Talicia Generic Name & Formulations
Legal Class
Rx
General Description
Omeprazole 10mg, amoxicillin 250mg, rifabutin 12.5mg; delayed-release caps.
Pharmacological Class
Proton pump inhibitor + antibiotics (penicillin + rifamycin).
How Supplied
Caps—84, 168
Manufacturer
Generic Availability
NO
Talicia Indications
Indications
Treatment of H. pylori infection.
Talicia Dosage and Administration
Adult
Swallow whole. Take with food. ≥18yrs: 4 caps every 8hrs for 14 days. Hepatic or severe renal (GFR <30mL/min) impairment: avoid.
Children
<18yrs: not established.
Talicia Contraindications
Contraindications
Omeprazole: concomitant rilpivirine-containing products. Rifabutin: concomitant delavirdine, voriconazole.
Talicia Boxed Warnings
Not Applicable
Talicia Warnings/Precautions
Warnings/Precautions
Discontinue if hypersensitivity or severe cutaneous reactions occur. Evaluate if diarrhea occurs. Discontinue and evaluate if acute tubulointerstitial nephritis is suspected. Cutaneous and systemic lupus erythematosus. Avoid in those with mononucleosis. Uveitis: refer for an eye exam if suspected; suspend therapy if needed. Hepatic or severe renal impairment (see Adult dose). Pregnancy. Nursing mothers.
Talicia Pharmacokinetics
See Literature
Talicia Interactions
Interactions
May be antagonized by other CYP2C19 or CYP3A4 inducers (eg, St. John's wort, rifampin); avoid. May antagonize hormonal contraceptives; use additional or alternative non-hormonal methods. Omeprazole antagonizes clopidogrel; consider alternative anti-platelet therapy. May be potentiated by CYP2C19 and/or CYP3A inhibitors (eg, fluconazole, itraconazole, posaconazole, clarithromycin); avoid. May potentiate CYP2C19 substrates (eg, citalopram, cilostazol, phenytoin, diazepam), high-dose methotrexate (avoid), digoxin, tacrolimus; monitor. Avoid concomitant amprenavir, indinavir, lopinavir/ritonavir, saquinavir/ritonavir, ritonavir, tipranavir/ritonavir, fosamprenavir/ritonavir, nelfinavir. Amoxicillin potentiated by probenecid. Increased incidence of skin rash with allopurinol; discontinue allopurinol if occurs. Monitor INR, PT with warfarin or other oral anticoagulants. May alter absorption of pH-dependent drugs (eg, iron salts, erlotinib, dasatinib, nilotinib, mycophenolate mofetil, ketoconazole, itraconazole). Monitor drugs metabolized by CYP450 (eg, cyclosporine, disulfiram). May interfere with neuroendocrine diagnostic tests; discontinue Talicia 14 days prior to CgA level assessment; may need to repeat test. Amoxicillin may cause false (+) glucose test with Benedict's soln. May cause false (+) results with secretin stimulation test or urine tests for tetrahydrocannabinol.
Talicia Adverse Reactions
Adverse Reactions
Diarrhea, headache, nausea, abdominal pain, chromaturia, rash, dyspepsia, oropharyngeal pain, vomiting, vulvovaginal candidiasis; possible C. difficile-associated diarrhea, severe cutaneous reactions (eg, SJS, TEN, AGEP, DRESS).
Talicia Clinical Trials
See Literature
Talicia Note
Not Applicable
Talicia Patient Counseling
See Literature
Talicia Generic Name & Formulations
Legal Class
Rx
General Description
Omeprazole 10mg, amoxicillin 250mg, rifabutin 12.5mg; delayed-release caps.
Pharmacological Class
Proton pump inhibitor + antibiotics (penicillin + rifamycin).
How Supplied
Caps—84, 168
Manufacturer
Generic Availability
NO
Talicia Indications
Indications
Treatment of H. pylori infection.
Talicia Dosage and Administration
Adult
Swallow whole. Take with food. ≥18yrs: 4 caps every 8hrs for 14 days. Hepatic or severe renal (GFR <30mL/min) impairment: avoid.
Children
<18yrs: not established.
Talicia Contraindications
Contraindications
Omeprazole: concomitant rilpivirine-containing products. Rifabutin: concomitant delavirdine, voriconazole.
Talicia Boxed Warnings
Not Applicable
Talicia Warnings/Precautions
Warnings/Precautions
Discontinue if hypersensitivity or severe cutaneous reactions occur. Evaluate if diarrhea occurs. Discontinue and evaluate if acute tubulointerstitial nephritis is suspected. Cutaneous and systemic lupus erythematosus. Avoid in those with mononucleosis. Uveitis: refer for an eye exam if suspected; suspend therapy if needed. Hepatic or severe renal impairment (see Adult dose). Pregnancy. Nursing mothers.
Talicia Pharmacokinetics
See Literature
Talicia Interactions
Interactions
May be antagonized by other CYP2C19 or CYP3A4 inducers (eg, St. John's wort, rifampin); avoid. May antagonize hormonal contraceptives; use additional or alternative non-hormonal methods. Omeprazole antagonizes clopidogrel; consider alternative anti-platelet therapy. May be potentiated by CYP2C19 and/or CYP3A inhibitors (eg, fluconazole, itraconazole, posaconazole, clarithromycin); avoid. May potentiate CYP2C19 substrates (eg, citalopram, cilostazol, phenytoin, diazepam), high-dose methotrexate (avoid), digoxin, tacrolimus; monitor. Avoid concomitant amprenavir, indinavir, lopinavir/ritonavir, saquinavir/ritonavir, ritonavir, tipranavir/ritonavir, fosamprenavir/ritonavir, nelfinavir. Amoxicillin potentiated by probenecid. Increased incidence of skin rash with allopurinol; discontinue allopurinol if occurs. Monitor INR, PT with warfarin or other oral anticoagulants. May alter absorption of pH-dependent drugs (eg, iron salts, erlotinib, dasatinib, nilotinib, mycophenolate mofetil, ketoconazole, itraconazole). Monitor drugs metabolized by CYP450 (eg, cyclosporine, disulfiram). May interfere with neuroendocrine diagnostic tests; discontinue Talicia 14 days prior to CgA level assessment; may need to repeat test. Amoxicillin may cause false (+) glucose test with Benedict's soln. May cause false (+) results with secretin stimulation test or urine tests for tetrahydrocannabinol.
Talicia Adverse Reactions
Adverse Reactions
Diarrhea, headache, nausea, abdominal pain, chromaturia, rash, dyspepsia, oropharyngeal pain, vomiting, vulvovaginal candidiasis; possible C. difficile-associated diarrhea, severe cutaneous reactions (eg, SJS, TEN, AGEP, DRESS).
Talicia Clinical Trials
See Literature
Talicia Note
Not Applicable
Talicia Patient Counseling
See Literature
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