Brand Name
Carbaglu
Generic Name
Carglumic
View Brand Information FDA approval date: March 18, 2010
Classification: Carbamoyl Phosphate Synthetase 1 Activator
Form: Tablet
What is Carbaglu (Carglumic)?
CARBAGLU is a carbamoyl phosphate synthetase 1 activator indicated in pediatric and adult patients as: Adjunctive therapy to standard of care for the treatment of acute hyperammonemia due to N-acetylglutamate synthase deficiency.
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Brand Information
Carbaglu (Carglumic Acid)
1DOSAGE FORMS AND STRENGTHS
Tablets for oral suspension: 200 mg of carglumic acid, white, elongated, functionally scored with 3 lines (for splitting into 4 equal portions) and printed "C" on one side.
2CONTRAINDICATIONS
None
3OVERDOSAGE
One patient treated with 650 mg/kg/day of CARBAGLU developed symptoms resembling monosodium glutamate intoxication-like syndrome and characterized by tachycardia, profuse sweating, increased bronchial secretions, increased body temperature, and restlessness. These symptoms resolved upon reduction of the dose.
4DESCRIPTION
CARBAGLU tablets for oral suspension contain 200 mg of carglumic acid. Carglumic acid, the active substance, is a carbamoyl phosphate synthetase 1 (CPS 1) activator and is soluble in boiling water, slightly soluble in cold water, and practically insoluble in organic solvents.
The chemical name of carglumic acid is N-carbamoyl-L-glutamic acid or (2S)-2-(carbamoylamino) pentanedioic acid. The empirical formula is C
The structural formula is:
The inactive ingredients of CARBAGLU are croscarmellose sodium, hypromellose, microcrystalline cellulose, silica colloidal anhydrous, sodium lauryl sulfate, and sodium stearyl fumarate.
5HOW SUPPLIED/STORAGE AND HANDLING
How Supplied
CARBAGLU is a white and elongated 200 mg tablet for oral suspension, functionally scored with 3 lines for splitting into 4 equal portions, and coded "C" on one side.
CARBAGLU is a white and elongated 200 mg tablet for oral suspension, functionally scored with 3 lines for splitting into 4 equal portions, and coded "C" on one side.
CARBAGLU is supplied in a high-density polyethylene bottle with a child resistant polypropylene cap and desiccant unit. Each bottle contains either 5 or 60 tablets.
Bottle of 5 tablets: NDC 52276-312-05
Bottle of 60 tablets: NDC 52276-312-60
Storage
Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original unopened bottle.
Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original unopened bottle.
After first opening of the bottle:
- Store at room temperature between 15°C and 30°C (59°F and 86°F). Do not refrigerate.
- Keep the bottle tightly closed between openings in order to protect from moisture.
- Write the date of opening on the bottle.
- Do not use CARBAGLU after the expiration date stated on the bottle.
- Discard bottle one month after first opening.
6PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (
Advise the patient or caregiver on the following:
Preparation and Administration[see Dosage and Administration (
- Disperse CARBAGLU tablets in water. Do not swallow whole or crushed.
- Take CARBABLU immediately before meals or feedings.
- CARBAGLU tablets dispersed in water can be administered orally or via a nasogastric tube or gastrostomy tube as described in the
Storage[see How Supplied/Storage and Handling (
- Store UNOPENED bottle in a refrigerator at 2°C to 8°C (36°F to 46°F).
- After first opening of the bottle: do not refrigerate, store at room temperature between 15°C and 30°C (59°F and 86°F). Keep the bottle tightly closed in order to protect from moisture. Write the date of opening on the bottle.
- Discard bottle one month after first opening. Do not use CARBAGLU after the expiration date stated on the bottle.
Pregnancy[see Use in Specific Populations (8.1)]
Advise women with NAGS deficiency who are exposed to CARBAGLU during pregnancy that there is a pregnancy surveillance program that monitors pregnancy outcomes.
Advise women with NAGS deficiency who are exposed to CARBAGLU during pregnancy that there is a pregnancy surveillance program that monitors pregnancy outcomes.
This product's labeling may have been updated. For the most recent Prescribing Information, please visit www.recordatirarediseases.com/us or www.carbaglu.com.
Supplied by:
Licensed to and Distributed by:
Carbaglu
7PACKAGING AND LABELING
NDC 52276-312-60
Carbaglu® 200 mg
carglumic acid
tablets for oral suspension
60 Tablets
Rx only
Before opening, store refrigerated at
2°C – 8°C (36°F – 46°F). Do not refrigerate.
Do not store above 30°C (86°F).
Discard one month after first opening
Date of first opening.
4022649 5/1344
Carbaglu® 200 mg
carglumic acid
tablets for oral suspension
60 Tablets
Rx only
Before opening, store refrigerated at
2°C – 8°C (36°F – 46°F). Do not refrigerate.
Do not store above 30°C (86°F).
Discard one month after first opening
Date of first opening.
4022649 5/1344
NDC 52276-312-60
Carbaglu® 200 mg
carglumic acid
tablets for oral suspension
60 Tablets
Rxonly
Disperse CARBAGLU tablets in water.
Do not swallow whole or crushed.
Supplied by:
Recordati Rare Diseases
Puteaux, France
Distributed by:
Recordati Rare Diseases Inc.
Lebanon, NJ 08833 USA
RECORDATI
Group
Carbaglu® 200 mg
carglumic acid
tablets for oral suspension
60 Tablets
Rxonly
Disperse CARBAGLU tablets in water.
Do not swallow whole or crushed.
Supplied by:
Recordati Rare Diseases
Puteaux, France
Distributed by:
Recordati Rare Diseases Inc.
Lebanon, NJ 08833 USA
RECORDATI
Group
NDC 52276-312-05
Carbaglu® 200 mg
carglumic acid
tablets for oral suspension
5 Tablets
Rxonly
Before opening, store refrigerated at
2°C – 8°C (36°F – 46°F). Do not refrigerate.
Do not store above 30°C (86°F).
Discard one month after first opening
Date of first opening.
4022647 5/1142
Carbaglu® 200 mg
carglumic acid
tablets for oral suspension
5 Tablets
Rxonly
Before opening, store refrigerated at
2°C – 8°C (36°F – 46°F). Do not refrigerate.
Do not store above 30°C (86°F).
Discard one month after first opening
Date of first opening.
4022647 5/1142
NDC 52276-312-05
Carbaglu® 200 mg
carglumic acid
tablets for oral suspension
5 Tablets
Rxonly
Disperse CARBAGLU tablets in water.
Do not swallow whole or crushed.
Supplied by:
Recordati Rare Diseases
Puteaux, France
Distributed by:
Recordati Rare Diseases Inc.
Lebanon, NJ 08833 USA
RECORDATI
Group
Carbaglu® 200 mg
carglumic acid
tablets for oral suspension
5 Tablets
Rxonly
Disperse CARBAGLU tablets in water.
Do not swallow whole or crushed.
Supplied by:
Recordati Rare Diseases
Puteaux, France
Distributed by:
Recordati Rare Diseases Inc.
Lebanon, NJ 08833 USA
RECORDATI
Group
