderately catabolic or depleted patients in whom the central venous route
is not indicated, diluted amino acid solutions mixed with 5 to 10% dextrose
solutions may be infused by peripheral vein, supplemented, if desired, with
fat emulsion.
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Aminosyn-PF
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