Talicia

Talicia is a prescription medication used to treat Helicobacter pylori (H. pylori) infection in adults. Talicia combines three medications into one capsule. Amoxicillin, a penicillin-like medication, and rifabutin are antibiotics which help kill the bacteria. It also includes omeprazole magnesium, a medication which helps reduce stomach acid and makes it easier for the antibiotics to kill the H. pylori bacteria.

Talicia capsules are taken by mouth every 8 hours with food for 14 days. Capsules should be swallowed whole with a full glass of water. Do not chew or crush capsules. Do not take Talicia with alcohol.

Common side effects include diarrhea, headache, nausea, and stomach pain.

Talicia is for the treatment of a bacteria, Helicobacter pylori (H. pylori), in the stomach of adults.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Talicia. See the "Talicia Precautions" section.

Common side effects of Talicia include:

• diarrhea
• headache
• nausea
• stomach pain
• rash
• indigestion
• mouth or throat pain
• vomiting
• vaginal yeast infection
• brown-orange discoloration of the urine, sweat or skin, which goes away after therapy is completed or discontinued

These are not all of the possible side effects of Talicia. 

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

Tell your healthcare provider about all medicines you take or plan to take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Some medicines may interact with one or all ingredients in Talicia causing side effects. Drug interaction studies with Talicia have not been conducted. The drug interaction information described here is based on the prescribing information of individual Talicia components: omeprazole, amoxicillin, and rifabutin. Especially tell your healthcare provider if you are taking:

• Rilpivirine
• Delavirdine
• Voriconazole
• Birth control. Talicia may reduce the effectiveness of oral or other forms of hormonal birth-control. You should use an additional non-hormonal highly effective method of birth control while taking Talicia.
• St. John's Wort
• Rifampin
• Ritonavir 
• Lopinavir/ritonavir 
• Fluconazole
• Posaconazole
• Itraconazole
• Clopidogrel
• Citalopram
• Cilostazol
• Phenytoin
• Diazepam
• Atazanavir
• Nelfinavir
• Saquinavir
• Probenecid
• Allopurinol
• Warfarin
• Methotrexate
• Digoxin
• Drugs Dependent on Gastric (stomach) pH for Absorption (e.g., iron salts, erlotinib, dasatinib, nilotinib, mycophenolate mofetil, ketoconazole/itraconazole)
• Tacrolimus
• Cyclosporine
• Disulfiram

This is not a complete list of Talicia drug interactions. Ask your doctor or pharmacist for more information.

Talicia can cause serious side effects including:

• Hypersensitivity Reactions. Signs of a hypersensitivity reaction include the following:
  • chest pain
  • swelling of the face, eyes, lips, tongue, arms, or legs
  • difficulty breathing or swallowing
  • fainting
  • rash
• Clostridioides difficile-Associated Diarrhea. The symptoms of C. diff infections include:
  • Diarrhea (loose, watery stools) or frequent bowel movements for several days
  • Fever
  • Stomach tenderness or pain
  • Loss of appetite
  • Nausea
• Reduced Efficacy of Hormonal Contraceptives. Talicia may reduce the efficacy of hormonal contraceptives. Therefore, an additional non-hormonal highly effective method of contraception should be used while taking Talicia.
• Acute Interstitial Nephritis. Interstitial nephritis is a kidney disorder in which the spaces between the kidney tubules become swollen (inflamed). This can cause problems with the way your kidneys work.
• Risk of Adverse Reactions or Loss of Efficacy Due to Drug Interactions (see Talicia Interactions)
• Cutaneous and Systemic Lupus Erythematosus
• Rash in Patients with Mononucleosis
• Uveitis
• Interactions with Diagnostic Investigations for Neuroendocrine Tumors
• Development of Drug-Resistant Bacteria

Call your healthcare provider immediately if while taking Talicia you develop:

• New rash or other skin changes, muscle or joint pains, swelling of any area of the body, severe flu-like symptoms, difficulty breathing, fever, blood in your urine, increased or decreased urination, drowsiness, confusion, nausea, vomiting, ongoing stomach pain, bloody diarrhea, or if diarrhea continues after therapy is completed, weight gain or changes in your eyesight.

Do not take Talicia if:

• you are known to be sensitive to any of the components of Talicia (omeprazole, amoxicillin, rifabutin), penicillins, proton pump inhibitors or rifamycins.
• you are taking rilpivirine-containing products, delavirdine or voriconazole.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Talicia, there are no specific foods that you must exclude from your diet when receiving this medication.

Before receiving Talicia, tell your healthcare provider about all of your medical conditions, including if you:

• Are pregnant or plan to become pregnant. Talicia may harm your unborn baby. Tell your healthcare provider if you become pregnant or think you may be pregnant during your treatment with Talicia.
• Have severe kidney disease or liver disease
• Are allergic to any medications, especially penicillin antibiotics, cephalosporins, rifamycins, or proton pump inhibitors (PPIs)
• Have mononucleosis

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Tell your healthcare provider if you are pregnant or plan to become pregnant. Talicia may harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Talicia.

Tell your healthcare provider if you are breastfeeding or planning to breastfeed. Amoxicillin (one component of Talicia) has been detected in human breast milk. Limited data suggest omeprazole may be present in human milk. There are no clinical data on the effects of omeprazole on the breast-fed infant or on milk production. There are no data on the presence of rifabutin in human milk or the effects of rifabutin on the breast-fed infant or on milk production. Because of the possibility for adverse reactions in nursing infants from Amoxicillin, a choice should be made whether to stop nursing or to stop use of this medication. The importance of the drug to the mother should be considered.

Talicia should be taken as directed – 4 capsules every 8 hours with food for 14 days. The entire course of therapy should be completed to help make sure the H. pylori bacteria has been killed. The capsules should be swallowed whole with a full glass of water and not crushed or chewed. You should not take Talicia with alcohol.

• You may feel better before the end of the 14 days, however, just because symptoms are gone does not mean that H. pylori has been completely killed.
• Talicia should be taken exactly as directed and for the entire 14 days. Skipping doses or not completing the therapy may not rid H. pylori from your stomach and may increase the chance that the bacteria will become stronger and may make it more difficult to treat with Talicia or other medications in the future.
• It is also recommended that your healthcare professional perform testing about 1 month after you complete therapy to make sure the bacteria is no longer in your stomach.

Take Talicia exactly as prescribed by your healthcare provider.

The recommended dose is four (4) Talicia capsules every 8 hours for 14 days with food. Each dose (4 capsules) of Talicia includes rifabutin 50 mg, amoxicillin 1,000 mg and omeprazole 40 mg.

If you take too much of this medication, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

Store at 20°C to 25°C (68°F to 77°F).

Store Talicia capsules in original container with a child-resistant closure. Keep bottle tightly closed.

Keep this and all medications out of reach of children.