What is the most important information I should know about carglumic acid?
Avoid eating foods that are high in protein when you first start taking carglumic acid. Follow your doctor's instructions about any other restrictions on food, beverages, or activity. If you skip a meal, do not take your dose of carglumic acid. Wait until your next meal.
Your blood will need to be tested often. A buildup of ammonia in the blood can quickly cause brain injury or death. Every person with a urea cycle disorder should remain under the care of a doctor.
What is carglumic acid?
Carglumic acid is a man-made form of an enzyme that occurs naturally in the liver. This enzyme is necessary for processing excess nitrogen produced when the body metabolizes proteins. Without this enzyme, nitrogen builds up in the form of ammonia and is not removed from the body. Ammonia is very toxic when it circulates in blood and tissues and can cause permanent brain damage, coma, or death.
Carglumic acid is used to treat hyperammonemia (HYE-per-AM-moe-NEE-mee-a), a urea cycle disorder caused by lack of a certain liver enzyme. Carglumic acid is usually given with other medications to treat this lifelong disorder.
Carglumic acid may also be used for purposes not listed in this medication guide.
What should I discuss with my healthcare provider before taking carglumic acid?
Tell your doctor about all of your medical conditions.
Carglumic acid is only part of a complete program of treatment that may also include a special diet and other medications. Follow all instructions of your doctor or dietitian. Learn about the foods to eat or avoid to help control your condition.
Follow your doctor's instructions about taking carglumic acid if you are pregnant. It is very important to control your ammonia levels during pregnancy. Do not stop taking this medicine without your doctor's advice, and tell your doctor right away if you become pregnant.
You should not breast-feed while you are using carglumic acid. Talk with your doctor about other medications that can be more safely used to control your ammonia levels while you are nursing a baby.
How should I take carglumic acid?
Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.
Carglumic acid is usually taken 2 to 4 times each day, just before each meal or feeding. Follow your doctor's instructions.
Carglumic acid doses are based on weight (especially in children and teenagers). Your dose needs may change if you gain or lose weight. Dose adjustments are especially important in children who are growing.
Do not crush or swallow the dispersible tablet whole. Place it into a glass of water and allow the tablet to disperse (it will not dissolve completely). Drink this mixture right away. Add a little more water to the glass, swirl gently and drink right away.
The dispersed tablet may also be taken with an oral syringe or through a nasogastric (NG) feeding tube. Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.
Your blood will need to be tested often. A buildup of ammonia in the blood can quickly cause brain injury or death. Even if you have no symptoms, tests can help your doctor determine if this medicine is effective. Every person with a urea cycle disorder should remain under the care of a doctor.
Store unopened bottles of carglumic acid tablets in the refrigerator, do not freeze.
After opening the bottle, store at room temperature away from moisture and heat. Do not store opened bottles in the refrigerator. Keep the bottle tightly closed when not in use.
When you open the bottle, write the date on the bottle. Throw away any unused tablets 1 month (30 days) after the date of opening, or if the expiration date printed on the label has passed.
What happens if I miss a dose?
Take your dose as soon as you can, but only if you are getting ready to eat a meal. If you skip a meal, skip the missed dose and wait until your next meal. Do not take two doses at one time.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Overdose symptoms may include fever, heavy sweating, fast heart rate, coughing up mucus, and feeling restless.
What should I avoid while taking carglumic acid?
Avoid eating foods that are high in protein when you first start taking carglumic acid.
Follow your doctor's instructions about any other restrictions on food, beverages, or activity.
What are the possible side effects of carglumic acid?
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have a serious side effect such as:
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signs of an ear infection --fever, ear pain or full feeling, trouble hearing, drainage from the ear, fussiness in a child;
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low red blood cells (anemia) --pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet; or
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low white blood cell counts --fever, mouth sores, skin sores, sore throat, cough, trouble breathing.
Common side effects may include:
- vomiting, diarrhea, stomach pain;
- fever, infections;
- headache; or
- stuffy nose, sore throat.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect carglumic acid?
Other drugs may affect carglumic acid, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.
Where can I get more information?
Your pharmacist can provide more information about carglumic acid.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
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