Sodium Phenylacetate and Sodium Benzoate

Sodium Phenylacetate and Sodium Benzoate

(SOW dee um fen il AS e tate & SOW dee um BENZ oh ate)

U.S. Brand Names

Ammonul®

Dosage Forms

• This medicine is available as an injection.

Pharmacologic Category

Antidote; Urea Cycle Disorder (UCD) Treatment Agent

Is it safe for my child to take this medicine?

• Not if your child has an allergy to sodium phenylacetate, sodium benzoate, or any other part of this medicine.

• Be sure to let healthcare provider know if your child has any allergies or reactions to medicine, food preservatives, or dyes. Make sure to tell about the allergy and how it affected your child. This includes telling about rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other symptoms involved.

Why does my child need this medicine?

• This medicine is used to treat urea cycle disorder.

How does this medicine work?

• Sodium phenylacetate and sodium benzoate decrease ammonia levels in the body.

How is this medicine given?

• This medicine is given as an infusion into a vein over a period of time.

How long does this medicine take to work?

• Your child may start feeling better soon after starting this medicine.

What do I do if my child misses a dose? (does not apply to patients in the hospital)

• Call healthcare provider for instructions.

What safety measures should I take while my child is using this medicine?

• If your child has kidney disease, talk with healthcare provider.

• If your child has liver disease, talk with healthcare provider.

• If your child has a weakened heart, talk with healthcare provider.

• Check your child's medicines with healthcare provider. This medicine may not mix well with other medicines.

What are some possible side effects of this medicine?

• Nausea or vomiting. Small frequent meals and frequent mouth care may help. Older children may suck hard, sugar-free candy.

• High blood sugar.

What should I monitor?

• Change in condition being treated. Is it better, worse, or about the same?

• For the occurrence of side effects.

• Check blood work regularly. Talk with healthcare provider.

• Follow up with healthcare provider.

When should I call my child's healthcare provider?

• If any of this information causes you to be concerned, any of the common side effects occur, or if your child's symptoms do not improve after taking this medicine.

• If your child shows signs of a life-threatening reaction, call healthcare provider immediately. These include wheezing; chest tightness; fever; itching; bad cough; blue skin color; fits; swelling of face, lips, tongue, or throat; or if your child exhibits any other unusual behavior.

• If your child shows any signs or symptoms of infection. These include a fever of 100.5 degrees or higher, chills, severe sore throat, ear or sinus pain, cough, increased sputum or change in color, painful urination, mouth sores, wound that will not heal, or anal itching or pain.

• If your child shows signs of severe dizziness or passes out.

• If your child has difficulty breathing.

• If your child has significant change in thinking clearly and logically.

• If your child has seizures.

• If your child has increased trips to the bathroom, increased thirst, or weight loss.

• If your child develops a rash.

• No improvement in condition or if you believe your child's condition is worse.

How should I store and/or dispose of this medicine?

• This medicine will be given to your child in a healthcare setting. You will not store it at home.

General statements

• If your child has a life-threatening allergy, he/she should wear an allergy identification bracelet at all times.

• This medicine is available by prescription only. If there are refills, contact your pharmacy. If no refills remain, you may need to contact your child's healthcare provider.

• This medicine should be thrown out when your child no longer needs it or if the medicine becomes outdated.

• Do not share your child's medicine with others and do not give anyone else's medicine to your child.

• Keep all medicine out of the reach of children and pets.

• Many medications interact with other medications. Keep a list of all your child's medicines (prescription, natural products, supplements, vitamins, over-the-counter) with you. Give this list to your child's healthcare provider (doctor, nurse, nurse practitioner, pharmacist, physician assistant).

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

• Talk with your child's healthcare provider before giving him/her any new medicine, including over-the-counter, natural products, or vitamins.

• Medicine can be dangerous if used incorrectly. Follow directions given by healthcare provider.



Created: 2008-07-21 12:03:11.0

Modified: 2008-07-23 11:07:14.0

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