renamin
Generic Name: (
Valine, leucine, isoleucine, methionine, phenylalanine, lysine, histidine, threonine, tryptophan, arginine, alanine, proline, glycine, serine and tyrosine)
Dosage Type: injection Organization: Baxter Healthcare Corporation
DESCRIPTION
RenAmin® (Amino
Acid) Injection is a sterile, nonpyrogenic, hypertonic solution of
essential and nonessential amino acids in a Pharmacy Bulk Package. A
Pharmacy Bulk Package is a container of a sterile preparation for
parenteral use that contains many single doses. The contents are
intended for use in a pharmacy admixture program and are restricted to
the preparation of admixtures for intravenous infusion.
Each 100 mL of
RenAmin® (Amino Acid) Injection contains:
|
Amino Acids |
6.5 g |
|
Total Nitrogen |
1 g |
| pH (pH
adjusted with glacial acetic acid) |
6.0 (5.0 to 7.0) |
Essential Amino
Acids
| Valine -
C5H11NO2 |
820
mg |
| Leucine -
C6H13NO2 |
600
mg |
| Isoleucine -
C6H13NO2 |
500
mg |
| Methionine -
C5H11NO2S |
500
mg |
| Phenylalanine -
C9H11NO2 |
490
mg |
| Lysine (added as the hydrochloride salt) -
C6H14N2O2 |
450 mg |
| Histidine -
C6H9N3O2 |
420
mg |
| Threonine -
C4H9NO3 |
380
mg |
| Tryptophan -
C11H12N2O2 |
160 mg |
Nonessential Amino
Acids
| Arginine –
C6H14N4O2 |
630 mg |
| Alanine – C3H7NO2 |
560 mg |
| Proline –
C5H9NO2 |
350 mg |
| Glycine –
C2H5NO2 |
300 mg |
| Serine –
C3H7NO3 |
300 mg |
| Tyrosine-C9H11NO3 |
40 mg |
Anion Profile per
Liter*
| Acetate (1) |
|
60 mEq |
| Chloride (2) |
|
31
mEq |
|
|
* Balanced by ions from amino acids
(1)
derived from pH adjustment with glacial acetic acid
(2) contributed by the Lysine Hydrochloride |
|
| 3 mEq/L sodium bisulfite
added as stabilizer |
|
| Osmolarity
(calc.) |
|
600 mOsmol/L |
CLINICAL PHARMACOLOGY
RenAmin® (Amino
Acid) Injection provides biologically utilizable source material for
protein synthesis when used with appropriate calorie sources (such as
hypertonic dextrose or fat emulsion), electrolytes, vitamins and
minerals.
As a concentrated
source of essential amino acids, RenAmin® (Amino Acid) Injection provides
maximal protein intake with low volume administration. The essential
amino acids are included as approximately 60% w/w of total amino acids.
Each 250 mL unit of this injection meets or exceeds the recommended
daily intake of essential amino acids. Nonessential amino acids have
been included to meet requirements established in investigations of
acute and chronic renal failure patients fed parenterally. The 40% w/w
of nonessential amino acids includes histidine (considered an essential
amino acid in renal failure), arginine, and other nonessential amino
acids as additional sources of nitrogen that have been shown to enhance
nitrogen balance and weight gain.
INDICATIONS AND USAGE
RenAmin® (Amino
Acid) Injection is indicated as an adjunct in the offsetting of nitrogen
loss or in the treatment of negative nitrogen balance in potentially
reversible renal decompensation when the alimentary tract cannot or
should not be used; gastrointestinal absorption of protein is impaired;
or metabolic requirements for protein are substantially increased, as
with extensive burns.
CONTRAINDICATIONS
Severe uncorrected
electrolyte and acid base imbalance
Severe liver
disease or hepatic coma
Hyperammonemia
Hypersensitivity to
one or more amino acids
Decreased
circulating blood volume
WARNINGS
This injection is for compounding only, not
for direct infusion.
Proper
administration of RenAmin® (Amino Acid) Injection requires a knowledge
of fluid and electrolyte balance and nutrition as well as clinical
expertise in recognition and treatment of the complications which may
occur.
Administration of
amino acid solutions to a patient with hepatic insufficiency may result
in serum amino acid imbalances, hyperammonemia, stupor and coma.
Hyperammonemia is
of special significance in infants.
This reaction appears to be related to a deficiency of the urea cycle
amino acids of genetic or product origin. It is essential that blood
ammonia be measured frequently in infants.
This injection has
no added electrolytes. Clinically significant hypocalcemia,
hypophosphatemia or hypomagnesemia may occur. Electrolyte replacement
may become necessary.
Contains sodium
bisulfite, 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.
This injection
should not be administered simultaneously with blood through the same
infusion set because of the possibility of pseudoagglutination.
RenAmin® (Amino
Acid) Injection does not replace dialysis and conventional supportive
therapy in patients with renal failure.
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 indicatesthat patients with impaired kidney function, including premature
neonates, who receive parenteral levels of aluminum at greater than 4 to
5 µg/kg/day accumulate aluminum at levels associated with central
nervous system and bone toxicity. Tissue loading may occur at even lower
rates of administration.
PRECAUTIONS
It is essential to
provide adequate calories concurrently if parenterally administered
amino acids are to be retained by the body and utilized for protein
synthesis. Concentrated dextrose solutions are an effective source of
such calories.
With the
administration of RenAmin® (Amino Acid) Injection in combination with
highly concentrated dextrose solutions, hyperglycemia, glycosuria and
hyperosmolar syndrome may result. Blood and urine glucose should be
monitored on a routine basis in patients receiving this therapy.
Sudden cessation in
administration of a concentrated dextrose solution may result in insulin
reaction due to continued endogenous insulin production. Parenteral
nutrition mixtures should be withdrawn slowly.
Electrolytes may be
added to RenAmin® (Amino Acid) Injection as dictated by the patient's
electrolyte profile.
Strongly hypertonic
nutrient solutions should be administered through an indwelling
intravenous catheter with the tip located in the superior vena cava.
Care should be
taken to avoid excess fluid accumulation, particularly in patients with
renal disease, pulmonary insufficiency and heart disease.
During amino acid
administration in the absence of supporting carbohydrate metabolism, an
accumulation of ketone bodies in the blood often occurs. Correction of
ketonemia usually can be accomplished by administering some
carbohydrates.
Drug product
contains no more than 25 µg/L of aluminum.
Laboratory Tests
Frequent clinical evaluation and laboratory determinations are necessary for proper monitoring during administration.
Studies
should include blood urea nitrogen, blood sugar, serum proteins,
kidney and liver function tests, electrolytes, acid-base
balance, hemogram, carbon dioxide combining power or content,
serum osmolarities, blood cultures and blood ammonia levels.
Circulating blood volume should be determined, if
indicated.
Carcinogenesis,
Mutagenesis, Impairment of Fertility:
Studies
with RenAmin® (Amino Acid) Injection have not been performed to
evaluate carcinogenesis potential, mutagenic potential, or
effects on fertility.
Pregnancy:
Teratogenic
Effects
Pregnancy Category C.
Animal reproduction studies have not been
conducted with RenAmin® (Amino Acid) Injection.
It is also not known whether RenAmin® (Amino
Acid) Injection can cause fetal harm when
administered to a pregnant woman or can affect
reproduction capacity. RenAmin® (Amino Acid)
Injection should be given to a pregnant woman
only if clearly needed.
Nursing Mothers:
It is not
known whether this drug is excreted in human milk. Because many
drugs are excreted in human milk, and because of the potential
for adverse reactions, e.g., hyperammonemia in nursing infants,
caution should be exercised when RenAmin® (Amino Acid) Injection
is administered to a nursing mother.
Pediatric Use:
Safety and
effectiveness of RenAmin® (Amino Acid) Injection have not been
established by adequate and well-controlled studies in pediatric patients.
Geriatric Use:
Clinical
studies of RenAmin® (Amino Acid) Injection did not include
sufficient numbers of subjects aged 65 and over to determine
whether they respond differently from other younger subjects.
Other reported clinical experience has not identified
differences in responses between the 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 drug therapy.
SPECIAL PRECAUTIONS
Administration of
amino acid solutions and other nutrients via central or peripheral
venous catheter may be associated with complications which can be
prevented or minimized by careful attention to all aspects of the
procedure. This includes attention 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.
Although a detailed
discussion of the complications is beyond the scope of this insert, the
following summary lists those based on current literature:
Technical:
The
placement of a central venous catheter should be regarded as a
surgical procedure. The physician should be fully acquainted
with various techniques of catheter insertion as well as
recognition and treatment of complications. For details of
techniques and placement sites consult the medical literature. X-ray is the best means of verifying catheter placement.
Complications known to occur from the placement of central
venous catheters are pneumothorax, hemothorax, hydrothorax,
artery puncture and transection, injury to the brachial plexus,
malposition of the catheter, formulation of arteriovenous
fistula, phlebitis, thrombosis, cardiac arrhythmia and catheter embolus.
Septic:
The
constant risk of sepsis is present during administration of
parenteral nutrition solution. Since contaminated solutions and
infusion catheters are potential sources of infection, it is
imperative that the preparation of the solution and the
placement and care of catheters be accomplished under controlled
aseptic conditions. If fever develops, the solution, its
delivery system and the site of the indwelling catheter should
be changed.
Metabolic:
The
following metabolic complications have been reported: metabolic
acidosis, hypophosphatemia, alkalosis, hyperglycemia and
glycosuria, osmotic diuresis and dehydration, rebound
hypoglycemia, elevated liver enzymes, hypo- and hypervitaminosis, electrolyte imbalances and hyperammonemia.
Frequent clinical evaluation and laboratory determinations are
necessary, especially during the first few days of therapy, to
prevent or minimize these complications.
Special Precautions
in Patients with Renal Insufficiency
Frequent
laboratory studies are necessary in patients with renal
insufficiency. In renal failure, hyperglycemia may not be
reflected by glycosuria. Blood glucose must be determined
frequently, often every six hours to guide dosage of dextrose,
and insulin should be given, if required.
Special Precautions
in Pediatric Patients
RenAmin®
(Amino Acid) Injection should be used with special caution in
pediatric patients with acute renal failure, especially low
birth weight infants. Laboratory and clinical monitoring of
pediatric patients, especially those who are nutritionally
depleted, must be extensive and frequent. See Children section under DOSAGE AND
ADMINISTRATION for additional information.
Frequent monitoring of blood glucose is required in low birth
weight or septic infants, as hypertonic dextrose infusion
involves a greater risk of hyperglycemia in such
patients.
ADVERSE REACTIONS
See WARNINGS
and PRECAUTIONS
Adverse effects
include metabolic, electrolyte, acid-base and fluid imbalances unless
special care with monitoring and corrective management is maintained
during RenAmin® (Amino Acid) injection administration.
Infusion of any
hypertonic solution can result in local inflammatory reactions. Policies
and procedures should be established for the recognition and management
of such reactions.
DOSAGE AND ADMINISTRATION
If a patient is unable to take oral nourishment for a prolonged period of time, institution of total parenteral nutrition (TPN) with exogenous calories
should be considered.
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.
Adult:
The total
daily dose of RenAmin® (Amino Acid) Injection depends on the
patient's metabolic requirement and clinical response. The
determination of nitrogen balance and accurate daily body
weights, corrected for fluid balance, are probably the best
means of assessing individual nitrogen requirements.
Nutritional
management of renal decompensation includes providing sufficient
amino acid and caloric support for protein synthesis while not exceeding renal capacity for excretion of metabolic wastes. A
dosage of 2.5 to 5.0 grams of nitrogen per day with adequate calories will maintain nitrogen equilibrium in most patients
with uremia. If more nitrogen and calories are required, higher
dosages may be administered, provided great care is taken to
avoid exceeding limits of fluid intake or glucose tolerance.
Dosage
should be guided by fluid, glucose and nitrogen tolerances, as
well as metabolic and clinical responses. The rate of increase
in blood urea nitrogen concentration generally diminishes when
infusion of amino acids is accompanied by adequate calories.
However, excessive intake of protein or increased protein
catabolism may alter this response.
The usual
daily dose ranges from 250 to 500 mL of RenAmin® (Amino Acid)
Injection equivalent to 2.5 to 5.0 grams of nitrogen in 16.2 to
32.5 grams of amino acids.
Adequate
calories should be administered simultaneously.
Patients
receiving RenAmin® (Amino Acid) Injection should be monitored
carefully and their electrolyte requirements individualized.
Electrolyte supplementation may be required. This injection
contains approximately 60 mEq acetate and 31 mEq chloride.
Electrolyte
(phosphorous, potassium and magnesium) concentrations usually
fall during administration of RenAmin® (Amino Acid) Injection.
Particular care should be taken in the presence of cardiac
arrhythmias or digitalis toxicity to assure that these
electrolytes are supplemented when necessary.
Children:
Pediatric
requirements vary depending upon growth, nutritional state and
degree of renal insufficiency. A dosage of 0.5 to 1.0 gram of
amino acids per kilogram body weight per day will meet the
requirements of the majority of pediatric patients. Initial
daily dosage should be low and increased slowly. More than one
gram of essential amino acids per kilogram of body weight per
day is not recommended. The total volume of nutritional
solution, and the rate at which it is administered, will vary
with the child’s age, nutritional and growth state, as well as
the degree of renal failure. See Special
Precautions in Pediatric Patients for additional
information.
Maintenance
vitamins, additional electrolytes and trace elements should be
administered as required.
Central Vein
Administration:
Hypertonic
mixtures of amino acids and dextrose may be administered safely
by continuous infusion through a central vein catheter with the
tip located in the vena cava. In addition to meeting nitrogen
needs, the administration rate is governed, especially during
the first few days of therapy, by the patient's tolerance to
dextrose. Daily intake of amino acids and dextrose should be
increased gradually to the maximum required dose as indicated by
frequent determinations of urine and blood sugar levels.
Uremic
patients frequently are glucose intolerant. Provision of adequate calories in the form of hypertonic dextrose may require
the administration of exogenous insulin to prevent hyperglycemia
and glycosuria.
Parenteral
nutrition may be started at lower administration rates and with
infusates containing lower concentrations of dextrose; dextrose
content and rate may be gradually increased to estimated caloric
needs as the patient’s glucose tolerance increases. The
patient’s fluid, nitrogen and glucose tolerance should be the
determining factor of the rate of administration.
Sudden
cessation in administration of concentrated dextrose solutions
may result in insulin reactions due to continued endogenous
insulin production. Such solutions should be withdrawn
slowly.
Peripheral Vein
Administration:
For
patients requiring parenteral nutrition in whom the central vein
route is not indicated, this injection can be mixed with low
concentration dextrose solutions and administered by peripheral
vein with fat emulsions.
Intravenous
fat emulsions provide approximately 1.1 kcal/mL (10%) or 2.0
kcal/mL (20%) and may be administered along with amino
acid-dextrose solutions through a short Y-connector near the
infusion site to supplement caloric intake. Fat, however, should
not be the sole caloric intake since studies have indicated that
glucose is more nitrogen sparing in the stressed patient.
Parenteral drug products should be inspected visually for particulate
matter and discoloration prior to administration whenever
solution and container permit. Use of a final filter is
recommended during administration of all parenteral solutions
where possible.
Do not use unless solution
is clear and vacuum is present. Unit must be used with a
vented set or a nonvented set with a vented spike
adapter.
RenAmin®
(Amino Acid) Injection in the Pharmacy Bulk Package is intended
for use in the preparation of sterile, intravenous admixtures.
Additives may be incompatible with the fluid withdrawn from this
container. Complete information is not available. Those
additives known to be incompatible should not be used. Consult
with pharmacist, if available. When compounding admixtures, use
aseptic technique. Mix thoroughly. Do not store any unused
portion of RenAmin® (Amino Acid) Injection.
Solutions
should be used promptly after mixing. Any storage should be
under refrigeration and limited to a brief period of time,
preferably less than 24 hours.
DIRECTIONS FOR USE OF THE
PHARMACY BULK PACKAGE CONTAINER
For compounding
only, not for direct infusion.
1. The Pharmacy
Bulk Package is to be used only in a suitable work area such as a
laminar flow hood (or an equivalent clean air compounding area).
2. Remove outer
seal and metal disc.
3. Swab surface of
stopper using approved technique.
4. Insert vented
connector of solution transfer set and suspend unit. Refer to directions
accompanying set.
Note: The closure
shall be penetrated only one time with a suitable sterile transfer
device or dispensing set which allows measured dispensing of the
contents.
5. Once container
closure has been penetrated, withdrawal of contents should be completed
without delay. After initial entry, maintain contents at room
temperature (25ºC/77ºF) and dispense within 4 hours.
HOW SUPPLIED
RenAmin® (Amino
Acid) Injection is available in glass Pharmacy Bulk Packages as follows:
| 2A6222 |
250
mL |
NDC
0338-0471-02 |
| 2A6223 |
500 mL |
NDC 0338-0471-03 |
Exposure of
pharmaceutical products to heat should be minimized. Avoid excessive
heat. Protect from freezing. It is recommended the product be stored at
room temperature (25ºC/77ºF): brief exposure up to 40ºC does not
adversely affect the product, Protect from light until immediately prior to use.
*For Bar Code
Position Only
071941631
Baxter Healthcare Corporation
Clintec Nutrition
Division
Deerfield, IL,
60015 USA
Printed in USA
©Copyright 1997,
2000, Baxter Healthcare Corporation. All rights reserved.
07-19-41-631
| RenAmin (Valine, leucine, isoleucine, methionine, phenylalanine, lysine, histidine, threonine, tryptophan, arginine, alanine, proline, glycine, serine and tyrosine) |
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Revised: 05/2006Baxter Healthcare Corporation