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.
Your doctor may occasionally change your dose to make sure you get the best results. Dose adjustments are especially important as your child grows.
To be sure this medicine is helping your condition and is not causing harmful effects, your blood will need to be tested often. A buildup of ammonia in the blood can quickly cause brain injury or death. Do not miss any follow up visits to your doctor for blood tests. Every person with a urea cycle disorder should remain under the care of a doctor.
If you skip a meal, do not take your dose of carglumic acid. Wait until your next meal.
Carglumic acid is only part of a complete program of treatment that may also include a special diet and other medications. It is very important to follow the diet plan created for you by your doctor or nutrition counselor. You should become very familiar with the list of foods you should eat or avoid to help control your condition.
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. It is very important to follow the diet plan created for you by your doctor or nutrition counselor. You should become very familiar with the list of foods you should eat or avoid to help control your condition.
FDA pregnancy category C. It is not known whether carglumic acid will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.
It is not known whether carglumic acid passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using carglumic acid.
How should I take carglumic acid?
Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.
Your doctor may occasionally change your dose to make sure you get the best results. Dose adjustments are especially important as your child grows.
Carglumic acid is usually taken 2 to 4 times each day, just before each meal or feeding. Follow your doctor's instructions.
Do not chew, crush, or swallow the carglumic acid tablet whole. Place it into a glass of water and allow the tablet to disperse in the liquid. The tablet will not dissolve completely. Drink this mixture right away. To make sure you get the entire dose, add a little more liquid to the same glass, swirl gently and drink right away.
The carglumic acid tablet may be taken with an oral syringe as follows: Place a 200-milligram tablet into an oral syringe and draw 2.5 milliliters of water into the syringe. Shake until the tablet is dispersed and then empty the syringe into your mouth. Refill the syringe with water, shake gently, and empty into your mouth.
The carglumic acid tablet can also be given through a nasogastric (NG) feeding tube as follows: Disperse the tablet in an oral syringe as directed above. Attach the syringe to the NG tube and push the plunger down to empty the syringe into the tube. Then flush the tube with more water to wash the contents down.
To be sure this medicine is helping your condition and is not causing harmful effects, your blood will need to be tested often. A buildup of ammonia in the blood can quickly cause brain injury or death. Do not miss any follow up visits to your doctor for blood tests. 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 the missed dose as soon as you remember, but only if you are getting ready to eat a meal. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
If you skip a meal, do not take your dose of carglumic acid. Wait until your next meal.
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 any of these 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:
- fever, chills, body aches, flu symptoms, sores in your mouth and throat;
- pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or
- pain or fullness in your ear, hearing problems.
Less serious side effects may include:
- vomiting, diarrhea, stomach pain;
- 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?
There may be other drugs that can interact with carglumic acid. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.
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.
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