Plenamine
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From MedlinePlus, U.S. National Library of Medicine
Amino Acid
Dosing in kidney impairment
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. 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.
Preparation and administration
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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 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: [See table below.] 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. [See table below.] 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. [See table below.] 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.
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.
| Volume | Amount | Final Concentration | |
|---|---|---|---|
| Plenamine™ 15% | 500 mL | 75 g | 7.5% |
| Dextrose 70% | 250 mL | 175 g | 17.5% |
| Intralipid® 20% | 250 mL | 50 g | 5.0% |
| Volume | Amount | Final Concentration | |
|---|---|---|---|
| Plenamine™ 15% | 500 mL | 75 g | 3.75% |
| Dextrose 50% | 1000 mL | 500 g | 25% |
| Intralipid® 20% | 500 mL | 100 g | 5% |
| Volume | Amount | Final Concentration | |
|---|---|---|---|
| Plenamine™ 15% | 500 mL | 75 g | 3.75% |
| Dextrose 30% | 1000 mL | 300 g | 15% |
| Intralipid® 10% | 500 mL | 50 g | 2.5% |
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.
Pregnancy and lactation
Pregnancy
D. Pregnancy Category C Animal reproduction studies have not been conducted with Plenamine™ 15%. It is also not known whether Plenamine™ 15% can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Plenamine™ 15% should be given to a pregnant woman only if clearly needed.
Lactation
E. Nursing Mothers Caution should be exercised when Plenamine™ 15% is administered to a nursing woman. 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.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
Not the price at the counterThese are not what a patient pays at the pharmacy counter. They are what pharmacies, health plans, and government buyers pay, before manufacturer rebates. A patient's cost depends on their insurance (copay, coinsurance, or deductible) or the pharmacy's cash price.