Every strength approved under this FDA application (2)
- Trophamine (this page)Amino Acids 6% (6GM/100ML)
- Trophamine 10%Amino Acids 10% (10GM/100ML)
Key facts
- Active ingredient
- Amino Acids
- Form
- Solution
- Strength
- Amino Acids 6% (6GM/100ML)
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- B Braun
- FDA application
- NDA019018
What is Trophamine?
From the FDA label:TrophAmine® (10% Amino Acid Injection) is a sterile, nonpyrogenic, hypertonic solution containing crystalline amino acids. All amino acids designated USP are the “L”-isomer with the exception of Glycine USP, which does not have an isomer. Each 100 mL contains: Essential Amino Acids 10% Isoleucine USP 0.82 g Leucine USP 1.4 g Lysine 0.82 g (added as Lysine Acetate USP 1.2 g) Methionine USP 0.34 g Phenylalanine USP 0.48 g Threonine USP 0.42 g Tryptophan USP 0.2 g Valine USP 0.78 g Cysteine <0.016 g (as Cysteine HCl∙H 2 O USP <0.024 g) Histidine USP Holt LE, Snyderman SE: The amino acid requirements of infants. JAMA 1961; 175(2):124–127. 0.48 g Tyrosine 0.24 g (added as Tyrosine USP 0.044 g and N-Acetyl-L-Tyrosine 0.24 g) Nonessential Amino Acids Alanine USP 0.54 g Arginine USP 1.2 g Proline USP 0.68 g Serine USP 0.38 g Glycine USP 0.36 g L-Aspartic Acid 0.32 g L-Glutamic Acid 0.5 g Taurine Rigo J, Senterre J: Is taurine essential for the neonates? Biol Neonate 1977; 32:73–76. Gaull G, Sturman JA, Räihä NCR: Development of mammalian sulfur metabolism: Absence of cystothionase in human fetal tissues. Pediatr Res 1972; 6:538–547. 0.025 g Water for Injection USP qs pH adjusted with Glacial Acetic Acid USP pH: 5.5 (5.0–6.0) Calc. Osmolarity (mOsmol/liter) 866 Total Amino Acids (grams/liter) 100 Total Nitrogen (grams/liter) 15.5 Protein Equivalent (grams/liter) 97 Electrolytes…
How to use
The objective of nutritional management of infants and young pediatric patients is the provision of sufficient amino acid and caloric support for protein synthesis and growth. The total daily dose of TrophAmine® (Amino Acid Injection) depends on daily protein requirements and on the patient’s metabolic and clinical response. The determination of nitrogen balance and accurate daily body weights, corrected for fluid balance, are probably the best means of assessing individual protein requirements. Dosage should also be guided by the patient’s fluid intake limits and glucose and nitrogen tolerances, as well as by metabolic and clinical response. Recommendations for allowances of protein in infant nutrition have ranged from 2 to 4 grams of protein per kilogram of body weight per day (2 to 4 g/kg/day). Suskind RM: Textbook of Pediatric Nutrition, Raven Press, New York, 1981. The recommended dosage of TrophAmine® is 2 to 2.5 grams of amino acids per kilogram of body weight per day (2 to 2.5 g/kg/day) for infants up to 10 kilograms. For infants and young pediatric patients larger than 10 kilograms, the total dosage of amino acids should include the 20 to 25 grams/day for the first 10 kg of body weight plus 1 to 1.25 g/day for each kg of body weight over 10 kilograms. Typically, TrophAmine® is admixed with 50% or 70% Dextrose Injection USP supplemented with electrolytes and vitamins…
Side effects
See “ WARNINGS ” and “ Special Precautions for Central Venous Nutrition . ” Reactions reported in clinical studies as a result of infusion of the parenteral fluid were water weight gain, edema, increase in BUN, and mild acidosis. Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia. Local reaction at the infusion site, consisting of a warm sensation, erythema, phlebitis and thrombosis, have been reported with peripheral amino acid infusions, especially if other substances are also administered through the same site. If electrolyte supplementation is required during peripheral infusion, it is recommended that additives be administered throughout the day in order to avoid possible venous irritation. Irritating additive medications may require injection at another site and should not be added directly to the amino acid infusate. Symptoms may result from an excess or deficit of one or more of the ions present in the solution; therefore, frequent monitoring of electrolyte levels is essential. Phosphorus deficiency may lead to impaired tissue oxygenation and acute hemolytic anemia. Relative to calcium, excessive phosphorus intake can precipitate hypocalcemia with cramps, tetany and muscular…
Warnings
Important safety information
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.
Who should not take Trophamine
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.
Overdose — what happens if you take too much
In the event of a fluid or solute overload during parenteral therapy, reevaluate the patient’s condition, and institute appropriate corrective treatment.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store.
Dosage forms
Solution
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
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Frequently asked questions
- Is there a coupon or discount for Trophamine?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Trophamine. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Trophamine?
- Trophamine is marketed by B Braun. You can see B Braun's full profile, rating, and other products on pharmaranks.
- Is Trophamine a brand-name or generic drug?
- Trophamine is a brand-name product with the active ingredient Amino Acids.
- Is Trophamine available over the counter?
- No. Trophamine is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Trophamine come in?
- Trophamine is currently marketed as solution, per the FDA's National Drug Code Directory.
- Is Trophamine FDA-registered?
- Trophamine is on record with the U.S. FDA under application number NDA019018. You can verify this on its official FDA label.
- Is Trophamine safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Trophamine. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Trophamine?
- Trophamine's side effects are taken directly from its FDA label. From the label: See “ WARNINGS ” and “ Special Precautions for Central Venous Nutrition . ” Reactions reported in clinical studies as a result of infusion of the parenteral fluid were water weight gain, edema, increase in BUN, and mild acidosis.… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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