Product Overview
[Drug Name]
Generic Name: Lansoprazole Enteric-Coated Capsules
Trade Name: Kelanberry Lansoprazole Enteric-Coated Capsules 15mg x 14 capsules
Pinyin Full Code: KeLanZuo LanSuoLaZuoChangRongJiaoNang 15mg x 14Li
[Main Ingredient]
The main ingredient of this product is 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, and anastomotic ulcers.
[Specifications]
15mg x 14 capsules
[Dosage and Administration]
Gastric ulcer, duodenal ulcer, anastomotic ulcer, and Zollinger-Ellison syndrome are usually treated with 30mg of lansoprazole orally once daily in adults. For gastric and anastomotic ulcers, take the drug for eight consecutive weeks; for duodenal ulcers, take the drug for six consecutive weeks. For reflux esophagitis, adults 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, increase the dose to 30 mg. [Dosage and Administration] For maintenance treatment of reflux esophagitis, switch to 30 mg orally only if 15 mg is ineffective or if relapses occur during treatment. For maintenance treatment, elderly patients, those with liver dysfunction, or those with impaired renal function, take lansoprazole 15 mg orally once daily.
[Adverse Reactions]
Gastric ulcer, duodenal ulcer, anastomotic ulcer, reflux esophagitis, and Zollinger-Ellison syndrome: Among 2,214 patients in pre-approval clinical trials of this product, 342 (15.4%) experienced adverse reactions, including laboratory abnormalities. In post-marketing drug use surveys (before the review was completed), 138 (2.2%) of 6,260 patients experienced adverse reactions. The following adverse reactions were reported by investigators and voluntarily. 1) Clinically Important Adverse Reactions: 1) Allergic reactions (such as generalized rash, facial edema, and dyspnea) (<0.1%), occasionally shock (<0.1%). Therefore, close observation is required. If abnormalities occur, discontinue the drug and implement appropriate management. 2) Pancytopenia, agranulocytosis, hemolytic anemia (<0.1%), or granulocytopenia, thrombocytopenia, or anemia may occur (0.1%-<5%). Therefore, close observation is required. If abnormalities occur, discontinue the drug and implement appropriate management. 3) Severe liver dysfunction (<0.1%), including jaundice and elevated AST (GOT) and ALT (GPT). If these abnormalities occur, discontinue the drug. 4) Lyell syndrome (toxic epidermal necrolysis) and Stevens-Johnson syndrome (mucocutaneous ocular syndrome) (<0.1%). Therefore, close observation is required. If any abnormalities occur, discontinue the drug and implement appropriate measures. 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 has occurred. Therefore, close monitoring of renal function tests (such as increases in blood urea nitrogen and creatinine) is necessary. If any abnormalities are detected, immediately discontinue Lansoprazole Enteric-Coated Capsules and implement appropriate measures. (2) Other adverse reactions Gastric ulcer, duodenal ulcer, anastomotic ulcer, reflux esophagitis and Zollinger-Ellison syndrome. Note 1) If the above symptoms occur, stop taking this product. Note 2) Close observation should be made. If abnormalities occur, appropriate measures should be taken, such as stopping taking this product. Note 3) If persistent diarrhea occurs, the patient may have colitis. Histological examination may show thickening of the submucosa of the large intestine, such as collagen bands, and/or infiltration of inflammatory cells, although no abnormalities of the intestinal mucosa can be observed by endoscopic examination. Therefore, stop taking Lansoprazole Enteric-coated Capsules immediately.
[Contraindications]
This product is contraindicated for the following patients. ((1) Patients with a history of allergy to the ingredients of this preparation are contraindicated. (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 concurrently with the following drugs.) (2) Precautions when taking concomitant medications (lansoprazole enteric-coated capsules should be administered with caution when taken concurrently 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 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 the drug should be discontinued. Regular endoscopic follow-up is recommended during maintenance treatment. 3. Other Precautions: 1) Visual disturbances have been reported with similar medications (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 developed a benign testicular Leydig cell tumor in one rat. Another study showed an increased incidence of benign testicular Leydig cell tumors in rats force-fed lansoprazole at doses exceeding 15 mg/kg/day for 24 months, 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, 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. 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).
[Pediatric Use]
The safety of this medication for pediatric use has not been established (due to limited clinical experience in pediatric patients).
[Elderly Use]
Generally, elderly patients have reduced gastric acid secretion and other physiological functions, so caution should be exercised, 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 its 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 activity of this enzyme and thus inhibiting gastric acid secretion. 2. Gastric Acid Secretion Inhibition 1) Pentagastrin-stimulated Gastric Acid Secretion: In healthy adults, a single oral dose or a 30 mg dose of lansoprazole once daily for 7 consecutive days significantly inhibited gastrin-induced acid secretion, and this effect persisted for 24 hours after administration. 2) Insulin-stimulated Acid Secretion: In healthy adults, a 30 mg dose of lansoprazole once daily for 7 consecutive days significantly inhibited insulin-induced acid secretion. 3) Nocturnal Acid Secretion: In healthy adults, a 30 mg dose of lansoprazole once daily for 7 consecutive days significantly inhibited nocturnal gastric acid secretion. 4) 24-Hour Acid Secretion: In healthy adults, a 30 mg dose of lansoprazole 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, a 30 mg dose of lansoprazole once daily for 7 consecutive days significantly inhibited 24-hour gastric acid secretion. 6) 24-hour monitoring of lower esophageal pH: For patients with reflux esophagitis, oral administration of lansoprazole 30 mg once daily for 7 to 9 consecutive days has a significant inhibitory effect on gastroesophageal reflux.
