PLENAMINE- lysine acetate, leucine, phenylalanine, valine, isoleucine, methionine, threonine, tryptophan, alanine, arginine, gly

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LYSINE ACETATE (UNII: TTL6G7LIWZ) (LYSINE - UNII:K3Z4F929H6), LEUCINE (UNII: GMW67QNF9C) (LEUCINE - UNII:GMW67QNF9C), PHENYLALANINE (UNII: 47E5O17Y3R) (PHENYLALANINE - UNII:47E5O17Y3R), VALINE (UNII: HG18B9YRS7) (VALINE - UNII:HG18B9YRS7), ISOLEUCINE (UNII: 04Y7590D77) (ISOLEUCINE - UNII:04Y7590D77), METHIONINE (UNII: AE28F7PNPL) (METHIONINE - UNII:AE28F7PNPL), THREONINE (UNII: 2ZD004190S) (THREONINE - UNII:2ZD004190S), TRYPTOPHAN (UNII: 8DUH1N11BX) (TRYPTOPHAN - UNII:8DUH1N11BX), ALANINE (UNII: OF5

Available from:

B. Braun Medical Inc.

INN (International Name):

LYSINE ACETATE

Composition:

LYSINE 1.18 g in 100 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. 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.

Product summary:

Plenamine™ 15% Amino Acids Injection is supplied sterile and nonpyrogenic in glass containers, Pharmacy Bulk Packages, packaged 6 per case. Store in the closed carton; do not expose solution to light until ready for use. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended that the product be stored at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Brief exposure to temperatures above 25°C during transport and storage will not adversely affect the product. Solution that has been frozen must not be used.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PLENAMINE- LYSINE ACETATE, LEUCINE, PHENYLALANINE, VALINE, ISOLEUCINE,
METHIONINE, THREONINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE,
HISTIDINE,
PROLINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID, AND TYROSINE SOLUTION
B. BRAUN MEDICAL INC.
----------
PLENAMINE™
15% AMINO ACIDS INJECTION
Package Insert
PHARMACY BULK PACKAGE
NOT FOR DIRECT INFUSION
PROTECT FROM LIGHT UNTIL USE.
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. 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
*
Sodium Metabisulfite, NF added
30
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
151
mEq/L
Osmolarity (calculated)
1383
mOsmol/L
pH 5.6 (5.2–6.0)
The formulas for the individual amino acids are as follows:
ESSENTIAL AMINO ACIDS
Lysine Acetate H N(CH ) CH(NH )COOH•CH COOH
Leucine
(CH ) CHCH CH(NH )COOH
Phenylalanine
Valine
(CH ) CHCH(NH )COOH
Isoleucine
CH CH CH(CH )CH(NH )COOH
Methionine
CH S(CH ) CH(NH )COOH
Threonine
CH CH(OH)CH(NH )COOH
Tryptophan
NONESSENTIAL AMINO ACIDS
Alanine
CH CH(NH )COOH
Arginine
H NC(NH)NH(CH ) CH(NH )COOH
Glycine
H NCH COOH
Histidine
Proline
Glutamic Acid
HOOC(CH ) CH(NH )COOH
Serine
HOCH CH(NH )COOH
Ac