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CARBAGLU is a brand name for Carglumic Acid, supplied as a tablet for suspension. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: CARBAGLU (Carglumic acid dispersible tablets) is indicated for: • Acute hyperammonemia in patients with NAGS deficiency: CARBAGLU is indicated as an adjunctive therapy in pediatric and adult patients for the treatment of acute hyperammonemia due to the deficiency of the hepatic enzyme N-acetylglutamate synthase…
Verbatim from this product's HC label. Tap a section to expand.
2 Recommended Dose and Dosage Adjustment AUG 2024 7 WARNINGS AND PRECAUTIONS AUG 2024 TABLE OF CONTENTS RECENT MAJOR LABEL CHANGES ............................................................................................ 2 TABLE OF CONTENTS ..............................................................................................................
2 PART I: HEALTH PROFESSIONAL INFORMATION ...................................................................... 4 1 INDICATIONS ...............................................................................................................
4 2 CONTRAINDICATIONS ................................................................................................. 4 4 DOSAGE AND ADMINISTRATION ................................................................................. 8 5 OVERDOSAGE..............................................................................................................
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). Continue treatment until the patient’s ammonia level is less than 50 μmol/L and for a maximum duration of 7 days. See 14 CLINICAL TRIALS. 73 m2). The recommended dosage of CARBAGLU in patients with moderate or severe renal impairment is shown below.
, one-quarter of a CARBAGLU tablet) Acute Hyperammonemia due to PA or MMA 75 mg/kg/day divided into two equal doses. A dose up to 125 mg/kg divided into 2-4 doses, may be considered on an individual patient basis, as guided by severity of hyperammonemia, tolerability and response to available treatments.
25 mg/kg/day divided into two equal doses. A dose up to 40 mg/kg divided into 2-4 doses, may be considered on an individual patient basis, as guided by severity of hyperammonemia, tolerability and response to available treatments. 4 Administration Oral Administration CARBAGLU tablets should not be swallowed whole or crushed.
CARBAGLU tablets is for oral use ONLY (ingestion by mouth or an oral syringe or via a nasogastric tube or gastrostomy tube). Based on pharmacokinetic data and clinical experience, it is recommended to divide the total daily dose into two to four doses to be given before meals or feedings.
The breaking of the tablets in halves allows most of the required posology adjustments. Occasionally, the use of quarter tablets may also be useful to adjust the posology prescribed by the physician. 5 ml of water and ingested immediately.
Use in other foods or liquids has not been studied clinically and therefore is not recommended. CARBAGLU tablets do not dissolve completely in water and undissolved particles of the tablet may remain in the mixing container. To ensure complete delivery of the dose, the mixing CARBAGLU (Carglumic acid dispersible tablets) Page 8 of 34 container should be rinsed with additional volumes of water and the contents swallowed immediately.
AUG 2024 TABLE OF CONTENTS RECENT MAJOR LABEL CHANGES ............................................................................................ 2 TABLE OF CONTENTS ..............................................................................................................
2 PART I: HEALTH PROFESSIONAL INFORMATION ...................................................................... 4 1 INDICATIONS ...............................................................................................................
4 2 CONTRAINDICATIONS ................................................................................................. 4 4 DOSAGE AND ADMINISTRATION ................................................................................. 8 5 OVERDOSAGE..............................................................................................................
8 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................. 9 7 WARNINGS AND PRECAUTIONS .................................................................................. 10 8 ADVERSE REACTIONS ................................................................................................
15 9 DRUG INTERACTIONS ................................................................................................ 16 10 CLINICAL PHARMACOLOGY .......................................................................................
17 11 STORAGE, STABILITY AND DISPOSAL ......................................................................... 19 12 SPECIAL HANDLING INSTRUCTIONS ........................................................................... 19 PART II: SCIENTIFIC INFORMATION .......................................................................................
19 13 PHARMACEUTICAL INFORMATION ............................................................................ 19 14 CLINICAL TRIALS ........................................................................................................
CARBAGLU (carglumic acid) is contraindicated: • In patients with known hypersensitivity to carglumic acid or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
2 Breast-feeding). CARBAGLU (Carglumic acid dispersible tablets) Page 5 of 34
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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The suspension has a slightly acidic taste. 5 ml of water to yield a concentration of 80 mg/ml in a mixing container. Shake gently to allow for quick dispersal; • Draw up the mixture in an oral syringe and administer immediately. Pieces of the tablet may remain in the oral syringe.
• Refill the oral syringe with a minimum volume of water (1 to 2 mL) and administer immediately. • Flush the oral syringe again, as needed, until no pieces of the tablet are left in the syringe.
Nasogastric (NG tube) or Gastrostomy (G-tube) administration:
It is recommended to divide the total daily dose into two to four doses to be given before feedings. 5 ml of water. Shake gently to allow for quick dispersal; • Administer the dispersion immediately through the nasogastric tube; • Flush with additional water to clear the NG tube or G-tube.
5 ml of water to yield a concentration of 80 mg/ml in a mixing container. Shake gently to allow for quick dispersal; • Draw up the appropriate volume of dispersion and administer immediately through the NG tube or G-tube. Discard the unused portion; • Flush with additional water to clear the NG tube or G-tube.
5 Missed Dose In the event a dose is missed, the dose should not be doubled to make up for the forgotten doses. The next dose should be taken according to the regular dosing interval. 5 OVERDOSAGE One patient treated with a dose increased up to 750 mg/kg/day of carglumic acid developed symptoms of intoxication characterized as a sympathomimetic reaction: tachycardia, profuse sweating, increased bronchial secretion, increased body temperature and restlessness.
These symptoms resolved upon reduction of the dose. For management of a suspected drug overdose, contact your regional poison control centre. CARBAGLU (Carglumic acid dispersible tablets) Page 9 of 34 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 2: Dosage Forms, Strengths, Composition and Packaging Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Oral Dispersible tablets / 200 mg Croscarmellose sodium, hypromellose, microcrystalline cellulose, silica colloidal anhydrous, sodium lauryl sulfate, sodium stearyl fumarate.
Description CARBAGLU is a white and elongated dispersible tablet with three score marks and engraved “C” on one side. The tablet can be divided into equal portions. Each tablet contains 200 mg of carglumic acid. CARBAGLU is available as 5 and 60 tablets in a high density polyethylene bottle with a child resistant polypropylene cap and desiccant unit.
7 WARNINGS AND PRECAUTIONS General Any episode of acute symptomatic hyperammonemia should be treated as a life-threatening emergency. Uncontrolled hyperammonemia can rapidly result in brain injury/damage or death, and prompt use of all therapies necessary to reduce plasma ammonia levels is essential, including the concomitant use of other ammonia lowering […]
20 15 MICROBIOLOGY ........................................................................................................ 26 16 NON-CLINICAL TOXICOLOGY .....................................................................................
26 PATIENT MEDICATION INFORMATION .................................................................................. 29 CARBAGLU (Carglumic acid dispersible tablets) Page 4 of 34 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS CARBAGLU (Carglumic acid dispersible tablets) is indicated for: • Acute hyperammonemia in patients with NAGS deficiency: CARBAGLU is indicated as an adjunctive therapy in pediatric and adult patients for the treatment of acute hyperammonemia due to the deficiency of the hepatic enzyme N-acetylglutamate synthase (NAGS).
During acute hyperammonemic episodes, concomitant administration of CARBAGLU with other ammonia lowering therapies such as alternate pathway medications, hemodialysis, and dietary protein […]