TROPHAMINE- isoleucine, leucine, lysine acetate, methionine, phenylalanine, threonine, tryptophan, valine, cysteine hydrochloride, histidine, tyrosine, n-acetyl-tyrosine, alanine, arginine, proline, serine, glycine, aspartic acid, glutamic acid, and taurine solution

TrophAmine by

Drug Labeling and Warnings

TrophAmine by is a Prescription medication manufactured, distributed, or labeled by B. Braun Medical Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

  • HOW SUPPLIED

    TrophAmine® is supplied sterile and nonpyrogenic in 500 mL glass containers with solid stoppers.

    NDCREFUnits per Case
     TrophAmine® (6% Amino Acid Injection)
     0264-9361-55 S9361-SS 12
     TrophAmine® (10% Amino Acid Injection)
     0264-9341-55 S9341-SS 6

    Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product.

    Protect from light until use.

  • SPL UNCLASSIFIED SECTION

    Rx only

    Revised: September 2019

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

  • Directions for Use of B. Braun Glass Containers with Solid Stoppers

    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. Remove plastic cap (See Figure 1).
      Figure 1 Illustration

    4. Swab exposed stopper surface with a suitable disinfectant.

      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 swabbing 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.
      Figure 2 Illustration
    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 swabbing, swab stopper surface again with a suitable disinfectant.

  • SPL UNCLASSIFIED SECTION

    B. Braun Medical Inc.
    Bethlehem, PA 18018-3524 USA
    1-800-227-2862

    Y36-003-005    LD-228-4

  • PRINCIPAL DISPLAY PANEL - 500 mL Container Label

    TrophAmine®
    (6% Amino Acid Injection)

    REF S9361-SS
    NDC: 0264-9361-55
    HK 50115

    500 mL

    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 HClH20 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.
    Bethlehem, PA 18018-3524 USA
    1-800-227-2862

    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.


    Y37-002-539   LD-301-2

    S9361-SS Container Label
  • PRINCIPAL DISPLAY PANEL - 500 mL Container Carton

    TrophAmine®
    (6% Amino Acid Injection)

    REF S9361-SS
    NDC: 0264-9361-55
    HK 50115

    500 mL

    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 HClH20 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)

    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)
    Calculated Osmolarity: 525 mOsmol/liter

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

    See adjacent panel for futher product information.

    B. Braun Medical Inc.
    Bethlehem, PA 18018-3524 USA
    1-800-227-2862

    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.

    X12-002-491   LD-345-2

    S9361-SS Folding Carton
  • PRINCIPAL DISPLAY PANEL - 500 mL Container Label

    TrophAmine®
    (10% Amino Acid Injection)

    REF S9341-SS
    NDC: 0264-9341-55

    500 mL

    Protect from light until use.

    Each 100 mL contains:
    Essential Amino Acids - 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 0.20 g
    Valine USP 0.78 g; Cysteine <0.016 g (as Cysteine HClH20 USP <0.024 g)
    Histidine USP 0.48 g; Tyrosine 0.24 g
    (added as Tyrosine USP 0.044 g and N-Acetyl-L-Tyrosine 0.24 g)

    B. Braun Medical Inc.
    Bethlehem, PA 18018-3524 USA
    1-800-227-2862

    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 0.50 g

    Taurine 0.025 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: 875 mOsmol/liter

    Electrolytes (mEq/liter): Sodium 5; Chloride <3
    Acetate 90.7 (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.

    Y37-002-523  LD-299-2

    S9341-SS Container Label
  • PRINCIPAL DISPLAY PANEL - 500 mL Container Carton

    TrophAmine®
    (10% Amino Acid Injection)

    REF S9341-SS
    NDC: 0264-9341-55

    500 mL

    Protect from light until use.

    Each 100 mL contains:
    Essential Amino Acids
    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; Typtophan USP 0.20 g
    Valine USP 0.78 g; Cysteine <0.016 g
    (as Cysteine HClH20 USP <0.024 g); Histidine USP 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 0.50 g

    Taurine 0.025 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)
    Calculated Osmolarity: 875 mOsmol/liter

    Electrolytes (mEq/liter):
    Sodium 5          Chloride <3
    Acetate 90.7 (see Package Insert)

    See adjacent panel for further product information.

    B. Braun Medical Inc.
    Bethlehem, PA 18018-3524 USA
    1-800-227-2862

    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.

    X12-002-490   LD-344-2

    S9341-SS Folding Carton
  • INGREDIENTS AND APPEARANCE
    TROPHAMINE 
    isoleucine, leucine, lysine acetate, methionine, phenylalanine, threonine, tryptophan, valine, cysteine hydrochloride, histidine, tyrosine, n-acetyl-tyrosine, alanine, arginine, proline, serine, glycine, aspartic acid, glutamic acid, and taurine solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 0264-9361
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOLEUCINE (UNII: 04Y7590D77) (ISOLEUCINE - UNII:04Y7590D77) ISOLEUCINE0.49 g  in 100 mL
    LEUCINE (UNII: GMW67QNF9C) (LEUCINE - UNII:GMW67QNF9C) LEUCINE0.84 g  in 100 mL
    LYSINE ACETATE (UNII: TTL6G7LIWZ) (LYSINE - UNII:K3Z4F929H6) LYSINE0.69 g  in 100 mL
    METHIONINE (UNII: AE28F7PNPL) (METHIONINE - UNII:AE28F7PNPL) METHIONINE0.2 g  in 100 mL
    PHENYLALANINE (UNII: 47E5O17Y3R) (PHENYLALANINE - UNII:47E5O17Y3R) PHENYLALANINE0.29 g  in 100 mL
    THREONINE (UNII: 2ZD004190S) (THREONINE - UNII:2ZD004190S) THREONINE0.25 g  in 100 mL
    TRYPTOPHAN (UNII: 8DUH1N11BX) (TRYPTOPHAN - UNII:8DUH1N11BX) TRYPTOPHAN0.12 g  in 100 mL
    VALINE (UNII: HG18B9YRS7) (VALINE - UNII:HG18B9YRS7) VALINE0.47 g  in 100 mL
    CYSTEINE HYDROCHLORIDE (UNII: ZT934N0X4W) (CYSTEINE - UNII:K848JZ4886) CYSTEINE0.020 g  in 100 mL
    HISTIDINE (UNII: 4QD397987E) (HISTIDINE - UNII:4QD397987E) HISTIDINE0.29 g  in 100 mL
    TYROSINE (UNII: 42HK56048U) (TYROSINE - UNII:42HK56048U) TYROSINE0.044 g  in 100 mL
    N-ACETYLTYROSINE (UNII: DA8G610ZO5) (N-ACETYLTYROSINE - UNII:DA8G610ZO5) N-ACETYLTYROSINE0.12 g  in 100 mL
    ALANINE (UNII: OF5P57N2ZX) (ALANINE - UNII:OF5P57N2ZX) ALANINE0.32 g  in 100 mL
    ARGININE (UNII: 94ZLA3W45F) (ARGININE - UNII:94ZLA3W45F) ARGININE0.73 g  in 100 mL
    PROLINE (UNII: 9DLQ4CIU6V) (PROLINE - UNII:9DLQ4CIU6V) PROLINE0.41 g  in 100 mL
    SERINE (UNII: 452VLY9402) (SERINE - UNII:452VLY9402) SERINE0.23 g  in 100 mL
    GLYCINE (UNII: TE7660XO1C) (GLYCINE - UNII:TE7660XO1C) GLYCINE0.22 g  in 100 mL
    ASPARTIC ACID (UNII: 30KYC7MIAI) (ASPARTIC ACID - UNII:30KYC7MIAI) ASPARTIC ACID0.19 g  in 100 mL
    GLUTAMIC ACID (UNII: 3KX376GY7L) (GLUTAMIC ACID - UNII:3KX376GY7L) GLUTAMIC ACID0.3 g  in 100 mL
    TAURINE (UNII: 1EQV5MLY3D) (TAURINE - UNII:1EQV5MLY3D) TAURINE0.015 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM METABISULFITE (UNII: 4VON5FNS3C) 0.05 g  in 100 mL
    WATER (UNII: 059QF0KO0R)  
    ACETIC ACID (UNII: Q40Q9N063P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 0264-9361-5512 in 1 CASE07/20/1984
    11 in 1 CARTON
    1500 mL in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01901807/20/1984
    TROPHAMINE 
    isoleucine, leucine, lysine acetate, methionine, phenylalanine, threonine, tryptophan, valine, cysteine hydrochloride, histidine, tyrosine, n-acetyl-tyrosine, alanine, arginine, proline, serine, glycine, aspartic acid, glutamic acid, and taurine solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 0264-9341
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOLEUCINE (UNII: 04Y7590D77) (ISOLEUCINE - UNII:04Y7590D77) ISOLEUCINE0.82 g  in 100 mL
    LEUCINE (UNII: GMW67QNF9C) (LEUCINE - UNII:GMW67QNF9C) LEUCINE1.4 g  in 100 mL
    LYSINE ACETATE (UNII: TTL6G7LIWZ) (LYSINE - UNII:K3Z4F929H6) LYSINE1.2 g  in 100 mL
    METHIONINE (UNII: AE28F7PNPL) (METHIONINE - UNII:AE28F7PNPL) METHIONINE0.34 g  in 100 mL
    PHENYLALANINE (UNII: 47E5O17Y3R) (PHENYLALANINE - UNII:47E5O17Y3R) PHENYLALANINE0.48 g  in 100 mL
    THREONINE (UNII: 2ZD004190S) (THREONINE - UNII:2ZD004190S) THREONINE0.42 g  in 100 mL
    TRYPTOPHAN (UNII: 8DUH1N11BX) (TRYPTOPHAN - UNII:8DUH1N11BX) TRYPTOPHAN0.2 g  in 100 mL
    VALINE (UNII: HG18B9YRS7) (VALINE - UNII:HG18B9YRS7) VALINE0.78 g  in 100 mL
    CYSTEINE HYDROCHLORIDE (UNII: ZT934N0X4W) (CYSTEINE - UNII:K848JZ4886) CYSTEINE0.024 g  in 100 mL
    HISTIDINE (UNII: 4QD397987E) (HISTIDINE - UNII:4QD397987E) HISTIDINE0.48 g  in 100 mL
    TYROSINE (UNII: 42HK56048U) (TYROSINE - UNII:42HK56048U) TYROSINE0.044 g  in 100 mL
    N-ACETYLTYROSINE (UNII: DA8G610ZO5) (N-ACETYLTYROSINE - UNII:DA8G610ZO5) N-ACETYLTYROSINE0.24 g  in 100 mL
    ALANINE (UNII: OF5P57N2ZX) (ALANINE - UNII:OF5P57N2ZX) ALANINE0.54 g  in 100 mL
    ARGININE (UNII: 94ZLA3W45F) (ARGININE - UNII:94ZLA3W45F) ARGININE1.2 g  in 100 mL
    PROLINE (UNII: 9DLQ4CIU6V) (PROLINE - UNII:9DLQ4CIU6V) PROLINE0.68 g  in 100 mL
    SERINE (UNII: 452VLY9402) (SERINE - UNII:452VLY9402) SERINE0.38 g  in 100 mL
    GLYCINE (UNII: TE7660XO1C) (GLYCINE - UNII:TE7660XO1C) GLYCINE0.36 g  in 100 mL
    ASPARTIC ACID (UNII: 30KYC7MIAI) (ASPARTIC ACID - UNII:30KYC7MIAI) ASPARTIC ACID0.32 g  in 100 mL
    GLUTAMIC ACID (UNII: 3KX376GY7L) (GLUTAMIC ACID - UNII:3KX376GY7L) GLUTAMIC ACID0.5 g  in 100 mL
    TAURINE (UNII: 1EQV5MLY3D) (TAURINE - UNII:1EQV5MLY3D) TAURINE0.025 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM METABISULFITE (UNII: 4VON5FNS3C) 0.05 g  in 100 mL
    WATER (UNII: 059QF0KO0R)  
    ACETIC ACID (UNII: Q40Q9N063P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 0264-9341-556 in 1 CASE07/20/1984
    11 in 1 CARTON
    1500 mL in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01901807/20/1984
    Labeler - B. Braun Medical Inc. (002397347)

  • Trademark Results [TrophAmine]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    TROPHAMINE
    TROPHAMINE
    78672902 not registered Dead/Abandoned
    B. Braun Medical, Inc.
    2005-07-18
    TROPHAMINE
    TROPHAMINE
    73425189 1281249 Live/Registered
    American Hospital Supply Corporation
    1983-05-09

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