Bismuth subcitrate potassium
Детермінований перегляд YAML-сутності з джерельної бази. Клінічний авторитет лишається за вказаними source ID та статусом клінічного sign-off.
| ID | DRUG-BISMUTH-SUBCITRATE |
|---|---|
| Тип | Препарат |
| Синоніми | Bismuth subcitrateColloidal bismuth subcitrate (CBS)De-NolGastrostatPylera (component, with metronidazole + tetracycline)Tripotassium dicitrato bismuthate (TDB)UlkavisБісмуту субцитрат калію |
| Статус | переглянуто 2026-05-18 |
| Хвороби | DIS-GASTRIC |
| Джерела | SRC-NCCN-BCELL-2025 |
Дані про препарат
| Клас | Bismuth salt — antimicrobial / mucosal protective (anti-Helicobacter pylori) |
|---|---|
| Механізм дії | Colloidal bismuth salt that, in the acid gastric milieu, precipitates as bismuth oxychloride and bismuth citrate, which: (i) adhere to ulcer craters and the gastric mucus layer to form a protective barrier; (ii) directly damage Helicobacter pylori cell wall and impair iron and nickel uptake — bactericidal effect; (iii) inhibit H. pylori urease, phospholipase, and proteolytic enzymes; (iv) stimulate prostaglandin E2, bicarbonate, and mucus secretion. Synergistic with metronidazole and tetracycline in quadruple therapy — also overcomes clarithromycin resistance, the primary mode of failure for standard triple therapy. |
| Типове дозування | H. pylori PBMT quadruple therapy (adult): 120 mg (one tablet) PO QID (taken with meals and at bedtime) × 10-14 days, together with omeprazole 20 mg PO BID + metronidazole 500 mg PO TID-QID + tetracycline 500 mg PO QID. Take ≥30 min before meals and at bedtime; avoid co-administration with milk, antacids, or H2 blockers within 30 min (chelation reduces efficacy). Avoid in moderate-severe renal impairment. The combination product Pylera (bismuth subcitrate potassium 140 mg + metronidazole 125 mg + tetracycline 125 mg per capsule, 3 capsules QID × 10 days, with a PPI) is approved in the US/EU as a fixed-dose alternative. |
| Зареєстровано в Україні | True |
| Відшкодовується НСЗУ | False |
| Остання перевірка для України | 2026-05-18 |
Нотатки
STUB — v0.2 prevention-workstream authoring; pending two-Clinical-Co-Lead signoff per CHARTER §6.1 dev-mode. Cornerstone of bismuth-based quadruple therapy (PBMT — PPI + bismuth + metronidazole + tetracycline) for H. pylori eradication, increasingly preferred over standard triple therapy in regions with clarithromycin resistance >15% (much of Europe including Ukraine). Overcomes clarithromycin and metronidazole resistance. The black tongue and black stools are the most patient- visible side effects — pre-counseling is essential to avoid panic. Encephalopathy is rare and historically associated with prolonged high- dose use; 10-14 day PBMT courses have a clean safety record. RxNorm has separate codes for "bismuth subcitrate" variants but no single canonical ID for "bismuth subcitrate potassium" was confirmed at draft time — orchestrator should verify. Ukraine: De-Nol is the dominant brand; widely available, out-of-pocket. Two-Co-Lead signoff queued for v0.2-A clinical review.
Де використовується
Access Pathways
AP-HP-ERADICATION-PHARMACY-OOP- H. pylori eradication (PPI + amox/clarithromycin / bismuth quadruple) — pharmacy out-of-p...
Contraindications
CI-BISMUTH-RENAL-FAILURE- CI-BISMUTH-RENAL-FAILURE
Regimens
REG-HP-BISMUTH-QUADRUPLE- Bismuth quadruple therapy (PBMT) — 14 days