Product Overview
[Generic Name]
Lansoprazole Enteric-Coated Tablets
[Drug Name]
Huanhua Lansoprazole Enteric-Coated Tablets
[Main Ingredients]
The main ingredient of this product is lansoprazole.
[Indications]
Gastric ulcer, duodenal ulcer, reflux esophagitis, Zollinger-Ellison syndrome.
[Dosage and Administration]
Do not chew this tablet; swallow it whole with water. 1. Duodenal ulcer: Generally, adults take 30 mg once daily for 4-6 weeks. 2. Gastric ulcer, reflux esophagitis, Zollinger-Ellison syndrome: Generally, adults take 30 mg once daily for 6-8 weeks.
[Adverse Reactions]
Common adverse reactions (1%-10%) with lansoprazole include diarrhea, dry mouth, nausea, bland taste, abnormal taste, dizziness, and headache. Other possible adverse reactions are as follows: 1. Hypersensitivity: Occasionally, symptoms such as rash and itching may occur. Discontinue use if these symptoms occur. 2. Hematologic: Occasionally, symptoms such as anemia, leukopenia, and eosinophilia may occur. Thrombocytopenia rarely occurs. 3. Digestive: Occasionally, symptoms such as constipation, diarrhea, thirst, and abdominal distension may occur. Elevated ALT, AST, ALP, LDH, and gamma-GTP levels may occur. Careful observation is recommended, and any abnormalities should be addressed, including discontinuation of the drug. 4. Neuropsychiatric: Occasionally, symptoms such as headache and drowsiness may occur. Insomnia and dizziness are rare. 5. Other: Occasionally, fever, elevated total cholesterol, and elevated uric acid may occur. (See package insert for details.)
【Precautions]
1.During the treatment with this product, the patient's condition should be closely monitored and the lowest therapeutic dose should be used as much as possible. Due to insufficient experience with long-term use, this product is not recommended for maintenance treatment.
2.The following patients should use this product with caution:
(1) Patients with a history of drug allergy;
(2) Patients with liver and kidney dysfunction (resulting in prolonged drug metabolism and excretion time);
(3) Elderly patients (see [Elderly Use]).
(3) Because this product can mask the symptoms of gastric cancer, gastric cancer must be ruled out before using this product.
(4) Fractures: Some published research reports have shown that proton pump inhibitor (PPI) treatment may increase the risk of osteoporotic fractures of the hip, wrist, and spine. Patients who receive high-dose, long-term treatment with proton pump inhibitors (one year or longer) have an increased risk of fractures. Patients should use the lowest dose and shortest duration of proton pump inhibitor treatment. Patients at risk of osteoporotic fractures should be treated according to relevant treatment guidelines.
(5) Clostridium difficile-associated diarrhea: Published observational studies suggest that PPI therapy may increase the risk of Clostridium difficile-associated diarrhea, particularly in hospitalized patients. This diagnosis should be considered if diarrhea does not improve. Patients should receive the lowest dose and shortest duration of PPI therapy appropriate for their medical condition.
(6) Hypomagnesemia: Rare cases of asymptomatic or hypomagnesemia have been reported in patients who have received PPI therapy for at least 3 months, with most symptoms occurring after one year of treatment. Serious adverse reactions include tetany, arrhythmias, and seizures. Most patients require magnesium replacement therapy and discontinuation of proton pump inhibitors to treat hypomagnesemia. For patients who anticipate prolonged treatment or who are receiving concomitant proton pump inhibitors and digoxin or drugs that may cause hypomagnesemia (e.g., diuretics), regular monitoring of blood magnesium levels before proton pump inhibitor therapy should be considered.
(7) Concomitant administration of lansoprazole and clopidogrel to healthy subjects had no clinically significant effect on the exposure to clopidogrel's active metabolite or on platelet inhibition caused by clopidogrel. No dose adjustment is required for clopidogrel when coadministered with approved doses of lansoprazole.
Clopidogrel is partially metabolized to its active metabolite by CYP2C19. In one study, 40 healthy subjects with extensive CYP2C19 metabolization received clopidogrel 75 mg once daily or in combination with lansoprazole 30 mg for nine consecutive days. The mean area under the curve for clopidogrel's active metabolite was approximately 14% lower when clopidogrel was coadministered with lansoprazole compared with clopidogrel alone (geometric mean ratio 86%, 90% CI: 80%-92%). Pharmacodynamic parameters demonstrated that changes in platelet aggregation inhibition (induced by 5 μM ADP) were associated with changes in clopidogrel's active metabolite; the clinical significance of this finding is unknown.
[Specifications]
30 mg*7 tablets/box
[Approval Number]
National Medicine Standard H20173038
[Manufacturer]
Shanghai Huanhua Pharmaceutical Co., Ltd.
