Product Overview
[Drug Name]
Generic Name: Lansoprazole Enteric-Coated Capsules
Trade Name: Youjiekang Lansoprazole Enteric-Coated Capsules 30mg*8 Capsules
Pinyin Full Code: YouJieKang LanSuoLaZuoChangRongJiaoNang 30mg*8Li
[Main Ingredient]
Lansoprazole.
[Properties]
This product is a white capsule containing white or off-white enteric-coated spherical granules.
[Indications/Main Functions]
Gastric ulcer, duodenal ulcer, reflux esophagitis, Zollinger-Ellison syndrome.
[Specifications]
30mg*8 capsules
[Dosage]
Duodenal ulcer: Generally, adults take 30mg (1 capsule) once daily for 4-6 weeks. Gastric ulcer, reflux esophagitis, Zollinger-Ellison syndrome: Generally, adults take 30mg (1 capsule) once daily for 6-8 weeks. If used for maintenance treatment, elderly patients, patients with liver dysfunction, or patients with renal impairment, the dose should be halved.
[Adverse Reactions]
Gastric ulcer, duodenal ulcer, anastomotic ulcer, reflux esophagitis, Zollinger-Ellison syndrome: Of the 2,214 patients in the pre-approval clinical trials of this product, 342 (15.4%) had adverse reactions, including abnormal laboratory tests. Of the 6,260 patients in the post-marketing drug use survey (before the end of the review), 138 (2.2%) had adverse reactions. The following adverse reactions were reported by researchers and spontaneously. (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 abnormalities occur, the drug should be discontinued and appropriate treatment should be taken. 2) Pancytopenia, agranulocytosis, hemolytic anemia (<0.1%), or granulocytopenia, thrombocytopenia, or anemia may occur (0.1%-<5%). Close observation is required; if abnormalities occur, discontinue the drug and administer appropriate treatment. 3) Jaundice and severe liver dysfunction accompanied by elevated AST (GOT) and ALT (GPT) levels (<0.1%) should be discontinued. 4) Lyell syndrome (toxic epidermal necrolysis) and Stevens-Johnson syndrome (mucocutaneous ocular syndrome) (<0.1%) should be closely observed; if abnormalities occur, discontinue the drug and administer appropriate treatment. 5) Interstitial pneumonitis (<0.1%): If fever, cough, dyspnea, or abnormal lung sounds (crepitus) occur, a chest X-ray 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 may have occurred. Therefore, it is necessary to pay close attention to the 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 Zollinger-Ellison syndrome. (Zollinger-Ellison 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 for the following patients. (1) Patients with a history of allergy to the ingredients of this preparation. (2) Patients currently taking atazanavir sulfate. [Drug Interactions] Lansoprazole Enteric-Coated Capsules are primarily 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 combined medications (Lansoprazole Enteric-Coated Capsules should be administered with caution when taken with the following drugs at the same time.) [Precautions] 1. Use with caution in the following patients: 1) Patients with a history of drug allergies 2) Patients with impaired liver function (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) 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 therapy is limited to recurrent and recurrent reflux esophagitis. If patients treated with 30 mg/day or 15 mg/day experience long-term symptom relief 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) 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. In another study, rats force-fed lansoprazole at doses exceeding 15 mg/kg/day for 24 months showed an increased incidence of benign testicular Leydig cell tumors. 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 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, so 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 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 can pierce the esophageal mucosa and cause 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 use).
[Use in Elderly Patients]
Generally speaking, 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]
Research data on overdose of this drug are lacking.
[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 (H+K+)-ATPase) distributed in this area, thereby inhibiting the enzyme's activity and thereby suppressing gastric acid secretion. 2. Gastric Acid Secretion Inhibition Effect: 1) Pentagastrin Stimulates 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: Lansoprazole 30 mg orally administered once daily for 7 consecutive days significantly inhibits insulin-stimulated acid secretion in healthy adults. 3) Nocturnal acid secretion: Lansoprazole 30 mg orally administered once daily for 7 consecutive days significantly inhibits nocturnal gastric acid secretion in healthy adults. 4) 24-hour acid secretion: Lansoprazole 30 mg orally administered once daily for 7 consecutive days in healthy adults significantly inhibits 24-hour gastric acid secretion as determined by 24-hour gastric fluid sampling. 5) 24-hour gastric pH monitoring: Lansoprazole 30 mg orally administered once daily for 7 consecutive days significantly inhibits 24-hour gastric acid secretion in healthy adults and patients with duodenal ulcers. 6) 24-hour lower esophageal pH monitoring: Lansoprazole 30 mg orally administered once daily for 7 to 9 consecutive days significantly inhibits gastroesophageal reflux in patients with reflux esophagitis.
