PLENAMINE Solution for injection (2022)

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1. 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 ...

2. 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. ...

3. 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 ...

4. 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.

5. 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 ...

6. Precautions

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. ...

6.1. General

It is essential to provide adequate calories concurrently if parenterally administered amino acids are to be retained by the body and utilized for protein synthesis. The administration of Plenamine 15% ...

6.3. Laboratory Tests

Infusion of Plenamine 15% without concomitant infusion of an adequate number of non-protein calories may result in elevated BUN. Monitoring of BUN is required and the balance between Plenamine 15% and ...

6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies with Plenamine 15% have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility.

6.7. Pregnancy

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 ...

6.9. Nursing Mothers

Caution should be exercised when Plenamine 15% is administered to a nursing woman.

6.10. Pediatric Use

Safety and effectiveness of Plenamine 15% Amino Acids Injection in pediatric patients have not been established by adequate and well-controlled studies. However, the use of amino acids injections in pediatric ...

7. Adverse Reactions

See WARNINGS, PRECAUTIONS and Special Precautions for Central Infusion.

9. Overdosage

In the event of overhydration or solute overload, re-evaluate the patient and institute appropriate corrective measures (See WARNINGS and PRECAUTIONS).

10. 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. ...

11. How Supplied

Plenamine 15% Amino Acids Injection is supplied sterile and nonpyrogenic in flexible plastic bags, Pharmacy Bulk Packages, 1000 mL packaged 8 per case and 2000 mL packaged 4 per case. NDC REF Size ...

12. Storage and Handling

Store in the closed corrugated case; do not expose solution to light until ready for use. Do not remove container from overwrap until ready to use. Do not use if overwrap has been opened or damaged. Exposure ...