Carglumic acid Oral tablet

What is this medicine?

CARGLUMIC ACID is used to lower the amount of ammonia in the blood of patients with N-acetylglutamate synthase deficiency. This medicine is not a cure.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• an unusual or allergic reaction to carglumic acid, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth. Tablets must be dissolved in water before taking. Do not use any other liquid or food to dissolve your medicine. Do not cut, crush, or chew this medicine. Do not swallow the tablets whole. Determine the number of 200 mg tablets you need for your dose. Dissolve a single tablet in a minimum of 2.5 ml of water and drink mixture right away. Repeat this process for each of the other tablets in your dose. The tablets do not dissolve completely in the water. Rinse the mixing container with extra water and drink it to make sure that you receive the whole dose. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for newborns for selected conditions, precautions do apply.

Overdosage: If you think you've taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Interactions are not expected.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse.

Wear a medical ID bracelet or chain and carry a card that describes your disease and details of your medicine and dosage times.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing difficulties

• dizziness

• fever or chills, cough, or sore throat

• unusually weak or tired

Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):

• diarrhea

• headache

• loss of appetite

• nausea, vomiting

• stomach pain

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

You will be instructed on how to store this medicine.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.