Uses

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).

How To Use

Read the Patient Information Leaflet if available from your pharmacist before you start taking sodium 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 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.

Carefully measure the dose using a special measuring device/spoon. Take this medication with water, fruit juice, or protein-free infant formula. You may also sprinkle the dose onto a spoonful of solid food (such as apple sauce) and eat right away to prevent salty taste. Do not chew the medication. Do not prepare a supply in advance.

Some brands may be given by a feeding tube (nasogastric/gastric). For specific directions, ask your health care professional.

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

Loss of appetite or menstrual changes (delayed/irregular/absent periods) may occur. If any of these effects last or get 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
• easy bruising/bleeding
• fast/pounding heartbeat
• mental/mood changes
• tiredness
• signs of metabolic imbalance (such as rapid breathing, muscle twitching/spasms)

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

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.

Some brands of this medication may contain sugar. Caution is advised if you have diabetes, fructose intolerance, or any other condition that requires you to limit/avoid sugar in your diet. Ask your doctor or pharmacist about using this medication safely.

This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

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.

Drug Interactions

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.

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. Alberta residents can call PADIS (Poison and Drug Information Service) 24 hours a day at 1-800-332-1414. Canada residents can call a provincial poison control center.

Notes

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.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

If you have questions about missing a dose or you don't have more medication, contact your healthcare provider or pharmacist.

Storage

Store the granules at room temperature away from light and moisture. Do not store in the bathroom. Use within 45 days of opening. 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.