| Product Description: | ProcalAmine (3% Amino Acid and 3% Glycerin Injection with Electrolytes) 1000 mL Container, Rx Only, Catalog No. S9050, Sterile, Single Dose Container, B Braun Medical Inc., Irvine CA 92614-5895, NDC 0264-1915-07 |
|---|---|
| Status: | Ongoing |
| City: | Irvine |
| State: | CA |
| Country: | US |
| Voluntary/Mandated: | Voluntary: Firm Initiated |
| Initial Firm Notification: | Letter |
| Distribution Pattern: | Nationwide, Puerto Rico and Spain |
| Classification: | Class I |
| Product Quantity: | 18,090 units |
| Reason For Recall: | Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units. |
| Recall Initiation Date: | 20131121 |
| Report Date: | 20140507 |
Procalamine
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Questions & Answers
Side Effects & Adverse Reactions
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:
- 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.
- Solutions containing potassium ions should be used with care in patients with hyperkalemia, renal insufficiency and in conditions in which potassium retention is present.
- Solutions containing acetate ions from inorganic salts should be used with care in patients with metabolic or respiratory alkalosis.
- Solutions containing calcium ions should not be administered through the same administration set as blood because of the likelihood of coagulation.
Care should be taken to avoid circulatory overload, particularly in patients with cardiac insufficiency.
Blood sugar levels should be monitored frequently in diabetic patients.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
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.
History
There is currently no drug history available for this drug.
Other Information
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.............................................................................. 0.15 g
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 ) 71; Acetate 472
- 1
- 3.5 mmole/liter; 10.9 mg% P
- 2
- 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.
Sources
Procalamine Manufacturers
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B. Braun Medical Inc.
![Procalamine (Glycerin, Isoleucine, Leucine, Lysine, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Glycine, Arginine, Histidine, Proline, Serine, Cysteine, Sodium Acetate, Magnesium Acetate, Calcium Acetate, Sodium Chloride, Potassium Chloride, Phosphoric Acid, And Potassium Metabisulfite) Injection [B. Braun Medical Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Procalamine | B. Braun Medical Inc.
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 UseProcalAmine® 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.
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