Source: FDA, National Drug Code (US) Revision Year: 2022
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. It is a sterile dosage form which contains several single doses for use in a pharmacy admixture program in the preparation of intravenous parenteral fluids.
Each 100 mL contains:
| Essential Amino Acids | ||
| Lysine (from Lysine Acetate, USP) | 1.18 | g |
| Leucine, USP | 1.04 | g |
| Phenylalanine, USP | 1.04 | g |
| Valine, USP | 960 | mg |
| Isoleucine, USP | 749 | mg |
| Methionine, USP | 749 | mg |
| Threonine, USP | 749 | mg |
| Tryptophan, USP | 250 | mg |
| Nonessential Amino Acids | ||
| Alanine, USP | 2.17 | g |
| Arginine, USP | 1.47 | g |
| Glycine, USP | 1.04 | g |
| Histidine, USP | 894 | mg |
| Proline, USP | 894 | mg |
| Glutamic Acid | 749 | mg |
| Serine, USP | 592 | mg |
| Aspartic Acid, USP | 434 | mg |
| Tyrosine, USP | 39 | mg |
| Water for Injection, USP | qs | |
| Essential Amino Acids | 6.7 | g |
| Nonessential Amino Acids | 8.3 | g |
| Total Amino Acids | 15.0 | g |
| Total Nitrogen | 2.37 | g |
| Acetate?footnote? | 147.4 | mEq/L |
| Osmolarity (calculated) | 1378 | mOsmol/L |
| pH 5.6 (5.2–6.0) |
* Acetate from Lysine Acetate, USP and acetic acid used for pH adjustment.
The formulas for the individual amino acids are as follows:
| Lysine Acetate | H2N(CH2)4CH(NH2)COOH•CH3COOH |
| Leucine | (CH3)2CHCH2CH(NH2)COOH |
| Phenylalanine |  |
| Valine | (CH3)2CHCH(NH2)COOH |
| Isoleucine | CH3CH2CH(CH3)CH(NH2)COOH |
| Methionine | CH3S(CH2)2CH(NH2)COOH |
| Threonine | CH3CH(OH)CH(NH2)COOH |
| Tryptophan |  |
| Alanine | CH3CH(NH2)COOH |
| Arginine | H2NC(NH)NH(CH2)3CH(NH2)COOH |
| Glycine | H2NCH2COOH |
| Histidine |  |
| Proline |  |
| Glutamic Acid | HOOC(CH2)2CH(NH2)COOH |
| Serine | HOCH2CH(NH2)COOH |
| Aspartic Acid | HOOCCH2CH(NH2)COOH |
| Tyrosine |  |
| 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.
Not made with natural rubber latex, DEHP or PVC. |
| Drug | Countries | |
|---|---|---|
| PLENAMINE | United States |
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