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:

Nonprotein energy source:

Glycerin USP (glycerol) 3.0 g

Essential amino acids

Isoleucine USP 0.21 g
Leucine USP 0.27 g
Lysine 0.22 g (added as Lysine Acetate USP 0.31 g)
Methionine USP 0.16 g
Phenylalanine USP 0.17 g
Threonine USP 0.12 g
Tryptophan USP 0.046 g
Valine USP 0.20 g

Nonessential amino acids

Alanine USP 0.21 g
Glycine USP 0.42 g
Arginine USP 0.29 g
Histidine USP 0.085 g
Proline USP 0.34 g
Serine USP 0.18 g
Cysteine < 0.014 g (as Cysteine HCl•H₂O USP < 0.020 g)
Sodium Acetate•3H₂O USP 0.20 g
Magnesium Acetate•4H₂O 0.054 g
Calcium Acetate•H₂O 0.026 g
Sodium Chloride USP 0.12 g
Potassium Chloride USP 0.15g
Phosphoric Acid NF 0.041 g
Potassium Metabisulfite NF (as an antioxidant) < 0.05 g
Water for Injection USP qs
pH adjusted with Glacial Acetic Acid USP
pH: 6.8 (6.5-7.0), Calculated Osmolarity: 735 mOsmol/liter
Concentration of Electrolytes (mEq/liter): Sodium 35; Potassium 24.5; Calcium 3 Magnesium 5; Chloride 41; Phosphate (HPO=4) 7*; Acetate 47**

*3.5 mmole/liter; 10.9 mg% P
**Acetate is provided as inorganic acetate salts (23 mEq/liter), acetic acid (9 mEq/liter), and lysine acetate (15 mEq/liter). It is thought that 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 experience seems to support this thinking, although confirmatory experimental evidence is not available.

Last updated on RxList: 12/18/2008

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.

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.

ProcalAmine® (3% Amino Acid and 3% Glycerin Injection with Electrolytes) is supplied sterile and nonpyrogenic in 1000 mL intravenous infusion bottles, packaged six per case.

NDC	Cat. No.	Size
ProcalAmine (3% Amino Acid and 3% Glycerin Injection with Electrolytes)
0264-1915-07	S9050 (Solid Stopper)	1000 mL
0264-1915-00	S9150 (Air Tube)	1000 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.

Protect from light until use.

Revised May 2003. B. Braun Medical Inc., Irvine CA USA 92614-5895. FDA Rev date: 12/24/2003

Last updated on RxList: 12/18/2008

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.

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.

Last updated on RxList: 12/18/2008

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 µg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.

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:

1. Solutions containing sodium ions should be used with care in patients with congestive heart failure, renal insufficiency and in clinical states in which there exists edema with sodium retention.
2. Solutions containing potassium ions should be used with care in patients with hyperkalemia, renal insufficiency and in conditions in which potassium retention is present.
3. Solutions containing acetate ions from inorganic salts should be used with care in patients with metabolic or respiratory alkalosis.
4. Solutions containing calcium ions should not be administered through the same administration set as blood because of the likelihood of coagulation.
5. Care should be taken to avoid circulatory overload, particularly in patients with cardiac insufficiency. Blood sugar levels should be monitored frequently in diabetic patients.

Care should be taken to avoid circulatory overload, particularly in patients with cardiac insufficiency. Blood sugar levels should be monitored frequently in diabetic patients.

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.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No in vitro or in vivo carcinogenesis, mutagenesis, or fertility studies have been conducted with ProcalAmine® (3% Amino Acid and 3% Glycerin Injection with Electrolytes).

Pregnancy

Teratogenic Effects - 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 WARNINGS and DOSAGE AND ADMINISTRATION.

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 WARNINGS.

Last updated on RxList: 12/18/2008

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

Renal failure.

Severe liver disease and hepatic coma.

Metabolic disorders associated with impaired nitrogen utilization.

Hypersensitivity to one or more amino acids.

Last updated on RxList: 12/18/2008

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 a-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® (3% Amino Acid and 3% Glycerin Injection with Electrolytes) showed a significant improvement in nitrogen balance when compared with patients receiving isonitrogenous amino acids.

Last updated on RxList: 12/18/2008

Directions for Use of B. Braun Glass Containers

General

Before use, perform the following checks:

1. Inspect each container. Read the label. Ensure solution is the one ordered and is within the expiration date. Check the security of bail and band.
2. Invert container and carefully inspect the solution in good light for cloudiness, haze, or particulate matter; check the bottle for cracks or other damage. In checking for cracks, do not be confused by normal surface marks and seams on the bottom and sides of the bottle. These are not flaws. Look for bright reflections that have depth and penetrate into the wall of the bottle. Reject any such bottle.
3. To remove the outer closure, lift the tear tab and pull up, over, and down until it is below the stopper (See Figure 1). Use a circular pulling motion on the tab until it breaks away.
4. Grasp and remove the metal disk, exercising caution not to touch the sterile latex disk underneath.
   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.
5. Refer to Directions for Use for the administration set in use.

Products with Air Tube

1. With the sterile latex disk exposed, check for vacuum by confirming the presence of depressions in the latex disk, which should be held tightly over stopper (See Figure 2). If the latex disk is puffed or depressions cannot be seen, the vacuum has dissipated and the bottle should be rejected. The sterile latex disk provides a surface for aseptic medication addition prior to administration.
   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 Figure 2): a triangular medication site, one large round outlet port, and one small air-inletting port.
2. Before removing the latex disk, add medication through the triangular (Δ) medication site (See Figure 3). The vacuum in the container will automatically draw the contents of a syringe or spiked vial into the container. Each addition/transfer will reduce the vacuum remaining in the bottle.
3. Remove the latex disk prior to inserting administration set. To remove the latex disk, grasp the lip of the disk, lift and pull up and away (See Figure 4). As the disk is lifted, and if no additions have been made, vacuum can be confirmed by an audible hiss.
4. Refer to Directions for Use of the set being used. Insert the set spike into the large round outlet port of the stopper and hang container.

Products with Solid Stopper

Designed for use with a vented set.

1. 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 (Δ) medication site; contents should be drawn by vacuum into the bottle. Admixture by spiked vial should be through the outlet port (See Figure 5). If contents of initial addition are not drawn into the bottle, vacuum is not present and the unit should be discarded. Each addition/transfer will reduce the vacuum remaining in the bottle.
2. If the first puncture of the stopper is the administration set spike, insert the spike fully into the outlet port of the stopper and promptly invert the bottle. Verify vacuum by observing rising air bubbles. Do not use the bottle if vacuum is not present.
3. If admixture or set insertion is not performed immediately following removal of protective metal disk, swab stopper surface

Last updated on RxList: 12/18/2008

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

AMINO ACIDS/ELECTROLYTES/GLYCERIN - INJECTION

(a-MEE-noe/eh-LEC-trow-lytes/GLIS-er-in)

COMMON BRAND NAME(S): Procalamine

USES: This medication is used to help maintain and improve the balance of body protein in patients who require a nutritional supplement for a short period of time. This product provides the body with amino acids as a protein source, essential minerals, and glycerin for energy.

HOW TO USE: Give this medication through a vein (intravenous-IV) as directed by a healthcare professional. You should infuse this medication by using an infusion pump at the prescribed rate. If irritation occurs at the IV site, you may use an in-line IV filter. Before starting this medication, learn all the preparation and usage instructions. If you have any questions, consult your doctor, nurse, or pharmacist.

Before using this product, check it visually for particles or discoloration. Do not use it if the solution is not clear. Also, do not use any bottle that appears to be damaged.

Do not add any medication to this product unless directed by your doctor or pharmacist. Also, do not give this medication through the same IV line as a blood infusion because blood clotting may occur. To reduce side effects, you should check the IV site periodically and make sure fluid is not leaking into the nearby skin area. (See Side Effects section.)

Dosage is based on your body weight, medical condition, and response to therapy.

Learn how to store and discard needles and medical supplies safely. Consult your pharmacist for more information.

SIDE EFFECTS: Flushing, nausea, warm sensation or mild redness/irritation at the IV infusion site may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

It is important to keep your IV site clean. Tell your doctor immediately if you notice: any signs of infection (e.g., fever, chills), unusual redness, swelling, or severe pain at the IV site.

Although unlikely to occur, you may develop an imbalance of body fluid, minerals, or nutrients while receiving this medication. Your therapy may need to be changed to correct the imbalance. It is important to keep your medical and laboratory appointments for regular monitoring by your healthcare professional. Tell your doctor immediately if any of these unlikely but serious side effects occur: change in the amount of urine, increased thirst/urination, mental/mood changes, muscle weakness, slow/irregular heartbeat, swelling of hands/feet/ankles.

A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching, swelling, dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using this medication, tell your doctor or pharmacist if you are allergic to any amino acid, glycerin, latex, sulfites; or if you have any other allergies.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: severe kidney or liver disease, certain metabolic disorder (impaired nitrogen utilization).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: asthma, bleeding problems, congestive heart failure, diabetes.

This product contains aluminum which may build up with prolonged use and may have harmful effects in certain patients (e.g., patients with kidney problems including premature newborns and the elderly). Consult your doctor for more details.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known whether this medication passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with them first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use.

Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly.

NOTES: Do not share this medication with others.

Monitor your weight regularly as directed by your doctor. Report any sudden/unusual weight changes to your doctor or pharmacist. Laboratory and/or medical tests (e.g., blood sugar, electrolytes, protein levels, kidney and liver function tests) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

This nutrition supplement is generally used for a short period of time (about 2 weeks). If nutritional support is needed for an extended period, you should consider other therapy options (e.g., enteral nutrition). Consult your doctor for more information.

MISSED DOSE: If the infusion is unexpectedly interrupted, contact your healthcare professional to establish a new dosing schedule.

STORAGE: Store at room temperature 77 degrees F (25 degrees C) away from light and moisture. Brief storage up to 104 degrees F (40 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.