PROSOL- valine, lysine, histidine, isoleucine, leucine, phenylalanine, threonine, methionine, tryptophan, alanine, glycine, arginine, proline, glutamic acid, serine, aspartic acid and tyrosine injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

VALINE (UNII: HG18B9YRS7) (VALINE - UNII:HG18B9YRS7), LYSINE ACETATE (UNII: TTL6G7LIWZ) (LYSINE - UNII:K3Z4F929H6), HISTIDINE (UNII: 4QD397987E) (HISTIDINE - UNII:4QD397987E), ISOLEUCINE (UNII: 04Y7590D77) (ISOLEUCINE - UNII:04Y7590D77), LEUCINE (UNII: GMW67QNF9C) (LEUCINE - UNII:GMW67QNF9C), PHENYLALANINE (UNII: 47E5O17Y3R) (PHENYLALANINE - UNII:47E5O17Y3R), THREONINE (UNII: 2ZD004190S) (THREONINE - UNII:2ZD004190S), METHIONINE (UNII: AE28F7PNPL) (METHIONINE - UNII:AE28F7PNPL), TRYPTOPHAN (UNII: 8DUH1N11BX) (TRYPTOPHAN - UNII:8DUH1N11BX), ALANINE (UNII: OF5P57N2ZX) (ALANINE - UNII:OF5P57N2ZX), GLYCINE (UNII: TE7660XO1C) (GLYCINE - UNII:TE7660XO1C), ARGININE (UNII: 94ZLA3W45F) (ARGININE - UNII:94ZLA3W45F), PROLINE (UNII: 9DLQ4CIU6V) (PROLINE - UNII:9DLQ4CIU6V), GLUTAMIC ACID (UNII: 3KX376GY7L) (GLUTAMIC ACID - UNII:3KX376GY7L), SERINE (UNII: 452VLY9402) (SERINE - UNII:452VLY9402), ASPARTIC ACID (UNII: 30KYC7MIAI) (ASPARTIC ACID - UNII:30KYC7MIAI), TYROSINE (UNII: 42HK56048U) (TYROSINE - UNII:42HK56048U)

Available from:

Baxter Healthcare Corporation

INN (International Name):

VALINE

Composition:

VALINE 1.44 g in 100 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

PROSOL is indicated as a source of amino acids for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. PROSOL may be used to treat negative nitrogen balance in patients. The use of PROSOL is contraindicated in: Risk Summary Limited published data with injectable amino acids solutions, including PROSOL in pregnant women are not sufficient to inform a drug associated risk for adverse developmental outcomes. However, malnutrition in pregnant women is associated with adverse maternal and fetal outcomes [see Clinical Considerations]. Animal reproduction studies have not been conducted with injectable amino acids solutions, including PROSOL. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. However, the background risk in the U.S. general population of major birth defects is 2 to 4% and of miscarriage is 15 to 20% of clinically recognized pregnancies. Clinical Considerations Disease-Associated Maternal and/or Embryo-Fetal Risk Severe malnutrition in pregnant women is associated with preterm delivery, low birth weight, intrauterine growth restriction, congenital malformations and perinatal mortality. Parenteral nutrition should be considered if a pregnant woman’s nutritional requirements cannot be fulfilled by oral or enteral intake. Risk Summary There are no data available to assess the presence of injectable amino acids, including PROSOL in human milk, the effects of PROSOL on the breastfed infant or the effects on milk production. The lack of clinical data during lactation precludes a clear determination of the risk of PROSOL to a child during lactation; therefore, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for PROSOL and any potential adverse effects on the breastfed child from PROSOL or from the underlying maternal condition. Neonates, especially premature infants with low birth weight, are at increased risk of developing hypo- or hyperglycemia and therefore need close monitoring during treatment with intravenous glucose solutions to ensure adequate glycemic control in order to avoid potential long term adverse effects [see Dosage and Administration (2.7)]. Plasma electrolyte concentrations should be closely monitored in the pediatric patients who may have impaired ability to regulate fluids and electrolytes. Hyperammonemia is of special significance in infants (birth to two years). This reaction appears to be related to a deficiency of the urea cycle amino acids of genetic or product origin. It is essential that blood ammonia be measured frequently in infants [see Warnings and Precautions (5.7)]. Because of immature renal function, preterm infants receiving prolonged parenteral nutrition treatment with PROSOL may be at risk of aluminum toxicity [see Warnings and Precautions (5.8)]. Patients, including pediatric patients, may be at risk for PNALD [see Warnings and Precautions (5.9)]. Clinical studies with PROSOL have not been performed to determine whether subjects aged 65 and over respond differently from other younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or drug therapy. In patients with impaired renal function, parenteral nutrition solutions containing PROSOL should be administered with caution. Frequent clinical evaluation and laboratory tests to monitor renal function such as serum electrolytes (especially phosphate and potassium) and fluid balance should be conducted [see Dosage and Administration (2.6) , and Warnings and Precautions (5.10)]. In patients with impaired liver function, parenteral nutrition solutions containing PROSOL should be administered starting at the low end of the dosing range [see Dosage and Administration (2.5)]. Frequent clinical evaluation and laboratory tests to monitor liver function such as bilirubin and liver function parameters should be conducted [see Warnings and Precautions (5.7) ].

Product summary:

PROSOL 20% (amino acids) injection is available in plastic Pharmacy Bulk Package flexible containers in the following size as shown in Table 5 below. 2B6186 2000 mL NDC 0338-0499-06 Minimize exposure of PROSOL to heat and avoid excessive heat. Protect from freezing. Store PROSOL at room temperature (25ºC/77ºF). Brief exposure up to 40ºC/104ºF does not adversely affect the product. Do not use if protective overpouch has been previously opened or damaged. For storage of admixed solutions [see Dosage and Administration (2.3) ].

Authorization status:

New Drug Application

Summary of Product characteristics

PROSOL- VALINE, LYSINE, HISTIDINE, ISOLEUCINE, LEUCINE, PHENYLALANINE,
THREONINE, METHIONINE,
TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, GLUTAMIC ACID,
SERINE, ASPARTIC ACID AND
TYROSINE INJECTION, SOLUTION
BAXTER HEALTHCARE CORPORATION
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PROSOL SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR PROSOL.
PROSOL (AMINO ACIDS) INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1998
RECENT MAJOR CHANGES
INDICATIONS AND USAGE
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
Adverse reactions include pulmonary vascular emboli, hypersensitivity
reactions infection, refeeding syndrome,
Dosage and Administration, Preparation Instructions for
Admixing Using a Parenteral Nutrition Container (2.3) 09/2020
PROSOL is indicated as a source of amino acids for patients requiring
parenteral nutrition when oral or enteral
nutrition is not possible, insufficient, or contraindicated. PROSOL
may be used to treat negative nitrogen balance in
patents. (1)
_Pharmacy Bulk Package. Not for direct intravenous infusion. _(2.1)
See full prescribing information for information on preparation,
administration, instructions for use, dosing
considerations, including the recommended dosage in adults and
pediatrics, and dosage modifications in patients with
renal impairment. (2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8)
Protect the admixed parenteral nutrition solution from light. (2.3)
Injection: 20% (0.2 grams/mL), 20 grams of amino acids per 100 mL in
2000 mL flexible containers. (3)
Known hypersensitivity to one or more amino acids (4)
Inborn errors of amino acid metabolism (4)
Patients with pulmonary edema or acidosis due to low cardiac output
(4)
Pulmonary Embolism due to Pulmonary Vascular Precipitates: if signs of
pulmonary distress occur, stop the infusion
and initiate a medical evaluation