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Pylera Capsules

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Pylera Capsules

Pylera Capsules

Pylera Capsules Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Pylera (bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride) is used to treat stomach ulcer with H pylori infection. This medication is usually used together with omeprazole (Prilosec). Bismuth subcitrate potassium is a mineral. Metronidazole and tetracycline are antibiotics. Common side effects include nausea, diarrhea, upset stomach, abdominal pain, changes in taste, headache, or dizziness.

Each dose of Pylera includes 3 capsules. Each dose of all 3 capsules should be taken 4 times a day, after meals and at bedtime for 10 days. Take capsules whole with a full 8 oz. glass of water. One omeprazole 20 mg capsule should be taken twice a day with Pylera after the morning and evening meal for 10 days. Pylera may interact with cimetidine, lithium, blood thinners, seizure medications, or penicillin antibiotics. Tell your doctor all medications you use. Pylera is not recommended for use during pregnancy because it may harm a fetus. Women who could become pregnant should use non-hormonal birth control (e.g., condom, diaphragm with spermicide) while taking this medication. Consult your doctor. This combination product contains drugs that may pass into breast milk and could have undesirable effects on a nursing infant. Breast-feeding is not recommended while using this drug.

Our Pylera (bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride) 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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Pylera Capsules in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • diarrhea that is watery or bloody;
  • seizures (convulsions);
  • numbness, burning, pain, or tingly feeling in your hands or feet;
  • burning or irritation in your throat, chest, or upper stomach;
  • fever, chills, body aches, flu symptoms;
  • easy bruising or bleeding, unusual weakness; or
  • nausea, stomach pain, loss of appetite, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • stomach pain;
  • nausea, upset stomach;
  • headache;
  • dizziness;
  • white patches or sores inside your mouth or on your lips;
  • metallic taste in your mouth; or
  • vaginal itching or discharge.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Pylera Capsules (Bismuth Subcitrate Potassium) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Pylera Capsules Overview - Patient Information: Side Effects

SIDE EFFECTS: Nausea, diarrhea, upset stomach, abdominal pain, changes in taste, headache, or dizziness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Your tongue may turn dark in color while you are taking this medication. This is harmless, and the effect will disappear when you stop the medication.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: numbness/tingling of arms/legs, discolored teeth, mental/mood changes (such as confusion, anxiety, irritability, depression), difficult/painful swallowing, heartburn, fast/pounding heartbeat, ringing in the ears, frequent/painful urination.

Tell your doctor immediately if any of these rare but very serious side effects occur: severe headache, stiff/painful neck, vision changes (e.g., blurred vision), change in the amount of urine, signs of infection (e.g., fever, persistent sore throat), easy bruising/bleeding, dark urine, yellowing eyes/skin, persistent nausea/vomiting, severe stomach/abdominal pain, unusual weakness/tiredness, seizures, chest pain.

This product commonly causes dark stools that are usually not serious. However, you may not be able to tell this effect apart from blood in the stool, which could be a sign of a serious condition. Therefore, tell your doctor immediately if you have dark stools.

This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of resistant bacteria. This condition may occur during treatment or weeks to months after treatment has stopped. Do not use anti-diarrhea products or narcotic pain medications if you have any of the following symptoms because these products may make them worse. Tell your doctor immediately if you develop: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool.

Use of this medication for prolonged or repeated periods may result in oral thrush or a new yeast infection. Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge, or other new symptoms.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Pylera Capsules (Bismuth Subcitrate Potassium)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Pylera Capsules FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Clinical Trials Experience

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 PYLERA plus omeprazole (OBMT) to eradicate Helicobacter pylori was assessed in an open-label, randomized, active-controlled clinical trial conducted in North America. The duration of treatment was 10 days with 147 patients exposed to PYLERA plus omeprazole (OBMT) and 152 exposed to control, consisting of omeprazole, amoxicillin, and clarithromycin (OAC). The age of the population in the study ranged from 18 to 75 years, with 59% male patients and 59% Caucasian patients.

Adverse drug reactions were reported in 58% of patients in the OBMT group and 59% of patients in the OAC group. There were no adverse reactions leading to discontinuation of the study during the clinical trial.

Adverse reactions with an incidence of ≥ 5% in OBMT group include abnormal feces, diarrhea, nausea, and headache. Adverse drug reactions with an incidence of ≥ 5% in OAC group include diarrhea, dysgeusia, dyspepsia, nausea and headache.

Table 2 lists adverse reactions with an incidence of ≥ 1%, in either groups (OBMT vs OAC) and in order of decreasing incidence for the OBMT group.

Table 2: Adverse reactions with an incidence of ≥ 1% from North American trial, [n (%)]

Preferred Term OBMT*
(n = 147)
OAC**
(n = 152)
Gastrointestinal disorders
Abnormal feces*** 23 (15.6%) 7 (4.6%)
Nausea 12 (8.2%) 14 (9.2%)
Diarrhea 10 (6.8%) 20(13.2%)
Abdominal Pain 7 (4.8%) 2(1.3%)
Dyspepsia 4 (2.7%) 10(6.6%)
Constipation 2 (1.4%) 5 (3.3%)
Dry Mouth 2(1.4%) 1 (0.7%)
Flatulence 0 4 (2.6%)
Glositis 0 2(1.3%)
General disorders and administration site conditions
Asthenia 5 (3.4%) 2(1.3%)
Infections and infestations
Vaginal infection 4 (2.7%) 3 (2.0%)
Nervous svstem disorders
Headache 8 (5.4%) 8 (5.3%)
Dysgeusia 6(4.1%) 18(11.8%)
Dizziness 4 (2.7%) 4 (2.6%)
Investigations
Laboratory test abnormal 3 (2.0%) 4 (2.6%)
Alanine aminotransferase increased 2(1.4%) 0
Aspartate aminotransferase increased 2 (1.4%) 0
Renal and urinarv disorders
Urine abnormality 2(1.4%) 0
Skin and subcutaneous tissue disorders
Rash Maculo-Papular 2(1.4%) 0
Rash 1 (0.7%) 3 (2.0%)
Pruritus 0 4 (2.6%)
*OBMT = Omeprazole + PYLERA
**OAC = Omeprazole + Amoxicillin + Clarithromycin;
*** Dark stools [See WARNINGS AND PRECAUTIONS]

Adverse reactions with an incidence of < 1% for OBMT group are: back pain, vomiting, tongue darkening [See WARNINGS AND PRECAUTIONS], anxiety, gastritis, gastroenteritis, myalgia, chest pain, increased appetite, blood creatine phosphokinase increased, malaise, somnolence, tachycardia, duodenal ulcer, visual disturbance, weight increased.

Postmarketing Experience

Additionally, the following adverse reactions, presented by system organ class in alphabetical order, have been identified during post approval use of PYLERA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

  • Gastrointestinal disorders: abdominal distention, eructation, flatulence
  • General disorders and administration site conditions: chest discomfort, fatigue.
  • Infections and infestations: candidiasis.

Other Important Adverse Reactions from Labeling for the Individual Components of PYLERA

Metronidazole

Blood and Lymphatic system disorders: reversible neutropenia (leucopenia) in cases of prolonged treatment; rarely reversible thrombocytopenia however no persistent haematological abnormalities attributable to metronidazole have been observed [See WARNINGS AND PRECAUTIONS].

Cardiac disorders: Flattening of the T-wave may be seen in electrocardiographic tracings.

Gastrointestinal disorders: Furry tongue, glositis, stomatitis; these may be associated with a sudden overgrowth of candida which may occur during therapy [See WARNINGS AND PRECAUTIONS].

Immune system disorders: Urticaria, erythematous rash, Stevens - Johnson syndrome, toxic epidermal necrolysis, flushing, nasal congestion, and fever [See CONTRAINDICATIONS].

Metabolism and nutrition disorders: Cases of pancreatitis have been reported, which abated on withdrawal of the drug, have been reported.

Nervous system disorders: The most serious adverse reactions reported in patients treated with metronidazole have been convulsive seizures, encephalopathy, aseptic meningitis, optic and peripheral neuropathy, the latter characterized mainly by numbness or paresthesia of an extremity. In addition, patients have reported syncope, vertigo, incoordination, ataxia, confusion, dysarthria, irritability, depression, weakness, and insomnia [See WARNINGS AND PRECAUTIONS].

Tetracycline Hydrochloride

Blood and lymphatic system disorders: Hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, neutropenia, and eosinophilia.

Gastrointestinal disorders: Rare instances of esophagitis and esophageal ulceration have been reported in patients taking the tetracycline-class antibiotics in capsule and tablet form. Most of the patients who experienced esophageal irritation took the medication immediately before going to bed. Permanent discoloration of teeth may be caused when tetracycline is used during tooth development. Enamel hypoplasia has also been reported [See WARNINGS AND PRECAUTIONS].

Nervous system disorders: Pseudotumor cerebri (benign intracranial hypertension) in adults and bulging fontanels in infants. Tinnitus and myasthenic syndrome have been reported rarely.

Renal and urinary disorders: Rise in BUN has been reported and is possibly dose related [See CONTRAINDICATIONS].

Skin and subcutaneous tissue disorders: Maculopapular and erythematous rashes have been reported. Steven-Johnson syndrome, toxic epidermal necrolysis, and erythema multiforme have been reported. Exfoliative dermatitis and photosensitivity have been rarely reported [See WARNINGS AND PRECAUTIONS].

Read the entire FDA prescribing information for Pylera Capsules (Bismuth Subcitrate Potassium) »

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Pylera Capsules - User Reviews

Pylera Capsules User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Pylera Capsules sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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