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:
- diarrhea,
- headache,
- nausea,
- abdominal pain,
- abnormally colored urine,
- rash,
- heartburn/indigestion,
- 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 InducersClinical ImpactDecreased exposure of omeprazole when used concomitantly with strong inducers.Prevention or ManagementSt. John’s Wort, rifampin:Avoid concomitant use with Talicia.Ritonavir-containing products: See prescribing information for specific drugs.CYP2C19 or CYP3A4 InhibitorsClinical ImpactIncreased blood levels of omeprazole and rifabutin.Prevention or ManagementVoriconazole:
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 ImpactIncreased plasma concentrations of CYP2C19 substrate drugs or
decreased/increased plasma concentrations of its active metabolite(s).Prevention or ManagementClopidogrel:
Consider use of alternative anti-platelet therapy. Avoid concomitant use with
Talicia.Antiretrovirals/Protease InhibitorsClinical ImpactAntiretrovirals/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.
- Decreased exposure of some antiretroviral drugs (e.g., rilpivirine,
atazanavir, and nelfinavir) when used concomitantly with omeprazole may
reduce antiviral effect and promote the development of drug resistance. - Increased exposure of other antiretroviral drugs (e.g., saquinavir) when
used concomitantly with omeprazole may increase toxicity.
There are other antiretroviral drugs which do not result in clinically relevant interactions with omeprazole.Prevention or ManagementDelavirdine:
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.ProbenecidClinical ImpactIncreased and prolonged blood levels of amoxicillin.AllopurinolClinical ImpactIncrease 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 ManagementDiscontinue allopurinol at the first appearance of skin rash. Assess benefit-risk of continuing
Talicia treatment.Warfarin, and Other Oral AnticoagulantsClinical ImpactAbnormal 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 ManagementMonitor INR and prothrombin time and adjust the dose of warfarin or other oral anticoagulants to maintain the desired level of anticoagulation.MethotrexateClinical 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 ManagementAvoid concomitant use of
Talicia in patients receiving high-dose methotrexate.DigoxinClinical ImpactPotential for increased digoxin blood levels.Prevention or ManagementMonitor 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 ImpactOmeprazole can alter the absorption of other drugs due to its effect of reducing intragastric acidity thereby increasing gastric pH.Prevention or ManagementMycophenolate mofetil (MMF):
Use Talicia with caution in transplant patients receiving MMF.See the prescribing information of other drugs dependent on gastric pH for absorption.TacrolimusClinical ImpactPotential for increased tacrolimus blood levels, especially in patients who are intermediate or poor metabolizers of CYP2C19.Prevention or ManagementMonitor 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 ImpactInteractions are reported with omeprazole and other drugs metabolized via the CYP450 enzymes.Prevention or ManagementMonitor patients to determine if it is necessary to adjust the dosage of these other drugs when taken concomitantly with
Talicia.Oral ContraceptivesClinical 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 ManagementPatients should be advised to use additional or alternative non-hormonal methods of contraception.Diagnostic Investigations for Neuroendocrine TumorsClinical 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 ManagementAssess 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 TestClinical ImpactHigh 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 ManagementGlucose tests based on enzymatic glucose oxidase reactions should be used.Interaction with Secretin Stimulation TestClinical ImpactHyper-response in gastrin secretion in response to secretin stimulation test may falsely suggest gastrinoma.Prevention or ManagementTest 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 ImpactThere have been reports of false positive urine screening tests for THC in patients receiving PPIs.Prevention or ManagementAn alternative confirmatory method should be considered to verify positive results.Other Laboratory TestsClinical ImpactFollowing 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.
QUESTION
Bowel regularity means a bowel movement every day.
See Answer
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.