TrophAmine

Trophamine is part of the drug classes:

• Other antidepressants

• Other irrigating solutions

• Electrolyte solutions

• Amino acids

• Antidotes

• Salt solutions

• Sodium

Protect from light until use.

TrophAmine® 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.

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 clinical 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.

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.

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. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly 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. It is essential that blood ammonia be measured frequently in infants. The mechanisms of this reaction are not clearly defined but may involve genetic defects and immature or subclinically impaired liver function.

Conservative doses of amino acids should be given, dictated by the nutritional status of the patient. Should symptoms of hyperammonemia develop, amino acid administration should be discontinued and the patient's clinical status reevaluated.

This product contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or 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.

In the event of a fluid or solute overload during parenteral therapy, reevaluate the patient's condition, and institute appropriate corrective treatment.

Designed for use with a vented set. Use 18 to 22 gauge needle size for admixing or withdrawing solutions from the glass bottle.

Before use, perform the following checks:

1. Inspect each container. Read the label. Ensure solution is the one ordered and is within the expiration date.
2. Invert container and carefully inspect the solution in good light for cloudiness, haze, or particulate matter; check the bottle for cracks or other damage. In checking for cracks, do not be confused by normal surface marks and seams on the bottom and sides of the bottle. These are not flaws. Look for bright reflections that have depth and penetrate into the wall of the bottle. Reject any such bottle.
3. To remove the outer closure, lift the tear tab and pull up, over, and down until it is below the stopper (See Figure 1). Use a circular pulling motion on the tab until it breaks away.
   
4. Grasp and remove the metal disk, exercising caution not to touch the exposed sterile stopper surface.
   
   Warning: Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store. 
5. When adding medication to the container prior to administration, swab the target area of the rubber stopper, inject medication and mix thoroughly by gentle agitation.
6. Refer to Directions for Use of the set being used. Insert the set spike into the bottle through the target area of the rubber stopper. Allow the fluid to flow and remove air from the tubing before administration begins. Hang the container.
7. After admixture and during administration, re-inspect the solution frequently. If any evidence of solution contamination or instability is found or if the patient exhibits any signs of fever, chills or other reactions not readily explainable, discontinue administration immediately and notify the physician.
8. Spiking, additions, or transfers should be made immediately after exposing the sterile stopper surface. Check for vacuum at first puncture of stopper. Admixture by needle or syringe should be made through the target area of the rubber stopper; contents should be drawn by vacuum into the bottle. Admixture by spiked vial should be through the target area of the rubber stopper (See Figure 2). If contents of initial addition are not drawn into the bottle, vacuum is not present and the unit should be discarded. Each addition/transfer will reduce the vacuum remaining in the bottle.
   
9. If the first puncture of the stopper is the administration set spike, insert the spike fully into the target area of the rubber stopper and promptly invert the bottle. Verify vacuum by observing rising air bubbles. Do not use the bottle if vacuum is not present.
10. If admixture or set insertion is not performed immediately following removal of protective metal disk, swab stopper surface.

B. Braun Medical Inc.
Irvine, CA 92614-5895 USA
1-800-227-2862
www.bbraun.com
Made in USA

Y36-002-853    LD-228-2

500 mL

NDC 0264-9361-55
S9361-SS

TrophAmine®
(6% Amino Acid Injection)

Protect from light until use.

Each 100 mL contains:
Essential Amino Acids – Isoleucine USP 0.49 g
Leucine USP 0.84 g; Lysine 0.49 g (added as Lysine Acetate USP 0.69 g)
Methionine USP 0.20 g; Phenylalanine USP 0.29 g
Threonine USP 0.25 g; Tryptophan USP 0.12 g
Valine USP 0.47 g; Cysteine <0.014 g (as Cysteine HCl•H20 USP <0.020 g)
Histidine USP 0.29 g; Tyrosine 0.14 g
(added as Tyrosine USP 0.044 g and N-Acetyl-L-Tyrosine 0.12 g)

B. Braun Medical Inc.
Irvine, CA 92614-5895 USA
1-800-227-2862
www.bbraun.com
Made in USA

Nonessential Amino Acids -
Alanine USP 0.32 g; Arginine USP 0.73 g
Proline USP 0.41 g; Serine USP 0.23 g
Glycine USP 0.22 g; L-Aspartic Acid 0.19 g
L-Glutamic Acid 0.30 g

Taurine 0.015 g; Sodium Metabisulfite NF
(antioxidant) <0.050 g; Water for Injection USP qs

pH adjusted with Glacial Acetic Acid USP
pH: 5.5 (5.0-6.0)
Calc. Osmolarity: 525 mOsmol/liter

Electrolytes (mEq/liter): Sodium 5; Chloride <3
Acetate 54.4 (see Package Insert)

Sterile, nonpyrogenic. Single dose container.

For intravenous use only. Use only if solution is clear and vacuum is present.

Recommended Storage:
Room temperature (25°C). Avoid excessive heat. Protect from freezing.
See Package Insert.

Rx only

TrophAmine is a registered trademark of B. Braun Medical Inc.

HK-50115
Y37-002-285   LD-301-1

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if you have any side effects that bother you or do not go away.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Some side effects of Trophamine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.