product name： Pantoprazole Sodium Enteric-coated Capsules

Instructions for pantoprazole sodium enteric capsules

 

Please read the instructions carefully and use them under the guidance of your physician

 

[name of drug]

 

General name: pantoprazole sodium enteric capsules

 

Pantoprazole Sodium Enteric Capsules

 

Pantuolazuona Changrong Jiaonang

 

[ingredients] chemical name: 5-difluoromethoxy2-{[(3,4 dimethoxy2-pyridine) methyl] -- sulfonyl} -1h-benzimidazole sodium monohydrate.

 

Chemical structure formula:

 

Molecular formula: C16H14F2N3NaO4S·H2O

 

Molecular weight: 423.38

 

[properties] the content of this product is enteric-soluble pellets.

 

[indications] for active peptic ulcer (gastric and duodenal ulcer), reflux esophagitis and zhuoai syndrome.

 

Specification: 20mg(C16H15F2N3O4S)

 

[usage and dosage] for duodenal ulcer, gastric ulcer and reflux esophagitis, take 40mg(2 pills) orally every morning. The course of treatment for duodenal ulcer is usually 2 to 4 weeks, and for gastric ulcer and reflux esophagitis is usually 4 to 8 weeks.

 

[adverse reactions] clinical application occasionally has dizziness, insomnia, lethargy, nausea, diarrhea and constipation, rash, muscle pain and other symptoms.

 

[contraindication] people who are allergic to this product, women who are breastfeeding, and women in the first trimester of pregnancy should not use this product.

 

[precautions]

 

1. Arrhythmia, increased transaminase, renal function changes, granulocyte reduction, etc. may occur in large doses.

 

2. This product is enteric-soluble preparation, do not chew when taking, but pour out the contents.

 

3. When gastric ulcer is suspected, the possibility of cancer should be first ruled out, because the treatment of this product can reduce its symptoms, thus delaying the diagnosis.

 

4. Patients with liver and kidney dysfunction should be careful to use this product. Patients with severe liver disease should reduce the dosage of this product to eliminate delay.

 

[drugs for pregnant and lactating women] it is contraindication for lactating women and women in the first trimester of pregnancy.

 

[medicines for children] data on the efficacy and safety of medicines for children have not been established. Infants are forbidden.

 

[medication for elderly patients] no dose adjustment requirements.

 

[drug interaction] this product has little interaction with other drugs. Compared with omeprazole, it has little effect on cytochrome P450 system and does not affect the action time of diazepam. It has no obvious interaction with oral contraceptives, digoxin, warfarin, phenytoin or theophylline.

 

[drug overdose] no related reports.

 

[pharmacology and toxicology] this product specifically ACTS on gastric mucosal parietal cells, reducing the activity of H+ and K+ -atpase in parietal cells, thus inhibiting the secretion of gastric acid. Compared with omeprazole, this product has a weak inhibitory effect on cytochrome p-dependent enzyme.

 

[pharmacokinetics] this product is rapidly and completely absorbed after oral administration, and the peak blood concentration can be reached about 2 ~ 3 hours after a single oral administration of 40mg, and the absolute bioavailability of the oral preparation is 77%. The plasma protein binding rate of pantoprazole is 98%, and the metabolism of pantoprazole sulfate is mainly in the liver. The half-life of pantoprazole is about 1 hour, and that of the demethylpantoprazole sulfate is 1-5 hours. 80% of the metabolites are excreted through the kidneys and the rest through bile and feces.

 

[storage] shading, sealing and storage in a cool place.

 

[packaging] aluminum-plastic packaging, 8 pieces/board, 2 boards/box

 

[validity period] 24 months.

 

[executive standard] the second edition of Chinese pharmacopoeia 2015

 

[approval document no.] Chinese medicine approval number H20052417

 

[production enterprise]

 

Company name: fuzhou minhai pharmaceutical co., LTD

 

Address: jingyang industrial zone, fuqing city, fujian province zip code: 350303

 

Telephone: 0591-85321769 85321776 fax: 85321766