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Details

Stereochemistry ABSOLUTE
Molecular Formula C16H14F3N3O2S
Molecular Weight 369.361
Optical Activity UNSPECIFIED
Defined Stereocenters 1 / 1
E/Z Centers 0
Charge 0

SHOW SMILES / InChI
Structure of DEXLANSOPRAZOLE

SMILES

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

InChI

InChIKey=MJIHNNLFOKEZEW-RUZDIDTESA-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)/t25-/m1/s1

HIDE SMILES / InChI

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

Dexlansoprazole (trade names Kapidex, Dexilant) is a proton pump inhibitor (PPI) that is marketed by Takeda Pharmaceuticals for the treatment of erosive esophagitis and gastro-oesophageal reflux disease. Dexlansoprazole is used to heal and maintain healing of erosive esophagitis and to treat heartburn associated with gastroesophageal reflux disease (GERD). It lasts longer than lansoprazole, to which it is chemically related, and needs to be taken less often. Dexlansoprazole is supplied for oral administration as a dual delayed-release formulation in capsules and orally disintegrating tablets. The capsules and tablets contain dexlansoprazole in a mixture of two types of enteric-coated granules with different pH-dependent dissolution profiles. The most significant adverse reactions (≥2%) reported in clinical trials were diarrhea, abdominal pain, nausea, upper respiratory tract infection, vomiting, and flatulence.

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
Advantage of expressing the variations in some digestive parameters as a function of gastric emptying instead of time.
2001
Drug interaction: omeprazole and phenprocoumon.
2001
Hyposecretion of the adrenal androgen dehydroepiandrosterone sulfate and its relation to clinical variables in inflammatory arthritis.
2001
Effects of pirenzepine, omeprazole, lansoprazole, and rabeprazole on human neutrophil functions.
2001 Apr
Lansoprazole treatment of patients with chronic idiopathic laryngitis: a placebo-controlled trial.
2001 Apr
Maximal acid reflux control for Barrett's oesophagus: feasible and effective.
2001 Apr
Effects of lansoprazole, clarithromycin and pH gradient on uptake of [14C]amoxycillin into rat gastric tissue.
2001 Apr
Helicobacter pylori eradication treatment does not benefit patients with nonulcer dyspepsia.
2001 Aug
Efficacy of ecabet sodium for Helicobacter pylori eradication triple therapy in comparison with a lansoprazole-based regimen.
2001 Aug
Do some patients with Helicobacter pylori infection benefit from an extension to 2 weeks of a proton pump inhibitor-based triple eradication therapy?
2001 Feb
Early stage gastric MALT lymphoma with high-grade component cured by Helicobacter pylori eradication.
2001 Feb
Aggressive acid control: minimizing progression of Barrett's esophagus.
2001 Feb
[A strategy for second-line anti-Helicobacter pylori therapy in patients with previously failed treatment].
2001 Feb
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
Healing and relapse rates in gastroesophageal reflux disease treated with the newer proton-pump inhibitors lansoprazole, rabeprazole, and pantoprazole compared with omeprazole, ranitidine, and placebo: evidence from randomized clinical trials.
2001 Jul
Effects on 24-hour intragastric pH: a comparison of lansoprazole administered nasogastrically in apple juice and pantoprazole administered intravenously.
2001 Jul
Proton pump inhibitors versus H2-antagonists: a meta-analysis of their efficacy in treating bleeding peptic ulcer.
2001 Jul
Follow-up of Helicobacter pylori status by using 13C-urea breath test in nonulcer dyspeptic patients after eradication therapy.
2001 Jun
[Bifid median nerve in the carpal tunnel: integrated imaging].
2001 Jun
CYP2C19 genotype and pharmacokinetics of three proton pump inhibitors in healthy subjects.
2001 Jun
Factors associated with non-response in proton pump inhibitor users: a study of lansoprazole therapy.
2001 Jun
Helicobacter pylori and early duodenal ulcer status post-treatment: a review.
2001 Jun
Discoloured tongue: a new cause?
2001 Jun
Laryngopharyngeal reflux symptoms improve before changes in physical findings.
2001 Jun
Pharmacological and pharmacodynamic essentials of H(2)-receptor antagonists and proton pump inhibitors for the practising physician.
2001 Jun
Three-day lansoprazole quadruple therapy for Helicobacter pylori-positive duodenal ulcers: a randomized controlled study.
2001 Jun
Proton pump inhibitors: a study of GPs' prescribing.
2001 Jun
Effect of Helicobacter pylori eradication on cyclooxygenase 2 (COX-2) and inducible nitric oxide synthase (iNOS) expression during gastric adaptation to aspirin (ASA) in humans.
2001 Jun 1
Pantoprazole versus lansoprazole in French patients with reflux esophagitis.
2001 Mar
Gastroprotective effect of aparisthman, a diterpene isolated from Aparisthmium cordatum, on experimental gastric ulcer models in rats and mice.
2001 Mar
The effect of culture results for Helicobacter pylori on the choice of treatment following failure of initial eradication.
2001 Mar
Acetaldehyde production and other ADH-related characteristics of aerobic bacteria isolated from hypochlorhydric human stomach.
2001 Mar
Pharmacokinetic differences between lansoprazole enantiomers and contribution of cytochrome P450 isoforms to enantioselective metabolism of lansoprazole in dogs.
2001 Mar
Effect of genotypic differences in CYP2C19 on cure rates for Helicobacter pylori infection by triple therapy with a proton pump inhibitor, amoxicillin, and clarithromycin.
2001 Mar
A case of gastric plasmacytoma associated with Helicobacter pylori infection: improvement of abnormal endoscopic and EUS findings after H. pylori eradication.
2001 Mar
[Gynecomastia associated with the simultaneous use of cisapride and lansoprazole].
2001 Mar 24
Improvement in atrophic gastritis and intestinal metaplasia in patients in whom Helicobacter pylori was eradicated.
2001 Mar 6
Haloperidol-stomach lesions attenuation by pentadecapeptide BPC 157, omeprazole, bromocriptine, but not atropine, lansoprazole, pantoprazole, ranitidine, cimetidine and misoprostol in mice.
2001 Mar 9
Proton pump inhibitors and their drug interactions: an evidence-based approach.
2001 May
Lansoprazole-based triple therapy versus ranitidine bismuth citrate-based dual therapy in the eradication of Helicobacter pylori in patients with duodenal ulcer: a multicenter, randomized, double-dummy study.
2001 May
Impact of different therapeutic regimens on the outcome of patients with Crohn's disease of the upper gastrointestinal tract.
2001 May
Reversible pheripheral edema in female patients taking proton pump inhibitors for peptic acid diseases.
2001 May
Control of intragastric pH with omeprazole 20 mg, omeprazole 40 mg and lansoprazole 30 mg.
2001 May
Proton pump inhibitor resistance in the treatment of laryngopharyngeal reflux.
2001 Oct
Are children with cystic fibrosis who are treated with a proton-pump inhibitor at risk for vitamin B(12) deficiency?
2001 Sep
Lansoprazole in children: pharmacokinetics and efficacy in reflux oesophagitis.
2001 Sep
Drug treatments in upper gastrointestinal bleeding: value of endoscopic findings as surrogate end points.
2001 Sep
Clinical and ethical concerns about switching patient treatment to "therapeutically interchangeable" medications.
2001 Sep 24
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
Gastroesophageal reflux disease presenting as xerophthalmia.
2001 Sep-Oct
Patents

Sample Use Guides

Duodenal Ulcers: 15 mg (7.5mg Levolansoprazole) Once daily for 4 weeks Gastroesophageal Reflux: 30 mg (15mg Levolansoprazole) Once daily for up to 8 weeks
Route of Administration: Oral
The activity of (H+/K+)-ATPase was measured as follows: the reaction mixture contained, in a total volume of 1 mL, 70 mM Tris-HCl buffer (pH 6.8), 5 mM MgCl 2 and 20 mkg/mL membrane protein with various concentrations of Levolansoprazole in the presence or absence of 10 mM KC1 and 10mkM valinomycin. The assay was carried out at 37 °. After a preincubation period of 1 hr, the reaction was initiated by adding 2 mM ATP and the preparation was incubated for 20 min. The reaction was stopped by adding 1 mL of 12% trichloroacetic acid. Inorganic phosphate produced by ATP hydrolysis was determined according to the method of Fiske and Subbarow
Name Type Language
DEXLANSOPRAZOLE
INN   MART.   ORANGE BOOK   USAN   VANDF   WHO-DD  
USAN   INN  
Official Name English
TAK-390
Code English
1H-BENZIMIDAZOLE, 2-((R)-((3-METHYL-4-(2,2,2-TRIFLUOROETHOXY)-2-PYRIDINYL)METHYL)SULFINYL)-
Systematic Name English
DEXILANT
Brand Name English
NSC-758710
Code English
T-168390
Code English
dexlansoprazole [INN]
Common Name English
LANSOPRAZOLE, (R)-
Common Name English
DEXLANSOPRAZOLE [VANDF]
Common Name English
DEXILANT SOLUTAB
Brand Name English
Dexlansoprazole [WHO-DD]
Common Name English
KAPIDEX
Brand Name English
2-((R)-((3-METHYL-4-(2,2,2-TRIFLUOROETHOXY)-2-PYRIDINYL)METHYL)SULFINYL)-1H-BENZIMIDAZOLE
Systematic Name English
DEXLANSOPRAZOLE [MART.]
Common Name English
LANSOPRAZOLE R-FORM
MI  
Common Name English
LANSOPRAZOLE R-FORM [MI]
Common Name English
(+)-2-((R)-((3-METHYL-4-(2,2,2-TRIFLUOROETHOXY)PYRIDIN-2-YL)METHYL)SULFINYL)-1H-BENZIMIDAZOLE
Systematic Name English
DEXLANSOPRAZOLE [USAN]
Common Name English
(R)-LANSOPRAZOLE
Common Name English
DEXLANSOPRAZOLE [ORANGE BOOK]
Common Name English
Classification Tree Code System Code
NDF-RT N0000000147
Created by admin on Thu Jul 06 00:01:57 UTC 2023 , Edited by admin on Thu Jul 06 00:01:57 UTC 2023
WHO-VATC QA02BC06
Created by admin on Thu Jul 06 00:01:57 UTC 2023 , Edited by admin on Thu Jul 06 00:01:57 UTC 2023
NCI_THESAURUS C29723
Created by admin on Thu Jul 06 00:01:57 UTC 2023 , Edited by admin on Thu Jul 06 00:01:57 UTC 2023
WHO-ATC A02BC06
Created by admin on Thu Jul 06 00:01:57 UTC 2023 , Edited by admin on Thu Jul 06 00:01:57 UTC 2023
NDF-RT N0000175525
Created by admin on Thu Jul 06 00:01:57 UTC 2023 , Edited by admin on Thu Jul 06 00:01:57 UTC 2023
LIVERTOX 290
Created by admin on Thu Jul 06 00:01:57 UTC 2023 , Edited by admin on Thu Jul 06 00:01:57 UTC 2023
Code System Code Type Description
PUBCHEM
9578005
Created by admin on Thu Jul 06 00:01:57 UTC 2023 , Edited by admin on Thu Jul 06 00:01:57 UTC 2023
PRIMARY
RXCUI
816346
Created by admin on Thu Jul 06 00:01:57 UTC 2023 , Edited by admin on Thu Jul 06 00:01:57 UTC 2023
PRIMARY RxNorm
EVMPD
SUB31929
Created by admin on Thu Jul 06 00:01:57 UTC 2023 , Edited by admin on Thu Jul 06 00:01:57 UTC 2023
PRIMARY
CAS
138530-94-6
Created by admin on Thu Jul 06 00:01:57 UTC 2023 , Edited by admin on Thu Jul 06 00:01:57 UTC 2023
PRIMARY
NSC
758710
Created by admin on Thu Jul 06 00:01:57 UTC 2023 , Edited by admin on Thu Jul 06 00:01:57 UTC 2023
PRIMARY
DAILYMED
UYE4T5I70X
Created by admin on Thu Jul 06 00:01:57 UTC 2023 , Edited by admin on Thu Jul 06 00:01:57 UTC 2023
PRIMARY
USAN
SS-95
Created by admin on Thu Jul 06 00:01:57 UTC 2023 , Edited by admin on Thu Jul 06 00:01:57 UTC 2023
PRIMARY
DRUG BANK
DB05351
Created by admin on Thu Jul 06 00:01:57 UTC 2023 , Edited by admin on Thu Jul 06 00:01:57 UTC 2023
PRIMARY
MERCK INDEX
M6683
Created by admin on Thu Jul 06 00:01:57 UTC 2023 , Edited by admin on Thu Jul 06 00:01:57 UTC 2023
PRIMARY Merck Index
FDA UNII
UYE4T5I70X
Created by admin on Thu Jul 06 00:01:57 UTC 2023 , Edited by admin on Thu Jul 06 00:01:57 UTC 2023
PRIMARY
NCI_THESAURUS
C73192
Created by admin on Thu Jul 06 00:01:57 UTC 2023 , Edited by admin on Thu Jul 06 00:01:57 UTC 2023
PRIMARY
SMS_ID
100000124233
Created by admin on Thu Jul 06 00:01:57 UTC 2023 , Edited by admin on Thu Jul 06 00:01:57 UTC 2023
PRIMARY
ChEMBL
CHEMBL1201863
Created by admin on Thu Jul 06 00:01:57 UTC 2023 , Edited by admin on Thu Jul 06 00:01:57 UTC 2023
PRIMARY
IUPHAR
5487
Created by admin on Thu Jul 06 00:01:57 UTC 2023 , Edited by admin on Thu Jul 06 00:01:57 UTC 2023
PRIMARY
DRUG CENTRAL
4162
Created by admin on Thu Jul 06 00:01:57 UTC 2023 , Edited by admin on Thu Jul 06 00:01:57 UTC 2023
PRIMARY
LACTMED
Dexlansoprazole
Created by admin on Thu Jul 06 00:01:57 UTC 2023 , Edited by admin on Thu Jul 06 00:01:57 UTC 2023
PRIMARY
INN
8524
Created by admin on Thu Jul 06 00:01:57 UTC 2023 , Edited by admin on Thu Jul 06 00:01:57 UTC 2023
PRIMARY
WIKIPEDIA
DEXLANSOPRAZOLE
Created by admin on Thu Jul 06 00:01:57 UTC 2023 , Edited by admin on Thu Jul 06 00:01:57 UTC 2023
PRIMARY