Product Overview
[Drug Name]
Trade Name: Shuwei
English Name: Promethazine Hydrochloride Tablets
Chinese Pinyin: Juyuansuanbi Leinitiding Jiaonang
[Ingredients]
Bismuth citrate ranitidine.
[Properties]
This product is a hard capsule containing an off-white to pale yellow powder.
[Indications]
1. Gastric and duodenal ulcers.
2. Used in combination with antibiotics to eradicate Helicobacter pylori.
[Dosage and Administration]
Oral administration: 2 tablets twice daily before meals. The course of treatment should not exceed 6 weeks. The dosage and duration of combined antibiotic use should be determined according to your doctor's instructions.
[Adverse Reactions]
Allergic reactions are rare, including pruritus and rash. Liver function abnormalities may occur. Headache, joint pain, and gastrointestinal disturbances such as nausea, diarrhea, abdominal discomfort, stomach pain, and constipation may occur occasionally. Neutropenia is rare.
[Contraindications]
This product is contraindicated in patients with allergies.
[Precautions]
1. This product should not be used in high doses for extended periods, and continuous use should not exceed 6 weeks. 2. Black stool and tongue discoloration may occur after taking this product, which is normal and will disappear after discontinuation of the drug.
3. Patients with a history of acute porphyria or a creatinine clearance of 25 mg/min should not use this product in combination with clarithromycin for the treatment of Helicobacter pylori.
[Special Population Use]
Precautions for Children:
No research data are available regarding the use of this product, so it is not suitable for use in children.
Precautions for Pregnancy and Lactation:
Not recommended for use in pregnant or lactating women.
Precautions for Elderly Patients:
1. In elderly patients (aged 65 and over) who experience only an increase in serum ranitidine after treatment, while serum bismuth citrate levels are no higher than those of the general population, dose adjustment is generally not necessary. 2. Reduced renal clearance may increase serum ranitidine and serum bismuth citrate. This product is contraindicated if the creatinine clearance is 25 ml/min.
[Drug Interactions] Ranitidine citrate does not interact with drug-metabolizing enzymes in the body. Due to its wide therapeutic index, no clinically significant pharmacokinetic interactions have been observed when ranitidine citrate is used in combination with antibiotics, antacids, or aspirin.
[Pharmacological Actions]
This product is a new compound chemically synthesized from bismuth citrate and ranitidine. It combines the gastric acid and pepsin inhibitory effects of ranitidine with the anti-Helicobacter pylori and gastric mucosal protective effects of bismuth citrate.
[Storage]
Store tightly closed in a dry place.
[Strength]
0.2 g
[Packaging]
Plastic bottle, 14 tablets/bottle.
[Expiration Period]
24 months
[Approval Number]
National Medicine Standard H20020725
[Manufacturer]
Company Name: Changzhou Lanling Pharmaceutical Co., Ltd.
