U.S. Department of Health & Human Services Divider Arrow National Institutes of Health Divider Arrow NCATS

Details

Stereochemistry RACEMIC
Molecular Formula C16H14F3N3O2S
Molecular Weight 369.361
Optical Activity ( + / - )
Defined Stereocenters 0 / 1
E/Z Centers 0
Charge 0

SHOW SMILES / InChI
Structure of LANSOPRAZOLE

SMILES

CC1=C(C[S+]([O-])C2=NC3=C(N2)C=CC=C3)N=CC=C1OCC(F)(F)F

InChI

InChIKey=MJIHNNLFOKEZEW-UHFFFAOYSA-N
InChI=1S/C16H14F3N3O2S/c1-10-13(20-7-6-14(10)24-9-16(17,18)19)8-25(23)15-21-11-4-2-3-5-12(11)22-15/h2-7H,8-9H2,1H3,(H,21,22)

HIDE SMILES / InChI

Description
Curator's Comment: description was created based on several sources, including https://www.ncbi.nlm.nih.gov/pubmed/22950496

Lansoprazole is a proton pump inhibitor, which prevents the stomach from producing acid. Lansoprazole has been marketed for many years and is one of several proton-pump inhibitors (PPI's). It was used for the treatment of acid-reflux disorders (GERD), peptic ulcer disease, H. pylori eradication, and prevention of gastrointestinal bleeds with NSAID use. Lansoprazole belongs to a class of ant secretory compounds, the substituted benzimidazoles, that do not exhibit anticholinergic or histamine H2-receptor antagonist properties, but that suppress gastric acid secretion by specific inhibition of the (H+, K+ )-ATPase enzyme system at the secretory surface of the gastric parietal cell. Because this enzyme system is regarded as the acid (proton) pump within the parietal cell, lansoprazole has been characterized as a gastric acid-pump inhibitor, in that it blocks the final step of acid production. This effect is dose-related and leads to inhibition of both basal and stimulated gastric acid secretion irrespective of the stimulus. Lansoprazole is extensively metabolized in the liver. Two metabolites have been identified in measurable quantities in plasma (the hydroxylated sulfinyl and sulfone derivatives of lansoprazole). These metabolites have very little or no antisecretory activity. Lansoprazole is thought to be transformed into two active species which inhibit acid secretion by (H+, K+ )-ATPase within the parietal cell canaliculus, but are not present in the systemic circulation. The plasma elimination half-life of lansoprazole does not reflect its duration of suppression of gastric acid secretion. Thus, the plasma elimination half-life is less than two hours, while the acid inhibitory effect lasts more than 24 hours.

Approval Year

TargetsConditions

Conditions

ConditionModalityTargetsHighest PhaseProduct
Primary
PREVACID

Approved Use

Use •treats frequent heartburn (occurs 2 or more days a week) •not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect

Launch Date

1.0306656E12
Primary
PREVACID

Approved Use

Use •treats frequent heartburn (occurs 2 or more days a week) •not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect

Launch Date

1.0306656E12
Primary
PREVACID

Approved Use

Use •treats frequent heartburn (occurs 2 or more days a week) •not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect

Launch Date

1.0306656E12
Primary
DEXILANT

Approved Use

DEXILANT is a proton pump inhibitor (PPI) indicated for: •Healing of all grades of erosive esophagitis (EE). (1.1) •Maintaining healing of EE and relief of heartburn. (1.2) •Treating heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD). (1.3) 1.1 Healing of Erosive Esophagitis DEXILANT is indicated for healing of all grades of erosive esophagitis (EE) for up to eight weeks. 1.2 Maintenance of Healed Erosive Esophagitis DEXILANT is indicated to maintain healing of EE and relief of heartburn for up to six months. 1.3 Symptomatic Non-Erosive Gastroesophageal Reflux Disease DEXILANT is indicated for the treatment of heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD) for four weeks.

Launch Date

1.23327362E12
Curative
DEXILANT

Approved Use

DEXILANT is a proton pump inhibitor (PPI) indicated for: •Healing of all grades of erosive esophagitis (EE). (1.1) •Maintaining healing of EE and relief of heartburn. (1.2) •Treating heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD). (1.3) 1.1 Healing of Erosive Esophagitis DEXILANT is indicated for healing of all grades of erosive esophagitis (EE) for up to eight weeks. 1.2 Maintenance of Healed Erosive Esophagitis DEXILANT is indicated to maintain healing of EE and relief of heartburn for up to six months. 1.3 Symptomatic Non-Erosive Gastroesophageal Reflux Disease DEXILANT is indicated for the treatment of heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD) for four weeks.

Launch Date

1.23327362E12
Primary
PREVACID

Approved Use

INDICATIONS AND USAGE. Short-Term Treatment of Active Duodenal Ulcer PREVACID is indicated for short-term treatment (up to 4 weeks) for healing and symptom relief of active duodenal ulcer. H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence. Triple Therapy: PREVACID/amoxicillin/clarithromycin. PREVACID in combination with amoxicillin plus clarithromycin as triple therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or one-year history of a duodenal ulcer) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. Dual Therapy: PREVACID/amoxicillin. PREVACID in combination with amoxicillin as dual therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or one-year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. Maintenance of Healed Duodenal Ulcers PREVACID is indicated to maintain healing of duodenal ulcers. Controlled studies do not extend beyond 12 months. Short-Term Treatment of Active Benign Gastric Ulcer PREVACID is indicated for short-term treatment (up to 8 weeks) for healing and symptom relief of active benign gastric ulcer Healing of NSAID-Associated Gastric Ulcer PREVACID IS INDICATED FOR THE TREATMENT OF NSAID-ASSOCIATED GASTRIC ULCER IN PATIENTS WHO CONTINUE NSAID USE. CONTROLLED STUDIES DID NOT EXTEND BEYOND 8 WEEKS. Risk Reduction of NSAID-Associated Gastric Ulcer PREVACID is indicated for reducing the risk of NSAID-associated gastric ulcers in patients with a history of a documented gastric ulcer who require the use of an NSAID. Controlled studies did not extend beyond 12 weeks. Gastroesophageal Reflux Disease (GERD) Short-Term Treatment of Symptomatic GERD PREVACID is indicated for the treatment of heartburn and other symptoms associated with GERD. Short-Term Treatment of Erosive Esophagitis PREVACID is indicated for short-term treatment (up to 8 weeks) for healing and symptom relief of all grades of erosive esophagitis. For patients who do not heal with PREVACID for 8 weeks (5-10%), it may be helpful to give an additional 8 weeks of treatment. If there is a recurrence of erosive esophagitis an additional 8-week course of PREVACID may be considered. Maintenance of Healing of Erosive Esophagitis PREVACID is indicated to maintain healing of erosive esophagitis. Controlled studies did not extend beyond 12 months. Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome PREVACID is indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.

Launch Date

1.03057922E12
Primary
PREVACID

Approved Use

INDICATIONS AND USAGE. Short-Term Treatment of Active Duodenal Ulcer PREVACID is indicated for short-term treatment (up to 4 weeks) for healing and symptom relief of active duodenal ulcer. H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence. Triple Therapy: PREVACID/amoxicillin/clarithromycin. PREVACID in combination with amoxicillin plus clarithromycin as triple therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or one-year history of a duodenal ulcer) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. Dual Therapy: PREVACID/amoxicillin. PREVACID in combination with amoxicillin as dual therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or one-year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. Maintenance of Healed Duodenal Ulcers PREVACID is indicated to maintain healing of duodenal ulcers. Controlled studies do not extend beyond 12 months. Short-Term Treatment of Active Benign Gastric Ulcer PREVACID is indicated for short-term treatment (up to 8 weeks) for healing and symptom relief of active benign gastric ulcer Healing of NSAID-Associated Gastric Ulcer PREVACID IS INDICATED FOR THE TREATMENT OF NSAID-ASSOCIATED GASTRIC ULCER IN PATIENTS WHO CONTINUE NSAID USE. CONTROLLED STUDIES DID NOT EXTEND BEYOND 8 WEEKS. Risk Reduction of NSAID-Associated Gastric Ulcer PREVACID is indicated for reducing the risk of NSAID-associated gastric ulcers in patients with a history of a documented gastric ulcer who require the use of an NSAID. Controlled studies did not extend beyond 12 weeks. Gastroesophageal Reflux Disease (GERD) Short-Term Treatment of Symptomatic GERD PREVACID is indicated for the treatment of heartburn and other symptoms associated with GERD. Short-Term Treatment of Erosive Esophagitis PREVACID is indicated for short-term treatment (up to 8 weeks) for healing and symptom relief of all grades of erosive esophagitis. For patients who do not heal with PREVACID for 8 weeks (5-10%), it may be helpful to give an additional 8 weeks of treatment. If there is a recurrence of erosive esophagitis an additional 8-week course of PREVACID may be considered. Maintenance of Healing of Erosive Esophagitis PREVACID is indicated to maintain healing of erosive esophagitis. Controlled studies did not extend beyond 12 months. Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome PREVACID is indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.

Launch Date

1.03057922E12
Primary
PREVACID

Approved Use

INDICATIONS AND USAGE. Short-Term Treatment of Active Duodenal Ulcer PREVACID is indicated for short-term treatment (up to 4 weeks) for healing and symptom relief of active duodenal ulcer. H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence. Triple Therapy: PREVACID/amoxicillin/clarithromycin. PREVACID in combination with amoxicillin plus clarithromycin as triple therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or one-year history of a duodenal ulcer) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. Dual Therapy: PREVACID/amoxicillin. PREVACID in combination with amoxicillin as dual therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or one-year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. Maintenance of Healed Duodenal Ulcers PREVACID is indicated to maintain healing of duodenal ulcers. Controlled studies do not extend beyond 12 months. Short-Term Treatment of Active Benign Gastric Ulcer PREVACID is indicated for short-term treatment (up to 8 weeks) for healing and symptom relief of active benign gastric ulcer Healing of NSAID-Associated Gastric Ulcer PREVACID IS INDICATED FOR THE TREATMENT OF NSAID-ASSOCIATED GASTRIC ULCER IN PATIENTS WHO CONTINUE NSAID USE. CONTROLLED STUDIES DID NOT EXTEND BEYOND 8 WEEKS. Risk Reduction of NSAID-Associated Gastric Ulcer PREVACID is indicated for reducing the risk of NSAID-associated gastric ulcers in patients with a history of a documented gastric ulcer who require the use of an NSAID. Controlled studies did not extend beyond 12 weeks. Gastroesophageal Reflux Disease (GERD) Short-Term Treatment of Symptomatic GERD PREVACID is indicated for the treatment of heartburn and other symptoms associated with GERD. Short-Term Treatment of Erosive Esophagitis PREVACID is indicated for short-term treatment (up to 8 weeks) for healing and symptom relief of all grades of erosive esophagitis. For patients who do not heal with PREVACID for 8 weeks (5-10%), it may be helpful to give an additional 8 weeks of treatment. If there is a recurrence of erosive esophagitis an additional 8-week course of PREVACID may be considered. Maintenance of Healing of Erosive Esophagitis PREVACID is indicated to maintain healing of erosive esophagitis. Controlled studies did not extend beyond 12 months. Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome PREVACID is indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.

Launch Date

1.03057922E12
Cmax

Cmax

ValueDoseCo-administeredAnalytePopulation
1705 ng/mL
30 mg single, intravenous
dose: 30 mg
route of administration: Intravenous
experiment type: SINGLE
co-administered:
LANSOPRAZOLE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: UNKNOWN
food status: UNKNOWN
1136 ng/mL
60 mg 1 times / day multiple, oral
dose: 60 mg
route of administration: oral
experiment type: multiple
co-administered:
DEXLANSOPRAZOLE plasma
Homo sapiens
population: unhealthy
age: Adolescents
sex:
food status:
691 ng/mL
30 mg 1 times / day multiple, oral
dose: 30 mg
route of administration: oral
experiment type: multiple
co-administered:
DEXLANSOPRAZOLE plasma
Homo sapiens
population: unhealthy
age: Adolescents
sex:
food status:
16.1 (ng/mL)/mg
60 mg 1 times / day multiple, oral
dose: 60 mg
route of administration: oral
experiment type: multiple
co-administered:
DEXLANSOPRAZOLE plasma
Homo sapiens
population: unhealthy
age: Children
sex:
food status:
33.5 (ng/mL)/mg
30 mg 1 times / day multiple, oral
dose: 30 mg
route of administration: oral
experiment type: multiple
co-administered:
DEXLANSOPRAZOLE plasma
Homo sapiens
population: unhealthy
age: Children
sex:
food status:
37.3 (ng/mL)/mg
15 mg 1 times / day multiple, oral
dose: 15 mg
route of administration: oral
experiment type: multiple
co-administered:
DEXLANSOPRAZOLE plasma
Homo sapiens
population: unhealthy
age: Children
sex:
food status:
1005 ng/mL
30 mg 1 times / day multiple, oral
dose: 30 mg
route of administration: oral
experiment type: multiple
co-administered:
DEXLANSOPRAZOLE plasma
Homo sapiens
population: unhealthy
age: Children
sex:
food status:
559 ng/mL
15 mg 1 times / day multiple, oral
dose: 15 mg
route of administration: oral
experiment type: multiple
co-administered:
DEXLANSOPRAZOLE plasma
Homo sapiens
population: unhealthy
age: Children
sex:
food status:
964 ng/mL
60 mg 1 times / day multiple, oral
dose: 60 mg
route of administration: oral
experiment type: multiple
co-administered:
DEXLANSOPRAZOLE plasma
Homo sapiens
population: unhealthy
age: Children
sex:
food status:
658 ng/mL
30 mg 1 times / day multiple, oral
dose: 30 mg
route of administration: Oral
experiment type: MULTIPLE
co-administered:
DEXLANSOPRAZOLE plasma
Homo sapiens
population: HEALTHY
age: UNKNOWN
sex: UNKNOWN
food status: UNKNOWN
1397 ng/mL
60 mg 1 times / day multiple, oral
dose: 60 mg
route of administration: Oral
experiment type: MULTIPLE
co-administered:
DEXLANSOPRAZOLE plasma
Homo sapiens
population: HEALTHY
age: UNKNOWN
sex: UNKNOWN
food status: UNKNOWN
AUC

AUC

ValueDoseCo-administeredAnalytePopulation
3192 ng × h/mL
30 mg single, intravenous
dose: 30 mg
route of administration: Intravenous
experiment type: SINGLE
co-administered:
LANSOPRAZOLE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: UNKNOWN
food status: UNKNOWN
143.2 (ng*h/mL)/mg
15 mg 1 times / day multiple, oral
dose: 15 mg
route of administration: oral
experiment type: multiple
co-administered:
DEXLANSOPRAZOLE plasma
Homo sapiens
population: unhealthy
age: Children
sex:
food status:
55.5 (ng*h/mL)/mg
60 mg 1 times / day multiple, oral
dose: 60 mg
route of administration: oral
experiment type: multiple
co-administered:
DEXLANSOPRAZOLE plasma
Homo sapiens
population: unhealthy
age: Children
sex:
food status:
87.6 (ng*h/mL)/mg
30 mg 1 times / day multiple, oral
dose: 30 mg
route of administration: oral
experiment type: multiple
co-administered:
DEXLANSOPRAZOLE plasma
Homo sapiens
population: unhealthy
age: Children
sex:
food status:
2149 ng*h/mL
15 mg 1 times / day multiple, oral
dose: 15 mg
route of administration: oral
experiment type: multiple
co-administered:
DEXLANSOPRAZOLE plasma
Homo sapiens
population: unhealthy
age: Children
sex:
food status:
2628 ng*h/mL
30 mg 1 times / day multiple, oral
dose: 30 mg
route of administration: oral
experiment type: multiple
co-administered:
DEXLANSOPRAZOLE plasma
Homo sapiens
population: unhealthy
age: Children
sex:
food status:
3330 ng*h/mL
60 mg 1 times / day multiple, oral
dose: 60 mg
route of administration: oral
experiment type: multiple
co-administered:
DEXLANSOPRAZOLE plasma
Homo sapiens
population: unhealthy
age: Children
sex:
food status:
128 (ng*h/mL)/mg
15 mg 1 times / day multiple, oral
dose: 15 mg
route of administration: oral
experiment type: multiple
co-administered:
DEXLANSOPRAZOLE plasma
Homo sapiens
population: unhealthy
age: Children
sex:
food status:
62 (ng*h/mL)/mg
60 mg 1 times / day multiple, oral
dose: 60 mg
route of administration: oral
experiment type: multiple
co-administered:
DEXLANSOPRAZOLE plasma
Homo sapiens
population: unhealthy
age: Children
sex:
food status:
96 (ng*h/mL)/mg
30 mg 1 times / day multiple, oral
dose: 30 mg
route of administration: oral
experiment type: multiple
co-administered:
DEXLANSOPRAZOLE plasma
Homo sapiens
population: unhealthy
age: Children
sex:
food status:
1914 ng*h/mL
15 mg 1 times / day multiple, oral
dose: 15 mg
route of administration: oral
experiment type: multiple
co-administered:
DEXLANSOPRAZOLE plasma
Homo sapiens
population: unhealthy
age: Children
sex:
food status:
2892 ng*h/mL
30 mg 1 times / day multiple, oral
dose: 30 mg
route of administration: oral
experiment type: multiple
co-administered:
DEXLANSOPRAZOLE plasma
Homo sapiens
population: unhealthy
age: Children
sex:
food status:
3747 ng*h/mL
60 mg 1 times / day multiple, oral
dose: 60 mg
route of administration: oral
experiment type: multiple
co-administered:
DEXLANSOPRAZOLE plasma
Homo sapiens
population: unhealthy
age: Children
sex:
food status:
3275 ng × h/mL
30 mg 1 times / day multiple, oral
dose: 30 mg
route of administration: Oral
experiment type: MULTIPLE
co-administered:
DEXLANSOPRAZOLE plasma
Homo sapiens
population: HEALTHY
age: UNKNOWN
sex: UNKNOWN
food status: UNKNOWN
6529 ng × h/mL
60 mg 1 times / day multiple, oral
dose: 60 mg
route of administration: Oral
experiment type: MULTIPLE
co-administered:
DEXLANSOPRAZOLE plasma
Homo sapiens
population: HEALTHY
age: UNKNOWN
sex: UNKNOWN
food status: UNKNOWN
T1/2

T1/2

ValueDoseCo-administeredAnalytePopulation
1.3 h
30 mg single, intravenous
dose: 30 mg
route of administration: Intravenous
experiment type: SINGLE
co-administered:
LANSOPRAZOLE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: UNKNOWN
food status: UNKNOWN
2.59 h
60 mg 1 times / day multiple, oral
dose: 60 mg
route of administration: oral
experiment type: multiple
co-administered:
DEXLANSOPRAZOLE plasma
Homo sapiens
population: unhealthy
age: Adolescents
sex:
food status:
1.66 h
30 mg 1 times / day multiple, oral
dose: 30 mg
route of administration: oral
experiment type: multiple
co-administered:
DEXLANSOPRAZOLE plasma
Homo sapiens
population: unhealthy
age: Adolescents
sex:
food status:
Doses

Doses

DosePopulationAdverse events​
30 mg 2 times / day multiple, intravenous
Dose: 30 mg, 2 times / day
Route: intravenous
Route: multiple
Dose: 30 mg, 2 times / day
Sources:
healthy, 18-29 years
n = 18
Health Status: healthy
Age Group: 18-29 years
Sex: M+F
Population Size: 18
Sources:
90 mg single, intravenous
Dose: 90 mg
Route: intravenous
Route: single
Dose: 90 mg
Sources:
healthy, 18-29 years
n = 8
Health Status: healthy
Age Group: 18-29 years
Sex: M+F
Population Size: 8
Sources:
300 mg single, oral
Highest studied dose
Dose: 300 mg
Route: oral
Route: single
Dose: 300 mg
Sources:
healthy, 35 years (range: 18 - 50 years)
n = 36
Health Status: healthy
Age Group: 35 years (range: 18 - 50 years)
Sex: M+F
Population Size: 36
Sources:
60 mg 1 times / day steady, oral
Recommended
unhealthy, 48 years (range: 18-90 years)
n = 2218
Health Status: unhealthy
Age Group: 48 years (range: 18-90 years)
Sex: M+F
Population Size: 2218
Sources:
Disc. AE: Diarrhea...
60 mg 1 times / day steady, oral
Recommended
Dose: 60 mg, 1 times / day
Route: oral
Route: steady
Dose: 60 mg, 1 times / day
Sources: Page: p. 35
unhealthy, 48 years (range: 18-90 years)
n = 2218
Health Status: unhealthy
Age Group: 48 years (range: 18-90 years)
Sex: M+F
Population Size: 2218
Sources: Page: p. 35
Disc. AE: Abdominal pain...
AEs leading to
discontinuation/dose reduction:
Abdominal pain (0.5%)
Sources: Page: p. 35
30 mg 1 times / day steady, oral
Dose: 30 mg, 1 times / day
Route: oral
Route: steady
Dose: 30 mg, 1 times / day
Sources: Page: p. 35
unhealthy, 48 years (range: 18-90 years)
n = 455
Health Status: unhealthy
Age Group: 48 years (range: 18-90 years)
Sex: M+F
Population Size: 455
Sources: Page: p. 35
Disc. AE: Diarrhea...
AEs leading to
discontinuation/dose reduction:
Diarrhea (0.2%)
Sources: Page: p. 35
90 mg 1 times / day steady, oral
Dose: 90 mg, 1 times / day
Route: oral
Route: steady
Dose: 90 mg, 1 times / day
Sources: Page: p. 35
unhealthy, 48 years (range: 18-90 years)
n = 1754
Health Status: unhealthy
Age Group: 48 years (range: 18-90 years)
Sex: M+F
Population Size: 1754
Sources: Page: p. 35
Disc. AE: Diarrhea, Abdominal pain...
AEs leading to
discontinuation/dose reduction:
Diarrhea (0.7%)
Abdominal pain (0.6%)
Sources: Page: p. 35
60 mg 1 times / day steady, oral
Recommended
Dose: 60 mg, 1 times / day
Route: oral
Route: steady
Dose: 60 mg, 1 times / day
Sources: Page: p. 36
unhealthy, adult
n = 2311
Health Status: unhealthy
Age Group: adult
Population Size: 2311
Sources: Page: p. 36
Disc. AE: Dyspepsia, Eructation...
AEs leading to
discontinuation/dose reduction:
Dyspepsia (3 patients)
Eructation (2 patients)
Nausea (6 patients)
Vomiting (6 patients)
Erosive esophagitis (1 patient)
Sources: Page: p. 36
90 mg 1 times / day steady, oral
Dose: 90 mg, 1 times / day
Route: oral
Route: steady
Dose: 90 mg, 1 times / day
Sources: Page: p. 36
unhealthy, adult
n = 2142
Health Status: unhealthy
Age Group: adult
Population Size: 2142
Sources: Page: p. 36
Disc. AE: Dyspepsia, Eructation...
AEs leading to
discontinuation/dose reduction:
Dyspepsia (1 patient)
Eructation (1 patient)
Nausea (9 patients)
Vomiting (6 patients)
Sources: Page: p. 36
60 mg 2 times / day steady, oral
Overdose
Dose: 60 mg, 2 times / day
Route: oral
Route: steady
Dose: 60 mg, 2 times / day
Sources:
unhealthy
Other AEs: Hypertension...
AEs

AEs

AESignificanceDosePopulation
Diarrhea 0.7%
Disc. AE
60 mg 1 times / day steady, oral
Recommended
unhealthy, 48 years (range: 18-90 years)
n = 2218
Health Status: unhealthy
Age Group: 48 years (range: 18-90 years)
Sex: M+F
Population Size: 2218
Sources:
Abdominal pain 0.5%
Disc. AE
60 mg 1 times / day steady, oral
Recommended
Dose: 60 mg, 1 times / day
Route: oral
Route: steady
Dose: 60 mg, 1 times / day
Sources: Page: p. 35
unhealthy, 48 years (range: 18-90 years)
n = 2218
Health Status: unhealthy
Age Group: 48 years (range: 18-90 years)
Sex: M+F
Population Size: 2218
Sources: Page: p. 35
Diarrhea 0.2%
Disc. AE
30 mg 1 times / day steady, oral
Dose: 30 mg, 1 times / day
Route: oral
Route: steady
Dose: 30 mg, 1 times / day
Sources: Page: p. 35
unhealthy, 48 years (range: 18-90 years)
n = 455
Health Status: unhealthy
Age Group: 48 years (range: 18-90 years)
Sex: M+F
Population Size: 455
Sources: Page: p. 35
Abdominal pain 0.6%
Disc. AE
90 mg 1 times / day steady, oral
Dose: 90 mg, 1 times / day
Route: oral
Route: steady
Dose: 90 mg, 1 times / day
Sources: Page: p. 35
unhealthy, 48 years (range: 18-90 years)
n = 1754
Health Status: unhealthy
Age Group: 48 years (range: 18-90 years)
Sex: M+F
Population Size: 1754
Sources: Page: p. 35
Diarrhea 0.7%
Disc. AE
90 mg 1 times / day steady, oral
Dose: 90 mg, 1 times / day
Route: oral
Route: steady
Dose: 90 mg, 1 times / day
Sources: Page: p. 35
unhealthy, 48 years (range: 18-90 years)
n = 1754
Health Status: unhealthy
Age Group: 48 years (range: 18-90 years)
Sex: M+F
Population Size: 1754
Sources: Page: p. 35
Erosive esophagitis 1 patient
Disc. AE
60 mg 1 times / day steady, oral
Recommended
Dose: 60 mg, 1 times / day
Route: oral
Route: steady
Dose: 60 mg, 1 times / day
Sources: Page: p. 36
unhealthy, adult
n = 2311
Health Status: unhealthy
Age Group: adult
Population Size: 2311
Sources: Page: p. 36
Eructation 2 patients
Disc. AE
60 mg 1 times / day steady, oral
Recommended
Dose: 60 mg, 1 times / day
Route: oral
Route: steady
Dose: 60 mg, 1 times / day
Sources: Page: p. 36
unhealthy, adult
n = 2311
Health Status: unhealthy
Age Group: adult
Population Size: 2311
Sources: Page: p. 36
Dyspepsia 3 patients
Disc. AE
60 mg 1 times / day steady, oral
Recommended
Dose: 60 mg, 1 times / day
Route: oral
Route: steady
Dose: 60 mg, 1 times / day
Sources: Page: p. 36
unhealthy, adult
n = 2311
Health Status: unhealthy
Age Group: adult
Population Size: 2311
Sources: Page: p. 36
Nausea 6 patients
Disc. AE
60 mg 1 times / day steady, oral
Recommended
Dose: 60 mg, 1 times / day
Route: oral
Route: steady
Dose: 60 mg, 1 times / day
Sources: Page: p. 36
unhealthy, adult
n = 2311
Health Status: unhealthy
Age Group: adult
Population Size: 2311
Sources: Page: p. 36
Vomiting 6 patients
Disc. AE
60 mg 1 times / day steady, oral
Recommended
Dose: 60 mg, 1 times / day
Route: oral
Route: steady
Dose: 60 mg, 1 times / day
Sources: Page: p. 36
unhealthy, adult
n = 2311
Health Status: unhealthy
Age Group: adult
Population Size: 2311
Sources: Page: p. 36
Dyspepsia 1 patient
Disc. AE
90 mg 1 times / day steady, oral
Dose: 90 mg, 1 times / day
Route: oral
Route: steady
Dose: 90 mg, 1 times / day
Sources: Page: p. 36
unhealthy, adult
n = 2142
Health Status: unhealthy
Age Group: adult
Population Size: 2142
Sources: Page: p. 36
Eructation 1 patient
Disc. AE
90 mg 1 times / day steady, oral
Dose: 90 mg, 1 times / day
Route: oral
Route: steady
Dose: 90 mg, 1 times / day
Sources: Page: p. 36
unhealthy, adult
n = 2142
Health Status: unhealthy
Age Group: adult
Population Size: 2142
Sources: Page: p. 36
Vomiting 6 patients
Disc. AE
90 mg 1 times / day steady, oral
Dose: 90 mg, 1 times / day
Route: oral
Route: steady
Dose: 90 mg, 1 times / day
Sources: Page: p. 36
unhealthy, adult
n = 2142
Health Status: unhealthy
Age Group: adult
Population Size: 2142
Sources: Page: p. 36
Nausea 9 patients
Disc. AE
90 mg 1 times / day steady, oral
Dose: 90 mg, 1 times / day
Route: oral
Route: steady
Dose: 90 mg, 1 times / day
Sources: Page: p. 36
unhealthy, adult
n = 2142
Health Status: unhealthy
Age Group: adult
Population Size: 2142
Sources: Page: p. 36
Hypertension serious
60 mg 2 times / day steady, oral
Overdose
Dose: 60 mg, 2 times / day
Route: oral
Route: steady
Dose: 60 mg, 2 times / day
Sources:
unhealthy
Overview

Overview

OverviewOther

Drug as perpetrator​

Drug as perpetrator​

TargetModalityActivityMetaboliteClinical evidence
unlikely
unlikely
unlikely
unlikely
unlikely
unlikely
unlikely
unlikely
no (co-administration study)
Comment: in vivo studies showed that DEXILANT did not have an impact on the pharmacokinetics of coadministered theophylline (CYP1A2 substrate)
Page: 11.0
unlikely
no (co-administration study)
Comment: in vivo studies showed that DEXILANT did not have an impact on the pharmacokinetics of coadministered phenytoin (CYP2C9 substrate)
Page: 11.0
weak
Drug as victim

Drug as victim

TargetModalityActivityMetaboliteClinical evidence
yes
yes
yes (pharmacogenomic study)
Comment: mean dexlansoprazole Cmax and AUC values were up to 2 times higher in intermediate compared to extensive metabolizers; in poor metabolizers, mean Cmax was up to 4 times higher and mean AUC was up to 12 times higher compared to extensive metabolizers
Page: 10,12
Sourcing

Sourcing

Vendor/AggregatorIDURL
PubMed

PubMed

TitleDatePubMed
The treatment of gastroesophageal reflux disease with proton-pump inhibitors and its implications on managed care--pharmacoeconomics and its application to antisecretory drugs: a case study.
2001
Advantage of expressing the variations in some digestive parameters as a function of gastric emptying instead of time.
2001
[The effectiveness of 7-day combined Helicobacter eradication therapy in patients with peptic ulcer and chronic gastritis].
2001
Effects of lansoprazole on human gastric lipase secretion and intragastric lipolysis in healthy human volunteers.
2001
Hyposecretion of the adrenal androgen dehydroepiandrosterone sulfate and its relation to clinical variables in inflammatory arthritis.
2001
Lansoprazole treatment of patients with chronic idiopathic laryngitis: a placebo-controlled trial.
2001 Apr
Intragastric acidification reduces the occurrence of false-negative urea breath test results in patients taking a proton pump inhibitor.
2001 Apr
[H2 receptor antagonists and proton pump inhibitors: principles and rules of use].
2001 Apr 15
[A strategy for second-line anti-Helicobacter pylori therapy in patients with previously failed treatment].
2001 Feb
Current approaches to reducing gastrointestinal toxicity of low-dose aspirin.
2001 Jan 8
Factors affecting Helicobacter pylori eradication using a seven-day triple therapy with a proton pump inhibitor, tinidazole and clarithromycin, in Brazilian patients with peptic ulcer.
2001 Jan-Feb
Inhibition of hyphal growth of Candida albicans by activated lansoprazole, a novel benzimidazole proton pump inhibitor.
2001 Jun
Helicobacter pylori and early duodenal ulcer status post-treatment: a review.
2001 Jun
Treatment of gastroesophageal reflux disease: to step or not to step.
2001 Jun
Proton pump inhibitors: a study of GPs' prescribing.
2001 Jun
Helicobacter pylori and symptomatic relapse of gastro-oesophageal reflux disease: a randomised controlled trial.
2001 Jun 2
Gastroprotective effect of aparisthman, a diterpene isolated from Aparisthmium cordatum, on experimental gastric ulcer models in rats and mice.
2001 Mar
Acetaldehyde production and other ADH-related characteristics of aerobic bacteria isolated from hypochlorhydric human stomach.
2001 Mar
Bioequivalence evaluation of lansoprazole 30-mg capsules (Lanfast and Lanzor) in healthy volunteers.
2001 Mar
[Gynecomastia associated with the simultaneous use of cisapride and lansoprazole].
2001 Mar 24
Shortcomings of the first-generation proton pump inhibitors.
2001 May
Impact of different therapeutic regimens on the outcome of patients with Crohn's disease of the upper gastrointestinal tract.
2001 May
Review article: long-term use of proton pump inhibitors in GORD--help or hindrance?
2001 Sep
Lansoprazole in children: pharmacokinetics and efficacy in reflux oesophagitis.
2001 Sep
Bedtime H2 blockers improve nocturnal gastric acid control in GERD patients on proton pump inhibitors.
2001 Sep
Noninvasive Helicobacter pylori testing for the "test-and-treat" strategy: a decision analysis to assess the effect of past infection on test choice.
2001 Sep 24
[New triple therapy for Helicobacter pylori infection in Japan].
2003 Jan
Safety and pharmacokinetics of oral lansoprazole in preadolescent rats exposed from weaning through sexual maturity.
2003 Jan-Feb
Does eradication of Helicobacter pylori reduce hypergastrinaemia during long term therapy with proton pump inhibitors?
2003 Mar
Flavor and taste of lansoprazole strawberry-flavored delayed-release oral suspension preferred over ranitidine peppermint-flavored oral syrup: in children aged between 5-11 years.
2004
Effect of lansoprazole and rabeprazole on tacrolimus pharmacokinetics in healthy volunteers with CYP2C19 mutations.
2004 Aug
Drug-induced tubulo-interstitial nephritis secondary to proton pump inhibitors: experience from a single UK renal unit.
2004 Jun
Lansoprazole ameliorates intestinal mucosal damage induced by ischemia-reperfusion in rats.
2004 Oct 1
Management of acid-related disorders in patients with dysphagia.
2004 Sep 6
Hyponatremia with consciousness disturbance associated with esomeprazole.
2005 Apr
Prediction of genotoxicity of chemical compounds by statistical learning methods.
2005 Jun
Preventive therapy for non-steroidal anti-inflammatory drug-induced ulcers in Japanese patients with rheumatoid arthritis: the current situation and a prospective controlled-study of the preventive effects of lansoprazole or famotidine.
2005 Jun
Comparison of enantioselective disposition of rabeprazole versus lansoprazole in renal-transplant recipients who are CYP2C19 extensive metabolizers.
2005 May
"Proton-pump inhibitor-first" strategy versus "step-up" strategy for the acute treatment of reflux esophagitis: a cost-effectiveness analysis in Japan.
2005 Nov
Helicobacter pylori infection with a duodenal ulcer in a 6-year-old boy.
2006 Oct
Lack of pharmacokinetic interaction between omeprazole or lansoprazole and ivabradine in healthy volunteers: an open-label, randomized, crossover, pharmacokinetic interaction clinical trial.
2006 Oct
Functional involvement of PHOSPHO1 in matrix vesicle-mediated skeletal mineralization.
2007 Apr
Protective effects of proton pump inhibitors against indomethacin-induced lesions in the rat small intestine.
2007 Jan
Antiulcerogenic effect and acute toxicity of a hydroethanolic extract from the cashew (Anacardium occidentale L.) leaves.
2007 Jun 13
Influence of H pylori on plasma ghrelin in patients without atrophic gastritis.
2007 Mar 14
Influence of rabeprazole and lansoprazole on the pharmacokinetics of tacrolimus in relation to CYP2C19, CYP3A5 and MDR1 polymorphisms in renal transplant recipients.
2007 May
Lansoprazole protects and heals gastric mucosa from non-steroidal anti-inflammatory drug (NSAID)-induced gastropathy by inhibiting mitochondrial as well as Fas-mediated death pathways with concurrent induction of mucosal cell renewal.
2008 May 23
Delayed release dexlansoprazole in the treatment of GERD and erosive esophagitis.
2009
Substrates, inducers, inhibitors and structure-activity relationships of human Cytochrome P450 2C9 and implications in drug development.
2009
New insights into the structural features and functional relevance of human cytochrome P450 2C9. Part II.
2009 Dec
Patents

Sample Use Guides

For erosive esophagitis: One 60 mg capsule once daily for up to 8 weeks Relief of Heartburn: One 30 mg capsule once daily
Route of Administration: Oral
A stably transfected gene reporter cell line AZ-AHR, derived from human hepatoma HepG2 cells transfected with a construct containing several AhR binding sites upstream of a luciferase reporter gene, was used for assessment of AhR transcriptional activity. Cells were incubated for 24 h with DEXLANSOPRAZOLE and/or vehicle (DMSO; 0.1% v/v), in the presence or absence of TCDD (10 nM; AZ-AHR cells) or DEX (100 nM; AZ-GR cells). After the treatments, cells were lysed and luciferase activity was measured. In parallel, cell viability was determined by conventional MTT test.
Name Type Language
LANSOPRAZOLE
EP   HSDB   INN   JAN   MART.   MI   ORANGE BOOK   USAN   USP   USP-RS   VANDF   WHO-DD  
INN   USAN  
Official Name English
LANSOPRAZOLE [MI]
Common Name English
LANZOR
Brand Name English
AG-1749
Code English
LANSOPRAZOLE [ORANGE BOOK]
Common Name English
2-[[[3-Methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl]methyl]sulfinyl]benzimidazole
Systematic Name English
LANSOPRAZOLE COMPONENT OF PREVPAC
Common Name English
LANSOPRAZOLE [USP MONOGRAPH]
Common Name English
PREVACID
Brand Name English
PREVPAC COMPONENT LANSOPRAZOLE
Brand Name English
TAKEPRON
Brand Name English
2-(((3-METHYL-4-(2,2,2-TRIFLUOROETHOXY)PYRIDIN-2-YL)METHYL)SULFINYL)-1H-BENZIMIDAZOLE
Systematic Name English
Lansoprazole [WHO-DD]
Common Name English
A-65006
Code English
LANSOPRAZOLE [EP MONOGRAPH]
Common Name English
LANZOPRAZOLE
Common Name English
AGOPTON
Brand Name English
lansoprazole [INN]
Common Name English
(±)-LANSOPRAZOLE
Common Name English
PREVONCO
Brand Name English
NSC-758638
Code English
LANSOX
Brand Name English
LANSOPRAZOLE [USP-RS]
Common Name English
LIMPIDEX
Brand Name English
LANSOPRAZOLE [HSDB]
Common Name English
LANSOPRAZOLE [JAN]
Common Name English
LANSOPRAZOLE [MART.]
Common Name English
1H-BENZIMIDAZOLE, 2-(((3-METHYL-4-(2,2,2-TRIFLUOROETHOXY)-2-PYRIDINYL)METHYL)SULFINYL)-
Systematic Name English
OGAST
Brand Name English
ZOTON
Brand Name English
OGASTORO
Brand Name English
LANSOPRAZOLE [VANDF]
Common Name English
LANSOPRAZOLE [USAN]
Common Name English
Classification Tree Code System Code
WHO-ATC A02BC03
Created by admin on Wed Jul 05 23:06:27 UTC 2023 , Edited by admin on Wed Jul 05 23:06:27 UTC 2023
WHO-VATC QA02BD07
Created by admin on Wed Jul 05 23:06:27 UTC 2023 , Edited by admin on Wed Jul 05 23:06:27 UTC 2023
LIVERTOX NBK548452
Created by admin on Wed Jul 05 23:06:27 UTC 2023 , Edited by admin on Wed Jul 05 23:06:27 UTC 2023
WHO-VATC QA02BD03
Created by admin on Wed Jul 05 23:06:27 UTC 2023 , Edited by admin on Wed Jul 05 23:06:27 UTC 2023
WHO-ATC A02BD03
Created by admin on Wed Jul 05 23:06:27 UTC 2023 , Edited by admin on Wed Jul 05 23:06:27 UTC 2023
WHO-VATC QA02BD02
Created by admin on Wed Jul 05 23:06:27 UTC 2023 , Edited by admin on Wed Jul 05 23:06:27 UTC 2023
WHO-ATC A02BD02
Created by admin on Wed Jul 05 23:06:27 UTC 2023 , Edited by admin on Wed Jul 05 23:06:27 UTC 2023
WHO-ATC A02BD10
Created by admin on Wed Jul 05 23:06:27 UTC 2023 , Edited by admin on Wed Jul 05 23:06:27 UTC 2023
WHO-ATC A02BD07
Created by admin on Wed Jul 05 23:06:27 UTC 2023 , Edited by admin on Wed Jul 05 23:06:27 UTC 2023
NCI_THESAURUS C29723
Created by admin on Wed Jul 05 23:06:27 UTC 2023 , Edited by admin on Wed Jul 05 23:06:27 UTC 2023
WHO-VATC QA02BC03
Created by admin on Wed Jul 05 23:06:27 UTC 2023 , Edited by admin on Wed Jul 05 23:06:27 UTC 2023
FDA ORPHAN DRUG 446014
Created by admin on Wed Jul 05 23:06:27 UTC 2023 , Edited by admin on Wed Jul 05 23:06:27 UTC 2023
WHO-ATC A02BC53
Created by admin on Wed Jul 05 23:06:27 UTC 2023 , Edited by admin on Wed Jul 05 23:06:27 UTC 2023
NDF-RT N0000000147
Created by admin on Wed Jul 05 23:06:27 UTC 2023 , Edited by admin on Wed Jul 05 23:06:27 UTC 2023
NDF-RT N0000175525
Created by admin on Wed Jul 05 23:06:27 UTC 2023 , Edited by admin on Wed Jul 05 23:06:27 UTC 2023
FDA ORPHAN DRUG 264508
Created by admin on Wed Jul 05 23:06:27 UTC 2023 , Edited by admin on Wed Jul 05 23:06:27 UTC 2023
WHO-ATC A02BD09
Created by admin on Wed Jul 05 23:06:27 UTC 2023 , Edited by admin on Wed Jul 05 23:06:27 UTC 2023
Code System Code Type Description
MERCK INDEX
M6683
Created by admin on Wed Jul 05 23:06:27 UTC 2023 , Edited by admin on Wed Jul 05 23:06:27 UTC 2023
PRIMARY Merck Index
DAILYMED
0K5C5T2QPG
Created by admin on Wed Jul 05 23:06:27 UTC 2023 , Edited by admin on Wed Jul 05 23:06:27 UTC 2023
PRIMARY
SMS_ID
100000089867
Created by admin on Wed Jul 05 23:06:27 UTC 2023 , Edited by admin on Wed Jul 05 23:06:27 UTC 2023
PRIMARY
RXCUI
17128
Created by admin on Wed Jul 05 23:06:27 UTC 2023 , Edited by admin on Wed Jul 05 23:06:27 UTC 2023
PRIMARY RxNorm
RS_ITEM_NUM
1356916
Created by admin on Wed Jul 05 23:06:27 UTC 2023 , Edited by admin on Wed Jul 05 23:06:27 UTC 2023
PRIMARY
NDF-RT
N0000009724
Created by admin on Wed Jul 05 23:06:27 UTC 2023 , Edited by admin on Wed Jul 05 23:06:27 UTC 2023
PRIMARY Inhibition Gastric Acid Secretion [PE]
PUBCHEM
3883
Created by admin on Wed Jul 05 23:06:27 UTC 2023 , Edited by admin on Wed Jul 05 23:06:27 UTC 2023
PRIMARY
DRUG CENTRAL
1547
Created by admin on Wed Jul 05 23:06:27 UTC 2023 , Edited by admin on Wed Jul 05 23:06:27 UTC 2023
PRIMARY
CAS
103577-45-3
Created by admin on Wed Jul 05 23:06:27 UTC 2023 , Edited by admin on Wed Jul 05 23:06:27 UTC 2023
PRIMARY
INN
6397
Created by admin on Wed Jul 05 23:06:27 UTC 2023 , Edited by admin on Wed Jul 05 23:06:27 UTC 2023
PRIMARY
IUPHAR
7208
Created by admin on Wed Jul 05 23:06:27 UTC 2023 , Edited by admin on Wed Jul 05 23:06:27 UTC 2023
PRIMARY
DRUG BANK
DB00448
Created by admin on Wed Jul 05 23:06:27 UTC 2023 , Edited by admin on Wed Jul 05 23:06:27 UTC 2023
PRIMARY
NCI_THESAURUS
C29150
Created by admin on Wed Jul 05 23:06:27 UTC 2023 , Edited by admin on Wed Jul 05 23:06:27 UTC 2023
PRIMARY
WIKIPEDIA
LANSOPRAZOLE
Created by admin on Wed Jul 05 23:06:27 UTC 2023 , Edited by admin on Wed Jul 05 23:06:27 UTC 2023
PRIMARY
MESH
C058687
Created by admin on Wed Jul 05 23:06:27 UTC 2023 , Edited by admin on Wed Jul 05 23:06:27 UTC 2023
PRIMARY
NSC
758638
Created by admin on Wed Jul 05 23:06:27 UTC 2023 , Edited by admin on Wed Jul 05 23:06:27 UTC 2023
PRIMARY
HSDB
7204
Created by admin on Wed Jul 05 23:06:27 UTC 2023 , Edited by admin on Wed Jul 05 23:06:27 UTC 2023
PRIMARY
LACTMED
Lansoprazole
Created by admin on Wed Jul 05 23:06:27 UTC 2023 , Edited by admin on Wed Jul 05 23:06:27 UTC 2023
PRIMARY
EPA CompTox
DTXSID4023200
Created by admin on Wed Jul 05 23:06:27 UTC 2023 , Edited by admin on Wed Jul 05 23:06:27 UTC 2023
PRIMARY
FDA UNII
0K5C5T2QPG
Created by admin on Wed Jul 05 23:06:27 UTC 2023 , Edited by admin on Wed Jul 05 23:06:27 UTC 2023
PRIMARY
EVMPD
SUB08403MIG
Created by admin on Wed Jul 05 23:06:27 UTC 2023 , Edited by admin on Wed Jul 05 23:06:27 UTC 2023
PRIMARY
ChEMBL
CHEMBL480
Created by admin on Wed Jul 05 23:06:27 UTC 2023 , Edited by admin on Wed Jul 05 23:06:27 UTC 2023
PRIMARY
USAN
AA-78
Created by admin on Wed Jul 05 23:06:27 UTC 2023 , Edited by admin on Wed Jul 05 23:06:27 UTC 2023
PRIMARY
CHEBI
6375
Created by admin on Wed Jul 05 23:06:27 UTC 2023 , Edited by admin on Wed Jul 05 23:06:27 UTC 2023
PRIMARY