SODIUM PHENYLBUTYRATE- sodium phenylbutyrate tablets, 500 mg tablet

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

SODIUM PHENYLBUTYRATE (UNII: NT6K61736T) (PHENYLBUTYRIC ACID - UNII:7WY7YBI87E)

Tilgængelig fra:

Par Pharmaceutical, Inc.

INN (International Name):

SODIUM PHENYLBUTYRATE

Sammensætning:

SODIUM PHENYLBUTYRATE 500 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Sodium Phenylbutyrate Tablets is indicated as adjunctive therapy in the chronic management of patients with urea cycle disorders involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC), or argininosuccinic acid synthetase (AS). It is indicated in all patients with neonatal-onset deficiency (complete enzymatic deficiency, presenting within the first 28 days of life). It is also indicated in patients with late-onset disease (partial enzymatic deficiency, presenting after the first month of life) who have a history of hyperammonemic encephalopathy. It is important that the diagnosis be made early and treatment initiated immediately to improve survival. Any episode of acute hyperammonemia should be treated as a life-threatening emergency. Sodium Phenylbutyrate Tablets must be combined with dietary protein restriction and, in some cases, essential amino acid supplementation. (See Nutritional Supplementation subsection of the DOSAGE AND ADMINISTRATION section.) Previously, ne

Produkt oversigt:

Sodium Phenylbutyrate Tablets are available as 500 mg in bottles of 250 Sodium Phenylbutyrate Tablets (NDC 49884-170-04). The bottles are equipped with child-resistant caps. White to off-white, oval shaped tablet debossed 'EP 340' on one side and plain on the other side. Each tablet contains 500 mg of sodium phenylbutyrate, USP. Store at 20º to 25º C (68º to 77ºF); [see USP Controlled Temperature]; Excursions permitted to 15º to 30ºC (59º to 86ºF) . After opening, keep bottle tightly closed.

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

SODIUM PHENYLBUTYRATE- SODIUM PHENYLBUTYRATE TABLETS, 500 MG TABLET
PAR PHARMACEUTICAL, INC.
----------
SODIUM PHENYLBUTYRATE TABLETS, 500 MG
RX ONLY
DESCRIPTION
Sodium Phenylbutyrate Tablets for oral administration contain Sodium
phenylbutyrate, USP. Sodium
Phenylbutyrate, USP is an off-white crystalline substance which is
soluble in water and has a strong
salty taste. Sodium Phenylbutyrate, USP 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 C
H O Na.
Chemical Structure:
Each tablet of Sodium Phenylbutyrate Tablets contains 500 mg of Sodium
Phenylbutyrate, USP and the
inactive ingredients calcium stearate NF, colloidal silicon dioxide
NF, magnesium stearate and
microcrystalline cellulose.
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.
ABS ORPTION:
Peak plasma levels of phenylbutyrate occur within 1 hour after a
single dose of 5 grams of sodium
phenylbutyrate tablet with a C
of 218 mcg/mL under fasting conditions. The effect of food on
phenylbutyrate's absorption is unknown.
DIS POS ITION:
The overall disposition of sodium phenylbutyrate and its metabolites
has not been characterized fully.
However, the drug is known to be metabolized to phenylacetate and
subsequently to
phenylacetylglutamine.
Following oral administration of 5 grams (tablets