What is Talicia, and how does it work?
Talicia (omeprazole magnesium, amoxicillin and rifabutin) is a three-drug combination of:
- a proton pump inhibitor,
- a penicillin-class antibacterial, and
- a rifamycin antibacterial indicated for the treatment of Helicobacter pylori infection in adults.
What are the side effects of Talicia?
Side effects of Talicia include:
- abdominal pain,
- abnormally colored urine,
- mouth and throat pain,
- vomiting, and
- vaginal yeast infection
What is the dosage for Talicia?
- Administer four (4) Talicia capsules every 8 hours for 14 days with food.
- Patients should swallow the Talicia capsules whole, with a full glass of water (8 ounces).
- Each dose (4 capsules) of Talicia includes rifabutin 50 mg, amoxicillin 1,000 mg and omeprazole 40 mg.
- Do not crush or chew Talicia capsules.
- Do not take Talicia with alcohol.
- If a dose is missed, patients should continue the normal dosing schedule until the medication is completed.
- Do not take two doses at one time to make up for a missed dose.
What drugs interact with Talicia?
Interactions With Other Drugs And Diagnostics
- 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.
- Rifabutin is a substrate and inducer of cytochrome P450 (CYP) 3A enzymes. Omeprazole is a substrate and an inhibitor of CYP2C19, and a substrate of CYP3A4. Co-administration of Talicia and other drugs that are substrates, inhibitors, or inducers of these enzymes may alter concentrations of rifabutin/omeprazole or other co-administered drugs [See Table 2 below].
- Omeprazole magnesium is a PPI. Refer to the prescribing information of the drugs used concomitantly with Talicia for further information on their interactions with PPIs.
Table 2: Interactions with Talicia When Co-Administered with Other Drugs and Diagnostics
|CYP2C19 or CYP3A4 Inducers|
|Clinical Impact||Decreased exposure of omeprazole when used concomitantly with strong inducers.|
|Prevention or Management||St. John’s Wort, rifampin: Avoid concomitant use with Talicia.|
|Ritonavir-containing products: See prescribing information for specific drugs.|
|CYP2C19 or CYP3A4 Inhibitors|
|Clinical Impact||Increased blood levels of omeprazole and rifabutin.|
|Prevention or Management||Voriconazole: Concomitant use with Talicia is contraindicated.|
|Fluconazole, posaconazole, and itraconazole: Avoid concomitant use with Talicia. If coadministration cannot be avoided, monitor patients for rifabutin associated adverse events, and lack of anti-fungal efficacy.|
|CYP2C19 Substrates (e.g., Clopidogrel, citalopram, cilostazol, phenytoin, diazepam)|
|Clinical Impact||Increased plasma concentrations of CYP2C19 substrate drugs or decreased/increased plasma concentrations of its active metabolite(s).|
|Prevention or Management||Clopidogrel: Consider use of alternative anti-platelet therapy. Avoid concomitant use with Talicia.|
|Clinical Impact||Antiretrovirals/protease inhibitors may increase rifabutin blood levels. The effect of PPIs (such as omeprazole in
Talicia) on antiretroviral drugs is variable. The clinical importance and the mechanisms behind these interactions are not always known.|
|Prevention or Management||Delavirdine: Combination treatment with Talicia and delavirdine is contraindicated.|
|Rilpivirine-containing products: Concomitant use with Talicia is contraindicated.|
|Avoid concomitant use of Talicia with amprenavir, indinavir, lopinavir/ritonavir, saquinavir/ritonavir, ritonavir, tipranavir/ritonavir, fosamprenavir/ritonavir, or nelfinavir. Other antiretrovirals: See prescribing information for specific antiretroviral drugs.|
|Clinical Impact||Increased and prolonged blood levels of amoxicillin.|
|Clinical Impact||Increase in the incidence of rashes is reported in patients receiving both allopurinol and amoxicillin together compared to patients receiving amoxicillin alone. It is not known whether this potentiation of amoxicillin rashes is due to allopurinol or the hyperuricemia present in these patients.|
|Prevention or Management||Discontinue allopurinol at the first appearance of skin rash. Assess benefit-risk of continuing Talicia treatment.|
|Warfarin, and Other Oral Anticoagulants|
|Clinical Impact||Abnormal prolongation of prothrombin time (increased international normalized ratio [INR]) has been reported in patients receiving amoxicillin and oral anticoagulants and in patients receiving PPIs, including omeprazole, and warfarin concomitantly.|
|Increases in INR and prothrombin time may lead to abnormal bleeding and even death.|
|Prevention or Management||Monitor INR and prothrombin time and adjust the dose of warfarin or other oral anticoagulants to maintain the desired level of anticoagulation.|
|Clinical Impact||Concomitant use of omeprazole with methotrexate (primarily at high doses) may elevate and prolong serum levels of methotrexate and/or its metabolite hydroxymethotrexate, possibly leading to methotrexate toxicities.|
|Prevention or Management||Avoid concomitant use of Talicia in patients receiving high-dose methotrexate.|
|Clinical Impact||Potential for increased digoxin blood levels.|
|Prevention or Management||Monitor digoxin concentrations. Dose adjustment may be needed to maintain therapeutic drug concentrations. See digoxin prescribing information.|
|Drugs Dependent on Gastric pH for Absorption (e.g., iron salts, erlotinib, dasatinib, nilotinib, mycophenolate mofetil, ketoconazole/itraconazole)|
|Clinical Impact||Omeprazole can alter the absorption of other drugs due to its effect of reducing intragastric acidity thereby increasing gastric pH.|
|Prevention or Management||Mycophenolate mofetil (MMF): Use Talicia with caution in transplant patients receiving MMF.|
|See the prescribing information of other drugs dependent on gastric pH for absorption.|
|Clinical Impact||Potential for increased tacrolimus blood levels, especially in patients who are intermediate or poor metabolizers of CYP2C19.|
|Prevention or Management||Monitor tacrolimus whole blood levels and adjust dose as per the prescribing information for tacrolimus.|
|Drugs Metabolized via the CYP450 Enzymes (e.g., cyclosporine, disulfiram)|
|Clinical Impact||Interactions are reported with omeprazole and other drugs metabolized via the CYP450 enzymes.|
|Prevention or Management||Monitor patients to determine if it is necessary to adjust the dosage of these other drugs when taken concomitantly with Talicia.|
|Clinical Impact||Concomitant use of amoxicillin and rifabutin with hormonal contraceptives may lead to loss of its efficacy due to lower estrogen reabsorption and decreased ethinylestradiol and norethindrone concentrations, respectively.|
|Prevention or Management||Patients should be advised to use additional or alternative non-hormonal methods of contraception.|
|Diagnostic Investigations for Neuroendocrine Tumors|
|Clinical Impact||PPI-induced decrease in gastric acidity may lead to increased serum chromogranin A (CgA) levels, which may cause false positive results in diagnostics for neuroendocrine tumors.|
|Prevention or Management||Assess CgA levels at least 14 days after stopping Talicia treatment and consider repeating the test if initial CgA levels are high. If serial tests are performed (e.g., for monitoring), the same commercial laboratory should be used for testing, as reference ranges between tests may vary.|
|Urine Glucose Test|
|Clinical Impact||High urine concentrations of ampicillin or amoxicillin may result in false-positive reactions when using glucose tests based on the Benedict’s copper reduction reaction that determines the amount of reducing substances like glucose in the urine.|
|Prevention or Management||Glucose tests based on enzymatic glucose oxidase reactions should be used.|
|Interaction with Secretin Stimulation Test|
|Clinical Impact||Hyper-response in gastrin secretion in response to secretin stimulation test may falsely suggest gastrinoma.|
|Prevention or Management||Test should be performed at least 14 days after stopping Talicia treatment to allow gastrin levels to return to baseline.|
|False Positive Urine Tests for Tetrahydrocannabinol (THC)|
|Clinical Impact||There have been reports of false positive urine screening tests for THC in patients receiving PPIs.|
|Prevention or Management||An alternative confirmatory method should be considered to verify positive results.|
|Other Laboratory Tests|
|Clinical Impact||Following administration of ampicillin or amoxicillin to pregnant women, a transient decrease in plasma concentration of total conjugated estriol, estriolglucuronide, conjugated estrone, and estradiol has been noted.|
Is Talicia safe to use while pregnant or breastfeeding?
- Based on animal reproduction studies, Talicia may cause fetal harm when administered to pregnant women.
- There are no adequate and well controlled studies of amoxicillin, omeprazole, or rifabutin (used separately or together) in pregnant women.
- Use of Talicia is generally not recommended for use in pregnancy.
- If Talicia is used during pregnancy, advise pregnant women of the potential risk to a fetus.
- Data from a published clinical lactation study reports that amoxicillin is present in human milk.
- Published adverse effects with amoxicillin exposure in the breast-fed infant include diarrhea.
- There are no data on the effects of amoxicillin on milk production.
- 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.
- The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Talicia and any potential adverse effects on the breast-fed child from Talicia or from the underlying condition.
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Talicia (omeprazole magnesium, amoxicillin and rifabutin) is a three-drug combination: a proton pump inhibitor, a penicillin-class antibacterial, and a rifamycin antibacterial indicated for the treatment of Helicobacter pylori infection in adults. Side effects of Talicia include diarrhea, headache, nausea, abdominal pain, abnormally colored urine, rash, heartburn/indigestion, mouth and throat pain, vomiting, and vaginal yeast infection.
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