Generic name: LYSINE ACETATE 1.18g in 100mL, LEUCINE 1.04g in 100mL, PHENYLALANINE 1.04g in 100mL, VALINE 960mg in 100mL, ISOLEUCINE 749mg in 100mL, METHIONINE 749mg in 100mL, THREONINE 749mg in 100mL, TRYPTOPHAN 250mg in 100mL, ALANINE 2.17g in 100mL, ARGININE 1.47g in 100mL, GLYCINE 1.04g in 100mL, HISTIDINE 894mg in 100mL, PROLINE 894mg in 100mL, GLUTAMIC ACID 749mg in 100mL, SERINE 592mg in 100mL, ASPARTIC ACID 434mg in 100mL, TYROSINE 39mg in 100mL
Dosage form: intravenous infusion
Drug class: Intravenous nutritional products
Medically reviewed by Drugs.com. Last updated on Oct 19, 2021.
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
Plenamine™ 15% in a Pharmacy Bulk Package is not intended for direct infusion. The container closure may be penetrated only once using a suitable unvented sterile transfer device or dispensing set which allows measured dispensing of the contents. The Pharmacy Bulk Package is to be used only in a suitable work area such as a laminar flow hood (or an equivalent clean air compounding area). Once the closure is penetrated, the contents should be dispensed as soon as possible; the transfer of contents must be completed within 4 hours of closure entry. The bag may be stored at room temperature (25°C) after the closure has been entered.
When using Plenamine™ 15% in patients with a need for fluid volume restriction, it can be diluted as follows:
|Plenamine™ 15%||500 mL||75 g||7.5%|
|Dextrose 70%||250 mL||175 g||17.5%|
|Intralipid® 20%||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 1559 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.
|Plenamine™ 15%||500 mL||75 g||3.75%|
|Dextrose 50%||1000 mL||500 g||25%|
|Intralipid® 20%||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 1631 mOsmol/L.
|Plenamine™ 15%||500 mL||75 g||3.75%|
|Dextrose 30%||1000 mL||300 g||15%|
|Intralipid® 10%||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 1126 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 Plenamine™ 15%) plus 4.4 grams (15 calories) of dextrose per kilogram of body weight per day are required to achieve nitrogen balance and weight stability. Intravenous fat emulsion may be used as a partial substitute for dextrose. This regimen provides a ratio of 150 non-protein calories per gram of nitrogen.
For patients stressed by surgery, trauma or sepsis, and those with unusual nitrogen losses, the dosage required for maintenance may be as high as 0.3 to 0.4 grams of nitrogen (13 to 17 mL Plenamine™ 15%) per kilogram of body weight per day, with proportionate increases in non-protein calories. Periodic assessment of nitrogen balance of the individual patient is the best indicator of proper dosage. Volume overload and glycosuria may be encountered at high dosage, and nitrogen balance may not be achieved in extremely hypermetabolic patients under these constraints. Concomitant insulin administration may be required to minimize glycosuria. Daily laboratory monitoring is essential.
Use of an infusion pump is advisable to maintain a steady infusion rate during central venous infusion.
B. Peripheral Nutrition
In patients for whom central venous catheterization is not advisable, protein catabolism can be reduced by peripheral use of diluted Plenamine™ 15% plus non-protein calorie sources. Dilution of 250 mL Plenamine™ 15% in 750 mL of 10% dextrose will reduce the osmolarity to a level (724 mOsmol/L) which is more favorable to the maintenance of the integrity of the walls of the veins. Intravenous fat emulsion can be infused separately or simultaneously; if infused simultaneously the fat emulsion will provide a dilution effect upon the osmolarity while increasing the energy supply.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
To reduce the risk of bacterial contamination, all intravenous administration sets should be replaced at least every 24 hours. Usage of admixtures must be initiated within 24 hours after mixing. If storage is necessary during this 24 hour period, admixtures must be refrigerated and completely used within 24 hours of beginning administration.
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