BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE (bismuth subcitrate potassium)

The pharmacokinetics of the individual components of bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride are summarized below. In addition, two studies on bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride were conducted to determine the effect of co-administration on the pharmacokinetics of the components. Bismuth Subcitrate Potassium (Bismuth) Absorption and

DistributionOrally absorbed bismuth is distributed throughout the entire body. Bismuth is...

14.1 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 (the North American Study). Patients were randomized to one of the following 10-day treatment regimens: Three (3) bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride capsules four times daily, after meals and at bedtime plus 20 mg omeprazo...

Most frequently reported adverse reactions (≥5%): abnormal feces, diarrhea, nausea, and headache. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Endo at 1-800-828-9393 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 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 o...

Concurrent usage of Methoxyflurane. ( 4.1 , 7.1 ) Disulfiram usage within the last two weeks. ( 4.2 , 7.2 ) Alcoholic beverage consumption for at least three days during or after therapy. ( 4.3 , 7.3 ) Patients with Cockayne syndrome ( 4.4 , 6.3 ) Severe renal impairment. ( 4.5 ) Women who are pregnant. ( 4.6 , 8.1 ) Known hypersensitivity to product components. ( 4.7 ) 4.1 Methoxyflurane Do not a...

Fetal Toxicity: Advise pregnant women of the risk throughout pregnancy for retardation of skeletal development seen in animal studies and permanent discoloration of teeth with tetracycline if used during the second or third trimester. ( 5.2 , 8.1 ) Maternal Toxicity: Risk of hepatotoxicity in pregnant women with high doses of intravenous tetracycline also resulting in stillborn or premature birth. ( 5.3 , 8.1 ) Tooth Enamel discoloration and hypoplasia: permanent discoloration may develop with u...

7 DRUG INTERACTIONS Methoxyflurane: Risk of fatal renal toxicity; do not co-administer. ( 4.1 , 7.1 ) Disulfiram: Psychotic reactions can occur; do not take concurrently or within the last 2 weeks of disulfiram. ( 4.2 , 7.2 ) Alcohol: Abdominal cramps, nausea, vomiting, headaches, and flushing can occur; do not consume during therapy and for at least 3 days afterwards. ( 4.3 , 7.3 ) Oral Contracep...