Rx Item-Sodium Phenylbutyrate Generic Buphenyl 500mg Tab 250 by Par Pharma

Clinical Information
Gen. Code and Des.
26624 sodium phenylbutyrate ORAL TABLET 500 MG
GCN and Des.
43371 sodium phenylbutyrate ORAL TABLET 500 MG
Strength
500MG
Dose Form
TABLET
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family

AHFS Class
40100000 AMMONIA DETOXICANTS
Active Ingredients
5955 sodium phenylbutyrate 1716127






BUPHENYL- sodium phenylbutyrate tablet
BUPHENYL- sodium phenylbutyrate powder
Horizon Pharma, Inc.


BUPHENYL� (sodium phenylbutyrate) Tablets
� (sodium phenylbutyrate) Powder

[bu'fen-?l](sodium phenylbutyrate)

Rx Only

DESCRIPTION

BUPHENYL (sodium phenylbutyrate) Tablets for oral administration and BUPHENYL (sodium phenylbutyrate) Powder for oral, nasogastric, or gastrostomy tube administration contain sodium phenylbutyrate. Sodium phenylbutyrate 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 C10 H11 O2 Na.



Chemical Structure:

Chemical Structure:
(click image for full-size original)

Each tablet of BUPHENYL contains 500 mg of sodium phenylbutyrate and the inactive ingredients microcrystalline cellulose NF, magnesium stearate NF, and colloidal silicon dioxide NF.

Each gram of BUPHENYL Powder contains 0.94 grams of sodium phenylbutyrate and the inactive ingredients calcium stearate NF, and colloidal silicon dioxide NF.

CLINICAL PHARMACOLOGY

Sodium phenylbutyrate is a pro-drug and is rapidly metabolized to phenylacetate. Phenylacetate is a metabolically-active compound that conjugates with glutamine via acetylation to form phenylacetylglutamine. Phenylacetylglutamine then is excreted by the kidneys. On a molar basis, it is comparable to urea (each containing two moles of nitrogen). Therefore, phenylacetylglutamine provides an alternate vehicle for waste nitrogen excretion.

PHARMACOKINETICS

General:
Pharmacokinetic studies have not been conducted in the primary patient population (neonates, infants, and children), but pharmacokinetic data were obtained from normal adult subjects.

Absorption:
Peak plasma levels of phenylbutyrate occur within 1 hour after a single dose of 5 grams of sodium phenylbutyrate tablet with a Cmax of 218 �g/mL under fasting conditions; peak plasma levels of phenylbutyrate occur within 1 hour after a single dose of 5 grams of sodium phenylbutyrate powder with a Cmax of 195 �g/mL under fasting conditions. The effect of food on phenylbutyrate's absorption is unknown.

SODIUM PHENYLBUTYRATE Generic Buphenyl
NDC No. 49884-0170-04 49884-170-04 UPC/GTIN No. 3-49884-17004-2 MPN 42608 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,

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SODIUM PHENYLBUTYRATE ORA
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

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