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Sodium phenylacetate/Sodium benzoate

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Active ingredients
  • Sodium Phenylacetate 100 mg/1 mL
  • Sodium Benzoate 100 mg/1 mL
Other brand names
Drug classes
Nitrogen Binding Agent, Nitrogen Binding Agent
Dosage form
Injection, Solution, Concentrate
Route
Intravenous
Prescription status
Rx (prescription)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2023
Label revision date
October 30, 2023
FDA Insert
Prescribing information, PDF file
Active ingredients
  • Sodium Phenylacetate 100 mg/1 mL
  • Sodium Benzoate 100 mg/1 mL
Other brand names
Drug classes
Nitrogen Binding Agent, Nitrogen Binding Agent
Dosage form
Injection, Solution, Concentrate
Route
Intravenous
Prescription status
Rx (prescription)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2023
Label revision date
October 30, 2023
Manufacturer
Zydus Pharmaceuticals USA Inc.
Registration number
ANDA217526
NDC root
70710-1926
FDA Insert
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

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Drug Overview

Sodium Phenylacetate and Sodium Benzoate Injection is a specialized medication used to help manage acute hyperammonemia, a condition characterized by elevated ammonia levels in the blood, particularly in patients with certain enzyme deficiencies related to the urea cycle. This injection contains two active ingredients: sodium phenylacetate and sodium benzoate, which work together to provide an alternative method for the body to excrete waste nitrogen.

When administered, sodium phenylacetate conjugates with glutamine in the liver and kidneys to form a compound called phenylacetylglutamine, which is then excreted by the kidneys. Similarly, sodium benzoate combines with glycine to create hippuric acid, also excreted by the kidneys. This process effectively reduces nitrogen overload in the body, helping to lower ammonia levels and support overall health in individuals with urea cycle disorders.

Uses

Sodium Phenylacetate and Sodium Benzoate Injection is used as an additional treatment for acute hyperammonemia, a condition characterized by high levels of ammonia in the blood, which can lead to serious brain complications (encephalopathy). This medication is specifically indicated for both children and adults who have enzyme deficiencies related to the urea cycle, a process that helps remove ammonia from the body.

It's important to note that the information provided does not indicate any teratogenic effects (harmful effects on fetal development) or nonteratogenic effects associated with this treatment.

Dosage and Administration

Before you receive Sodium Phenylacetate and Sodium Benzoate Injection, it needs to be mixed with sterile 10% Dextrose Injection (D10W). This step is crucial to ensure the medication is safe and effective. The injection is given through a central venous catheter, which is a special type of tube placed in a large vein. It's important to avoid using a peripheral line (a smaller vein) for this medication, as it can cause burns.

The medication is administered intravenously (into a vein) in two parts. First, you will receive a loading dose, which is infused over 90 to 120 minutes. After that, you will continue with a maintenance dose that is infused over the next 24 hours. For detailed dosing recommendations, please refer to the full prescribing information provided by your healthcare provider.

What to Avoid

It's important to be aware of certain considerations when using this medication. Currently, there are no specific contraindications, which means there are no known conditions that would prevent you from taking it. However, details regarding its classification as a controlled substance, risks of abuse or misuse, and concerns about dependence (which refers to a condition where your body becomes reliant on a substance) have not been provided.

Since there are no explicit "do not take" or "do not use" instructions listed, it's always best to consult with your healthcare provider for personalized advice and to ensure that this medication is appropriate for you. They can help clarify any concerns and guide you on safe usage.

Side Effects

You may experience some side effects while using Sodium Phenylacetate and Sodium Benzoate Injection. The most common reactions include vomiting, high blood sugar (hyperglycemia), low potassium levels (hypokalemia), convulsions, and mental impairment. It's important to monitor your potassium levels, as they can decrease significantly.

Be cautious if you have conditions like congestive heart failure or severe kidney issues, as these can be worsened by fluid overload. There is also a risk of skin damage if the injection leaks into surrounding tissues, especially in infants. Additionally, watch for signs of neurotoxicity, which can affect your nervous system, and symptoms similar to salicylate overdose, such as rapid breathing and metabolic acidosis (an imbalance in your body's acid-base levels). If you experience severe symptoms or suspect an overdose, seek medical attention immediately.

Warnings and Precautions

It's important to be aware of some key warnings and precautions when using Sodium Phenylacetate and Sodium Benzoate Injection. You should have your plasma potassium levels monitored regularly, as well as your blood chemistry profiles, including blood pH and pCO2 measurements. If you have conditions like congestive heart failure or severe kidney issues, be cautious, as this medication contains sodium, which can lead to fluid retention.

During administration, the injection site needs to be closely monitored to prevent skin damage, especially in infants, as the medication can cause tissue necrosis if it leaks out of the vein. Additionally, be alert for any signs of acute neurotoxicity, which can occur in some patients, particularly those with cancer. If you notice any unusual symptoms, it's important to contact your doctor right away.

Overdose

If you or someone you know is receiving Sodium Phenylacetate and Sodium Benzoate Injection and experiences an overdose, it’s important to act quickly. Overdosage has been reported in patients with urea cycle disorders, and in some cases, it has led to serious outcomes, including death. Signs of overdose can include confusion or decreased alertness (obtundation), rapid breathing (hyperventilation), severe metabolic imbalances, and even cardiovascular collapse.

If an overdose occurs, stop the medication immediately and seek emergency medical help. Medical professionals may monitor your condition closely and may need to perform procedures like hemodialysis (a method to filter waste from the blood) to remove the drug from your system. Remember, timely intervention is crucial, so don’t hesitate to get help if you suspect an overdose.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that there is currently not enough data to determine if using Sodium Phenylacetate and Sodium Benzoate poses any risk of major birth defects, miscarriage, or other negative outcomes for you or your baby. While animal studies have not been conducted with this medication, all pregnancies carry a natural risk of complications, including birth defects and loss.

In the general U.S. population, the estimated risk of major birth defects in recognized pregnancies is between 2% and 4%, while the risk of miscarriage ranges from 15% to 20%. It's essential to discuss any concerns with your healthcare provider to ensure you have the most accurate information for your situation.

Lactation Use

If you are breastfeeding and considering the use of Sodium Phenylacetate and Sodium Benzoate Injection, it's important to know that there is currently no information available about whether these substances are present in human or animal milk, or how they might affect your baby or your milk production.

While breastfeeding offers many developmental and health benefits for your infant, you should weigh these advantages against your need for this medication and any potential risks it may pose to your baby. Always consult with your healthcare provider to make the best decision for you and your child.

Pediatric Use

Sodium Phenylacetate and Sodium Benzoate Injection is a treatment option for children, including newborns, who are experiencing acute hyperammonemia (a condition where there is too much ammonia in the blood). If your child is diagnosed with this condition, this medication may be recommended by their healthcare provider to help manage it effectively. Always consult with your child's doctor for specific guidance on dosage and administration tailored to their age and health needs.

Geriatric Use

When considering Sodium Phenylacetate and Sodium Benzoate Injection for older adults, it's important to note that clinical studies have not specifically included patients aged 65 and over. This means we don't know if older adults respond differently than younger patients. Urea cycle disorders, which this medication addresses, primarily affect children and younger adults.

For older adults, healthcare providers typically recommend starting at a lower dose. This cautious approach is due to the higher likelihood of decreased liver, kidney, or heart function, as well as the presence of other health conditions or medications. Always consult with your healthcare provider to ensure the safest and most effective treatment plan tailored to your needs.

Renal Impairment

If you have severe kidney problems (renal insufficiency) or conditions that cause your body to retain sodium and lead to swelling (edema), it's important to be cautious when using Sodium Phenylacetate and Sodium Benzoate Injection. This medication may not be suitable for you without careful monitoring.

Always consult your healthcare provider before starting this treatment, as they may need to adjust your dosage or monitor your condition more closely to ensure your safety. Your health and well-being are the top priority, so make sure to discuss any concerns you have with your doctor.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular liver function tests (which check how well your liver is working) to ensure your safety while using any medication.

Drug Interactions

It's important to talk to your healthcare provider about any medications you are taking, as some can interact with each other in ways that may affect your health. For example, certain antibiotics like penicillin can change how another drug is processed in your body. Additionally, medications such as probenecid can influence how your kidneys eliminate certain substances, which may be significant for your treatment.

If you are taking valproic acid and have a urea cycle disorder, it could worsen your condition and reduce the effectiveness of other treatments. Similarly, corticosteroids might lead to increased ammonia levels in your blood, especially if your body struggles to eliminate it. Always keep your healthcare provider informed about all the medications and supplements you are using to ensure safe and effective treatment.

Storage and Handling

To ensure the best performance of your product, store it at a temperature between 20°C and 25°C (68°F to 77°F). It’s acceptable for the temperature to occasionally range from 15°C to 30°C (59°F to 86°F). The product comes in a sterile (free from germs) and non-pyrogenic (does not cause fever) single-dose glass vial, which helps maintain its safety and effectiveness.

When handling the vial, make sure to do so in a clean environment to avoid contamination. Always use the product as directed and dispose of any unused portions according to local regulations to ensure safety.

Additional Information

You should have your plasma potassium levels monitored regularly while receiving this treatment, along with checks on your blood chemistry profiles, blood pH, and pCO2 (partial pressure of carbon dioxide in the blood). It's important to know that this medication must be given through a central venous catheter and should never be administered undiluted.

In some cases, patients receiving intravenous phenylacetate have reported neurotoxicity, which can include symptoms like drowsiness, fatigue, dizziness, headaches, changes in taste, hearing issues, confusion, memory problems, and worsening of existing nerve conditions. If you experience any of these symptoms, be sure to inform your healthcare provider.

FAQ

What is Sodium Phenylacetate and Sodium Benzoate Injection?

It is a sterile, concentrated aqueous solution used as a nitrogen binding agent, containing sodium phenylacetate and sodium benzoate.

What conditions is this injection used to treat?

It is indicated as adjunctive therapy for acute hyperammonemia and associated encephalopathy in patients with deficiencies in enzymes of the urea cycle.

How is Sodium Phenylacetate and Sodium Benzoate Injection administered?

It must be diluted with sterile 10% Dextrose Injection and administered intravenously through a central venous catheter.

What are the most common side effects of this injection?

Common side effects include vomiting, hyperglycemia, hypokalemia, convulsions, and mental impairment.

What precautions should be taken when using this injection?

Monitor plasma potassium levels and be cautious in patients with congestive heart failure or severe renal insufficiency.

Is Sodium Phenylacetate and Sodium Benzoate Injection safe during pregnancy?

Available data are insufficient to identify a drug-associated risk of major birth defects or adverse outcomes in pregnant women.

Can this injection be used in breastfeeding mothers?

There is no data on the presence of the drug in human or animal milk, so the benefits of breastfeeding should be weighed against potential risks.

What should be monitored during treatment with this injection?

Patients should be monitored for symptoms of acute neurotoxicity and blood chemistry profiles, including blood pH and pCO2.

What is the storage requirement for this injection?

Store at 20°C to 25°C (68°F to 77°F), with excursions permitted between 15°C to 30°C (59°F to 86°F).

Are there any contraindications for using this injection?

There are no specific contraindications mentioned for Sodium Phenylacetate and Sodium Benzoate Injection.

Packaging Info

The table below lists all NDC Code configurations of Sodium Phenylacetate and Sodium Benzoate, the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Sodium Phenylacetate and Sodium Benzoate.
Details

FDA Insert (PDF)

This is the full prescribing document for Sodium Phenylacetate and Sodium Benzoate, submitted to the U.S. Food and Drug Administration (FDA). It contains official information for healthcare providers, including how to use the medication, possible side effects, and safety warnings.

View FDA-approved insert (PDF)

Description

Sodium Phenylacetate and Sodium Benzoate Injection 10% per 10% is a sterile, concentrated, aqueous solution containing sodium phenylacetate and sodium benzoate, designed for intravenous administration via a central venous catheter after dilution. The solution has a pH range of 7.0 to 8.0. Sodium phenylacetate appears as a white to off-white powder, with a molecular weight of 158.14 and a molecular formula of C₈H₇NaO₂, and is soluble in water. Sodium benzoate, also a white to off-white powder, has a molecular weight of 144.10 and a molecular formula of C₇H₅NaO₂, and is readily soluble in water. Each milliliter of the injection contains 100 mg of sodium phenylacetate and 100 mg of sodium benzoate, along with Water for Injection. Sodium hydroxide and/or hydrochloric acid may be utilized for pH adjustment.

Uses and Indications

Sodium Phenylacetate and Sodium Benzoate Injection is indicated as adjunctive therapy for the treatment of acute hyperammonemia and associated encephalopathy in pediatric and adult patients with deficiencies in enzymes of the urea cycle.

Limitations of Use: The safety and efficacy of Sodium Phenylacetate and Sodium Benzoate Injection have not been established in populations other than those with urea cycle disorders. There are no reported teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Sodium Phenylacetate and Sodium Benzoate Injection must be diluted with sterile 10% Dextrose Injection (D10W) prior to administration. It is essential that the injection is administered through a central venous catheter, as administration via a peripheral line may result in burns.

The initial loading dose should be infused intravenously over a period of 90 to 120 minutes. Following the loading dose, an equivalent maintenance dose should be administered as a continuous infusion over a duration of 24 hours.

For complete dosing recommendations, healthcare professionals are advised to refer to the Full Prescribing Information.

Contraindications

There are no identified contraindications for the use of this product. It is deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

Warnings and Precautions

Plasma potassium levels must be closely monitored, and appropriate treatment should be administered as necessary. Sodium Phenylacetate and Sodium Benzoate Injection contains 30.5 mg of sodium per mL of the undiluted product. Caution is advised when administering this injection to patients with congestive heart failure, severe renal insufficiency, or conditions that predispose to sodium retention with edema.

Extravasation of Sodium Phenylacetate and Sodium Benzoate Injection into the perivenous tissues during high flow bolus infusion poses a risk of skin necrosis, particularly in infants. Therefore, the infusion site should be monitored meticulously for signs of tissue infiltration throughout the administration of the drug.

Due to the prolonged plasma levels of phenylacetate observed in pharmacokinetic studies, repeat loading doses are contraindicated. Additionally, neurotoxicity associated with phenylacetate has been documented in cancer patients; thus, healthcare professionals should vigilantly monitor patients for symptoms indicative of acute neurotoxicity.

Sodium Phenylacetate and Sodium Benzoate Injection may elicit side effects commonly associated with salicylate overdose, including hyperventilation and metabolic acidosis. It is essential to monitor patient blood chemistry profiles and conduct frequent assessments of blood pH and pCO2 levels.

In summary, healthcare professionals are advised to implement the following monitoring parameters:

  • Regular assessment of plasma potassium levels.

  • Continuous monitoring of blood chemistry profiles, including frequent blood pH and pCO2 measurements.

  • Vigilant observation for symptoms of acute neurotoxicity.

Side Effects

Patients receiving Sodium Phenylacetate and Sodium Benzoate Injection may experience a range of adverse reactions. The most frequently reported adverse reactions, occurring in 6% or more of participants, include vomiting, hyperglycemia, hypokalemia, convulsions, and mental impairment.

Serious adverse reactions have been noted, particularly concerning the management of plasma potassium levels, which should be carefully monitored. Appropriate treatment should be administered when necessary to address decreased potassium levels. Additionally, caution is advised when administering this injection to patients with congestive heart failure, severe renal insufficiency, or conditions associated with sodium retention and edema, as these may lead to fluid overload.

Extravasation of the injection into perivenous tissues during high flow bolus infusion can result in skin necrosis, especially in infants. Therefore, it is essential to closely monitor the infusion site for potential tissue infiltration during drug administration.

Neurotoxicity related to phenylacetate has been reported in cancer patients, necessitating vigilant monitoring for symptoms of acute neurotoxicity. Furthermore, the injection may induce side effects typically associated with salicylate overdose, such as hyperventilation and metabolic acidosis. Regular monitoring of patient blood chemistry profiles, including frequent blood pH and pCO2 measurements, is recommended.

In cases of overdosage, particularly in urea cycle-deficient patients, severe outcomes have been documented, including cardiorespiratory failure or arrest, hyperammonemia, increased intracranial pressure, and other serious conditions leading to death. Signs of intoxication may manifest as obtundation (in the absence of hyperammonemia), hyperventilation, severe compensated metabolic acidosis, large anion gap, hypernatremia, hyperosmolarity, progressive encephalopathy, cardiovascular collapse, and potentially death.

Overall, careful monitoring and management of these adverse reactions are critical to ensure patient safety during treatment with Sodium Phenylacetate and Sodium Benzoate Injection.

Drug Interactions

Some antibiotics, particularly penicillin, may influence the overall disposition of the infused drug, potentially altering its therapeutic effectiveness.

Probenecid has been shown to impact the renal excretion of phenylacetylglutamine and hippurate, which may necessitate monitoring of these metabolites in patients receiving both agents.

In patients with urea cycle disorders, the administration of valproic acid may exacerbate their condition. This is due to valproic acid's ability to inhibit the synthesis of N-acetylglutamate, a critical co-factor for carbamyl phosphate synthetase, thereby antagonizing the efficacy of Sodium Phenylacetate and Sodium Benzoate Injection.

Corticosteroids may lead to the breakdown of body protein, which can result in increased plasma ammonia levels in patients who have a compromised ability to form urea. Close monitoring of ammonia levels is advised in these patients to prevent potential complications.

Packaging & NDC

The table below lists all NDC Code configurations of Sodium Phenylacetate and Sodium Benzoate, the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Sodium Phenylacetate and Sodium Benzoate.
Details

Pediatric Use

Sodium Phenylacetate and Sodium Benzoate Injection has been utilized for the treatment of acute hyperammonemia in pediatric patients, including those in the early neonatal period. Clinical experience supports its use in this population, although specific dosage adjustments may be necessary based on the age and clinical condition of the patient. Healthcare professionals should exercise caution and closely monitor these patients due to the potential for varying responses and the need for individualized treatment plans.

Geriatric Use

Clinical studies of Sodium Phenylacetate and Sodium Benzoate Injection did not include any patients aged 65 and over, and therefore, it is not possible to determine whether elderly patients respond differently from younger patients. Urea cycle disorders primarily affect pediatric and younger adult populations, and no pharmacokinetic studies have been conducted specifically in geriatric patients.

In general, dose selection for elderly patients should be approached with caution. It is recommended to start at the low end of the dosing range, taking into account the increased likelihood of decreased hepatic, renal, or cardiac function, as well as the presence of concomitant diseases or other drug therapies in this population. Careful monitoring is advised to ensure safety and efficacy in geriatric patients receiving this treatment.

Pregnancy

Available data on the combination use of Sodium Phenylacetate and Sodium Benzoate in pregnant patients are insufficient to identify a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with Sodium Phenylacetate and Sodium Benzoate Injection, limiting the understanding of potential risks in human pregnancies.

It is important to note that all pregnancies carry a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is approximately 2 to 4% and 15 to 20%, respectively. Given the lack of specific data regarding the use of this combination in pregnant women, healthcare professionals should weigh the potential benefits against the unknown risks when considering treatment options for women of childbearing potential.

Lactation

There are no data on the presence of sodium phenylacetate or sodium benzoate in either human or animal milk, nor are there any known effects on breastfed infants or on milk production.

The developmental and health benefits of breastfeeding should be weighed against the mother's clinical need for Sodium Phenylacetate and Sodium Benzoate Injection. Additionally, potential adverse effects on the breastfed infant from Sodium Phenylacetate and Sodium Benzoate Injection or from the underlying maternal condition should be considered.

Renal Impairment

Caution should be exercised when administering Sodium Phenylacetate and Sodium Benzoate Injection to patients with severe renal insufficiency or in those with conditions characterized by sodium retention and edema. Monitoring of renal function is recommended in these populations to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

Overdosage has been documented in patients receiving Sodium Phenylacetate and Sodium Benzoate Injection, particularly among those with urea cycle deficiencies. In an uncontrolled open-label study, all participants were intended to receive a uniform dosage of the injection; however, some individuals inadvertently received doses exceeding the protocol specifications.

In a review of clinical outcomes, it was noted that 16 out of 64 fatalities involved patients who had received a confirmed overdose of Sodium Phenylacetate and Sodium Benzoate Injection. The causes of death in these cases were varied and included cardiorespiratory failure or arrest (6 patients), hyperammonemia (3 patients), increased intracranial pressure (2 patients), and other complications such as pneumonitis with septic shock and coagulopathy (1 patient), error in dialysis procedure (1 patient), respiratory failure (1 patient), intractable hypotension with probable sepsis (1 patient), and one case with an unknown cause.

Signs of intoxication may manifest as obtundation (in the absence of hyperammonemia), hyperventilation, severe compensated metabolic acidosis potentially accompanied by a respiratory component, a large anion gap, hypernatremia, hyperosmolarity, progressive encephalopathy, cardiovascular collapse, and ultimately, death.

In the event of an overdose, it is imperative to discontinue the administration of Sodium Phenylacetate and Sodium Benzoate Injection immediately. Healthcare professionals should initiate appropriate emergency medical monitoring and interventions. In severe cases, the preferred management strategy is hemodialysis; however, peritoneal dialysis may be considered if hemodialysis is not available.

Nonclinical Toxicology

Long-term studies in animals have not been performed to evaluate the carcinogenic potential of Sodium Phenylacetate and Sodium Benzoate Injection. Additionally, studies to assess the possible impairment of fertility or mutagenic potential of Sodium Phenylacetate and Sodium Benzoate Injection have not been conducted. However, results indicate that sodium benzoate is not mutagenic or carcinogenic and does not impair fertility.

In animal studies, subcutaneous administration of phenylacetate to rat pups at doses ranging from 190 to 474 mg/kg resulted in decreased proliferation and increased loss of neurons, as well as reduced central nervous system (CNS) myelin. The maturation of cerebral synapses was retarded, leading to a reduction in the number of functioning nerve terminals in the cerebrum, which ultimately impaired brain growth. Pregnant rats received phenylacetate at a dose of 3.5 μmol/g/day subcutaneously from gestation day 7 through normal delivery. Prenatal exposure of rat pups to phenylacetate resulted in lesions in layer 5 cortical pyramidal cells, characterized by longer and thinner dendritic spines than normal, along with a reduced number of these spines.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. The most frequently observed adverse reactions include vomiting, hyperglycemia, hypokalemia, convulsions, and mental impairment. These events have been documented in the context of postmarketing surveillance, contributing to the overall understanding of the product's safety profile.

Patient Counseling

Healthcare providers should advise patients and caregivers regarding the safe use of Sodium Phenylacetate and Sodium Benzoate Injection. It is important to inform them that once plasma ammonia levels have normalized, dietary protein intake can typically be increased, aiming for unrestricted protein consumption.

Providers should also discuss the potential adverse reactions associated with this treatment. The most common adverse reactions include vomiting, hyperglycemia, hypokalemia, convulsions, and mental impairment. Patients should be made aware of these risks and instructed to report any concerning symptoms promptly.

Additionally, healthcare providers should clarify that BUPHENYL is generally discontinued during the administration of Sodium Phenylacetate and Sodium Benzoate Injection. This information is crucial for ensuring the safe and effective use of the medication.

Storage and Handling

The product is supplied in a sterile, non-pyrogenic, single-dose glass vial. It should be stored at a temperature range of 20°C to 25°C (68°F to 77°F), with permissible excursions between 15°C to 30°C (59°F to 86°F). Proper handling and storage conditions are essential to maintain the integrity of the product.

Additional Clinical Information

Plasma potassium levels should be carefully monitored in patients, along with blood chemistry profiles, blood pH, and pCO2. Administration of the product must be conducted through a central venous catheter, and it is important to avoid administering the undiluted product.

In postmarketing experience, neurotoxicity has been reported in cancer patients receiving intravenous phenylacetate. Symptoms associated with this neurotoxicity include somnolence, fatigue, lightheadedness, headaches, dysgeusia, hypoacusis, disorientation, impaired memory, and exacerbation of pre-existing neuropathy.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Sodium Phenylacetate and Sodium Benzoate as submitted by Zydus Pharmaceuticals USA Inc.. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Sodium Phenylacetate and Sodium Benzoate, retrieved by a validated AI data-extraction workflow.

All FDA-approved dosage forms and strengths are listed in the Packaging & NDC Codes section above. Regulatory status, pharmacologic class (EPC), and mechanism of action (MoA) were cross-checked against the FDA Orange Book (ANDA217526) and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

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Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.