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Carbaglu (Carglumic acid): Uses, Side Effects and Dosage

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Facts
Status:
Prescription (Rx)
Strength:
200 mg
Drug class:
Active ingredient:
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Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - Carbaglu

INSTRUCTIONS FOR USE

CARBAGLU® (CAR-buh-gloo)

(carglumic acid)

Tablets for oral suspension

Important information:

  • CARBAGLU tablets for oral suspension (CARBAGLU tablet) must be mixed in water before taking. CARBAGLU tablets should not be mixed in any other food or liquid.
  • Do not swallow CARBAGLU tablets whole.
  • Do not crush CARBAGLU tablets.
  • Take CARBAGLU right before meals or feedings.
  • The CARBAGLU tablet and water mixture has a slightly sour taste.

You may need to ask your healthcare provider or pharmacist for a medicine cup to measure the correct amount of water you will need to prepare the dose of CARBAGLU.

The CARBAGLU tablet has 3 lines used for splitting the tablet into 4 equal parts in order to get the prescribed dose. Ask your healthcare provider if you have any questions about how to split the tablet the right way or have any questions about the prescribed dose.

Taking CARBAGLU tablets by mouth using a cup:

Children and Adults

  1. 1.

    Add a minimum of 2.5 mL of water into a small cup for each CARBAGLU tablet, or each ½ or ¼ CARBAGLU tablet, needed for the prescribed dose. For example:

    • If the prescribed dose is 2 CARBAGLU tablets, add a minimum of 5 mL of water into the cup.
    • If the prescribed dose is 2 and a ¼ CARBAGLU tablets, add a minimum of 7.5 mL of water into the cup.
    • If the prescribed dose is 2 and a ½ CARBAGLU tablets, add a minimum of 7.5 mL of water into the cup.
    • Ask your healthcare provider if you are not sure of how much water you should use for the prescribed dose of CARBAGLU.
  2. 2. Place the prescribed number of CARBAGLU tablets into the water in the cup.
  3. 3. Carefully stir the CARBAGLU tablet and water mixture in the cup to avoid spilling the mixture. CARBAGLU tablets do not dissolve completely in water.
  4. 4. Swallow the CARBAGLU tablet and water mixture right away.
  5. 5. Pieces of the tablet may remain in the cup. Add more water to the cup to rinse the cup and swallow the mixture right away.
  6. 6. Repeat step 5 until there are no pieces of the tablet left in the cup.

Taking CARBAGLU tablets by mouth using an oral syringe:

Children

  1. 1.

    Add a minimum of 2.5 mL of water into a small cup for each CARBAGLU tablet, or each ½ or ¼ CARBAGLU tablet, needed for the prescribed dose. For example:

    • If the prescribed dose is 2 CARBAGLU tablets, add a minimum of 5 mL of water into the cup.
    • If the prescribed dose is 2 and a ¼ CARBAGLU tablets, add a minimum of 7.5 mL of water into the cup.
    • If the prescribed dose is 2 and a ½ CARBAGLU tablets, add a minimum of 7.5 mL of water into the cup.
    • Ask your healthcare provider if you are not sure of how much water you should use for the prescribed dose of CARBAGLU.
  2. 2. Place the prescribed number of CARBAGLU tablets into the water in the cup.
  3. 3. Carefully stir the CARBAGLU tablet and water mixture in the cup to avoid spilling the mixture. CARBAGLU tablets do not dissolve completely in water.
  4. 4. Draw up all of the CARBAGLU tablet and water mixture in the cup into an oral syringe.
  5. 5. Give your child the CARBAGLU tablet and water mixture right away by placing the tip of the oral syringe along the inner cheek of their mouth, on either the right or left side. Slowly push all the way down on the plunger to give the medicine.
  6. 6. Pieces of the tablet may remain in the oral syringe. Refill the oral syringe with a minimum of 1 mL to 2 mL of water and give your child the mixture right away.
  7. 7. Repeat step 6 until there are no pieces of the tablet left in the oral syringe.

Giving CARBAGLU tablets through a nasogastric (NG) or gastrostomy tube (G-tube):

Children and Adults

  1. 1.

    Add a minimum of 2.5 mL of water into a small cup for each CARBAGLU tablet, or each ½ or ¼ CARBAGLU tablet, needed for the prescribed dose. For example:

    • If the prescribed dose is 2 CARBAGLU tablets, add a minimum of 5 mL of water into the cup.
    • If the prescribed dose is 2 and a ¼ CARBAGLU tablets, add a minimum of 7.5 mL of water into the cup.
    • If the prescribed dose is 2 and a ½ CARBAGLU tablets, add a minimum of 7.5 mL of water into the cup.
    • Ask your healthcare provider if you are not sure of how much water you should use for the prescribed dose of CARBAGLU.
  2. 2. Place the prescribed number of CARBAGLU tablets into the water in the cup.
  3. 3. Carefully stir the CARBAGLU tablet and water mixture in the cup to avoid spilling the mixture. CARBAGLU tablets do not dissolve completely in water.
  4. 4. Draw up all of the CARBAGLU tablet and water mixture in the cup into a catheter-tip syringe.
  5. 5. Connect the catheter-tip syringe to the NG tube or G-tube.
  6. 6. Give the CARBAGLU tablet and water mixture through the NG tube or G-tube right away.
  7. 7. Pieces of the tablet may remain in the catheter-tip syringe or NG tube or G-tube.
  8. 8. Refill the catheter-tip syringe with 1 mL to 2 mL of water and flush the NG tube or G-tube right away.
  9. 9. Repeat step 8 until there are no pieces of the tablet left in the catheter-tip syringe or NG tube or G-tube.

How should I store CARBAGLU?

  • Before opening, store CARBAGLU in a refrigerator between 36°F to 46°F (2°C to 8°C) in the bottle it comes in.

  • After opening, store CARBAGLU at room temperature between 59°F to 86°F (15°C to 30°C). Do not store CARBAGLU in a refrigerator after opening.

    • Keep CARBAGLU tablets in a tightly closed bottle to protect the tablets from moisture.
    • Write the date the CARBAGLU bottle is opened on the bottle label. Throw away any unused tablets one month after opening the bottle.
  • Do not use CARBAGLU tablets after the expiration date on the bottle.
  • Keep CARBAGLU and all medicines out of the reach of children.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Distributed by:

Recordati Rare Diseases Inc.

Bridgewater, NJ 08807

Issued: 1/2024

Carbaglu® is a licensed trademark of Recordati Rare Diseases

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: NDA 022562 · View the label on DailyMed

Revision date stated in the text: January 2024

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Carbaglu

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Drug class Carbamoyl Phosphate Synthetase 1 Activator
Active ingredient Carglumic acid 200 mg
Dosage form Tablet, for suspension
Route Oral
Marketing status listed in the FDA NDC Directory
Company (applicant) RECORDATI RARE
FDA approval NDA 022562New Drug Application (NDA) Approved March 18, 2010
Reference listed drug This is the reference listed drug (RLD) that generics are compared with.
Therapeutic equivalence (TE) code ABCodes starting with A mean the FDA rates the drug therapeutically equivalent to its reference drug (Orange Book).
Generics Carglumic Acid with the same TE code
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
200 mg – 5 in 1 bottle NDC 52276-312-05
200 mg – 60 in 1 bottle NDC 52276-312-60

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.