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Ranitidine bismuth citrate tablets

Function and Efficacy

This product is a complex of antacids and bismuth agents. It can play an anti-peptic ulcer role by inhibiting gastric acid secretion, inhibiting pepsin, inhibiting Helicobacter pylori, and forming a protective isolation layer on the surface of the gastric mucosa. The oral LD50 value of this product in mice is 3723.05 (3475.84-3987.84) mg/kg; the intravenous LD50 value is 52.28 (48.69-56.13) mg/kg. Rats orally administered this product (800, 400, 100 mg/kg) and Beagle dogs orally administered this product (400, 50 mg/kg) for 90 consecutive days, no obvious toxic effects were found. After 90 days of administration of the high-dose group of Beagle dogs, routine urine examination revealed red blood cells and protein, which gradually recovered after discontinuation of the drug, and no delayed toxic reactions were observed. No mutagenic effect, no teratogenic effect.

Ingredients

Ranitidine bismuth citrate

Name Description Content CAS NO. Manufacturer
RanitidinebismuthcitrateIngredients

This product is a complex of antacids and bismuth agents, which can play an anti-peptic ulcer role through multiple pathways such as inhibiting gastric acid secretion, inhibiting pepsin, inhibiting Helicobacter pylori, and forming a protective isolation layer on the surface of the gastric mucosa.

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128345-62-0 2

Appearance

This product is a film-coated tablet, which appears off-white or slightly yellow after removing the coating.

Indication

It is suitable for the treatment of benign gastric ulcers and active duodenal ulcers; combined with clarithromycin to treat Helicobacter pylori-positive active duodenal ulcers, it can significantly reduce the recurrence of ulcers.

Usage and Dosage

Adults: 0.4g each time, twice a day, before or after meals. Treatment of duodenal ulcer: 0.4g each time, twice a day, for 4 weeks. Treatment of benign gastric ulcer: 0.4g each time, twice a day, for 6 to 8 weeks. Treatment of Helicobacter pylori-positive duodenal ulcer: 0.4g of bismuth citrate ranitidine tablets each time, twice a day, for 4 weeks; combined with clarithromycin 0.5g two or three times a day for the first two weeks (total daily dose 1 to 1.5g).

Adverse Reactions

Allergic reactions: rare, including skin itching, rash, etc.; Gastrointestinal dysfunction: nausea, vomiting, abdominal pain, diarrhea, bloating, abdominal discomfort, stomach pain, constipation; Abnormal liver function: transient abnormal transaminase (ALT and AST); rare granulocytopenia; Central nervous system disorders: occasional dizziness, headache, insomnia, abnormal taste, and rare tremor; adverse reactions related to ranitidine may also occur.

Precautions

1. Patients who are allergic to ranitidine citrate or any of its components are contraindicated. 2. Patients with severe renal impairment are contraindicated.

Special Population Medication

Precautions for children: There is no research data on the use of this product in children, so it is not suitable for children. Precautions for pregnancy and lactation: It is not recommended for pregnant and lactating women. Precautions for the elderly: It is not clear yet.

Drug Interactions

1. When used in combination with clarithromycin, the concentrations of serum ranitidine, bismuth citrate and 14-hydroxyclarithromycin increased by 57%, 48% and 31% respectively; 2. When used in combination with large doses of antacids (170mEq), the serum ranitidine concentration decreased by 28%, and the serum bismuth citrate concentration also decreased; 3. When used in combination with aspirin, the absorption of acetylsalicylic acid decreased slightly; 4. Food can reduce the absorption of bismuth. Experiments have shown that taking 800mg of ranitidine citrate bismuth after a meal, its absorption rate and absorption degree decreased by 50% and 25% respectively compared with taking it half an hour before a meal, but it does not affect the clinical efficacy.

Storage

Keep away from light, seal tightly, and store in a dry place (10-30℃).

Packaging Specification

0.2g

Validity Period

24 months

Manufacturer

Livzon (GROUP) Pharmaceutical FACTORY

  • Founded in:

    1989-11-26
  • Address:

    No. 38 Chuangye North Road, Jinwan District, Zhuhai City
  • Tax NO.:

    91440400617489061P
  • Registered Funds:

    450 million yuan
  • Website:

  • Email:

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