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Trophamine

Posted by admin on November 5th, 2009

TrophAmine

Protect from light until use.

TrophAmine Description

TrophAmine (6% and 10% Amino Acid Injections) are sterile, nonpyrogenic, hypertonic solutions containing crystalline amino acids.

All amino acids designated USP are the “L”-isomer with the exception of Glycine USP, which does not have an isomer.

TrophAmine – Clinical Pharmacology

TrophAmine provides a mixture of essential and nonessential amino acids as well as taurine and a soluble form of tyrosine, N-Acetyl-L-Tyrosine (NAT). This amino acid composition has been specifically formulated to provide a well tolerated nitrogen source for nutritional support and therapy for infants and young pediatric patients. When administered in conjunction with cysteine hydrochloride, TrophAmine results in the normalization of the plasma amino acid concentrations to a profile consistent with that of a breast-fed infant.

The rationale for TrophAmine

Clinical studies in infants and young pediatric patients who required TPN therapy showed that infusion of TrophAmine with a cysteine hydrochloride admixture resulted in a normalization of the plasma amino acid concentrations. 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, TrophAmine provides total parenteral nutrition in infants and young pediatric patients, with the exception of essential fatty acids.

It is thought that the acetate from lysine acetate and acetic acid, 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 chloride present in TrophAmine are not of clinical significance.

The addition of cysteine hydrochloride will contribute to the chloride load.

The electrolyte content of any additives that are introduced should be carefully considered and included in total input computations.

Indications and Usage for TrophAmine

TrophAmine is indicated for the nutritional support of infants (including those of low birth weight) and young pediatric patients requiring TPN via either central or peripheral infusion routes. Parenteral nutrition with TrophAmine is indicated to prevent nitrogen and weight loss or treat negative nitrogen balance in infants and young pediatric patients 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 nutritional support, and vein tolerance. See

Central Venous Nutrition

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 5–10% dextrose solutions may be infused by peripheral vein, supplemented, if desired, with fat emulsion. In pediatric patients, the final solution should not exceed twice normal serum osmolarity (718 mOsmol/L).

Contraindications

TrophAmine 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.

Warnings

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 clinical 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.

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.

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. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly 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. The mechanisms of this reaction are not clearly defined but may involve genetic defects and immature or subclinically impaired liver function.

Conservative doses of amino acids should be given, 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 reevaluated.

This product contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or 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.

Precautions

General

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.

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.

Peripheral administration of TrophAmine

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. TrophAmine

TrophAmine 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.

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.

Use only if solution is clear, the seal unbroken, and vacuum is present.

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.

Laboratory tests should include measurement of blood sugar, electrolyte, and serum protein concentrations; kidney and liver function tests; and evaluation of acid-base balance and fluid balance. Other laboratory tests may be suggested by the patient’s condition.

Drug Interactions

Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No in vitro or in vivo carcinogenesis, mutagenesis, or fertility studies have been conducted with TrophAmine.

Pregnancy

Animal reproduction studies have not been conducted with TrophAmine (Amino Acid Injections). It is also not known whether TrophAmine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. TrophAmine should be given to a pregnant woman only if clearly needed.

Labor and Delivery

Information is unknown.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised with TrophAmine if administered to a nursing woman.

Pediatric Use

As in all cases of fluid and electrolyte replacement and parenteral nutrition, careful monitoring and special caution is required in pediatric use, especially in pediatric patients with renal failure, acute sepsis, or low birth weight.

The total volume of nutritional fluid and the rate of administration in each patient will be based on individually calculated maintenance and/or replacement fluid requirements, and nutritional needs, and will vary with the child’s age, body weight and renal function.

In neonates and very small infants, particularly careful monitoring will be required to maintain fluid and electrolyte balance, including monitoring of blood glucose.

See

Geriatric Use

TrophAmine has not been studied in geriatric patients. Elderly patients are known to be more prone to fluid overload and electrolyte imbalance than younger patients. This may be related to impairment of renal function which is more frequent in an elderly population. As a result the need for careful monitoring of fluid and electrolyte therapy is greater in the elderly.

All patients, including the elderly, require an individual dose of all parenteral nutrition products to be determined by the physician on an individual case-by-case basis, which will be based on body weight, clinical condition and the results of laboratory monitoring tests. There is no specific geriatric dose.

See

Special Precautions for Central Venous Nutrition

Administration by central venous catheter should be used only by those familiar with this technique and its complications.

Central venous nutrition may be associated with complications which can be prevented or minimized by careful attention to all aspects of the procedure, including 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. One 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, formation of arteriovenous fistula, phlebitis, thrombosis, and air and catheter embolus.

Septic. The constant risk of sepsis is present during central venous nutrition. Since contaminated solutions and infusion catheters are potential sources of infection, it is imperative that the preparation of parenteral nutrition solutions and the placement and care of catheters be accomplished under controlled aseptic conditions.

Solutions should ideally be prepared in the hospital pharmacy in a laminar flow hood. The key factor in their preparation is careful aseptic technique to avoid inadvertent touch contamination during mixing of solutions and subsequent admixtures.

Parenteral nutrition solutions should be used promptly after mixing. Any storage should be under refrigeration for as brief a time as possible. Administration time for a single bottle and set should never exceed 24 hours.

Consult the medical literature for a discussion of the management of sepsis during central venous nutrition. In brief, typical management includes replacing the solution being administered with a fresh container and set, and the remaining contents are cultured for bacterial or fungal contamination. If sepsis persists and another source of infection is not identified, the catheter is removed, the proximal tip cultured, and a new catheter reinserted when the fever has subsided. Non-specific, prophylactic antibiotic treatment is not recommended. Clinical experience indicates that the catheter is likely to be the prime source of infection as opposed to aseptically prepared and properly stored solutions.

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 in pediatric patients. Frequent clinical evaluation and laboratory determinations are necessary, especially during the first few days of venous nutrition, to prevent or minimize these complications.

Adverse Reactions

See

Reactions reported in clinical studies as a result of infusion of the parenteral fluid were water weight gain, edema, increase in BUN, and mild acidosis.

Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia.

Local reaction at the infusion site, consisting of a warm sensation, erythema, phlebitis and thrombosis, have been reported with peripheral amino acid infusions, especially if other substances are also administered through the same site.

If electrolyte supplementation is required during peripheral infusion, it is recommended that additives be administered throughout the day in order to avoid possible venous irritation. Irritating additive medications may require injection at another site and should not be added directly to the amino acid infusate.

Symptoms may result from an excess or deficit of one or more of the ions present in the solution; therefore, frequent monitoring of electrolyte levels is essential.

Phosphorus deficiency may lead to impaired tissue oxygenation and acute hemolytic anemia. Relative to calcium, excessive phosphorus intake can precipitate hypocalcemia with cramps, tetany and muscular hyperexcitability.

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.

Overdosage

In the event of a fluid or solute overload during parenteral therapy, reevaluate the patient’s condition, and institute appropriate corrective treatment.

TrophAmine Dosage and Administration

The objective of nutritional management of infants and young pediatric patients is the provision of sufficient amino acid and caloric support for protein synthesis and growth.

The total daily dose of TrophAmine

Recommendations for allowances of protein in infant nutrition have ranged from 2 to 4 grams of protein per kilogram of body weight per day (2.0 to 4.0 g/kg/day).

Typically, TrophAmine is admixed with B. Braun’s 50% or 70% Dextrose Injection USP supplemented with electrolytes and vitamins and administered continuously over a 24 hour period.

Total daily fluid intake should be appropriate for the patient’s age and size. A fluid dose of 125 mL per kilogram body weight per day is appropriate for most infants on TPN. Although nitrogen requirements may be higher in severely hypercatabolic or depleted patients, provision of additional nitrogen may not be possible due to fluid intake limits, nitrogen, or glucose intolerance.

Cysteine is considered to be an essential amino acid in infants and young pediatric patients. An admixture of cysteine hydrochloride to the TPN solution is therefore recommended. Based on clinical studies, the recommended dosage is 1.0 mmole of L-cysteine hydrochloride monohydrate per kilogram of body weight per day.

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.

Fat emulsion coadministration should be considered when prolonged (more than 5 days) parenteral nutrition is required in order to prevent essential fatty acid deficiency (E.F.A.D.). Serum lipids should be monitored for evidence of E.F.A.D. in patients maintained on fat free TPN.

The provision of sufficient intracellular electrolytes, principally potassium, magnesium, and phosphate, is required for optimum utilization of amino acids. In addition, sufficient quantities of the major extracellular electrolytes sodium, calcium, and chloride, must be given. In patients with hyperchloremic or other metabolic acidoses, sodium and potassium may be added as the acetate salts to provide bicarbonate precursor. The electrolyte content of TrophAmine must be considered when calculating daily electrolyte intake. Serum electrolytes, including magnesium and phosphorus, should be monitored frequently.

Appropriate vitamins, minerals and trace elements should also be provided.

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, TrophAmine

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

TrophAmine may be admixed with solutions which contain phosphate or which have been supplemented with phosphate. The presence of calcium and magnesium ions in an additive solution should be considered when phosphate is also present, in order to avoid precipitation.

Care must be taken to avoid incompatible admixtures. Consult with pharmacist.

How is TrophAmine Supplied

TrophAmine is supplied sterile and nonpyrogenic in 500 mL glass containers with solid stoppers.

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.

Protect from light until use.

Rx only

Revised: March 2007

TrophAmine is a registered trademark of B. Braun Medical Inc.

Made in USA

Directions for Use of B. Braun Glass Containers with Solid Stoppers

Designed for use with a vented set.

Before use, perform the following checks:

Warning: Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store.

Spiking, additions, or transfers should be made immediately after exposing the sterile stopper surface. Check for vacuum at first puncture of stopper. Admixture by needle or syringe should be made through the triangular (

B. Braun Medical Inc.

©2007 B. Braun Medical Inc.

Y36-002-611

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TPN Electrolytes

Posted by admin on November 5th, 2009

TPN Electrolytes

MULTIPLE ELECTROLYTE ADDITIVE

Contains No Phosphate

R

CONCENTRATED SOLUTION  FOR INTRAVENOUS USE ONLY AFTER DILUTION AND THOROUGH MIXING. FORMULATED TO PROVIDE ADDITIVE ELECTROLYTES FOR PATIENTS RECEIVING TOTAL PARENTERAL NUTRITION.

Plastic Vial

TPN Electrolytes Description

TPN Electrolytes (multiple electrolyte additive) is a sterile, nonpyrogenic, concentrated solution of intra- and extracellular ions for intravenous infusion after dilution as a maintenance electrolyte replenisher only. It contains no phosphate and no bacteriostat, antimicrobial agent or added buffer. The pH is 6.6 (6.0 to 7.5). May contain hydrochloric acid for pH adjustment. The osmolar concentration is 6.2 mOsmol/mL (calc.).

__________________________

*Total Parenteral Nutrition

Ingredients and ion constituents of the solution are as follows:

Ingredient or Ion

mg/20 mL

mEq/20 mL

Sodium Chloride

321

Calcium Chloride (dihydrate)

331

Potassium Chloride

1491

Magnesium Chloride (hexahydrate)

508

Sodium Acetate (anhydrous)

2420

Sodium (Na

35

Potassium (K

20

Calcium (Ca

4.5

Magnesium (Mg

5

Chloride (Cl

35

Acetate (CH

29.5

Sodium Chloride, USP is chemically designated NaCl, a white crystalline compound freely soluble in water.

Calcium Chloride, USP dihydrate is chemically designated CaCl

Potassium Chloride, USP is chemically designated KCl, a white granular powder freely soluble in water.

Magnesium Chloride, USP hexahydrate is chemically designated MgCl

Sodium Acetate, USP anhydrous is chemically designated C

Water for Injection, USP is chemically designated H

The semi-rigid container is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. The container requires no vapor barrier to maintain the proper drug concentration.

TPN Electrolytes – Clinical Pharmacology

TPN Electrolytes (multiple electrolyte additive) helps to maintain normal cellular metabolism during TPN (total parenteral nutrition). Providing electrolytes in appropriate amounts prevents deficiency symptoms which otherwise would occur in their absence.

Cations: Sodium is the principal extracellular cation; it helps maintain motor nerve depolarization, proper fluid balance and normal renal metabolism. Potassium is the principal intracellular cation; it helps transport dextrose across the cell membrane and contributes to normal renal function. Magnesium is an important cofactor for enzymatic reactions and helps to maintain normal CNS (central nervous system) activity and amino acid utilization. Calcium participates in muscle contraction, blood coagulation and helps maintain normal neuromuscular function.

Anions: Chloride is the principal extracellular anion which, along with bicarbonate, is involved in maintaining proper anion balance. Acetate is an important metabolic intermediate in the tricarboxylic acid cycle and is a bicarbonate alternate.

The distribution and excretion of sodium (Na

Approximately 80% of body calcium (Ca

Potassium (K

Magnesium (Mg

Acetate (CH

Indications and Usage for TPN Electrolytes

TPN Electrolytes (multiple electrolyte additive) is indicated for use as a supplement to nutritional solutions containing concentrated dextrose and amino acids delivered by central venous infusion, to help maintain electrolyte homeostasis in adult patients.

Contraindications

TPN Electrolytes (multiple electrolyte additive) is contraindicated in pathological conditions where additives of potassium, sodium, calcium, magnesium or chloride could be clinically deleterious, e.g., anuria, hyperkalemia, heart block or myocardial damage and severe edema due to cardiovascular, renal or hepatic failure.

Warnings

CONCENTRATED, HYPERTONIC, ADDITIVE SOLUTION. Must be diluted in TPN solution prior to administration.

CONTAINS NO PHOSPHATE. Patients receiving TPN solutions containing concentrated dextrose require additive phosphate, in addition to TPN Electrolytes. Between 10 and 15 mM (310 to 465 mg) phosphorus are physically compatible with as much as 10 to 12 mEq calcium in the same admixture. The phosphate supplement should first be added to the amino acid or dextrose bottle and diluted well to avoid precipitation with calcium.

CONTAINS 20 mEq of POTASSIUM. The potassium content of other additives, such as potassium phosphate or potassium-containing antibiotics, must be considered in the context of total potassium delivered. TPN patients usually require 30 to 50 mEq of potassium per liter of TPN solution containing concentrated (2025%) dextrose.

NOT INTENDED FOR PEDIATRIC USE.

Solutions containing sodium ions 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 ions 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.

In patients with diminished renal function, administration of solutions containing sodium or potassium ions may result in sodium or potassium retention.

Solutions containing acetate ions 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.

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 levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.

Precautions

Do not administer unless solution is clear and seal is intact. Discard unused portion.

Blood levels of sodium, potassium, calcium, magnesium, phosphorus and chloride should be monitored frequently during TPN (total parenteral nutrition). Significant deviations from normal may justify further supplementation or substitution of individual electrolyte additives (in place of TPN Electrolytes) to tailor the electrolyte supplement to meet individual patient requirements.

In patients with renal dysfunction or cardiovascular insufficiency, especially in elderly or postsurgical patients, consider the potential effects of sodium (35 mEq) and potassium (20 mEq) present in TPN Electrolytes.

Extraordinary electrolyte losses are not necessarily corrected by TPN Electrolytes. In protracted vomiting or diarrhea or in patients with fistula drainage or nasogastric suction, separate replacement therapy may be necessary, based upon analysis of losses sustained.

Caution must be exercised in the administration of parenteral fluids, especially those containing sodium ions, to patients receiving corticosteroids or corticotropin.

Solutions containing acetate ions should be used with caution as excess administration may result in metabolic alkalosis.

Pregnancy Category C.

Animal reproduction studies have not been conducted with TPN Electrolytes. It is also not known whether TPN Electrolytes can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. TPN Electrolytes should be given to a pregnant woman only if clearly needed.

GERIATRIC USE

An evaluation of current literature revealed no clinical experience identifying differences in response between 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 other drug therapy.

Sodium ions and phosphorus are known to be substantially secreted by the kidney, and the risk of toxic reactions 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.

Adverse Reactions

Symptoms may result from an excess or deficit of one or more of the ions present in TPN Electrolytes. Therefore, frequent monitoring of electrolyte blood levels is recommended. Sodium excess can cause edema and exacerbation of congestive heart failure. Excess potassium can cause deviations from the normal ECG (electrocardiogram). Potassium deficits can impair neuromuscular function, causing muscle weakness or frank paralysis, intestinal dilatation and ileus. Calcium deficits can produce neuromuscular hyperexcitability, ranging from paresthesias, cramps and laryngospasm to tetany and grand mal seizures. Depressed calcium levels can accompany administration of parenteral phosphorus or large amounts of albumin. Magnesium deficiency can precipitate neuromuscular dysfunction, hyperirritability, psychotic behavior, tachycardia and hypertension. Magnesium excess can cause muscle weakness, ECG changes, sedation and mental confusion.

Drug Abuse and Dependence

None known.

Overdosage

In the event of overhydration or solute overload, re-evaluate the patient and institute appropriate corrective measures. See WARNINGS and PRECAUTIONS.

TPN Electrolytes Dosage and Administration

One 20 mL volume of TPN Electrolytes (multiple electrolyte additive) is added to each liter of amino acid/dextrose solution. Alternatively, the TPN Electrolytes can be added to the bottle of amino acids or concentrated dextrose, to permit addition of the necessary phosphate additive to the remaining bottle. This latter technique helps avoid physical incompatibilities between calcium and phosphorus. A potassium phosphate additive is recommended for addition to nutritional solutions containing TPN Electrolytes. Between 10 and 30 mEq of potassium (as phosphate) should be added per liter of TPN solution, to augment the 20 mEq of potassium provided by TPN Electrolytes.

Between two and three liters of TPN solution with added TPN Electrolytes are usually administered daily to adults. Solutions are given continuously over the entire 24-hour period at a constant rate, ranging from 83 to 125 mL/hour. TPN solutions containing TPN Electrolytes and concentrated dextrose are administered intravenously, through a central venous catheter.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS.

How is TPN Electrolytes Supplied

TPN Electrolytes (multiple electrolyte additive) is supplied in the following single-dose delivery systems:

List No.

Type Container

5779

Plastic Fliptop Vial, 20 mL

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.

Store at controlled room temperature 15° to 30°C (59° to 86°F). [See USP.]

©Hospira 2004

EN-0206

Printed in USA

HOSPIRA, INC., LAKE FOREST, IL 60045 USA

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Renamin

Posted by admin on November 5th, 2009

RenAmin

RenAmin Description

Essential Amino Acids

Nonessential Amino Acids

Anion Profile per Liter*

RenAmin – Clinical Pharmacology

Indications and Usage for RenAmin

Contraindications

Warnings

Precautions

Laboratory Tests

Carcinogenesis, Mutagenesis, Impairment of Fertility:

Pregnancy:

Pregnancy Category C.

Nursing Mothers:

Pediatric Use:

Geriatric Use:

SPECIAL PRECAUTIONS

Technical:

Septic:

Metabolic:

Special Precautions in Patients with Renal Insufficiency

Special Precautions in Pediatric Patients

Adverse Reactions

RenAmin Dosage and Administration

Adult:

Children:

Central Vein Administration:

Peripheral Vein Administration:

DIRECTIONS FOR USE OF THE PHARMACY BULK PACKAGE CONTAINER

How is RenAmin Supplied

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ProSol

Posted by admin on November 5th, 2009

ProSol

ProSol Description

ProSol – Clinical Pharmacology

Indications and Usage for ProSol

Central Vein Administration:

Peripheral Vein Administration:

Protein-Sparing:

Contraindications

Warnings

Precautions

Laboratory Tests

Carcinogenesis and Mutagenesis and Impairment of Fertility

Pregnancy

Pregnancy Category C.

Nursing Mothers

Pediatric Use

Geriatric Use

SPECIAL PRECAUTIONS

Technical:

Septic:

Metabolic:

Adverse Reactions

Overdosage

ProSol Dosage and Administration

Central Vein Administration:

Peripheral Vein Administration:

Protein-Sparing:

DIRECTIONS FOR USE OF VIAFLEX PLASTIC PHARMACY BULK PACKAGE CONTAINER

To Open

Preparation for Admixing

How is ProSol Supplied

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Procalamine

Posted by admin on November 5th, 2009

ProcalAmine

Protect from light until use.

ProcalAmine Description

ProcalAmine (3% Amino Acid and 3% Glycerin Injection with Electrolytes) is a sterile, nonpyrogenic, moderately hypertonic intravenous injection containing crystalline amino acids, a nonprotein energy substrate and maintenance electrolytes. A 1000 mL unit provides a total of 29 g of protein equivalent (4.6 g N) and 130 nonprotein calories.

All amino acids designated USP are the “L”-isomer with the exception of Glycine USP which does not have an isomer.

Each 100 mL contains:

Essential amino acids

Nonessential amino acids

pH adjusted with Glacial Acetic Acid USP

ProcalAmine – Clinical Pharmacology

ProcalAmine provides a physiological ratio of biologically utilizable essential and nonessential amino acids, a nonprotein energy source, and a balanced pattern of maintenance electrolytes.

The amino acids provide substrates for protein synthesis as well as sparing body protein and muscle mass. Glycerin USP (glycerol), a utilizable energy substrate, is also provided which serves to preserve body protein. Glycerol participates as an active energy substrate through its phosphorylation to α-glycerophosphate and subsequent conversion to dihydroxyacetone phosphate, one of the two key trioses in the metabolism of glucose for energy generation.

The metabolism of glycerol has been investigated in both animals and humans. The liver is chiefly responsible for the high potential of glycerol utilization for gluconeogenesis, accounting for at least three-fourths of the total capacity of the body to utilize glycerol. Further, the kidney accounts for up to one-fifth of this total capacity. Among other kinds of cells and tissues shown to utilize glycerol at various rates are the brain, intestine, muscle, leukocytes, lungs and spermatozoa.

In a multicenter clinical study, mildly catabolic post-surgical patients receiving ProcalAmine

Indications and Usage for ProcalAmine

ProcalAmine is indicated for peripheral administration in adults to preserve body protein and improve nitrogen balance in well-nourished, mildly catabolic patients who require short-term parenteral nutrition.

Contraindications

Renal failure.

Severe liver disease and hepatic coma.

Metabolic disorders associated with impaired nitrogen utilization.

Hypersensitivity to one or more amino acids.

Warnings

This product contains potassium 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: 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.

Peripheral intravenous infusion of amino acids may cause a normal, modest rise in blood urea nitrogen (BUN) as a result of increased protein intake. The BUN may become elevated in patients with impaired renal or hepatic function. If the BUN levels exceed post-prandial limits and continue to rise, further use of ProcalAmine should be reevaluated.

Administration of amino acid solutions to a patient with hepatic insufficiency may result in serum amino acid imbalances, hyperammonemia, prerenal azotemia, stupor and coma.

Should symptoms of hyperammonemia develop, amino acid administration should be discontinued and the patient’s clinical status reevaluated.

Undesirable side effects of glycerol reported in the literature include hemolysis, hemoglobinuria and renal damage. None of these side effects was observed in clinical trials with ProcalAmine. The manifestation of these side effects is highly dependent on dose and route of administration as well as on formulation. In general, high concentrations of glycerol (up to 40%) are not hemolytic, provided solution is prepared with isotonic saline. Subcutaneous injection of low doses of glycerol alone, e.g., 3% without other solutes, can cause hemolysis. Much higher doses, up to 20 times that of subcutaneous injection are required to obtain similar effects intravenously. Subcutaneous injection of glycerol at low doses can produce hemoglobinuria. Therefore, there should be frequent monitoring to ensure early detection of infiltrations.

Administration of solutions containing electrolytes should be undertaken with extreme caution in the following circumstances:

Care should be taken to avoid circulatory overload, particularly in patients with cardiac insufficiency.

Blood sugar levels should be monitored frequently in diabetic patients.

Precautions

General

Safe, effective use of parenteral nutrition requires a knowledge of nutrition as well as clinical expertise in recognition and treatment of complications which can occur. Frequent evaluation and laboratory determinations are necessary for proper monitoring of parenteral nutrition. Peripheral infusion therapy is intended to provide nutritional support for a limited period of time. If a patient requires an extended period of nutritional support, enteral or parenteral regimens should include nonprotein calories adequate for weight maintenance.

The electrolyte pattern of ProcalAmine is designed for maintenance only during peripheral infusion therapy in adults. Abnormal losses should be monitored and replaced as required.

During peripheral vein infusion of ProcalAmine, care should be taken to assure proper placement of the needle or catheter.

The utilization of hypertonic solutions has been associated with an increased incidence of phlebitis. The incidence of phlebitis with ProcalAmine was marginally higher than that observed with a less hypertonic solution. Phlebitis can be minimized by using an in-line filter and/or by changing the site of infusion.

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.

Use only if solution is clear and vacuum is present.

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.

Laboratory tests should include measurement of blood sugar, electrolyte, and serum protein concentrations; kidney and liver function tests; and evaluation of acid-base balance and fluid balance. Other laboratory tests may be suggested by the patient’s condition.

Drug Interactions

Administration of barbiturates, narcotics, hypnotics or systemic anesthetics should be adjusted with caution in patients also receiving magnesium-containing solutions because of an additive central depressive effect.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No in vitro or in vivo carcinogenesis, mutagenesis, or fertility studies have been conducted with ProcalAmine

Pregnancy

Pregnancy Category C

Animal reproduction studies have not been conducted with ProcalAmine (3% Amino Acid and 3% Glycerin Injection with Electrolytes). It is also not known whether ProcalAmine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. ProcalAmine should be given to a pregnant woman only if clearly needed.

Labor and Delivery

Information is unknown.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised with ProcalAmine if administered to a nursing woman.

Pediatric Use

Safety and effectiveness of amino acid injections in pediatric patients have not been established by adequate and well-controlled studies. However, the use of amino acid injections in pediatric patients as an adjunct in the offsetting of nitrogen loss or in the treatment of negative nitrogen balance is well established in the medical literature. See

Geriatric Use

Clinical studies of ProcalAmine did not include sufficient numbers of subjects age 65 and over to determine whether they respond differently from 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 other drug therapy.

This drug is known to be substantially excreted by the kidney, and the risk of toxic 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.

See

Adverse Reactions

Local reactions of the infusion site consisting of a warm sensation, erythema, phlebitis and thrombosis have been reported in the literature with peripheral amino acid infusions. Generalized flushing, fever and nausea have been reported in the literature during the peripheral administration of amino acids.

Overdosage

In the event of a fluid or solute overload during parenteral therapy, reevaluate the patient’s condition and institute appropriate corrective treatment.

ProcalAmine Dosage and Administration

ProcalAmine is a convenient source of nonprotein calories to preserve lean body mass, amino acids, maintenance electrolytes, and water for adult patients.

Determination of nitrogen balance and accurate daily body weights (corrected for fluid balance) are probably the best means of assessing individual protein requirements.

Approximately three liters per day of ProcalAmine will provide a total of 90 grams of amino acids, 390 nonprotein calories and the recommended daily intake of principal intra- and extracellular electrolytes for the stable patient. Therapy can begin with three liters of ProcalAmine on the first day with close monitoring of the patient.

As with all intravenous fluid therapy, the goal is to provide adequate water to compensate for insensible, urinary and other losses, and electrolytes for replacement and maintenance. These requirements should be determined frequently and appropriately administered.

Additional electrolytes should be administered evenly throughout the day, and irritating medications should be injected at an alternate infusion site.

Pediatric Use

ProcalAmine is intended for use in adults. Use of ProcalAmine in pediatric patients is governed by the same considerations that affect the use of any amino acid solution in pediatrics. The amount administered is dosed on the basis of grams of amino acids/kg of body weight/day. Two to three g/kg of body weight for infants with adequate calories are generally sufficient to satisfy protein needs and promote positive nitrogen balance. Solutions administered by peripheral vein should not exceed twice normal serum osmolarity (718 mOsmol/L).

Venous irritation at an infusion site can be minimized by the selection of a large peripheral vein as well as by slowing the rate of infusion. In pediatric patients, the final solution should not exceed twice normal serum osmolarity (718 mOsmol/L).

Parenteral drug products should be inspected visually for particulate matter and discoloration, prior to administration, whenever solution and container permit.

How is ProcalAmine Supplied

ProcalAmine

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.

Protect from light until use.

Rx only

Revised: March 2007

ProcalAmine is a registered trademark of B. Braun Medical Inc.

Made in USA

Directions for Use of B. Braun Glass Containers

General

Before use, perform the following checks:

Warning: Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store.

After admixture and during administration, reinspect the solution frequently. If any evidence of solution contamination or instability is found or if the patient exhibits any signs of fever, chills or other reactions not readily explainable, discontinue administration immediately and notify the physician.

When adding medication to the container during administration, swab the triangular medication site, inject medication and mix thoroughly by gentle agitation.

Products with Air Tube

Note: When vacuum is essential for the use of the product (medication addition or transfer, etc.) the latex disk should be left in place until all additions or transfers are completed.

Medication addition or transfers should be made immediately after exposing the sterile latex disk. Identify three depressions in the latex disk prior to adding medication (See

Before removing the latex disk, add medication through the triangular

Products with Solid Stopper

Designed for use with a vented set.

Spiking, additions or transfers should be made immediately after exposing the sterile stopper surface. Check for vacuum at first puncture of stopper. Admixture by needle or syringe should be made through the triangular

B. Braun Medical Inc.

©2007 B. Braun Medical Inc.

Y36-002-607

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Plasma-Lyte 56

Posted by admin on November 5th, 2009

Plasma-Lyte 56

Plasma-Lyte 56 Description

Plasma-Lyte 56 – Clinical Pharmacology

Indications and Usage for Plasma-Lyte 56

Contraindications

Warnings

Precautions

Pregnancy

Pregnancy Category C

Pediatric Use

Geriatric Use

Adverse Reactions

Plasma-Lyte 56 Dosage and Administration

How is Plasma-Lyte 56 Supplied

DIRECTIONS FOR USE OF VIAFLEX PLASTIC CONTAINER

To Open

Preparation for Administration

To Add Medication

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Novamine

Posted by admin on November 5th, 2009

Novamine

Pharmacy Bulk Package

Not For Direct Infusion

Novamine Description

Novamine

Novamine

Each 100 mL contains:

Essential Amino Acids

Lysine (from Lysine Acetate, USP)………………………………………………….1.18

g

Leucine, USP………………………………………………………………………..1.04

g

Phenylalanine, USP……………………………………………………………………….1.04

g

Valine, USP……………………………………………………………………………960

mg

Isoleucine, USP……………………………………………………………………………..749

mg

Methionine, USP……………………………………………………………………………749

mg

Threonine, USP……………………………………………………………………………..749

mg

Tryptophan, USP……………………………………………………………………………250

mg

Nonessential Amino Acids

Alanine, USP………………………………………………………………………………2.17

g

Arginine, USP……………………………………………………………………………..1.47

g

Glycine, USP………………………………………………………………………………1.04

g

Histidine, USP……………………………………………………………………………..894

mg

Proline, USP…………………………………………………………………………..894

mg

Glutamic Acid………………………………………………………………………………749

mg

Serine, USP…………………………………………………………………………………592

mg

Aspartic Acid, USP…………………………………………………………………………434

mg

Tyrosine, USP………………………………………………………………………………..39

mg

Sodium Metabisulfite, NF added…………………………………………………………30

mg

Water for Injection, USP…………………………………………………………………….

qs

Essential Amino Acids………………………………………………………………….6.7

g

Nonessential Amino Acids………………………………………………………………..8.3

g

Total Amino Acids………………………………………………………………………15.0

g

Total Nitrogen…………………………………………………………………………..2.37

g

Acetate*………………………………………………………………………………………..151

mEq/L

Osmolarity (calculated)………………………………………………………………………1388

mOsmol/L

pH……………………………………………………………………………………………..5.6(5.2 – 6.0)

*Acetate from Lysine Acetate, USP and acetic acid used for pH adjustment.

The formulas for the individual amino acids are as follows:

Novamine – Clinical Pharmacology

Novamine

A. Total Parenteral Nutrition (Central Infusion)

When enteral feeding is inadvisable, Novamine

B. Total Parenteral Nutrition (Peripheral Infusion)

Novamine

Reduction of protein loss can be achieved by use of diluted Novamine

Indications and Usage for Novamine

Novamine

— 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.

Contraindications

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.

Warnings

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: 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.

Precautions

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

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

Initiation and termination of infusions of TPN fluids must be gradual to permit adjustment of endogenous insulin release.

Undiluted Novamine

Caution against volume overload should be exercised.

Drug product contains no more than 25 mcg/L of aluminum.

B. Laboratory Tests

Infusion of Novamine

C. Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies with Novamine

D. Pregnancy Category C

Animal reproduction studies have not been conducted with Novamine

E. Nursing Mothers

Caution should be exercised when Novamine

F. Pediatric Use

Safety and effectiveness of Novamine

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.

Adverse Reactions

See WARNINGS, PRECAUTIONS and Special Precautions for Central Infusion.

Overdosage

In the event of overhydration or solute overload, re-evaluate the patient and institute appropriate corrective measures. See WARNINGS and PRECAUTIONS.

Novamine Dosage and Administration

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

When using Novamine

Volume

Amount

Final Concentration

Novamine

500 mL

75 g

7.5%

Dextrose 70%

250 mL

175 g

17.5%

Intralipid

250 mL

50 g

5.0%

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.

Volume

Amount

Final Concentration

Novamine

500 mL

75 g

3.75%

Dextrose 50%

1000 mL

500 g

25%

Intralipid

500 mL

100 g

5%

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.

Volume

Amount

Final Concentration

Novamine

500 mL

75 g

3.75%

Dextrose 30%

1000 mL

300 g

15%

Intralipid

500 mL

50 g

2.5%

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

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

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

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.

How is Novamine Supplied

Novamine

500 mL NDC 0409-0468-05

STORAGE

Store 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 2005

EN-1010

Hospira, Inc., Lake Forest, IL 60045 USA

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Liposyn II

Posted by admin on November 5th, 2009

Liposyn II

INTRAVENOUS FAT EMULSION

R

Liposyn II Description

Liposyn II (Intravenous Fat Emulsion) is a sterile, nonpyrogenic fat emulsion for intravenous administration. It is supplied in both a 10% and 20% concentration.

Liposyn II 10% contains 5% safflower oil, 5% soybean oil, up to 1.2% egg phosphatides added as an emulsifier and 2.5% glycerin in water for injection. May contain sodium hydroxide for pH adjustment. pH 8.0 (6.0 − 9.0). Liposyn II 10% has an osmolarity of 276 mOsmol/liter (actual). The total caloric value of Liposyn II 10% including fat, phospholipid and glycerol is 1.1 kcal/mL. Of this total, approximately 0.6 kcal/mL is supplied by linoleic acid.

Liposyn II 20% contains 10% safflower oil, 10% soybean oil, 1.2% egg phosphatides and 2.5% glycerin in water for injection. May contain sodium hydroxide for pH adjustment. pH 8.3 (6.0 − 9.0). Liposyn II 20% has an osmolarity of 258 mOsmol/liter (actual). The total caloric value of Liposyn II 20% including fat, phospholipid and glycerol is 2 kcal/mL. Of this total, approximately 1.2 kcal/mL are supplied by linoleic acid.

Both Liposyn II 10% and Liposyn II 20% contain emulsified fat particles of approximately 0.4 micron in diameter, similar to naturally occurring chylomicrons.

Safflower oil and Soybean Oil, USP are mixtures of neutral triglycerides with the following structure:

Egg phosphatides, purified, are primarily a mixture of naturally occurring phospholipids which are isolated from the egg yolk. These phospholipids have the following general structure:

Glycerin, USP is chemically designated C

Liposyn II – Clinical Pharmacology

Liposyn II (Intravenous Fat Emulsion) provides the patient requiring parenteral nutrition with a source of calories and the essential fatty acids normally obtained from a nutritionally complete oral diet. The supplemental polyunsaturated fat prevents biochemical changes of essential fatty acid deficiency (EFAD) and prevents and reverses EFAD clinical manifestations (e.g., scaliness of skin, growth retardation, poor wound healing and sparse hair growth).

The infused fat particles are cleared from the bloodstream in a manner thought to be similar to the clearing of chylomicrons. Following infusion, there is a transient increase in plasma triglycerides. The triglycerides are hydrolyzed to free fatty acids and glycerol by the enzyme, lipoprotein lipase. The free fatty acids either enter the tissues (where they may be oxidized or resynthesized into triglycerides and stored) or circulate in the plasma, bound to albumin. In the liver, circulating free fatty acids are oxidized or converted to very low density lipoproteins that re-enter the bloodstream.

Phosphatides are the hydrophobic components of membranes and provide electrically insulated layers. They are involved in the formation of membrane structures. Choline prevents the deposition of fat in the liver.

Glycerol is metabolized to carbon dioxide and glycogen or is used in the synthesis of body fats.

Indications and Usage for Liposyn II

Liposyn II is indicated as a source of calories for patients requiring parenteral nutrition. Where such nutrition is required for extended periods of time (more than 5 days), Liposyn II is also indicated as a source of essential fatty acids to prevent or reverse biochemical changes in fatty acid composition of plasma lipids (elevated triene/tetraene ratio) and the clinical manifestations of EFAD.

Contraindications

The administration of Liposyn II (Intravenous Fat Emulsion) is contraindicated in patients demonstrating disturbances in normal fat metabolism such as pathologic hyperlipemia, lipoid nephrosis or acute pancreatitis if accompanied by hyperlipemia.

Warnings

Deaths in preterm infants after infusion of intravenous fat emulsions have been reported in the medical literature.

Caution should be exercised in administering Liposyn II (Intravenous Fat Emulsion) to patients with severe liver damage, pulmonary disease, anemia or blood coagulation disorders or when there is danger of fat embolism. The too rapid administration of Liposyn II can cause fluid and/or fat overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states, pulmonary edema, impaired pulmonary diffusion capacity or metabolic acidosis.

Caution should be exercised when admixing Liposyn II (Intravenous Fat Emulsion).

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.

Precautions

Because free fatty acids displace bilirubin bound to albumin, the use of lipid infusions in jaundiced or premature infants should be undertaken with caution.

During Liposyn II administration, the patient’s hemogram, blood coagulation, liver function, platelet count and plasma lipid profile must be closely monitored. The lipemia must clear between daily infusions. Liposyn II should be discontinued should a significant abnormality in any one of these parameters be attributed to the infusion.

Pregnancy Category C.

Animal reproduction studies have not been conducted with Liposyn II. It is also not known whether Liposyn II can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Liposyn II should be given to a pregnant woman only if clearly needed.

Nursing Mothers.

It is not known whether the drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Liposyn II is administered to a nursing woman.

Frequent (some advise daily) platelet counts should be done in neonatal patients receiving parenteral nutrition with Liposyn II.

Liposyn II is supplied in single-dose containers. Partially used containers must be discarded and should not be stored or resterilized for later use. Do not administer the contents of any container in which the emulsion appears to be oiling out.

This product contains no more than 25 mcg/L of aluminum.

Adverse Reactions

Sepsis due to contamination of administration equipment and thrombophlebitis due to vein irritation from concurrently administered hypertonic solutions have been encountered. These are attributable to I.V. therapy in general or to the type of infusion administered.

Adverse reactions directly related to fat emulsions are of two types: (1) immediate (acute) and (2) long term (chronic). In studies of lipid products in general, the following immediate reactions have been noted: Allergic reactions, hyperlipemia, dyspnea, cyanosis, flushing, dizziness, headache, sleepiness, nausea, vomiting, hyperthermia, sweating, chest and back pain, thrombocytopenia (rarely in neonates), hypercoagulability and transient increases in liver enzymes.

The following reactions have been noted with long-term therapy with lipid infusions in general: Hepatomegaly, jaundice due to central lobular cholestasis, splenomegaly, thrombocytopenia, leucopenia, transient increases in liver function tests, overloading syndrome and deposition of brown pigment (“fat pigment”) in the reticuloendothelial tissue of the liver. The significance of this last occurrence and its cause are unknown.

Overdosage

In the event of fat overload during therapy, stop the infusion of Liposyn II (Intravenous Fat Emulsion) until visual inspection of the plasma, determination of triglyceride concentrations, or measurement of plasma light-scattering activity by nephelometry indicates the lipid has cleared. Re-evaluate the patient and institute appropriate corrective measures. See WARNINGS and PRECAUTIONS.

Liposyn II Dosage and Administration

Liposyn II (Intravenous Fat Emulsion) should be administered as part of an intravenous total nutrition program via peripheral vein or central venous catheter.

Adult Patients

Liposyn II can provide up to 60% of daily calories at a dose not to exceed 3 g/kg of body weight per day. The other 40% should be provided by carbohydrate and amino acids.

For the prevention of essential fatty acid deficiency, the recommended daily requirement is approximately 4% of the caloric intake as linoleate. In most adult patients, this can be supplied as 500 mL of Liposyn II 10% or 250 mL of Liposyn II 20% administered twice weekly.

The initial infusion rate for the first 15 minutes should be 1 mL/minute for Liposyn II 10% and 0.5 mL/minute for Liposyn II 20%. If no adverse effects are observed during this initial infusion, the rate can be increased to allow no more than 500 mL of Liposyn II 10% or 250 mL of Liposyn II 20% to be given over a period of four to six hours.

Pediatric Patients

Liposyn II can provide up to 60% of daily calories at a dose not to exceed 4 g/kg of body weight per day. The other 40% should be provided by carbohydrate and amino acids.

For the prevention of essential fatty acid deficiency, the recommended daily requirement is approximately 4% of the caloric intake as linoleate. The daily dosage of Liposyn II ranges from 5 mL to 10 mL per kilogram for the 10% emulsion and 2.5 mL to 5 mL per kilogram for the 20% emulsion, depending upon the size and maturity of the patient.

The infusion should be started at a rate of 0.1 mL/minute for the first 15 minutes. If no adverse effects are observed during this initial infusion, the rate can be increased to allow no more than 100 mL of Liposyn II 10% or 50 mL of Liposyn II 20% per hour.

Administration

With the exception of heparin at 1 to 2 units/mL of fat emulsion, additives to the Liposyn II bottle are contraindicated.

Partly used containers must not be stored for later use. Filters of less than 1.2 micron porosity must not be used with Liposyn II. Do not use any bottle in which there appears to be an oiling out of the emulsion.

See CONTRAINDICATIONS regarding mixing this emulsion with other I.V. fluids or additives.

Liposyn II can be infused into the same central or peripheral vein as the carbohydrate/amino acid solutions by means of a short Y-connector near the infusion site. This allows for mixing of the solutions immediately before entering the vein or for alternation of each solution. Flow rates of each solution should be controlled separately by infusion pumps, if these are used. Fat emulsion may also be infused through a separate peripheral site. If desired, heparin may be added to Liposyn II at a concentration of 1 to 2 units per mL prior to administration. Alternatively, studies have documented the stability of Liposyn

Aminosyn

Aminosyn II w/

Concentrations

(pH 6)

Aminosyn II

Electrolytes

7%

X

X

X

8.5%

X

X

X

10%

X

X

X

Admixtures were compounded in either a nonphthalate polyvinylchloride (PVC) or an ethylene vinyl acetate (EVA) container. (See NOTE). SEE MIXING INSTRUCTIONS FOR COMBINED ADMINISTRATION. Compounded admixtures may be stored under refrigeration for up to 24 hours. Administration of admixtures should be completed within 24 hours after removal from refrigeration.

Conventional administration sets contain polyvinyl chloride (PVC) components that have DEHP (diethylhexyl phthalate) as a plasticizer. Fat-containing fluids such as Liposyn II extract DEHP from this PVC component, and it may be advisable to consider infusion of Liposyn II or the 3-in-1 admixture through a non-DEHP administration set.

A 1.2 micron air-eliminating filter can be used to deliver either a stable 3-in-1 admixture containing Liposyn II or the emulsion alone. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

MIXING INSTRUCTIONS FOR COMBINED ADMINISTRATION

Caution should be exercised when admixing Liposyn II (Intravenous Fat Emulsion).

It is absolutely essential that the admixture be prepared using strict aseptic techniques as this nutrient mixture is a good growth media for microorganisms.

Studies have documented the stability of Liposyn

Aminosyn

Aminosyn II w/

Concentrations

(pH 6)

Aminosyn II

Electrolytes

7%

X

X

X

8.5%

X

X

X

10%

X

X

X

NOTE: The TPN admixture containers used in the stability studies were formulated to minimize lipid/container interactions. The principal bag materials were a nonphthalate polyvinylchloride (PVC) or ethylene vinyl acetate (EVA). The only significant leachable from EVA is acetate. Acetate is found in total parenteral nutrition (TPN) admixtures as acetic acid, used for adjusting the pH of amino acid solutions, and as lysine acetate. The level of leachable acetate from EVA is not sufficient to alter the final acetate concentration significantly. Compounded admixtures may be stored under refrigeration for up to 24 hours. Administration of admixtures should be completed within 24 hours after removal from refrigeration. Reference should be made to the individual package inserts for detailed information on each component.

The prime destabilizers of emulsions are excessive acidity (low pH) and inappropriate electrolyte content. Careful consideration should be given to the dosage levels of the divalent cations (Ca

The following proper mixing sequence must be followed to minimize pH-related problems by ensuring that typically acidic dextrose injections are not mixed with lipid emulsion alone:

Admixing should be accompanied by gentle agitation to avoid localized concentration effects. Simultaneous or sequential mixing of Liposyn II with other nutritional substrates using an automated, gravimetric pumping system is considered an acceptable method for admixture compounding, especially for institutions with a high volume of 3-in-1 admixtures.

How is Liposyn II Supplied

Liposyn II (Intravenous Fat Emulsion) 10% and 20% is a white to slightly off-white emulsion with no evidence of oiling out of the emulsion.

Liposyn II 10% (List No. 9786) is supplied in 200, 250 and 500 mL single-dose containers.

Liposyn II 20% (List No. 9789) is supplied in 200, 250 and 500 mL single-dose containers.

Store at 20 to 25ºC (68 to 77ºF). [See USP Controlled Room Temperature.] Protect from freezing.

References

Revised: August, 2005

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Intralipid

Posted by admin on November 5th, 2009

Intralipid

Intralipid Description

Intralipid

Intralipid

The soybean oil is a refined natural product consisting of a mixture of neutral triglycerides of predominantly unsaturated fatty acids with the following structure:

where

The major component fatty acids are linoleic (44-62%), oleic (19-30%), palmitic (7-14%), linolenic (4-11%) and stearic (1.4-5.5%)

Purified egg phosphatides are a mixture of naturally occurring phospholipids which are isolated from the egg yolk. These phospholipids have the following general structure:

Glycerin is chemically designated C

Intralipid

The total caloric value, including fat, phospholipid and glycerin, is 2.0 kcal per mL of Intralipid

The primary container is manufactured from Excel

The plastic container is made from multilayered film specifically designed for parenteral drugs. It contains no plasticizers and exhibits virtually no leachables. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container is nontoxic and biologically inert. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary.

Intralipid – Clinical Pharmacology

Intralipid

Intralipid

Indications and Usage for Intralipid

Intralipid

Contraindications

The administration of Intralipid

Intralipid

Deaths in preterm infants after infusion of intravenous fat emulsion have been reported in the medical literature.

Warnings

Caution should be exercised in administering of Intralipid

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.

Precautions

When Intralipid

During long term intravenous nutrition with Intralipid

Drug product contains no more than 25 mcg/L of aluminum.

Carcinogenesis, Mutagenesis, Impairment of Fertility. Studies with Intralipid

Pregnancy Category C: Animal reproduction studies have not been conducted with Intralipid

Nursing Mothers: Caution should be exercised when Intralipid

Pediatric Use: See DOSAGE AND ADMINISTRATION.

AVOID OVERDOSAGE ABSOLUTELY.

Adverse Reactions

The adverse reactions observed can be separated into two classes:

The deposition of a brown pigmentation in the reticuloendothelial system, the so-called “intravenous fat pigment,” has been reported in patients infused with Intralipid

Overdosage

In the event of fat overload during therapy, stop the infusion containing Intralipid

Intralipid Dosage and Administration

Intralipid

Directions For Proper Use of Pharmacy Bulk Package.

Intralipid

Admixtures made using Intralipid

Adult Patients

The initial infusion rate of the nutrient admixture in adults should be 0.1 g fat/minute for the first 15 to 30 minutes of infusion. If no untoward reactions occur (see ADVERSE. REACTIONS section), the infusion rate can be increased to 0.2 g fat/minute. For adults, the admixture should not contain more than 500 mL of Intralipid

Pediatric Patients

The dosage for premature infants starts at 0.5 g fat/kg body weight/24 hours (2.5 mL Intralipid

The initial rate of infusion in older pediatric patients should be no more than 0.01 g fat/minute for the first 10 to 15 minutes. If no untoward reactions occur, the rate can be changed to permit infusion of 0.1 g of fat/kg/hour. The daily dosage should not exceed 3 g of fat/kg of body weight

Essential Fatty Acid Deficiency

When Intralipid

Administration

See MIXING GUIDELINES AND LIMITATIONS section for information regarding mixing this fat emulsion with other parenteral fluids.

Intralipid

The flow rate of the admixture should be controlled with an infusion pump. Filters of less than 1.2 micron pore size must not be used with admixtures containing Intralipid

Do not use any bag in which there appears to be an oiling out on the surface of the emulsion.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. whenever solution and container permit.

MIXING GUIDELINES AND LIMITATIONS

Investigations have been conducted which demonstrate the compatibility of Intralipid

Perform all manipulations in a suitable work area, such as a laminar flow hood.

Failure to follow the Mixing Guidelines and Limitations below, including recommended storage temperature, storage time. order of mixing, etc., may result in an unstable admixture.

The following proper mixing sequence must be followed to minimize pH related problems by ensuring that typically acidic Dextrose Injections are not mixed with lipid emulsions alone:

Note: Amino Acid Injection, (Novamine

These admixtures should be used promptly with storage under refrigeration (2-8°C) not to exceed 24 hours and must be completely used within 24 hours after removal from refrigeration.

It is essential that the admixture be prepared using strict aseptic techniques as this nutrient mixture is a good growth medium for microorganisms.

Additives other than those named above may be incompatible. Complete information is not available. Those additives known to be incompatible should not be used. Consult with pharmacist, if available. If, in the informed judgment of the physician, it is deemed advisable to introduce additives, use aseptic technique. Mix thoroughly when additives have been introduced. Do not store solutions containing additives (e.g., vitamins and minerals). Additives must not be added directly to Intralipid

Supplemental electrolytes, trace metals or multivitamins may be required in accordance with the prescription of the attending physician.

The prime destabilizers of emulsions are excessive acidity (low pH) and inappropriate electrolyte content. Careful consideration should be given to addition of divalent cations (Ca

The admixture should be inspected carefully for “breaking or oiling out” of the emulsion. “Breaking or oiling out” is described as the separation of the emulsion and can be visibly identified by a yellowish streaking or the accumulation of yellowish droplets in the admixed emulsion. The admixture should also be examined for particulates. The admixture must be discarded if any of the above is observed.

How is Intralipid Supplied

Intralipid

Intralipid

STORAGE

Intralipid

REFERENCES

(Rev June 2006)

Manufactured for

Manufactured by

Intralipid

Instruction for Use – Intralipid

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Hepatasol

Posted by admin on November 5th, 2009

Hepatasol

Hepatasol Description

Hepatasol – Clinical Pharmacology

Indications and Usage for Hepatasol

Contraindications

Warnings

Precautions

General

Usage in Pregnancy

Nursing Mothers:

Pediatric Use:

Special Precautions for Central Venous Nutrition

Adverse Reactions

Overdosage

Hepatasol Dosage and Administration

Pediatric Use:

How is Hepatasol Supplied

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