Omeprazole/Amoxicillin/Rifabutin - Oral

Pronunciation: oh-MEP-ra-zole/a-MOX-i-SIL-in/RIF-a-BUE-tin

Important: How To Use This Information

This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Uses

This product is used to treat H. pylori infection in the stomach. H. pylori can cause stomach problems such as ulcers.

Omeprazole is known as a proton pump inhibitor (PPI). It works by blocking acid production in the stomach. Decreasing excess stomach acid can help treat stomach problems and allow ulcers to heal. Amoxicillin and rifabutin are antibiotics used to treat a wide variety of bacterial infections (including H. pylori). Treating the infection helps to reduce the risk of stomach problems (such as ulcers). Amoxicillin is a penicillin-type antibiotic and rifabutin is a rifamycin antibiotic. They work by stopping the growth of bacteria.

The antibiotics in this product treat only bacterial infections. Antibiotics do not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections.

How To Use

Take this medication by mouth with food as directed by your doctor, usually 1 dose (4 pills) every 8 hours. Swallow the capsules whole with a full glass of water (8 ounces or 240 milliliters). Do not crush or chew the capsules or take with alcohol.

For the best effect, take this product at evenly spaced times. To help you remember, take this product at the same times every day. Continue to take this medication until the full prescribed amount is finished, even if symptoms disappear after a few days. Stopping the medication too early may result in a return of the infection.

Tell your doctor if your condition lasts or gets worse.

Side Effects

Diarrhea, headache, nausea, vomiting, and changes in your sense of taste may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

This medication may cause urine, sweat, saliva, or tears to turn brown-orange. This effect is harmless and will disappear when the medication is stopped. However, dentures and contact lenses may be permanently stained.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

  • muscle weakness/pain
  • dark urine
  • yellowing eyes/skin
  • easy bruising/bleeding
  • signs of an infection (such as sore throat/cough that doesn't go away, fever)
  • eye pain/redness
  • vision problems
  • signs of lupus (such as rash on nose and cheeks, new or worsening joint pain)

This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of resistant bacteria. This condition may occur during treatment or weeks to months after treatment has stopped. Tell your doctor right away if you develop:

  • diarrhea that doesn't stop
  • abdominal or stomach pain/cramping
  • blood/mucus in your stool

Do not use anti-diarrhea or opioid medications if you have any of these symptoms because these products may make them worse.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

  • rash
  • itching/swelling (especially of the face/tongue/throat)
  • severe dizziness
  • trouble breathing
  • signs of kidney problems (such as change in the amount of urine)

Amoxicillin can commonly cause a mild rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe allergic reaction. Get medical help right away if you develop any rash.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before taking this product, tell your doctor or pharmacist if you are allergic to omeprazole, amoxicillin, or rifabutin; or to penicillins (such as ampicillin), cephalosporins (such as cephalexin), rifamycin antibiotics (such as rifampin), or to proton pump inhibitors (such as esomeprazole); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

  • liver disease
  • kidney disease
  • a certain blood disorder (porphyria)
  • a certain type of viral infection (mononucleosis)
  • lupus

Some symptoms may actually be signs of a more serious condition. Get medical help right away if you have:

  • heartburn with lightheadedness/sweating/dizziness
  • chest/jaw/arm/shoulder pain (especially with shortness of breath, unusual sweating)
  • unexplained weight loss

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication may cause live bacterial vaccines (such as typhoid vaccine) to not work as well. Do not have any immunizations/vaccinations while using this medication unless your doctor tells you to.

Older adults may be more sensitive to the side effects of this drug, especially Clostridium difficile infection (see Side Effects section).

During pregnancy, this product should be used only when clearly needed. Discuss the risks and benefits with your doctor.

Amoxicillin and omeprazole pass into breast milk. It is unknown if rifabutin passes into breast milk. Consult your doctor before breast-feeding.

Drug Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug are:

  • azole antifungals (itraconazole, ketoconazole, posaconazole, voriconazole)
  • clopidogrel
  • delavirdine
  • methotrexate (especially high-dose treatment)
  • voriconazole

Rifabutin can speed up the removal of other medications from your body, which may affect how they work. Examples of affected drugs include artemether/lumefantrine, lurasidone, phenytoin, ranolazine, suvorexant, calcium channel blockers (such as diltiazem, nifedipine, verapamil), certain products used to treat chronic hepatitis C (such as daclatasvir, ombitasvir/paritaprevir/ritonavir), among others.

Other medications can affect the removal of omeprazole from your body, which may affect how omeprazole works. Examples include rifampin, St. John's wort, among others.

Some products need stomach acid so that the body can absorb them properly. Omeprazole decreases stomach acid, so it may change how well these products work. Some affected products include atazanavir, erlotinib, nelfinavir, pazopanib, rilpivirine, among others.

This medication may decrease the effectiveness of hormonal birth control such as pills, patch, or ring. This could cause pregnancy. Discuss with your doctor or pharmacist if you should use reliable backup birth control methods while using this medication. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well.

Omeprazole is very similar to esomeprazole. Do not use any medications containing esomeprazole while using omeprazole.

This medication may interfere with certain lab tests (including urine glucose test), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: confusion, blurred vision, fast heartbeat, change in the amount of urine.

Notes

Do not share this medication with others.

This medication has been prescribed for your current condition only. Do not use it later for another infection unless your doctor tells you to.

Lab and/or medical tests may be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Storage

Store in original container at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Is it an emergency?

If you or someone in your care has chest pains, difficulty breathing, or severe bleeding, it could be a life-threatening emergency. Call 9-1-1 or the local emergency number immediately.
If you are concerned about a possible poisoning or exposure to a toxic substance, call Poison Control now at 1-800-567-8911.

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