Overview
11 DESCRIPTION Bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride capsules are a combination antimicrobial product containing bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride for oral administration. Each size 0 elongated capsule contains: bismuth subcitrate potassium, 140 mg metronidazole, 125 mg smaller capsule (size 3) containing tetracycline...
Mechanism of Action
12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride capsules are a combination of antibacterial agents (metronidazole and tetracycline hydrochloride) and bismuth subcitrate potassium [ see Microbiology ( 12.4 ) ] . 12.3 Pharmacokinetics The pharmacokinetics of the individual components of bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride capsules, bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride are summarized below. In addition, two studies on bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride capsules were conducted to determine the effect of co-administration on the pharmacokinetics of the components.
Indications
- 1 INDICATIONS AND USAGE Bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride capsule is a combination of metronidazole, a nitroimidazole antimicrobial, tetracycline, - a tetracycline class antimicrobial and bismuth subcitrate potassium, indicated for use, in combination with omeprazole, 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. ( 1.
Common Doses
- 20 mg
Dosage
2 DOSAGE AND ADMINISTRATION Administer three bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride 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 bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride capsules after the morning and evening meal for 10 days ( Table 1 ). Table 1: Daily Dosing Schedule for Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride Capsules Time of dose Number of capsules of bismuth subcitrate potassium, metronidazole and...
Black Box Warning
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 ) ] . WARNING: POTENTIAL FOR CARCINOGENICITY See full prescribing information for complete boxed warning. Metronidazole has been shown to be carcinogenic in mice and rats. It is unknown whether metronidazole is associated with carcinogenicity in humans ( 5.1 ).
Contraindications
- 4 CONTRAINDICATIONS Disulfiram usage within the last two weeks. ( 4.1 , 7.1 ) Alcoholic beverage consumption for at least three days during or after therapy. ( 4.2 , 7.2 ) Patients with Cockayne syndrome. ( 4.3 , 6.3 ) Severe renal impairment. ( 4.4 ) Women who are pregnant. ( 4.5 , 8.1 ) Known hypersensitivity to product components. ( 4.6 ) 4.1 Disulfiram Bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride capsules are contraindicated in patients who have taken disulfiram within the last two weeks.
Side Effects
- 6 ADVERSE REACTIONS Most frequently reported adverse reactions (≥5%): abnormal feces, diarrhea, nausea, and headache. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Ingenus Pharmaceuticals, LLC at 1-877-748-1970 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 observed in practice.
Interactions
- 7 DRUG INTERACTIONS Disulfiram: Psychotic reactions can occur; do not take concurrently or within the last 2 weeks of disulfiram. ( 4.1 , 7.1 ) Alcohol: Abdominal cramps, nausea, vomiting, headaches, and flushing can occur; do not consume during therapy and for at least 3 days afterwards. ( 4.2 , 7.2 ) Oral Contraceptives: Decreased efficacy possibly resulting in pregnancy; use a different or additional form of contraception. ( 5.14 , 7.