Product Overview
[Drug Name]
Generic Name: Lansoprazole Enteric-Coated Capsules
Trade Name: Biaozhi Lansoprazole Enteric-Coated Capsules, 30mg x 7 capsules
Pinyin Full Code: LanSuoLaZuoChangRongJiaoNang
[Main Ingredient]
The main ingredient of this product is lansoprazole.
[Properties]
This product contains white enteric-coated spherical granules.
[Indications/Main Functions]
Gastric ulcer, duodenal ulcer, reflux esophagitis, Zollinger-Ellison syndrome, anastomotic ulcer.
[Specifications]
30mg x 7 capsules (Biaozhi)
[Dosage and Administration]
1. For gastric ulcer, duodenal ulcer, anastomotic ulcer, and Zollinger-Ellison syndrome, adults should generally take 30mg of lansoprazole orally once daily. For gastric ulcer and anastomotic ulcer, take the drug for eight consecutive weeks; for duodenal ulcer, take the drug for six consecutive weeks. 2. For reflux esophagitis, adults should typically take lansoprazole 30 mg orally once daily for eight consecutive weeks. For maintenance treatment of recurrent and recurrent reflux esophagitis, take 15 mg orally once daily. If symptom relief is inadequate, the dose may be increased to 30 mg.
[Adverse Reactions]
1. Use with caution in the following patients: 1) Patients with a history of drug allergies; 2) Patients with impaired liver function (which may prolong drug metabolism and excretion); 3) Elderly patients (see [Use in Elderly Patients]).
2. Important Precautions: 1) During treatment, patients should be carefully observed and the minimum dose required for treatment should be used based on their symptoms. 2) Due to the lack of sufficient long-term experience, this drug is not recommended for maintenance treatment of gastric ulcers, duodenal ulcers, and anastomotic ulcers. 3) Maintenance treatment is limited to recurrent and recurrent reflux esophagitis. If patients achieve long-term symptom relief after treatment with 30 mg/day or 15 mg/day, and dose reduction or discontinuation does not result in relapse, the dose should be reduced to 15 mg/day or discontinued. Regular endoscopic follow-up is recommended during maintenance therapy.
3. Other Precautions: 1) Visual impairment has been reported with the use of similar medications (e.g., omeprazole). 2) In animal studies, rats force-fed lansoprazole at a dose of 50 mg/kg/day (approximately 100 times the clinical dose) for 52 weeks resulted in one case of a benign testicular Leydig cell tumor. Another study found that rats force-fed lansoprazole at doses exceeding 15 mg/kg/day for 24 months had an increased incidence of benign testicular Leydig cell tumors, and gastric carcinoids may develop in rats fed doses exceeding 5 mg/kg/day. Furthermore, the incidence of retinal atrophy increased in female rats fed lansoprazole at doses exceeding 15 mg/kg/day and in male rats fed at doses exceeding 50 mg/kg/day. However, testicular Leydig cell tumors and retinal atrophy were not observed in mouse tumorigenicity studies or toxicity studies in dogs and monkeys. Therefore, these findings are likely specific to rats. 3) Because this drug can mask the symptoms of gastric cancer, gastric cancer must be excluded before administration. 4) The safety of long-term use of this product has not been established (there is a lack of experience with long-term use).
4. During drug delivery: PTP-packaged medications should be removed from the PTP sheet before administration (there have been reports of accidental ingestion of the hard, sharp corners of the PTP sheet piercing the esophageal mucosa, leading to perforation and serious complications such as mediastinitis).
[Contraindications]
1. This product is contraindicated in patients with a history of allergy to any of the ingredients in this product.
2. This product is contraindicated in patients currently taking atazanavir sulfate (see [Drug Interactions]). [Drug Interactions]
1. Contraindications for Concomitant Use (Lansoprazole Enteric-Coated Capsules should not be taken with the following drugs.)
2. Precautions for Concomitant Use (Lansoprazole Enteric-Coated Capsules should be administered with caution when taken with the following drugs.)
[Precautions]
1. Use with caution in the following patients: 1) Patients with a history of drug allergies 2) Patients with impaired liver function (which may prolong drug metabolism and excretion) 3) Elderly patients (see [Use in Elderly Patients]). 2. Important Precautions 1) During treatment, patients should be carefully observed and the minimum dose required for treatment should be used based on their symptoms. 2) Due to the lack of sufficient long-term experience, this drug is not recommended for maintenance treatment of gastric ulcers, duodenal ulcers, and anastomotic ulcers. 3) Maintenance treatment is limited to recurrent and recurrent reflux esophagitis. If patients achieve long-term symptom relief on 30 mg/day or 15 mg/day therapy and dose reduction or discontinuation does not result in recurrence, the dose should be reduced to 15 mg/day or discontinued. Regular endoscopic follow-up is recommended during maintenance therapy. 3. Other Precautions: 1) There have been reports of visual impairment with the use of similar medications (e.g., omeprazole). 2) In animal studies, rats force-fed lansoprazole at a dose of 50 mg/kg/day (approximately 100 times the clinical dose) for 52 weeks resulted in one case of a benign testicular Leydig cell tumor. In another study, rats force-fed lansoprazole at doses exceeding 15 mg/kg/day for 24 months increased the incidence of benign testicular Leydig cell tumors, and gastric carcinoids may develop in rats fed doses exceeding 5 mg/kg/day. Furthermore, the incidence of retinal atrophy increased in female rats fed lansoprazole at doses exceeding 15 mg/kg/day and in male rats at doses exceeding 50 mg/kg/day. However, testicular Leydig cell tumors and retinal atrophy were not observed in mouse tumorigenicity studies or toxicity studies in dogs and monkeys. Therefore, these findings are considered to be specific to rats. 3) Because this drug can mask the symptoms of gastric cancer, gastric cancer must be excluded before administration. 4) The safety of long-term use of this drug has not been established (due to a lack of experience with long-term use). 4. Upon delivery: PTP-packaged medications should be removed from the PTP sheet before administration (there have been reports of accidental ingestion of the hard, sharp corners of the PTP sheet piercing the esophageal mucosa, leading to perforation and serious complications such as mediastinitis).
[Pediatric Use]
The safety of this drug for pediatric use has not been established (due to limited clinical experience in pediatric patients).
[Elderly Use]
Generally speaking, gastric acid secretion and other physiological functions are reduced in elderly patients, so caution should be exercised when using this drug, such as starting with a lower dose.
[Overdose]
Research data on overdose with this drug are lacking.
[Pharmacology and Toxicology]
1. Mechanism of Action: After translocating to the acid-secreting tubules of the gastric mucosal parietal cells, this drug transforms into an active form under acidic conditions. This active form binds to the SH group of the proton pump (Hsup+/sup]+Kisup]+[/sup]-ATPase) distributed in this area, thereby inhibiting the enzyme's activity and, therefore, inhibiting gastric acid secretion. 2. Gastric Acid Secretion Inhibition: 1) Pentagastrin-stimulated Gastric Acid Secretion: In healthy adults, a single oral dose or daily administration of lansoprazole 30 mg for 7 consecutive days significantly inhibits gastrin-induced acid secretion, and this effect persists for 24 hours after administration. 2) Insulin-stimulated Acid Secretion: In healthy adults, a daily administration of lansoprazole 30 mg for 7 consecutive days significantly inhibits insulin-induced acid secretion. 3) Nocturnal Acid Secretion: In healthy adults, a daily administration of lansoprazole 30 mg for 7 consecutive days significantly inhibits nocturnal gastric acid secretion. 4) 24-Hour Acid Secretion: In healthy adults, lansoprazole 30 mg orally administered once daily for 7 consecutive days significantly inhibited 24-hour gastric acid secretion as measured by 24-hour gastric fluid sampling. 5) 24-Hour Gastric pH Monitoring: In healthy adults and patients with duodenal ulcers, lansoprazole 30 mg orally administered once daily for 7 consecutive days significantly inhibited 24-hour gastric acid secretion. 6) 24-Hour Lower Esophageal pH Monitoring: In patients with reflux esophagitis, lansoprazole 30 mg orally administered once daily for 7 to 9 consecutive days significantly inhibited gastroesophageal reflux.
