Sodium Phenylbutyrate Powder

Name: Sodium Phenylbutyrate Powder

How do I store and/or throw out Sodium Phenylbutyrate Powder?

  • Store at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

Sodium Phenylbutyrate Powder Description

Sodium Phenylbutyrate Powder nasogastric, or gastrostomy tube administration contain sodium phenylbutyrate. Sodium Phenylbutyrate Powder is an off-white crystalline substance which is soluble in water and has a strong salty taste. Sodium phenylbutyrate also is freely soluble in methanol and practically insoluble in acetone and diethyl ether. It is known chemically as 4-phenylbutyric acid, sodium salt with a molecular weight of 186 and the molecular formula C10H11O2Na.

Chemical Structure:

 

Each gram of Sodium Phenylbutyrate Powder contains 0.94 grams of sodium phenylbutyrate and the inactive ingredients calcium stearate and colloidal silicon dioxide.  

Contraindications

Sodium phenylbutyrate should not be used to manage acute hyperammonemia, which is a medical emergency.

Warnings

Sodium Phenylbutyrate Powder contains 11.7 grams of sodium per 100 grams of powder, corresponding to 125 mg of sodium per gram of sodium phenylbutyrate (12.4% w/w). Sodium phenylbutyrate should be used with great care, if at all, in patients with congestive heart failure or severe renal insufficiency, and in clinical states in which there is sodium retention with edema.

Because sodium phenylbutyrate is metabolized in the liver and kidney, and phenylacetylglutamine is primarily excreted by the kidney, use caution when administering the drug to patients with hepatic or renal insufficiency or inborn errors of beta oxidation. Probenecid is known to inhibit the renal transport of many organic compounds, including hippuric acid, and may affect renal excretion of the conjugated product of sodium phenylbutyrate as well as its metabolite.

Use of corticosteroids may cause the breakdown of body protein and increase plasma ammonia levels.

Package label. principal display panel


SODIUM PHENYLBUTYRATE 
Sodium Phenylbutyrate Powder
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49884-006
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM PHENYLBUTYRATE (PHENYLBUTYRIC ACID) SODIUM PHENYLBUTYRATE 0.94 g  in 1 g
Inactive Ingredients
Ingredient Name Strength
CALCIUM STEARATE  
SILICON DIOXIDE  
Product Characteristics
Color WHITE Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description
1 NDC:49884-006-04 1 BOTTLE in 1 CARTON
1 250 g in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203918 08/31/2016
Labeler - Par Pharmaceutical, Inc. (092733690)
Registrant - Par Pharmaceutical Inc. (092733690)
Revised: 07/2017   Par Pharmaceutical, Inc.
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