sodium phenylbutyrate 4 gram oral pellets for suspension in a packet

Generic name:
Sodium phenylbutyrate pellets - oral

Pronunciation
(SOE-dee-um FEN-il-BUE-ti-rate)

Brand name(s)
Olpruva

This medication is used along with diet changes for long-term treatment of a certain inherited disorder (urea cycle disorder). Sodium phenylbutyrate 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, nausea, vomiting, irritability, trouble speaking, trouble walking, fainting).

Read the Patient Information Leaflet and Instructions for Use provided by your pharmacist before you start taking sodium phenylbutyrate and each time you get a refill. Follow the illustrated directions for the proper use of this medication. 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 weight or 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.

This medication must be mixed as directed before taking. To prepare a dose, pour the contents of the thickening packet into a cup with 4 ounces/120 milliliters of water. Stir well for at least 30 seconds until the water thickens. Then, open the packet(s) containing sodium phenylbutyrate and pour its contents into the cup with the thickened water mixture. Stir well for 15 seconds and drink all of the mixture within 5 minutes of mixing. Add more water to the cup, stir, and drink all of the mixture to make sure you are getting the entire dose. Discard mixture after 30 minutes. Do not prepare a supply in advance. Do not give through a feeding tube.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.

Loss of appetite or menstrual changes (delayed/irregular/absent periods) may occur. If either of these effects lasts or gets worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor 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:

• drowsiness/lightheadedness
• fast/pounding heartbeat
• mental/mood changes (such as confusion)
• unusual tiredness

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.

Before taking sodium phenylbutyrate, 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:

• a certain heart problem (heart failure)
• kidney disease
• liver disease
• swelling (edema)

This medication contains salt (sodium). Before taking this medication, tell your doctor or pharmacist if you are on a low-salt diet.

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 breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

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 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

Lab and/or medical tests (such as plasma ammonia/amino acid levels, complete blood count, blood chemistries, urine tests, drug levels) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

If you miss a dose, take it as soon as you remember if it is on the same day. If you do not remember until the next day, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

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.