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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
- Ammonul (by Ucyclyd Pharma Inc.)
- Sodium Phenylacetate and Sodium Benzoate (by Ailex Pharmaceuticals, Llc)
- Sodium Phenylacetate and Sodium Benzoate (by Fosun Pharma Usa Inc)
- Sodium Phenylacetate and Sodium Benzoate (by Maia Pharmaceuticals)
- Sodium Phenylacetate and Sodium Benzoate (by Maia Pharmaceuticals, Inc)
- Sodium Phenylacetate and Sodium Benzoate (by Navinta Llc)
- Sodium Phenylacetate and Sodium Benzoate (by Omnivium Pharmaceuticals Llc)
- Sodium Phenylacetate and Sodium Benzoate (by Omnivium Pharmaceuticals Llc)
- Sodium Phenylacetate and Sodium Benzoate (by Zydus Pharmaceuticals Usa Inc.)
- Sodium Phenylacetate and Sodium Benzoate (by Zydus Pharmaceuticals Usa Inc.)
- View full label-group details →
- 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 2025
- Label revision date
- December 6, 2025
- FDA Insert
- Prescribing information, PDF file
- Active ingredients
- Sodium Phenylacetate 100 mg/1 mL
- Sodium Benzoate 100 mg/1 mL
- Other brand names
- Ammonul (by Ucyclyd Pharma Inc.)
- Sodium Phenylacetate and Sodium Benzoate (by Ailex Pharmaceuticals, Llc)
- Sodium Phenylacetate and Sodium Benzoate (by Fosun Pharma Usa Inc)
- Sodium Phenylacetate and Sodium Benzoate (by Maia Pharmaceuticals)
- Sodium Phenylacetate and Sodium Benzoate (by Maia Pharmaceuticals, Inc)
- Sodium Phenylacetate and Sodium Benzoate (by Navinta Llc)
- Sodium Phenylacetate and Sodium Benzoate (by Omnivium Pharmaceuticals Llc)
- Sodium Phenylacetate and Sodium Benzoate (by Omnivium Pharmaceuticals Llc)
- Sodium Phenylacetate and Sodium Benzoate (by Zydus Pharmaceuticals Usa Inc.)
- Sodium Phenylacetate and Sodium Benzoate (by Zydus Pharmaceuticals Usa Inc.)
- View full label-group details →
- 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 2025
- Label revision date
- December 6, 2025
- Manufacturer
- Navinta LLC
- Registration number
- ANDA217526
- NDC root
- 68475-513
- FDA Insert
- Prescribing information, PDF file
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Drug Overview
Sodium phenylacetate and sodium benzoate injection is a sterile solution used as a nitrogen binding agent. It is primarily indicated as an adjunctive therapy for treating acute hyperammonemia, a condition characterized by elevated ammonia levels in the blood, and associated encephalopathy in both pediatric and adult patients who have deficiencies in enzymes of the urea cycle.
This medication works by providing alternatives to urea for the excretion of waste nitrogen. Sodium phenylacetate conjugates with glutamine in the liver and kidneys to form phenylacetylglutamine, which is then excreted by the kidneys, effectively removing nitrogen from the body. Similarly, sodium benzoate conjugates with glycine to form hippuric acid, which is also rapidly excreted, helping to lower nitrogen levels.
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 harmful effects on fetal development (teratogenic effects) or any other non-harmful effects. If you have questions about how this treatment may affect you or your loved ones, be sure to discuss them with your healthcare provider.
Dosage and Administration
Before you receive Sodium Phenylacetate and Sodium Benzoate Injection, it needs to be mixed with sterile 10% Dextrose Injection (D10W). This is an important step 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 crucial 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
You can feel reassured that there are no specific contraindications, risks of abuse or misuse, or concerns about dependence (which means relying on a substance) associated with this medication. Additionally, there are no particular instructions advising against taking or using it. Always consult with your healthcare provider if you have any questions or concerns about your treatment.
Side Effects
You may experience some side effects while using Sodium Phenylacetate and Sodium Benzoate Injection. The most common reactions reported include vomiting, high blood sugar (hyperglycemia), low potassium levels (hypokalemia), convulsions, and mental impairment. It's important to monitor your potassium levels, as they may decrease and require treatment.
Be cautious if you have conditions like congestive heart failure or severe kidney issues, as these can be affected by fluid overload. Additionally, if the injection leaks into surrounding tissues during administration, it could cause skin damage, particularly in infants. There are also potential risks of neurotoxicity, especially in cancer patients, so watch for any unusual neurological symptoms. In cases of overdose, serious complications can arise, including respiratory failure and severe metabolic issues, which may be life-threatening. Regular monitoring of your blood chemistry and pH levels is advised.
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, blood pH, and pCO2 levels. 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 infusion site must be closely monitored to prevent skin damage, especially in infants, as the medication can cause tissue infiltration. Be alert for any signs of neurotoxicity (nervous system damage) and symptoms similar to salicylate overdose, such as rapid breathing or metabolic acidosis (an imbalance in body acidity). If you experience any concerning symptoms, it's crucial to stop the medication and contact your doctor for further guidance.
Overdose
If you or someone you know is receiving Sodium Phenylacetate and Sodium Benzoate Injection and there is a concern about an overdose, it’s important to be aware of the potential risks. Overdosage has been linked to serious outcomes, including cardiorespiratory failure (when the heart and lungs stop working effectively), hyperammonemia (high levels of ammonia in the blood), and increased pressure in the brain. Signs of overdose may include confusion, rapid breathing, severe metabolic issues, high sodium levels, and even loss of consciousness or death.
If an overdose occurs, you should immediately stop the medication and seek emergency medical help. Medical professionals will monitor the situation closely and may need to perform procedures like hemodialysis or peritoneal dialysis to remove excess substances from the body, especially in severe cases. Always prioritize safety and act quickly 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 a risk of major birth defects, miscarriage, or other negative outcomes for you or your baby. While animal studies have not been conducted on 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 medications with your healthcare provider to ensure the best care for you and your baby.
Lactation Use
When considering the use of Sodium Phenylacetate and Sodium Benzoate Injection while breastfeeding, it's important to note that there is currently no information available about whether these substances are present in human or animal milk, or how they might affect your breastfed infant or your milk production.
As you weigh the benefits of breastfeeding against your need for this medication, keep in mind the potential risks to your baby from both the medication and any underlying health issues you may have. 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.
It's important to follow your doctor’s guidance regarding the use of this injection in children, as they will determine the appropriate dosage and monitor your child's response to the treatment. Always discuss any concerns or questions you may have with your child's healthcare team.
Geriatric Use
When considering Sodium Phenylacetate and Sodium Benzoate Injection for older adults, it's important to note that clinical studies have not 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, and there have been no specific studies on how this injection works in older individuals.
If you or a loved one is an older adult, it's crucial to approach dosage with caution. Doctors typically recommend starting at the lower end of the dosing range. This is because older adults often have a higher chance of having reduced liver, kidney, or heart function, as well as other health conditions or medications that could affect how the drug works. Always consult with a healthcare provider to ensure safe and effective treatment.
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 discuss your kidney health with your healthcare provider before starting this treatment to ensure it is safe and appropriate for your situation.
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 tests to ensure your safety while using any medication. Your well-being is a priority, so don't hesitate to ask questions or express any concerns you may have.
Drug Interactions
It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you. Always share your complete list of medications and any health conditions you have to receive the best care possible.
Storage and Handling
To ensure the best quality and safety of your product, store it at a temperature between 20°C to 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), but try to keep it within the recommended limits. The product comes in a sterile (free from germs) and non-pyrogenic (does not cause fever) single-dose glass vial, which helps maintain its integrity.
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
It's important to monitor your plasma potassium levels if you're receiving this treatment, as well as your blood chemistry profiles, blood pH, and pCO2 (partial pressure of carbon dioxide in the blood). The medication should only be administered through a central venous catheter, and you should never use the undiluted product.
In some cases, patients receiving intravenous phenylacetate have reported neurotoxicity, which can include symptoms like drowsiness, fatigue, lightheadedness, 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 discuss them with your healthcare provider.
FAQ
What is Sodium Phenylacetate and Sodium Benzoate Injection used for?
It 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.
How is Sodium Phenylacetate and Sodium Benzoate Injection administered?
It must be diluted with sterile 10% Dextrose Injection and administered through a central venous catheter as a loading dose infusion over 90 to 120 minutes, followed by a maintenance dose infusion over 24 hours.
What are the common side effects of Sodium Phenylacetate and Sodium Benzoate 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, severe renal insufficiency, or sodium retention with edema.
Are there any contraindications for Sodium Phenylacetate and Sodium Benzoate Injection?
There are no contraindications mentioned for this injection.
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.
What should be monitored during treatment with Sodium Phenylacetate and Sodium Benzoate Injection?
You should monitor blood chemistry profiles, blood pH, pCO2, and plasma potassium levels.
What are the storage conditions for Sodium Phenylacetate and Sodium Benzoate Injection?
Store it 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).
What is the composition of Sodium Phenylacetate and Sodium Benzoate Injection?
Each mL contains 100 mg of sodium phenylacetate and 100 mg of sodium benzoate, along with Water for Injection.
What should be done in case of overdose?
Signs of overdose may include hyperventilation, severe metabolic acidosis, and cardiovascular collapse. Seek immediate medical attention.
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.
Details | ||||
|---|---|---|---|---|
| Injection, Solution, Concentrate |
| ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
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.
Description
Sodium Phenylacetate and Sodium Benzoate Injection 10% per 10% is a sterile, concentrated, aqueous solution containing sodium phenylacetate and sodium benzoate. The pH of the solution ranges from 7.0 to 8.0. Sodium phenylacetate is presented as a white to off-white powder, soluble in water, with a molecular weight of 158.14 and a molecular formula of C8H7NaO2. Sodium benzoate is also a white to off-white powder, readily soluble in water, with a molecular weight of 144.10 and a molecular formula of C7H5NaO2. Each mL of the injection contains 100 mg of sodium phenylacetate and 100 mg of sodium benzoate, along with Water for Injection.
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: There are no reported teratogenic or nonteratogenic effects associated with the use of 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 administration occurs exclusively through a central venous catheter, as administration via a peripheral line may result in burns.
The initial loading dose should be administered intravenously as an infusion over a period of 90 to 120 minutes. Following the loading dose, an equivalent maintenance dose should be infused 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 contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no identified risks of abuse, misuse, or dependence. Therefore, the product can be used without specific restrictions related to contraindications.
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 characterized by 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 drug administration process.
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, it is imperative to monitor these 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.
General precautions include the necessity to monitor patient blood chemistry profiles regularly, alongside frequent measurements of blood pH and pCO2. Specifically, plasma potassium levels should be assessed to ensure patient safety during treatment.
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 warrant particular attention. Decreased potassium levels (hypokalemia) should be monitored closely, and appropriate treatment should be administered as necessary. 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, particularly in infants. Therefore, the infusion site must be monitored closely for signs of tissue infiltration during administration. Neurotoxicity related to phenylacetate has been reported in cancer patients, necessitating vigilant monitoring for symptoms of acute neurotoxicity.
Other notable adverse reactions include hyperventilation and metabolic acidosis, which may occur and are typically associated with salicylate overdose. It is essential to monitor patient blood chemistry profiles and perform frequent assessments of blood pH and pCO2 levels.
In cases of overdose, serious outcomes have been reported, including cardiorespiratory failure or arrest, hyperammonemia, increased intracranial pressure, pneumonitis with septic shock and coagulopathy, respiratory failure, intractable hypotension, and potential sepsis. 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 death.
Drug Interactions
There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.
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.
Details | ||||
|---|---|---|---|---|
| Injection, Solution, Concentrate |
| ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
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 known whether elderly patients respond differently from younger patients. Urea cycle disorders, for which this medication is indicated, primarily affect pediatric and younger adult populations.
No pharmacokinetic studies have been conducted specifically in geriatric patients. Consequently, healthcare providers should exercise caution when prescribing Sodium Phenylacetate and Sodium Benzoate Injection to elderly patients. It is generally recommended that dose selection for this population be approached with care, typically starting at the lower end of the dosing range. This recommendation is based on the increased likelihood of diminished hepatic, renal, or cardiac function, as well as the presence of concomitant diseases or other drug therapies in geriatric patients. Regular monitoring and assessment of the patient's response to therapy are advised to ensure safety and efficacy.
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 the breastfed infant 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 the 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 conditions associated with sodium retention and edema. Monitoring of renal function is recommended in these patients 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. Notably, 16 out of 64 reported deaths were associated with known overdose incidents.
Clinical Manifestations
The clinical consequences of overdose can be severe and may include cardiorespiratory failure or arrest, hyperammonemia, and increased intracranial pressure. Signs of intoxication typically manifest as obtundation, hyperventilation, severe compensated metabolic acidosis, a large anion gap, hypernatremia, hyperosmolarity, progressive encephalopathy, cardiovascular collapse, and, in extreme cases, death.
Recommended Actions
In the event of an overdose, it is imperative to discontinue the administration of the drug immediately. Healthcare professionals should initiate appropriate emergency medical monitoring and procedures to manage the patient's condition effectively.
Management of Severe Overdose
For severe overdose cases, advanced interventions may be necessary. Hemodialysis is recommended to facilitate the removal of toxic metabolites; however, if hemodialysis is not available, peritoneal dialysis may be considered as an alternative treatment option.
Nonclinical Toxicology
Long-term studies in animals have not been conducted to assess the carcinogenic potential of Sodium Phenylacetate and Sodium Benzoate Injection. However, available data indicate that sodium benzoate is not mutagenic or carcinogenic and does not impair fertility.
Studies evaluating the potential impairment of fertility or mutagenic effects of Sodium Phenylacetate and Sodium Benzoate Injection have not been performed. 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 a reduction in central nervous system (CNS) myelin. Additionally, cerebral synapse maturation was delayed, and the number of functioning nerve terminals in the cerebrum was diminished, leading to impaired brain growth.
In a separate study, pregnant rats received subcutaneous doses of phenylacetate at 3.5 μmol/g/day from gestation day 7 until normal delivery. Prenatal exposure to phenylacetate resulted in lesions in layer 5 cortical pyramidal cells of rat pups, 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 routine pharmacovigilance activities.
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, with the ultimate goal of achieving unrestricted protein intake.
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 closely 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 critical 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 Navinta LLC. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.