Product Overview
[Drug Name]
Trade Name: Jindele
English Name: Ranitidine Bismuth Citrate Tablets
Chinese Pinyin: Juyuansuanbi Leinitiding Pian
[Ingredients]
Ranitidine Bismuth Citrate
[Properties]
This product is a film-coated tablet that appears off-white or slightly yellow after removal of the coating.
[Indications]
Indicated for the treatment of benign gastric ulcers and active duodenal ulcers. Combination with clarithromycin for the treatment of active duodenal ulcers in patients with Helicobacter pylori-positive disease can significantly reduce ulcer recurrence.
[Dosage and Administration]
Adults: 0.4g twice daily, before or after meals. For duodenal ulcers: 0.4g twice daily for 4 weeks. For benign gastric ulcers: 0.4g twice daily for 6-8 weeks. For the treatment of Helicobacter pylori-positive duodenal ulcers: Bismuth ranitidine citrate tablets 0.4g twice daily for 4 weeks; co-administer clarithromycin 0.5g two or three times daily for the first two weeks (total daily dose 1-1.5g).
[Adverse Reactions]
Allergic reactions: Rare, including pruritus and rash; Gastrointestinal disturbances: Nausea, vomiting, abdominal pain, diarrhea, bloating, abdominal discomfort, stomach pain, and constipation; Liver function abnormalities: Transient abnormalities in transaminases (ALT and AST); Rare granulocytopenia; Central nervous system disturbances: Occasionally dizziness, headache, insomnia, taste disturbances, and rarely tremor; Ranitidine-related adverse reactions may also occur.
[Contraindications]
1. This product is contraindicated in patients with allergies to Bismuth ranitidine citrate or any of its components.
2. This product is contraindicated in patients with severe renal impairment.
[Precautions]
1. This product may cause darkening of the stool and tongue, which may be easily confused with melena, but this condition disappears after discontinuation of the drug.
2. This product should not be used in high doses (not exceeding) 12 weeks.
3. It should not be used or is contraindicated in patients with renal insufficiency (creatinine clearance 25 ml/min).
4. Patients with gastric ulcers must exclude the possibility of malignancy before use.
5. When used in combination with clarithromycin, the precautions in the antibiotic's instructions should be followed.
6. If Helicobacter pylori is not eradicated after combined use with antibiotics, antibiotic resistance testing should be performed and antibiotics should be changed if necessary.
7. This product should not be used in patients with a history of acute porphyria.
8. Do not discard expired medication or discarded packaging.
[Use in Special Populations]
Precautions for Children: There are no research data on the use of this product in children, so it is not suitable for use in children.
Precautions for Pregnancy and Lactation: This product is not recommended for use in pregnant and lactating women.
Precautions for Elderly: This product is not recommended for use in children.
[Drug Interactions]
1. When used in combination with clarithromycin, serum concentrations of ranitidine, bismuth citrate, and 14-hydroxyclarithromycin increased by 57%, 48%, and 31%, respectively.
2. When used in combination with high-dose antacids (170 mEq), serum ranitidine concentrations decreased by 28%, and serum bismuth citrate concentrations also decreased.
3. When used in combination with aspirin, the absorption of acetylsalicylic acid was slightly decreased.
4. Food can reduce the absorption of bismuth. Experimental studies have shown that the absorption rate and concentration of ranitidine citrate (800 mg) taken after a meal decreased by 50% and 25%, respectively, compared to when taken half an hour before a meal. However, this did not affect clinical efficacy.
[Pharmacological Actions]
This product is a combination of an antacid and a bismuth agent. It exerts its anti-peptic ulcer effect through multiple pathways, including inhibition of gastric acid secretion, inhibition of pepsin, inhibition of Helicobacter pylori, and formation of a protective barrier on the gastric mucosal surface. The oral LD50 value for 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. Oral administration of this product to rats (800, 400, and 100 mg/kg) and to Beagle dogs (400 and 50 mg/kg) for 90 consecutive days revealed no significant toxic effects. Urinalysis of Beagle dogs in the high-dose group after 90 days of administration revealed red blood cells and protein, which gradually recovered after drug discontinuation, with no evidence of delayed toxic effects. This product is non-mutagenic and non-teratogenic.
[Storage]
Store in a dry, airtight container (10-30°C) away from light.
[Specifications]
0.2g
[Packaging]
12 tablets/box
[Validity Period]
36 months
[Approval Number]
National Medicine Approval No. H20050670
[Manufacturer]
Livzon Pharmaceutical Factory, Livzon Group
