Nizatidine Capsules

The product is an H2 receptor blocker. Animal experiments show that the inhibitory effect of this product on gastric acid secretion caused by stimulation such as histamine, gastrin and food is 8.9 times stronger than that of cimetidine, and its anti-ulcer effect is 34 times stronger than that of cimetidine, and is similar to that of ranitidine. Clinical studies have shown that this product can significantly inhibit nocturnal gastric acid secretion for up to 12 hours. Healthy subjects took 300 mg of this product orally once, and the average inhibition of nocturnal gastric acid secretion was 90%, and gastric acid secretion was still reduced by 52% after 10 hours. Oral administration of 75.300 mg of this product does not affect the activity of pepsin in gastric secretions, and the reduction in total pepsin secretion is proportional to the reduction in gastric secretion volume. This product has almost no effect on hypergastrinemia caused by basal serum gastrin or food; no rebound of gastric secretion was observed after eating 12 hours after taking this product. This product has no anti-androgen effect. After oral administration of this product, the absolute bioavailability exceeds 90%. When 150mg or 300mg is administered, Cmax is 700, 1800mu;g/L. and 14003600mu;g/L, tmax is 0.5-5 hours, and the blood concentration is lower than 10mu;g/L 12 hours after administration; t, 1/2beta; is 12 hours, Vd 0.81.5L/kg, CL is 40-60L/h, and AUC is 314.6 (mu;gh)/ml when 150mg is administered orally. Due to the short half-life and rapid clearance of this product, individuals with normal renal function generally do not accumulate. More than 90% of the oral dose of this product is excreted in urine within 12 hours, less than 6% of the dose is excreted in feces, and about 60% of the oral dose is excreted in its original form; CLr is 500ml/min, which indicates that this product is excreted through active secretion of the renal tubules. Moderate to severe renal dysfunction significantly prolongs the half-life of this product and reduces its clearance rate. The plasma protein binding rate of this product is about 35%.

Nizatidine.

This product is a hard capsule, and the contents are off-white or slightly yellow granules or powder.

Active duodenal ulcer and benign gastric ulcer, treatment course is 8 weeks; it can also be used for prevention after duodenal ulcer heals.

Active duodenal ulcer: Oral, once a day, 300 mg before bedtime, or twice a day, 150 mg each time; Benign gastric ulcer: Oral, once a day, 300 mg before bedtime; Prevention of duodenal ulcer: Oral, once a day, 150 mg before bedtime.

Clinical studies involving more than 6,000 patients have shown that this product is well tolerated. The most common adverse reactions of patients taking nizatidine are anemia and urticaria, with incidences of 0.2% and 0.5%, respectively; compared with placebo, the incidences of anemia and urticaria in patients were 0% and 0.1%, respectively, and the difference was significant. Adverse reactions greater than 1% after taking nizatidine are roughly equivalent to those taking placebo. Adverse reactions mainly include systemic: headache (16.6%), abdominal pain (7.5%), pain (4.2%), weakness (3.1%), back pain (2.4%), chest pain (2.3%), infection (1.7%), fever (1.6%), surgery (1.4%) and injury, accident (1.2%). Digestive system: diarrhea (7.2%)

Patients who are allergic to this product or other histamine H2 receptor antagonists are contraindicated

Precautions for children: The efficacy and safety of this product for children are not yet known. It is recommended that children do not use it. Precautions for pregnancy and lactation: Pregnant women should use it with caution; lactating women should stop breastfeeding during medication. Precautions for the elderly: The efficacy and safety of this product for elderly patients are no different from those for young patients. For elderly patients with impaired renal function, see [Usage and Dosage].

This product has no drug interactions with theophylline, chlordiazepoxide, lorazepam, lidocaine, phenytoin sodium and warfarin. Since this product does not inhibit the cytochrome P-450 drug metabolizing enzyme system, drug interactions caused by inhibition of liver drug metabolism will not occur. Patients taking large doses of aspirin (3900 mg) daily and taking this product 150 mg orally twice a day will have increased serum salicylate concentrations.

Keep away from light, sealed and stored in a dry place.

0.15g

24 months

Guangdong Yuanning Pharmaceutical Co., Ltd.

• Founded in:

  2012-02-15

• Address:

  No. 178 Renmin Road, Nanjie Street, Guangning County

• Tax NO.:

  91441223590110620R

• Registered Funds:

  20 million yuan

• Email:

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