Omeprazole, amoxicillin, and rifabutin (Oral)

Talicia® contains three ingredients: omeprazole, amoxicillin, and rifabutin. It is used to treat patients with H. pylori infection.

Omeprazole is a proton pump inhibitor (PPI). It reduces the amount of acid made by the stomach. Amoxicillin and rifabutin are both antibiotics. They kill bacteria or stop them from growing. However, this medicine will not work for colds, flu, or other viral infections.

You can get this medicine only with a prescription from your doctor.

It is important for your doctor to check your progress at regular visits. This will help your doctor see if the medicine is working properly and decide if you should keep using it. Blood, urine, and other lab tests may be needed to check for side effects. If your condition does not improve or gets worse, talk to your doctor.

Do not use this medicine with delavirdine (Rescriptor®), rilpivirine (Edurant®) or products that contain rilpivirine (for example, Complera®, Odefsey®), or voriconazole (Vfend®). Using these medicines together may increase the risk of serious side effects.

Using this medicine while you are pregnant can harm your unborn baby. Use birth control pills along with another form of birth control (for example, condom, diaphragm, or contraceptive foam or jelly) to prevent pregnancy. If you think you might be pregnant while using this medicine, tell your doctor right away.

This medicine may cause serious allergic reactions, including anaphylaxis and angioedema, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have chest tightness, rash, itching, fast heartbeat, trouble breathing or swallowing, or large swelling like hives on your face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs while using this medicine.

Check with your doctor right away if you have blistering, peeling, or loosening skin, chills, cough, diarrhea, itching, joint or muscle pain, red irritated eyes, red skin lesions often with a purple center, sore throat, sores, ulcers, or white spots in the mouth or on the lips, or unusual tiredness or weakness. These may be symptoms of serious skin reactions, including Stevens-Johnson syndrome, acute generalized exanthematous pustulosis (AGEP), toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS).

This medicine may cause diarrhea, which can be severe in some cases. It may happen 2 months or more after stopping this medicine. Do not take any medicine for diarrhea without first checking with your doctor. If you have questions or if mild diarrhea continues or worsens, talk to your doctor.

Check with your doctor right away if you notice a change in how often you urinate or the amount of urine, blood in the urine, fever, joint pain, loss of appetite, skin rash, swelling of the body, feet, or ankles, unusual tiredness or weakness, or unusual weight gain after taking this medicine. These could be symptoms of acute tubulointerstitial nephritis.

Cutaneous or systemic lupus erythematosus may occur or worsen in patients taking a PPI. Call your doctor right away if you have joint pain or a skin rash on your cheeks or arms that gets worse in the sun.

Check with your doctor immediately if you experience blurred vision, difficulty reading, or any other change in vision during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

Make sure any doctor or dentist treating you knows that you are using this medicine. This medicine may affect the results of some medical tests.

Talk with your doctor before using this medicine if you plan to have children. Some men who use this medicine have become infertile (unable to have children).

Avoid taking this medicine with alcohol.

This medicine may cause your skin, tears, saliva, sweat, urine, or bowel movements to turn a brownish-orange color. Your contact lenses could become permanently discolored.

Do not take other medicines unless you have discussed them with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (for example, St. John's wort) or vitamin supplements.

In deciding to use a medicine, the risks of using the medicine must be weighed against the beneficial it will do. This is a decision you and your doctor will make. For this drug, the following should be considered:

Allergies

Inform your clinician if you have ever had any unusual or allergic reaction to this drug or any other medicines. Also inform 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.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of Talicia® in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific issues that would limit the usefulness of Talicia® in the elderly. Nevertheless, elderly patients are more likely to have kidney issues, which may require caution and an adjustment in the dose for patients receiving this medication.

Breast Feeding

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

Interactions with 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 clinician may want to change the dose, or other precautions may be necessary. When you are using this drug, it is especially important that your healthcare professional know if you are using any of the medications listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medication with any of the following drugs is not recommended. Your doctor may decide not to treat you with this medication or change some of the other drugs you take.

• Artemether
• Delamanid
• Delavirdine
• Lumefantrine
• Lurasidone
• Mavacamten
• Ranolazine
• Rilpivirine
• Voriconazole

Using this drug with any of the following drugs is usually not advised, but may be required in some cases. If both medicines are prescribed together, your physician may change the dose or how frequently you use one or both of the medicines.

• Abametapir
• Acalabrutinib
• Alfentanil
• Amiodarone
• Amphetamine
• Amprenavir
• Apremilast
• Atazanavir
• Atezolizumab
• Atogepant
• Atovaquone
• Avacopan
• Avapritinib
• Bedaquiline
• Belumosudil
• Belzutifan
• Benzhydrocodone
• Benzphetamine
• Bictegravir
• Boceprevir
• Bosutinib
• Brigatinib
• Buprenorphine
• Capecitabine
• Capmatinib
• Cefuroxime Axetil
• Ceritinib
• Chlortetracycline
• Cholera Vaccine, Live
• Cilostazol
• Citalopram
• Clarithromycin
• Clopidogrel
• Clorazepate
• Cobicistat
• Codeine
• Conivaptan
• Crizotinib
• Cyclosporine
• Dabrafenib
• Daclatasvir
• Dacomitinib
• Daridorexant
• Darunavir
• Dasabuvir
• Dasatinib
• Delavirdine
• Demeclocycline
• Desogestrel
• Dextroamphetamine
• Diazepam
• Dienogest
• Digoxin
• Dihydrocodeine
• Doravirine
• Doxorubicin
• Doxorubicin Hydrochloride Liposome
• Doxycycline
• Dronedarone
• Drospirenone
• Duvelisib
• Efavirenz
• Elacestrant
• Elagolix
• Elexacaftor
• Elvitegravir
• Encorafenib
• Entrectinib
• Enzalutamide
• Eravacycline
• Erdafitinib
• Erlotinib
• Escitalopram
• Eslicarbazepine Acetate
• Estetrol
• Estradiol
• Ethinyl Estradiol
• Ethynodiol
• Etonogestrel
• Etravirine
• Exemestane
• Fedratinib
• Fentanyl
• Fexinidazole
• Finerenone
• Fluconazole
• Fosamprenavir
• Fosnetupitant
• Fosphenytoin
• Gefitinib
• Gestodene
• Glasdegib
• Hemin
• Hydrocodone
• Ibrexafungerp
• Idelalisib
• Ifosfamide
• Indinavir
• Infigratinib
• Irinotecan
• Irinotecan Liposome
• Itraconazole
• Ivacaftor
• Ketoconazole
• Lapatinib
• Larotrectinib
• Ledipasvir
• Lefamulin
• Lemborexant
• Lenacapavir
• Leniolisib
• Levoketoconazole
• Levonorgestrel
• Linagliptin
• Lisdexamfetamine
• Lopinavir
• Lorlatinib
• Lumateperone
• Lymecycline
• Maribavir
• Mavacamten
• Meclocycline
• Medroxyprogesterone
• Meperidine
• Mestranol
• Methacycline
• Methadone
• Methamphetamine
• Methotrexate
• Methylphenidate
• Mifepristone
• Minocycline
• Mitapivat
• Mobocertinib
• Mycophenolate Mofetil
• Nelfinavir
• Neratinib
• Netupitant
• Nifedipine
• Nilotinib
• Nirmatrelvir
• Nomegestrol
• Norelgestromin
• Norethindrone
• Norgestimate
• Norgestrel
• Octreotide
• Olanzapine
• Olutasidenib
• Omaveloxolone
• Ombitasvir
• Oxycodone
• Oxytetracycline
• Pacritinib
• Palbociclib
• Palovarotene
• Panobinostat
• Paritaprevir
• Pazopanib
• Pemigatinib
• Pentazocine
• Pexidartinib
• Phenobarbital
• Phenytoin
• Pimavanserin
• Piperaquine
• Pirtobrutinib
• Posaconazole
• Pralsetinib
• Pretomanid
• Primidone
• Quizartinib
• Rifampin
• Rilpivirine
• Rimegepant
• Ripretinib
• Ritonavir
• Rolitetracycline
• Saquinavir
• Sarecycline
• Secretin Human
• Segesterone
• Selpercatinib
• Selumetinib
• Sildenafil
• Sonidegib
• Sorafenib
• Sotorasib
• Sparsentan
• St John's Wort
• Sufentanil
• Sulfasalazine
• Sunitinib
• Tacrolimus
• Tazemetostat
• Telaprevir
• Tenofovir Alafenamide
• Tetracycline
• Tezacaftor
• Tigecycline
• Tipranavir
• Tocilizumab
• Tolvaptan
• Tramadol
• Ubrogepant
• Ulipristal
• Vandetanib
• Velpatasvir
• Venlafaxine
• Vincristine
• Vincristine Sulfate Liposome
• Vismodegib
• Voclosporin
• Vonoprazan
• Voriconazole
• Voxelotor
• Voxilaprevir
• Warfarin
• Zanubrutinib
• Zolpidem
• Zuranolone

Using this medication with any of the following drugs may cause an increased risk of certain adverse effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how frequently you use one or both of the medications.

• Acenocoumarol
• Armodafinil
• Azithromycin
• Carbamazepine
• Cyanocobalamin
• Dapsone
• Didanosine
• Disulfiram
• Ginkgo Biloba
• Iron
• Khat
• Levothyroxine
• Nevirapine
• Ospemifene
• Probenecid
• Raltegravir
• Sirolimus
• Sulfamethoxazole
• Tipranavir
• Triazolam
• Trimetrexate
• Warfarin
• Zidovudine

Interactions with Food/Tobacco/Alcohol

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 medications may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this drug with any of the following may cause an increased chance of certain side effects but may be unavoidable in some cases. If used together, your clinician may change the dose or how often you use this medication, or give you special instructions about the use of food, alcohol, or tobacco.

• Cranberry

Other Medical Problems

The presence of other medical issues may affect the use of this medication. Make sure you tell your physician if you have any other medical problems, especially:

• Allergy to penicillin, history of—May increase chance for more severe reactions.

• Diarrhea or
• Eye or vision problems (eg, uveitis) or
• Kidney issues or
• Systemic lupus erythematosus (SLE)—Use with caution. May make these conditions worse.

• Kidney disease, serious or
• Liver disease—Use is not recommended in patients with these conditions.

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 immediately if any of the following side effects occur:

Incidence not known

• Black, tarry stools
• bleeding gums
• blistering, peeling, loosening of the skin
• blood in the urine or stools
• blurred vision or other change in vision
• chest pain or tightness
• chills
• cloudy urine
• confusion
• cough
• cracks in the skin
• decreased urine
• diarrhea
• difficulty in moving
• difficulty with swallowing
• dizziness
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• dry mouth
• eye pain
• fast heartbeat
• fever
• greatly decreased frequency of urination or amount of urine
• hives, itching, or skin rash
• increased thirst
• joint or muscle pain
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• loss of heat from the body
• mood or mental changes
• muscle aches, cramps, pains, or stiffness
• muscle cramps in the hands, arms, feet, legs, or face
• numbness and tingling around the mouth, fingertips, or feet
• painful or difficult urination
• pinpoint red spots on the skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• red, irritated eyes
• red skin lesions, often with a purple center
• red, swollen skin
• scaly skin
• seizures
• sensitivity of the eye to light
• severe stomach cramps and pain
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips
• stomach tenderness
• sweating
• swelling of the breasts or breast soreness in both females and males
• swelling of the feet or lower legs
• tearing
• trembling
• trouble breathing
• unusual bleeding or bruising
• unusual tiredness or weakness
• watery and severe diarrhea, which may also be bloody

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Headache

Less common

• Acid or sour stomach
• back pain
• belching
• change or loss of taste
• difficulty having a bowel movement (stool)
• heartburn
• indigestion
• itching of the vagina or genitals
• loss of appetite
• stomach discomfort or upset
• thick, white vaginal discharge with mild or no odor
• trouble sleeping

Incidence not known

• Change in taste bad unusual or unpleasant (after) taste
• continuing ringing or buzzing or other unexplained noise in ears
• decreased interest in sexual intercourse
• dry skin
• hair loss or thinning of the hair
• hearing loss
• inability to have or keep an erection
• increased sweating
• loss in sexual ability, desire, drive, or performance

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.

• Talicia

Available Dosage Forms:

• Capsule, Delayed Release

Therapeutic Class: Antibiotic Combination

Pharmacologic Class: Omeprazole

Chemical Class: Rifamycin

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

Swallow the delayed-release capsules whole with a full glass of water. Do not crush, chew, or open it. Take it with food.

Keep using this medicine for the full treatment time, even if you feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (delayed-release capsules):For treatment of H. pylori infections: Adults—4 capsules 3 times a day at least 4 hours apart for 14 days, to be taken with food. Each capsule of Talicia® contains 12.5 milligrams (mg) of rifabutin, 250 mg of amoxicillin, and 10 mg of omeprazole. Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose and it is more than 4 hours until your next scheduled dose, take it as soon as possible, and then go back to your regular schedule. If you miss a dose and it is less than 4 hours until your next scheduled dose, skip the missed dose and take your next dose at the regular time.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Store the medicine in its original container. Keep the bottle tightly closed.