sodium phenylbutyrate 500 mg/1
sodium phenylbutyrate · TABLET · GLENMARK PHARMACEUTICALS INC., USA
sodium phenylbutyrate is a tablet containing sodium phenylbutyrate at 500 mg/1, taken oral. Manufactured by GLENMARK PHARMACEUTICALS INC., USA.
Key Facts
- Brand Name
- sodium phenylbutyrate
- Generic Name
- sodium phenylbutyrate
- NDC Code (Product)
68462-853- Manufacturer
- GLENMARK PHARMACEUTICALS INC., USA
- Strength
- 500 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA216462
- Marketing Start
- 11/01/2022
Recall History
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
SigmaPharm Laboratories LLC
Failed Impurities/Degradation Specifications; Out of Specification impurity results obtained during routine testing.
SigmaPharm Laboratories LLC
Failed Impurities Specifications: Out of Specification impurity results obtained during routine testing.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Sodium phenylbutyrate tablets are 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, neonatal-onset disease was almost universally fatal within the first year of life, even when treated with peritoneal dialysis and essential amino acids or th…
Dosage & Administration
DOSAGE AND ADMINISTRATION For oral use only. The use of sodium phenylbutyrate tablets is indicated for children weighing more than 20 kg and for adults. The usual total daily dose of sodium phenylbutyrate tablets for patients with urea cycle disorders is 450 to 600 mg/kg/day in patients weighing less than 20 kg, or 9.9 to 13.0 g/m 2 /day in larger patients. The tablets is to be taken in equally divided amounts with each meal or feeding (i.e., three to six times per day). The safety or efficacy of doses in excess of 20 grams (40 tablets) per day has not been established.
Warnings
WARNINGS Each sodium phenylbutyrate tablet contains 62 mg of sodium (9.2% w/w) (corresponding to 124 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.
Contraindications
CONTRAINDICATIONS Sodium phenylbutyrate tablets should not be used to manage acute hyperammonemia, which is a medical emergency.
Adverse Reactions
ADVERSE REACTIONS The assessment of clinical adverse events came from 206 patients treated with sodium phenylbutyrate. Adverse events (both clinical and laboratory) were not collected systematically in these patients, but were obtained from patient visit reports by the 65 co-investigators. Causality of adverse effects is sometimes difficult to determine in this patient population because they may result from either the underlying disease, the patient’s restricted diet, intercurrent illness, or sodium phenylbutyrate. Furthermore, the rates may be underestimated because they were reported primarily by parent or guardian and not the patient. Clinical Adverse Events In female patients, the most common clinical adverse event reported was amenorrhea/menstrual dysfunction (irregular menstrual cycles), which occurred in 23% of the menstruating patients. Decreased appetite occurred in 4% of all patients. Body odor (probably caused by the metabolite, phenylacetate) and bad taste or taste aversion were each reported in 3% of patients. Other adverse events reported in 2% or fewer patients were: Gastrointestinal : abdominal pain, gastritis, nausea and vomiting; constipation, rectal bleeding, pe…
Frequently Asked Questions
What is sodium phenylbutyrate used for?
sodium phenylbutyrate contains sodium phenylbutyrate. It is a tablet taken oral. Consult your doctor for specific uses.
Is sodium phenylbutyrate a controlled substance?
sodium phenylbutyrate is not classified as a controlled substance by the DEA.
What is the generic name for sodium phenylbutyrate?
The generic name for sodium phenylbutyrate is sodium phenylbutyrate. There are 11 other brand versions of sodium phenylbutyrate.
What is the NDC code for sodium phenylbutyrate 500 mg/1?
The NDC (National Drug Code) for sodium phenylbutyrate 500 mg/1 is 68462-853, listed by GLENMARK PHARMACEUTICALS INC., USA.