pharmacopeia
GET
/api/v1/drug/aspartic-acid

Mechanism of action

Sourced from openFDA

Mechanism-of-action class: Biological Macromolecular Activity.

Indications

Sourced from openFDA
  • Aminosyn-PF 7%, Sulfite-Free, (an amino acid injection — pediatric formula) is indicated for the nutritional support of infants (including those of low birth weight) and young children requiring TPN via either central or peripheral infusion routes. Parenteral nutrition with Aminosyn-PF 7% is indicated to prevent nitrogen and weight loss or treat negative nitrogen balance in infants and young children where (1) the alimentary tract by the oral gastrostomy, or jejunostomy route, cannot or should not be used or adequate protein intake is not feasible by these routes, (2) gastrointestinal absorption of protein is impaired; or (3) protein requirements are substantially increased as with extensive burns.

Contraindications

Sourced from openFDA
  • Aminosyn-PF 7%, Sulfite-Free, (an amino acid injection — pediatric formula) is contraindicated in patients with untreated anuria, hepatic coma, inborn errors of amino acid metabolism (including those involving branched chain amino acid metabolism such as maple syrup urine disease and isovaleric acidemia), or hypersensitivity to one or more amino acids present in the solution.contraindicated

Dosage & administration

Sourced from openFDA

The total daily dose of the solution depends on the daily protein requirements and on the patient's metabolic and clinical response. Pediatric requirements for parenteral nutrition are constrained by the greater relative fluid requirements of the infant and greater caloric requirements per kilogram than in the adult. The recommended intravenous dose of Aminosyn-PF 7%, Sulfite-Free, (an amino acid injection — pediatric formula) is up to 2.5 g amino acid/kg/day for infants up to 10 kg. For infants and children larger than 10 kg, the total daily dose of amino acids should be up to 25 g amino acids/day for the first 10 kg of body weight plus 1 to 1.25 g amino acid for each kg of body weight over 10 kg. Initial amino acid dosage levels of 1 g/kg/day may be increased gradually in increments of 0.5 g/kg/day to approximate desired intake levels. Aminosyn-PF 7% should be diluted with dextrose prior to use. Nonprotein calories should constitute approximately 100 to 130 kcal/kg/day. Part of the nonprotein caloric requirement may be provided as lipid emulsion administered concurrently to provide up to 60% of daily calories at a dose not to exceed 4 g fat/kg/day. Fluid intake for the infant receiving central venous TPN should be approximately 125 mL/kg/day (range: 100 to 175 mL/kg/day), depending on the clinical condition of the patient. Premature infants with respiratory distress syndrome suspected of having a patent ductus arteriosus should be given fluids more cautiously.

Warnings & precautions

Sourced from openFDA

Safe, effective use of parenteral nutrition requires a knowledge of nutrition as well as clinical expertise in recognition and treatment of the complications which can occur. FREQUENT EVALUATION AND LABORATORY DETERMINATIONS ARE NECESSARY FOR PROPER MONITORING OF PARENTERAL NUTRITION. Studies should include blood sugar, serum proteins, kidney and liver function tests, electrolytes, hemogram, carbon dioxide content, serum osmolalities, blood cultures, and blood ammonia levels. Administration of amino acids in the presence of impaired renal function or gastrointestinal bleeding may augment an already elevated blood urea nitrogen. Patients with azotemia from any cause should not be infused with amino acids without regard to total nitrogen intake. Administration of intravenous solutions can cause fluid and/or solute overload resulting in dilution of serum electrolyte concentrations, overhydration, congested states, or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentrations of the solutions. Administration of amino acid solutions to a patient with hepatic insufficiency may result in plasma amino acid imbalances, hyperammonemia, prerenal azotemia, stupor and coma. Hyperammonemia is of special significance in infants , as its occurrence in the syndrome caused by genetic metabolic defects is sometimes associated, although not necessarily in a causal relationship, with mental retardation. This reaction appears to be dose-related and is more likely to develop during prolonged therapy.

Adverse reactions

Sourced from openFDA

Local reactions consisting of erythema, phlebitis and thrombosis at the infusion site have occurred with peripheral intravenous infusion of amino acids particularly if other substances, such as antibiotics, are also administered through the same site. In such cases the infusion site should be changed promptly to another vein. Use of large peripheral veins, inline filters, and slowing the rate of infusion may reduce the incidence of local venous irritation. Electrolyte additives should be spread throughout the day. Irritating additive medications may need to be injected at another venous site. Generalized flushing, fever and nausea also have been reported during peripheral infusions of amino acid solutions. If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.

Use in specific populations

Sourced from openFDA

Pregnancy Category C Animal reproduction studies have not been conducted with Aminosyn-PF 7%. It is also not known whether Aminosyn-PF 7% can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Aminosyn-PF 7% should be given to a pregnant woman only if clearly needed.

Overdosage

Sourced from openFDA

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

Approval history

Sourced from openFDA
  • Jul 20, 1984NDANDA019018B Braun
  • Sep 6, 1985NDANDA019398Otsuka Icu Medcl
  • Oct 17, 1986NDANDA019492Otsuka Icu Medcl
  • Dec 19, 1991NDANDA020041Otsuka Icu Medcl
  • Dec 19, 1991NDANDA020015Otsuka Icu Medcl
  • Aug 30, 1996ANDAANDA020512Baxter Hlthcare
  • Aug 26, 1998NDANDA020849Baxter Hlthcare
  • Aug 25, 2014NDANDA200656Fresenius Kabi Usa

FAERS reports

View JSON
Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
508 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Parenteral Nutrition Associated Liver Disease509.8%
  2. 2Chills326.3%
  3. 3Nausea295.7%
  4. 4Pyrexia285.5%
  5. 5Vomiting254.9%
  6. 6Death224.3%
  7. 7Asthenia203.9%
  8. 8Chest Discomfort203.9%
  9. 9Palpitations203.9%
  10. 10Diarrhoea193.7%
  11. 11Dyspnoea193.7%
  12. 12Pneumonia193.7%
  13. 13Foetal Growth Restriction173.3%
  14. 14Anaemia163.1%
  15. 15Pruritus153.0%

Literature

View JSON

Recent PubMed references pinned to Aspartic Acid as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

View JSON

The 10 most recently updated of 306 ClinicalTrials.gov registrations naming Aspartic Acid as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Aspartic Acid work?
Mechanism-of-action class: Biological Macromolecular Activity.
What is Aspartic Acid used for?
According to FDA labeling, Aspartic Acid carries indications including: Aminosyn-PF 7%, Sulfite-Free, (an amino acid injection — pediatric formula) is indicated for the nutritional support of infants (including those of low birth weight) and young children requiring TPN via either central or peripheral infusion routes. Parenteral nutrition with Aminosyn-PF 7% is indicated to prevent nitrogen and weight loss or treat negative nitrogen balance in infants and young children where (1) the alimentary tract by the oral gastrostomy, or jejunostomy route, cannot or should not be used or adequate protein intake is not feasible by these routes, (2) gastrointestinal absorption of protein is impaired; or (3) protein requirements are substantially increased as with extensive burns.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Aspartic Acid?
Aspartic Acid is classified as Biological Macromolecular Activity, Metabolic Activity Alteration.
What are the contraindications for Aspartic Acid?
Aspartic Acid labeling lists contraindications including: Aminosyn-PF 7%, Sulfite-Free, (an amino acid injection — pediatric formula) is contraindicated in patients with untreated anuria, hepatic coma, inborn errors of amino acid metabolism (including those involving branched chain amino acid metabolism such as maple syrup urine disease and isovaleric acidemia), or hypersensitivity to one or more amino acids present in the solution.. Always consult the full prescribing information and a clinician.
Note. Data for aspartic-acid is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

Search pharmacopeia

Search drugs, classes, and ingredients