carglumic acid (cont.)
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What should I discuss with my healthcare provider before taking carglumic acid (Carbaglu)?
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 (Carbaglu)?
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.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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