【藥品性質提示】 根據 2019 AGS Beers Criteria，本藥品為【潛在不適當用藥 (PIM)】，非下述情況之老年病患，不建議使用超過八周：潰瘍高風險族群(如長期使用口服類固醇、NSAID)、糜爛性食道炎(EE)、胃酸分泌過多、無法使用H2 antagonist者。 #特殊劑型：不建議磨粉、管灌藥品

Gastroesophageal reflux disease (GERD): Short-term (up to 8 weeks) treatment of symptomatic GERD in patients ≥1 y/o; short-term (up to 8 weeks in patients ≥12 y/o; up to 12 weeks in children 1-11 y/o) treatment for all grades of erosive esophagitis; to maintain healing of erosive esophagitis in adults
Hypersecretory conditions: Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome in adults
Peptic ulcer disease: Short-term (4 weeks) treatment of active duodenal ulcers in adults; maintenance treatment of healed duodenal ulcers in adults; as part of a multidrug regimen for H. pylori eradication; short-term (up to 8 weeks) treatment of active benign gastric ulcer in adults; NSAID-associated gastric ulcer

#仿單變更2022

Proton Pump Inhibitor
1. Oro-dispensible (OD) tablet is a new innovation dosage form, not only provides the rapidly efficacy, also be convenient for patients who is difficulty for swallowing.
2. Lansoprazole's inhibition of (H+, K+)-ATPase results in inhibition of gastric acid secretion. The inhibitory effect is dose-related.

Duration: at least 24 hours
Bioavailability: 81-91%; food will affect the pharmacokinetics; both peak serum levels and AUC are reduced by approximately 50%
Protein binding: 97-99%
Metobplism: Extensively metabolized in liver

Previous hypersensitivity to lansoprazole.

B

Avoided

Common:
Nausea, diarrhea, anorexia, skin rash, fatigue, dizziness, headache, hypergastrinemia
Warnings:
1. Carcinoma:
No reports of enterochromaffin-like (ECL) cell carcinoids, dysplasia, or neoplasia has occurred.
2. Clostridioides difficile-associated diarrhea (CDAD):
Especially in hospitalized patients; consider CDAD diagnosis in patients with persistent diarrhea that does not improve
3. Cutaneous and systemic lupus erythematosus:
Has been reported as new onset or exacerbation of existing autoimmune disease; Discontinue therapy if signs or symptoms of CLE or SLE occur , most patients improve 4-12 weeks after discontinuation
4. Fractures:
Increased incidence of osteoporosis-related bone fractures of the hip, spine, or wrist may occur with PPI therapy; use the lowest effective dose for the shortest duration of time, use vitamin D and calcium supplementation
5. Fundic gland polyps:
Increases risk of fundic gland polyps, especially with long-term use >1 year; May occur with or without symptoms (nausea, vomiting, abdominal pain, GI bleeding and/or anemia)
6. Hypomagnesemia、Hypocalcemia、hypokalemia、hyponatremia:
Hypomagnesemia may lead to hypocalcemia and hypokalemia, and may exacerbate potential hypocalcemia in high-risk patients. Most patients with hypocalcemia need to supplement magnesium ions for treatment and stop using PPIs Ingredients. <20230512> Reported rarely, severe cases may cause tetany, seizures, and cardiac arrhythmias; Magnesium levels typically return to normal within 1 week of stopping
7. Tubulointerstitial nephritis:
Acute tubulointerstitial nephritis has been observed in patients taking PPIs; may occur at any time during therapy, present with symptoms such as anorexia, malaise, nausea
8. Vitamin B12 deficiency:
Prolonged treatment (≥2 years) may lead to vitamin B12 deficiency; The magnitude is dose-related and the association is stronger in females and those younger in age (<30 years of age)
9. Heart valve thickening:
Use in pediatric patients <1 year of age is not recommended in the product labeling; animal models (rat) have shown mitral valve heart thickening<20220209>

Duodenal ulcer:
15 mg once daily for 4 weeks
Gastric ulcer:
30 mg once daily for up to 8 weeks
NSAID-associated gastric ulcer (healing):
30 mg once daily for 8 weeks; controlled studies did not extend past 8 weeks
Gastroesophageal reflux disease (GERD):
1. Mild and intermittent symptoms: 15mg QD for 8 weeks; if symptoms persist after 8 weeks, increase to 30 mg once daily; Discontinue therapy when asymptomatic for 8 weeks with therapy.
2. Severe or frequent symptoms, erosive esophagitis, or Barrett esophagus: 30 mg once daily
Hypersecretory conditions (including Zollinger-Ellison syndrome):
1. Initial: 60 mg once daily
2. Adjust dose based upon patient response, doses of 90 mg twice daily have been used; administer doses >120 mg/day in divided doses

Gastroesophageal reflux disease (GERD), symptomatic:<20220209>
1. Children 1-11 y/o: (≤30 kg): 15 mg once daily; (>30 kg): 30 mg once daily
2. Children ≥12 years and Adolescents: 15 mg once daily
Erosive esophagitis, treatment:<20220209>
1. Children 1-11 y/o: (≤30 kg): 15 mg once daily; (>30 kg): 30 mg once daily
2. Children ≥12 years and Adolescents: 30 mg once daily