PREVACID FDT Lansoprazole 30mg Fast Disintegrating Tablet 1's
RXDRUG-DR-XY29628-1pc
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Features
Brand
Prevacid FDT
Full Details
Dosage Strength
30 mg
Drug Ingredients
- Lansoprazole
Drug Packaging
Fast Disintegrating Tablet 1's
Generic Name
Lansoprazole
Dosage Form
Fast Disintegrating Tablet
Registration Number
DR-XY29628
Drug Classification
Prescription Drug (RX)
Description
Indications/Uses
Prevacid FDT: Duodenal ulcer, gastric ulcer, stomal ulcer, Helicobacter pylori associated peptic ulcer, reflux esophagitis, pediatric GERD, Zollinger-Ellison syndrome, nonsteroidal anti-inflammatory drug (NSAID)-induced/associated gastric ulcers.
Precautions for Indications: Prevention of recurrence of gastric ulcer or duodenal ulcer during NSAIDs administration: This drug should be administered to the patients who are under continuous administration of NSAIDs for purpose such as pain management of rheumatoid arthritis or osteoarthritis, etc. History of gastric ulcer or duodenal ulcer should be confirmed before starting administration.
Prevacid IV: Patients with the following conditions who are unable to take the oral formulations: Gastric ulcer, duodenal ulcer, acute stress ulcer and acute gastric mucosal lesion accompanied by bleeding.
Precautions for Indications: Prevention of recurrence of gastric ulcer or duodenal ulcer during NSAIDs administration: This drug should be administered to the patients who are under continuous administration of NSAIDs for purpose such as pain management of rheumatoid arthritis or osteoarthritis, etc. History of gastric ulcer or duodenal ulcer should be confirmed before starting administration.
Prevacid IV: Patients with the following conditions who are unable to take the oral formulations: Gastric ulcer, duodenal ulcer, acute stress ulcer and acute gastric mucosal lesion accompanied by bleeding.
Dosage/Direction for Use
Prevacid FDT: Duodenal Ulcer: Usually, for adults, a daily oral dose of 30 mg of Lansoprazole is administered once a day for 4-6 weeks.
Gastric ulcer, stomal ulcer, reflux esophagitis and Zollinger-Ellison syndrome: Usually, for adults, a daily oral dose of 30 mg of Lansoprazole is administered once a day up to 8 weeks.
In the maintenance of healing of reflux esophagitis that repeats occurrence and recrudescence, a daily oral dose of 15 mg is administered once a day. However, when the effect is insufficient, a daily oral dose of 30 mg may be administered once a day.
Pediatric: (1 to 11 years of age): Short-Term Treatment of Symptomatic GERD, Short-Term Treatment of Erosive Esophagitis: ≤ 30 kg: 15 mg once daily for up to 12 weeks; > 30 kg: 30 mg once daily for up to 12 weeks.
(12 to 17 years of age): Short-Term Treatment of Symptomatic GERD: Non-erosive GERD: 15 mg once daily for up to 8 weeks; Erosive esophagitis: 30 mg once daily for up to 8 weeks.
For the maintenance therapy of reflux esophagitis and duodenal ulcers, for elderly patients and for patients with impaired hepatic function, 15 mg Lansoprazole is orally administered once daily.
The recommended doses for Lansoprazole-containing regimens for Helicobacter pylori eradication in patients with duodenal ulcer and gastric ulcer are 30 mg Lansoprazole twice daily plus two of the following antibiotics for seven (7) days: clarithromycin 250 mg twice daily, amoxicillin 1 g twice daily or metronidazole 500 mg twice daily.
Precautions concerning dosage and administration: Reflux Esophagitis: In the maintenance of healing, the administration of a daily dose of 30 mg should be confined to the cases in which a daily dose of 15 mg is not effective enough, such as the cases of recurrence during administration of a daily dose of 15 mg.
Nonerosive Gastroesophageal Reflux Disease: In the treatment of nonerosive gastroesophageal reflux disease, effect of Lansoprazole (Prevacid FDT) should be checked about 2 weeks after the start of this drug. If no improvement is observed in the symptoms, causes other than acid reflux are conceivable. Therefore, such consideration as the change to more appropriate treatment should be made.
Prevacid IV: Usually, for adults Lansoprazole (Prevacid IV) 30 mg is mixed with 0.9% Sodium Chloride (NaCl) solution or 5% Dextrose in Water and administered by intravenous drip twice a day; alternatively, Lansoprazole (Prevacid IV) 30 mg is dissolved in 20 ml of 0.9% sodium chloride solution or 5% Dextrose in Water and administered slowly by intravenously injection twice a day.
Precautions: As Lansoprazole (Prevacid IV) 30 mg was shown to have high hemostatic effect based on the data up to 3 days after starting treatment, once the patient is able to take medications orally, therapy should be switched to an oral formulation and this drug should not be administered aimlessly for a long period.
There is no clinical experience of treatment over 7 days in Japanese clinical trials.
Gastric ulcer, stomal ulcer, reflux esophagitis and Zollinger-Ellison syndrome: Usually, for adults, a daily oral dose of 30 mg of Lansoprazole is administered once a day up to 8 weeks.
In the maintenance of healing of reflux esophagitis that repeats occurrence and recrudescence, a daily oral dose of 15 mg is administered once a day. However, when the effect is insufficient, a daily oral dose of 30 mg may be administered once a day.
Pediatric: (1 to 11 years of age): Short-Term Treatment of Symptomatic GERD, Short-Term Treatment of Erosive Esophagitis: ≤ 30 kg: 15 mg once daily for up to 12 weeks; > 30 kg: 30 mg once daily for up to 12 weeks.
(12 to 17 years of age): Short-Term Treatment of Symptomatic GERD: Non-erosive GERD: 15 mg once daily for up to 8 weeks; Erosive esophagitis: 30 mg once daily for up to 8 weeks.
For the maintenance therapy of reflux esophagitis and duodenal ulcers, for elderly patients and for patients with impaired hepatic function, 15 mg Lansoprazole is orally administered once daily.
The recommended doses for Lansoprazole-containing regimens for Helicobacter pylori eradication in patients with duodenal ulcer and gastric ulcer are 30 mg Lansoprazole twice daily plus two of the following antibiotics for seven (7) days: clarithromycin 250 mg twice daily, amoxicillin 1 g twice daily or metronidazole 500 mg twice daily.
Precautions concerning dosage and administration: Reflux Esophagitis: In the maintenance of healing, the administration of a daily dose of 30 mg should be confined to the cases in which a daily dose of 15 mg is not effective enough, such as the cases of recurrence during administration of a daily dose of 15 mg.
Nonerosive Gastroesophageal Reflux Disease: In the treatment of nonerosive gastroesophageal reflux disease, effect of Lansoprazole (Prevacid FDT) should be checked about 2 weeks after the start of this drug. If no improvement is observed in the symptoms, causes other than acid reflux are conceivable. Therefore, such consideration as the change to more appropriate treatment should be made.
Prevacid IV: Usually, for adults Lansoprazole (Prevacid IV) 30 mg is mixed with 0.9% Sodium Chloride (NaCl) solution or 5% Dextrose in Water and administered by intravenous drip twice a day; alternatively, Lansoprazole (Prevacid IV) 30 mg is dissolved in 20 ml of 0.9% sodium chloride solution or 5% Dextrose in Water and administered slowly by intravenously injection twice a day.
Precautions: As Lansoprazole (Prevacid IV) 30 mg was shown to have high hemostatic effect based on the data up to 3 days after starting treatment, once the patient is able to take medications orally, therapy should be switched to an oral formulation and this drug should not be administered aimlessly for a long period.
There is no clinical experience of treatment over 7 days in Japanese clinical trials.
Overdosage
Lansoprazole is not removed from the circulation by hemodialysis.
Prevacid FDT: In one reported overdose, a patient consumed 600 mg of PREVACID with no adverse reaction. Oral lansoprazole doses up to 5000 mg/kg in rats [approximately 1300 times the 30 mg human dose based on body surface area (BSA)] and in mice (about 675.7 times the 30 mg human dose based on BSA) did not produce deaths or any clinical signs.
In the event of over-exposure, treatment should be symptomatic and supportive.
Prevacid IV: Daily doses of up to 180 mg of lansoprazole orally and up to 90 mg of lansoprazole intravenously have been administered in trials without significant undesirable effects. If an overdose occurs, treatment should be symptomatic and supportive.
Prevacid FDT: In one reported overdose, a patient consumed 600 mg of PREVACID with no adverse reaction. Oral lansoprazole doses up to 5000 mg/kg in rats [approximately 1300 times the 30 mg human dose based on body surface area (BSA)] and in mice (about 675.7 times the 30 mg human dose based on BSA) did not produce deaths or any clinical signs.
In the event of over-exposure, treatment should be symptomatic and supportive.
Prevacid IV: Daily doses of up to 180 mg of lansoprazole orally and up to 90 mg of lansoprazole intravenously have been administered in trials without significant undesirable effects. If an overdose occurs, treatment should be symptomatic and supportive.
Administration
Should be taken on an empty stomach: Do not chew/crush.
Contraindications
Lansoprazole (Prevacid FDT/Prevacid IV) are contraindicated in the following patients: Patients with a history of hypersensitivity to any of the ingredients of this drug.
Patients who are receiving atazanavir sulfate or rilpivirine hydrochloride (see Interactions).
Patients who are receiving atazanavir sulfate or rilpivirine hydrochloride (see Interactions).
Special Precautions
Careful Administration: Lansoprazole (Prevacid FDT/Prevacid IV) should be administered with care in in the following patients: Patients with a history of drug hypersensitivity; Patients with hepatic disorders. [A delay in the metabolism and excretion of Lansoprazole (Prevacid FDT/Prevacid IV) may occur]; Elderly patients (see Use in the Elderly as follows).
Important Precautions: Daily treatment with any acid-suppressing medications over a long period of time (e.g. longer than three years) may lead to malabsorption of cyanocobalamin (Vitamin B12) caused by hypo- or achlorhydria. Rare reports of cyanocobalamin deficiency occurring with acid-suppressing therapy have been reported in the literature. This diagnosis should be considered if clinical symptoms consistent with cyanocobalamin deficiency are observed.
Increased Chromogranin A (CgA) level may interfere with investigations for neuroendocrine tumors. To avoid this interference, Prevacid FDT treatment should be stopped for at least 5 days before CgA measurements. If CgA and gastrin levels have not returned to reference range after initial measurement, measurements should be repeated 14 days after cessation of proton pump inhibitor.
Prevacid FDT: For the treatment of gastric ulcer, duodenal ulcer and stomal ulcer, it is advisable not to use this drug for maintenance therapy because there has not been enough experience in long term use.
In the maintenance of healing reflux esophagitis, Lansoprazole (Prevacid FDT) can be administered only to the patients who repeat recurrence and recrudescence of the condition. Administration to the patients who do not necessitate maintenance of healing should be avoided. When the healing is maintained over a long period by once daily administration of 30 mg or 15 mg, and when there is no risk of recurrence resulting from dose reduction or discontinuation of administration, the dose should be reduced to a daily dose of 15 mg or administration should be discontinued. Careful observation by such means as periodic endoscopy is recommended during the maintenance of healing.
In the treatment of non-erosive gastroesophageal reflux disease, Lansoprazole (Prevacid FDT) should be administered after repeats (2 or more days in a week) of acid reflux symptoms such as heartburn and acid belching are confirmed on inquiry.
The administration of Lansoprazole (Prevacid FDT) may mask the symptoms of a malignant tumor such as gastric/esophageal cancer or of other gastrointestinal disorders. It is therefore necessary to ascertain that no such diseases are present on endoscopy etc.
Prevacid IV: If the patient has projectile bleeding or oozing bleeding, or it is considered at risk for rapid bleeding such as the case of presence of exposed blood vessels, the patients should undergo endoscopic hemostasis such as heater probe or clipping.
Precautions Concerning Patients With Specific Backgrounds: Patients with Complication or History of Diseases, etc.; Patients with a history of drug hypersensitivity; Patients with Hepatic disorders: A delay in the metabolism and excretion of Lansoprazole (Prevacid IV) may occur.
Other Precautions: In an animal study in which 50 mg/kg/day (about 100 times the clinical dose) of lansoprazole was given to rats by gavage administration for 52 weeks, benign testicular interstitial cell tumors were observed in one animal. In another study in which 15 mg/kg/day or more was given to rats by gavage for 24 months, an increase in the frequency of benign testicular interstitial cell tumors was observed and, in which 5 mg/kg/day or more was given, carcinoid tumors in the stomach were observed. In addition, in the group of female rats given 15 mg/kg/day or more of lansoprazole and the group of male rats given 50 mg/kg/day or more, an increase in the frequency of retinal atrophy was observed. Testicular interstitial cell tumors and retinal atrophy were not observed in carcinogenicity studies in mice, as well as in toxicity studies in dogs or monkeys. Thus, these changes are considered to be specific to rats.
The administration of Lansoprazole (Prevacid FDT/Prevacid IV) may mask the symptoms of gastric cancer. It is therefore, necessary to ascertain the ulcer is not of a malignant nature before initiating the administration of this drug.
In several observational studies in overseas, an increased risk for osteoporosis-related fractures of the hip, wrist or spine under the treatment with proton pump inhibitors has been reported. The risk of fracture was especially increased in the patients receiving high dose or long term (a year or longer) treatment.
In several overseas observational studies, mainly in hospitalized patients, increased risk of gastrointestinal infection caused by Clostridium difficile was reported in patients received proton pump inhibitors.
Prevacid FDT: It has been reported that visual disturbance occurred with use of a similar drug (omeprazole).
It has been reported that benign gastric polyp occurred during the long-term administration of Lansoprazole (Prevacid FDT).
In an animal study in which lansoprazole (>15 mg/kg/day) and amoxicillin hydrate (2,000 mg/kg/day) were concomitantly given to rats by gavage for 4 weeks and in another study in which lansoprazole (100 mg/kg/day), amoxicillin hydrate (500 mg/kg/day) and clarithromycin (25 mg/kg/day) were concomitantly given to dogs by gavage for 4 weeks, crystalluria was observed in animals after administration of amoxicillin hydrate alone or concomitantly. The crystal was proved to be a precipitation of amoxicillin hydrate being formed after micturition, not that being precipitated within the body.
Clinical trials revealed that, in the treatment of nonerosive gastroesophageal reflux disease, therapeutic effects of lansoprazole became unsatisfactory in the case of patients with neither middle/advanced age, obesity, nor presence of findings of hiatus hernia, which are high-risk factors for esophageal acid reflux.
It was suggested by clinical trials that the risk of recurrence of gastric ulcer or duodenal ulcer during low-dose aspirin administration may increase with positive Helicobacter pylori or increasing age.
Use in Pregnancy: Lansoprazole (Prevacid FDT/Prevacid IV) should be used in pregnant women or women who may be pregnant only if the expected therapeutic benefit is thought to outweigh any possible risk. In animal studies (rats, oral dose) higher plasma concentration of lansoprazole in the fetus than in the mother animal was observed. In pregnant rabbits (oral doses of 30 mg/kg/day), an increased fetus death rate was observed.
Prevacid FDT: In a study in which lansoprazole (50 mg/kg/day), amoxicillin hydrate (500 mg/kg/day) and clarithromycin (160 mg/kg/day) were concomitantly administered to rats, increased effects on fetal growth were observed along with increased toxicity in maternal animals.
Use in Lactation: The continuation or discontinuation of breastfeeding should be considered while taking account of the expected therapeutic benefits and the benefits of maternal feeding. It has been reported in animal studies (rats) that lansoprazole is transferred to mother's milk.
Use in Children No clinical study has been conducted in children.
Use in the Elderly: Since gastric acid secretion and other physiological functions are decreased in elderly patients, Lansoprazole (Prevacid FDT/Prevacid IV) should be carefully administered, e.g., by starting with lower dose.
Important Precautions: Daily treatment with any acid-suppressing medications over a long period of time (e.g. longer than three years) may lead to malabsorption of cyanocobalamin (Vitamin B12) caused by hypo- or achlorhydria. Rare reports of cyanocobalamin deficiency occurring with acid-suppressing therapy have been reported in the literature. This diagnosis should be considered if clinical symptoms consistent with cyanocobalamin deficiency are observed.
Increased Chromogranin A (CgA) level may interfere with investigations for neuroendocrine tumors. To avoid this interference, Prevacid FDT treatment should be stopped for at least 5 days before CgA measurements. If CgA and gastrin levels have not returned to reference range after initial measurement, measurements should be repeated 14 days after cessation of proton pump inhibitor.
Prevacid FDT: For the treatment of gastric ulcer, duodenal ulcer and stomal ulcer, it is advisable not to use this drug for maintenance therapy because there has not been enough experience in long term use.
In the maintenance of healing reflux esophagitis, Lansoprazole (Prevacid FDT) can be administered only to the patients who repeat recurrence and recrudescence of the condition. Administration to the patients who do not necessitate maintenance of healing should be avoided. When the healing is maintained over a long period by once daily administration of 30 mg or 15 mg, and when there is no risk of recurrence resulting from dose reduction or discontinuation of administration, the dose should be reduced to a daily dose of 15 mg or administration should be discontinued. Careful observation by such means as periodic endoscopy is recommended during the maintenance of healing.
In the treatment of non-erosive gastroesophageal reflux disease, Lansoprazole (Prevacid FDT) should be administered after repeats (2 or more days in a week) of acid reflux symptoms such as heartburn and acid belching are confirmed on inquiry.
The administration of Lansoprazole (Prevacid FDT) may mask the symptoms of a malignant tumor such as gastric/esophageal cancer or of other gastrointestinal disorders. It is therefore necessary to ascertain that no such diseases are present on endoscopy etc.
Prevacid IV: If the patient has projectile bleeding or oozing bleeding, or it is considered at risk for rapid bleeding such as the case of presence of exposed blood vessels, the patients should undergo endoscopic hemostasis such as heater probe or clipping.
Precautions Concerning Patients With Specific Backgrounds: Patients with Complication or History of Diseases, etc.; Patients with a history of drug hypersensitivity; Patients with Hepatic disorders: A delay in the metabolism and excretion of Lansoprazole (Prevacid IV) may occur.
Other Precautions: In an animal study in which 50 mg/kg/day (about 100 times the clinical dose) of lansoprazole was given to rats by gavage administration for 52 weeks, benign testicular interstitial cell tumors were observed in one animal. In another study in which 15 mg/kg/day or more was given to rats by gavage for 24 months, an increase in the frequency of benign testicular interstitial cell tumors was observed and, in which 5 mg/kg/day or more was given, carcinoid tumors in the stomach were observed. In addition, in the group of female rats given 15 mg/kg/day or more of lansoprazole and the group of male rats given 50 mg/kg/day or more, an increase in the frequency of retinal atrophy was observed. Testicular interstitial cell tumors and retinal atrophy were not observed in carcinogenicity studies in mice, as well as in toxicity studies in dogs or monkeys. Thus, these changes are considered to be specific to rats.
The administration of Lansoprazole (Prevacid FDT/Prevacid IV) may mask the symptoms of gastric cancer. It is therefore, necessary to ascertain the ulcer is not of a malignant nature before initiating the administration of this drug.
In several observational studies in overseas, an increased risk for osteoporosis-related fractures of the hip, wrist or spine under the treatment with proton pump inhibitors has been reported. The risk of fracture was especially increased in the patients receiving high dose or long term (a year or longer) treatment.
In several overseas observational studies, mainly in hospitalized patients, increased risk of gastrointestinal infection caused by Clostridium difficile was reported in patients received proton pump inhibitors.
Prevacid FDT: It has been reported that visual disturbance occurred with use of a similar drug (omeprazole).
It has been reported that benign gastric polyp occurred during the long-term administration of Lansoprazole (Prevacid FDT).
In an animal study in which lansoprazole (>15 mg/kg/day) and amoxicillin hydrate (2,000 mg/kg/day) were concomitantly given to rats by gavage for 4 weeks and in another study in which lansoprazole (100 mg/kg/day), amoxicillin hydrate (500 mg/kg/day) and clarithromycin (25 mg/kg/day) were concomitantly given to dogs by gavage for 4 weeks, crystalluria was observed in animals after administration of amoxicillin hydrate alone or concomitantly. The crystal was proved to be a precipitation of amoxicillin hydrate being formed after micturition, not that being precipitated within the body.
Clinical trials revealed that, in the treatment of nonerosive gastroesophageal reflux disease, therapeutic effects of lansoprazole became unsatisfactory in the case of patients with neither middle/advanced age, obesity, nor presence of findings of hiatus hernia, which are high-risk factors for esophageal acid reflux.
It was suggested by clinical trials that the risk of recurrence of gastric ulcer or duodenal ulcer during low-dose aspirin administration may increase with positive Helicobacter pylori or increasing age.
Use in Pregnancy: Lansoprazole (Prevacid FDT/Prevacid IV) should be used in pregnant women or women who may be pregnant only if the expected therapeutic benefit is thought to outweigh any possible risk. In animal studies (rats, oral dose) higher plasma concentration of lansoprazole in the fetus than in the mother animal was observed. In pregnant rabbits (oral doses of 30 mg/kg/day), an increased fetus death rate was observed.
Prevacid FDT: In a study in which lansoprazole (50 mg/kg/day), amoxicillin hydrate (500 mg/kg/day) and clarithromycin (160 mg/kg/day) were concomitantly administered to rats, increased effects on fetal growth were observed along with increased toxicity in maternal animals.
Use in Lactation: The continuation or discontinuation of breastfeeding should be considered while taking account of the expected therapeutic benefits and the benefits of maternal feeding. It has been reported in animal studies (rats) that lansoprazole is transferred to mother's milk.
Use in Children No clinical study has been conducted in children.
Use in the Elderly: Since gastric acid secretion and other physiological functions are decreased in elderly patients, Lansoprazole (Prevacid FDT/Prevacid IV) should be carefully administered, e.g., by starting with lower dose.
Use In Pregnancy & Lactation
Pregnant Women: Lansoprazole (Prevacid FDT/Prevacid IV) should be used in pregnant women or women who may be pregnant only if the expected therapeutic benefit is thought to outweigh any possible risk. In animal studies (rats, oral dose) higher plasma concentration of lansoprazole in the fetus than in the mother animal was observed. In pregnant rabbits (oral doses of 30 mg/kg/day), an increased fetus death rate was observed.
Prevacid FDT: In a study in which lansoprazole (50 mg/kg/day), amoxicillin hydrate (500 mg/kg/day) and clarithromycin (160 mg/kg/day) were concomitantly administered to rats, increased effects on fetal growth were observed along with increased toxicity in maternal animals.
Breast-feeding Woman: The continuation or discontinuation of breastfeeding should be considered while taking account of the expected therapeutic benefits and the benefits of maternal feeding. It has been reported in animal studies (rats) that lansoprazole is transferred to mother's milk.
Prevacid FDT: In a study in which lansoprazole (50 mg/kg/day), amoxicillin hydrate (500 mg/kg/day) and clarithromycin (160 mg/kg/day) were concomitantly administered to rats, increased effects on fetal growth were observed along with increased toxicity in maternal animals.
Breast-feeding Woman: The continuation or discontinuation of breastfeeding should be considered while taking account of the expected therapeutic benefits and the benefits of maternal feeding. It has been reported in animal studies (rats) that lansoprazole is transferred to mother's milk.
Adverse Reactions
Prevacid FDT: Following adverse reactions may occur. Therefore, close observation should be made, and if abnormality is observed, administration of Lansoprazole (Prevacid FDT) should be discontinued, and appropriate measures should be taken.
Clinically significant adverse reactions: Anaphylaxis (generalized rash, facial edema, dyspnea, etc) (<0.1%) and shock (<0.1%).
Pancytopenia, agranulocytosis or hemolytic anemia may occur (<0.1%). Granulocytopenia, thrombocytopenia or anemia (<0.1% - <5%).
Severe hepatic dysfunction with jaundice, increased GOT, GPT, etc., may occur (<0.1%).
Toxic epidermal necrolysis (TEN) and oculomucocutaneous syndrome (Stevens-Johnson Syndrome) (<0.1%).
Serious colitis accompanied with bloody stools, such as pseudomembranous colitis, may occur due to amoxicillin or clarithromycin being used for H. pylori eradication (<0.1%). If abdominal pain and frequent diarrhea occur, appropriate measures, such as immediate discontinuation of the treatment should be taken.
Interstitial pneumonia (<0.1%) may occur. Therefore, if fever, coughing, dyspnea, abnormal lung sound (crepitation), etc., are observed, such examinations as chest x-ray should be immediately be performed, and Lansoprazole (Prevacid FDT) should be discontinued. Appropriate measures such as treatment with corticosteroid preparation should be taken.
Interstitial nephritis (frequency unknown) may occur, resulting in acute renal failure in some cases. Therefore, pay attention to renal function test values (increase in BUN, creatinine, etc), and if any abnormality is observed, Lansoprazole (Prevacid FDT) should be discontinued and appropriate measures taken.
Other adverse reactions: Gastric ulcer, duodenal ulcer, stomal ulcer, reflux esophagitis, Zollinger-Ellison syndrome, non-erosive gastroesophageal reflux disease, prevention of recurrence of gastric ulcer or duodenal ulcer during low-dose aspirin administration, and prevention of recurrence of gastric ulcer or duodenal ulcer during NSAIDs administration. (See Table 4.)
Clinically significant adverse reactions: Anaphylaxis (generalized rash, facial edema, dyspnea, etc) (<0.1%) and shock (<0.1%).
Pancytopenia, agranulocytosis or hemolytic anemia may occur (<0.1%). Granulocytopenia, thrombocytopenia or anemia (<0.1% - <5%).
Severe hepatic dysfunction with jaundice, increased GOT, GPT, etc., may occur (<0.1%).
Toxic epidermal necrolysis (TEN) and oculomucocutaneous syndrome (Stevens-Johnson Syndrome) (<0.1%).
Serious colitis accompanied with bloody stools, such as pseudomembranous colitis, may occur due to amoxicillin or clarithromycin being used for H. pylori eradication (<0.1%). If abdominal pain and frequent diarrhea occur, appropriate measures, such as immediate discontinuation of the treatment should be taken.
Interstitial pneumonia (<0.1%) may occur. Therefore, if fever, coughing, dyspnea, abnormal lung sound (crepitation), etc., are observed, such examinations as chest x-ray should be immediately be performed, and Lansoprazole (Prevacid FDT) should be discontinued. Appropriate measures such as treatment with corticosteroid preparation should be taken.
Interstitial nephritis (frequency unknown) may occur, resulting in acute renal failure in some cases. Therefore, pay attention to renal function test values (increase in BUN, creatinine, etc), and if any abnormality is observed, Lansoprazole (Prevacid FDT) should be discontinued and appropriate measures taken.
Other adverse reactions: Gastric ulcer, duodenal ulcer, stomal ulcer, reflux esophagitis, Zollinger-Ellison syndrome, non-erosive gastroesophageal reflux disease, prevention of recurrence of gastric ulcer or duodenal ulcer during low-dose aspirin administration, and prevention of recurrence of gastric ulcer or duodenal ulcer during NSAIDs administration. (See Table 4.)
Adjunct to Helicobacter pylori eradication: See table 5.
The following table shows the adverse reactions (incidence: >1%) observed in clinical studies abroad: (See Table 6.)
Prevacid IV: *Adverse reactions, including abnormalities in laboratory data, were observed in 31 (14.0%) of 221 patients given lansoprazole at a dose of 30 mg twice a day in clinical trials before approval. Main adverse reactions included abnormal changes in laboratory data such as increased ALT (GPT) (6.2%), AST (GOT) (5.7%), LDH (2.0%), and γ-GTP (1.5%). (At the time of approval).
Adverse reactions, including abnormalities in laboratory data, were observed in 35 (3.1%) of 1,142 patients in the postmarketing investigations. The major adverse reactions were diarrhea, hepatic dysfunction, hepatic disorder, fever and leukocyte count decreased (0.3% each). (As of the end of the reexamination).
Following adverse reactions may occur. Therefore, close observation should be made, and if abnormality is observed, administration of Lansoprazole (Prevacid IV) should be discontinued, and appropriate measures should be taken.
*Clinically significant adverse reactions (All frequencies unknown): Anaphylaxis (generalized rash, facial edema, dyspnea, etc) and shock.
Pancytopenia, agranulocytosis, hemolytic anemia, granulocytopenia, thrombocytopenia or anemia.
Severe hepatic dysfunction with jaundice, increased AST(GOT), ALT(GPT), etc., may occur. Therefore, close observation should be made. If any abnormality is observed.
Toxic epidermal necrolysis: TEN and oculomucocutaneous syndrome (Stevens-Johnson syndrome) may occur.
Interstitial pneumonia may occur. Therefore, if fever, coughing, dyspnea, abnormal lung sound (crepitation), etc., are observed, examination such as chest X-ray should immediately be performed, and Lansoprazole (Prevacid IV) 30 mg should be discontinued. Appropriate measures, such as treatment with a corticosteroid preparation, should be taken.
Interstitial nephritis may occur, resulting in acute renal failure in some cases. Therefore, pay attention to renal function test values (increases in BUN, creatinine, etc.) and if any abnormality is observed, Lansoprazole (Prevacid IV) 30 mg should be discontinued and appropriate measures taken.
Clinically significant adverse reactions (similar drug): The following adverse reactions are reported in a similar drug (Omeprazole): Visual disturbance may occur. Therefore, if any abnormality is observed, Lansoprazole (Prevacid) Tablet should be discontinued and appropriate measures taken.
Other adverse reactions: See Table 7.
Adverse reactions, including abnormalities in laboratory data, were observed in 35 (3.1%) of 1,142 patients in the postmarketing investigations. The major adverse reactions were diarrhea, hepatic dysfunction, hepatic disorder, fever and leukocyte count decreased (0.3% each). (As of the end of the reexamination).
Following adverse reactions may occur. Therefore, close observation should be made, and if abnormality is observed, administration of Lansoprazole (Prevacid IV) should be discontinued, and appropriate measures should be taken.
*Clinically significant adverse reactions (All frequencies unknown): Anaphylaxis (generalized rash, facial edema, dyspnea, etc) and shock.
Pancytopenia, agranulocytosis, hemolytic anemia, granulocytopenia, thrombocytopenia or anemia.
Severe hepatic dysfunction with jaundice, increased AST(GOT), ALT(GPT), etc., may occur. Therefore, close observation should be made. If any abnormality is observed.
Toxic epidermal necrolysis: TEN and oculomucocutaneous syndrome (Stevens-Johnson syndrome) may occur.
Interstitial pneumonia may occur. Therefore, if fever, coughing, dyspnea, abnormal lung sound (crepitation), etc., are observed, examination such as chest X-ray should immediately be performed, and Lansoprazole (Prevacid IV) 30 mg should be discontinued. Appropriate measures, such as treatment with a corticosteroid preparation, should be taken.
Interstitial nephritis may occur, resulting in acute renal failure in some cases. Therefore, pay attention to renal function test values (increases in BUN, creatinine, etc.) and if any abnormality is observed, Lansoprazole (Prevacid IV) 30 mg should be discontinued and appropriate measures taken.
Clinically significant adverse reactions (similar drug): The following adverse reactions are reported in a similar drug (Omeprazole): Visual disturbance may occur. Therefore, if any abnormality is observed, Lansoprazole (Prevacid) Tablet should be discontinued and appropriate measures taken.
Other adverse reactions: See Table 7.
Drug Interactions
Lansoprazole (Prevacid FDT/Prevacid IV) is metabolized mainly by hepatic drug-metabolizing enzyme CYP2C19 and CYP3A4.
Gastric antisecretory effect of Lansoprazole (Prevacid FDT/Prevacid IV) may promote or inhibit absorption of concomitant drugs.
Contraindications for co-administration [Lansoprazole (Prevacid FDT/Prevacid IV) should not be co-administered with the followings drugs]: See Table 8.
Gastric antisecretory effect of Lansoprazole (Prevacid FDT/Prevacid IV) may promote or inhibit absorption of concomitant drugs.
Contraindications for co-administration [Lansoprazole (Prevacid FDT/Prevacid IV) should not be co-administered with the followings drugs]: See Table 8.
Precautions for co-administration [Lansoprazole (Prevacid FDT/Prevacid IV) should be administered with care when co-administered with the following drugs.]: See Table 9.
Influence on Laboratory Tests: Prevacid FDT: 13 C-urea breath test may show pseudonegative results during and immediately after administration of proton pump inhibitors such as lansoprazole, antibiotics such as amoxicillin hydrate and clarithromycin, and metronidazole. It is, therefore, advisable to perform 13C-urea breath test for the decision of the result of Helicobacter pylori eradication at a time point over 4 weeks after discontinuation of administration of these drugs.
Caution For Usage
Precautions Concerning Use: Prevacid FDT: When dispensing the drug: The patient must be instructed to remove the tablets from the press-through package (PTP) before they are ingested. [It has been reported that, if the PTP sheet is swallowed, the sharp corners of the sheet may puncture the esophageal mucosa, and this could result in serious complications such as mediastinitis.]
When taking the drug: It can be swallowed with saliva alone after placing the tablet on the tongue, moistening with saliva and squeezing gently with the tongue. It can also be taken with water.
Administration Options: Alternatively, for children or other patients who have difficulty of swallowing tablets, Lansoprazole (Prevacid FDT) can be delivered in two different ways.
Lansoprazole (Prevacid FDT) Oral Syringe: For administration via oral syringe, Lanzoprazole (Prevacid FDT) can be administered as follows: Place a 15 mg tablet in oral syringe and draw up approximately 4 mL of water, or place a 30 mg tablet in oral syringe and draw up approximately 10 mL of water.
Shake gently to allow for a quick dispersal.
After the tablet has dispersed, administer the contents within 15 minutes.
Refill the syringe with approximately 2 mL (5 mL for the 30 mg tablet) of water, shake gently and administer any remaining contents.
Lansoprazole (Prevacid FDT) Nasogastric Tube Administration (≥8 French): For administration via a nasogastric tube, Lansoprazole (Prevacid FDT) can be administered as follows: Place a 15 mg tablet in a syringe and draw up to 4 mL of water, or place a 30 mg tablet in a syringe and draw up 10 mL of water.
Shake gently to allow for a quick dispersal. After the tablet has dispersed, inject through the nasogastric tube into the stomach within 15 minutes.
Refill the syringe with approximately 5 mL of water, shake gently, and flush the nasogastric tube.
Prevacid IV: Route of administration: Lansoprazole (Prevacid IV) 30 mg should be used only by intravenous route.
After dissolution: Lansoprazole (Prevacid IV) 30 mg should be used immediately after dissolution and the dissolved solution should not be stored since the solution may deteriorate over time.
Method of administration: A dedicated infusion line should be used for the administration of Lansoprazole (Prevacid IV) 30 mg.
The infusion line should not be shared with other drugs. If it is inevitable to administer Lansoprazole (Prevacid IV) 30 mg using the infusion line for other drugs via a Y-site, the infusion of other drugs should be stopped and the line should be flushed by 0.9% Sodium Chloride (NaCl) or 5% Dextrose in Water before and after administration of Lansoprazole (Prevacid IV) 30 mg.
Incompatibility: Lansoprazole (Prevacid IV) 30 mg should not be mixed with solutions, infusion fluid, replacement fluid and other medical products except 0.9% Sodium Chloride (NaCl) and 5% Dextrose in Water since discoloration and precipitation may occur in the mixed solution.
When taking the drug: It can be swallowed with saliva alone after placing the tablet on the tongue, moistening with saliva and squeezing gently with the tongue. It can also be taken with water.
Administration Options: Alternatively, for children or other patients who have difficulty of swallowing tablets, Lansoprazole (Prevacid FDT) can be delivered in two different ways.
Lansoprazole (Prevacid FDT) Oral Syringe: For administration via oral syringe, Lanzoprazole (Prevacid FDT) can be administered as follows: Place a 15 mg tablet in oral syringe and draw up approximately 4 mL of water, or place a 30 mg tablet in oral syringe and draw up approximately 10 mL of water.
Shake gently to allow for a quick dispersal.
After the tablet has dispersed, administer the contents within 15 minutes.
Refill the syringe with approximately 2 mL (5 mL for the 30 mg tablet) of water, shake gently and administer any remaining contents.
Lansoprazole (Prevacid FDT) Nasogastric Tube Administration (≥8 French): For administration via a nasogastric tube, Lansoprazole (Prevacid FDT) can be administered as follows: Place a 15 mg tablet in a syringe and draw up to 4 mL of water, or place a 30 mg tablet in a syringe and draw up 10 mL of water.
Shake gently to allow for a quick dispersal. After the tablet has dispersed, inject through the nasogastric tube into the stomach within 15 minutes.
Refill the syringe with approximately 5 mL of water, shake gently, and flush the nasogastric tube.
Prevacid IV: Route of administration: Lansoprazole (Prevacid IV) 30 mg should be used only by intravenous route.
After dissolution: Lansoprazole (Prevacid IV) 30 mg should be used immediately after dissolution and the dissolved solution should not be stored since the solution may deteriorate over time.
Method of administration: A dedicated infusion line should be used for the administration of Lansoprazole (Prevacid IV) 30 mg.
The infusion line should not be shared with other drugs. If it is inevitable to administer Lansoprazole (Prevacid IV) 30 mg using the infusion line for other drugs via a Y-site, the infusion of other drugs should be stopped and the line should be flushed by 0.9% Sodium Chloride (NaCl) or 5% Dextrose in Water before and after administration of Lansoprazole (Prevacid IV) 30 mg.
Incompatibility: Lansoprazole (Prevacid IV) 30 mg should not be mixed with solutions, infusion fluid, replacement fluid and other medical products except 0.9% Sodium Chloride (NaCl) and 5% Dextrose in Water since discoloration and precipitation may occur in the mixed solution.
Storage
Store at temperatures not exceeding 25°C.
Prevacid IV: Store at temperatures not exceeding 30°C. Protect from light.
Prevacid IV: Store at temperatures not exceeding 30°C. Protect from light.
Action
Pharmacology: Mechanism of action: Lansoprazole is firstly transferred to the acid-producing region of the gastric mucosal parietal cells, and transformed into an activated form through conversion reaction by acid. This reaction product is considered to combine with the SH-groups of (H+, K+)-ATPase which is locally located in the acid-producing region and playing a role of the proton pump, suppressing the enzyme activity to inhibit the acid secretion.
Prevacid IV: It has been reported that blood coagulation and platelet aggregation capacities are severely impaired under acidic conditions, and that fibrin formed as a result of blood coagulation is dissolved by pepsin under acidic conditions. Lansoprazole is considered to increase gastric pH, thereby improving blood coagulation and platelet aggregation capacities and inhibiting peptic activity, resulting in suppression of bleeding.
Also, lansoprazole is considered to increase gastric pH by inhibiting acid secretion, thereby promoting repair of injured mucosa, which is inhibited under acidic conditions.
Prevacid FDT: Inhibiting activity on gastric acid secretion: Pentagastrin-stimulated gastric acid secretion: By a single oral administration or by a once daily oral administration of 30 mg of lansoprazole for 7 days to healthy adults, a prominent inhibition of gastric acid secretion is observed, sustaining 24 hours after administration.
Insulin-stimulated gastric acid secretion: By a once daily oral administration of 30 mg of lansoprazole for 7 days to healthy adults, a prominent inhibition of gastric acid secretion is observed.
Nocturnal gastric acid secretion: By a once daily oral administration of 30 mg of lansoprazole for 7 days to healthy adults, a prominent inhibition of gastric acid secretion is observed.
Twenty-four hour gastric acid secretion: By a once daily oral administration of 30 mg of lansoprazole for 7 days to healthy adults, a prominent inhibition of gastric acid secretion is observed throughout the day in 24-hour sampling test of gastric juice.
Twenty-four hour monitoring of gastric pH: By a once daily oral administration of 30 mg of lansoprazole for 7 days to healthy adults or patients in scar stage of duodenal ulcer, a prominent inhibition of gastric acid secretion is observed throughout the day.
Twenty-four hour monitoring of lower esophageal pH: By a once daily oral administration of 30 mg of lansoprazole for 7 to 9 days to patients with reflux esophagitis, a prominent inhibition of gastroesophageal reflux is observed.
Adjunctive effect on eradication of Helicobacter pylori: By concomitant use with lansoprazole, increase in tissue concentrations of the stomach of both amoxicillin hydrate and clarithromycin was observed after oral administration (rats).
The role of lansoprazole in the Helicobacter pylori eradication is considered to increase intragastric pH leading to the enhancement of antibacterial activity of amoxicillin hydrate and clarithromycin which are concomitantly administered.
Prevacid IV: Inhibiting activity on gastric bleeding: In rats (intravenous dose), lansoprazole shows an inhibiting activity on gastric bleeding due to hemorrhagic shock.
Inhibiting activity on formation of gastric mucosal injury: In rats (intravenous dose), lansoprazole inhibits gastric mucosal injury due to aspirin or indomethacin.
Inhibiting activity on gastric acid secretion (24-hour gastric pH monitoring): By intravenous administration of lansoprazole at a dose of 30 mg twice a day to healthy adults, continuous inhibition of gastric acid secretion is observed. The rates of 24-hour gastric pH 4 holding time (the time that the gastric pH is 4 or over) are similar between intravenous injection (approximately 3 minutes) and intravenous drip infusion (30 minutes).
In addition, the gastric acid secretion inhibiting effect (pH 4 holding time every 24 hours) after intravenous administration of lansoprazole at a dose of 30 mg twice a day to healthy adults whose metabolizer types for lansoprazole were identified as EM or PM is as follows: The rates of pH 4 holding time are 56-69% in EMs and 90% in PMs on day 1 and 80-89% in EMs and 98% in PMs on day 5.
Pharmacokinetics: Prevacid FDT: Blood Concentrations: After a single oral administration of Lansoprazole (Prevacid FDT) 15 mg to 24 healthy adults and Lansoprazole (Prevacid FDT) 30 mg to other 24 healthy adults, each under fasting in the morning in crossover studies, in the blood mainly the unchanged lansoprazole was detected. The following figures shows the blood concentrations of the unchanged compound. The bioequivalency of each preparation of the FDT tablets was confirmed. (See Table 1 and Figures 1 and 2.)
Prevacid IV: It has been reported that blood coagulation and platelet aggregation capacities are severely impaired under acidic conditions, and that fibrin formed as a result of blood coagulation is dissolved by pepsin under acidic conditions. Lansoprazole is considered to increase gastric pH, thereby improving blood coagulation and platelet aggregation capacities and inhibiting peptic activity, resulting in suppression of bleeding.
Also, lansoprazole is considered to increase gastric pH by inhibiting acid secretion, thereby promoting repair of injured mucosa, which is inhibited under acidic conditions.
Prevacid FDT: Inhibiting activity on gastric acid secretion: Pentagastrin-stimulated gastric acid secretion: By a single oral administration or by a once daily oral administration of 30 mg of lansoprazole for 7 days to healthy adults, a prominent inhibition of gastric acid secretion is observed, sustaining 24 hours after administration.
Insulin-stimulated gastric acid secretion: By a once daily oral administration of 30 mg of lansoprazole for 7 days to healthy adults, a prominent inhibition of gastric acid secretion is observed.
Nocturnal gastric acid secretion: By a once daily oral administration of 30 mg of lansoprazole for 7 days to healthy adults, a prominent inhibition of gastric acid secretion is observed.
Twenty-four hour gastric acid secretion: By a once daily oral administration of 30 mg of lansoprazole for 7 days to healthy adults, a prominent inhibition of gastric acid secretion is observed throughout the day in 24-hour sampling test of gastric juice.
Twenty-four hour monitoring of gastric pH: By a once daily oral administration of 30 mg of lansoprazole for 7 days to healthy adults or patients in scar stage of duodenal ulcer, a prominent inhibition of gastric acid secretion is observed throughout the day.
Twenty-four hour monitoring of lower esophageal pH: By a once daily oral administration of 30 mg of lansoprazole for 7 to 9 days to patients with reflux esophagitis, a prominent inhibition of gastroesophageal reflux is observed.
Adjunctive effect on eradication of Helicobacter pylori: By concomitant use with lansoprazole, increase in tissue concentrations of the stomach of both amoxicillin hydrate and clarithromycin was observed after oral administration (rats).
The role of lansoprazole in the Helicobacter pylori eradication is considered to increase intragastric pH leading to the enhancement of antibacterial activity of amoxicillin hydrate and clarithromycin which are concomitantly administered.
Prevacid IV: Inhibiting activity on gastric bleeding: In rats (intravenous dose), lansoprazole shows an inhibiting activity on gastric bleeding due to hemorrhagic shock.
Inhibiting activity on formation of gastric mucosal injury: In rats (intravenous dose), lansoprazole inhibits gastric mucosal injury due to aspirin or indomethacin.
Inhibiting activity on gastric acid secretion (24-hour gastric pH monitoring): By intravenous administration of lansoprazole at a dose of 30 mg twice a day to healthy adults, continuous inhibition of gastric acid secretion is observed. The rates of 24-hour gastric pH 4 holding time (the time that the gastric pH is 4 or over) are similar between intravenous injection (approximately 3 minutes) and intravenous drip infusion (30 minutes).
In addition, the gastric acid secretion inhibiting effect (pH 4 holding time every 24 hours) after intravenous administration of lansoprazole at a dose of 30 mg twice a day to healthy adults whose metabolizer types for lansoprazole were identified as EM or PM is as follows: The rates of pH 4 holding time are 56-69% in EMs and 90% in PMs on day 1 and 80-89% in EMs and 98% in PMs on day 5.
Pharmacokinetics: Prevacid FDT: Blood Concentrations: After a single oral administration of Lansoprazole (Prevacid FDT) 15 mg to 24 healthy adults and Lansoprazole (Prevacid FDT) 30 mg to other 24 healthy adults, each under fasting in the morning in crossover studies, in the blood mainly the unchanged lansoprazole was detected. The following figures shows the blood concentrations of the unchanged compound. The bioequivalency of each preparation of the FDT tablets was confirmed. (See Table 1 and Figures 1 and 2.)
In addition, it has been reported in foreign countries that the simultaneous administration of lansoprazole and sucralfate or aluminum hydroxide gel/magnesium hydroxide decreased the blood concentration of lansoprazole.
Urinary excretion: After a single oral administration of 30 mg (capsule preparation) of lansoprazole under fasting or after meal, and after oral administration of 15 mg (capsule preparation) under fasting to healthy adults (6 subjects), no unchanged compound was detected in the urine; all detected were metabolites. The urinary excretion rate up to 24 hours after administration was 13.1-23.0%.
Pharmacokinetics at consecutive administration: It is considered that lansoprazole will not cause any accumulation in the body, in view of the time course of blood concentration and urinary excretion rate after the once daily oral administration of 30 mg or 15 mg (each capsule preparation) to healthy adults (6 subjects) every morning under fasting for 7 consecutive days.
Pharmacokinetic at concomitant administration of lansoprazole, amoxicillin hydrate and clarithromycin: The following table shows pharmacokinetic parameters of the unchanged substance of lansoprazole when the following 3 drugs were orally administered at the same time to healthy adults (6 subjects): 30 mg/dose of lansoprazole (capsule preparation), 1,000 mg (potency)/dose as amoxicillin hydrate, and 400 mg (potency)/dose of clarithromycin. (See Table 2.)
Urinary excretion: After a single oral administration of 30 mg (capsule preparation) of lansoprazole under fasting or after meal, and after oral administration of 15 mg (capsule preparation) under fasting to healthy adults (6 subjects), no unchanged compound was detected in the urine; all detected were metabolites. The urinary excretion rate up to 24 hours after administration was 13.1-23.0%.
Pharmacokinetics at consecutive administration: It is considered that lansoprazole will not cause any accumulation in the body, in view of the time course of blood concentration and urinary excretion rate after the once daily oral administration of 30 mg or 15 mg (each capsule preparation) to healthy adults (6 subjects) every morning under fasting for 7 consecutive days.
Pharmacokinetic at concomitant administration of lansoprazole, amoxicillin hydrate and clarithromycin: The following table shows pharmacokinetic parameters of the unchanged substance of lansoprazole when the following 3 drugs were orally administered at the same time to healthy adults (6 subjects): 30 mg/dose of lansoprazole (capsule preparation), 1,000 mg (potency)/dose as amoxicillin hydrate, and 400 mg (potency)/dose of clarithromycin. (See Table 2.)
The blood concentration of each drug at concomitant administration of these 3 drugs showed almost the same time-course changes as they were used individually.
In addition, it is considered that lansoprazole will not cause any accumulation in the body, in view of the pharmacokinetic data obtained after repeated oral administration of these 3 drugs to healthy adults (7 cases) twice daily for 7 days.
Prevacid IV: Blood concentrations: The serum concentration of lansoprazole after intravenous administration of Lansoprazole (Prevacid) IV 30 mg varies among individuals. The following figure shows the serum concentration of lansoprazole after intravenous drip of 30 mg lansoprazole twice a day for 5 days to 12 healthy male adults classified into their extensive metabolizer (EM) group (8 subjects) in which lansoprazole is rapidly metabolized or poor metabolizer (PM) group (4 subjects) in which the drug is slowly metabolized according to CYP2C19 genotype. (See Table 3 and Figure 3.)
In addition, it is considered that lansoprazole will not cause any accumulation in the body, in view of the pharmacokinetic data obtained after repeated oral administration of these 3 drugs to healthy adults (7 cases) twice daily for 7 days.
Prevacid IV: Blood concentrations: The serum concentration of lansoprazole after intravenous administration of Lansoprazole (Prevacid) IV 30 mg varies among individuals. The following figure shows the serum concentration of lansoprazole after intravenous drip of 30 mg lansoprazole twice a day for 5 days to 12 healthy male adults classified into their extensive metabolizer (EM) group (8 subjects) in which lansoprazole is rapidly metabolized or poor metabolizer (PM) group (4 subjects) in which the drug is slowly metabolized according to CYP2C19 genotype. (See Table 3 and Figure 3.)
Protein binding rate: The human serum protein binding rate of lansoprazole at the concentration range of 0.05 to 5 μg/mL is approximately 98%.
Metabolism: Lansoprazole is mainly metabolized by CYP2C19 and CYP3A4. It has been reported that there is genetic polymorphism of CYP2C19, and the frequency of poor metabolizers among Asian-Mongolian populations including Japanese is approximately 10-20%.
Urinary excretion: After single intravenous administration of 30 mg lansoprazole to healthy male adults (9 subjects), no unchanged compound was detected in the urine; all detected were metabolites. The accumulated urinary excretion rate up to 24 hours after administration was 12-17%.
Metabolism: Lansoprazole is mainly metabolized by CYP2C19 and CYP3A4. It has been reported that there is genetic polymorphism of CYP2C19, and the frequency of poor metabolizers among Asian-Mongolian populations including Japanese is approximately 10-20%.
Urinary excretion: After single intravenous administration of 30 mg lansoprazole to healthy male adults (9 subjects), no unchanged compound was detected in the urine; all detected were metabolites. The accumulated urinary excretion rate up to 24 hours after administration was 12-17%.
MedsGo Class
Antacids, Antireflux Agents & Antiulcerants
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