Ammonul

Ammonul

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Questions & Answers

Side Effects & Adverse Reactions

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Legal Issues

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FDA Safety Alerts

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Manufacturer Warnings

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FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

AMMONUL is indicated as adjunctive therapy in pediatric and adult patients for the treatment of acute hyperammonemia and associated encephalopathy in patients with deficiencies in enzymes of the urea cycle. During acute hyperammonemic episodes, arginine supplementation, caloric supplementation, dietary protein restriction, hemodialysis, and other ammonia lowering therapies should be considered [see Warnings and Precautions (5)].

History

There is currently no drug history available for this drug.

Other Information

AMMONUL (sodium phenylacetate and sodium benzoate) Injection 10% per 10% (a nitrogen binding agent), is a sterile, concentrated, aqueous solution of sodium phenylacetate and sodium benzoate. The pH of the solution is between 6 and 8. Sodium phenylacetate is a crystalline, white to off-white powder with a strong, offensive odor. It is soluble in water. Sodium benzoate is a white and odorless, crystalline powder that is readily soluble in water.

Figure 1

Chemical Structure

Sodium phenylacetate has a molecular weight of 158.13 and the molecular formula C8H7NaO2. Sodium benzoate has a molecular weight of 144.11 and the molecular formula C7H5NaO2.

Each mL of AMMONUL contains 100 mg of sodium phenylacetate and 100 mg of sodium benzoate, and Water for Injection. Sodium hydroxide and/or hydrochloric acid may have been used for pH adjustment.

AMMONUL injection is a sterile, concentrated solution intended for intravenous administration via a central line only after dilution [see Dosage and Administration (2)].

Ammonul Manufacturers


  • Valeant Pharmaceuticals North America Llc
    Ammonul (Sodium Phenylacetate And Sodium Benzoate) Injection, Solution, Concentrate [Valeant Pharmaceuticals North America Llc]
  • Ucyclyd Pharma Inc.
    Ammonul (Sodium Phenylacetate And Sodium Benzoate) Injection, Solution, Concentrate [Ucyclyd Pharma Inc.]

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