IDkit Hp (Oral)

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

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

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

If you are taking antibiotics, proton pump inhibitors (for example, omeprazole, lansoprazole), or medicines that contain bismuth, these may affect the test results. Your doctor will ask you to stop taking them for at least 2 weeks before the test.

In deciding to use a diagnostic test, any risks of the test must be weighed against the benefits it may provide. This is a choice you and your doctor will make together. Other factors may also affect test results. For this test, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare provider know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For products that do not require a prescription, read the label or package ingredients carefully.

Pediatric

There have not been enough studies on how 13C urea and citric acid affect children. Safety and effectiveness have not been established.

Geriatric

There is no information available on how 13C urea and citric acid affects older adults.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits and risks before taking this medication during breastfeeding.

Interactions with Medicines

Some medicines should not be taken together at all, while in other cases, two different medicines may be used together even if an interaction might happen. In these situations, your doctor may adjust the dose, or other precautions may be necessary. It is especially important for your healthcare provider to know if you are taking any of the medicines listed below while you are receiving this diagnostic test. The following interactions are selected based on their potential importance and are not necessarily a complete list.

Receiving this diagnostic test with any of the following medicines is not recommended. Your doctor may decide to avoid using 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 necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both 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

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken at or around the time of eating food or certain types of food because interactions may occur. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk to your healthcare provider about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect the use of this diagnostic test. Be sure to tell your doctor if you have any other medical issues, especially:

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

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

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

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may need medical attention.

Check with your doctor or nurse right away 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
• Trouble 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.

In the U.S.

• IDkit Hp

Available Dosage Forms:

• Tablet
• Powder

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.