"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
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 (amino acid and glycerin) should be reevaluated.
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 (amino acid and glycerin) . 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.
Care should be taken to avoid circulatory overload, particularly in patients with cardiac insufficiency. Blood sugar levels should be monitored frequently in diabetic patients.
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 (amino acid and glycerin) 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 (amino acid and glycerin) , 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 (amino acid and glycerin) 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
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
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 (amino acid and glycerin) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. ProcalAmine (amino acid and glycerin) should be given to a pregnant woman only if clearly needed
Labor and Delivery
Information is unknown.
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 (amino acid and glycerin) if administered to a nursing woman.
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.
Clinical studies of ProcalAmine (amino acid and glycerin) 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 reviewed on RxList: 12/18/2008
This monograph has been modified to include the generic and brand name in many instances.
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