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PYLERA is a brand name for Bismuth Oxide, supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Pylera® (bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride capsules), in combination with omeprazole, are indicated for: • the eradication of H. pylori in patients with H. pylori infection and active duodenal ulcer Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer…
Verbatim from this product's HC label. Tap a section to expand.
). 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 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.
In patients with a recent history of duodenal ulcers who are H. pylori positive, eradication therapy may reduce the rate of recurrence of duodenal ulcers. 1 Pediatrics (<18 years) Safety and effectiveness of Pylera® and omeprazole in pediatric patients infected with H.
3 Pediatrics). 2 Geriatrics (> 75 years) Safety and effectiveness of Pylera® in patients over 75 years old infected with H. 4 Geriatrics). 2 CONTRAINDICATIONS • Patients who are hypersensitive to bismuth, metronidazole or other nitroimidazole derivatives, any of the tetracyclines, or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see
) Metronidazole should not be administered to patients with active neurological disorders or a Pylera® Page 5 of 35 history of blood dyscrasia, hypothyroidism or hypoadrenalism. Omeprazole should not be administered to patients who are hypersensitive to omeprazole or any of the components of this medication.
The Product Monograph for omeprazole should be consulted. 2 Recommended Dose and Dosage Adjustment Three capsules of Pylera® should be administered four times a day (after meals and at bedtime) for a total daily dose of 12 capsules.
Pylera® should be administered for 10 days. Pylera® should be administered with omeprazole 20 mg taken twice a day (after morning and evening meals). 1 Pediatrics). 4 Administration The capsules should not be opened but be swallowed whole with a full glass (250 mL) of water.
Pylera® and omeprazole should be taken after a meal. Ingestion of adequate amounts of fluid while standing or sitting upright, particularly with the bedtime dose, is recommended to reduce the risk of esophageal irritation and ulceration by tetracycline hydrochloride.
Patients should not lay down immediately after Pylera® and omeprazole intake. 5 Missed Dose Missed doses can be made up by continuing the normal dosage schedule until the medication is gone. 5 OVERDOSAGE In a case of overdose, patients should contact a physician, poison control centre, or emergency room.
There is neither a pharmacologic basis nor data suggesting an increased toxicity of the combination compared to individual components.
Bismuth Subcitrate Potassium:
The optimal treatment of bismuth overdosage is unknown. Gastric lavage, purgation, and hydration should be considered, even if the patient presents late, as bismuth may be absorbed from the colon. Chelating agents may be effective in the early stages following ingestion.
, Cardiovascular 08/2024 7 WARNINGS AND PRECAUTIONS, Gastrointestinal 08/2024 7 WARNINGS AND PRECAUTIONS, Neurologic 08/2024 7 WARNINGS AND PRECAUTIONS, Renal 08/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed.
RECENT MAJOR LABEL CHANGES ............................................................................... 2 TABLE OF CONTENTS ...................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION ......................................................
4 1 INDICATIONS ........................................................................................................... 4 2 CONTRAINDICATIONS ...........................................................................................
4 4 DOSAGE AND ADMINISTRATION ........................................................................ 5 5 OVERDOSAGE......................................................................................................... 5 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .............
6 7 WARNINGS AND PRECAUTIONS ......................................................................... 11 8 ADVERSE REACTIONS ........................................................................................ 15 9 DRUG INTERACTIONS .........................................................................................
17 10 CLINICAL PHARMACOLOGY .............................................................................. 18 11 STORAGE, STABILITY AND DISPOSAL ............................................................ 20 12 SPECIAL HANDLING INSTRUCTIONS ...............................................................
20 PART II: SCIENTIFIC INFORMATION ............................................................................ 20 13 PHARMACEUTICAL INFORMATION .................................................................. 20 14 CLINICAL TRIALS .................................................................................................
08/2024 7 WARNINGS AND PRECAUTIONS, Cardiovascular 08/2024 7 WARNINGS AND PRECAUTIONS, Gastrointestinal 08/2024 7 WARNINGS AND PRECAUTIONS, Neurologic 08/2024 7 WARNINGS AND PRECAUTIONS, Renal 08/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed.
RECENT MAJOR LABEL CHANGES ............................................................................... 2 TABLE OF CONTENTS ...................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION ......................................................
4 1 INDICATIONS ........................................................................................................... 4 2 CONTRAINDICATIONS ...........................................................................................
4 4 DOSAGE AND ADMINISTRATION ........................................................................ 5 5 OVERDOSAGE......................................................................................................... 5 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .............
6 7 WARNINGS AND PRECAUTIONS ......................................................................... 11 8 ADVERSE REACTIONS ........................................................................................ 15 9 DRUG INTERACTIONS .........................................................................................
17 10 CLINICAL PHARMACOLOGY .............................................................................. 18 11 STORAGE, STABILITY AND DISPOSAL ............................................................ 20 12 SPECIAL HANDLING INSTRUCTIONS ...............................................................
20 PART II: SCIENTIFIC INFORMATION ............................................................................ 20 13 PHARMACEUTICAL INFORMATION .................................................................. 20 14 CLINICAL TRIALS .................................................................................................
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Haemodialysis may be necessary but whether this hastens tissue clearance is uncertain.
Metronidazole:
Massive ingestion may produce vomiting, ataxia and slight disorientation. 4 g every other day. There is no specific antidote for metronidazole overdose. Management of the patient should consist of symptomatic and supportive therapy. Metronidazole is dialyzable.
Give ipecac syrup or perform gastric lavage. Activated charcoal combined with a cathartic may also be used.
Tetracycline:
The acute toxicity of tetracycline in overdose is not well established in the literature. Therapeutic and overdose quantities of tetracycline can cause gastrointestinal symptoms such as nausea, vomiting, diarrhea, esophagitis or esophageal ulceration.
Pylera® Page 6 of 35 Hypersensitivity reactions including anaphylaxis may also occur. There is no specific antidote for tetracycline overdose. Management of the patient should consist of symptomatic and supportive therapy. Tetracycline is not dialyzable.
Dilute well with water or milk due to the possibility of esophageal ulceration. g. calcium carbonate or lactate, milk of magnesia, aluminum hydroxide). Measures to reduce absorption such as induction of emesis or use of cathartic may be beneficial in certain patients.
For management of a suspected drug overdose, contact your regional poison control centre. 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 1: Dosage Forms, Strengths, Composition and Packaging Pylera® is a hard gelatin capsule, size 0 (a red body and cap), with “BMT” printed on the cap.
Each capsule contains the following components: - a smaller capsule (size 3) containing tetracycline hydrochloride, 125 mg - metronidazole, 125 mg - bismuth subcitrate potassium, 140 mg (equivalent to 40 mg bismuth oxide). Each capsule contains 61 mg of lactose monohydrate and 32 mg of potassium.
Pylera® is supplied in bottles of 120 capsules. 7 WARNINGS AND PRECAUTIONS General The use of Pylera® should be avoided in chronic users of bismuth (>20 days/month) especially in the presence of renal or hepatic insufficiency. Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients oral capsule Bismuth subcitrate potassium (140 mg) [equivalent to 40 mg bismuth oxide], metronidazole (125 mg) and tetracycline hydrochloride (125 mg) D&C Yellow # 10, FD&C Blue # 1, FD&C Red # 40, gelatin, lactose, magnesium stearate, talc, titanium dioxide and white ink Pylera® Page 7 of 35 Bismuth Subcitrate Potassium Bismuth subcitrate potassium may cause a temporary and harmless darkening of the tongue and/or black stool.
Stool darkening should not be confused with melaena. Metronidazole Known or previously unrecognized candidiasis may present more prominent symptoms during therapy with metronidazole and requires treatment with a candicidal agent. Tetracycline Hydrochloride 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 DISCOLOURATION 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, AS A COMPONENT OF PYLERA® THEREFORE SHOULD NOT BE USED IN THESE PATIENT POPULATIONS (see 2 CONTRAINDICATIONS).
As with other antibiotics, use of tetracycline hydrochloride may result in overgrowth of non- susceptible organisms, including fungi. If superinfection occurs, tetracycline should be discontinued and appropriate therapy should be instituted.
Carcinogenesis and Mutagenesis Metronidazole Metronidazole has been shown to be carcinogenic in mice and rats (see 16 NON-CLINICAL TOXICOLOGY). Unnecessary use of the drug should be avoided. Its use should be reserved for the conditions described in the 1 INDICATIONS […]
22 Eradication of H. 22 15 MICROBIOLOGY.................................................................................................... 23 16 NON-CLINICAL TOXICOLOGY ............................................................................
25 PATIENT MEDICATION INFORMATION ........................................................................ 30 Pylera® Page 4 of 35 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS Pylera® (bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride capsules), in combination with omeprazole, are indicated for: • the eradication of H.
pylori in patients with H. pylori infection and active duodenal ulcer Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. Appropriate doses of omeprazole for the treatment of active duodenal ulcers should be prescribed in all patients (see 4 DOSAGE AND ADMINISTRATION).
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Pylera® and other antibacterial […]
22 Eradication of H. 22 15 MICROBIOLOGY.................................................................................................... 23 16 NON-CLINICAL TOXICOLOGY ............................................................................
25 PATIENT MEDICATION INFORMATION ........................................................................ 30 Pylera® Page 4 of 35 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS Pylera® (bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride capsules), in combination with omeprazole, are indicated for: • the eradication of H.
pylori in patients with H. pylori infection and active duodenal ulcer Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. Appropriate doses of omeprazole for the treatment of active duodenal ulcers should be prescribed in all patients (see