部份中文兰索拉唑处方资料（仅供参考）
通用名称：兰索拉唑片
英文名称：Lansoprazole Tablets
成份
兰索拉唑片主要成份为兰索拉唑。
性状
兰索拉唑片为白色肠溶片，除去肠溶衣后显白色或类白色。
适应症
胃溃疡、十二指肠溃疡、反流性食管炎、佐-艾（Zollinger-Ellison）综合征（胃泌素瘤）。
用法用量
十二指肠溃疡，通常成人每日一次，口服兰索拉唑15mg～30mg，连续服用4～6周；胃溃疡、反流性食道炎、Zollinger-Ellison症候群、吻合口部溃疡，通常成人每日一次，口服兰索拉唑30mg，连续服用6～8周。但用做维持治疗、高龄者、有肝功能障碍、肾功能低下的患者，每日一次，口服兰索拉唑15mg。
不良反应
1.过敏症：偶有皮疹、瘙痒等症状，如出现上述症状时请停止用药。
2.肝脏：偶有GOT、GPT、ALP、LDH、γ-GTP上升等现象，所以须细心观察，如有异常现象就应采取停药等适当的处置。
3.血液：偶有贫血、白细胞减少，嗜酸球增多等症状，血小板减少之症状极少发生。
4.消化系：偶有便秘，腹泻，口渴，腹胀等症状。
5.精神神经系：偶有头痛、嗜睡等症状。失眠，头晕等症状极少发生。
6.其他：偶有发热，总胆固醇上升，尿酸上升等症状。
禁忌
对兰索拉唑片过敏者禁用。
孕妇及哺乳妇女用药
1.已确认兰索拉唑在大白鼠胎仔的血浆浓度比在母鼠中高。又在兔子（经口给药30mg/kg）的实验发现胎仔死亡率增加，故对孕妇或有可能怀孕的妇女，需事先判断治疗上的益处超过危险性时，方可用药。
2.曾有报告指出，在动物实验中药品会转移到乳汁中。所以本药品不适合用于正在哺乳中的妇女。如不得已需服药时，应避免哺乳。
儿童用药
对小儿的性尚未被确立（由于在小儿的临床经验极少）。
药物相互作用
会延迟安定（diazepam）及苯妥英钠（phenytoin Sodium）的代谢与排泄，资料已被发表于类似药物奥美拉唑的报告中。
药理毒理
兰索拉唑片为新型的抑制胃酸分泌的药物，它作用于胃壁细胞的H+-K+-ATP酶，使壁细胞的H+不能转运到胃中去，以致胃液中胃酸量大为减少，临床上用于十二指肠溃疡、胃溃疡、反流性食管炎，佐-艾（Zollinger-Ellison）综合征（胃泌素瘤）的治疗，，对幽门螺杆菌有抑制作用。
药代动力学
兰索拉唑片口服后1小时左右可在血中检出，达峰时间为3.6小时，吸收相半衰期为1.3小时，消除相半衰期为2.1小时。该药从小肠吸收经门脉而广泛分布于以胃壁和小肠壁为中心的各组织中。该药主要在肝脏被代谢，大多经胆汁于粪中排泄。原型药及其代谢物在体内无蓄积。
贮藏
遮光，密封，在凉暗干燥处保存。
制造和进口商：Samil Pharmaceutical
Product name: Ranojolje 15mg (Lanozol Tab. 15mg)
Manufacturing and Importer: Samil Pharmaceutical
Welfare Division Classification: Peptic ulcer solvent
Ingredients: Lansoprazole 15 mg
한글 Ingredient name: lansoprazole 15 mg
Production: Production
US FDA Pregnancy Stability: Classification
Appearance: reddish brown circular coating tablets
Formulation: Film-coated tablet
Display (front): Mark LZ15
Display (back):
Mark (front):
Mark (back):
Color front: pink
Color back:
Before the splitting line:
After split:
Long axis (mm): 6.7
Shortening (mm): 6.7
Thickness (mm): 2.8
Identification mark Registration date: 2007-04-26
Efficacy/Effectiveness:
1. Short-term treatment of active duodenal ulcer
2. Short-term treatment of active benign gastric ulcer
3. Eradication of Helicobacter pylori to prevent recurrence of duodenal ulcer
4. Post-treatment maintenance therapy of duodenal ulcer
5. Treatment of nonsteroidal anti-inflammatory analgesic-induced gastric ulcer
6. Reduced risk of nonsteroidal anti-inflammatory analgesic-induced gastric ulcer
7. Short-term treatment of symptoms related to gastroesophageal reflux disease
8. Short-term treatment of erosive esophagitis
9. Maintenance therapy after erosive esophagitis
10. Pathological hypersecretion condition, including Zollinger-Ellison syndrome
Usage/Capacity:
This drug should be administered before meals.
Do not take this medicine after opening or chewing or rubbing it.
<Adult>
1. Short-term treatment of active duodenal ulcer: Lansoprazole 15 mg is orally administered once a day for 4 weeks.
2. Short-term treatment of active gastric ulcer: Lansoprazole 30 mg is orally administered once a day for 8 weeks.
3. Eradication of Helicopater pylori to prevent recurrence of duodenal ulcer
(1) Lansoprazole 30 mg is administered twice daily (every 12 hours) for 7 or 14 days with 500 mg of clarithromycin and 1000 mg of amoxicillin.
(2) Lansoprazole 30 mg and amoxicillin 1000 mg should be given in triplicate three times a day (every 8 hours) for 14 days.
4. Post-treatment maintenance therapy for duodenal ulcer: Lansoprazole 15 mg is orally administered once a day. The comparative study did not exceed 12 months.
5. Treatment of nonsteroidal anti-inflammatory analgesic-induced gastric ulcer: Lansoprazole 30 mg is orally administered once a day for 8 weeks. The duration of the comparative study did not exceed 8 weeks.
6. Reduce the risk of nonsteroidal anti-inflammatory analgesic-induced gastric ulcer: Lansoprazole 15 mg is orally administered once a day for 12 weeks. The duration of the comparative study did not exceed 12 weeks.
7. Short-term treatment of erosive esophagitis: 30 mg lansoprazole is orally administered once a day for 8 weeks.
8. Maintenance therapy after erosive esophagitis: Lansoprazole 15 mg is orally administered once a day.
9. Short-term treatment of symptoms related to gastroesophageal reflux disease
Lansoprazole 15 mg is orally administered once a day for 8 weeks.
10. Pathological hypersecretion condition, including Zollinger-Ellison syndrome
The dosage of lansoprazole according to the pathological hypersecretion differs depending on the individual patient. Usually, 60 mg once a day for adults to start dosing. The dose should be adjusted according to the needs of the patient and may be administered as long as it is clinically effective. 90 mg twice a day. When administered at a dose of 120 mg or more per day, it should be administered in divided doses.
Precautions for use:
1. Warning
Because artificial sweetener aspartame contained in this medicine is degraded in the body and metabolized to phenylalanine, it is not administered to patients with phenylketonuria, a hereditary disease that needs to control phenylalanine intake.
2. Do not administer to the following patients
1) patients with hypersensitivity to the components of this drug
2) patients with hypersensitivity to penicillin antibiotics (in combination with amoxicillin for eradication of H. pylori)
3) Macrolide antibiotic hypersensitivity
Patients taking terfenadine due to cardiac abnormalities or electrolyte disturbances (only when used in combination with clarithromycin to eradicate H. pylori)
Patients receiving Atazanavir sulfate (see 6. Interaction)
3. The following patients should be administered with caution
1) History of drug hypersensitivity Patient
2) Patients with hepatic impairment (dosage should be adjusted.)
3) The elderly
4) Pregnant women, lactating women and children
4. Adverse reactions
1) Significant adverse reactions
Significant adverse reactions in the post-marketing study and voluntary reporting of the patients were as follows.
(1) An anaphylactic reaction (systemic rash, facial edema, dyspnea, etc.) (less than 0.1%) was observed and there was an example of causing shock (less than 0.1%). Appropriate measures should be taken.
(2) Stop the administration if the observation is sufficient and the abnormality is confirmed, because there may be a decrease in blood cell count, agranulocytosis, hemolytic anemia (less than 0.1%), granulocyte reduction, platelet reduction and anemia Action should be taken.
③ In some cases, addictive liver dysfunction (less than 0.1%) accompanied by jaundice, AST and ALT elevation is observed. If observation is sufficient and abnormal reaction is confirmed, discontinue administration and take appropriate measures.
④ An addictive epidermal necrolysis (Lyell syndrome) and mucocutaneous mucosal syndrome (Stevens-Johnson syndrome) (0.1%) may occur. If the observation is sufficient and adverse reactions are confirmed, the administration should be discontinued and appropriate measures should be taken.
⑤ Interstitial pneumonia (less than 0.1%) may occur. If fever, seawater, difficulty in breathing, or abnormal sounds in the mouth (sinusoidal tone) appear, prompt examination of the chest X-ray, Take appropriate measures such as stopping the administration and administering corticosteroids.
⑥ Interstitial nephritis may occur and may cause acute renal failure occasionally. Care should be taken for renal function test (BUN, creatinine elevation, etc.) and if any abnormalities appear, discontinue administration and take appropriate measures.
2) In clinical trials, headache appeared in more than 1%, but more frequent in placebo-treated patients. The incidence of diarrhea was similar in the placebo-treated group, lansoprazole 15 mg, and 30 mg-treated group, but higher in lansoprazole 60 mg-treated group. (2.9%, 1.4%, 4.2%, and 7.4%, respectively). The most common adverse event reported to be causally related to the administration of the test drug during the maintenance phase was diarrhea. Clinical trials in the United States and other countries or post-marketing adverse events reported less than 1% are as follows.
① Whole body: arthritis, candidiasis, chest pain, edema, heat, flu syndrome, bad breath, infection, malaise
② Cardiovascular: cardiovascular, cerebrovascular accident, hypertension/ hypotension, myocardial infarction, palpitations, shock (circulatory failure), vasodilation
③ Digestive system: Digestive system: Esophagus, stomach palsy, gastric ulcer, gastric ulcer, gastric ulcer, gastric ulcer, gastric ulcer, gastric ulcer, gastric ulcer, gastric ulcer, gastric ulcer, gastric ulcer, Gastroduodenal hemorrhage, hematochezia, increased appetite, increased saliva, anal bleeding, stomatitis, this sudden onset, ulcerative colitis, vomiting
④ Endocrine system: diabetes, goiter, hyperlipidemia / hypolipidemia
⑤ Blood and lymphatic system: Anemia, bleeding
⑥ Metabolic and nutritional diseases: Gout, weight gain/decrease
⑦ Musculoskeletal: Arthritis/joint pain, musculoskeletal pain, muscle pain
⑧ Nervous system: irritability, amnesia, anxiety, indifference, confusion, depression, dizziness/syncope, hallucinations, unilateral paralysis, hostility deterioration, loss of libido, neurosis,
⑨ Circulatory system: asthma, bronchitis, increased cough, dyspnea, non-bleeding, hemoptysis, hiccups, pneumonia, upper respiratory tract infection
⑩ Skin and appendages: Acne, hair loss, itching, rash, urticaria
⑪ Special sensory organs: blurred vision, deafness, aching, otitis media, tinnitus, tinnitus, visual field stenosis
⑫ Urinary tract disorders: menstrual disorders, albuminuria, breast enlargement / gynecomastia, chest tenderness, diabetes (glycosuria), hematuria, erectile dysfunction,
3) We carry out postmarketing safety investigation. Most of the cases described below are due to other causes and the causal relationship with lansoprazole has not been verified. Since these adverse reactions are reported arbitrarily, the incidence is unknown.
① Whole body: anaphylactoid reaction
② Digestive system: hepatotoxicity, vomiting
③ Blood and lymphatic system: agranulocytosis, aplastic anemia, hemolytic anemia, granulocytopenia, neutropenia, prothrombocytopenia, thrombocytopenia, thrombotic thrombocytopenic purpura
④ Special sensory organs: Speech disorder
⑤ Urinary tract: Yogurts
4) Post-marketing surveillance (number of cases: 897) The reported adverse events are as follows. Abdominal pain
5) Combination with amoxicillin and clarithromycin
No clinical adverse events were observed in combination with lansoprazole, amoxicillin, or clarithromycin. The adverse reactions that occurred were as previously reported in connection with lansoprazole, amoxicillin, and clarithromycin.
3 Remedies: lansoprazole, amoxicillin, clarithromycin
Diarrhea (7%), headache (6%) and taste arrival (5%) were the most frequent adverse events seen in patients who received the 14-day 3-regimen. There was no statistically significant difference in the incidence of adverse events between 10 and 14 days of triple therapy.
6) Test results
The following changes in the laboratory test were reported as adverse reactions to lansoprazole.
Abnormal liver function test, increase in SGOT (AST), increase in SGPT (ALT), increase in creatinine, increase in Al-P, increase in globulin, increase in GGTP, increase in WBC, increase in AG ratio, over RBC, bilirubinemia, eosinophilia , Abnormal lipidemia, electrolyte elevation/decrease, cholesterol increase/ decrease, glucocorticoid increase, LDH increase, platelet increase/decrease/ abnormality, gastrin concentration increase.
In the placebo-controlled trial, SGOT (AST) and SGPT (ALT) were measured 0.4% (1/250) in the placebo group and 0.3% (2/795) in the lansoprazole group three times It was big. No jaundice was reported in patients during the study period.
In clinical trials with lansoprazole, amoxicillin, and clarithromycin combined, there was no specific increase in laboratory measurements compared to single administration.
5. General caution
1) It is recommended not to use it for maintenance therapy because it is not enough experience for long-term use when it is used for ulcer and ulcer of stomach ulcer,
2) When using clarismycin or amoxicillin for eradication of H.pylori, refer to the information on administration of antibiotics.
① Clarithromycin should not be given to pregnant women except when there is no appropriate alternative therapy. If pregnancy occurs while taking clarithromycin, the patient should be aware of the potential risks to the fetus.
② Pseudomembranous colitis has been reported in almost all antibiotics such as clarithromycin and amoxicillin, and it varies from mild to life-threatening. Therefore, diagnosis of diarrhea patients after antibiotic treatment is important. Antibiotic therapy can alter normal colonies of the colon and induce overgrowth of Clostridia. Several studies have shown that toxins produced by Clostridium difficinale are the major cause of antibiotic-associated colitis. After diagnosis of pseudomembranous colitis, treatment should be started. Mild pseudomembranous colitis responds only to the discontinuation of drug administration. Clinically effective antibiotic therapy for body fluids and electrolytes, protein supply, and Clostridium difficinate colitis is considered for moderate or severe cases. Serious and sometimes fatal hypersensitivity reactions (anaphylaxis) have been reported in patients undergoing penicillin treatment. These reactions are likely to occur in people with a history of penicillin hypersensitivity reactions or susceptibility to allergens. There are many reports that patients who have experienced severe hypersensitivity reactions to cephalosporin have a history of hypersensitivity reactions to penicillin. Before starting treatment with penicillin, you should investigate whether you are hypersensitive to penicillin drugs, cephalosporins, or other allergens. If hypersensitivity occurs, amoxicillin should be discontinued and alternative therapies should be considered. Severe anaphylactic reactions require immediate treatment such as airway maintenance, including immediate epinephrine, oxygen, intravenous steroids, and intubation.
6. Interaction
1) The inhibitory effect of lansoprazole on the secretion of acid is inhibited by concomitant use of atanavaz sulfate because of the lowering of the solubility of atanazabysulfate and the decrease in the concentration of atanazabir in the blood, thereby decreasing the effect of atanavar sulfate.
2) Similar agents (omeprazole) have been reported to delay the metabolism and excretion of diazepam, phenytoin.
3) Lansoprazole was shown to increase the clearance rate of theophylline by 10% when combined with theophylline (CYP1A2, CYP3A). Therefore, to confirm clinically effective blood levels at the start or end of lansoprazole treatment, appropriate titration of theophylline dose need.
4) lansoprazole competitively inhibits the metabolism of tacrolimus by the drug metabolizing enzyme in the liver when it is coadministered with tacrolimus, so that the administration of lansoprazole may increase the blood concentration of tacrolimus.
5) Single-dose cross-over study with lansoprazole 30 mg and omeprazole 20 mg alone or in combination with sucralfate simultaneously resulted in a delayed uptake of lansoprazole and omeprazole and reduced bioavailability by 17% and 16%, respectively. Therefore, the proton pump inhibitor should be administered 30 minutes prior to sucralfate.
6) Lansoprazole exhibits remarkably long-lasting inhibition of gastric acid secretion, so lansoprazole is effective against the absorption of drugs (eg, ketoconazole, itraconazole, ampicillin esters, iron salts, digoxin, methyldigoxin and gefitinib) It can have an impact.
7) There has been an increase in INR (International Normalized Ratio) and prothrombin time in patients receiving concurrent proton pump inhibitors and warfarin, including lansoprazole. Patients receiving concurrent proton pump inhibitors and warfarin may require monitoring of INR and prothrombin time increases, since increased INR and prothrombin time can cause not only abnormal bleeding but also death.
7. Administration to pregnant and lactating women
1) The plasma concentration of fetus in rats was higher than that of mother animal. In addition, an increase in fetal mortality rate is recognized in rabbits (oral 30 mg / kg), so it should be administered only to pregnant women who are pregnant or likely to be pregnant if the therapeutic benefit is judged to be higher than the risk.
2) Since animal studies have reported transmission to breast milk, feeding should be discontinued for women in lactation, and feeding should be discontinued.
8. Administration to children
1) The safety of the child is not established (the experience is limited) (Adults only)
2) The safety and efficacy of esophageal reflux disease related symptoms and erosive esophagitis in pediatric patients aged 1 to 17 years were studied. Additional clinical trials, pharmacokinetic and pharmacodynamic studies were conducted on pediatric patients based on controlled trials of lansoprazole use in adults. Adverse events in pediatric patients were similar to those in adults. Studies in the United States did not reveal any new adverse events not found in adults. The safety and efficacy of lansoprazole in patients under 1 year of age has not been studied.
The most commonly reported (two or more) adverse events associated with test drug administration in children aged 1 to 11 years (N = 66) were constipation (5%) and headache (3%). No new side effects have been reported in clinical trials in the United States that have not been found in adults.
The most commonly reported (3% or more) adverse events associated with test drug administration in children aged 12 to 17 years (N = 87) were headache (7%), abdominal pain (5%), diarrhea Dizziness (3%). In the case of vertigo, it was reported in less than 1% of adults and in 3 adults with non-erosive gastroesophageal reflux disease, and was reported to have migraine, dyspnea, and dizziness with vomiting symptoms. (Only in the case of pediatric use)
9. Administration to elderly people
Generally, in the elderly, gastric acid secretion is decreased and other physiological functions are lowered.
10. Storage and Handling Precautions
1) Keep out of reach of children
2) It is not preferable to change into another container because of cause of accident or quality maintenance.
3) It is not suitable to use automatic dispenser because it can be easily broken (only in oral cavity).
11. Other
1) In one case of 52-week forced oral administration (approximately 100 times of clinical dose) to rats (50 mg/kg/day), positive testicular hepatocyte, 24-month forced oral administration (15mg/kg/ In one case of female, there is a report that the above cartiloid tumor is recognized. In addition, an increase in the incidence of retinal atrophy was observed in the female rats at 15mg/kg/day or more and in the male rats at 50mg/kg/day or more. Sickle cell tumors and retinal atrophy are not identified in the carcinogenicity test of mice, toxicity tests of dogs and monkeys, and may be unusual changes in rats.
2) The administration of this drug may conceal the symptoms of gastric cancer, so it should be confirmed that it is not malignant.
3) Omeprazole injections have been reported to cause visual impairment in foreign countries.
Storage: airtight container, room temperature (1 ~ 30 ℃) Storage, 36 months from date of manufacture
Packing unit: 28 tablets