Carglumic acid (By mouth)

Warnings While Using This Medicine

• Make sure your doctor knows if you are pregnant or breastfeeding.
• Hyperammonemia (too much ammonia in the blood) is a life-threatening condition that requires immediate medical attention. Check with your doctor right away if you or your child have any of the following symptoms: nausea or vomiting that continues, an increase in the frequency of seizures, a loss of appetite, swelling of the face, tiredness and weakness, or yellow eyes or skin.
• Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to keep all appointments. Blood tests may be needed to check for unwanted effects.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Fever, chills, cough, sore throat, and body aches.
• Increased sweating.
• Shortness of breath or troubled breathing.
• Swollen glands.
• Unusual bleeding, bruising, or weakness.

If you notice these less serious side effects, talk with your doctor:

• Change or loss of taste.
• Diarrhea, vomiting, or stomach pain.
• Ear pain or change in hearing.
• Headache.
• Loss of appetite.
• Rash.
• Sleepiness or unusual drowsiness.
• Stuffy or runny nose.

If you notice other side effects that you think are caused by this medicine, tell your doctor

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

Introduction

Carglumic Acid (kar-GLOO-mik AS-id)

Treats and prevents high amounts of ammonia in the blood. Often used together with a special diet and other medicines.

Brand Name(s)

When This Medicine Should Not Be Used

How to Use This Medicine

Tablet

• Your doctor will tell you how much of this medicine to use and how often. Your dose may need to be changed several times in order to find out what works best for you. Do not use more medicine or use it more often than your doctor tells you to.
• It is important that you and your child 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.
• It is best to take this medicine on an empty stomach.
• Do not swallow the tablet whole. Do not break, crush, or chew it.
• To use:
  • Dissolve the tablet in a small container or medicine cup with at least 2.5 milliliters (one-half teaspoonful) of water. Shake the container gently to dissolve the tablet.
  • Drink the mixture right away.
  • Some small particles or specks may be left at the bottom of the container.
  • Rinse the mixing container with water and drink the water right away to make sure you take all of the medicine.
• To use with a nasogastric tube (NGT):
  • Dissolve the tablet in a small container or medicine cup with at least 2.5 milliliters (one-half teaspoonful) of water. Shake the container gently to dissolve the tablet.
  • Pour the mixture into the tube right away.
  • Some small particles or specks may be left at the bottom of the container or in the tubing.
  • Rinse the mixing container with water and pour the water into the tube right away. This will clear the particles from the tube and make sure you have given all of the medicine.
• To use with an oral syringe:
  • Dissolve the tablet in a small container or medicine cup with at least 2.5 milliliters (mL) or one-half teaspoonful of water. Shake the container gently to dissolve the tablet.
  • Use an oral syringe to measure the correct amount of mixture for the dose and give it right away. Throw away any unused medicine in the container.
  • Some small particles or specks may be left in the oral syringe.
  • Refill the oral syringe with 1 to 2 mL of water and give the water right away. This will clear the particles from the syringe and make sure you have given all of the medicine.

If a dose is missed:

• If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.

How to Store and Dispose of This Medicine

• Before you open the bottle, store it in the refrigerator. Do not freeze.
• After you open the bottle for the first time, store it at room temperature. Keep the bottle tightly closed, and away from heat, moisture, and direct light. Do not refrigerate the bottle. Write the date you used the first tablet on the bottle. Throw away any unused medicine 30 days after the date on the bottle.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.