Overview
DESCRIPTION Plenamine™ 15% Amino Acids Injection in a Pharmacy Bulk Package is a sterile, clear, nonpyrogenic solution of essential and nonessential amino acids for intravenous infusion in parenteral nutrition following appropriate dilution. Plenamine™ 15% in a Pharmacy Bulk Package is not for direct infusion.
Mechanism of Action
CLINICAL PHARMACOLOGY Plenamine™ 15% Amino Acids Injection provides seventeen crystalline amino acids. This completely utilizable substrate promotes protein synthesis and wound healing and reduces the rate of protein catabolism. A. Total Parenteral Nutrition (Central Infusion) When enteral feeding is inadvisable, Plenamine™ 15% given by central venous infusion in combination with energy sources, vitamins, trace elements and electrolytes, will completely satisfy the requirements for weight maintenance or weight gain, depending upon the dose selected. The energy component in parenteral nutrition by central infusion may be derived solely from dextrose or may be provided by a combination of dextrose and intravenous fat emulsion.
Indications
- INDICATIONS AND USAGE Plenamine™ 15% is indicated as an amino acid (nitrogen) source in parenteral nutrition regimens. This use is appropriate when the enteral route is inadvisable, inadequate or not possible, as when: — Gastrointestinal absorption is impaired by obstruction, inflammatory disease or its complications, or antineoplastic therapy; — Bowel rest is needed because of gastrointestinal surgery or its complications such as ileus, fistulae or anastomotic leaks; — Tube feeding methods alone cannot provide adequate nutrition.
Common Doses
- 500 mL
- 75 g
- 250 mL
- 175 g
Dosage
DOSAGE AND ADMINISTRATION 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.
Contraindications
- 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.
Side Effects
- ADVERSE REACTIONS (See WARNINGS , PRECAUTIONS and Special Precautions for Central Infusion .)
Interactions
- No major interactions listed on the FDA label. Always consult a healthcare professional.