Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/2982
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Aminosyn-PF (Injection, Solution)
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dailymed-instance:dosage |
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 7%, Sulfite-Free, (an amino acid injection���pediatric
formula) 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 to
1.25 g amino acid for each kg of body weight over 10 kg. Initial amino acid
dosage levels of 1 g/kg/day may be increased gradually in increments of 0.5
g/kg/day to approximate desired intake levels. Aminosyn-PF
7% 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. 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 (179 mL) of Aminosyn-PF 7% 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 7% 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 daily caloric 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. WARNING: Do not use flexible container in series connections.
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dailymed-instance:descripti... |
Aminosyn-PF 7%, Sulfite-Free, (an amino
acid injection���pediatric formula) is a sterile, nonpyrogenic solution
for intravenous infusion. Aminosyn-PF 7% is oxygen sensitive.
The formulation is described below: * Amount cited is for lysine alone and does not include
the acetate salt. From lysine acetate. The formulas for the individual amino acids present in
Aminosyn-PF 7% 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.
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dailymed-instance:clinicalP... |
Aminosyn-PF 7% 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 7% results in plasma amino
acid concentrations approximating a profile consistent with that of a breast-fed
infant. The rationale for Aminosyn-PF 7% 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 7% 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 7% 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 7% 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 7%, 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 in the solution.
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dailymed-instance:supply |
Exposure of pharmaceutical products to heat should be minimized.
Avoid excessive heat. Protect from freezing. Store at 20 to 25��C (68
to 77��F). [See USP Controlled Room Temperature.]Avoid
exposure to light. November, 2004 ��Hospira
2004 EN-0533 Printed in USA 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 7%, 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
infusions 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
7% contains no chloride. Aminosyn-PF 7% 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
7% contains no more than 25 mcg/L of aluminum. To minimize
the risk of possible incompatabilities 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.<br/>General Precautions: N/A 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 EXPERIENCEDTEAM. SUMMARY
HIGHLIGHTS OF COMPLICATIONS (See also Current Medical Literature).<br/>Pregnancy Category C: Animal reproduction studies have not been conducted with
Aminosyn-PF 7%. It is also not known whether Aminosyn-PF 7% can cause fetal
harm when administered to a pregnant woman or can affect reproduction capacity.
Aminosyn-PF 7% should be given to a pregnant woman only if clearly needed.
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dailymed-instance:overdosag... |
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, Glycine, Histidine, Proline, Serine, Taurine and Tyrosine
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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 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 7%, 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 7% 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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