Carglumic acid 200 mg Tablet, For Suspension, 60-count
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Carbamoyl Phosphate Synthetase 1 Activator class.
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🏭 Manufacturer & labeler
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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167.7 mg
UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
1 inactive ingredient listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $163.29 | — |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Carglumic acid 200 mgthis 35573-0459-60 | Burel | 60 tablets | — | AB | FDA listed | — |
| Carbaglu 200 mg 52276-0312-05 | Recordati | 5 tablets | — | AB | FDA listed | — |
| Carglumic acid 200 mg 68475-0006-01 | Navinta | 5 tablets | — | AB | FDA listed | — |
| Carglumic Acid 200 mg 71863-0114-60 | Eton | 60 tablets | — | AB | FDA listed | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 35573-0459-60 You're viewing this | 60 TABLET, FOR SUSPENSION in 1 BOTTLE (35573-459-60) | 2022-12-19 | Active |
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| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Carglumic acid tablets for oral suspension is a carbamoyl phosphate synthetase 1 (CPS 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 (NAGS) deficiency. ( 1.1 ) Maintenance therapy for the treatment of chronic hyperammonemia due to NAGS deficiency. ( 1.1 )
1.1Acute and Chronic Hyperammonemia due to N-acetylglutamate Synthase (NAGS) Deficiency Carglumic acid tablets for oral suspension is indicated in adult and pediatric patients as: Adjunctive therapy to standard of care for the treatment of acute hyperammonemia due to NAGS deficiency. Maintenance therapy for the treatment of chronic hyperammonemia due to NAGS deficiency.
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Acute Hyperammonemia due to NAGS deficiency ( 2.2 ) The recommended dosage in adult and pediatric patients is 100 mg/kg to 250 mg/kg orally daily. Divide the daily dosage into 2 to 4 doses. Chronic Hyperammonemia due to NAGS deficiency (2.2) The recommended dosage in adult and pediatric patients is 10 mg/kg to 100 mg/kg orally daily.
Divide the daily dosage into 2 to 4 doses. Therapeutic Monitoring for NAGS Deficiency (2.2) Closely monitor plasma ammonia and titrate dosage to maintain the ammonia level within normal range for the patient's age, taking into consideration their clinical condition. Patients with Renal Impairment ( 2.4 ) See Full Prescribing Information for Instructions on Dosage Adjustment.
Preparation and Administration ( 2.5 ) Disperse carglumic acid tablets for oral suspension in water. Do not swallow whole or crushed. Take immediately before meals or feedings.
For additional instructions on preparation and administration orally or through a nasogastric tube or gastrostomy tube, see the full prescribing information.
2.1Important Administration Instructions Disperse carglumic acid tablets for oral suspension in water. Do not swallow whole or crush [see Dosage and Administration (2.5) ] . Carglumic acid tablets for oral suspension may be administered by mouth or via a nasogastric or gastrostomy tube [see Dosage and Administration (2.5) ] .
2.2Recommended Dosage for Acute or Chronic Hyperammonemia due to NAGS Deficiency Treatment Initiation Initiate Carglumic acid tablets for oral suspension treatment as soon as the diagnosis of NAGS deficiency is suspected, which may be as soon as at birth, and supervised by a healthcare provider experienced in the treatment of metabolic disorders. Dosage for Acute Hyperammonemia due to NAGS Deficiency The recommended dosage of Carglumic acid tablets for oral suspension in adult and pediatric patients for acute hyperammonemia due to NAGS deficiency is (based on actual body weight) 100 mg/kg to 250 mg/kg orally daily.
Divide the daily dosage into 2 to 4 doses and round to the nearest 100 mg (i.e., half of a Carglumic acid tablets for oral suspension). During acute hyperammonemic episodes, administer Carglumic acid tablets for oral suspension with other ammonia lowering therapies, such as alternate pathway medications, hemodialysis, and protein restriction. Dosage for Chronic Hyperammonemia due to NAGS Deficiency The recommended dosage of Carglumic acid tablets for oral suspension in adult and pediatric patients for chronic hyperammonemia due to NAGS deficiency is (based on actual body weight) 10 mg/kg to 100 mg/kg orally daily.
Divide the daily dosage into 2 to 4 doses and round to the nearest 100 mg (i.e., half of a Carglumic acid tablets for oral suspension). During maintenance therapy, the concomitant use of other ammonia lowering therapies and protein restriction may be needed based on plasma ammonia levels. Therapeutic Monitoring Closely monitor plasma ammonia levels.
Titrate the Carglumic acid tablets for oral suspension dosage to maintain the plasma ammonia level within the normal range for the patient's age, taking into consideration their clinical condition (e.g., nutritional requirements, protein intake, growth parameters, etc.). Adjust the recommended dosage in patients with moderate or severe renal impairment [see Dosage and Administration (2.4)] .
2.4Dosage Adjustment in Patients with Renal Impairment No dosage adjustment is warranted in patients with mild renal impairment (eGFR 60-89 mL/min/1.73 m 2 ). The recommended dosage of carglumic acid tablets for oral suspension in patients with moderate or severe renal impairment is shown below. Moderate Renal Impairment (eGFR 30-59 mL/min/1.73 m 2 ) Severe Renal Impairment (eGFR 15-29 mL/min/1.73 m 2 ) Acute Hyperammonemia due to NAGS Deficiency 50 mg/kg/day to 125 mg/kg/day divided into 2 to 4 doses and rounded to the nearest 50 mg (i.e., one-quarter of a carglumic acid tablets for oral susp…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Carglumic acid tablets for oral suspension 200 mg are white to off-white elongated tablets, functionally scored with 3 lines (for splitting into 4 equal portions) and engraved "N" on one side. Tablets for oral suspension: 200 mg, functionally scored. (3)
⛔ Contraindications ▾
4 CONTRAINDICATIONS None None.
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS NAGS deficiency : Most common adverse reactions (≥13%) are vomiting, abdominal pain, pyrexia, tonsillitis, anemia, diarrhea, ear infection, infections, nasopharyngitis, hemoglobin decreased, and headache. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Navinta LLC at 1-609-883-1135, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Acute and Chronic Hyperammonemia due to NAGS Deficiency In a retrospective case series of 23 NAGS deficiency patients treated with Carglumic acid tablets for oral suspension, 17 of the 23 patients reported an adverse reaction.
The most common adverse reactions (occurring in ≥ 13% of patients) were vomiting, abdominal pain, pyrexia, tonsillitis, anemia, diarrhea, ear infection, infections, nasopharyngitis, hemoglobin decreased, and headache. Table 1 summarizes adverse reactions occurring in 2 or more patients treated with carglumic acid tablets for oral suspension. Table 1: Adverse Reactions Reported in ≥ 2 Patients with NAGS deficiency Treated with Carglumic Acid Tablets for Oral Suspension in the Retrospective Case Series Adverse Reaction Number of Patients (N) (%) Vomiting 6 (26) Abdominal pain 4 (17) Pyrexia 4 (17) Tonsillitis 4 (17) Anemia 3 (13) Diarrhea 3 (13) Ear infection 3 (13) Infections 3 (13) Nasopharyngitis 3 (13) Hemoglobin decreased 3 (13) Headache 3 (13) Dysgeusia 2 (9) Asthenia 2 (9) Hyperhidrosis 2 (9) Influenza 2 (9) Pneumonia 2 (9) Weight decreased 2 (9) Anorexia 2 (9) Somnolence 2 (9) Rash 2 (9)
6.2Postmarketing Experience The following adverse reactions have been identified during postapproval use of Carglumic acid tablets for oral suspension. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or to establish a causal relationship to drug exposure. Psychiatric disorders : mania Skin and subcutaneous tissue disorders : pruritus, rash including rash erythematous, rash maculopapular, rash pustular
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary Although rare case reports of carglumic acid tablets for oral suspension use in pregnant women are insufficient to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes, untreated NAGS deficiency can result in irreversible neurologic damage and death in pregnant women (see Clinical Considerations) . In an animal reproduction study, decreased survival and growth occurred in offspring born to rats that received carglumic acid at a dose approximately 38 times the maximum reported human maintenance dose.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, miscarriage, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Pregnant women with urea cycle disorders may experience an increase in catabolic stress which can trigger a hyperammonemic crisis both in the intrapartum and in the post-partum (3 - 14 days post-partum) periods. Maternal complications related to hyperammonemic crisis can include neurological impairment, coma and in some cases death. Data Animal Data No effects on embryo-fetal development were observed in pregnant rats treated with up to 2000 mg/kg/day (approximately 38 times the maximum reported human maintenance dose [100 mg/kg/day] based on AUC [area under the plasma concentration-time curve]) from two weeks prior to mating through organogenesis or in pregnant rabbits treated with up to 1000 mg/kg/day (approximately 6 times the maximum reported human maintenance dose [100 mg/kg/day] based on AUC) during organogenesis.
In a pre- and post-natal developmental study, female rats received oral carglumic acid from organogenesis through lactation at doses of 500 mg/kg/day and 2000 mg/kg/day. Decreased growth of offspring was observed at 500 mg/kg/day and higher (approximately 38 times the maximum reported human maintenance dose [100 mg/kg/day] based on AUC), and reduction in offspring survival during lactation was observed at 2000 mg/kg/day (approximately 38 times the maximum reported human maintenance dose [100 mg/kg/day] based on AUC).
No effects on physical and sexual development, learning and memory, or reproductive performance were observed through maturation of the surviving offspring at maternal doses up to 2000 mg/kg/day. The high dose (2000 mg/kg/day) produced maternal toxicity (impaired weight gain and approximately 10% mortality).
8.2Lactation Risk Summary It is not known whether carglumic acid is present in human milk. There are no available data on the effects of carglumic acid on the breastfed infant or the effects on milk production. Carglumic acid is present in milk from treated rats.
When a drug is present in animal milk, it is likely that the drug will be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for carglumic acid tablets for oral suspension and any potential adverse effects on the breastfed child from carglumic acid tablets for oral suspension or from the underlying maternal condition.
8.4Pediatric Use The safety and effectiveness of carglumic acid tablets for oral suspension for the treatment of pediatric patients (birth to 17 years of age) with acute or chronic hyperammonemia due to NAGS deficiency have been established, and the information on these uses are discussed throughout the labeling. There are insufficient data to determine if there is a difference in clinical or biochemical responses between adult and pediatric patients treated with Carglumic acid tablets for oral suspension.
8.5 Geriatric Use Clinical studies of Carglumic acid tablets for oral susp…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Although rare case reports of carglumic acid tablets for oral suspension use in pregnant women are insufficient to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes, untreated NAGS deficiency can result in irreversible neurologic damage and death in pregnant women (see Clinical Considerations) . In an animal reproduction study, decreased survival and growth occurred in offspring born to rats that received carglumic acid at a dose approximately 38 times the maximum reported human maintenance dose.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, miscarriage, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Pregnant women with urea cycle disorders may experience an increase in catabolic stress which can trigger a hyperammonemic crisis both in the intrapartum and in the post-partum (3 - 14 days post-partum) periods. Maternal complications related to hyperammonemic crisis can include neurological impairment, coma and in some cases death. Data Animal Data No effects on embryo-fetal development were observed in pregnant rats treated with up to 2000 mg/kg/day (approximately 38 times the maximum reported human maintenance dose [100 mg/kg/day] based on AUC [area under the plasma concentration-time curve]) from two weeks prior to mating through organogenesis or in pregnant rabbits treated with up to 1000 mg/kg/day (approximately 6 times the maximum reported human maintenance dose [100 mg/kg/day] based on AUC) during organogenesis.
In a pre- and post-natal developmental study, female rats received oral carglumic acid from organogenesis through lactation at doses of 500 mg/kg/day and 2000 mg/kg/day. Decreased growth of offspring was observed at 500 mg/kg/day and higher (approximately 38 times the maximum reported human maintenance dose [100 mg/kg/day] based on AUC), and reduction in offspring survival during lactation was observed at 2000 mg/kg/day (approximately 38 times the maximum reported human maintenance dose [100 mg/kg/day] based on AUC).
No effects on physical and sexual development, learning and memory, or reproductive performance were observed through maturation of the surviving offspring at maternal doses up to 2000 mg/kg/day. The high dose (2000 mg/kg/day) produced maternal toxicity (impaired weight gain and approximately 10% mortality).
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of carglumic acid tablets for oral suspension for the treatment of pediatric patients (birth to 17 years of age) with acute or chronic hyperammonemia due to NAGS deficiency have been established, and the information on these uses are discussed throughout the labeling. There are insufficient data to determine if there is a difference in clinical or biochemical responses between adult and pediatric patients treated with Carglumic acid tablets for oral suspension.
🧓 Geriatric Use ▾
8.5Geriatric Use Clinical studies of Carglumic acid tablets for oral suspension did not include patients 65 years of age and older to determine whether they respond differently from younger patients.
🆘 Overdosage ▾
10 OVERDOSAGE One patient treated with 650 mg/kg/day of Carglumic acid tablets for oral suspension developed symptoms resembling monosodium glutamate intoxication-like syndrome and characterized by tachycardia, profuse sweating, increased bronchial secretion, increased body temperature, and restlessness. These symptoms resolved upon reduction of the dose.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Carglumic acid is a synthetic structural analogue of N-acetylglutamate (NAG) which is produced from glutamate and acetyl-CoA in a reaction catalyzed by N-acetylglutamate synthase (NAGS), a mitochondrial liver enzyme. NAG acts as the essential allosteric activator of carbamoyl phosphate synthetase 1 (CPS 1), a mitochondrial liver enzyme which catalyzes the first reaction of the urea cycle. The urea cycle, whose role is the disposition of ammonia, includes a series of biochemical reactions in the liver resulting in the conversion of ammonia into urea, which is then excreted through the urine.
Carglumic acid acts as a CPS1 activator, improves or restores the function of the urea cycle, and facilitates ammonia detoxification and urea production.
12.2Pharmacodynamics In a retrospective review of the clinical course in 23 patients with NAGS deficiency, carglumic acid reduced plasma ammonia levels within 24 hours when administered with and without concomitant ammonia lowering therapies. No dose-response relationship has been identified. Cardiac Electrophysiology The effect of carglumic acid was evaluated in a Phase 1, randomized study in 76 healthy volunteers.
The study suggests a lack of clinically relevant QT prolongation effect at the highest therapeutic dose level (250 mg/kg/day).
12.3Pharmacokinetics The pharmacokinetics of carglumic acid in healthy subjects following an intravenous (IV) infusion over 2 hours at 8 mg/kg or an oral administration at 100 mg/kg are summarized in Table 3 . Table 3: Mean (SD) Pharmacokinetic Parameter Values of Carglumic Acid in Healthy Subjects # Median (range); N/A, not applicable PK parameter IV infusion 8 mg/kg (N=10) Oral 100 mg/kg (N=12) C max (ng/mL) 8613 (558) 3284 (321) T max (hr) # 2 (1-2) 3 (2-4) AUC (ng*hr/mL) 24501 (1613) 31426 (2150) T 1/2 (hr) 31 (3) 25 (2) CL (L/hr/kg) 0.34 (0.02) N/A Vd (L/kg) 15 (1) N/A Absorption Following an oral administration of Carglumic acid tablets for oral suspension 100 mg/kg in healthy subjects, the absolute bioavailability was approximately 10%.
Distribution Carglumic acid is not bound to plasma proteins. Elimination Carglumic acid is predominantly excreted by the kidneys as unchanged product. Metabolism A proportion of carglumic acid may be metabolized by the intestinal bacterial flora.
The likely end product of carglumic acid metabolism is carbon dioxide, eliminated through the lungs. Excretion Following an oral administration of radiolabeled carglumic acid tablets for oral suspension at 100 mg/kg, 9% of the dose is excreted unchanged in the urine and up to 60% of the dose is recovered unchanged in the feces. Specific Populations Patients with Renal Impairment The pharmacokinetics of carglumic acid in subjects with renal impairment were compared with healthy subjects with normal renal function following oral administration of a single dose of carglumic acid tablets for oral suspension 40 mg/kg or 80 mg/kg.
The C max and AUC 0-t of carglumic acid are summarized in Table 4 . The geometric mean ratio (90% CI) of C max in subjects with mild, moderate, and severe renal impairment relative to those in their matched control subjects with normal renal function were approximately 1.3 (0.95, 1.86), 2.0 (1.62, 2.50), and 4.4 (3.11, 6.28) respectively. The geometric mean ratio (90% CI) of AUC 0-t in subjects with mild, moderate, and severe renal impairment relative to those in their matched control subjects with normal renal function were approximately 1.4 (1.09, 1.73), 2.8 (2.27, 3.47), and 6.9 (5.21, 9.24), respectively [see Dosage and Administration (2.4)] .
Table 4: Mean (SD) C max and AUC 0-t of Carglumic Acid Following Single Oral Dose Administration of Carglumic Acid Tablets for Oral Suspension 80 mg/kg or 40 mg/kg in Subjects with Renal Impairment and Matched Healthy Control Subjects with Normal Renal Function Treatment groups 1a and 1b represent two separate matched control groups of healthy subjects with…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Carglumic acid is a synthetic structural analogue of N-acetylglutamate (NAG) which is produced from glutamate and acetyl-CoA in a reaction catalyzed by N-acetylglutamate synthase (NAGS), a mitochondrial liver enzyme. NAG acts as the essential allosteric activator of carbamoyl phosphate synthetase 1 (CPS 1), a mitochondrial liver enzyme which catalyzes the first reaction of the urea cycle. The urea cycle, whose role is the disposition of ammonia, includes a series of biochemical reactions in the liver resulting in the conversion of ammonia into urea, which is then excreted through the urine.
Carglumic acid acts as a CPS1 activator, improves or restores the function of the urea cycle, and facilitates ammonia detoxification and urea production.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Carglumic acid tablets for oral suspension 200 mg are white to off-white elongated tablets, functionally scored with 3 lines for splitting into 4 equal portions, and engraved 'N's on one side. Carglumic acid tablets for oral suspension is supplied in a high-density polyethylene bottle with child resistant polypropylene cap and desiccant unit. Each bottle contains 60 tablets.
Bottles of 60 tablets: NDC 35573-459-60 Storage Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. 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 carglumic acid tablets for oral suspension after the expiration date stated on the bottle.
Discard bottle one month after first opening.
📋 Description ▾
11 DESCRIPTION Carglumic acid 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 dimethyl formamide and sparingly soluble in water. The chemical name of carglumic acid is N-carbamoyl-L-glutamic acid or (2S)-2-(carbamoylamino) pentanedioic acid.
The empirical formula is C 6 H 10 N 2 O 5 and the molecular weight is 190.16. The structural formula is: The inactive ingredients of carglumic acid tablets for oral suspension are croscarmellose sodium, microcrystalline cellulose, sodium lauryl sulfate, colloidal silicon dioxide and sodium stearyl fumarate. Image
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Instructions for Use). Advise the patient or caregiver on the following: Preparation and Administration [see Dosage and Administration (2.5) ] Disperse carglumic acid tablets for oral suspension in water. Do not swallow whole or crushed.
Take carglumic acid tablets for oral suspension immediately before meals or feedings. Carglumic acid tablets for oral suspension dispersed in water can be administered orally or via a nasogastric tube or gastrostomy tube as described in the Instructions for Use . Storage [see How Supplied/Storage and Handling (16)] Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].
After first opening of the bottle: Do not refrigerate. Store at room temperature between 15° to 30°C (59° to 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 carglumic acid tablets for oral suspension after the expiration date stated on the bottle.
Manufactured for: Burel Pharmaceuticals, LLC Mason, OH 45040 USA Revised: 03/2024 31230922 R2 INSTRUCTIONS FOR USE Carglumic Acid Tablets for Oral Suspension Important information: Carglumic acid tablet for oral suspension must be mixed in water before taking. Carglumic acid tablets for oral suspension should not be mixed in any other food or liquid. Do not swallow carglumic acid tablets for oral suspension whole.
Do not crush carglumic acid tablets for oral suspension. Take carglumic acid tablets for oral suspension right before meals or feedings. The carglumic acid tablet for oral suspension 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 carglumic acid tablets for oral suspension. The Carglumic acid tablets for oral suspension 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 carglumic acid tablets for oral suspension by mouth using a cup: Children and Adults 1. Add a minimum of 2.5 mL of water into a small cup for each carglumic acid tablet for oral suspension, or each ½ or ¼ carglumic acid tablet for oral suspension, needed for the prescribed dose. For example: ● If the prescribed dose is 2 carglumic acid tablets for oral suspension, add a minimum of 5 mL of water into the cup. ● If the prescribed dose is 2 and a ¼ carglumic acid tablets for oral suspension, add a minimum of 7.5 mL of water into the cup. ● If the prescribed dose is 2 and a ½ carglumic acid tablets for oral suspension, 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 carglumic acid tablets for oral suspension.
2. Place the prescribed number of carglumic acid tablets for oral suspension into the water in the cup. 3.
Carefully stir the carglumic acid tablet for oral suspension and water mixture in the cup to avoid spilling the mixture. Carglumic acid tablets for oral suspension do not dissolve completely in water. 4.
Swallow the carglumic acid tablet for oral suspension and water mixture right away . 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. Repeat step 5 until there are no pieces of the tablet left in the cup.
Taking carglumic acid tablets for oral suspension by mouth using an oral syringe: Children 1. Add a minimum of 2.5 mL of water into a small cup for each carglumic acid tablet for oral suspension, or each ½ or ¼ carglumic acid tablet for oral suspension, needed for the prescribed dose. F…