pharmacopeia

N-acetyltyrosine

US-FDASourced from openFDA
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Boxed warning

Pharmacy Bulk Package – Not For Direct Infusion.

Indications

Sourced from openFDA
  • Aminosyn II, Sulfite-Free, (an amino acid injection) infused with dextrose by peripheral vein infusion is indicated as a source of nitrogen in the nutritional support of patients with adequate stores of body fat, in whom, for short periods of time, oral nutrition cannot be tolerated, is undesirable, or inadequate. SUPPLEMENTAL ELECTROLYTES, IN ACCORDANCE WITH THE PRESCRIPTION OF THE ATTENDING PHYSICIAN, MUST BE ADDED TO AMINOSYN II SOLUTIONS WITHOUT ELECTROLYTES.

Contraindications

Sourced from openFDA
  • This preparation should not be used in patients with hepatic coma or metabolic disorders involving impaired nitrogen utilization.contraindicated

Dosage & administration

Sourced from openFDA

Each 100 mL of Aminosyn II contains: Amino Acids Nitrogen Aminosyn II 10% 10 g 1.53 g Aminosyn II 15% 15 g 2.30 g The total daily dose of the solution depends on the daily protein requirements and on the patient’s metabolic and clinical response. In many patients, provision of adequate calories in the form of hypertonic dextrose may require the administration of exogenous insulin to prevent hyperglycemia and glycosuria. To prevent rebound hypoglycemia, a solution containing 5% dextrose should be administered when hypertonic dextrose infusions are abruptly discontinued. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. COLOR VARIATION FROM PALE YELLOW TO YELLOW IS NORMAL AND DOES NOT ALTER EFFICACY. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. Aminosyn II in the 2000 mL flexible Pharmacy Bulk Package is designed for use with manual, gravity flow operations and automated gravimetric compounding devices for preparing intravenous nutritional admixtures. Admixtures must be stored under refrigeration and used within 24 hours of admixing. Peripheral Vein Nutritional Maintenance A mixture of Aminosyn II and dextrose diluted to a final concentration of 5% to 10% amino acids and 5% to 10% dextrose is suitable for administration by peripheral vein.

Warnings & precautions

Sourced from openFDA

Intravenous infusion of amino acids may induce a rise in blood urea nitrogen (BUN), especially in patients with impaired hepatic or renal function. Appropriate laboratory tests should be performed periodically and infusion discontinued if BUN levels exceed normal postprandial limits and continue to rise. It should be noted that a modest rise in BUN normally occurs as a result of increased protein intake. Administration of amino acid solutions to a patient with hepatic insufficiency may result in serum amino acid imbalances, metabolic alkalosis, prerenal azotemia, hyperammonemia, stupor and coma. Administration of amino acid solutions in the presence of impaired renal function may augment an increasing BUN, as does any protein dietary component. Solutions containing sodium ion should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency and in clinical states in which there exists edema with sodium retention. Solutions which contain potassium ion should be used with great care, if at all, in patients with hyperkalemia, severe renal failure and in conditions in which potassium retention is present. Solutions containing acetate ion should be used with great care in patients with metabolic or respiratory alkalosis. Acetate should be administered with great care in those conditions in which there is an increased level or an impaired utilization of this ion, such as severe hepatic insufficiency. Hyperammonemia is of special significance in infants, as it can result in mental retardation.

Adverse reactions

Sourced from openFDA

Peripheral Infusions A 3.5% to 5% solution of amino acids (without additives) is slightly hypertonic. 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 infused at another venous site. Generalized flushing, fever and nausea also have been reported during peripheral infusions of amino acid solutions.

Use in specific populations

Sourced from openFDA

Pregnancy Category C. Animal reproduction studies have not been conducted with Aminosyn II (an amino acid injection). It is not known whether Aminosyn II can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Aminosyn II 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
  • Dec 19, 1991NDANDA020041Otsuka Icu Medcl
  • Dec 19, 1991NDANDA020015Otsuka Icu Medcl

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.
4 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. 1Arthralgia125%
  2. 2Furuncle125%
  3. 3Pain In Extremity125%
  4. 4Product Colour Issue125%
  5. 5Product Dispensing Error125%
  6. 6Product Odour Abnormal125%
  7. 7Product Preparation Error125%
  8. 8Product Quality Issue125%
  9. 9Product Supply Issue125%
  10. 10Rheumatoid Arthritis125%
  11. 11Uterine Disorder125%

Clinical trials

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The 1 most recently updated of 1 ClinicalTrials.gov registrations naming N-acetyltyrosine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

What is N-acetyltyrosine used for?
According to FDA labeling, N-acetyltyrosine carries indications including: Aminosyn II, Sulfite-Free, (an amino acid injection) infused with dextrose by peripheral vein infusion is indicated as a source of nitrogen in the nutritional support of patients with adequate stores of body fat, in whom, for short periods of time, oral nutrition cannot be tolerated, is undesirable, or inadequate. SUPPLEMENTAL ELECTROLYTES, IN ACCORDANCE WITH THE PRESCRIPTION OF THE ATTENDING PHYSICIAN, MUST BE ADDED TO AMINOSYN II SOLUTIONS WITHOUT ELECTROLYTES.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What are the contraindications for N-acetyltyrosine?
N-acetyltyrosine labeling lists contraindications including: This preparation should not be used in patients with hepatic coma or metabolic disorders involving impaired nitrogen utilization.. Always consult the full prescribing information and a clinician.
Note. Data for n-acetyltyrosine 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.

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