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Bismuth Subcitrate

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Bismuth Subcitrate HIGHLIGHTS OF PRESCRIBING INFORMATION • Tooth Enamel discoloration and hypoplasia: permanent discoloration may These highlights do not include all the information needed to use develop with use during tooth development (last half of pregnancy, PYLERA safely and effectively. See full prescribing information for infancy, and childhood to the age of 8 years). (5.4) PYLERA • Central and Peripheral Nervous System Effects: encephalopathy, ® convulsive seizures, aseptic meningitis and peripheral neuropathy with PYLERA (bismuth subcitrate potassium, metronidazole, tetracycline metronidazole, intracranial hypertension with tetracycline and hydrochloride) capsules, for oral use neurotoxicity with bismuth-containing products. Monitor patients with Initial U.S. Approval: 2006 CNS conditions closely and discontinue promptly if abnormal neurologic signs develop. (5.5) WARNING: POTENTIAL FOR CARCINOGENICITY • Photosensitivity: avoid exposure to sun and sun lamps. (5.7) See full prescribing information for complete boxed warning • Blood Dyscrasias: Use with caution in patients with a history of blood dyscrasias (5.9) Metronidazole has been shown to be carcinogenic in mice and rats. It is • Hepatic Impairment: Use with caution in patients with hepatic unknown whether metronidazole is associated with carcinogenicity in impairment. (5.10) humans (5.1). • Cutaneous Reactions: Stevens-Johnson, toxic epidermal necrolysis, DRESS syndrome. Discontinue treatment at the first evidence of a ----------------------------RECENT MAJOR CHANGES-------------------------- cutaneous reaction. (5.13) Boxed Warning 1/2017 Contraindications (4) 1/2017 ------------------------------ADVERSE REACTIONS------------------------------- Warnings and Precautions (5) 1/2017 Most frequently reported adverse reactions (≥5%); abnormal feces, diarrhea, nausea, and headache. (6.1) ----------------------------INDICATIONS AND USAGE--------------------------- PYLERA is a combination antibacterial indicated for the treatment of patients To report SUSPECTED ADVERSE REACTIONS, contact APTALIS with Helicobacter pylori infection and duodenal ulcer disease (active or Pharma US, Inc. at 1-800-472-2634 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch history of within the past 5 years) to eradicate H. pylori. (1.1) ------------------------------DRUG INTERACTIONS------------------------------- To reduce the development of drug-resistant bacteria and maintain the • Methoxyflurane: Risk of fatal renal toxicity; do not co-administer. (4.1, effectiveness of PYLERA and other antibacterial drugs, PYLERA should be 7.1). used only to treat or prevent infections that are proven or strongly suspected to • Disulfiram: Psychotic reactions can occur; do not take concurrently or be caused by bacteria. (1.2) within the last 2 weeks of disulfiram. (4.2, 7.2) ----------------------DOSAGE AND ADMINISTRATION----------------------- • Alcohol: Abdominal cramps, nausea, vomiting, headaches, and flushing • Administer three PYLERA capsules 4 times a day (after meals and at can occur; do not consume during therapy and for at least 3 days bedtime) for 10 days. (2) afterwards. (4.3, 7.3) • Administer PYLERA with omeprazole 20 mg twice daily (after the • Oral Contraceptives: Decreased efficacy possibly resulting in pregnancy; morning and evening meals). (2) use a different or additional form of contraception. (5.14, 7.4) • ---------------------DOSAGE FORMS AND STRENGTHS---------------------- Anticoagulants: Potentiation of the anticoagulant effect; Prothrombin Each capsule of PYLERA contains: (3) time, International Normalized Ratio (INR), or other suitable anticoagulation tests should be closely monitored. (5.14, 7.5) • 140 mg of bismuth subcitrate potassium • Lithium: Increased lithium serum concentrations; measure serum lithium • 125 mg metronidazole and serum creatinine concentrations during therapy. (5.14, 7.6) • 125 mg of tetracycline hydrochloride • Antacids, Multivitamins or Dairy Products: Decreased absorption of ------------------------------- CONTRAINDICATIONS----------------------------- PYLERA; do not take concomitantly. (7.7) • Concurrent usage of Methoxyflurane.(4.1, 7.1) • Busulfan: Increased busulfan serum concentrations; avoid concomitant • Disulfiram usage within the last two weeks.(4.2, 7.2) use, monitor for busulfan toxicity (7.8) • Alcoholic beverage consumption for at least three days during or • CYP inducers and CYP inhibitors: Prolonged or accelerated half-life of after therapy. (4.3, 7.3) metronidazole or concomitant medications; use with caution (7.9, 7.10) • Severe renal impairment. (4.4) -----------------------USE IN SPECIFIC POPULATIONS------------------------ • Women who are pregnant. (4.5, 8.1) • Lactation: A woman should pump and discard human milk for the • Known hypersensitivity to product components. (4.6) duration of PYLERA therapy, and for 2 days after therapy ends, (8.2) -----------------------WARNINGS AND PRECAUTIONS------------------------ • Pediatric Use: Tetracycline may cause permanent discoloration of the • Fetal Toxicity: Advise pregnant women of the risk throughout pregnancy teeth. Enamel hypoplasia has also been reported. Do not use in children for retardation of skeletal development seen in animal studies and less than 8 years of age. (5.4, 8.4) permanent discoloration of teeth with tetracycline if used during the second or third trimester. (5.2, 8.1) See 17 for PATIENT COUNSELING INFORMATION. • Maternal Toxicity: Risk of hepatotoxicity in pregnant women with high doses of intravenous tetracycline also resulting in stillborn or premature Revised: 1/2017 birth. (5.3, 8.1) ___________________________________________________________________________________________________________________________ Reference ID: 4046304 FULL PRESCRIBING INFORMATION: CONTENTS* 7 DRUG INTERACTIONS 7.1 Methoxyflurane WARNING: POTENTIAL FOR CARCINOGENICITY 7.2 Disulfiram 1 INDICATIONS AND USAGE 7.3 Alcohol 1.1 Eradication of Helicobacter pylori in Patients with Active 7.4 Oral Contraceptives Duodenal Ulcer or History of Duodenal Ulcer Disease 7.5 Anticoagulants 1.2 Usage 7.6 Lithium 2 DOSAGE AND ADMINISTRATION 7.7 Antacids, Multivitamins, or Dairy Products 3 DOSAGE FORMS AND STRENGTHS 7.8 Busulfan 4 CONTRAINDICATIONS 7.9 Inhibitors of CYP450 liver enzymes 4.1 Methoxyflurane 7.10 Inducers of CYP450 liver enzymes 4.2 Disulfiram 8 USE IN SPECIFIC POPULATIONS 4.3 Alcohol 8.1 Pregnancy 4.4 Renal Impairment 8.2 Lactation 4.5 Pregnancy 8.3 Pediatric Use 4.6 Hypersensitivity Reactions 8.4 Geriatric Use 5 WARNINGS AND PRECAUTIONS 8.5 Renal Impairment 5.1 Potential for Carcinogenicity 8.6 Hepatic Impairment 5.2 Fetal Toxicity 10 OVERDOSAGE 5.3 Maternal Toxicity 11 DESCRIPTION 5.4 Tooth Enamel Discoloration and Hypoplasia 12 CLINICAL PHARMACOLOGY 5.5 Central and Peripheral Nervous System Effects 12.1 Mechanism of Action 5.6 Development of Superinfections 12.3 Pharmacokinetics 5.7 Photosensitivity 12.4 Microbiology 5.8 Darkening of the Tongue and/or Black Stool 13 NONCLINICAL TOXICOLOGY 5.9 Use in Patients with Blood Dyscrasias 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 5.10 Increased Plasma Concentrations in Patients with Hepatic 14 CLINICAL STUDIES Impairment 14.1 Eradication of Helicobacter pylori in Patients with Active 5.11 Laboratory Test Interactions Duodenal Ulcer or History of Duodenal Ulcer Disease 5.12 Development of Drug Resistant Bacteria 15 REFERENCES 5.13 Cutaneous Reactions 16 HOW SUPPLIED/STORAGE AND HANDLING 5.14 Drug Interactions 17 PATIENT COUNSELING INFORMATION 6 ADVERSE REACTIONS 6.1 Clinical Trials Experience *Sections or subsections omitted from the full prescribing information 6.2 Postmarketing Experience are not listed. 6.3 Other Important Adverse Reactions from Labeling for the Individual Components of PYLERA Reference ID: 4046304 FULL PRESCRIBING INFORMATION WARNING: POTENTIAL FOR CARCINOGENICITY Metronidazole has been shown to be carcinogenic in mice and rats. It is unknown whether metronidazole is associated with carcinogenicity in humans [see Warning and Precautions (5.1)]. 1 INDICATIONS AND USAGE 1.1 Eradication of Helicobacter pylori in Patients with Active Duodenal Ulcer or History of Duodenal Ulcer Disease PYLERA 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. 1.2 Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of PYLERA and other antibacterial drugs, PYLERA should be used to treat only indicated 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. 2 DOSAGE AND ADMINISTRATION Administer three PYLERA capsules 4 times a day (after meals and at bedtime) for 10 days. One omeprazole 20 mg capsule should be taken twice a day with PYLERA after the morning and evening meal for 10 days (Table 1). Table 1: Daily Dosing Schedule for PYLERA Time of dose Number of capsules of Number of capsules of PYLERA omeprazole 20 mg After morning meal 3 1 After lunch 3 0 After evening meal 3 1 At bedtime 3 0 Instruct patients to swallow the PYLERA capsules whole with a full glass of water
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