Carglumic acid

This is not a complete list of Carglumic Aciddrug interactions. Ask your doctor or pharmacist for more information.

Take carglumic acid exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The Carglumic Acid dose your doctor recommends will be based on the following (use any or all that apply):

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

Carglumic Acid is available in the following doses:

• Carglumic Acid 200 Mg Oral Tablet, Dispersible

Ammonia detoxicant; a synthetic structural analog of N-acetylglutamate (NAG), a physiologic activator of the urea cycle.1 3 4

Carglumic acid is used together with diet and other medicines to treat and prevent hyperammonemia (too much ammonia in the blood) when it is caused by the lack of a liver enzyme called N-acetylglutamate synthase (NAGS).

Ammonia is formed in the body when we digest protein. A person without the NAGS enzyme can not process ammonia properly, and too much ammonia will collect in the blood. This will cause serious unwanted effects. Carglumic acid acts by replacing the NAGS enzyme and helps reduce the amount of ammonia in the blood.

carglumic acid is available only with your doctor's prescription.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about carglumic acid, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about carglumic acid. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using carglumic acid.

Review Date: October 4, 2017

• Carbaglu

Hyperammonemia: Adjunctive treatment of acute hyperammonemia and maintenance therapy of chronic hyperammonemia due to the deficiency of the hepatic enzyme N-acetylglutamate synthase (NAGS) in adult and pediatric patients

There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).

Take immediately prior to meals or feedings.

Before opening, store refrigerated at 2°C to 8°C (36°F to 46°F). After opening, do not refrigerate or store above 30°C (86°F). Protect from moisture. Discard 1 month after opening.

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience headache, diarrhea, abdominal pain, change in taste, pharyngitis, rhinitis, weight loss, lack of appetite, vomiting, or nausea. Have patient report immediately to prescriber signs of infection, fatigue, sweating a lot, ear pain, or severe loss of strength and energy (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

The total daily dose should be divided into 2 to 4 doses and rounded to the nearest 100 mg.

Initial dose: 100 to 250 mg/kg orally per day in 2 to 4 divided doses immediately prior to meals. Concomitant administration of other ammonia lowering therapies is recommended. Dosing should be titrated based on individual patient plasma ammonia levels and clinical symptoms.

Maintenance dose: Usually less than 100 mg/kg orally per day in 2 to 4 divided doses immediately prior to meals. The recommended maintenance dose should be titrated to target normal plasma ammonia level for age.