Sodium Phenylbutyrate
Sodium Phenylbutyrate Uses, Dosage, Side Effects, Mechanism of Action, How Long Does it Take to Work? Sodium Phenylbutyrate is a brand name. Its generic name is sodium phenylbutyrate.
Sodium Phenylbutyrate
Sodium phenylbutyrate is a medication commonly used to treat urea cycle disorders, specifically those associated with elevated levels of protein compounds (ammonia) in the blood. It is usually used in combination with a low-protein diet. It can also reduce ammonia levels in the blood of adults with cirrhosis, and it is used to treat HIV infection in combination with other anti-retroviral medications. The active ingredient is phenylbutyric acid, which is a derivative of the amino acid valine.
Uses
Sodium phenylbutyrate is used to treat urea cycle disorders, which are inherited metabolic disorders that can range from mild to severe. Specifically, it is used as an adjunct to a low-protein diet to reduce the symptoms caused by elevated amounts of nitrogen compounds like ammonia in the blood. It can also be used to reduce ammonia levels in the blood of adults with cirrhosis, and to reduce HIV viral load in combination with other anti-retroviral medications.
Mechanism of Action
The mechanism of action of Sodium Phenylbutyrate is not fully understood. It is believed to work through conversion of the amino acid phenylalanine to phenylbutyric acid, which eliminates ammonia from the body. It is also believed to act as an antioxidant to reduce cell damage caused by free radicals.
How Long Does it Take to Work?
Sodium phenylbutyrate usually starts showing its effects within 1 to 2 weeks of beginning therapy. Its full effects, however, take several weeks or months to be noticeable. Its effects depend on the amount of ammonia in the blood and the severity of the underlying medical condition.
Absorption
Sodium phenylbutyrate is rapidly and completely absorbed from the gastrointestinal tract. Its peak blood concentrations occur within 1 to 2 hours of oral administration. It is also well-distributed in body tissues and organs.
Route of Elimination
Sodium phenylbutyrate is eliminated mainly in the urine, with some being eliminated in the feces. It is metabolized in the liver before elimination.
Dosage
Sodium phenylbutyrate is available as a pill in the following dosage forms and strengths: 125 mg, 250 mg, and 500 mg. The recommended daily dose depends on the patient’s age and the severity of the condition being treated. The following are the recommended daily doses for Sodium Phenylbutyrate:
- Infants and Children (up to 8 years old): 10-30 mg/kg/day in two to four divided doses.
- Children (8 to 16 years old): 10-30 mg/kg/day in two to four divided doses.
- Adults: 20-25 g/day in four to five divided doses.
Administration
Sodium phenylbutyrate is to be taken orally with or without food. It should be taken as directed by the doctor. The dosage should not be changed without the doctor’s approval.
Side Effects
The most common side effects of Sodium Phenylbutyrate include nausea, vomiting, diarrhea, stomach pain, constipation, headache, dizziness and drowsiness. These effects usually resolve over time.
Toxicity
In clinical studies, Sodium Phenylbutyrate was found to be well tolerated with minimal side effects. No evidence of serious toxicity has been reported.
Precaution
Patients taking Sodium Phenylbutyrate should be monitored for any signs of side effects. The medication should not be taken by pregnant women, nursing mothers or anyone with kidney or liver disease.
Interactions
Sodium phenylbutyrate should not be taken with any other medications, vitamins or herbal supplements. It may interact with the following drugs: Amiodarone, Atazanavir, Carbamazepine, Diltiazem, Fluoxetine, and Warfarin.
Disease Interactions
Sodium phenylbutyrate should not be used in patients with kidney or liver disease, or in those taking any medications that lower blood ammonia levels.
Drug Interactions
Sodium phenylbutyrate may increase the effects of certain drugs, so patients should inform their doctor of all the medications they are taking before beginning therapy with the drug.
Food Interactions
Sodium phenylbutyrate may interact with certain foods and drinks, such as alcohol and dairy products. Patients should avoid or limit these when taking the medication.
Pregnancy Use
Sodium phenylbutyrate is not recommended for pregnant women due to a lack of safety data. Women who are pregnant or planning to become pregnant should speak to their doctor before taking this medication.
Lactation Use
Sodium phenylbutyrate is not recommended for nursing mothers due to a lack of safety data. Women who are breastfeeding or planning to breastfeed should speak to their doctor before taking this medication.
Acute Overdose
In case of an overdose of Sodium Phenylbutyrate, the patient should seek immediate medical help. Symptoms of an overdose may include dizziness, drowsiness, weakness, and difficulty breathing.
Contraindication
Sodium phenylbutyrate is contraindicated in patients with known hypersensitivity to the medication or any of its components.
Use Direction
Sodium phenylbutyrate should be taken as directed by the doctor, in the dosage and frequency prescribed. It should not be taken more often than prescribed, and the dosage should not be changed without consulting a doctor.
Storage Condition
Sodium phenylbutyrate should be stored at room temperature and away from light, moisture and heat. It should be kept out of the reach of children.
Volume of Distribution
The volume of distribution of Sodium Phenylbutyrate is approximately 1.4 L/kg.
Half Life
The elimination half-life of Sodium Phenylbutyrate is approximately 2-3 hours.
Clearance
The clearance of Sodium Phenylbutyrate is approximately 100 mL/min.
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