Pronunciation:

13C ure-EE-a, SIT-rik AS-id

Brand Names:

• IDkit Hp

Dosage Forms:

• Tablet
• Powder

Uses of This Medicine:

13C urea and citric acid are medicines used in a diagnostic test called Exalenz BreathID® non-invasive breath test. It is a test that analyzes a breath sample before and after taking 13C-enriched urea to help diagnose patients with infections in the stomach caused by a bacteria called H. pylori.

Both of these medicines are taken by the mouth. If any H. pylori bacteria are present in the stomach, they will cause the 13C urea to be broken down into carbon dioxide gas. When you breathe out by the mouth, the amount of carbon dioxide can be measured by Exalenz BreathID® Hp System to detect whether the bacteria are in your stomach.

These medicines are available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a diagnostic test, any risks of the test must be weighed against the good it will do. This is a decision you and your doctor will make. Also, other things may affect test results. For this test, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of 13C urea and citric acid in the pediatric population. Safety and efficacy have not been established.

Older adults—

No information is available on the relationship of age to the effects of 13C urea and citric acid in geriatric patients.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this diagnostic test, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Receiving this diagnostic test with any of the following medicines is not recommended. Your doctor may decide not to use this diagnostic test or change some of the other medicines you take.

• Aclidinium
• Amantadine
• Amiloride
• Amitriptyline
• Amoxapine
• Anisotropine
• Atropine
• Belladonna
• Benztropine
• Biperiden
• Bornaprine
• Brompheniramine
• Butylscopolamine
• Canrenoate
• Canrenone
• Carbinoxamine
• Carisoprodol
• Chlorpheniramine
• Chlorpromazine
• Cimetropium
• Clemastine
• Clidinium
• Clomipramine
• Clozapine
• Cyclobenzaprine
• Cyclopentolate
• Cyproheptadine
• Darifenacin
• Desipramine
• Dicyclomine
• Dimenhydrinate
• Diphenhydramine
• Doxepin
• Emepronium
• Eplerenone
• Fesoterodine
• Flavoxate
• Fluphenazine
• Glycopyrrolate
• Glycopyrronium Tosylate
• Homatropine
• Hydroxyzine
• Hyoscyamine
• Imipramine
• Ipratropium
• Isopropamide
• Loxapine
• Mebeverine
• Meclizine
• Mepenzolate
• Methantheline
• Methixene
• Methscopolamine
• Nortriptyline
• Olanzapine
• Orphenadrine
• Oxitropium Bromide
• Oxybutynin
• Paroxetine
• Perphenazine
• Pimozide
• Pinaverium
• Pipenzolate Bromide
• Pirenzepine
• Prochlorperazine
• Procyclidine
• Promethazine
• Propantheline
• Propiverine
• Protriptyline
• Quetiapine
• Revefenacin
• Scopolamine
• Solifenacin
• Spironolactone
• Stramonium
• Terodiline
• Thioridazine
• Thiothixene
• Tiotropium
• Tizanidine
• Tolterodine
• Triamterene
• Trifluoperazine
• Trihexyphenidyl
• Trimethobenzamide
• Trimipramine
• Tropicamide
• Trospium
• Umeclidinium
• Valethamate

Receiving this diagnostic test with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aceclofenac
• Acemetacin
• Aliskiren
• Amtolmetin Guacil
• Aspirin
• Azilsartan
• Azilsartan Medoxomil
• Benazepril
• Bromfenac
• Bufexamac
• Candesartan
• Captopril
• Celecoxib
• Choline Salicylate
• Cilazapril
• Clonixin
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Diflunisal
• Dipyrone
• Droxicam
• Enalapril
• Enalaprilat
• Eprosartan
• Etodolac
• Etofenamate
• Etoricoxib
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Floctafenine
• Flufenamic Acid
• Flurbiprofen
• Fosinopril
• Ibuprofen
• Indomethacin
• Irbesartan
• Ketoprofen
• Ketorolac
• Lisinopril
• Lornoxicam
• Losartan
• Loxoprofen
• Lumiracoxib
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Moexipril
• Morniflumate
• Nabumetone
• Naproxen
• Nepafenac
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Olmesartan
• Oxaprozin
• Oxyphenbutazone
• Parecoxib
• Perindopril
• Phenylbutazone
• Piketoprofen
• Piroxicam
• Pranoprofen
• Proglumetacin
• Propyphenazone
• Proquazone
• Quinapril
• Ramipril
• Rofecoxib
• Salicylic Acid
• Salsalate
• Sodium Salicylate
• Spirapril
• Sulindac
• Telmisartan
• Tenoxicam
• Tiaprofenic Acid
• Tolfenamic Acid
• Tolmetin
• Trandolapril
• Valdecoxib
• Valsartan
• Zofenopril

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this diagnostic test. Make sure you tell your doctor if you have any other medical problems, especially:

• Achlorhydria—The lack of acid in the stomach may interfere with the results of this test.

• Gastrectomy (removal of the stomach by surgery), partial or total—Use is not recommended in these patients.

• Phenylketonuria—This medicine contains phenylalanine, which can make this condition worse.

Proper Use of This Medicine:

Exalenz BreathID® non-invasive breath test is a diagnostic test that analyzes a breath sample before and after taking 13C-enriched urea to help identify patients with H. pylori infection.

Your doctor will start the breath test by collecting your breath samples using the BreathID® Hp device. You will drink a mixed solution of 13C-urea tablet and citric acid powder. You must drink the solution within 2 hours after mixing it. Then, you have to breathe normally via the cannula while the test is being performed.

Do not eat for at least 1 hour before taking the mixed solution.

If the mixed solution has large particles after mixing it for 5 minutes, do not use it and open a new kit.

Precautions While Using This Medicine:

If you are taking antibiotics, proton pump inhibitors (eg, omeprazole, lansoprazole), or medicines containing bismuth, these may interact with the test. Your doctor will ask you to stop taking them for at least 2 weeks before the test.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

Incidence not known

Fast heartbeat

fever

hives, itching, or rash

hoarseness

irritation

joint pain, stiffness, or swelling

redness of the skin

swelling of the eyelids, face, lips, hands, or feet

tightness in the chest

troubled breathing or swallowing

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.