Amoxicillin-Omeprazole-Rifabutin

Amoxicillin-Omeprazole-Rifabutin is a combination medication used for the treatment of Helicobacter pylori infection associated with peptic ulcer disease.

• Amoxicillin-Omeprazole-Rifabutin is available under various brand names: Talicia.

Common side effects of Amoxicillin-Omeprazole-Rifabutin include:

• red, orange, or brown discoloration of your skin, tears, sweat, saliva, urine, or stools,
• indigestion,
• stomach pain,
• nausea,
• vomiting,
• diarrhea,
• headache,
• discolored urine,
• sore throat,
• rash, and
• vaginal itching or discharge.

Serious side effects of Amoxicillin-Omeprazole-Rifabutin include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• fever,
• sore throat,
• burning eyes,
• skin pain,
• red or purple skin rash with blistering and peeling,
• severe stomach pain,
• watery or bloody diarrhea  (even if it occurs months after your last dose),
• lightheadedness,
• easy bruising,
• unusual bleeding,
• purple or red spots under the skin,
• eye pain or redness,
• vision problems,
• seeing spots,
• eyes becoming more sensitive to light,
• chills,
• sweating,
• tiredness,
• body aches,
• vomiting,
• chest pain,
• cough,
• shortness of breath,
• urinating more or less than usual,
• nausea,
• blood in the urine,
• confusion,
• swelling,
• rapid weight gain,
• muscle or joint pain,
• flu symptoms,
• chest pain, and
• rash or patchy skin color that worsens in sunlight

Rare side effects of Amoxicillin-Omeprazole-Rifabutin include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Capsule (delayed release)

• 250 mg/10 mg/12.5 mg per capsule

Helicobacter Pylori Infection

Adult dosage

• Administer 4 capsules orally with food every 8 hours for 14 days
• Each dose (4 capsules) include 1000 mg amoxicillin, 40 mg omeprazole, and 50 mg rifabutin

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Amoxicillin-Omeprazole-Rifabutin has severe interactions with at least 28 other drugs.
• Amoxicillin-Omeprazole-Rifabutin has serious interactions with at least 231 other drugs.
• Amoxicillin-Omeprazole-Rifabutin has moderate interactions with at least 279 other drugs.
• Amoxicillin-Omeprazole-Rifabutin has minor interactions with at least 78 other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Hypersensitivity to drug components or excipients
• Concomitant administration with rilpivirine containing products (due to omeprazole, a drug component)
• Concomitant administration with delavirdine or voriconazole (due to rifabutin, a drug component)

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Amoxicillin-Omeprazole-Rifabutin?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Amoxicillin-Omeprazole-Rifabutin?”

Cautions

• Serious and fatal hypersensitivity reactions reported with all the drug components; inquire about history of hypersensitivity reactions to drug components before initiating therapy; institute immediate therapy, if hypersensitivity reactions occur
• Clostridioides difficile-associated diarrhea (CDAD) ranging in severity from mild diarrhea to fatal colitis reported with all drug components; may occur over two months after initiating therapy; assess for CDAD all patients who present with diarrhea following therapy administration; discontinue if confirmed; institute appropriate fluid and electrolyte management, protein supplementation, antibacterial drug treatment of C. difficile as clinically indicated
• Therapy may reduce efficacy of hormonal contraceptives; additional non-hormonal highly effective method of contraception should be used while receiving therapy
• Acute tubulointerstitial nephritis (TIN) reported in patients taking PPIs; TIN may occur at any point during PPI therapy; patients may present with varying signs and symptoms from symptomatic hypersensitivity reactions, to non-specific symptoms of decreased renal function (eg, malaise, nausea, anorexia); in reported case series, some patients were diagnosed on biopsy and in the absence of extra-renal manifestations (eg, fever, rash or arthralgia); discontinue drug and evaluate patients with suspected acute TIN
• Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) reported in patients taking PPIs; reported as both new onset and an exacerbation of existing autoimmune disease; discontinue therapy and evaluate as appropriate if symptoms consistent with CLE or SLE develop while administering therapy
• Severe cutaneous adverse reactions (SCAR), such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP) reported with components of the drug rifabutin, amoxicillin, and omeprazole; in addition, drug reaction with eosinophilia and systemic symptoms (DRESS) has been reported with rifabutin, a component of the drug combination; monitor closely and discontinue the drug at first signs of SCAR
• A high percentage of patients with mononucleosis who receive amoxicillin develop an erythematous skin rash; avoid therapy in patients with mononucleosis
• Due to the possible occurrence of uveitis, carefully monitor patients when drug, is given in combination with clarithromycin (or other macrolides) and/or fluconazole and related compounds; if uveitis suspected, refer for an ophthalmologic evaluation and, if considered necessary, suspend therapy
• Serum chromogranin A (CgA) levels increase secondary to drug-induced decreases in gastric acidity; the increased CgA level may cause false-positive results in diagnostic investigations for neuroendocrine tumors; assess CgA levels at least 14 days after therapy and consider repeating the test if initial CgA levels are high
• Prescribing drug either in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to patient and increases risk of development of drug-resistant bacteria
• Drug interaction overview
  • Avoid concomitant use with other CYP2C19 or CYP3A4 inducers (e.g. St. John’s Wort, rifampin) as they can substantially decrease omeprazole concentrations
  • Avoid concomitant use of with CYP2C19 and/or CYP3A4 inhibitors (e.g. fluconazole, itraconazole) as it may significantly increase plasma concentration of drug component (s)
  • Depending on protease inhibitor, concomitant use of drug should be avoided (e.g. amprenavir, indinavir) or dose adjustments for a concomitantly administered protease inhibitor(s) may be required
  • Concomitant use of PPIs with methotrexate (primarily at high dose) may elevate and prolong serum levels of methotrexate and/or its metabolite, possibly leading to methotrexate toxicities; avoid therapy in patients on high-dose methotrexate
  • Concomitant use of clopidogrel and omeprazole reduces pharmacological activity of clopidogrel; avoid therapy in patients on clopidogrel; when administering drug, consider alternative anti-platelet therapy

Pregnancy & Lactation

• Based on animal reproduction studies, therapy 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; therapy is generally not recommended for use in pregnancy; if therapy administered during pregnancy, advise pregnant women of potential risk to fetus
• Rifabutin
  • Fetal malformations not observed in rat or rabbit reproduction studies given rifabutin at dose levels up to 200 mg/kg (6 to 13 times recommended human dose); in rats, given rifabutin at 200 mg/kg/day (about 6 times recommended human daily dose), there was a decrease in fetal viability; increased skeletal anomalies were observed in rats and rabbits at 40 and 80 mg/kg/day, respectively (corresponding to approximately an equivalent dose and 5 times the recommended human daily dose); maternal toxicity was noted at 80 mg/kg in rabbits
• Omeprezole
  • There are no adequate and well-controlled studies in pregnant women; available epidemiologic data fail to demonstrate an increased risk of major congenital malformations or other adverse pregnancy outcomes with first trimester omeprazole use; reproduction studies in rats and rabbits resulted in dose-dependent embryo-lethality at omeprazole doses that were approximately 1.13 to 11 times an oral human dose of 120 mg
  • Teratogenicity was not observed in animal reproduction studies with administration of oral esomeprazole (an enantiomer of omeprazole) magnesium in rats and rabbits during organogenesis with 23 times and 14 times, respectively, of an oral human dose of 120 mg esomeprazole or omeprazole; changes in bone morphology were observed in offspring of rats dosed through most of pregnancy and lactation at doses equal to or greater than approximately 11 times an oral human dose of 120 mg esomeprazole or omeprazole; when maternal administration was confined to gestation only, there were no effects on bone physeal morphology in offspring at any age
• Amoxicillin
  • Available data from published epidemiologic studies and pharmacovigilance case reports over several decades with amoxicillin use have not established drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes; no adverse developmental effects were observed in animal reproduction studies with administration of amoxicillin to pregnant mice and at doses up to 3 to 6 times an oral human dose of 3 grams
• Contraception
  • Drug components interact with hormonal contraceptives resulting in lower levels of these contraceptives; female patients taking hormonal contraceptives should use an additional non-hormonal highly effective method of contraception while receiving therapy
• Infertility
  • Based on findings in rodents, drug may impair fertility in males of reproductive potential
• Lactation
  • The developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breast-fed child from drug or from the underlying condition
• Rifabutin
  • There are no data on presence of drug in human milk, effects on breast-fed infant or on milk production
• Omeprazole
  • There are no clinical data on effects of drug on breast-fed infant or on milk production
• Amoxicillin
  • Data from a published clinical lactation study reports that drug is present in human milk; published adverse effects with amoxicillin exposure in breast-fed infant include diarrhea; There are no data on the effects of amoxicillin on milk production