Sodium phenylacetate and benzoate (Intravenous)

Sodium phenylacetate and benzoate injection combination is used to treat hyperammonemia, a condition where there is too much ammonia in the blood. Ammonia comes from the breakdown of protein in the body. If the body cannot remove the ammonia, high levels in the blood can lead to serious unwanted effects. This medicine helps to lower the amount of ammonia in the blood.

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

It is very important that your doctor monitors you or your child's progress closely while receiving this medicine to ensure it is working properly. Blood tests may be required to check for unwanted effects.

This medicine may cause unwanted effects on the nervous system. Contact your doctor immediately if you or your child experience lightheadedness, muscle tingling or weakness, sleepiness or unusual drowsiness, or tiredness.

Contact 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.

In deciding to use a medicine, you need to consider the risks of taking it against the benefits it will provide. This decision is made between you and your doctor. For this medicine, the following points should be considered:

Allergies

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

Pediatric

So far, studies have not shown any specific problems in children that would limit the use of sodium phenylacetate and benzoate injection.

Geriatric

While there have not been specific studies on age-related effects of sodium phenylacetate and benzoate injection in older adults, no specific problems have been noted to date. However, older patients are more likely to have age-related kidney, liver, or heart issues, which may require caution and a dose adjustment when receiving sodium phenylacetate and benzoate injection.

Breast Feeding

There are no sufficient studies in women to determine the risk to infants when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

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

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken at or around meal times, or with certain types of food, due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect the use of this medicine. Make sure you inform your doctor if you have any other medical issues, 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 worsen these conditions.

• Kidney disease or
• Liver disease—Use with caution. The effects may be stronger because the medicine is removed from the body more slowly.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, 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. Your health care professional may also be able to tell you ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, 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.

In the U.S.

• Ammonul

Available Dosage Forms:

• Solution

Therapeutic Class: Hyperammonemia Agent

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.