Aminosyn-RF

Name: Aminosyn-RF

Aminosyn®-RF 5.2% Sulfite-Free AN AMINO ACID INJECTION RENAL FORMULA Flexible Plastic Container

Rx only

Aminosyn-RF - Clinical Pharmacology

Aminosyn-RF 5.2%, Sulfite-Free, (an amino acid injection renal formula) is a mixture of amino acids specifically designed for patients with acute renal failure who are unable to eat. The use of these essential amino acids in the management of the uremic patient is based on the minimal requirements for each of the eight amino acids essential in adult nutrition established by Rose. In renal failure nonspecific nitrogen such as urea, glycine, or ammonium chloride, are broken down in the intestine. The ammonia formed is absorbed into the portal system and incorporated by the liver into nonessential amino acids, provided requirements for essential amino acids are being met. By this metabolic route, urea nitrogen contributes to protein synthesis when the proper combination of essential amino acids, sufficient calories and other required nutrients are administered.

Thus, the administration of essential amino acids to uremic patients, particularly those who are protein-deficient, results in the utilization of retained urea in protein synthesis, and may be followed by a drop in BUN and resolution of many of the symptoms associated with azotemia.

Aminosyn-RF 5.2% contains histidine, an amino acid considered essential for infant growth, and identified as an essential amino acid for uremic patients.

In patients with potentially reversible acute renal failure who cannot eat, maintenance of adequate nutrition may assist in reducing morbidity.

Contraindications

  1. Severe uncorrected electrolyte or acid-base imbalance.

  2. Hyperammonemia.

  3. Decreased circulating blood volume.

Im-0682

bag ndc 0409-4166-03

Wr-0305

overwrap ndc 0409-4166-03

AMINOSYN RF 
isoleucine, leucine, lysine acetate, methionine, phenylalanine, threonine, tryptophan, valine, arginine, and histidine injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0409-4166
Route of Administration INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ISOLEUCINE (ISOLEUCINE) ISOLEUCINE 462 mg  in 100 mL
LEUCINE (LEUCINE) LEUCINE 726 mg  in 100 mL
LYSINE ACETATE (LYSINE) LYSINE 535 mg  in 100 mL
METHIONINE (METHIONINE) METHIONINE 726 mg  in 100 mL
PHENYLALANINE (PHENYLALANINE) PHENYLALANINE 726 mg  in 100 mL
THREONINE (THREONINE) THREONINE 330 mg  in 100 mL
TRYPTOPHAN (TRYPTOPHAN) TRYPTOPHAN 165 mg  in 100 mL
VALINE (VALINE) VALINE 528 mg  in 100 mL
ARGININE (ARGININE) ARGININE 600 mg  in 100 mL
HISTIDINE (HISTIDINE) HISTIDINE 429 mg  in 100 mL
Inactive Ingredients
Ingredient Name Strength
ACETIC ACID  
Packaging
# Item Code Package Description
1 NDC:0409-4166-03 12 POUCH (12 POUCH) in 1 CASE
1 1 BAG (1 BAG) in 1 POUCH
1 500 mL in 1 BAG
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018429 02/18/2011
Labeler - Hospira, Inc. (141588017)
Revised: 03/2011   Hospira, Inc.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of fluid and electrolyte problems like mood changes, confusion, muscle pain or weakness, a heartbeat that does not feel normal, very bad dizziness or passing out, fast heartbeat, more thirst, seizures, feeling very tired or weak, not hungry, unable to pass urine or change in the amount of urine produced, dry mouth, dry eyes, or very bad upset stomach or throwing up.
  • Shortness of breath, a big weight gain, or swelling in the arms or legs.
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