Talicia

— THERAPEUTIC DISORDERS TREATED —
  • Bacterial infections
  • Hyperacidity, GERD, and ulcers

Talicia Generic Name & Formulations

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

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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