Pronunciation:

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

Brand Names:

• Ucephan

Dosage Forms:

• Solution

Classifications:

Therapeutic

Hyperammonemia Agent

Uses of This Medicine:

Sodium benzoate and sodium phenylacetate combination is used to treat a condition caused by too much ammonia in the blood (hyperammonemia). This medicine works by causing less ammonia to be produced by the body.

Ammonia is formed from the breakdown of protein in the body. If the ammonia cannot be removed by the body, then a buildup may cause serious unwanted effects.

Sodium benzoate and sodium phenylacetate combination is available only with your doctor's prescription.

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

This medicine has been tested in children and, in effective doses, has not been shown to cause different side effects or problems than it does in adults.

Older adults

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing the use of sodium benzoate and sodium phenylacetate in the elderly with use in other age groups.

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:

• Cancer Use of sodium benzoate and sodium phenylacetate may increase your chance of side effects

• Edema (swelling) or
• Heart disease Increased retention of water may make these conditions worse

• Kidney disease or
• Liver disease May increase the amount of medicine in your body

Proper Use of This Medicine:

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

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form (solution):
  • Treatment of too much ammonia in the blood:
    • Adults and children The dose is based on body weight and must be determined by the doctor.

Missed dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using This Medicine:

Your doctor should check your progress at regular visits to make sure that this medicine is working properly.

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.

Stop taking this medicine and get emergency help immediately if any of the following effects occur:

More common

Confusion

convulsions

decreased urine

dry mouth

headache

increase in frequency of seizures

increased thirst

irregular heartbeat

loss of appetite

mood changes

muscle pain or cramps

nausea

numbness or tingling in hands, feet, or lips

problems with movement, walking or speech

shortness of breath

swelling of face

unusual tiredness or weakness

vomiting

yellow eyes or skin

Less common

Blood in stools

blood in urine

bruising

change in consciousness

coughing or vomiting blood

difficulty in breathing

drowsiness

loss of consciousness

mental changes

muscle cramps in hands, arms, feet, legs, or face

muscle tremors

persistent bleeding or oozing from puncture sites, mouth, or nose

rapid, deep breathing

rash

restlessness

shortness of breath

stomach cramps

tightness in chest

tremor

troubled breathing

wheezing

Frequency unknown

Abnormally slow deep breathing

blue lips, fingernails, or skin

blurred vision

bulging soft spot on head of an infant

change in ability to see colors, especially blue or yellow

chest pain or discomfort

dizziness or fainting

injection site hemorrhage

insomnia

irregular, fast or slow, or shallow breathing

lightheadedness

severe headache

shakiness

sleepiness

slow heartbeat

slow to respond

slurred speech

unconsciousness

Symptoms of overdose

Agitation

back pain

blue lips, fingernails, or skin

blurred vision

bulging soft spot on head of an infant

change in ability to see colors, especially blue or yellow

chest pain or discomfort

chills

cold, clammy, pale skin

coma

confusion

continuing nausea or vomiting

cough

deep or fast breathing with dizziness

difficult or troubled breathing

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

drowsiness

fainting

fast heartbeat

fever

general feeling of discomfort or illness

hallucinations

headache

high blood pressure

insomnia

irregular, fast or slow, or shallow breathing

irregular heartbeats

irritability

lightheadedness

loss of appetite

mood or mental changes

muscle twitching

no blood pressure

not alert

numbness to feet, hands and around mouth

rapid, shallow breathing

restlessness

seizures

slow heart rate

stiff neck

sweating

swelling of face

swelling of feet or lower legs

thickening of bronchial secretions

trouble with coordination

unusual tiredness or weakness

vomiting

weakness

yellow eyes or skin

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:

More common

Changes in skin color

cold hands and feet

confusion or excitement

cough or hoarseness;

dry mouth;

fever or chills

flushed, dry skin;

fruit-like breath odor

increased hunger

increased thirst

increased urination

lower back or side pain

mental depression or anxiety

nightmares or unusually vivid dreams

painful or difficult urination

pain, redness, or swelling in arm or leg

skin disorders

sweating

unexplained weight loss

Less common

Bladder pain

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

decrease in urine-concentrating ability

diarrhea

difficult, burning, or painful urination

frequent urge to urinate

hyperventilation

nervousness

pale skin

shaking

troubled breathing with exertion

trouble sleeping

unusual bleeding or bruising

Frequency unknown

Blister

full or bloated feeling or pressure in the stomach

itching skin

rash with flat lesions or small raised lesions on the skin

swelling of abdominal or stomach area

uncontrolled jerking movement

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.