Product Overview
[Drug Name]
Generic Name: Lansoprazole Enteric-Coated Capsules
Trade Name: Furen Lansoprazole Enteric-Coated Capsules 30mg x 7 capsules
[Main Ingredients]
The main ingredient of this product is lansoprazole.
[Indications/Main Functions]
Gastric ulcer, duodenal ulcer, reflux esophagitis, Zollinger-Elison syndrome, anastomotic ulcer.
[Specifications]
30mg x 7 capsules
[Dosage and Administration]
Gastric ulcer, duodenal ulcer, anastomotic ulcer, and Zollinger-Elison syndrome are usually treated with lansoprazole 30mg orally once daily for adults. For gastric ulcers and anastomotic ulcers, the dosage should be eight weeks, and for duodenal ulcers, the dosage should be six weeks. For reflux esophagitis, the dosage should be lansoprazole 30mg orally once daily for eight weeks. For maintenance treatment of recurrent and recurrent reflux esophagitis, 15mg can be taken orally once daily. If symptoms persist, continue to be treated. The dose can be increased to 30 mg. [Usage and Dosage Notes] For maintenance treatment of reflux esophagitis, only when 15 mg treatment is ineffective or relapses during treatment should the dose be changed to 30 mg orally. For maintenance treatment, elderly patients, patients with liver dysfunction, and patients with renal impairment, take 15 mg of lansoprazole orally once a day.
[Adverse Reactions]
Gastric ulcer, duodenal ulcer, anastomotic ulcer, reflux esophagitis, Zollinger-Ellison syndrome: Among the 2214 cases in the pre-approval clinical trials of this product, 342 cases (accounting for 15.4%) had adverse reactions, including laboratory abnormalities. Among the 6260 cases in the post-marketing drug use survey (before the end of the review), 18 cases (accounting for 22%) had adverse reactions. The following adverse reactions are from investigator reports and spontaneous reports. (1) Clinically important adverse reactions 1) Allergic reactions (rash, facial edema, dyspnea, etc.) (<0.1%), occasionally shock (<0.1%). Therefore, close observation is required. If any abnormalities occur, the drug should be discontinued and appropriate treatment should be implemented. 2) Pancytopenia, agranulocytosis, hemolytic anemia (<0.1%), or granulocytopenia, thrombocytopenia, or anemia may occur (0.1%-<5%). Therefore, close observation is required. If any abnormalities occur, the drug should be discontinued and appropriate treatment should be implemented. 3) Jaundice and severe liver dysfunction accompanied by elevated AST (GOT) and ALT (GPT) (<0.1%). If any abnormalities occur, the drug should be discontinued. 4) Lyel syndrome (toxic epidermal necrolysis) and Stevens-Johnson syndrome (mucocutaneous ocular syndrome) (<0.1%). Therefore, close observation is required. If any abnormalities occur, the drug should be discontinued and appropriate treatment should be implemented. 5) Interstitial lung disease (<0.1%). If fever, cough, dyspnea, or abnormal lung sounds (crepitus) occur, a chest paracentesis should be performed, the drug should be discontinued, and treatment with corticosteroids should be administered. 6) Interstitial nephritis may occur (frequency unknown), and in some cases, acute renal failure has occurred. Therefore, close attention should be paid to renal function test values (increase in blood urea nitrogen, creatinine, etc.). If any abnormality is found, the use of Lansoprazole Enteric-Coated Capsules should be stopped immediately and appropriate measures should be taken. (2) Other adverse reactions Gastric ulcer, duodenal ulcer, anastomotic ulcer, reflux esophagitis and Zolinger-Elison syndrome. (Zolinger-Elison syndrome) Note 1) If the above symptoms occur, the use of this product should be stopped. Note 2) Close observation should be made, and if abnormalities are found, appropriate measures such as stopping the use of this product should be taken. Note 3) If persistent diarrhea occurs, the patient may have colitis. Histological examination can show thickening of the submucosa of the large intestine, such as collagen bands, and/or infiltration of inflammatory cells, although no abnormalities in the intestinal mucosa can be observed by endoscopic examination. Therefore, the use of Lansoprazole Enteric-Coated Capsules should be stopped immediately.
[Contraindications]
This product is contraindicated in the following patients. (1) Patients with a history of allergy to the ingredients of this preparation are contraindicated. (2) Patients who are taking atazanavir sulfate.
[Drug Interactions]
Lansoprazole enteric-coated capsules are mainly metabolized by the hepatic drug metabolizing enzymes CYP2C19 and CYP3A4. The gastric secretion inhibitory effect of lansoprazole enteric-coated capsules may promote or inhibit the absorption of concomitant drugs. (1) Contraindications for concurrent use of drugs (lansoprazole enteric-coated capsules should not be taken with the following drugs at the same time.) (2) Caution when taking concomitant medications (lansoprazole enteric-coated capsules should be given with caution when taken with the following drugs at the same time.)
[Precautions]
1. Use the drug with caution in the following patients: 1) Patients with a history of drug allergies 2) Patients with liver dysfunction (resulting in prolonged drug metabolism and excretion time) 3) Elderly patients (see [Precautions for Use in Elderly Patients]) 2. Important Precautions 1) During treatment, patients should be fully observed and the minimum dose required for treatment should be used according to their symptoms. 2) For gastric ulcers, duodenal ulcers and anastomotic ulcers, due to the lack of sufficient long-term use experience, it is recommended not to use this product for maintenance treatment. 3) Maintenance therapy is limited to recurrent and recurrent reflux esophagitis. If patients experiencing long-term symptom relief after treatment with 30 mg/day or 15 mg/day do not experience relapses, 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 similar medications (omeprazole). 2) In an animal study, rats were force-fed lansoprazole at a dose of 50 mg/kg/day (approximately 100 times the clinical dose) for 52 weeks, resulting in one case of a benign testicular Leydig cell tumor. Another study showed an increased incidence of benign testicular Leydig cell tumors in rats force-fed at doses exceeding 15 mg/kg/day for 24 months. Gastric carcinoids may develop in rats fed at doses exceeding 5 mg/kg/day. Furthermore, retinal atrophy was 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, the aforementioned lesions are considered to be specific to rats. 3) Because this drug can mask the symptoms of gastric cancer, gastric cancer must be ruled out before administration. 4) The safety of this drug for long-term use 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, which have pierced the esophageal mucosa and caused perforation, leading to serious complications such as mediastinitis.) Please read the package insert carefully and use as directed by your doctor.
[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, gastric acid secretion and other physiological functions are reduced in elderly patients. Therefore, caution should be exercised when using this drug, such as starting with a lower dose.
[Overdose]
Overdose research data are lacking for this drug.
[Pharmacology and Toxicology]
1. Mechanism of Action: After translocation 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]+K[sup]+[/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 suppressed 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 suppressed 24-hour gastric acid secretion. 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 suppressed gastroesophageal reflux.
