Pronunciation:

SOE-dee-um BEN-zoe-ate, SOE-dee-um fen-il-AS-e-tate

Brand Names:

• Ammonul

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Hyperammonemia Agent

Uses of This Medicine:

Sodium phenylacetate and benzoate injection combination is used to treat hyperammonemia, which is a condition where there is too much ammonia in the blood. Ammonia is formed from the breakdown of protein in the body. If the ammonia cannot be removed by the body, high amounts in the blood may cause serious unwanted effects. This medicine works to reduce the amount of ammonia in the blood.

This medicine is to be given only by or under the direct supervision of a doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of sodium phenylacetate and benzoate injection in children.

Older adults—

Although appropriate studies on the relationship of age to the effects of sodium phenylacetate and benzoate injection have not been performed in the geriatric population, no geriatric-specific problems have been documented to date. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving sodium phenylacetate and benzoate injection.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Congestive heart failure or
• Edema (swelling) or
• Hyperglycemia (high blood sugar) or
• Hypokalemia (low potassium in the blood) or
• Seizures (convulsions), history of—Use with caution. May make these conditions worse.

• Kidney disease or
• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

A nurse or other trained health professional will give you or your child this medicine in a hospital. This medicine is given through a needle placed in one of your veins.

Your doctor will give you or your child a few doses of this medicine until your condition improves, and then switch you to an oral medicine that works the same way. If you have any concerns about this, talk to your doctor.

It is also important that you follow any special diet instructions from your doctor, such as using a low protein diet. If you have any questions about this, check with your doctor.

Precautions While Using This Medicine:

It is very important that your doctor check your or your child's progress closely while you are receiving this medicine to make sure the medicine is working properly. Blood tests may be needed to check for unwanted effects.

This medicine may cause unwanted effects on the nervous system. Check with your doctor right away if you or your child have lightheadedness, muscle tingling or weakness, sleepiness or unusual drowsiness, or tiredness.

Check with your doctor right away if you or your child have more than one of the following symptoms while receiving this medicine: confusion; deep or fast breathing with dizziness; muscle tremors; nausea; numbness of the feet, hands, and around the mouth; rapid, deep breathing; restlessness; stomach cramps; or unusual tiredness or weakness.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Abdominal or stomach pain or cramps

blurred vision

decreased urine

dry mouth

fatigue

flushed, dry skin

fruit-like breath odor

increased hunger

increased thirst

increased urination

irregular heartbeat

loss of appetite

muscle pain or cramps

nausea or vomiting

numbness or tingling in the hands, feet, or lips

seizures

shortness of breath

sweating

troubled breathing

unexplained weight loss

unusual tiredness or weakness

Less common

Agitation

anxiety

bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

bleeding or oozing from the puncture site, mouth, or nose that continues

bloody or cloudy urine

bloody, black, or tarry stools

confusion

coughing that sometimes produces a pink frothy sputum

depression

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

drowsiness

feeling, seeing, or hearing things that are not there

feeling that others are watching you or controlling your behavior

headache

lightheadedness

mood or mental changes

muscle tremors

nightmares or unusually vivid dreams

pale skin

rapid, deep breathing

restlessness

skin rash

sleepiness or unusual drowsiness

trouble with breathing when moving or walking

unusual bleeding or bruising

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Diarrhea

fever

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.