Product Overview
[Drug Name]
Trade Name: Takeda
English Name: Lansoprazole Enteric-coated Capsules
Chinese Pinyin: Lansuolazuo Jiaonang
[Ingredients]
The main ingredient of this product is lansoprazole, whose chemical name is (±)-2[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl]methyl]sulfinyl]benzimidazole. Molecular Formula: C16H14F3N3O2S Molecular Weight: 369.36
[Properties]
This product is a white capsule containing white or off-white enteric-coated spherical granules.
[Indications]
Gastric ulcer, duodenal ulcer, reflux esophagitis, Zollinger-Ellison syndrome, and anastomotic ulcers.
Dosage and Administration:
For duodenal ulcers, adults should typically take lansoprazole 15mg-30mg orally once daily for 4-6 weeks. For gastric ulcers, reflux esophagitis, Zollinger-Ellison syndrome, and anastomotic ulcers, adults should typically take lansoprazole 30mg orally once daily for 6-8 weeks. However, for maintenance therapy, in the elderly, or in patients with liver or renal impairment, lansoprazole 15mg orally once daily can be used.
[Adverse Reactions]
Gastric ulcers, duodenal ulcers, anastomotic ulcers, reflux esophagitis, and Zollinger-Ellison syndrome: Adverse reactions, including laboratory abnormalities, occurred in 342 (15.4%) of 2,214 patients in pre-approval clinical trials of this product. 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 (rash, facial edema, dyspnea, etc.) (<0.1%), occasionally shock (<0.1%). Therefore, close observation is required. If any abnormality occurs, the drug should be discontinued and appropriate treatment should be given. 2) Pancytopenia, granulocytopenia, hemolytic anemia (<0.1%), or granulocytopenia, thrombocytopenia or anemia may occur (0.1%-<5%). Therefore, close observation is required. If any abnormality occurs, the drug should be discontinued and appropriate treatment should be given. 3) Jaundice, severe liver dysfunction accompanied by elevated AST (GOT), ALT (GPT), etc. (<0.1%). If any abnormality occurs, the drug should be discontinued. 4) Lyell syndrome (toxic epidermal necrolysis) and Stevens-Johnson syndrome (mucocutaneous eye syndrome) (<0.1%). Therefore, close observation is required. If any abnormality occurs, the drug should be discontinued and appropriate treatment should be given. 5) Interstitial pneumonia (<0.1%). If fever, cough, dyspnea, abnormal lung sounds (crepitus), etc. occur, a chest X-ray should be performed and the drug should be discontinued, and corticosteroids should be given. 6 Interstitial nephritis may occur (the frequency of occurrence is 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.). Once any abnormality is found, the use of lansoprazole enteric-coated capsules should be stopped 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 occur, 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 submucosal layer 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, lansoprazole enteric-coated capsules should be discontinued immediately. The following table lists adverse reactions (incidence ≥ 1%) observed in overseas clinical studies (see package insert for details).
[Contraindications]
This product is contraindicated in patients with a history of allergic reactions to any of the ingredients in this product.
[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)
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 product 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 symptoms are long-term relieved in patients treated 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) There have been reports of visual impairment with the use of 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 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 in female rats fed lansoprazole at doses exceeding 15 mg/kg/day and in male rats fed at doses exceeding 50 mg/kg/day was increased. However, testicular Leydig cell tumors and retinal atrophy were not observed in mouse tumorigenicity studies or in 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 ruled out 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, which has pierced the esophageal mucosa and caused perforation, leading to serious complications such as mediastinitis).
[Use in Special Populations]
Precautions for use in children:
The safety of this drug for use in children has not been established (due to limited clinical experience in pediatric settings).
Precautions during pregnancy and lactation:
1. Lansoprazole plasma concentrations in rat fetuses have been confirmed to be higher than in maternal rats. Furthermore, studies in rabbits (oral administration of 30 mg/kg) have shown an increase in fetal mortality. Therefore, for pregnant women or women who may become pregnant, it is important to determine in advance that the therapeutic benefits outweigh the risks. 2. In animal studies (rat), there have been reports that this drug can be transferred into breast milk. Therefore, this drug is not suitable for breastfeeding women. If medication is unavoidable, breastfeeding should be avoided.
Precautions for Elderly Patients:
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.
[Drug Interactions]
It may delay the metabolism and excretion of diazepam and phenytoin. This information has been reported for the similar drug omeprazole.
[Pharmacological Actions]
After translocating 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), thereby inhibiting the enzyme's activity and thereby inhibiting gastric acid secretion. 1. Inhibition of (H++K+)-ATPase activity. Lansoprazole inhibits (H++K+)-ATPase activity in dog gastric mucosal microsomes (in vitro). 2. Inhibition of acid production in parietal cells. Lansoprazole inhibits acid secretion in isolated dog gastric mucosal parietal cells stimulated by histamine, acetylcholine, and gastrin (in vitro studies). 3. Inhibitory effect on gastric acid secretion. 1) Gastrin-stimulated acid secretion: In healthy adults, oral administration of 30 mg of lansoprazole once daily for 7 consecutive days significantly inhibited gastrin-stimulated acid secretion, and this effect lasted for 24 hours. 2) Insulin-stimulated acid secretion: In healthy adults, oral administration of 30 mg of lansoprazole once daily for 7 consecutive days significantly inhibited insulin-stimulated acid secretion. 3) Nocturnal acid secretion: In healthy adults, oral administration of 30 mg of lansoprazole once daily for 7 consecutive days significantly inhibited nocturnal gastric acid secretion. 4) 24-hour acid secretion: In a 24-hour gastric fluid sampling test in healthy adults, oral administration of 30 mg of lansoprazole once daily for 7 consecutive days significantly inhibited 24-hour gastric acid secretion. 5) 24-Hour Gastric pH Monitoring: Lansoprazole 30 mg orally administered once daily for 7 consecutive days significantly inhibited 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 inhibited gastroesophageal reflux in patients with reflux esophagitis. 7) Gastric Acid Secretion in Rats and Gastric Pouch Dogs: This drug significantly and persistently inhibited basal acid secretion in rats and acid secretion induced by histamine, gastrin, carbamylcholine, 2-deoxy-D-glucose, or water immersion stress (in the duodenum). This drug also significantly and persistently inhibited acid secretion in gastric pouch dogs induced by various stimuli, demonstrating stable acid secretion inhibition during repeated dosing (oral administration). 4. Promoting the healing of chronic ulcers. In rat studies, lansoprazole significantly promoted the healing of chronic gastric and duodenal ulcers induced by acetic acid (oral administration). 5. Inhibitory Effect on Ulcer Formation: In rat studies, lansoprazole significantly inhibited gastric ulcers induced by water immersion stress, aspirin, or ethanol, duodenal ulcers induced by mepirisol or haloperidol, and reflux esophagitis (oral or intraduodenal administration).
[Storage]
Store tightly in a dry place.
[Specifications]
30mg x 14 tablets
[Packaging]
Box
[Expiration Date]
36 months.
[Approval Number]
National Medicine Standard H10980035
[Manufacturer]
Company Name: Tianjin Takeda Pharmaceutical Co., Ltd.
