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Overview
What is Novamine?
Novamine 15% Amino Acids Injection in a Pharmacy Bulk Package is a sterile, clear, nonpyrogenic solution of essential and nonessential amino acids for intravenous infusion in parenteral nutrition following appropriate dilution.
Novamine 15% in a Pharmacy Bulk Package is not for direct infusion. It is a sterile dosage from which contains several single doses for use in a pharmacy admixture program in the preparation of intravenous parenteral fluids.
Each 100 mL contains:
The formulas for the individual amino acids are as follows:
What does Novamine look like?
What are the available doses of Novamine?
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What should I talk to my health care provider before I take Novamine?
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How should I use Novamine?
Novamine 15% is indicated as an amino acid
(nitrogen) source in parenteral nutrition regimens. This use is appropriate
when the enteral route is inadvisable, inadequate or not possible, as when:
—
Gastrointestinal absorption is impaired by obstruction, inflammatory disease
or its complications, or antineoplastic therapy;
—
Bowel rest is needed because of gastrointestinal surgery or its complications
such as ileus, fistulae or anastomotic leaks;
—
Tube feeding methods alone cannot provide adequate nutrition.
The appropriate daily dose of amino acids to be used with
dextrose or with dextrose and intravenous fat emulsion will depend upon the
metabolic status and clinical response of the patient as therapy proceeds.
Doses which achieve nitrogen equilibrium or positive balance are the most
desirable. The dosage on the first day should be approximately half the anticipated
optimal dosage and should be increased gradually to minimize glycosuria; similarly,
withdrawal should be accomplished gradually to avoid rebound hypoglycemia.
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.
The amount administered
is dosed on the basis of amino acids/kg of body weight/day. In general, two
to three g/kg of body weight for neonates and infants with adequate calories
are sufficient to satisfy protein needs and promote positive nitrogen balance.
In pediatric patients, the final solution should not exceed twice normal serum
osmolarity (718 mOsmol/L).
DIRECTIONS
FOR PROPER USE OF PHARMACY BULK PACKAGE
Novamine 15%
in a Pharmacy Bulk Package is not intended for direct infusion. The container
closure may be penetrated only once using a suitable sterile transfer device
or dispensing set which allows measured dispensing of the contents. 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). Once the closure
is penetrated, the contents should be dispensed as soon as possible; the transfer
of contents must be completed within 4 hours of closure entry. The bottle
may be stored at room temperature (25°C) after the closure has been entered.
Date and time of container entry should be noted in the area designated on
the container label.
When using Novamine 15%
in patients with a need for fluid volume restriction, it can be diluted as
follows:
This will provide 1395 kilocalories (kcal) per 1000 mL
of admixture with a ratio of 118 non-protein calories per gram of nitrogen
and an osmolarity of 1561 mOsmol/L.
In patients where
the need for fluid restriction is not so marked, either of the following regimens
may be used dependent upon the energy needs of the patient.
This will provide 1500 kcal per 1000 mL of admixture with
a ratio of 228 non-protein calories per gram of nitrogen and an osmolarity
of 1633 mOsmol/L.
This will provide 935 kcal per 1000 mL of admixture with
a ratio of 158 non-protein calories per gram of nitrogen and an osmolarity
of 1128.5 mOsmol/L.
A. Total Parenteral Nutrition (Central
Infusion)
In unstressed adult patients with no unusual
nitrogen losses, a minimum dosage of 0.1 gram nitrogen (4.2 mL of Novamine 15%)
plus 4.4 grams (15 calories) of dextrose per kilogram of body weight per day
are required to achieve nitrogen balance and weight stability. Intravenous
fat emulsion may be used as a partial substitute for dextrose. This regimen
provides a ratio of 150 non-protein calories per gram of nitrogen.
For
patients stressed by surgery, trauma or sepsis, and those with unusual nitrogen
losses, the dosage required for maintenance may be as high as 0.3 to 0.4 grams
of nitrogen (13 to 17 mL Novamine 15%) per kilogram of body
weight per day, with proportionate increases in non-protein calories. Periodic
assessment of nitrogen balance of the individual patient is the best indicator
of proper dosage. Volume overload and glycosuria may be encountered at high
dosage, and nitrogen balance may not be achieved in extremely hypermetabolic
patients under these constraints. Concomitant insulin administration may be
required to minimize glycosuria. Daily laboratory monitoring is essential.
Use
of an infusion pump is advisable to maintain a steady infusion rate during
central venous infusion.
B. Peripheral Nutrition
In
patients for whom central venous catheterization is not advisable, protein
catabolism can be reduced by peripheral use of diluted Novamine 15%
plus non-protein calorie sources. Dilution of 250 mL Novamine 15%
in 750 mL of 10% dextrose will reduce the osmolarity to a level (724 mOsmol/L)
which is more favorable to the maintenance of the integrity of the walls of
the veins. Intravenous fat emulsion can be infused separately or simultaneously;
if infused simultaneously the fat emulsion will provide a dilution effect
upon the osmolarity while increasing the energy supply.
Parenteral
drug products should be inspected visually for particulate matter and discoloration
prior to administration, whenever solution and container permit.
To
reduce the risk of bacterial contamination, all intravenous administration
sets should be replaced at least every 24 hours. Usage of admixtures must
be initiated within 24 hours after mixing. If storage is necessary during
this 24 hour period, admixtures must be refrigerated and completely used within
24 hours of beginning administration.
What interacts with Novamine?
This solution should not be used in patients in hepatic coma, severe renal failure, metabolic disorders involving impaired nitrogen utilization or hypersensitivity to one or more amino acids.
What are the warnings of Novamine?
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of , and surgical evaluation should be instituted as clinically indicated.
Administration of amino acids solutions at excessive rates
or to patients with hepatic insufficiency may result in plasma amino acid
imbalances, hyperammonemia, prerenal azotemia, stupor and coma. Conservative
doses of amino acids should be given to these patients, dictated by the nutritional
status of the patient. Should symptoms of hyperammonemia develop, amino acid
administration should be discontinued and the patient’s clinical status
re-evaluated.
Contains sodium metabisulfite, 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.
WARNING:
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.
What are the precautions of Novamine?
A. GENERAL
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.
The administration of Novamine 15% Amino Acids Injection as part of total parenteral nutrition (TPN) with large volumes of hyperosmotic fluids requires periodic monitoring of the patient for signs of hyperosmolarity, hyperglycemia, glycosuria and hypertriglyceridemia.
During parenteral nutrition with concentrated dextrose and amino acids solutions, essential fatty acid deficiency syndrome may develop but may not be clinically apparent. Early demonstration of this condition can only be accomplished by gas liquid chromatographic analysis of plasma lipids. The syndrome may be prevented or corrected by appropriate treatment with intravenous fat emulsions.
For complete nutritional support, TPN regimens must also include multiple vitamins and trace elements. Potentially incompatible ions such as calcium and phosphate may be added to alternate infusate bottles to avoid precipitation. Although the metabolizable acetate ion in Novamine 15% diminishes the risk of acidosis, the physician must be alert to the potential appearance of this disorder.
Initiation and termination of infusions of TPN fluids must be gradual to permit adjustment of endogenous insulin release.
Undiluted Novamine 15% should not be administered peripherally. When administered centrally, it should be diluted with appropriate diluents, e.g., dextrose, electrolytes and other nutrient components, to at least half strength. See DOSAGE AND ADMINISTRATION.
Caution against volume overload should be exercised.
Drug product contains no more than 25 mcg/L of aluminum.
B. Laboratory Tests
Infusion of Novamine 15% without concomitant infusion of an adequate number of non-protein calories may result in elevated BUN. Monitoring of BUN is required and the balance between Novamine 15% and the calorie source may require adjustment. Frequent clinical evaluations and laboratory determinations are required to prevent the complications which may occur during the administration of solutions used in TPN. Laboratory tests should include blood glucose, serum electrolytes, liver and kidney function, serum osmolarity, blood ammonia, serum protein, pH, hematocrit, WBC and urinary glucose. When Novamine 15% is combined with electrolytes, care should be used in administering this solution to patients with congestive heart failure, renal failure, edema, adrenal hyperactivity, acid-base imbalance and those receiving diuretics or antihypertensive therapy. Total volume infused should be closely monitored. Serum electrolytes should be monitored daily in these patients.
C. Carcinogenesis, Mutagenesis, Impairment of Fertility
Studies with Novamine 15% have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility.
D. Pregnancy Category C
Animal reproduction studies have not been conducted with Novamine 15%. It is also not known whether Novamine 15% can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Novamine 15% should be given to a pregnant woman only if clearly needed.
E. Nursing Mothers
Caution should be exercised when Novamine 15% is administered to a nursing woman.
F. Pediatric Use
Safety and effectiveness of Novamine 15% Amino Acids Injection in pediatric patients have not been established by adequate and well-controlled studies. However, the use of amino acids injections in pediatric patients as an adjunct in the offsetting of nitrogen loss or in the treatment of negative nitrogen balance is referenced in the medical literature.
G. Special Precautions for Central Infusion
TPN delivered by indwelling catheter through a central or large peripheral vein is a special technique requiring a team effort by physician, nurse and pharmacist. The responsibility for administering this therapy should be confined to those trained in the procedures and alert to signs of complications. Complications known to occur from the placement of central venous catheter are pneumothorax, hemothorax, hydrothorax, artery puncture and transection, injury to the brachial plexus, malposition of the catheter, formation of arteriovenous fistula, phlebitis, thrombosis, and air/catheter emboli. The risk of sepsis is present during intravenous therapy, especially when using central venous catheters for prolonged periods. It is imperative that the preparation of admixtures and the placement and care of the catheters be accomplished under controlled aseptic conditions.
H. Admixtures
Admixtures should be prepared under a laminar flow hood using aseptic technique.
Admixtures should be stored under refrigeration and must be administered within 24 hours after removal from refrigerator.
Filters of less than 1.2 micron pore size must not be used with admixtures containing fat emulsion.
I. Do not administer unless solution is clear and the seal is intact.
IT IS ESSENTIAL THAT A CAREFULLY PREPARED PROTOCOL, BASED ON CURRENT MEDICAL PRACTICES, BE FOLLOWED, PREFERABLY BY AN EXPERIENCED TEAM.
What are the side effects of Novamine?
See WARNINGS, PRECAUTIONS and Special Precautions for Central
Infusion.
What should I look out for while using Novamine?
This solution should not be used in patients in hepatic coma,
severe renal failure, metabolic disorders involving impaired nitrogen utilization
or hypersensitivity to one or more amino acids.
Administration of amino acids solutions at excessive rates
or to patients with hepatic insufficiency may result in plasma amino acid
imbalances, hyperammonemia, prerenal azotemia, stupor and coma. Conservative
doses of amino acids should be given to these patients, dictated by the nutritional
status of the patient. Should symptoms of hyperammonemia develop, amino acid
administration should be discontinued and the patient’s clinical status
re-evaluated.
Contains sodium metabisulfite, 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.
WARNING:
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.
What might happen if I take too much Novamine?
In the event of overhydration or solute overload, re-evaluate
the patient and institute appropriate corrective measures. See WARNINGS and
PRECAUTIONS.
How should I store and handle Novamine?
StorageStore at 25ºC (77ºF); excursions permitted to 15º-30ºC (59º-86ºF) [see USP Controlled Room Temperature].StorageStore at 25ºC (77ºF); excursions permitted to 15º-30ºC (59º-86ºF) [see USP Controlled Room Temperature].Novamine 15% Amino Acids Injection is supplied as a Pharmacy Bulk Package in 500 mL containers.500 mL 0409-0468-05STORAGEStore in the closed carton; do not expose solution to light until ready for use. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended that the product be stored at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Brief exposure to temperatures above 25°C during transport and storage will not adversely affect the product. Solution that has been frozen must not be used.Hospira, Inc., Lake Forest, IL 60045 USA Novamine 15% Amino Acids Injection is supplied as a Pharmacy Bulk Package in 500 mL containers.500 mL 0409-0468-05STORAGEStore in the closed carton; do not expose solution to light until ready for use. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended that the product be stored at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Brief exposure to temperatures above 25°C during transport and storage will not adversely affect the product. Solution that has been frozen must not be used.Hospira, Inc., Lake Forest, IL 60045 USA Novamine 15% Amino Acids Injection is supplied as a Pharmacy Bulk Package in 500 mL containers.500 mL 0409-0468-05STORAGEStore in the closed carton; do not expose solution to light until ready for use. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended that the product be stored at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Brief exposure to temperatures above 25°C during transport and storage will not adversely affect the product. Solution that has been frozen must not be used.Hospira, Inc., Lake Forest, IL 60045 USA Novamine 15% Amino Acids Injection is supplied as a Pharmacy Bulk Package in 500 mL containers.500 mL 0409-0468-05STORAGEStore in the closed carton; do not expose solution to light until ready for use. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended that the product be stored at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Brief exposure to temperatures above 25°C during transport and storage will not adversely affect the product. Solution that has been frozen must not be used.Hospira, Inc., Lake Forest, IL 60045 USA Novamine 15% Amino Acids Injection is supplied as a Pharmacy Bulk Package in 500 mL containers.500 mL 0409-0468-05STORAGEStore in the closed carton; do not expose solution to light until ready for use. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended that the product be stored at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Brief exposure to temperatures above 25°C during transport and storage will not adversely affect the product. Solution that has been frozen must not be used.Hospira, Inc., Lake Forest, IL 60045 USA
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Novamine 15% Amino Acids Injection provides
seventeen crystalline amino acids. This completely utilizable substrate promotes
protein synthesis and wound healing and reduces the rate of protein catabolism.
A.
Total Parenteral Nutrition (Central Infusion)
When enteral
feeding is inadvisable, Novamine 15% given by central venous
infusion in combination with energy sources, vitamins, trace elements and
electrolytes, will completely satisfy the requirements for weight maintenance
or weight gain, depending upon the dose selected. The energy component in
parenteral nutrition by central infusion may be derived solely from dextrose
or may be provided by a combination of dextrose and intravenous fat emulsion.
The addition of intravenous fat emulsion provides essential fatty acids and
permits a dietary balance of fat and carbohydrate, at the same time offering
the option of reducing the dextrose load and/or increasing the total caloric
input. An adequate energy supply is essential for optimal utilization of amino
acids.
B. Total Parenteral Nutrition (Peripheral Infusion)
Novamine 15%
can also be administered as part of a total parenteral nutrition program by
peripheral vein when the enteral route is inadvisable and use of the central
venous catheter is contraindicated.
Reduction of protein
loss can be achieved by use of diluted Novamine 15% in combination
with dextrose or with dextrose and intravenous fat emulsion by peripheral
infusion. Complete peripheral intravenous nutrition can be achieved in patients
with low caloric requirements by a Novamine15%-dextrose-fat
regimen.
Non-Clinical Toxicology
This solution should not be used in patients in hepatic coma, severe renal failure, metabolic disorders involving impaired nitrogen utilization or hypersensitivity to one or more amino acids.Administration of amino acids solutions at excessive rates or to patients with hepatic insufficiency may result in plasma amino acid imbalances, hyperammonemia, prerenal azotemia, stupor and coma. Conservative doses of amino acids should be given to these patients, dictated by the nutritional status of the patient. Should symptoms of hyperammonemia develop, amino acid administration should be discontinued and the patient’s clinical status re-evaluated.
Contains sodium metabisulfite, 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.
WARNING:
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.
Many drugs affect thyroid hormone pharmacokinetics and metabolism (e.g., absorption, synthesis, secretion, catabolism, protein binding, and target tissue response) and may alter the therapeutic response to Levothyroxine Sodium Tablets, USP. In addition, thyroid hormones and thyroid status have varied effects on the pharmacokinetics and action of other drugs. A listing of drug-thyroidal axis interactions is contained in .
The list of drug-thyroidal axis interactions in may not be comprehensive due to the introduction of new drugs that interact with the thyroidal axis or the discovery of previously unknown interactions. The prescriber should be aware of this fact and should consult appropriate reference sources (e.g., package inserts of newly approved drugs, medical literature) for additional information if a drug-drug interaction with levothyroxine is suspected.
A. GENERAL
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.
The administration of Novamine 15% Amino Acids Injection as part of total parenteral nutrition (TPN) with large volumes of hyperosmotic fluids requires periodic monitoring of the patient for signs of hyperosmolarity, hyperglycemia, glycosuria and hypertriglyceridemia.
During parenteral nutrition with concentrated dextrose and amino acids solutions, essential fatty acid deficiency syndrome may develop but may not be clinically apparent. Early demonstration of this condition can only be accomplished by gas liquid chromatographic analysis of plasma lipids. The syndrome may be prevented or corrected by appropriate treatment with intravenous fat emulsions.
For complete nutritional support, TPN regimens must also include multiple vitamins and trace elements. Potentially incompatible ions such as calcium and phosphate may be added to alternate infusate bottles to avoid precipitation. Although the metabolizable acetate ion in Novamine 15% diminishes the risk of acidosis, the physician must be alert to the potential appearance of this disorder.
Initiation and termination of infusions of TPN fluids must be gradual to permit adjustment of endogenous insulin release.
Undiluted Novamine 15% should not be administered peripherally. When administered centrally, it should be diluted with appropriate diluents, e.g., dextrose, electrolytes and other nutrient components, to at least half strength. See DOSAGE AND ADMINISTRATION.
Caution against volume overload should be exercised.
Drug product contains no more than 25 mcg/L of aluminum.
B. Laboratory Tests
Infusion of Novamine 15% without concomitant infusion of an adequate number of non-protein calories may result in elevated BUN. Monitoring of BUN is required and the balance between Novamine 15% and the calorie source may require adjustment. Frequent clinical evaluations and laboratory determinations are required to prevent the complications which may occur during the administration of solutions used in TPN. Laboratory tests should include blood glucose, serum electrolytes, liver and kidney function, serum osmolarity, blood ammonia, serum protein, pH, hematocrit, WBC and urinary glucose. When Novamine 15% is combined with electrolytes, care should be used in administering this solution to patients with congestive heart failure, renal failure, edema, adrenal hyperactivity, acid-base imbalance and those receiving diuretics or antihypertensive therapy. Total volume infused should be closely monitored. Serum electrolytes should be monitored daily in these patients.
C. Carcinogenesis, Mutagenesis, Impairment of Fertility
Studies with Novamine 15% have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility.
D. Pregnancy Category C
Animal reproduction studies have not been conducted with Novamine 15%. It is also not known whether Novamine 15% can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Novamine 15% should be given to a pregnant woman only if clearly needed.
E. Nursing Mothers
Caution should be exercised when Novamine 15% is administered to a nursing woman.
F. Pediatric Use
Safety and effectiveness of Novamine 15% Amino Acids Injection in pediatric patients have not been established by adequate and well-controlled studies. However, the use of amino acids injections in pediatric patients as an adjunct in the offsetting of nitrogen loss or in the treatment of negative nitrogen balance is referenced in the medical literature.
G. Special Precautions for Central Infusion
TPN delivered by indwelling catheter through a central or large peripheral vein is a special technique requiring a team effort by physician, nurse and pharmacist. The responsibility for administering this therapy should be confined to those trained in the procedures and alert to signs of complications. Complications known to occur from the placement of central venous catheter are pneumothorax, hemothorax, hydrothorax, artery puncture and transection, injury to the brachial plexus, malposition of the catheter, formation of arteriovenous fistula, phlebitis, thrombosis, and air/catheter emboli. The risk of sepsis is present during intravenous therapy, especially when using central venous catheters for prolonged periods. It is imperative that the preparation of admixtures and the placement and care of the catheters be accomplished under controlled aseptic conditions.
H. Admixtures
Admixtures should be prepared under a laminar flow hood using aseptic technique.
Admixtures should be stored under refrigeration and must be administered within 24 hours after removal from refrigerator.
Filters of less than 1.2 micron pore size must not be used with admixtures containing fat emulsion.
I. Do not administer unless solution is clear and the seal is intact.
IT IS ESSENTIAL THAT A CAREFULLY PREPARED PROTOCOL, BASED ON CURRENT MEDICAL PRACTICES, BE FOLLOWED, PREFERABLY BY AN EXPERIENCED TEAM.
See WARNINGS, PRECAUTIONS and Special Precautions for Central Infusion.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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