Pantoprazole enteric-coated tablets

Mechanism of Action Pantoprazole is a benzimidazole derivative that inhibits gastric acid secretion by specifically integrating with the proton pump of the gastric wall fiber. Pantoprazole is activated to active formation under the acidic environment of the parietal cells, inhibiting H, K-ATPase, the final link of gastric acid secretion. The inhibition is dose-dependent and affects the basal acid secretion and maximum acid secretion of gastric acid. Like other proton pump inhibitors and H2 receptor antagonists, after treatment with pantoprazole, gastric acid secretion decreases and gastrin levels increase accordingly with the decrease in gastric acid. This increase in gastrin levels is reversible. Because pantoprazole binds to the distal end of the enzyme at the cell receptor level, pantoprazole can affect gastric acid secretion independently or under the stimulation of other substances (acetylcholine, histamine, gastrin). Oral and intravenous use of pantoprazole can achieve the same effect.

Pantoprazole sodium pantoprazoleNa (pregnancy grade: B)

This product is a yellow enteric-coated tablet, which appears white or off-white after removing the coating.

It is suitable for active peptic ulcer (gastric and duodenal ulcer), reflux esophagitis and Zollinger-Ellison syndrome.

If this product is not prescribed by a doctor, it should be taken according to the following methods. Please follow these methods, otherwise the effect may not be good. Duodenal ulcers or gastric ulcers with Helicobacter pylori infection must be eradicated with combined therapy. The combined use of Pantoloc and antibacterial drugs can adopt any of the following schemes: a. 1 tablet of Pantoloc enteric-coated tablets × 2/day + 1000mg amoxicillin × 2/day + 500mg clarithromycin × 2/day, b. 1 tablet of Pantoloc enteric-coated tablets × 2/day + 500mg metronidazole × 2/day + 500mg clarithromycin × 2/day, c. 1 tablet of Pantoloc enteric-coated tablets × 2/day + 1000mg amoxicillin × 2/day + 500mg metronidazole × 2/day. In combined therapy, the scheme with metronidazole is only used when other schemes cannot eradicate Helicobacter pylori infection. If the patient has no indication for combined therapy, such as negative Helicobacter pylori test, Pantoloc can be used alone at the following doses unless otherwise prescribed by a physician: Patients with duodenal ulcer, gastric ulcer and reflux esophagitis generally take 1 tablet of Pantoloc enteric-coated tablets daily. In individual cases, especially when other treatments are ineffective, the dose can be doubled (i.e. 2 tablets of Pantoloc enteric-coated tablets daily). Note: The daily dose of Pantoloc for patients with impaired renal function and the elderly should generally not exceed 40 mg, but there are exceptions. When combined therapy is used to eradicate Helicobacter pylori infection, elderly patients also use regular doses of Pantoloc (40 mg × 2/day) in 1-week treatment. The dose of patients with severe liver damage and failure should be reduced to 1 tablet (40 mg) of Pantoloc every other day. Dosage and course of treatment: Pantoloc enteric-coated tablets should be taken completely with water 1 hour before breakfast. When combined therapy is used to eradicate Helicobacter pylori infection, the second dose of the day should be taken before dinner. The combined therapy usually lasts for 7 days. If the symptoms persist, Pantoloc should be continued to ensure complete healing of the ulcer. The recommended dosage for the treatment of gastric and duodenal ulcers should be followed. Duodenal ulcers usually heal within 2 weeks, while gastric ulcers and reflux esophagitis require 4 weeks of treatment. In individual cases, the course of treatment can be appropriately extended to 4 weeks (duodenal ulcers) or 8 weeks (gastric ulcers and reflux esophagitis). Due to limited experience with long-term medication, the course of treatment should not exceed 8 weeks.

1. Digestive system Common (≥1%～10%) Upper abdominal pain Diarrhea Constipation or abdominal distension Uncommon (≥0.1%～1%) Nausea. 2. Systemic system and injection site Rare (0.01%) Peripheral edema disappears at the end of treatment. 3. Hepatobiliary system Rare (0.01%) Severe hepatocellular damage with or without jaundice. 4. Immune system Rare (0.01%) Allergic reaction such as anaphylactic shock. 5. Measurement values Rare (0.01%) Increased liver enzyme measurement values (transaminase-GT) Increased triglyceride levels Fever Return to normal at the end of treatment. 6. Skeletal musculoskeletal system Connective tissue Rare (0.01%) Myalgia disappears at the end of treatment. 7. Nervous system Common (≥1%～10%) Headache Uncommon (≥0.1%～1%) Dizziness or visual impairment (blurred vision). 8. Mental system Rare (0.01%) Depression disappears at the end of treatment. 9. Kidney and urinary system Rare (0.01%) Interstitial nephritis. 10. Skin and subcutaneous tissue Uncommon (≥0.1% to 1%) allergic reactions such as itching, rash, rare (0.01%) urticaria, angioedema, severe skin reactions such as Stevens J.

Pantoprazole should not be used in patients with known allergies to certain components of the drug. Combination therapy to eradicate Helicobacter pylori infection is contraindicated in patients with moderate to severe liver and kidney dysfunction, as there is currently a lack of clinical experience on the efficacy and safety of combination therapy for such patients.

Precautions for children: There is no experience of using it for children. Precautions for pregnancy and lactation: There is limited clinical experience for pregnant women. In animal experiments, there was mild embryotoxicity when the dose exceeded 5 mg/kg. There is no report of pantoprazole entering human breast milk. This product can only be used when the benefits of pantoprazole to the mother outweigh its potential harm to the fetus or infant. Precautions for the elderly: See [Usage and Dosage].

Pantoprazole may reduce the absorption of drugs whose bioavailability depends on gastric pH (e.g. ketoconazole). Please note that this also applies to drugs taken shortly before oral administration of pantoprazole. The active ingredient of pantoprazole is metabolized in the liver by the cytochrome P450 enzyme system, so other drugs metabolized by this enzyme system are not excluded from the possibility of interaction with it, however, many such drugs have been specifically tested, such as carbamazepine, caffeine, diazepam, diclofenac, digoxin, ethanol, glyburide, metoprolol, nifedipine, phenprocoumon, phenytoin, theophylline, warfarin, and oral contraceptives, and no clinically significant interactions with them have been observed. Pantoprazole also does not interact with concomitantly used alkaline antacids.

Keep away from light and store in sealed container.

40 mg (as pantoprazole)

36 months