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Basic Drug Info
Drug Name:Aminosyn II in Dextrose
Manufacturer:HOSPIRA, INC.
Other Info:

DO NOT USE IF AMINOSYN II IS DISCOLORED OR IF CLAMP IS OPEN OR MISSING.

COLOR VARIATION IN THE DEXTROSE INJECTION FROM PALE YELLOW TO YELLOW IS NORMAL AND DOES NOT ALTER EFFICACY.To Open:Tear outer wrap at notch.

After removing the overwrap, check for minute leaks by squeezing the container firmly.

If leaks are found, discard solution as sterility may be impaired.

If supplemental medication is desired, follow directions below before preparing for administration.To Add Medication:Prepare the appropriate additive port.Using aseptic technique and an additive delivery needle of appropriate length, puncture resealable additive port at target area through inner diaphragm and inject.

Withdraw needle after injecting medication.The additive ports should be protected by covering with additive caps.Mix container contents thoroughly.Preparation for Administration(Use aseptic technique)Open clamp between the two chambers.

Completely drain all the solution and air into the lower chamber.

To achieve this, stretch the side wall of the emptied top chamber.

Close flow control clamp of administration set.Remove cover from outlet port at bottom of container.Insert piercing pin of administration set into port with a twisting motion until the set is firmly seated.

NOTE: See full directions on administration set carton.Suspend from hanger at top of container.Squeeze and release drip chamber to establish proper fluid level in chamber.Open flow control clamp to expel air from set.

Close flow control clamp.Connect to infusion catheter.Regulate rate of administration with flow control clamp. Ensure that all solution and air are in the lower chamber when reading fluid levels.WARNING: Do not use flexible container in series connections.



Clinical Trials:


Indications and Usage
Aminosyn II 3.5% in 5% Dextrose Injection infused through a peripheral vein is indicated as a source of nitrogen in the nutritional support of patients in whom for short periods of time oral nutrition cannot be tolerated, is undesirable or inadequate. The addition of supplemental electrolytes will be required in accordance with the prescription of the attending physician.
Contraindications
This preparation should not be used in patients with hepatic coma or metabolic disorders involving impaired nitrogen utilization.
Hepatic Coma --

Unspecified disorder of metabolism -- Generic term for diseases caused by an abnormal metabolic process. It can be congenital due to inherited enzyme abnormality (METABOLISM, INBORN ERRORS) or acquired due to disease of an endocrine organ or failure of a metabolically important organ such as the liver. (Stedman, 26th ed)

Warnings

Parenteral infusion of amino acids, similar to the enteral ingestion of any protein, may induce a rise in blood urea nitrogen (BUN) especially in patients with impaired renal function.

Appropriate laboratory tests should be performed periodically and the infusion eventually 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. 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. Aminosyn II 3.5% in 5% Dextrose Injection contains sodium hydrosulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people.

The overall prevalence of sulfite sensitivity in the general population is unknown and probably low.

Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people. Parenteral administration of amino acids may result in increased plasma ammonia concentration.

Instances of asymptomatic hyperammonemia have been reported in patients without overt liver dysfunction.

The mechanisms of this reaction are not clearly defined, but may involve genetic defects and immature or subclinically impaired liver function. Hyperammonemia is of special significance in infants, as it can result in mental retardation.

Therefore, it is essential that blood ammonia levels be monitored frequently in infants. WARNING: This product contains aluminum that may be toxic.

Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum. Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity.

Tissue loading may occur at even lower rates of administration.

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