Bivinol (Tablets) Instructions for Use

Marketing Authorization Holder

B-PHARM, LLC (Russia)

Manufactured By

Vifitech, CJSC (Russia)

ATC Code

A02BX05 (Bismuthate, tripotassium dicitrato)

Active Substance

Bismuthate, tripotassium dicitrato (BP British Pharmacopoeia)

Dosage Form

Bivinol

Film-coated tablets 120 mg: 28, 32, 40, 48, 50, 56, 60, 64, 70, 80, 84, 96, 98, 100, 112, 120, 140, 168, or 196 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets round, biconvex, coated with a white or almost white film coating. 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.

Excipients: povidone K-25 – 17.7 mg, macrogol – 6 mg, magnesium stearate – 2 mg, crospovidone 1.5 mg, corn starch to obtain a tablet core weighing 425 mg.

Shell excipients hypromellose – 5.5 mg, titanium dioxide – 3 mg, macrogol – 1.5 mg. Theoretical tablet weight – 435 mg.

8 pcs. – contour cell packaging (4) – cardboard packs.
8 pcs. – contour cell packaging (5) – cardboard packs.
8 pcs. – contour cell packaging (6) – cardboard packs.
8 pcs. – contour cell packaging (7) – cardboard packs.
8 pcs. – contour cell packaging (8) – cardboard packs.
8 pcs. – contour cell packaging (10) – cardboard packs.
8 pcs. – contour cell packaging (12) – cardboard packs.
8 pcs. – contour cell packaging (14) – cardboard packs.
10 pcs. – contour cell packaging (4) – cardboard packs.
10 pcs. – contour cell packaging (5) – cardboard packs.
10 pcs. – contour cell packaging (6) – cardboard packs.
10 pcs. – contour cell packaging (7) – cardboard packs.
10 pcs. – contour cell packaging (8) – cardboard packs.
10 pcs. – contour cell packaging (10) – cardboard packs.
10 pcs. – contour cell packaging (12) – cardboard packs.
10 pcs. – contour cell packaging (14) – cardboard packs.
14 pcs. – contour cell packaging (4) – cardboard packs.
14 pcs. – contour cell packaging (5) – cardboard packs.
14 pcs. – contour cell packaging (6) – cardboard packs.
14 pcs. – contour cell packaging (7) – cardboard packs.
14 pcs. – contour cell packaging (8) – cardboard packs.
14 pcs. – contour cell packaging (10) – cardboard packs.
14 pcs. – contour cell packaging (12) – cardboard packs.
14 pcs. – contour cell packaging (14) – cardboard packs.
28 pcs. – polyethylene jars (1) – cardboard packs.
32 pcs. – polyethylene jars (1) – cardboard packs.
56 pcs. – polyethylene jars (1) – cardboard packs.
112 pcs. – polyethylene jars (1) – cardboard packs.

Clinical-Pharmacological Group

Antiulcer drug that exerts a bactericidal effect on Helicobacter pylori

Pharmacotherapeutic Group

Intestinal antiseptic and astringent

Pharmacological Action

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, 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 defect area. 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. A small amount of bismuth that has entered the plasma is excreted by the kidneys.

Indications

Peptic ulcer of the stomach and duodenum 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 mainly with symptoms of diarrhea; functional dyspepsia not associated with organic diseases of the gastrointestinal tract.

ICD codes

Dosage Regimen

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 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 the 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 a concentration of more than 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 medicines, 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.