Product Overview
[Drug Name]
Generic Name: Lansoprazole Enteric-Coated Capsules
Trade Name: Beilishu Lansoprazole Enteric-Coated Capsules 30mg x 14 capsules
[Main Ingredients]
The main ingredient of this product is lansoprazole. Chemical name: (±)-2[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl]methyl]sulfinyl]-1H-benzimidazole. Molecular formula: C₁₆H₁₄F₃N₃O₂S
Molecular Weight: 369.37
[Properties]
This product consists of white or off-white enteric-coated pellets.
[Indications/Main Functions]
Gastric ulcer, duodenal ulcer, reflux esophagitis, Zollinger-Ellison syndrome
[Specifications]
30mg x 14 tablets
[Dosage and Administration]
Take before meals; do not crush or chew. For patients with gastric ulcer, duodenal ulcer, reflux esophagitis, and Zollinger-Ellison syndrome. Typically, take 30mg (1 tablet) once daily for 6-8 weeks for gastric ulcer, reflux esophagitis, and Zollinger-Ellison syndrome, and 4-8 weeks for duodenal ulcer. 6 weeks. If used for maintenance treatment of recurrent reflux esophagitis, in patients with liver dysfunction, or in elderly patients, the dose should be halved.
[Adverse Reactions]
1. Major Adverse Reactions: 1) Allergic reactions (such as generalized rash, facial edema, and dyspnea) (<0.1%). Shock may occur occasionally (<0.1%). Close observation is required. If any abnormality occurs, discontinue the drug and administer appropriate treatment.
2) Pancytopenia, agranulocytosis, hemolytic anemia (<0.1%), or granulocytopenia, thrombocytopenia, and anemia (<0.1%-0.5%). Close observation is required. If any abnormality occurs, discontinue the drug and administer appropriate treatment. 3) Jaundice, severe liver dysfunction associated with elevated alanine aminotransferase (ALT) (<0.1%). Close observation is required. If any abnormality occurs, discontinue the drug and administer appropriate treatment. 4) Toxic epidermal necrolysis and mucocutaneous ocular syndrome (<0.1%) require close observation. If any abnormalities occur, discontinue the drug and implement appropriate treatment. 5) Interstitial pneumonitis (<0.1%): If fever, cough, dyspnea, or abnormal lung sounds (crepitus) occur, prompt chest examination, discontinue the drug, and implement appropriate treatment, such as with corticosteroids. 6) Interstitial nephritis (frequency unknown), which can lead to acute renal failure in some cases, requires close monitoring of renal function tests (blood urea nitrogen, creatinine). If any abnormalities occur, discontinue the drug immediately and implement appropriate treatment. 2. Other adverse reactions Common adverse reactions of lansoprazole (1% to 10%) include diarrhea, dry mouth, nausea, stomatitis, abnormal taste, dizziness, headache, etc. Other possible adverse reactions are as follows: 1) Allergic reactions: Occasionally (0.1% to 1%), adverse reactions such as rash and itching may occur. If the above symptoms occur, the drug should be discontinued. Rare serious adverse reactions such as systemic rash, facial edema, dyspnea, shock, etc. (<0.1%) should be discontinued, appropriate treatment should be implemented, and close observation should be carried out. 2. Blood system: Anemia, leukopenia, eosinophilia, and thrombocytopenia may occur occasionally; serious adverse reactions such as pancytopenia, granulocytopenia, and hemolytic anemia may occur rarely. Close observation, discontinuation of the drug, and appropriate treatment should be implemented. 3) Digestive System: Abdominal distension, abdominal pain, vomiting, loss of appetite, candidiasis or colitis, and elevated alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), lactate dehydrogenase (LDH), and γ-guanosine triphosphate (γ-GTP) levels may occur occasionally. In the rare case of severe liver dysfunction with jaundice accompanied by elevated liver enzymes, the drug should be discontinued, appropriate treatment should be instituted, and close observation should be conducted. 4) Neuropsychiatric System: Symptoms such as drowsiness may occur occasionally. Adverse reactions such as depression, insomnia, and tremor may occur rarely. 5) Other: Adverse reactions such as fever, elevated total cholesterol, and elevated uric acid may occur occasionally; rare cases include gynecomastia in men, edema, malaise, numbness of the tongue, lips, or limbs, muscle pain, or hair loss; blurred vision, fatigue, or arthralgia have also been reported. The following adverse reactions/events (frequency unknown) have also been observed with lansoprazole formulations since marketing: hypomagnesemia, fractures, and Clostridium difficile-associated diarrhea.
[Contraindications] Contraindications]
1. This product is contraindicated in patients allergic to any of its ingredients. 2. This product is contraindicated in patients currently taking atazanavir sulfate (see [Drug Interactions]).
[Precautions]
1. Warning: A symptomatic response to lansoprazole treatment for gastric cancer does not rule out the presence of gastric cancer. Fractures: Published studies have shown that proton pump inhibitor (PP) therapy may increase the risk of osteoporotic fractures of the hip, wrist, and spine. Patients receiving high-dose, multidrug, long-term treatment (one year or longer) with proton pump inhibitors are at increased risk of fractures. Patients should receive the lowest dose and shortest duration of proton pump inhibitor therapy. Patients at risk of osteoporotic fractures should adhere to established treatment guidelines. Hypomagnesemia: Hypomagnesemia with or without symptoms rarely occurs in patients treated with proton pump inhibitors for at least three months; most symptoms appear after one year of treatment. Serious adverse reactions include: Including hand and foot convulsions, arrhythmias and epileptic seizures. Most patients require magnesium replacement therapy and discontinuation of proton pump inhibitors to treat hypomagnesemia. For patients who wish to prolong treatment or patients who use proton pump inhibitors and take digoxin or drugs that can cause hypomagnesemia (such as diuretics), regular testing of magnesium ions before proton pump inhibitor treatment should be considered. 2. The following patients should use the drug with caution: () Patients with a history of drug allergies. () Patients with liver dysfunction (resulting in prolonged metabolism and excretion time of lansoprazole). (3) Elderly patients (see [Elderly Use]). 3. Important precautions (1) During treatment, careful observation should be made and the minimum dose should be used according to their symptoms. (2) For patients with gastric ulcers and duodenal ulcers, maintenance treatment with lansoprazole is not recommended due to lack of long-term use experience. (3) Maintenance treatment is limited to recurrent and recurrent reflux For patients with esophagitis who have achieved long-term symptom relief with 30 mg/day or 15 mg/day treatment, if dose reduction or discontinuation does not cause recurrence, the dose should be reduced to 15 mg/day or the drug should be discontinued. Regular endoscopic examinations are recommended during the maintenance treatment period. (4) Lansoprazole has the effect of masking malignant tumors such as gastric cancer, esophageal cancer and other digestive organ diseases, so endoscopy is required for diagnosis before medication. 4. Other precautions () There have been reports of visual impairment caused by taking omeprazole, which is similar to lansoprazole. (2) The safety of long-term use of lansoprazole has not been established (there are no cases of long-term use of lansoprazole). 5. Clostridium difficile-associated diarrhea: Published observational studies have shown that Pl treatment may increase the risk of Clostridium difficile-associated diarrhea, especially in hospitalized patients. If diarrhea does not improve, this diagnosis should be considered. Patients should use the lowest dose according to their medical situation. 6. Concomitant administration of lansoprazole and clopidogrel in healthy subjects had no clinically significant effect on exposure to clopidogrel's active metabolite or on clopidogrel-induced platelet inhibition. No dose adjustment is required when clopidogrel is coadministered with approved doses of lansoprazole. Clopidogrel is partially metabolized to its active metabolite by CYP2C19. In one study, 40 healthy subjects, who were extensive CYP2C19 metabolizers, received clopidogrel 75 mg once daily or in combination with lansoprazole 30 mg for nine consecutive days. When clopidogrel was coadministered with lansoprazole, the mean area under the curve for clopidogrel's active metabolite was reduced by approximately 14% (geometric mean ratio 86%, 90% CI: 80%-92%) compared to clopidogrel alone. Pharmacodynamic parameters demonstrated that changes in platelet aggregation inhibition (induced by 5 micromolar ADP) were associated with changes in clopidogrel's active metabolite; the clinical significance of this finding is unclear.
