Bismuth subcitrate potassium, Metronidazole, Tetracycline hydrochloride 140 mg/1
Bismuth subcitrate potassium, Metronidazole, Tetracycline hydrochloride · CAPSULE · Ingenus Pharmaceuticals, LLC
Bismuth subcitrate potassium, Metronidazole, Tetracycline hydrochloride is a prescription capsule containing bismuth subcitrate potassium, metronidazole, tetracycline hydrochloride at 140 mg/1, taken oral. Manufactured by Ingenus Pharmaceuticals, LLC.
Key Facts
- Brand Name
- Bismuth subcitrate potassium, Metronidazole, Tetracycline hydrochloride
- Generic Name
- Bismuth subcitrate potassium, Metronidazole, Tetracycline hydrochloride
- NDC Code (Product)
50742-283- Manufacturer
- Ingenus Pharmaceuticals, LLC
- Strength
- 140 mg/1
- Dosage Form
- CAPSULE
- Route
- ORAL
- Marketing Status
- HUMAN PRESCRIPTION DRUG
- Application #
- ANDA217511
- Drug Class
- Bismuth [CS]; Bismuth [EPC]
- Marketing Start
- 07/04/2023
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
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. ( 1.1 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride capsules and other antibacterial drugs, bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride capsule should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. ( 1.2 ) 1.1 Eradication of Helicobacter pylori in Patients with Active Duodenal Ulcer or History of Duodenal Ulcer Disease Bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride capsules in combination with omeprazole are indicated for the treatment of patients with Helicobacter pylori infection an…
Dosage & Administration
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 tetracycline hydrochloride 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 Instruct patients to swallow the bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride capsules whole with a full glass of water (8 ounces). 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. If a dose is missed, patients should continue the normal dosing schedule until medication is gone. Patients should not ta…
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. Psychotic reactions have been reported in alcoholic patients who are using metronidazole, a component of bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride capsules, and disulfiram concurrently [see Drug Interactions ( 7.1 ) ]. 4.2 Alcohol Alcoholic beverages or other products containing propylene glycol should not be consumed during and for at least 3 days after therapy with bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride capsules. A disulfiram-like reaction (abdominal cramps, nausea, vomiting, headaches, and flushing) may occur due to the interaction between alcohol or propylene glycol and metronidazole, a compo…
Drug 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 , 7.3 ) Anticoagulants: Potentiation of the anticoagulant effect; Prothrombin time, International Normalized Ratio (INR), or other suitable anticoagulation tests should be closely monitored. ( 5.14 , 7.4 ) Lithium: Increased lithium serum concentrations; measure serum lithium and serum creatinine concentrations during therapy. ( 5.14 , 7.5 ) Antacids, Multivitamins or Dairy Products: Decreased absorption of bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride capsules; do not take concomitantly. ( 7.6 ) Busulfan: Increased busulfan serum concentrations; avoid concomitant use, monitor for busulfan toxicity. ( 7.7 ) CYP inducers and CYP inhibitors: Prolonged or accelerated half-life of metronidazole or concomitant medications; use wi…
Adverse Reactions
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. The safety of bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride capsules plus omeprazole (OBMT) to eradicate Helicobacter pylori was assessed in an open-label, randomized, active-controlled clinical trial conducted in North America. The duration of treatment was 10 days with 147 patients exposed to bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride capsules plus omeprazole (OBMT) and 152 exposed to control, consisting of omeprazole, amoxicillin, and clarithromycin (OAC). The age of the population in the study ranged from 18 to 75 years, with 59% male patients and 59% Caucasian pa…
Frequently Asked Questions
What is Bismuth subcitrate potassium, Metronidazole, Tetracycline hydrochloride used for?
Bismuth subcitrate potassium, Metronidazole, Tetracycline hydrochloride contains Bismuth subcitrate potassium, Metronidazole, Tetracycline hydrochloride. It is a capsule taken oral. Consult your doctor for specific uses.
Is Bismuth subcitrate potassium, Metronidazole, Tetracycline hydrochloride a controlled substance?
Bismuth subcitrate potassium, Metronidazole, Tetracycline hydrochloride is not classified as a controlled substance by the DEA.
What is the generic name for Bismuth subcitrate potassium, Metronidazole, Tetracycline hydrochloride?
The generic name for Bismuth subcitrate potassium, Metronidazole, Tetracycline hydrochloride is Bismuth subcitrate potassium, Metronidazole, Tetracycline hydrochloride. There are no other listed brand versions of Bismuth subcitrate potassium, Metronidazole, Tetracycline hydrochloride.
What is the NDC code for Bismuth subcitrate potassium, Metronidazole, Tetracycline hydrochloride 140 mg/1?
The NDC (National Drug Code) for Bismuth subcitrate potassium, Metronidazole, Tetracycline hydrochloride 140 mg/1 is 50742-283, listed by Ingenus Pharmaceuticals, LLC.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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