Де нол

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Де нол

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Method of action: Antiulcer

Treatment option:

Medically reviewed

Marina Burgos

Last updated on 10/01/2026

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Де нол

What is De-Nol?

Property Description
Active ingredient Bismuth Tripotassium Dicitrate (Colloidal Bismuth Subcitrate)
Form Film-coated tablets, oral route
Pharmacological class Anti-ulcer agent, Gastroprotective agent
General use Protection and healing of the stomach/duodenal lining
Origin Synthetic, organo-metallic compound

What is De-Nol: Composition and Pharmacological Class?

De-Nol is a widely recognized anti-ulcer medication containing the active ingredient Bismuth Tripotassium Dicitrate. It is classified primarily as a gastroprotective agent and is supplied as film-coated tablets intended for oral use.

This drug is a synthetic, single-ingredient compound whose active component is often referred to as Colloidal Bismuth Subcitrate. Its pharmacological classification reflects its main therapeutic role: providing protection and support to the damaged lining of the stomach and duodenum. The core chemical substance is recognized for its use in treating peptic ulcers.


How is De-Nol different from common heartbeat remedies?

De-Nol's function goes beyond the temporary relief provided by common heartburn remedies like antacids, as it works via a dual mechanism that is crucial for mucosal healing. Unlike simple acid-neutralizers, De-Nol’s primary action is to form a physical protective barrier over ulcers and erosions, shielding the vulnerable tissue from aggressive stomach acid and digestive enzymes.

Crucially, the bismuth compound has a targeted effect against the bacterium Helicobacter pylori, a major cause of chronic gastritis and peptic ulcers. This ability to fight the microbe while simultaneously protecting the gut lining is the key distinction of the drug, setting it apart from treatments that only manage acid levels.


General Purpose: What is De-Nol Used For?

The general purpose of De-Nol is to promote the comprehensive healing and protection of the gastrointestinal mucous membrane in damaged areas of the stomach and duodenum.

By creating a stable, physical shield over injured tissue and simultaneously helping to eliminate H. pylori, the medication supports the body’s innate ability to repair itself. This action helps to soothe irritation and restore the integrity of the digestive tract lining, establishing a stronger barrier against future injury. The therapeutic role of bismuth in H. pylori eradication regimens is widely recognized in clinical practice.

What side effects are possible with Де нол?

Possible Side Effects and Safety Information

The safety profile for Bismuth Tripotassium Dicitrate (the active ingredient in De-Nol) is primarily characterized by effects on the digestive system, alongside specific safety constraints defined in regulatory documents.


Documented Adverse Reactions

Adverse reactions are classified according to frequency, as established by regulatory authorities. The most frequently documented effects involve the gastrointestinal system.

Classification System-Organ Class Examples
Uncommon Gastrointestinal disorders Nausea, Vomiting, Constipation, Diarrhea
Skin and subcutaneous tissue disorders Rash, Urticaria
Very Rare Immune system disorders Anaphylactic reaction

Expected Physiological Changes and Serious Risks

An expected effect of treatment, which is non-pathological, is the darkening or blackening of the stool and, occasionally, the tongue. This change results from the bismuth compound reacting in the gastrointestinal tract and is not a cause for alarm.

Regulatory documentation also defines certain serious, rare events. Anaphylactic reaction is listed as a very rare, severe systemic hypersensitivity reaction. Furthermore, Bismuth encephalopathy is a rare neurotoxic event that has been associated with prolonged use of high doses and requires specific safety attention.


Population and Duration Safety Constraints

The most critical constraint in the regulatory labeling relates to individuals with impaired organ function. The medication is contraindicated for use in patients with severe renal impairment due to the potential for systemic absorption and increased plasma levels of bismuth, which raises the risk of neurotoxicity. Therefore, use of the drug is formally restricted regarding duration and patient population to manage this specific safety concern.

Overdose and Emergency Response

Overdose and When to Seek Help

The information presented here details the official overdose profile for Bismuth Tripotassium Dicitrate, derived strictly from government regulatory documentation.

Domain Official Regulatory Statements
Documented Overdose Presentations Reversible neurotoxicity (encephalopathy) linked to prolonged, high-dose exposure, manifesting as myoclonus, ataxia, and mood changes. Also, signs consistent with acute renal failure (nephrotoxicity).
Physiological Systems Affected (as stated in label) Renal system (kidneys) and Central Nervous System (CNS).
Dose-related or Exposure-related Factors (if applicable) Massive acute overdose (associated with fatalities) and prolonged exposure to high doses.
Population-specific Overdose Notes (if applicable) Increased risk of neurotoxicity is documented for patients with impaired renal function due to reduced clearance.
Emergency-response Statements (as written in official documents) Symptomatic and supportive treatment is the officially described management. Intensive monitoring of renal function is required.
When immediate medical help is required (label-derived phrasing only) Seek immediate medical attention or contact emergency services if overdose is suspected.

Overdose Classifications (High-Level)

Classification Official Regulatory Statement
Severity Classification (as defined in official documents) Severe nephrotoxicity and documented fatalities in cases of massive acute overdose.
Regulatory Basis (EMA / FDA / etc.) Regulatory documents (SmPC / Prescribing Information).
Overdose-Context Constraints (as defined in official documents) No specific antidote is known; intensive monitoring of renal function is required.

Resulting Overdose Structure

Official overdose statements:

  • Overdose is officially associated with systemic bismuth accumulation and documented severe effects on the kidneys, including acute renal failure.
  • Prolonged, high-dose exposure carries the documented risk of reversible neurotoxicity, presenting with symptoms such as myoclonus and ataxia.
  • Immediate medical attention is required upon suspicion of overdose, as regulatory documents state that no specific antidote is known.

Connection to the overall overdose profile (2–4 sentences): The official regulatory profile emphasizes that high exposure to Bismuth Tripotassium Dicitrate creates critical risks of renal and neurological toxicity. Management is defined as strictly symptomatic and supportive, and the need to seek emergency care is mandatory due to the severity of these documented effects and the absence of a specific reversal agent.

Therapeutic Uses of Де нол

Main Indications for Use

De-Nol is primarily utilized in gastroenterology for the management of acid-related disorders and inflammatory conditions affecting the upper gastrointestinal tract. Its therapeutic application focuses on protecting the mucosal lining and addressing underlying factors that contribute to tissue erosion.

Peptic Ulcer Disease

The medication is indicated for the treatment of gastric and duodenal ulcers during the acute phase. It facilitates the healing process by forming a protective barrier over the ulcerated area, which prevents further irritation from gastric acid and digestive enzymes.

Gastritis and Gastroduodenitis

De-Nol is used to treat chronic gastritis and gastroduodenitis, particularly during periods of exacerbation. It helps reduce inflammation in the stomach and duodenal lining, alleviating symptoms such as discomfort and heaviness.

Helicobacter pylori Eradication

A significant application of the drug is its role in eliminating Helicobacter pylori bacteria. When used as part of a combined therapeutic regimen, its antimicrobial properties contribute to the successful eradication of this pathogen, which is a common cause of recurring ulcers and chronic inflammation.

Functional Dyspepsia

The medication may be used for patients experiencing functional dyspepsia that is not associated with organic diseases of the gastrointestinal tract. It addresses symptoms of indigestion and upper abdominal pain by supporting mucosal integrity.

Irritable Bowel Syndrome (IBS)

In certain clinical presentations, De-Nol is applied to manage irritable bowel syndrome, specifically when the condition is accompanied by diarrhea and inflammatory changes in the intestinal mucosa.

Therapeutic Benefits

  • Mucosal Protection: The active substance reacts with the proteins of the damaged tissue to create a physical film, shielding the area from the aggressive environment of the stomach.
  • Cytoprotective Effect: It stimulates the natural production of prostaglandins and mucus, enhancing the body's own defense mechanisms against acid and pepsin.
  • Targeted Antibacterial Activity: It possesses direct activity against H. pylori without promoting bacterial resistance, making it a stable component of complex treatment plans.
  • Anti-inflammatory Action: By inhibiting specific enzyme activities, it reduces local inflammation, which aids in the restoration of healthy tissue.

Eligibility and Restrictions for Use

Who Can and Cannot Use Де-Нол?

Eligibility for using De-Nol (Bismuth Tripotassium Dicitrate) is determined by the official criteria established in government regulatory documents. These rules define the populations for whom the medicine is safe and effective, and those who must not use it.


Contraindications and Absolute Restrictions

De-Nol is formally contraindicated and must not be used by the following patient groups:

  • Children under 14 years of age.
  • Patients with severe renal impairment (severe kidney disease), due to the risk of bismuth accumulation.
  • Individuals with a known hypersensitivity or allergy to the active ingredient or any of the product's components.

Conditional Use and Life-Stage Limitations

Use is subject to special consideration or is officially not recommended for certain populations:

Population Group Regulatory Status Constraint Context
Adolescents (14–18 years) Not Recommended Insufficient data or limited use profile.
Pregnancy Not Recommended Should only be used if the potential benefit outweighs the unknown risk.
Breastfeeding Not Recommended Unknown if the drug is excreted in human milk.
Mild/Moderate Renal Impairment Use with Caution Risk of increased systemic bismuth exposure; monitoring may be required.

Adults without these specific contraindications or limitations are the primary population for whom the medicine is approved.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documents define the interaction profile of Bismuth Tripotassium Dicitrate primarily through modifications to its absorption and systemic exposure.


Administration Timing and Absorption

The most significant and mandatory restriction is the requirement for timing separation from certain products. Antacids, milk, and dairy products officially interfere with the local action and absorption of the Bismuth compound. These substances must be separated from Bismuth Tripotassium Dicitrate by a minimum of 30 minutes before or after administration to maintain adequate bioavailability.

Pharmacokinetic Interactions

Co-administration with gastric acid reducers represents a key pharmacokinetic interaction. Agents such as Proton Pump Inhibitors ( PPIs) and H2-receptor Antagonists ( H2 RAs) officially cause a pH-dependent increase in Bismuth’s gastrointestinal absorption. This interaction results in elevated plasma concentration ( C max) and increased systemic exposure ( AUC). Additionally, Bismuth Tripotassium Dicitrate may reduce the oral absorption and serum concentration of co-administered Tetracycline antibiotics.

Restrictions and Special Populations

No formal contraindicated combinations with other medicinal products are universally documented in the official labeling. However, the drug is officially contraindicated in patients with severe renal impairment. This is due to the heightened risk of Bismuth accumulation and subsequent toxicity, which is exacerbated by co-administering drugs that increase Bismuth exposure.

Mechanism of Action

How Де нол Works: The Mechanism of Action

The pharmacological action of Bismuth Tripotassium Dicitrate is achieved through a localized dual mechanism within the gastrointestinal tract, targeting both physical protection and microbial control, which influences the rate of tissue repair processes.


Creating a Physical Mucosal Shield

This domain focuses on the selective binding of the bismuth compound to exposed proteins at the base of ulcers and erosions. This non-receptor-mediated chemical action immediately forms a highly adherent, acid-resistant protective barrier, thereby limiting the exposure of the damaged tissue to gastric acid and the enzyme pepsin.


Targeted Antimicrobial Disruption and Cytoprotection

This mechanism involves the compound's bactericidal/bacteriostatic activity and modulation of the mucosal defense system. It acts directly against Helicobacter pylori by disrupting its cell structure and inhibiting key microbial enzymes, which results in the reduction of the microbial population. Furthermore, the compound stimulates the local release of protective mediators, such as prostaglandins, which enhances bicarbonate and mucus secretion to enhance the mechanical integrity of the defense barrier and supports the progression of tissue repair.

Dosage and Administration Information

How to Use Де нол: Official Administration Guidelines

Administration of Де нол (Bismuth Tripotassium Dicitrate) is structured to support the intended utilization of the medication. The following details outline the standard administration protocols for this substance.


Standard Dosing Regimens

Bismuth Tripotassium Dicitrate is administered orally as a film-coated tablet containing 120 mg of the active substance. The total adult daily dose is approximately 480 mg, which is administered using one of the following two schedules:

Regimen Dose Frequency Timing
Four Times Daily (QID) 1 tablet (120 mg) 4 times per day 30 minutes before meals and at bedtime
Twice Daily (BID) 2 tablets (240 mg) 2 times per day 30 minutes before breakfast and dinner

Procedural and Time Constraints

The tablets must be swallowed whole with a sufficient amount of water and should not be crushed or chewed. To maintain the drug’s expected efficacy, specific limitations on co-ingestion are observed:

  • Fasting State: The dose is taken on an empty stomach, requiring a waiting period of approximately 30 minutes before a meal.
  • Restricted Co-administration: Milk, fruit juices, and antacids are not to be consumed within 30 minutes before or after administering the dose.

Course Duration and Limits

Treatment adheres to specific time constraints to prevent excessive exposure to bismuth. For the healing of ulcers, the typical continuous course is 4 to 8 weeks. For its use in H. pylori eradication regimens, the duration is typically shorter, often 7 to 14 days. The maximum continuous duration of use does not exceed 2 months (8 weeks). A minimum interval of two months must pass before initiating a new course of any bismuth-containing product.

Population Rules

Safety and efficacy have not been established for use in children under 14 years of age. Dose modification for older adults is not typically required based solely on age.

Recent Clinical Evidence

Research Evidence / Overview of Studies

Mechanism and Primary Studies

Bismuth Tripotassium Dicitrate (CBS) is studied for its action in treating erosive and ulcerative diseases of the gastrointestinal tract. This compound is described as having multiple biological activities, including a direct action against the bacterium Helicobacter pylori and the formation of a protective layer over the gastric and duodenal mucosa. This mechanism is hypothesized to influence the healing of ulcers and erosions by creating a barrier to hydrochloric acid and inhibiting peptic activity.

Key Trial Findings

Initial and later Randomized Controlled Trials (RCTs) evaluated the use of CBS, both as monotherapy for peptic ulcers and as a component of combination therapy for H. pylori eradication. Findings indicated that in treatment-naïve patients, CBS, when combined with a proton pump inhibitor (PPI) and antibiotics, was associated with high rates of pathogen eradication, often exceeding 85% in intention-to-treat analyses, especially in regions with high antibiotic resistance.

Combination Therapy Research

Bismuth Quadruple Therapy (BQT), which includes CBS, a PPI, and two antibiotics (typically tetracycline and metronidazole), has been widely assessed. Research examined BQT's comparative profile against other regimens, such as triple therapy. Studies have noted that the addition of bismuth compounds may increase the treatment’s effectiveness in overcoming antibiotic resistance compared to triple therapy alone.

Long-Term Monitoring

Safety studies examining the compound's profile over long-term study periods indicate minimal systemic absorption of the active bismuth moiety. Study protocols often include exclusion criteria for participants with pre-existing conditions that could increase the risk of accumulation. Research has shown that, when used within standard therapeutic durations, potential side effects are generally mild and self-limiting.

Frequently Asked Questions (FAQ)

Common questions about Де нол (FAQ)


Q: What is the expected duration of treatment with Де нол?

The official duration of treatment is determined by the condition being addressed. For the healing of ulcers, the typical continuous course is 4 to 8 weeks. When used as part of an H. pylori eradication regimen, the course is usually shorter, often lasting 7 to 14 days.


Q: Is it common to see a black stool while taking Де нол?

Yes, the blackening or darkening of the stool is described in official documentation as an expected physiological effect of this drug. This change results from the bismuth compound reacting within the digestive tract. It is noted to be a non-pathological change described in official documentation.


Q: How long does the blackening effect on the tongue or stool from Де нол last?

The darkening of the stool or tongue is temporary. Studies and official information indicate this effect goes away when the medicine is stopped. This change may take several days to clear completely after the treatment course has been finished.


Q: Can Де нол cause constipation or diarrhea?

Constipation and Diarrhea are listed in regulatory documents as documented adverse reactions. These effects are generally classified as uncommon gastrointestinal disorders.


Q: Is it possible to take Де нол for a shorter or longer time than usually recommended?

Official instructions impose specific constraints on the duration of use. The maximum continuous treatment period must not exceed 2 months (8 weeks). Furthermore, a minimum break of two months must pass before any new course with a bismuth-containing product is initiated.


Q: Can Де нол be used for heartburn or acid reflux?

Regulatory documents indicate that the main use is for the healing of ulcers and H. pylori eradication. However, some regulatory-sourced information lists Gastro-oesophageal Reflux Disease (GERD) as an indication for the active ingredient. This indicates its potential use in the management of certain conditions associated with acid reflux.


Q: Are there specific foods or drinks to avoid while using Де нол?

Yes, the official product information mandates restrictions on the consumption of certain products around the time of dosing. Specifically, milk, fruit juices, and antacids must be separated from the dose by a minimum of 30 minutes. This timing separation is mandated to maintain the drug’s intended efficacy and local action.


Q: Is Де нол a type of antibiotic?

No, the drug is officially classified as an Anti-ulcer/Gastroprotective agent. Although it demonstrates bactericidal/bacteriostatic activity by directly acting against Helicobacter pylori, its primary pharmacological class is related to its ability to protect the gut lining.


Q: What are the differences between Де нол and generic bismuth subcitrate?

The active ingredient in Де нол, Bismuth Tripotassium Dicitrate, is often referred to by the synonym Colloidal Bismuth Subcitrate. This means that both the brand-name product and generic bismuth subcitrate contain the same main component, which is used for its gastroprotective properties.


Q: What should I do if I forget to take a dose of Де нол?

According to the official missed dose policy, if a dose is missed, it should be taken as soon as possible. However, if it is almost time for the next scheduled dose, the instruction is to skip the missed dose entirely. Official guidance notes that doses must not be doubled to compensate for a missed one.


Q: Can Де нол be taken at the same time as other medications?

The primary instruction is the mandatory timing separation from antacids, milk, and fruit juices by 30 minutes. While the simultaneous use of other medications is not generally prohibited, specific interactions, such as reduced absorption of tetracycline antibiotics, are officially documented in the regulatory labeling.


Q: Is Де нол the same as Pepto-Bismol (bismuth subsalicylate)?

No, these are not the same product. Де нол contains Bismuth Tripotassium Dicitrate (bismuth subcitrate) as its active component. Pepto-Bismol, on the other hand, contains the chemically different compound Bismuth Subsalicylate.


Q: Can Де нол affect the absorption of other oral medications?

Official documentation defines specific risks of altered absorption. It is noted that Bismuth Tripotassium Dicitrate may specifically reduce the oral absorption and serum concentration of co-administered Tetracycline antibiotics. This interaction is defined in the regulatory labeling.


Q: Are there different strengths or forms of Де нол available?

The standard presentation described in the official labeling is a film-coated tablet containing 120 mg of the active substance. The prescribed dosing regimens are based on this strength to achieve the necessary daily total dose.


Q: What is the evidence regarding Де нол's use in preventing recurrence of ulcers?

Research and official drug information indicate that the anti-H. pylori effect of the drug is associated with certain patient outcomes. This includes a documented lower frequency of ulcer recurrence during the first year after treatment compared to certain other single-drug options.


Q: Can Де нол be crushed or split before taking?

No. Official administration instructions mandate that the tablets must be swallowed whole with a sufficient amount of water. The regulatory guidance explicitly states that the tablets should not be crushed or chewed.


Q: Why is the active ingredient in Де нол called bismuth subcitrate and not just bismuth?

The active ingredient is a complex substance called Bismuth Tripotassium Dicitrate, which is a specific salt form of bismuth, citrate, and potassium. This chemical structure is what enables its selective action in the gut, distinguishing it from elemental bismuth.


Q: Is it true that Де нол is not absorbed much into the bloodstream?

Yes. Regulatory analysis and pharmacokinetic data indicate that the drug has low systemic bioavailability. The majority of the bismuth compound remains localized in the gastrointestinal tract to perform its protective action, and most of the dose is excreted through the feces.

How should Де нол be stored and disposed of?

Official Storage and Disposal Requirements

The storage and disposal of De-Nol (bismuth tripotassium dicitrate) must conform strictly to the conditions specified in the official regulatory product information.

Storage Domain Official Regulatory Requirement
Temperature Store below 25 C
Protection Must be protected from light and moisture
Packaging Store in the original package; tablets must remain in the blister pack until immediately before use
Child Safety Keep out of the sight and reach of children
Stability Do not use the medicine after the expiry date

For disposal, unused or expired De-Nol must not be thrown into household waste or wastewater. The official instruction requires consulting a pharmacist for guidance on how to properly discard the medicine to ensure environmental protection.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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