Talicia
- Generic Name: omeprazole magnesium, amoxicillin and rifabutin delayed-release capsules
- Brand Name: Talicia
Talicia (Omeprazole Magnesium, Amoxicillin and Rifabutin Delayed-release Capsules) side effects drug center
- Related Drugs
- a proton pump inhibitor,
- a penicillin-class antibacterial, and
- a rifamycin antibacterial indicated for the treatment of Helicobacter pylori infection in adults.
- diarrhea,
- headache,
- nausea,
- abdominal pain,
- abnormally colored urine,
- rash,
- heartburn/indigestion,
- mouth and throat pain,
- vomiting, and
- vaginal yeast infection
- voriconazole,
- St. John's wort,
- rifampin,
- ritonavir,
- fluconazole,
- posaconazole,
- itraconazole,
- clopidogrel,
- citalopram,
- cilostazol,
- phenytoin,
- diazepam,
- antiretrovirals,
- protease inhibitors,
- probenecid,
- allopurinol,
- oral anticoagulants,
- methotrexate,
- digoxin,
- cyclosporine,
- disulfiram, and
- hormonal contraceptives
- severe stomach pain, diarrhea that is watery or bloody (even if it occurs months after your last dose);
- a light-headed feeling, like you might pass out;
- easy bruising, unusual bleeding, purple or red spots under your skin;
- eye pain or redness, vision problems, seeing spots, your eyes may be more sensitive to light;
- flu-like symptoms--fever, chills, sweating, tiredness, body aches, vomiting, chest pain, cough, feeling short of breath;
- kidney problems--urinating more or less than usual, fever, nausea, vomiting, blood in your urine, confusion, swelling, rapid weight gain; or
- lupus-like symptoms--muscle or joint pain, flu symptoms, chest pain, and a rash or patchy skin color that worsens in sunlight.
- 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; or
- vaginal itching or discharge.
- Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]
- Clostridioides difficile-Associated Diarrhea [see WARNINGS AND PRECAUTIONS]
- Acute Tubulointerstitial Nephritis [see WARNINGS AND PRECAUTIONS]
- Cutaneous and Systemic Lupus Erythematosus [see WARNINGS AND PRECAUTIONS]
- Rash in Patients with Mononucleosis [see WARNINGS AND PRECAUTIONS]
- Uveitis [see WARNINGS AND PRECAUTIONS]
What Is Talicia?
Talicia (omeprazole magnesium, amoxicillin and rifabutin) is a three-drug combination of:
What Are Side Effects of Talicia?
Side effects of Talicia include:
Dosage for Talicia
The dosage of Talicia is four (4) capsules every 8 hours with food for 14 days.
Talicia In Children
Safety and effectiveness of Talicia in pediatric patients below the age of 18 years with H. pylori infection has not been established.
What Drugs, Substances, or Supplements Interact with Talicia?
Talicia may interact with other medicines such as:
Tell your doctor all medications and supplements you use.
Talicia During Pregnancy and Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant before using Talicia; it may harm a fetus. Both rifabutin and amoxicillin components of Talicia interact with hormonal contraceptives resulting in lower levels of these contraceptives. Female patients taking hormonal contraceptives should use an additional non-hormonal method of contraception while taking Talicia. Amoxicillin passes into breast milk. Omeprazole may pass into breast milk. It is unknown if rifabutin passes into breast milk. Consult your doctor before breastfeeding.
Additional Information
Our Talicia (omeprazole magnesium, amoxicillin and rifabutin) Delayed-Release Capsules, for Oral Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).
Call your doctor at once if you have:
Common side effects may include:
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Talicia (Omeprazole Magnesium, Amoxicillin and Rifabutin Delayed-release Capsules)
SIDE EFFECTS
The following serious adverse reactions are described below and elsewhere in labeling:
Clinical Trials Experience With TALICIA
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of TALICIA was assessed in adult patients who were screened and found to be positive for H. pylori infection in one active-controlled (Study 1) and one placebo-controlled (Study 2) clinical trial. Patients received TALICIA, amoxicillin and omeprazole, or placebo every eight hours for 14 consecutive days taken with food. A total of 305 patients received TALICIA in Studies 1 and 2, 227 patients received amoxicillin and omeprazole (as omeprazole magnesium) in Study 1, and 41 patients received placebo in Study 2. These patients had a mean age of 46.4 years (range 18 to 70 years); 62.3% were female, 80.3% were white with 64.2% Hispanic or Latino.
Adverse Reactions Leading To Discontinuation
Treatment discontinuation due to an adverse reaction occurred in 1% (4/305) of patients receiving TALICIA, <1% (1/227) of patients receiving amoxicillin and omeprazole, and 2% (1/41) of patients receiving placebo.
Adverse reactions leading to discontinuation of TALICIA were nausea and vomiting, nausea, nasal congestion, and nasopharyngitis, in one patient each.
Most Common Adverse Reactions
Selected adverse reactions occurring in ≥1% of patients receiving TALICIA in Study 1 and 2 are described in Table 1.
Table 1: Selected Adverse Reactions Occurring in 1% or Greater of Patients Receiving TALICIA in Studies 1 and 2
| Adverse Reaction | Study 1 | Study 2 | ||
| TALICIA (N=228) n (%) | Amoxicillin and Omeprazole (N=227) n (%) | TALICIA (N=77) n (%) | Placebo (N=41) n (%) | |
| Diarrhea | 23 (10.1) | 18 (7.9) | 11 (14.3) | 4 (9.8) |
| Headachea | 17 (7.5) | 16 (7.0) | 12 (15.6) | 4 (9.8) |
| Nausea | 11 (4.8) | 12 (5.3) | 3 (3.9) | 1 (2.4) |
| Abdominal painb | 8 (3.5) | 11 (4.8) | 3 (3.9) | 2 (4.9) |
| Chromaturiac | 0 | 0 | 10 (13.0) | 1 (2.4) |
| Rashd | 6 (2.6) | 2 (0.9) | 4 (5.2) | 0 |
| Dyspepsiae | 5 (2.2) | 3 (1.3) | 1 (1.3) | 0 |
| Vomiting | 5 (2.2) | 5 (2.2) | 1 (1.3) | 2 (4.9) |
| Oropharyngeal pain | 2 (0.9) | 2 (0.9) | 3 (3.9) | 0 |
| Vulvovaginal candidiasisf | 5 (2.2) | 5 (2.2) | 0 | 0 |
| a Headache includes: headache and migraine. b Abdominal pain includes: abdominal pain, abdominal pain upper, and abdominal pain lower. c Riboflavin was administered in Study 1 to prevent unintentional unblinding and may have contributed to under-reporting of chromaturia. d Rash includes: rash, rash maculo-papular, rash morbilliform, and urticaria. e Dyspepsia includes: dyspepsia and epigastric discomfort. f Vulvovaginal candidiasis includes: vulvovaginal candidiasis, vulvovaginal mycotic infection, fungal infection, and vaginal discharge + vulvovaginal burning sensation + vulvovaginal pruritus. | ||||
Other Important Adverse Reactions From The Labeling Of The Individual Components Of TALICIA
Additional adverse reactions that occurred in 1% or greater of patients treated with omeprazole or rifabutin alone in clinical trials were as follows:
Omeprazole
Flatulence, acid regurgitation, upper respiratory infection, constipation, dizziness, asthenia, back pain, and cough.
Rifabutin
Flatulence, asthenia, chest pain, fever, pain, leucopenia, anemia, anorexia, eructation, myalgia, insomnia, and taste perversion.
The following selected adverse reactions occurred in less than 1% of patients treated with rifabutin alone: flu-like syndrome, hepatitis, hemolysis, arthralgia, myositis, dyspnea, skin discoloration, thrombocytopenia, pancytopenia, and jaundice.
Post-Marketing Experience With Components Of TALICIA
Because these reactions are voluntarily reported from a population of uncertain size, it is not always possible to reliably estimate their actual frequency or establish a causal relationship to drug exposure.
Omeprazole
Cardiovascular: angina, tachycardia, bradycardia, palpitations, elevated blood pressure, peripheral edema
Endocrine: gynecomastia
Gastrointestinal: pancreatitis including fatal pancreatitis, anorexia, irritable colon, fecal discoloration, mucosal atrophy of the tongue, stomatitis, abdominal swelling, dry mouth, microscopic colitis, fundic gland polyps, gastroduodenal carcinoids in patients with Zollinger-Ellison syndrome on long-term treatment as a manifestation of the underlying condition associated with such tumors
Hepatic: fatal hepatic failure or necrosis, hepatic encephalopathy, hepatocellular disease, cholestatic disease, mixed hepatitis, jaundice
Metabolism and Nutritional disorders: hypoglycemia, hypomagnesemia, with or without hypocalcemia and/or hypokalemia, hyponatremia, weight gain
Musculoskeletal: muscle weakness, myalgia, muscle cramps, joint pain, leg pain, bone fracture.
Nervous System/Psychiatric: depression, agitation, aggression, hallucinations, confusion, insomnia, nervousness, apathy, somnolence, anxiety, dream abnormalities, tremors, paresthesia, vertigo
Respiratory: epistaxis
Skin: photosensitivity, urticaria, pruritus, petechiae, purpura, alopecia, dry skin, hyperhidrosis
Special Senses: tinnitus, taste perversion
Ocular: optic atrophy, optic neuritis, dry eye syndrome, ocular irritation, blurred vision, double vision
Urogenital: hematuria, proteinuria, elevated serum creatinine, microscopic pyuria, urinary tract infection, glycosuria, urinary frequency, testicular pain
Hematologic: Agranulocytosis, hemolytic anemia, pancytopenia, neutropenia, anemia, thrombocytopenia, leukopenia, leukocytosis
Amoxicillin
Gastrointestinal: black hairy tongue
Liver: hepatic dysfunction, cholestatic jaundice, cholestasis, acute cytolytic hepatitis
Renal: crystalluria [see OVERDOSE]
Hemic and Lymphatic Systems: anemia, hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia, and agranulocytosis
Central Nervous System: hyperactivity, agitation, anxiety, insomnia, confusion, convulsions, behavioral changes, and/or dizziness
Rifabutin
Blood and lymphatic system disorders: agranulocytosis, lymphopenia
Read the entire FDA prescribing information for Talicia (Omeprazole Magnesium, Amoxicillin and Rifabutin Delayed-release Capsules)
© Talicia Patient Information is supplied by Cerner Multum, Inc. and Talicia Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
