Glycerol Phenylbutyrate
NA
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Drug Status
Government Approvals
US(FDA)
WHO Essential Medicine
NO
Known Teratogen
No
Pharmaceutical Class
NA
Controlled Drug Substance
No
Summary
Glycerol phenylbutyrate is used to manage urea cycle disorders, which are conditions that affect how the body removes waste. These disorders can lead to a dangerous buildup of ammonia in the blood, causing serious health issues like brain damage. The medication helps reduce ammonia levels, preventing these complications.
Glycerol phenylbutyrate works by helping your body remove excess nitrogen, which is a waste product, through urine. It acts like a sponge that soaks up extra nitrogen, preventing it from turning into ammonia, which can be harmful. This helps prevent serious complications like brain damage.
The usual starting dose for adults is 5.7 mL taken three times a day with meals. The maximum recommended dose is 17.4 mL three times a day. For children, the dose is based on body surface area and should be determined by a healthcare provider. Always follow your doctor's specific dosing instructions.
Common side effects of glycerol phenylbutyrate include diarrhea, abdominal pain, and nausea. These effects are generally mild and occur in a small percentage of people. If you notice new symptoms after starting the medication, they might be temporary or unrelated to the medication.
Glycerol phenylbutyrate can cause serious side effects like neurotoxicity, which is damage to the nervous system, if ammonia levels in the blood become too high. It's not recommended for people with severe liver problems. Always follow your doctor's instructions and report any unusual symptoms immediately.
Indications and Purpose
How does glycerol phenylbutyrate work?
Glycerol phenylbutyrate works by helping your body remove excess nitrogen, which is a waste product, through urine. It belongs to a class of medicines called nitrogen-binding agents. Think of it like a sponge that soaks up extra nitrogen in your body, preventing it from turning into ammonia, which can be harmful. By reducing ammonia levels in the blood, glycerol phenylbutyrate helps prevent serious complications like brain damage. This makes it effective for managing urea cycle disorders, which affect how the body removes waste.
Is glycerol phenylbutyrate effective?
Glycerol phenylbutyrate is effective in managing urea cycle disorders, which are conditions that affect how the body removes waste. This medication helps reduce ammonia levels in the blood, preventing serious complications like brain damage. Clinical studies show that glycerol phenylbutyrate effectively lowers ammonia levels and improves health outcomes in people with urea cycle disorders. It's important to take the medication as prescribed and have regular check-ups with your doctor to monitor its effectiveness and adjust treatment as needed.
What is glycerol phenylbutyrate?
Glycerol phenylbutyrate is a medication used to manage urea cycle disorders, which are conditions that affect how the body removes waste. It belongs to a class of medicines called nitrogen-binding agents. This medication works by helping your body remove excess nitrogen, which is a waste product, through urine. By reducing ammonia levels in the blood, glycerol phenylbutyrate helps prevent serious complications like brain damage. It's an important part of treatment for people with urea cycle disorders.
Directions for Use
For how long do I take glycerol phenylbutyrate?
Glycerol phenylbutyrate is usually a long-term medication for managing urea cycle disorders, which affect how the body removes waste. You'll typically take glycerol phenylbutyrate every day as a lifelong treatment unless your doctor suggests otherwise. Stopping this medication without medical advice could cause your condition to worsen. How long you'll need this medication depends on your body's response, any side effects you experience, and changes in your overall health. Always talk with your doctor before changing or stopping your glycerol phenylbutyrate treatment.
How do I dispose of glycerol phenylbutyrate?
To dispose of glycerol phenylbutyrate, take it to a drug take-back program or collection site at a pharmacy or hospital. They will dispose of the medication properly to prevent harm to people or the environment. If you can't find a take-back program, you can throw the medication in the trash at home. First, take it out of its original container, mix it with something undesirable like used coffee grounds, seal the mixture in a plastic bag, and throw it away. Always keep medications out of reach of children and pets.
How do I take glycerol phenylbutyrate?
Take glycerol phenylbutyrate exactly as your doctor prescribes. It's usually taken three times a day with meals. Do not crush or chew the medication. It's important to take it with food to help your body absorb it properly. If you miss a dose, take it as soon as you remember, unless it's almost time for your next dose. In that case, skip the missed dose and continue with your regular schedule. Never take two doses at once. Always follow your doctor's specific instructions regarding your medication and any dietary or beverage restrictions.
How long does it take for glycerol phenylbutyrate to start working?
Glycerol phenylbutyrate begins working in your body shortly after you take it. The medication helps reduce ammonia levels in the blood, which can prevent serious complications like brain damage. You may not notice all the benefits right away, but regular blood tests to monitor ammonia levels will show its effectiveness. How quickly the medication works can depend on your overall health and how well you follow your treatment plan. Take it exactly as prescribed for the best results.
How should I store glycerol phenylbutyrate?
Store glycerol phenylbutyrate at room temperature, away from moisture and light. Keep it in its original container with the lid tightly closed. Do not refrigerate or freeze the medication. Avoid storing it in humid places like bathrooms, as moisture can affect its effectiveness. Always keep glycerol phenylbutyrate out of reach of children and pets to prevent accidental ingestion. Check the expiration date regularly and properly dispose of any unused or expired medication.
What is the usual dose of glycerol phenylbutyrate?
The usual starting dose of glycerol phenylbutyrate for adults is 5.7 mL taken three times a day with meals. Your doctor may adjust the dose based on your response and needs. The maximum recommended dose is 17.4 mL three times a day. For children, the dose is based on body surface area and should be determined by a healthcare provider. Elderly patients may require careful monitoring and dose adjustments. Always follow your doctor's specific dosing instructions for your health needs.
Warnings and Precautions
Can glycerol phenylbutyrate be taken safely while breastfeeding?
The safety of glycerol phenylbutyrate while breastfeeding is not well-established. It's unclear if this medication passes into human breast milk. If you're taking glycerol phenylbutyrate and want to breastfeed, talk with your doctor about the potential risks and benefits. They can help determine the best course of action for you and your baby. Your doctor may suggest alternative treatments that would allow you to nurse safely while managing your health condition.
Can glycerol phenylbutyrate be taken safely while pregnant?
The safety of glycerol phenylbutyrate during pregnancy is not well-established. Limited data is available on its use in pregnant women. However, managing urea cycle disorders, which affect how the body removes waste, is crucial during pregnancy to prevent serious complications. If you're pregnant or planning to become pregnant, talk with your doctor about the safest way to manage your condition. Your doctor can help create a pregnancy-specific treatment plan that protects both you and your baby.
Can I take glycerol phenylbutyrate with other prescription drugs?
There are no major or moderate drug interactions specifically associated with glycerol phenylbutyrate. However, it's important to inform your doctor about all the medications you are taking to prevent any potential interactions. This includes prescription drugs, over-the-counter medications, and supplements. Your doctor can help ensure your treatment is safe and effective by monitoring for any interactions that might increase the risk of adverse effects or reduce the effectiveness of glycerol phenylbutyrate.
Does glycerol phenylbutyrate have adverse effects?
Adverse effects are unwanted reactions that can occur with medication use. With glycerol phenylbutyrate, common adverse effects include diarrhea, abdominal pain, and nausea. These effects are generally mild to moderate. Serious adverse effects, like neurotoxicity, which is damage to the nervous system, can occur if ammonia levels in the blood become too high. If you experience severe or persistent symptoms, contact your doctor immediately. Regular monitoring of ammonia levels is important to prevent serious complications. Always inform your healthcare provider about any new or worsening symptoms.
Does glycerol phenylbutyrate have any safety warnings?
Yes, glycerol phenylbutyrate has important safety warnings. It can cause serious side effects like neurotoxicity, which is damage to the nervous system, if ammonia levels in the blood become too high. This medication is used to manage urea cycle disorders, which are conditions that affect how the body removes waste. Not adhering to safety warnings can lead to severe health issues, including brain damage. Always follow your doctor's instructions and report any unusual symptoms immediately. Regular monitoring of ammonia levels is crucial while on this medication.
Is glycerol phenylbutyrate addictive?
Glycerol phenylbutyrate is not addictive or habit-forming. This medication doesn't cause dependency or withdrawal symptoms when you stop taking it. It works by helping your body remove excess nitrogen, which is a waste product, through urine. This mechanism doesn't affect brain chemistry in ways that could lead to addiction. You won't experience cravings for this medication or feel compelled to take more than prescribed. If you have concerns about medication dependence, you can feel confident that glycerol phenylbutyrate doesn't carry this risk while managing your health condition.
Is glycerol phenylbutyrate safe for the elderly?
Elderly individuals may be more vulnerable to the side effects of glycerol phenylbutyrate, such as stomach upset or diarrhea. It's important for older adults to be closely monitored while taking this medication. Regular check-ups and blood tests to monitor ammonia levels are crucial. If any unusual symptoms occur, they should be reported to a healthcare provider immediately. The doctor may adjust the dose or suggest alternative treatments to ensure safety and effectiveness for elderly patients.
Is it safe to drink alcohol while taking glycerol phenylbutyrate?
It's best to avoid alcohol while taking glycerol phenylbutyrate. Alcohol can affect how your body processes waste and may interfere with the medication's effectiveness. Drinking alcohol can also increase the risk of side effects like stomach upset. If you choose to drink occasionally, limit your alcohol intake and watch for any unusual symptoms. Talk with your doctor about alcohol use while taking glycerol phenylbutyrate to get personalized advice based on your specific health situation.
Is it safe to exercise while taking glycerol phenylbutyrate?
You can exercise while taking glycerol phenylbutyrate, but keep a few things in mind. This medication can cause stomach upset, which might affect your comfort during physical activity. If you experience any symptoms like dizziness or nausea, slow down or stop exercising and rest. To exercise safely, drink plenty of water before, during, and after physical activity. Most people can maintain their regular exercise routine while taking glycerol phenylbutyrate, but check with your doctor if you have concerns about your specific situation.
Is it safe to stop glycerol phenylbutyrate?
Stopping glycerol phenylbutyrate suddenly can be risky, especially if you have a urea cycle disorder, which affects how your body removes waste. This medication is usually used long-term to manage chronic conditions. Stopping it can lead to a dangerous buildup of ammonia in your blood, causing serious health issues like brain damage. Always talk with your doctor before stopping glycerol phenylbutyrate. They might suggest gradually reducing your dose or switching to a different medication to keep your condition under control. Your doctor will help you make any medication changes safely.
What are the most common side effects of glycerol phenylbutyrate?
Side effects are unwanted reactions that can happen when taking a medication. Common side effects of glycerol phenylbutyrate include diarrhea, abdominal pain, and nausea. These effects are generally mild and occur in a small percentage of people. If you notice new symptoms after starting glycerol phenylbutyrate, they might be temporary or unrelated to the medication. It's important to talk with your doctor before stopping any medication. They can help determine if your symptoms are related to the medication and provide guidance on how to manage them.
Who should avoid taking glycerol phenylbutyrate?
Glycerol phenylbutyrate should not be used if you are allergic to it or any of its ingredients. Serious allergic reactions, which cause rash, hives, or swelling that makes breathing difficult, require immediate medical help. This medication is not recommended for people with severe liver problems, which affect how the body processes waste. Caution is needed if you have a history of gastrointestinal issues, as the medication can cause stomach upset. Always consult your doctor about any concerns or conditions before starting glycerol phenylbutyrate.
