Product Overview
[Drug Name]
Trade Name: Siyu
English Name: Nizatidine Dispersible Tablets
Chinese Pinyin: NiZhaTiDingFenSanPian
[Ingredients]
Nizatidine.
[Properties]
This product is a film-coated tablet. After removing the coating, it appears off-white or slightly yellow.
[Indications]
This product is used to treat active duodenal ulcers and benign gastric ulcers; for maintenance treatment after healing of duodenal ulcers; and for the treatment of endoscopically diagnosed gastroesophageal reflux disease (GERD) and associated heartburn.
[Dosage and Administration]
This product is a dispersible tablet and can be taken directly orally, or by dispersing an appropriate amount of the product into approximately 100ml of water, shaking, and then orally. For active duodenal ulcers and benign gastric ulcers: Adults: Take two 300mg tablets once daily at bedtime; or take one 150mg tablet twice daily for up to 8 weeks. Maintenance treatment after duodenal ulcer healing: Adults take 150mg tablet once daily at bedtime. For gastroesophageal reflux disease and heartburn symptoms: Adults take 150mg tablet twice daily for up to 12 weeks. For patients with moderate to severe renal insufficiency, reduce the dosage as follows: 1. For active duodenal ulcers, benign gastric ulcers, and gastroesophageal reflux disease, reduce creatinine clearance to 20-50 ml/min, 150mg once daily.
[Adverse Reactions]
Clinical studies involving over 6000 patients abroad have shown that this product is well tolerated. The most common adverse reactions to nizatidine are anemia and urticaria, with incidence rates of 0.2% and 0.5%, respectively; in placebo control, the incidence rates of anemia and urticaria were 0% and 0.1%, respectively, showing a significant difference.
[Contraindications]
This product is contraindicated in patients with hypersensitivity to this product or other histamine H2 receptor antagonists.
[Precautions]
1. Before using this product, exclude the possibility of gastric malignancy. 2. Because this product is primarily excreted via the kidneys, patients with moderate to severe renal impairment should use a reduced dose. 3. The pharmacokinetics of this product in patients with hepatorenal syndrome are unknown. This product is partially metabolized in the liver. Patients with hepatic impairment and normal renal function and no comorbidities should use the drug similarly to those with normal renal function. 4. Urobilinogen tests may show a false-positive result after taking this product. Please read the package insert carefully and use as directed by your doctor.
[Use in Special Populations]
Precautions for Pediatric Patients:
The efficacy and safety of this product in pediatric patients are unknown. It is not recommended for use in pediatric patients.
Precautions for Pregnancy and Lactation:
Use with caution in pregnant women; lactating women should discontinue breastfeeding during this medication period.
Precautions for the Elderly:
The efficacy and safety of this product in elderly patients are no different from those in younger patients. For elderly patients with renal impairment, see [Dosage and Administration].
[Drug Interactions]
This product has no drug interactions with theophylline, nitrazepam, chlorpheniramine, lidocaine, phenytoin sodium, or warfarin. Because this product does not inhibit the cytochrome P-450 drug-metabolizing enzyme system, no drug interactions resulting from hepatic drug metabolism inhibition will occur. In patients taking a high dose of aspirin (3900 mg) daily, concurrently taking this product (150 mg) twice daily, an increase in serum salicylate concentration may occur.
[Pharmacological Action]
Not yet clear.
[Storage]
Store in a tightly closed container in a dry place.
[Specifications]
0.15g
[Packaging Specifications]
Pharmaceutical packaging: PTP aluminum foil, pharmaceutical PVC rigid sheet blister pack, 8 tablets/box
[Shelf Life]
24 months
[Approval Number]
National Drug Approval Number H20090065
[Manufacturer]
Company Name: Weite (Hunan) Pharmaceutical Co., Ltd.
