GLYCEROL PHENYLBUTYRATE - ORAL

GLYCEROL PHENYLBUTYRATE - ORAL

PHONETIC PRONUNCIATION: (GLIS-er-ol FEN-il-BUE-ti-rate)

COMMON BRAND NAME(S): Ravicti

GENERIC NAME(S): glycerol phenylbutyrate

Uses

USES: This medication is used along with diet changes for long-term treatment of a certain inherited disorder (urea cycle disorder). It helps remove a certain chemical (ammonia) from the body. Too much ammonia in the body can cause brain damage and sometimes death. This medication should not be used to treat sudden, severely high levels of ammonia in the body. Get medical help right away if you have sudden symptoms of too much ammonia, such as trouble thinking, vomiting, irritability, slurred speech, trouble walking, fainting.


How to use GLYCEROL PHENYLBUTYRATE - ORAL

HOW TO USE: Read the Medication Guide provided by your pharmacist before you start taking glycerol phenylbutyrate and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth exactly as directed by your doctor. The dosage is based on your body size, medical condition, and response to treatment. The total daily dose should be divided into equal amounts and taken with each meal or feeding (such as 3 to 6 times daily). Do not increase or decrease your dose without your doctor's approval. Carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose. If you are giving this medication through a tube into the stomach (nasogastric or gastric tube), ask your health care professional for detailed instructions on how to properly give it. Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.

Side Effects

SIDE EFFECTS: Loss of appetite, diarrhea, or gas may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if you have any serious side effects, including: nausea, vomiting, headache, drowsiness/lightheadedness, mental/mood changes (such as confusion), tiredness, decreased hearing. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: disease of the pancreas, difficulty absorbing fat from food (malabsorption), kidney disease, liver disease. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

Interactions

Overdose

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

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Faq for GLYCEROL PHENYLBUTYRATE - ORAL

Glycerol Phenylbutyrate is an oral medication used to treat urea cycle disorders (UCDs). UCDs are genetic disorders that affect the body's ability to break down and eliminate ammonia, leading to a buildup of ammonia in the blood.

Glycerol Phenylbutyrate works by helping to remove excess nitrogen from the body. It is converted into phenylacetate, which binds with glutamine in the liver, leading to the formation of phenylacetylglutamine. This compound is then excreted in the urine, removing excess nitrogen from the body.

Common side effects of Glycerol Phenylbutyrate may include diarrhea, abdominal pain, vomiting, headache, and dry mouth.

Glycerol Phenylbutyrate should be taken exactly as prescribed by your doctor. It is usually taken three times daily with meals or snacks. The capsules should be swallowed whole and not crushed or chewed.

Before taking Glycerol Phenylbutyrate, inform your doctor about any other medications or supplements you are taking. It is important to inform your doctor if you have any liver or kidney problems or if you are pregnant or breastfeeding.

Glycerol Phenylbutyrate may interact with other medications, so it is important to tell your doctor about all the medications you are currently taking. This includes prescription medications, over-the-counter drugs, and herbal supplements.

The effectiveness of Glycerol Phenylbutyrate may vary from person to person. It may take several weeks for the medication to start working, and regular monitoring of ammonia levels in the blood may be required.

If you miss a dose of Glycerol Phenylbutyrate, take it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not take a double dose to make up for a missed one.

It is generally advisable to avoid alcohol while taking Glycerol Phenylbutyrate, as alcohol can increase the risk of liver damage.



Disclaimer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.