Talicia (omeprazole magnesium, amoxicillin and rifabutin)

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.

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

• 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.

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

• 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.