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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

Molecular Formula C16H14F3N3O2S
Molecular Weight 369.361
Charge 0
Count
Stereochemistry ACHIRAL
Additional Stereochemistry No
Defined Stereocenters 0 / 0
E/Z Centers 0
Optical Activity NONE

Description
Curator's Comment: description was created based on several sources, including https://www.ncbi.nlm.nih.gov/pubmed/24773330 | https://www.ncbi.nlm.nih.gov/pubmed/25881966 | http://www.sciencedirect.com/science/article/pii/000629529190584R?via%3Dihub

Levolansoprazole is the levorotary (L-enantiomer) form of proton-pump inhibitor (PPI) Lansoprazole. Lansoprazole is a racemic 1:1 mixture of the enantiomers dexlansoprazole (Dexilant, formerly named Kapidex) and Levolansoprazole. Lansoprazole has used to the treatment of acid-reflux disorders (GERD), peptic ulcer disease, H. pylori eradication, and prevention of gastrointestinal bleeds with NSAID use. Levolansoprazole is extensively metabolized in the liver. Two metabolites have been identified in measurable quantities in plasma (the hydroxylated sulfinyl and sulfone derivatives of Levolansoprazole).

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

2002
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

2002
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

2002
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

2009
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

2009
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

2002
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

2002
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

2002
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
[Evaluation of the effect of proton pump inhibitors on stomal ulcer].
1992 Jan
[Proton pump inhibitors in the treatment of peptic ulcers resistant to H2-receptor antagonists].
1992 Jan
Standard-dose lansoprazole is more effective than high-dose ranitidine in achieving endoscopic healing and symptom relief in patients with moderately severe reflux oesophagitis. The Dutch Lansoprazole Study Group.
1999 Dec
Peptic ulcer recurrence during maintenance therapy with H2-receptor antagonist following first-line therapy with proton pump inhibitor.
2000
Fluorometric screening for metabolism-based drug--drug interactions.
2000 Jul-Aug
Lansoprazole in the treatment of gastro-oesophageal reflux disease in childhood.
2000 Nov
Role of CYP3A4 and CYP2C19 in the stereoselective metabolism of lansoprazole by human liver microsomes.
2001 Dec
Gastroesophageal reflux in infants and children.
2001 Dec 1
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
Proton pump inhibitors versus H2-antagonists: a meta-analysis of their efficacy in treating bleeding peptic ulcer.
2001 Jul
Management of heartburn in a large, randomized, community-based study: comparison of four therapeutic strategies.
2001 Jun
High-performance liquid chromatographic assay for the simultaneous determination of lansoprazole enantiomers and metabolites in human liver microsomes.
2001 Jun 5
Pharmacokinetic differences between lansoprazole enantiomers and contribution of cytochrome P450 isoforms to enantioselective metabolism of lansoprazole in dogs.
2001 Mar
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
Reversible pheripheral edema in female patients taking proton pump inhibitors for peptic acid diseases.
2001 May
Evaluation of the cost-effectiveness of Helicobacter pylori eradication triple therapy vs. conventional therapy for ulcers in Japan.
2001 Nov
A systematic gene expression screen of Caenorhabditis elegans cytochrome P450 genes reveals CYP35 as strongly xenobiotic inducible.
2001 Nov 15
Endogenous gastrin stimulates regeneration of remnant pancreas after partial pancreatectomy.
2001 Oct
[Submicroscopic aspects of the mechanism of inhibitors of H+/K+-ATPase in gastric parietal cells].
2002
Gastroesophageal reflux in children: pathogenesis, prevalence, diagnosis, and role of proton pump inhibitors in treatment.
2002
Determinants of headache in lansoprazole users in The Netherlands: results from a nested case-control study.
2002
Effect of hypergastrinemia on pancreatic carcinogenesis.
2002 Apr
Comparison of lansoprazole and famotidine for gastric acid inhibition during the daytime and night-time in different CYP2C19 genotype groups.
2002 Apr
Potential role of endocrine gastrin in the colonic adenoma carcinoma sequence.
2002 Aug 27
Tetany secondary to the use of a proton-pump inhibitor.
2002 Aug 6
Acute manic psychosis induced by triple therapy for H. pylori.
2002 Jan-Feb
Are proton pump inhibitors the first choice for acute treatment of gastric ulcers? A meta analysis of randomized clinical trials.
2002 Jul 15
A comparative study on the activity of lansoprazole, omeprazole and PD-136450 on acidified ethanol- and indomethacin-induced gastric lesions in the rat.
2002 Mar
Time-dependent transcriptional induction of CYP1A1, CYP1A2 and CYP1B1 mRNAs by H+/K+ -ATPase inhibitors and other xenobiotics.
2003 Feb
Safety and pharmacokinetics of oral lansoprazole in preadolescent rats exposed from weaning through sexual maturity.
2003 Jan-Feb
Structural and functional characterization of gastric mucosa and central nervous system in histamine H2 receptor-null mice.
2003 May 2
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
Comparison of inhibitory effects of the proton pump-inhibiting drugs omeprazole, esomeprazole, lansoprazole, pantoprazole, and rabeprazole on human cytochrome P450 activities.
2004 Aug
Identification and relative contributions of human cytochrome P450 isoforms involved in the metabolism of glibenclamide and lansoprazole: evaluation of an approach based on the in vitro substrate disappearance rate.
2004 May
Lansoprazole ameliorates intestinal mucosal damage induced by ischemia-reperfusion in rats.
2004 Oct 1
Lansoprazole enantiomer activates human liver microsomal CYP2C9 catalytic activity in a stereospecific and substrate-specific manner.
2005 Feb
Neuropathy associated with lansoprazole treatment.
2005 Jan
Effect of concomitant dosing of famotidine with lansoprazole on gastric acid secretion in relation to CYP2C19 genotype status.
2005 Jul 1
Prediction of genotoxicity of chemical compounds by statistical learning methods.
2005 Jun
Effect of clarithromycin on the enantioselective disposition of lansoprazole in relation to CYP2C19 genotypes.
2005 Jun
Comparison of the effects of proton pump inhibitors on human plasma adrenocorticotropic hormone and cortisol levels under the starved condition.
2006 Apr
Lansoprazole, a proton pump inhibitor, reduces the severity of indomethacin-induced rat enteritis.
2006 Jan
Beyond gastric acid reduction: proton pump inhibitors induce heme oxygenase-1 in gastric and endothelial cells.
2006 Jul 7
Sensitive determination of omeprazole and its two main metabolites in human plasma by column-switching high-performance liquid chromatography: application to pharmacokinetic study in relation to CYP2C19 genotypes.
2006 Mar 7
Protective effects of proton pump inhibitors against indomethacin-induced lesions in the rat small intestine.
2007 Jan
Estimation of the area under the concentration-time curve of racemic lansoprazole by using limited plasma concentration of lansoprazole enantiomers.
2008 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
Substrates, inducers, inhibitors and structure-activity relationships of human Cytochrome P450 2C9 and implications in drug development.
2009
Hypersensitivity to proton pump inhibitors: lansoprazole-induced Kounis syndrome.
2009 May 29
Patents

Sample Use Guides

Duodenal Ulcers: 15 mg Once daily for 4 weeks Gastroesophageal Reflux: 30 mg Once daily for up to 8 weeks
Route of Administration: Oral
In Vitro Use Guide
Lansoprazole is a gastric parietal cell proton pump inhibitor that is also active against Helicobacter pylori in vitro. The antimicrobial activity of lansoprazole and of its sulfenamide, a rearrangement product occurring spontaneously in acid environments, was studied by determining the MICs and MBCs for 11 cytotoxic and eight non-cytotoxic H. pylori strains and by measuring the rapidity of bacterial killing. The MIC90 and MBC90 were 2.5 mg/L and 10 mg/L, respectively, both for lansoprazole and for its sulfenamide.
Substance Class Chemical
Created
by admin
on Fri Dec 15 15:37:11 GMT 2023
Edited
by admin
on Fri Dec 15 15:37:11 GMT 2023
Record UNII
0K5C5T2QPG
Record Status Validated (UNII)
Record Version
  • Download
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 Fri Dec 15 15:37:11 GMT 2023 , Edited by admin on Fri Dec 15 15:37:11 GMT 2023
WHO-VATC QA02BD07
Created by admin on Fri Dec 15 15:37:11 GMT 2023 , Edited by admin on Fri Dec 15 15:37:11 GMT 2023
LIVERTOX NBK548452
Created by admin on Fri Dec 15 15:37:11 GMT 2023 , Edited by admin on Fri Dec 15 15:37:11 GMT 2023
WHO-VATC QA02BD03
Created by admin on Fri Dec 15 15:37:11 GMT 2023 , Edited by admin on Fri Dec 15 15:37:11 GMT 2023
WHO-ATC A02BD03
Created by admin on Fri Dec 15 15:37:11 GMT 2023 , Edited by admin on Fri Dec 15 15:37:11 GMT 2023
WHO-VATC QA02BD02
Created by admin on Fri Dec 15 15:37:11 GMT 2023 , Edited by admin on Fri Dec 15 15:37:11 GMT 2023
WHO-ATC A02BD02
Created by admin on Fri Dec 15 15:37:11 GMT 2023 , Edited by admin on Fri Dec 15 15:37:11 GMT 2023
WHO-ATC A02BD10
Created by admin on Fri Dec 15 15:37:11 GMT 2023 , Edited by admin on Fri Dec 15 15:37:11 GMT 2023
WHO-ATC A02BD07
Created by admin on Fri Dec 15 15:37:11 GMT 2023 , Edited by admin on Fri Dec 15 15:37:11 GMT 2023
NCI_THESAURUS C29723
Created by admin on Fri Dec 15 15:37:11 GMT 2023 , Edited by admin on Fri Dec 15 15:37:11 GMT 2023
WHO-VATC QA02BC03
Created by admin on Fri Dec 15 15:37:11 GMT 2023 , Edited by admin on Fri Dec 15 15:37:11 GMT 2023
FDA ORPHAN DRUG 446014
Created by admin on Fri Dec 15 15:37:11 GMT 2023 , Edited by admin on Fri Dec 15 15:37:11 GMT 2023
WHO-ATC A02BC53
Created by admin on Fri Dec 15 15:37:11 GMT 2023 , Edited by admin on Fri Dec 15 15:37:11 GMT 2023
NDF-RT N0000000147
Created by admin on Fri Dec 15 15:37:11 GMT 2023 , Edited by admin on Fri Dec 15 15:37:11 GMT 2023
NDF-RT N0000175525
Created by admin on Fri Dec 15 15:37:11 GMT 2023 , Edited by admin on Fri Dec 15 15:37:11 GMT 2023
FDA ORPHAN DRUG 264508
Created by admin on Fri Dec 15 15:37:11 GMT 2023 , Edited by admin on Fri Dec 15 15:37:11 GMT 2023
WHO-ATC A02BD09
Created by admin on Fri Dec 15 15:37:11 GMT 2023 , Edited by admin on Fri Dec 15 15:37:11 GMT 2023
Code System Code Type Description
MERCK INDEX
m6683
Created by admin on Fri Dec 15 15:37:11 GMT 2023 , Edited by admin on Fri Dec 15 15:37:11 GMT 2023
PRIMARY Merck Index
DAILYMED
0K5C5T2QPG
Created by admin on Fri Dec 15 15:37:11 GMT 2023 , Edited by admin on Fri Dec 15 15:37:11 GMT 2023
PRIMARY
SMS_ID
100000089867
Created by admin on Fri Dec 15 15:37:11 GMT 2023 , Edited by admin on Fri Dec 15 15:37:11 GMT 2023
PRIMARY
RXCUI
17128
Created by admin on Fri Dec 15 15:37:11 GMT 2023 , Edited by admin on Fri Dec 15 15:37:11 GMT 2023
PRIMARY RxNorm
RS_ITEM_NUM
1356916
Created by admin on Fri Dec 15 15:37:11 GMT 2023 , Edited by admin on Fri Dec 15 15:37:11 GMT 2023
PRIMARY
NDF-RT
N0000009724
Created by admin on Fri Dec 15 15:37:11 GMT 2023 , Edited by admin on Fri Dec 15 15:37:11 GMT 2023
PRIMARY Inhibition Gastric Acid Secretion [PE]
PUBCHEM
3883
Created by admin on Fri Dec 15 15:37:11 GMT 2023 , Edited by admin on Fri Dec 15 15:37:11 GMT 2023
PRIMARY
DRUG CENTRAL
1547
Created by admin on Fri Dec 15 15:37:11 GMT 2023 , Edited by admin on Fri Dec 15 15:37:11 GMT 2023
PRIMARY
CAS
103577-45-3
Created by admin on Fri Dec 15 15:37:11 GMT 2023 , Edited by admin on Fri Dec 15 15:37:11 GMT 2023
PRIMARY
INN
6397
Created by admin on Fri Dec 15 15:37:11 GMT 2023 , Edited by admin on Fri Dec 15 15:37:11 GMT 2023
PRIMARY
IUPHAR
7208
Created by admin on Fri Dec 15 15:37:11 GMT 2023 , Edited by admin on Fri Dec 15 15:37:11 GMT 2023
PRIMARY
DRUG BANK
DB00448
Created by admin on Fri Dec 15 15:37:11 GMT 2023 , Edited by admin on Fri Dec 15 15:37:11 GMT 2023
PRIMARY
NCI_THESAURUS
C29150
Created by admin on Fri Dec 15 15:37:11 GMT 2023 , Edited by admin on Fri Dec 15 15:37:11 GMT 2023
PRIMARY
WIKIPEDIA
LANSOPRAZOLE
Created by admin on Fri Dec 15 15:37:11 GMT 2023 , Edited by admin on Fri Dec 15 15:37:11 GMT 2023
PRIMARY
MESH
C058687
Created by admin on Fri Dec 15 15:37:11 GMT 2023 , Edited by admin on Fri Dec 15 15:37:11 GMT 2023
PRIMARY
NSC
758638
Created by admin on Fri Dec 15 15:37:11 GMT 2023 , Edited by admin on Fri Dec 15 15:37:11 GMT 2023
PRIMARY
HSDB
7204
Created by admin on Fri Dec 15 15:37:11 GMT 2023 , Edited by admin on Fri Dec 15 15:37:11 GMT 2023
PRIMARY
LACTMED
Lansoprazole
Created by admin on Fri Dec 15 15:37:11 GMT 2023 , Edited by admin on Fri Dec 15 15:37:11 GMT 2023
PRIMARY
EPA CompTox
DTXSID4023200
Created by admin on Fri Dec 15 15:37:11 GMT 2023 , Edited by admin on Fri Dec 15 15:37:11 GMT 2023
PRIMARY
FDA UNII
0K5C5T2QPG
Created by admin on Fri Dec 15 15:37:11 GMT 2023 , Edited by admin on Fri Dec 15 15:37:11 GMT 2023
PRIMARY
EVMPD
SUB08403MIG
Created by admin on Fri Dec 15 15:37:11 GMT 2023 , Edited by admin on Fri Dec 15 15:37:11 GMT 2023
PRIMARY
ChEMBL
CHEMBL480
Created by admin on Fri Dec 15 15:37:11 GMT 2023 , Edited by admin on Fri Dec 15 15:37:11 GMT 2023
PRIMARY
USAN
AA-78
Created by admin on Fri Dec 15 15:37:11 GMT 2023 , Edited by admin on Fri Dec 15 15:37:11 GMT 2023
PRIMARY
CHEBI
6375
Created by admin on Fri Dec 15 15:37:11 GMT 2023 , Edited by admin on Fri Dec 15 15:37:11 GMT 2023
PRIMARY
Related Record Type Details
ENANTIOMER -> RACEMATE
BASIS OF STRENGTH->SUBSTANCE
ASSAY (TITRATION)
EP
METABOLIC ENZYME -> SUBSTRATE
DEGRADENT -> PARENT
CHROMATOGRAPHIC PURITY (HPLC/UV)
SALT/SOLVATE -> PARENT
METABOLIC ENZYME -> INDUCER
ENANTIOMER -> RACEMATE
BASIS OF STRENGTH->SUBSTANCE
ASSAY (HPLC)
USP
BINDER->LIGAND
BINDING
TARGET -> INHIBITOR
DEGRADENT -> PARENT
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
Related Record Type Details
METABOLITE ACTIVE -> PRODRUG
METABOLITE ACTIVE -> PRODRUG
METABOLITE ACTIVE -> PRODRUG
METABOLITE -> PARENT
These metabolites have very little or no antisecretory activity.
METABOLITE -> PARENT
Related Record Type Details
IMPURITY -> PARENT
CHROMATOGRAPHIC PURITY (HPLC/UV)
USP
IMPURITY -> PARENT
UNSPECIFIED
EP
IMPURITY -> PARENT
CHROMATOGRAPHIC PURITY (HPLC/UV)
USP
IMPURITY -> PARENT
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
IMPURITY -> PARENT
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
IMPURITY -> PARENT
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
IMPURITY -> PARENT
CHROMATOGRAPHIC PURITY (HPLC/UV)
USP
IMPURITY -> PARENT
UNSPECIFIED
EP
IMPURITY -> PARENT
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
Name Property Type Amount Referenced Substance Defining Parameters References
Biological Half-life PHARMACOKINETIC
Volume of Distribution PHARMACOKINETIC
Biological Half-life PHARMACOKINETIC With Hepatic impairment
PHARMACOKINETIC
Elderly
PHARMACOKINETIC