Bismuthi tripotassium dicitrate (Tablets) Instructions for Use
ATC Code
A02BX05 (Bismuthate, tripotassium dicitrato)
Active Substance
Bismuthate, tripotassium dicitrato (BP British Pharmacopoeia)
Clinical-Pharmacological Group
A drug that exerts a protective effect on the gastric and duodenal mucosa. Antiulcer drug
Pharmacotherapeutic Group
Acid-related disorder treatment agents; antiulcer agents and agents for the treatment of gastroesophageal reflux disease (GERD); other antiulcer agents and agents for the treatment of GERD
Pharmacological Action
An antiulcer agent with bactericidal activity against Helicobacter pylori. It also has anti-inflammatory and astringent effects.
In the acidic environment of the stomach, it forms insoluble bismuth oxychloride and citrate, and also forms chelate compounds with the protein substrate in the form of a protective film on the surface of ulcers and erosions.
By increasing the synthesis of prostaglandin E, the formation of mucus, and the secretion of bicarbonate, it stimulates the activity of cytoprotective mechanisms and increases the resistance of the gastrointestinal mucosa to the effects of pepsin, hydrochloric acid, enzymes, and bile salts.
It leads to the accumulation of epidermal growth factor in the area of the defect. It reduces the activity of pepsin and pepsinogen.
Pharmacokinetics
Bismuthate, tripotassium dicitrato is practically not absorbed from the gastrointestinal tract.
However, a small amount of bismuth may enter the systemic circulation. It is excreted mainly with feces.
The small amount of bismuth that enters the plasma is excreted by the kidneys.
Indications
Gastric and duodenal ulcer in the acute phase (including associated with Helicobacter pylori); chronic gastritis and gastroduodenitis in the acute phase (including associated with Helicobacter pylori); irritable bowel syndrome occurring predominantly with symptoms of diarrhea; functional dyspepsia not associated with organic diseases of the gastrointestinal tract.
ICD codes
| ICD-10 code | Indication |
| K25 | Gastric ulcer |
| K26 | Duodenal ulcer |
| K27 | Peptic ulcer |
| K29 | Gastritis and duodenitis |
| K30 | Functional dyspepsia (digestive disorder) |
| K58 | Irritable bowel syndrome |
| ICD-11 code | Indication |
| DA42.Z | Gastritis, unspecified |
| DA51.Z | Duodenitis, unspecified |
| DA60.Z | Gastric ulcer, unspecified |
| DA61 | Peptic ulcer of unspecified site |
| DA63.Z | Duodenal ulcer, unspecified |
| DA7Z | Diseases of stomach or duodenum, unspecified |
| DD90.0 | Globus sensation |
| DD90.1 | Functional dysphagia |
| DD90.3 | Functional dyspepsia |
| DD90.Z | Functional disorders of esophagus or gastroduodenal system, unspecified |
| DD91.0Z | Irritable bowel syndrome, unspecified |
Dosage Regimen
| The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen. |
Tablets
For adults and children over 4 years old – orally 2-4 times/day 30 minutes before meals. The dose depends on the patient’s age.
The course of treatment is 4-8 weeks. For the next 8 weeks, preparations containing bismuth should not be taken.
For the eradication of Helicobacter pylori, it is advisable to use bismuth tripotassium dicitrate in combination with antibacterial drugs that have anti-Helicobacter activity.
Adverse Reactions
From the digestive system, transient effects are possible – nausea, vomiting, increased stool frequency, constipation.
Dermatological reactions: skin rash, itching.
From the central nervous system with long-term use in high doses – encephalopathy associated with the accumulation of bismuth in the central nervous system.
Contraindications
Severe renal impairment, pregnancy, lactation period, hypersensitivity to bismuth tripotassium dicitrate.
Use in Pregnancy and Lactation
Contraindicated for use during pregnancy and during the lactation (breastfeeding) period.
Use in Renal Impairment
Contraindicated in severe renal impairment.
Pediatric Use
Used in children over 4 years of age according to the dosage regimen.
Special Precautions
Should not be used for more than 8 weeks.
During treatment, it is not recommended to exceed the established daily doses for adults and children.
After completing the course of treatment at recommended doses, the concentration of the active substance in the blood plasma does not exceed 3-58 µg/l, and intoxication is observed only at concentrations above 100 µg/l.
During use, stool may turn black due to the formation of bismuth sulfide. Sometimes a slight darkening of the tongue is noted.
Drug Interactions
With the simultaneous use of other drugs, as well as food and liquids, in particular, antacids, milk, fruits and fruit juices, a change in the effectiveness of bismuth tripotassium dicitrate is possible.
Storage Conditions
Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.
Dispensing Status
Over-the-Counter
Important Safety Information
This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.
Medical DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Film-coated tablets, 120 mg: 10, 20, 30, 40, 50, 60 or 100 pcs.
Marketing Authorization Holder
Avexima JSC (Russia)
Manufactured By
Irbit Chemical Pharmaceutical Plant, JSC (Russia)
Or
Avexima Siberia LLC (Russia)
Dosage Form
 |
Bismuthate, tripotassium dicitrato | Film-coated tablets, 120 mg: 10, 20, 30, 40, 50, 60 or 100 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets white or almost white, round, biconvex, odorless or with a slight characteristic odor; on the cross-section, two layers are visible: a core of white or white with a yellowish tint and a film coating.
| 1 tab. | |
| Bismuthate, tripotassium dicitrato | 304.6 mg, |
| In terms of bismuth oxide | 120 mg |
Excipients: corn starch, potassium polyacrylate, povidone K-25, macrogol 6000, magnesium stearate.
Film coating composition: hypromellose, titanium dioxide, macrogol 4000.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (4) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.
10 pcs. – contour cell packs (10) – cardboard packs.
10 pcs. – polyethylene jars (1) – cardboard packs.
20 pcs. – polyethylene jars (1) – cardboard packs.
30 pcs. – polyethylene jars (1) – cardboard packs.
Film-coated tablets, 120 mg: from 7 to 480 pcs.
Marketing Authorization Holder
Atoll LLC (Russia)
Manufactured By
Ozon, LLC (Russia)
Dosage Form
|
Bismuthate, tripotassium dicitrato | Film-coated tablets, 120 mg: from 7 to 480 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets white or almost white, round, biconvex, odorless or with a slight characteristic odor; on the cross-section, two layers are visible: a core of white or white with a yellowish tint and a film coating.
| 1 tab. | |
| Bismuthate, tripotassium dicitrato | 304.6 mg |
| Equivalent to bismuth oxide content | 120 mg |
Excipients: corn starch – 71.1 mg, potassium polyacrylate – 23.6 mg, povidone K25 – 17.7 mg, macrogol-6000 – 6 mg, magnesium stearate – 2 mg.
Film coating composition: hypromellose – 5.5 mg; titanium dioxide – 3 mg; macrogol-4000 – 1.5 mg.
From 7 to 30 pcs. – contour cell packs (from 1 to 16 pcs.) – cardboard packs.
Film-coated tablets 120 mg: from 28 to 196 pcs.
Marketing Authorization Holder
Biopharmkombinat, LLC (Russia)
Dosage Form
|
Bismuthate, tripotassium dicitrato | Film-coated tablets 120 mg: from 28 to 196 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets round biconvex, white or almost white; on the cross-section, the core is from white to almost white with a brownish tint; inclusions from gray to brown are allowed; marbling and slight roughness of the tablet surface are allowed.
| 1 tab. | |
| Bismuthate, tripotassium dicitrato | 304.6 mg |
| Equivalent to bismuth oxide content | 120 mg |
Excipients: povidone K-25 – 17.7 mg, macrogol – 6 mg, magnesium stearate – 2 mg, crospovidone – 1.5 mg.
Coating composition: hypromellose – 5.5 mg, titanium dioxide – 3 mg, macrogol – 1.5 mg.
8 pcs. – contour cell packs (from 4 to 14 pcs.) – cardboard packs.
10 pcs. – contour cell packs (from 4 to 14 pcs.) – cardboard packs.
14 pcs. – contour cell packs (from 4 to 14 pcs.) – cardboard packs.
28 pcs. – polymer jars (1) – cardboard packs.
56 pcs. – polymer jars (1) – cardboard packs.
112 pcs. – polymer jars (1) – cardboard packs.
Film-coated tablets, 120 mg: 8, 10, 16, 20, 24, 28, 30, 32, 40, 42, 48, 50, 56, 60, 64, 70, 72, 80, 84, 90, 98, 100, 112, 126 or 140 pcs.
Marketing Authorization Holder
Bright Way, LLC (Russia)
Manufactured By
Velpharm, LLC (Russia)
Dosage Form
|
Bismuthate, tripotassium dicitrato | Film-coated tablets, 120 mg: 8, 10, 16, 20, 24, 28, 30, 32, 40, 42, 48, 50, 56, 60, 64, 70, 72, 80, 84, 90, 98, 100, 112, 126 or 140 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets light yellow, round, biconvex, on the cross-section the core is white or almost white.
| 1 tab. | |
| Bismuthate, tripotassium dicitrato | 304.6 mg, |
| Equivalent to bismuth oxide content | 120 mg |
Excipients: corn starch, povidone K30, potassium polyacrylate, macrogol 6000 (polyethylene glycol 6000, polyethylene oxide 6000), magnesium stearate.
Coating composition Opadry II 85F38077 yellow, consists of polyvinyl alcohol, macrogol 3350, quinoline yellow dye (E104), talc, titanium dioxide, indigo carmine (E132).
8 pcs. – cardboard cell packs (1) – cardboard packs.
8 pcs. – cardboard cell packs (2) – cardboard packs.
8 pcs. – cardboard cell packs (3) – cardboard packs.
8 pcs. – cardboard cell packs (4) – cardboard packs.
8 pcs. – cardboard cell packs (5) – cardboard packs.
8 pcs. – cardboard cell packs (6) – cardboard packs.
8 pcs. – cardboard cell packs (7) – cardboard packs.
8 pcs. – cardboard cell packs (8) – cardboard packs.
8 pcs. – cardboard cell packs (9) – cardboard packs.
8 pcs. – cardboard cell packs (10) – cardboard packs.
10 pcs. – cardboard cell packs (1) – cardboard packs.
10 pcs. – cardboard cell packs (2) – cardboard packs.
10 pcs. – cardboard cell packs (3) – cardboard packs.
10 pcs. – cardboard cell packs (4) – cardboard packs.
10 pcs. – cardboard cell packs (5) – cardboard packs.
10 pcs. – cardboard cell packs (6) – cardboard packs.
10 pcs. – cardboard cell packs (7) – cardboard packs.
10 pcs. – cardboard cell packs (8) – cardboard packs.
10 pcs. – cardboard cell packs (9) – cardboard packs.
10 pcs. – cardboard cell packs (10) – cardboard packs.
14 pcs. – cardboard cell packs – cardboard packs.
14 pcs. – cardboard cell packs (2) – cardboard packs.
14 pcs. – cardboard cell packs (3) – cardboard packs.
14 pcs. – cardboard cell packs (4) – cardboard packs.
14 pcs. – cardboard cell packs (5) – cardboard packs.
14 pcs. – cardboard cell packs (6) – cardboard packs.
14 pcs. – cardboard cell packs (7) – cardboard packs.
14 pcs. – cardboard cell packs (8) – cardboard packs.
14 pcs. – cardboard cell packs (9) – cardboard packs.
14 pcs. – cardboard cell packs (10) – cardboard packs.
56 pcs. – jars – cardboard packs.
112 pcs. – jars – cardboard packs.
Film-coated tablets, 120 mg: 56 or 112 pcs.
Marketing Authorization Holder
Kron, LLC (Russia)
Manufactured By
Avva Rus, JSC (Russia)
Dosage Form
|
Bismuthate, tripotassium dicitrato | Film-coated tablets, 120 mg: 56 or 112 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets white or almost white, round, biconvex; on the cross-section, the core is from white to almost white with a grayish-brownish or brownish tint; inclusions from gray to brown are allowed; marbling and slight roughness of the tablet surface are allowed.
| 1 tab. | |
| Bismuthate, tripotassium dicitrato | 300 mg, |
| Equivalent to bismuth oxide content | 120 mg |
Excipients: povidone K17 – 17.7 mg, macrogol – 6 mg, magnesium stearate – 2 mg, crospovidone – 1.5 mg, corn starch – to obtain an uncoated tablet weighing 430 mg.
Film coating composition mixture for film coating “VTVACOAT®” — to obtain a coated tablet weighing 445 mg (hypromellose — 35%, methacrylic acid and ethyl acrylate copolymer (1:1) — 30%, talc — 18%, titanium dioxide — 10%, triacetin — 7%).
8 pcs. – cardboard cell packs (7) – cardboard packs.
8 pcs. – cardboard cell packs (14) – cardboard packs.
14 pcs. – cardboard cell packs (8) – cardboard packs.
Film-coated tablets, 120 mg: from 7 to 480 pcs.
Marketing Authorization Holder
Ozon, LLC (Russia)
Manufactured By
Ozon Pharm, LLC (Russia)
Or
Ozon, LLC (Russia)
Dosage Form
|
Bismuthate, tripotassium dicitrato | Film-coated tablets, 120 mg: from 7 to 480 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets white or almost white, round, biconvex, odorless or with a slight characteristic odor, on the cross-section two layers are visible: a core of white or white with a yellowish tint and a film coating.
| 1 tab. | |
| Bismuthate, tripotassium dicitrato | 304.6 mg, |
| Equivalent to bismuth oxide content | 120 mg |
Excipients: corn starch – 71.1 mg, potassium polyacrylate – 23.6 mg, povidone K25 – 17.7 mg, macrogol-6000 – 6 mg, magnesium stearate – 2 mg.
Film coating composition: hypromellose – 5.5 mg; titanium dioxide – 3 mg; macrogol-4000 – 1.5 mg.
From 7 to 30 pcs. – cardboard cell packs (from 1 to 16 pcs.) – cardboard packs.
Film-coated tablets, 120 mg: 28, 30, 56, 60, 112 or 120 pcs.
Marketing Authorization Holder
Vertex, JSC (Russia)
Dosage Form
|
Bismuthate, tripotassium dicitrato-Vertex | Film-coated tablets, 120 mg: 28, 30, 56, 60, 112 or 120 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets almost white in color, round, biconvex, odorless or with a slight characteristic odor; on the cross-section, the core is white or almost white.
| 1 tab. | |
| Bismuthate, tripotassium dicitrato | 304.6 mg, |
| Equivalent to bismuth oxide Bi2O3 content | 120 mg |
Excipients: corn starch – 70.6 mg, povidone K30 – 17.7 mg, polacrilin potassium – 23.6 mg, macrogol 6000 (polyethylene glycol 6000) – 6 mg, magnesium stearate – 2 mg.
Shell composition [hypromellose 2910 — 3.2 mg, macrogol 6000 (polyethylene glycol 6000) — 1.1 mg] or [dry mix for film coating containing hypromellose 2910 (74.4 %), macrogol 6000 (polyethylene glycol 6000) (25.6 %)] — 4.3 mg.
14 pcs. – contour cell packs (2) – cardboard packs.
14 pcs. – contour cell packs (4) – cardboard packs.
14 pcs. – contour cell packs (8) – cardboard packs.
15 pcs. – contour cell packs (2) – cardboard packs.
15 pcs. – contour cell packs (4) – cardboard packs.
15 pcs. – contour cell packs (8) – cardboard packs.
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