Saturday, December 20, 2014
Home
Pylera Capsules

Pylera Capsules


Take the Tummy Trouble Digestive Quiz

Pylera Capsules Drug Description


PYLERA™ Capsules
(bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride)
140 mg/125 mg/125 mg

To reduce the development of drug-resistant bacteria and maintain the effectiveness of PYLERA™ and other antibacterial drugs, PYLERA™ should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

WARNING

Metronidazole has been shown to be carcinogenic in mice and rats. (See PRECAUTIONS) Unnecessary use of the drug should be avoided. Its use should be reserved for the conditions described in the INDICATIONS AND USAGE section below.

DRUG DESCRIPTION

PYLERA™ capsules (bismuth subcitrate potassium) are a combination antimicrobial product containing bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride for oral administration. Each size 0 elongated hard gelatin capsule contains:

-           bismuth subcitrate potassium, 140 mg
-           metronidazole, 125 mg
-           smaller capsule (size 3) containing tetracycline hydrochloride, 125 mg

Bismuth subcitrate potassium is a white or almost white powder. It is a soluble, complex bismuth salt of citric acid. The schematized empirical molecular formula of bismuth subcitrate potassium is Bi(Citrate)2K5•3 H2O. The equivalent theoretical molecular formula is BiC12H14K5O17. The molecular mass of the theoretical molecular formula of a single unit of bismuth subcitrate potassium is 834.71.

Metronidazole is a white to pale yellow crystalline powder. Metronidazole is 2-methyl-5-nitroimidazole-1-ethanol, with a molecular formula of C6H9N3O3 and the following structural formula:

Pylera (Metronidazole) structural formula illustration

Molecular weight: 171.2

Tetracycline hydrochloride is a yellow, odorless, crystalline powder. Tetracycline is stable in air, but exposure to strong sunlight causes it to darken. Tetracycline hydrochloride is (4S,4aS,5aS,6S,12aS)-4- (dimethylamino)-1,4,4a,5,5a,6,11, 12a-octahydro-3,6,10,12, 12a-penta-hydroxy-6-methyl-1, 11-dioxo-2-naphthacenecarboxamide hydrochloride, with a molecular formula of C22H24N2O8•HCl and the following structural formula:

Pylera (Tetracycline hydrochloride) structural formula illustration

Each PYLERA™ capsule contains the following inactive ingredients: Magnesium Stearate NF, Lactose Monohydrate NF, Talc USP, Gelatin USP, and Titanium Dioxide NF. Printed with red ink.

 

What are the possible side effects of bismuth subcitrate potassium, metronidazole, and tetracycline (Pylera)?

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,...

Read All Potential Side Effects and See Pictures of Pylera Capsules »

 

What are the precautions when taking bismuth subcitrate potassium (Pylera Capsules)?

Before taking this product, tell your doctor or pharmacist if you are allergic to bismuth subcitrate, metronidazole, or tetracycline; or to other nitroimidazoles (e.g., tinidazole); or to other tetracyclines (e.g., doxycycline); or to other bismuth products (e.g., bismuth subsalicylate); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: kidney disease, liver disease.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood disorders, brain/spinal cord...

 

Pylera Capsules


Pylera Capsules Indications & Dosage


INDICATIONS

PYLERA™ capsules (bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride), in combination with omeprazole are indicated for the treatment of patients with Helicobacter pylori infection and duodenal ulcer disease (active or history of within the past 5 years) to eradicate H. pylori. The eradication of Helicobacter pylori has been shown to reduce the risk of duodenal ulcer recurrence. (See CLINICAL STUDIES and DOSAGE AND ADMINISTRATION)

To reduce the development of drug-resistant bacteria and maintain the effectiveness of PYLERA™ and other antibacterial drugs, PYLERA™ should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

DOSAGE AND ADMINISTRATION

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. Patients should be instructed to swallow the PYLERA™ capsules (bismuth subcitrate potassium) whole with a full glass of water (8 ounces). One omeprazole 20 mg capsule should be taken twice a day with PYLERA™ after the morning and evening meal for 10 days.

Table 6: Daily Dosing Schedule for PYLERA™ and Omeprazole

Time of dose Number of capsules of PYLERA™ Number of capsules of Omeprazole 20 mg
After morning meal 3 1
After lunch 3 0
After evening meal 3 1
At bedtime 3 0

Ingestion of adequate amounts of fluid, particularly with the bedtime dose, is recommended to reduce the risk of esophageal irritation and ulceration by tetracycline hydrochloride.

HOW SUPPLIED

PYLERA™ is supplied as a white opaque capsule containing 140 mg bismuth subcitrate potassium, 125 mg metronidazole, and 125 mg tetracycline hydrochloride, with Axcan Pharma logo printed on body and BMT printed on cap. PYLERA™ is supplied in bottles of 120 capsules.

NDC Number 58914-600-21, Bottle of 120.

Store at controlled room temperature [68° to 77°F or 20° to 25°C].

CAUTION: Federal law prohibits dispensing without a prescription.

Pylera(tm) is a trademark owned by Axcan Pharma Inc.
Axcan Pharma™ and the Axcan Pharma™ logo are trademarks of Axcan Pharma Inc., the parent company of Axcan Scandipharm Inc.
PYLERA™ Capsules (bismuth subcitrate potassium) are manufactured by Draxis Health Inc. for Axcan Scandipharm Inc., Birmingham, AL 35242
FDA rev date: 5/24/2007

 

Pylera Capsules


Pylera Capsules Side Effects & Drug Interactions


SIDE EFFECTS

The safety of PYLERA™ plus omeprazole for 10 days to eradicate Helicobacter pylori was evaluated in 324 patients (aged 18 to 75 years) in two clinical trials world-wide. One trial was conducted in the US and Canada (North American Trial). The other trial was conducted in Europe, Australia, Canada and the US (International Trial).

In the North American trial, patients with a duodenal ulcer or history of an ulcer were randomized to PYLERA™ plus omeprazole (OBMT) or omeprazole, amoxicillin, and clarithromycin (OAC). The International trial differed from the North American trial in that there was no comparator group and all patients received OBMT. Also, patients enrolled in the International trial all had gastrointestinal symptoms (i.e., non-ulcer dyspepsia). It was not necessary for these patients to have a history or current duodenal ulcer.

Two hundred and ninety-nine (299) patients (147 OBMT and 152 OAC) were exposed to at least one dose of the study drugs in the North American trial. Of these patients, 86/147 (58.5%) in the OBMT group and 90/152 (59.2%) in the OAC group reported adverse events. In the OBMT group there were 212 events reported and 236 events reported in the OAC group. An adverse event was defined as any event not present prior to exposure to study medication or any event present at study entry that worsens in either intensity or frequency following exposure to study medication.

The most frequent adverse events incidence >1%) by treatment group from the North American trial in order of decreasing incidence for the OBMT group are shown below in Table 5. For both treatments, gastrointestinal adverse events (e.g., diarrhea, dyspepsia, abdominal pain, and nausea) are the most commonly reported.

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 or another drug and may not reflect the rates observed in practice.

Table 5. Adverse Events of Incidence > 1% in Controlled Clinical Trial By Treatment Group, By Decreasing Frequency [n (%)]

Preferred Term OBMT* (n = 147) OAC** (n = 152)
Stool Abnormality 23 (15.6) 7 ( 4.6)
Diarrhea 13 ( 8.8) 23 (15.1)
Dyspepsia 13 (8.8) 17 (11.2)
Abdominal Pain 13 (8.8) 15 (9.9)
Nausea 12 (8.2) 16 (10.5)
Headache 12 (8.2) 11 (7.2)
Flu Syndrome 8 (5.4) 5 (3.3)
Taste Perversion 7 (4.8) 18 (11.8)
Asthenia 6 (4.1) 4 (2.6)
Vaginitis 6 (4.1) 4 (2.6)
Dizziness 5 (3.4) 4 (2.6)
Lab Test Abnormality 4 (2.7) 4 (2.6)
Pain 3 (2.0) 7 (4.6)
Infection 3 (2.0) 5 ( 3.3)
Pharyngitis 3 (2.0) 4 (2.6)
Pain Back 3 (2.0) 2 (1.3)
SGPT Increased 3 (2.0) 0
Urinary abnormality 3 (2.0) 0
Infection 2 (1.4) 6 (3.9)
Rhinitis 2 (1.4) 4 (2.6)
Dry Mouth 2 (1.4) 1 (0.7)
< td=""> <> 2 (1.4) 1 (0.7)
Anxiety 2 (1.4) 0
Gastritis 2 (1.4) 0
Gastroenteritis 2 (1.4) 0
Pain, Chest 2 (1.4) 0
Palpitation 2 (1.4) 0
Rash Maculo-Papular 2 (1.4) 0
SGOT Increase 2 (1.4) 0
Flatulence 1 (0.7) 6 (3.9)
Cough 1 (0.7) 3 (2.0)
Rash 1 (0.7) 3 (2.0)
Sinusitis 1 (0.7) 2 (1.3)
Pruritis 0 4 (2.6)
Glossitis 0 2 (1.3)
OBMT = Omeprazole+PYLERA™ (bismuth subcitrate potassium/metronidazole/tetracycline HCl);
OAC = Omeprazole+Amoxicillin+Clarithromycin

The following selected adverse reactions from the labeling for bismuth subsalicylate, a similar bismuth-containing product to bismuth subcitrate potassium, are provided for information.

Gastrointestinal: black stools

Mouth: temporary and harmless darkening of the tongue

The following selected adverse reactions from the labeling for metronidazole are provided for information.

Mouth: A sharp, unpleasant metallic taste is not unusual. Furry tongue, glossitis, stomatitis have occurred; these may be associated with a sudden overgrowth of Candida which may occur during therapy.

Blood: Reversible neutropenia (leukopenia); rarely, reversible thrombocytopenia.

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

CNS: Two serious adverse reactions reported in patients treated with metronidazole have been convulsive seizures and peripheral neuropathy, the latter characterized mainly by numbness or paresthesia of an extremity. Since persistent peripheral neuropathy has been reported in some patients receiving prolonged administration of metronidazole, patients should be specifically warned about these reactions and should be told to stop the drug and report immediately to their physicians if any neurologic symptoms occur.

Hypersensitivity: urticaria, erythematous rash, flushing, nasal congestion, dryness of mouth (vagina or vulva), and fever.

Other: If patients receiving metronidazole drink alcoholic beverages, they may experience abdominal distress, nausea, vomiting, flushing, or headache. A modification of the taste of alcoholic beverages has also been reported. Rare cases of pancreatitis, which abated on withdrawal of the drug, have been reported.

The following selected adverse reactions from the labeling for tetracycline hydrochloride are provided for information.

Gastrointestinal: 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. (See DOSAGE AND ADMINISTRATION)

Liver: Hepatotoxicity and liver failure have been observed in patients receiving large doses of tetracycline and in tetracycline-treated patients with renal impairment. Increases in liver enzymes and hepatic toxicity have been reported rarely.

Teeth: Permanent discoloration of teeth may be caused during tooth development. Enamel hypoplasia has also been reported. (See WARNINGS)

Blood: hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, neutropenia, and eosinophilia

CNS: Pseudotumor cerebri (benign intracranial hypertension) in adults and bulging fontanels in infants. (See PRECAUTIONS/Tetracycline) Dizziness, tinnitus, and visual disturbances have been reported. Myasthenic syndrome has been reported rarely.

Renal: Rise in BUN has been reported and is apparently dose related. (See WARNINGS)

Skin: Maculopapular and erythematous rashes have been reported. Exfoliative dermatitis has been rarely reported. Photosensitivity has been reported rarely. (See WARNINGS)

DRUG INTERACTIONS

Interactions with Metronidazole

Lithium

In patients stabilized on relatively high doses of lithium, short-term metronidazole therapy has been associated with elevation of serum lithium and, in a few cases, signs of lithium toxicity. Serum lithium and serum creatinine should be obtained several days after beginning metronidazole to detect any increase that may precede clinical symptoms of lithium intoxication.

Alcohol

Alcoholic beverages should not be consumed during metronidazole therapy and for at least 1 day afterward because abdominal cramps, nausea, vomiting, headaches, and flushing may occur. Since some pharmaceutical products may contain alcohol, caution should be exercised in patients taking these medications. Psychotic reactions have been reported in alcoholic patients who are using metronidazole and disulfiram concurrently. Metronidazole should not be given to patients who have taken disulfiram within the last 2 weeks.

Anticoagulants

Metronidazole has been reported to potentiate the anticoagulant effect of warfarin and other oral coumarin anticoagulants, resulting in a prolongation of prothrombin time. Therefore, frequent monitoring therapy with appropriate adjustment of the anticoagulant dosage is warranted with initiation of PYLERA™.

Cimetidine, Phenytoin, or Phenobarbital

The simultaneous administration of drugs that decrease microsomal liver enzyme activity, such as cimetidine, may prolong the half-life and decrease plasma clearance of metronidazole. The simultaneous administration of drugs that induce microsomal liver enzymes, such as phenytoin or phenobarbital, may accelerate the elimination of metronidazole, resulting in reduced plasma levels. Impaired clearance of phenytoin has also been reported in this situation.

Interactions with Tetracycline

Methoxyflurane and Tetracycline

The concurrent use of tetracycline and methoxyflurane has been reported to result in fatal renal toxicity.

Oral Contraceptives and Tetracycline

Concurrent use of tetracycline may render oral contraceptives less effective. Patients should be advised to use a different or additional form of contraception. Breakthrough bleeding has been reported. Women who become pregnant while on PYLERA™ should be advised to notify their prescriber immediately.

Anticoagulants

Tetracycline has been shown to depress plasma prothrombin activity. Therefore, frequent monitoring of anticoagulant therapy with appropriate adjustment of the anticoagulant dosage is warranted with initiation of PYLERA™.

Penicillin

Since bacteriostatic drugs, such as the tetracycline class of antibiotics, may interfere with the bactericidal action of penicillin, it is not advisable to administer these drugs concomitantly.

Antacids, Multivitamins, or Dairy Products

Absorption of tetracyclines is impaired by antacids containing aluminum, calcium, or magnesium; preparations containing iron, zinc, or sodium bicarbonate; or milk or dairy products. The clinical significance of reduced tetracycline systemic exposure is unknown as the relative contribution of systemic versus local antimicrobial activity against Helicobacter pylori has not been established. PYLERA™ should be given after meals and at bedtime, in combination with omeprazole twice a day. (See DOSAGE AND ADMINISTRATION)

Bismuth

There is an anticipated reduction in tetracycline systemic absorption due to an interaction with bismuth. The clinical significance of reduced tetracycline systemic exposure is unknown as the relative contribution of systemic versus local antimicrobial activity against Helicobacter pylori has not been established.

Drug/Laboratory Test Interactions

Bismuth absorbs x-rays and may interfere with x-ray diagnostic procedures of the gastrointestinal tract.

Bismuth subcitrate potassium may cause a temporary and harmless darkening of the stool. However, this does not interfere with standard tests for occult blood.

Metronidazole may interfere with certain types of determinations of serum chemistry values, such as aspartate aminotransferase (AST, SGOT), alanine aminotransferase (ALT, SGPT), lactate dehydrogenase (LDH), triglycerides, and hexokinase glucose. Values of zero may be observed. All of the assays in which interference has been reported involve enzymatic coupling of the assay to oxidation-reduction of nicotinamide (NAD+ <=> NADH). Interference is due to the similarity in absorbance peaks of NADH (340 nm) and metronidazole (322 nm) at pH 7.

 

Pylera Capsules


 

Pylera Capsules Warnings & Precautions


WARNINGS

Bismuth-containing Products

There have been rare reports of neurotoxicity associated with excessive doses of various bismuth-containing products. Effects have been reversible with discontinuation of therapy.

Metronidazole

Central Nervous System Effects

Convulsive seizures and peripheral neuropathy, the latter characterized mainly by numbness or paresthesia of an extremity, have been reported in patients treated with metronidazole. The prevalence and severity of the neuropathy are directly related to the cumulative dose and duration of therapy, being most prevalent in patients taking high doses for prolonged treatment periods. The appearance of abnormal neurologic signs demands the prompt discontinuation of metronidazole therapy. Metronidazole should be administered with caution to patients with central nervous system diseases.

Tetracycline

THE USE OF DRUGS OF THE TETRACYCLINE CLASS DURING TOOTH DEVELOPMENT (LAST HALF OF PREGNANCY, INFANCY, AND CHILDHOOD TO THE AGE OF 8 YEARS) MAY CAUSE PERMANENT DISCOLORATION OF THE TEETH (YELLOW-GRAY-BROWN). This adverse reaction is more common during long-term use of the drugs but has been observed following repeated short-term courses. Enamel hypoplasia has also been reported. TETRACYCLINE HYDROCHLORIDE IS A COMPONENT OF PYLERA™ CAPSULES (bismuth subcitrate potassium) . THEREFORE, PYLERA™ CAPSULES (bismuth subcitrate potassium) SHOULD NOT BE USED IN THESE PATIENT POPULATIONS. (See CONTRAINDICATIONS)

Tetracycline hydrochloride should not be used during pregnancy (see WARNINGS above about use during tooth development). Results of animal studies indicate that tetracycline crosses the placenta, is found in fetal tissues, and can have toxic effects on the developing fetus (often related to retardation of skeletal development). Evidence of embryotoxicity has also been noted in animals treated early in pregnancy. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.

Photosensitivity, manifested by an exaggerated sunburn reaction, has been observed in some individuals taking tetracycline. Patients apt to be exposed to direct sunlight or ultraviolet light should be advised that this reaction can occur with tetracycline drugs. Treatment should be discontinued at the first evidence of skin erythema.

The antianabolic action of the tetracyclines may cause an increase in blood urea nitrogen (BUN). While this is not a problem in those with normal renal function, in patients with significantly impaired renal function, higher serum levels of tetracycline may lead to azotemia, hyperphosphatemia, and acidosis.

PRECAUTIONS

General

Prescribing PYLERA™ in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Bismuth-containing Products

Bismuth subcitrate potassium and other bismuth-containing products may cause a temporary and harmless darkening of the tongue and/or black stool. Stool darkening must not be confused with melena.

Metronidazole

Patients with severe hepatic disease metabolize metronidazole slowly, with resultant accumulation of metronidazole and its metabolites in plasma. (See CONTRAINDICATIONS) Metronidazole is a nitroimidazole and should be used with caution in patients with evidence of, or history of, blood dyscrasia. A mild leukopenia has been observed; however, no persistent hematologic abnormalities attributable to metronidazole have been observed.

Known or previously unrecognized candidiasis may present more prominent symptoms during therapy with metronidazole and requires treatment with an antifungal agent.

Tetracycline

As with other antibiotics, use of tetracycline hydrochloride may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, tetracycline should be discontinued and appropriate therapy should be instituted.

Pseudotumor cerebri (benign intracranial hypertension) in adults has been associated with the use of tetracycline. The usual clinical manifestations are headache and blurred vision. While this condition and related symptoms usually resolve soon after discontinuation of the tetracycline, the possibility for permanent sequelae exists.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No long-term studies have been performed to evaluate the effect of the combined use of bismuth subcitrate potassium, metronidazole, and tetracycline on carcinogenesis, mutagenesis, or impairment of fertility.

Bismuth Subcitrate Potassium

No carcinogenicity or reproductive toxicity studies have been conducted with bismuth subcitrate potassium. Bismuth subcitrate potassium did not show mutagenic potential in the NTP Salmonella plate assay.

Metronidazole

Metronidazole has shown evidence of carcinogenic activity in a number of studies involving chronic, oral administration in mice and rats. Prominent among the effects in the mouse was an increased incidence of pulmonary tumorigenesis. This has been observed in all six reported studies in that species, including one study in which the animals were dosed on an intermittent schedule (administration during every fourth week only). At the highest dose levels, (approximately 500 mg/kg/day, which is approximately 1.4 times the indicated human dose for a 50 kg adult based on body surface area), there was a statistically significant increase in the incidence of malignant liver tumors in male mice. Also, the published results of one of the mouse studies indicate an increase in the incidence of malignant lymphomas as well as pulmonary neoplasms associated with lifetime feeding of the drug. All these effects are statistically significant. Long-term, oral-dosing studies in the rat showed statistically significant increases in the incidence of various neoplasms, particularly in mammary and hepatic tumors, among female rats administered metronidazole over those noted in the concurrent female control groups.

Two lifetime tumorigenicity studies in hamsters have been performed and reported to be negative.

Although metronidazole has shown mutagenic activity in a number of in vitro assay systems, studies in mammals (in vivo) have failed to demonstrate a potential for genetic damage.

Metronidazole, at doses up to 400 mg/kg/day (approximately 2 times the indicated human dose based on mg/m2) for 28 days, failed to produce any adverse effects on fertility and testicular function in male rats. Fertility studies have been performed in mice at doses up to six times the maximum recommended human dose based on mg/m2 and have revealed no evidence of impaired fertility.

Tetracycline hydrochloride

There has been no evidence of carcinogenicity for tetracycline hydrochloride in studies conducted with rats and mice. Some related antibiotics (oxytetracycline, minocycline) have shown evidence of oncogenic activity in rats.

There was evidence of mutagenicity by tetracycline hydrochloride in two in vitro mammalian cell assay systems (L51784y mouse lymphoma and Chinese hamster lung cells).

Tetracycline hydrochloride had no effect on fertility when administered in the diet to male and female rats at a daily intake of 25 times the human dose.

Pregnancy

Teratogenic Effects. Pregnancy Category D

Category D is based on the pregnancy category for tetracycline hydrochloride. (See CONTRAINDICATIONS and WARNINGS/Tetracycline subsections)

Metronidazole crosses the placental barrier and its effects on the human fetal organogenesis are not known. No fetotoxicity was observed when metronidazole was administered orally to pregnant mice at 20 mg/kg/day, approximately 5 percent of the indicated human dose (1500 mg/day) based on body surface area; however, in a single small study where the drug was administered intraperitoneally, some intrauterine deaths were observed. The relationship of these findings to the drug is unknown. There are no adequate and well-controlled studies in pregnant women.

Non-teratogenic Effects

Pregnant women with renal disease may be more prone to develop tetracycline-associated liver failure. (See WARNINGS)

Labor and Delivery

The effect of this therapy on labor and delivery is unknown.

Nursing Mothers

Metronidazole and tetracycline are both secreted into human milk. Metronidazole is secreted in human milk in concentrations similar to those found in plasma. Because of the potential for tumorigenicity shown for metronidazole in mouse and rat studies, and because of the potential for serious adverse reactions in nursing infants from tetracyclines, a decision should be made whether to discontinue nursing or to discontinue therapy, taking into account the importance of the therapy to the mother. (See CONTRAINDICATIONS)

Pediatric Use

Tetracycline use in children may cause permanent discoloration of the teeth. Enamel hypoplasia has also been reported. PYLERA™ should not be used in children less than 8 years of age. Safety and effectiveness of PYLERA™ in pediatric patients infected with Helicobacter pylori have not been established. (See CONTRAINDICATIONS and WARNINGS)

Geriatric Use

Of the 324 patients who received PYLERA™ in clinical studies, 40 were ≥ 65 years old. Clinical studies of PYLERA™ did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy in elderly patients should be considered when prescribing PYLERA™. As stated in the CONTRAINDICATIONS section, PYLERA™ is contraindicated in patients with renal or hepatic impairment.

 

Pylera Capsules


Pylera Capsules Overdosage & Contraindications


OVERDOSE

In case of an overdose, patients should contact a physician, poison control center, or emergency room. There is neither a pharmacological basis nor data suggesting an increased toxicity of the combination compared to individual components.

CONTRAINDICATIONS

PYLERA™ therapy is contraindicated in pregnant or nursing women, pediatric patients, in patients with renal or hepatic impairment, and in those with known hypersensitivity to bismuth subcitrate potassium, metronidazole or other nitroimidazole derivatives, or tetracyclines. (See WARNINGS and PRECAUTIONS)

 

Pylera Capsules


Pylera Capsules Clinical Pharmacology


CLINICAL PHARMACOLOGY

Pharmacokinetics

The pharmacokinetics of the individual components of PYLERA™, bismuth subcitrate potassium, metronidazole and tetracycline, are summarized below. In addition, two studies on PYLERA™ were conducted by Axcan to determine the effect of co-administration on the pharmacokinetics of the components.

Bismuth Subcitrate Potassium (Bismuth)

Orally absorbed bismuth is distributed throughout the entire body. Bismuth is highly bound to plasma proteins (>90%). The elimination half-life of bismuth is approximately 5 days in both blood and urine. Elimination of bismuth is primarily through urinary and biliary routes. The rate of renal elimination appears to reach steady state 2 weeks after treatment discontinuation with similar rates of elimination at 6 weeks after discontinuation. The average urinary elimination of bismuth is 2.6% per day in the first two weeks after discontinuation (urine drug concentrations 24 to 250 µg/mL) suggesting tissue accumulation and slow elimination.

Metronidazole

Following oral administration, metronidazole is well absorbed, with peak plasma concentrations occurring between 1 and 2 hours after administration. Plasma concentrations of metronidazole are proportional to the administered dose, with oral administration of 500 mg producing a peak plasma concentration of 12 µg/mL.

Metronidazole appears in the plasma mainly as unchanged compound with lesser quantities of the 2-hydroxymethyl metabolite also present. Less than 20% of the circulating metronidazole is bound to plasma proteins. Metronidazole also appears in cerebrospinal fluid, saliva, and breast milk in concentrations similar to those found in plasma.

The average elimination half-life of metronidazole in normal volunteers is 8 hours. The major route of elimination of metronidazole and its metabolites is via the urine (60% to 80% of the dose), with fecal excretion accounting for 6% to 15% of the dose. The metabolites that appear in the urine result primarily from side-chain oxidation [1-(β-hydroxyethyl)2-hydroxymethyl-5-nitroimidazole and 2-methyl-5-nitroimidazole-1-yl-acetic acid] and glucuronide conjugation, with unchanged metronidazole accounting for approximately 20% of the total. Renal clearance of metronidazole is approximately 10 mL/min/1.73 m2.

Decreased renal function does not alter the single dose pharmacokinetics of metronidazole. In patients with decreased liver function, plasma clearance of metronidazole is decreased.

Tetracycline Hydrochloride

Tetracycline is absorbed (60%-90%) in the stomach and upper small intestine. The presence of food, milk or cations may significantly decrease the extent of absorption. In the plasma, tetracycline is bound to plasma proteins in varying degrees. It is concentrated by the liver in the bile and excreted in the urine and feces at high concentrations in a biologically active form.

Tetracycline is distributed into most body tissues and fluids. It is distributed into the bile and undergoes varying degrees of enterohepatic recirculation. Tetracycline tends to localize in tumors, necrotic or ischemic tissue, liver and spleen and form tetracycline-calcium orthophosphate complexes at sites of new bone formation or tooth development. Tetracycline readily crosses the placenta and is excreted in high amounts in breast milk.

PYLERA™ Capsules (bismuth subcitrate potassium)

The clinical significance of systemic, as compared to local, drug concentrations for antimicrobial activity against Helicobacter pylori, has not been established. A comparative bioavailability study of metronidazole (375 mg), tetracycline (375 mg) and bismuth subcitrate potassium (420 mg, equivalent to 120 mg Bi2O3) administered as PYLERA™ or as 3 separate capsule formulations administered simultaneously was conducted in healthy male volunteers. The pharmacokinetic parameters for the individual drugs when administered as separate capsule formulations or as PYLERA™ are similar, as shown in Table 1.

Table 1. Mean (%CV) Pharmacokinetic Parameters for Metronidazole, Tetracycline, and Bismuth Subcitrate Potassium in Healthy Volunteers (N=18)


Cmax
(ng/mL)
(%C.V.**)
AUCT
(ng • h/mL)
(%C.V.**)
AUC
(ng • h/mL)
(%C.V.**)
Metronidazole Metronidazole Capsule 9044.7 (20) 80289 (15) 81849 (16)
PYLERA™* 8666.3 (22) 83018 (17) 84413 (17)
Tetracycline Tetracycline Capsules 748.0 (40) 9544 (55) 9864 (53)
PYLERA™* 773.8 (47) 9674 (50) 9987 (49)
Bismuth Bismuth Capsule 21.3 (123) 46.5 (129) 65.4 (113)
PYLERA™* 16.7 (202) 42.5 (191) 56.5 (178)
*PYLERA™ given as a single dose of 3 capsules
**C.V. - Coefficient Variation

The pharmacokinetic parameters for metronidazole, tetracycline and bismuth were also determined when PYLERA™ was administered under fasting and fed conditions, as shown in Table 2. Food reduced the systemic absorption of all three PYLERA™ components, with AUC values for metronidazole, tetracycline and bismuth being reduced by 6%, 34% and 60%, respectively. Reduction in the absorption of all three PYLERA™ components in the presence of food is not considered to be clinically significant. PYLERA™ should be given after meals and at bedtime, in combination with omeprazole twice a day. (See DOSAGE AND ADMINISTRATION)

Table 2. Mean PYLERA™ Pharmacokinetic Parameters in Fasted and Fed States (N=18)*



Omeprazole Capsules

The effect of omeprazole on bismuth absorption was assessed in 34 healthy volunteers given PYLERA™ (qid) with or without omeprazole (20 mg bid) for 6 days. In the presence of omeprazole, the extent of absorption of bismuth from PYLERA™ was significantly increased, compared to when no omeprazole was given (Table 3). Concentration-dependent neurotoxicity is associated with long-term use of bismuth and not likely to occur with short-term administration or at steady state concentrations below 50 ng/mL. One subject transiently achieved a maximum bismuth concentration (Cmax) higher than 50 ng/mL (73 ng/mL) following multiple dosing of PYLERA™ with omeprazole. The patient did not exhibit symptoms of neurotoxicity during the study. There is no clinical evidence to suggest that short-term exposure to Cmax concentrations above 50 ng/mL is associated with neurotoxicity.

Table 3. Mean Bismuth Pharmacokinetic Parameters following PYLERA™
Administration* With and Without Omeprazole (N=34)


Parameter Without omeprazole With omeprazole
Mean %C.V.** Mean %C.V.**
Cmax (ng/mL) 8.1 84 25.5 69
AUCT (ng • h/mL) 48.5 28 140.9 42
*PYLERA™ given as 3 capsules qid for 6 days with or without 20 mg omeprazole bid
**C.V. - Coefficient Variation

Microbiology

The ingredients in PYLERA™ capsules (bismuth subcitrate potassium) are active as antibacterial agents. Tetracycline hydrochloride interacts with the 30S subunit of the bacterial ribosome and inhibits protein synthesis. Metronidazole is metabolized through reductive pathways into reactive intermediates that have cytotoxic action. The antibacterial action of bismuth salts is not well understood.

PYLERA™ plus omeprazole therapy has been shown to be active against most strains of Helicobacter pylori in vitro, and in clinical infections as described in the CLINICAL STUDIES and INDICATIONS AND USAGE sections.

Susceptibility Testing for Helicobacter pylori

Susceptibility testing of Helicobacter pylori isolates was performed for metronidazole using agar dilution methodology according to CLSI1 guidelines and minimum inhibitory concentrations (MICs) were determined.

Susceptibility testing of Helicobacter pylori for metronidazole has not been standardized. No interpretive criteria have been established for testing metronidazole against H. pylori.

The clinical significance of metronidazole MIC values against H. pylori is unknown. In the North American study, pre-treatment metronidazole MIC values showed no correlation with clinical outcome in patients treated with PYLERA™ and omeprazole therapy.

CLINICAL STUDIES

Eradication of Helicobacter pylori in Patients with Active Duodenal Ulcer or History of Duodenal Ulcer Disease

An open-label, parallel group, active-controlled, multicenter study in Helicobacter pylori positive patients with current duodenal ulcer or a history of duodenal ulcer disease was conducted in the United States and Canada.

Patients were randomized to one of the following 10-day treatment regimens:

  • Three (3) PYLERA™ capsules (bismuth subcitrate potassium) four times daily, after meals and at bedtime plus 20 mg omeprazole twice a day after breakfast and supper (OBMT).
  • Clarithromycin 500 mg plus 1000 mg amoxicillin plus 20 mg omeprazole twice a day before breakfast and supper (OAC).

H. pylori eradication rates, defined as two negative 13C-urea breath tests performed at 4 and 8 weeks post-therapy are shown in Table 4 for OBMT and OAC. The eradication rates for both groups were found to be similar using either the Modified Intent-to-Treat (MITT) or Per Protocol (PP) populations.

Table 4. Helicobacter pylori Eradication at 8 Weeks after 10 Day Treatment Regimen Percent (%) of Patients Cured [95% Confidence Interval] (Number of Patients)


Treatment Group Difference
OBMT* OAC* * c
Per Protocola 92.5%
[87.8, 97.2]
(n=120)
85.7%
[76.9, 91.8]
(n=126)
6.8
[-0.9, 14.5]
Modified Intent-to-Treatb 87.7%
[82.2, 93.2]
(n=138)
83.2
[77.0, 89.5]
(n=137)
4.5
[-3.9, 12.8]
* OBMT: Omeprazole + PYLERA™ (bismuth subcitrate potassium / metronidazole / tetraycyline HCl)
** OAC: Omeprazole + Amoxicillin + Clarithromycin
aPatients were included in the analysis if they had H. pylori infection documented at baseline, defined as a positive 13C-UBT plus histology or culture, had at least one endoscopically verified duodenal ulcer ≥0.3 cm at baseline or had a documented history of duodenal ulcer disease, and were not protocol violators. Additionally, if patients dropped out of the study due to an adverse event related to the study drug, they were included in the evaluable analysis as failures of therapy.
b Patients were included in the analysis if they had documented H. pylori infection at baseline as defined above, and had at least one documented duodenal ulcer at baseline or had a documented history of duodenal ulcer disease, and took at least one dose of study medication. All dropouts were included as failures of therapy.
cResults for OAC treatment represent all isolates regardless of clarithromycin susceptibility. Eradication rates for clarithromycin susceptible organisms, as defined by an MIC &le;0.25 µg/mL, were 94.6% and 92.1% for the PP and MITT analysis, respectively. Eradication rates for clarithromycin non-susceptible organisms, as defined by an MIC ≥0.5 µg/mL, were 23.1% and 21.4% for the PP and MITT analysis, respectively.1

REFERENCES

1. Clinical and Laboratory Standards Institute. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard --Seventh Edition. Clinical and Laboratory Standards Institute document M7-A7, Vol. 26, No. 2, CLSI, Wayne, PA, January 2006.

 

Pylera Capsules


Pylera Capsules Medication Guide


PATIENT INFORMATION

  • 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. Patients should be instructed to swallow the PYLERA™ capsules (bismuth subcitrate potassium) whole with a full glass of water (8 ounces). One omeprazole 20 mg capsule should be taken twice a day with PYLERA™ after the morning and evening meal for 10 days.

Daily Dosing Schedule for PYLERA™ and Omeprazole:

Time of dose Number of capsules of PYLERA™ Number of capsules of Omeprazole 20 mg
After morning meal 3 1
After lunch 3 0
After evening meal 3 1
At bedtime 3 0
  • Administration of adequate amounts of fluid, particularly with the bedtime dose of PYLERA™, is recommended to reduce the risk of esophageal irritation and ulceration, which can be associated with tetracycline hydrochloride.
  • Concurrent use of tetracyclines may render oral contraceptives less effective. Patients should be advised to use a different or additional form of contraception. Breakthrough bleeding has been reported. Women who become pregnant while taking PYLERA™, which contains tetracycline hydrochloride, should be advised to notify their prescriber immediately. (See CONTRAINDICATIONS and WARNINGS)
  • Patients taking PYLERA™, which contains tetracycline hydrochloride, should be cautioned to avoid exposure to sun or sun lamps. (See WARNINGS)
  • Alcoholic beverages should be avoided while taking PYLERA™, which contains metronidazole, and for at least one day afterward. (See DRUG INTERACTIONS)
  • Bismuth subcitrate potassium, contained in PYLERA™, may cause temporary and harmless darkening of the tongue and/or black stool. Stool darkening should not be confused with melena (blood in the stool).
  • Missed doses can be made up by continuing the normal dosing schedule until the medication is gone. Patients should not take double doses. If more than 4 doses are missed, the prescriber should be contacted.

 

Pylera Capsules


Pylera Capsules Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

BISMUTH SUBCITRATE/METRONIDAZOLE/TETRACYCLINE - ORAL

 

(BIZ-muth sub-SIT-rate/MET-roe-NYE-da-zole/TET-ra-SYE-kleen)

 

COMMON BRAND NAME(S): Pylera

 

USES: This combination medication is used with an acid blocker (e.g., a proton pump inhibitor such as omeprazole). It is used to treat stomach/intestinal ulcers caused by the bacteria H. pylori and to prevent the ulcers from returning.

Each capsule contains 3 medications: bismuth subcitrate, metronidazole, and tetracycline. Bismuth subcitrate is often used to treat upset stomach, but it is used in this combination to help stop the growth of bacteria. Metronidazole and tetracycline are antibiotics used to treat a wide variety of bacterial infections. They work by stopping the growth of bacteria.

This product treats only bacterial infections. It will not work for viral infections (e.g., common cold, flu). Unnecessary use or misuse of any antibiotic can lead to its decreased effectiveness.

This product is not recommended for use in children.

 

HOW TO USE: Take this medication by mouth 4 times daily (after meals and at bedtime) for 10 days. Take each dose (3 capsules) with a full glass of water (8 ounces or 240 milliliters) unless your doctor directs you otherwise. Swallow the capsules whole. Do not crush or chew the capsules. Do not lie down for 10 minutes after taking this medication.

Follow your doctor's instructions on how to correctly take an acid blocker with this medication.

Take this medication 2 to 3 hours before or after taking any products containing magnesium, aluminum, or calcium. These products bind with tetracycline, preventing its full absorption. Some examples include quinapril, certain forms of didanosine (e.g., chewable/dispersible buffered tablets or pediatric oral solution), vitamins/minerals, and antacids. Dairy products (e.g., milk, yogurt), calcium-enriched juice, sucralfate, iron, and zinc are also included.

Take this medication regularly in order to get the most benefit from it. Continue to take this medication and the acid blocker until the full prescribed amount is finished, even if symptoms disappear after a few days. Stopping the medication too early may result in a return of the infection/ulcer.

Tell your doctor if your condition persists or worsens.

 

Pylera Capsules


Pylera Capsules Consumer (continued)

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.

 

PRECAUTIONS: Before taking this product, tell your doctor or pharmacist if you are allergic to bismuth subcitrate, metronidazole, or tetracycline; or to other nitroimidazoles (e.g., tinidazole); or to other tetracyclines (e.g., doxycycline); or to other bismuth products (e.g., bismuth subsalicylate); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: kidney disease, liver disease.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood disorders, brain/spinal cord disorders (e.g., seizures), trouble swallowing, esophagus problems (e.g., hiatal hernia, reflux disease-GERD).

Before having surgery, tell your doctor or dentist that you are using this product.

Tetracycline may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

This product may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages and products that contain alcohol (e.g., certain cough-and-cold products) while taking this product and for at least 1 day afterward. Alcohol may increase dizziness or cause a severe reaction with metronidazole (including abdominal cramping, nausea, vomiting, headache, and flushing).

The elderly may be at greater risk for side effects while using this product.

Children should not take this product because it contains tetracycline. Tetracycline may cause permanent tooth discoloration and other problems in children younger than 8 years. Tooth discoloration has also occurred in older children and young adults. Consult the doctor for more information.

This product is not recommended for use during pregnancy because it may harm an unborn baby. Women who could become pregnant should use effective, non-hormonal birth control (e.g., condom, diaphragm with spermicide) while taking this medication. Consult your doctor for more details. See also Drug Interactions.

This combination product contains drugs that may pass into breast milk and could have undesirable effects on a nursing infant. Therefore, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.

Pylera Capsules


Pylera Capsules Consumer (continued)

DRUG INTERACTIONS: 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 them first.

This drug should not be used with the following medications because very serious interactions may occur: acitretin, alitretinoin, amprenavir solution taken by mouth, isotretinoin, strontium, tretinoin taken by mouth.

Avoid disulfiram for 2 weeks before and during treatment with this medication.

If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting this product.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: atovaquone, "blood thinners" (e.g., warfarin, heparin), busulfan, digoxin, drugs affecting liver enzymes that remove metronidazole from your body (such as cimetidine, certain anti-seizure medicines including phenytoin, phenobarbital), fluorouracil, lithium, live bacterial vaccines (e.g., typhoid vaccine), methoxyflurane, penicillins (e.g., amoxicillin, dicloxacillin), tretinoin applied to the skin.

Although most antibiotics probably do not affect hormonal birth control such as pills, patch, or ring, some antibiotics may decrease their effectiveness. This could cause pregnancy. Examples include rifamycins such as rifampin or rifabutin. Be sure to ask your doctor or pharmacist if you should use additional reliable birth control methods while using this antibiotic.

This product may interfere with certain laboratory tests (including liver function tests, triglycerides, hexokinase glucose, lactate dehydrogenase), possibly causing false test results. This product may also interfere with X-ray exams of the stomach/intestines. Make sure laboratory personnel and all your doctors know you use this drug.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

 

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: seizures.

 

NOTES: Do not share this medication with others.

Laboratory and/or medical tests may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

This medication has been prescribed for your current condition only. Do not use it later for another infection unless told to do so by your doctor. A different medication may be necessary in that case.

 

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up. Contact your doctor if you miss more than 4 doses.

 

STORAGE: Store at room temperature between 68-77 degrees F (20-25 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Pylera Capsules


Pylera Capsules Patient Information Including Side Effects

Brand Names: Pylera

Generic Name: bismuth subcitrate potassium, metronidazole, and tetracycline (Pronunciation: BIZ muth sub SIT rate poe TASS ee um, MET roe NYE da zole, TET ra SYE kleen)

 

  • What is bismuth subcitrate potassium, metronidazole, and tetracycline (Pylera Capsules)?
  • What are the possible side effects of bismuth subcitrate potassium, metronidazole, and tetracycline (Pylera Capsules)?
  • What is the most important information I should know about bismuth subcitrate potassium, metronidazole, and tetracycline (Pylera Capsules)?
  • What should I discuss with my health care provider before taking bismuth subcitrate potassium, metronidazole, and tetracycline (Pylera Capsules)?
  • How should I take bismuth subcitrate potassium, metronidazole, and tetracycline (Pylera Capsules)?
  • What happens if I miss a dose (Pylera Capsules)?
  • What happens if I overdose (Pylera Capsules)?
  • What should I avoid while taking bismuth subcitrate potassium, metronidazole, and tetracycline (Pylera Capsules)?
  • What other drugs will affect bismuth subcitrate potassium, metronidazole, and tetracycline (Pylera Capsules)?
  • Where can I get more information?

 

What is bismuth subcitrate potassium, metronidazole, and tetracycline (Pylera Capsules)?

Bismuth subcitrate potassium is a mineral.

Metronidazole and tetracycline are antibiotics that fight bacteria in the body.

The combination of bismuth subcitrate potassium, metronidazole, and tetracycline is used to treat stomach ulcer with H pylori infection. This medication is usually used together with omeprazole (Prilosec).

This medication may also be used for other purposes not listed in this medication guide.

What are the possible side effects of bismuth subcitrate potassium, metronidazole, and tetracycline (Pylera Capsules)?

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.

What is the most important information I should know about bismuth subcitrate potassium, metronidazole, and tetracycline (Pylera Capsules)?

Do not use this medication if you are pregnant. It could cause harm to the unborn baby, including permanent discoloration of the teeth later in life. Tetracycline can make birth control pills less effective. Use a second method of birth control while you are using this bismuth subcitrate potassium, metronidazole, and tetracycline to keep from getting pregnant.

Tetracycline passes into breast milk and may affect bone and tooth development in a nursing baby. Do not take this medication without telling your doctor if you are breast-feeding a baby.

Do not give this medication to a child.

Do not drink alcohol while you are taking this medication and for at least 1 day after you stop taking it. You may have unpleasant side effects such as fast heartbeats, warmth or redness under your skin, tingly feeling, nausea, and vomiting.

Check the labels of any medicines or food products you use to make sure they do not contain alcohol.

Avoid taking this medication with milk or other dairy products. Also avoid taking iron supplements, multivitamins, calcium supplements, or antacids. These products can make it harder for your body to absorb tetracycline.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, call your doctor. Do not use any medicine to stop the diarrhea unless your doctor has told you to.

Related Drug Centers
  • Pylera Capsules

Pylera Capsules


Pylera Capsules Patient Information including How Should I Take

In this Article

  • What is bismuth subcitrate potassium, metronidazole, and tetracycline (Pylera Capsules)?
  • What are the possible side effects of bismuth subcitrate potassium, metronidazole, and tetracycline (Pylera Capsules)?
  • What is the most important information I should know about bismuth subcitrate potassium, metronidazole, and tetracycline (Pylera Capsules)?
  • What should I discuss with my health care provider before taking bismuth subcitrate potassium, metronidazole, and tetracycline (Pylera Capsules)?
  • How should I take bismuth subcitrate potassium, metronidazole, and tetracycline (Pylera Capsules)?
  • What happens if I miss a dose (Pylera Capsules)?
  • What happens if I overdose (Pylera Capsules)?
  • What should I avoid while taking bismuth subcitrate potassium, metronidazole, and tetracycline (Pylera Capsules)?
  • What other drugs will affect bismuth subcitrate potassium, metronidazole, and tetracycline (Pylera Capsules)?
  • Where can I get more information?

What should I discuss with my health care provider before taking bismuth subcitrate potassium, metronidazole, and tetracycline (Pylera Capsules)?

You should not use this medication if you are allergic to bismuth subcitrate potassium, metronidazole, or tetracycline, or if you have certain conditions. Be sure your doctor knows if you have:

  • liver disease;
  • kidney disease;
  • if you are pregnant; or
  • if you are breast-feeding a baby.

Do not give this medication to a child.

Before using bismuth subcitrate potassium, metronidazole, and tetracycline, tell your doctor if you are allergic to any drugs, or if you have:

  • epilepsy or other seizure disorder; or
  • nerve disorders.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take this medication.

FDA pregnancy category D. This medication can cause harm to an unborn baby, including permanent discoloration of the teeth later in life. Do not use tetracycline without your doctor's consent if you are pregnant. Tell your doctor if you become pregnant during treatment. Tetracycline can make birth control pills less effective. Use a non-hormonal method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while you are taking tetracycline.

Metronidazole and tetracycline can pass into breast milk and may cause harm to a nursing baby. Tetracycline can affect bone and tooth development in a nursing infant. Do not take this medication without telling your doctor if you are breast-feeding a baby.

How should I take bismuth subcitrate potassium, metronidazole, and tetracycline (Pylera Capsules)?

Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Bismuth subcitrate potassium, metronidazole, and tetracycline is usually given 4 times per day, after meals and at bedtime. The omeprazole taken with this medication is usually given twice per day, after the morning and the evening meal. The usual course of treatment with this combination of medicines is 10 days. Follow your doctor's instructions.

Take bismuth subcitrate potassium, metronidazole, and tetracycline with a full glass (8 ounces) of water. Swallow the capsule whole.

This medication may cause your tongue to become darker in color. It may also cause your stools to appear black in color. These are temporary and harmless side effects of bismuth subcitrate potassium, metronidazole, and tetracycline.

This medication can interfere with X-ray tests of your stomach or intestines. Tell any doctor who treats you that you are taking bismuth subcitrate potassium, metronidazole, and tetracycline.

If you need to have any type of surgery, tell the surgeon ahead of time that you are taking tetracycline. You may need to stop using the medicine for a short time.

Store bismuth subcitrate potassium, metronidazole, and tetracycline at room temperature away from moisture and heat.

Related Drug Centers
  • Pylera Capsules

Pylera Capsules


Pylera Capsules Patient Information including If I Miss a Dose

In this Article

  • What is bismuth subcitrate potassium, metronidazole, and tetracycline (Pylera Capsules)?
  • What are the possible side effects of bismuth subcitrate potassium, metronidazole, and tetracycline (Pylera Capsules)?
  • What is the most important information I should know about bismuth subcitrate potassium, metronidazole, and tetracycline (Pylera Capsules)?
  • What should I discuss with my health care provider before taking bismuth subcitrate potassium, metronidazole, and tetracycline (Pylera Capsules)?
  • How should I take bismuth subcitrate potassium, metronidazole, and tetracycline (Pylera Capsules)?
  • What happens if I miss a dose (Pylera Capsules)?
  • What happens if I overdose (Pylera Capsules)?
  • What should I avoid while taking bismuth subcitrate potassium, metronidazole, and tetracycline (Pylera Capsules)?
  • What other drugs will affect bismuth subcitrate potassium, metronidazole, and tetracycline (Pylera Capsules)?
  • Where can I get more information?

What happens if I miss a dose (Pylera Capsules)?

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

If you miss more than 4 doses, call your doctor for instructions.

What happens if I overdose (Pylera Capsules)?

Seek emergency medical attention if you think you have used too much of this medicine.

Symptoms of a bismuth subcitrate potassium, metronidazole, and tetracycline overdose are not known.

What should I avoid while taking bismuth subcitrate potassium, metronidazole, and tetracycline (Pylera Capsules)?

Do not drink alcohol while you are taking this medication and for at least 1 day after you stop taking it. You may have unpleasant side effects such as fast heartbeats, warmth or redness under your skin, tingly feeling, nausea, and vomiting.

Check the labels of any medicines or food products you use to make sure they do not contain alcohol.

Avoid taking this medication with milk or other dairy products. Also avoid taking iron supplements, multivitamins, calcium supplements, or antacids. These products can make it harder for your body to absorb tetracycline.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, call your doctor. Do not use any medicine to stop the diarrhea unless your doctor has told you to.

Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Tetracycline can make your skin more sensitive to sunlight and sunburn may result. Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun.

What other drugs will affect bismuth subcitrate potassium, metronidazole, and tetracycline (Pylera Capsules)?

The following drugs can interact with bismuth subcitrate potassium, metronidazole, and tetracycline. Tell your doctor if you are using any of these:

  • cimetidine (Tagamet);
  • lithium (Lithobid, Eskalith, others);
  • a blood thinner such as warfarin (Coumadin);
  • seizure medication such as phenytoin (Dilantin) or phenobarbital (Luminal, Solfoton); or
  • a penicillin antibiotic such as amoxicillin (Amoxil, Trimox, others), penicillin (BeePen-VK, Pen-Vee K, Veetids, others), dicloxacillin (Dynapen), carbenicillin (Geocillin), oxacillin (Bactocill), and others.

This list is not complete and there may be other drugs that can interact with bismuth subcitrate potassium, metronidazole, and tetracycline. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about bismuth subcitrate potassium, metronidazole, and tetracycline.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2010 Cerner Multum, Inc. Version: 1.03. Revision date: 4/12/2009.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

Healthwise

 

Related Drug Centers
  • Pylera Capsules
Share
 
Ruai Pharm Stats