Pronunciation:

oh-MEP-ra-zole mag-NEE-zee-um, a-mox-i-SIL-in, rif-a-BUE-tin

Brand Names:

• Talicia

Dosage Forms:

• Capsule, Delayed Release

Classifications:

Therapeutic—

Antibiotic Combination

Pharmacologic—

Omeprazole

Chemical—

Rifamycin

Uses of This Medicine:

Talicia® is a product containing three components: omeprazole, amoxicillin, and rifabutin. This medicine is used to treat patients with H. pylori infection.

Omeprazole is a proton pump inhibitor (PPI). It works by decreasing the amount of acid produced by the stomach. Amoxicillin and rifabutin both belong to the class of medicines known as antibiotics. They work by killing bacteria or preventing their growth. However, this medicine will not work for colds, flu, or other virus infections.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, 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 Talicia® in the pediatric population. Safety and efficacy have not been established.

Older adults—

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

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 taking this medicine, 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.

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

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

Using this medicine 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.

• 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
• 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 medicine with any of the following medicines may cause an increased risk of certain side 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 often you use one or both of the medicines.

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

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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

• Cranberry

Other medical problems—

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

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

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

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

Proper Use of This Medicine:

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.

Precautions While Using This Medicine:

It is important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to use it. Blood, urine, and other laboratory tests may be needed to check for unwanted effects. If your condition does not improve, or if it becomes worse, discuss this with your doctor.

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

Using this medicine while you are pregnant can harm your unborn baby. Use birth control pills together with another form of birth control (eg, condom, diaphragm, or contraceptive foam or jelly) to keep from getting pregnant. If you think you have become pregnant while using the 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, hive-like swelling of the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs while you are using this medicine.

Check with your doctor right away if you have blistering, peeling, or loosening of the 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, and in some cases it can be severe. It may occur 2 months or more after you stop taking this medicine. Do not take any medicine to treat diarrhea without first checking with your doctor. If you have any questions or if mild diarrhea continues or gets worse, check with your doctor.

Check with your doctor right away if you have a change in frequency of urination or 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 get worse in patients receiving a PPI. Call your doctor right away if you have joint pain or a skin rash on your cheeks or arms that gets worse when exposed to the sun.

Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs 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 who treats you knows that you are using this medicine. This medicine may affect the results of certain 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 they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

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 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.