Nizatidine Capsules

Nizatidine (hereinafter referred to as this product) is a histamine H2 receptor antagonist. Nizatidine competitively binds to histamine H2 receptors and reversibly inhibits the function of receptors, especially acting on H2 receptors on gastric parietal cells that secrete gastric acid, blocking gastric acid formation and reducing basal gastric acid. It can also inhibit gastric acid secretion caused by food and chemical stimulation. Oral administration of 300 mg of this product can significantly inhibit gastric acid secretion at night (about 12 hours) with an inhibition rate of 90%; it significantly inhibits gastric acid secretion caused by food, caffeine, aminopyrazole and pentagastrin stimulation, with inhibition rates of 97%, 96%, 99%, and 67%, respectively. Oral administration of 75-300 mg of this product does not affect the activity of pepsin in gastric secretions, but the total pepsin secretion increases with gastric secretion.

N-[2-[[[2-[(Dimethylamino)methyl]-4-thiazolyl]methyl]thio]ethyl]-N′-methyl-2-nitro]-1,1-ethylenediamine

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

This product is suitable for the treatment of active duodenal ulcer; suitable for maintenance treatment after healing of duodenal ulcer; suitable for the treatment of endoscopically diagnosed esophagitis (including erosive and ulcerative esophagitis) and gastroesophageal reflux disease (GERD) as well as heartburn symptoms due to GERD; suitable for the treatment of benign gastric ulcer.

Active duodenal ulcer: Adults take two tablets (300 mg) orally once a day before bedtime; or, take one tablet (150 mg) twice a day, for up to 8 weeks. Maintenance treatment after healing of duodenal ulcer: Adults take one tablet (150 mg) orally once a day before bedtime. The results of continuous treatment for more than one year are not yet clear. Gastroesophageal reflux disease (GERD): Adults take one tablet (150 mg) twice a day to treat erosive esophagitis, ulcerative esophagitis, and heartburn symptoms caused by GERD, for up to 12 weeks. Benign gastric ulcer: Once a day, take two tablets (300 mg) orally before bedtime; or, take one tablet (150 mg) twice a day, for up to 8 weeks.

Clinical studies involving more than 600 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, with significant differences. 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 experience an increase in serum salicylate concentrations.

Keep in a dark, airtight, dry place. Valid for two years.

150mg

36 months

Shanghai Yan’an Pharmaceutical Co., Ltd.

• Founded in:

  1989-01-06

• Address:

  No. 65, Huaning Road, Minhang District, Shanghai

• Tax NO.:

  91310112133307700K

• Registered Funds:

  18 million yuan

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