CLOBAZAM

Details

Stereochemistry	ACHIRAL
Molecular Formula	C16H13ClN2O2
Molecular Weight	300.74
Optical Activity	NONE
Defined Stereocenters	0 / 0
E/Z Centers	0
Charge	0

SHOW SMILES / InChI

Structure Search

SMILES

CN1C2=C(C=C(Cl)C=C2)N(C3=CC=CC=C3)C(=O)CC1=O

InChI

InChIKey=CXOXHMZGEKVPMT-UHFFFAOYSA-N

InChI=1S/C16H13ClN2O2/c1-18-13-8-7-11(17)9-14(13)19(16(21)10-15(18)20)12-5-3-2-4-6-12/h2-9H,10H2,1H3

HIDE SMILES / InChI

Molecular Formula	C16H13ClN2O2
Molecular Weight	300.74
Charge	0
Count

Stereochemistry	ACHIRAL
Additional Stereochemistry	No
Defined Stereocenters	0 / 0
E/Z Centers	0
Optical Activity	NONE

Description
Sources: http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202067s003,203993s003lbl.pdf
Curator's Comment: Description was created based on several sources, including https://www.drugs.com/cdi/clobazam.html; http://www.epilepsy.com/medications/clobazam https://www.ncbi.nlm.nih.gov/pubmed/?term=23318278

Clobazam belongs to the 1,5-benzodiazepine class of drugs with antiepileptic properties. It has been used to treat anxiety and epilepsy since 1970s. In the US clobazam was approved for marketing in October of 2011 for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome. It is also approved for adjunctive therapy for epilepsy in patients who have not responded to first-line drugs and in children who are refractory to first-line drugs. The mechanism of action for clobazam is not fully understood but is thought to involve what is known as potentiation of GABAergic neurotransmission resulting from binding at a benzodiazepine site at the GABA(A) receptor. Possible side effects: constipation, fever, drowsiness, sedation, ataxia, aggressive behavior, lethargy, drooling, and irritability. Other side effects include: urinary tract infection, pneumonia, cough, dysphagia, dysarthria, bronchitis, insomnia, fatigue, decreased appetite, and increased appetite.

CNS Activity

Originator

Approval Year

Targets

Primary Target	Pharmacology	Condition	Potency
GABA-A receptor; anion channel 202 Target ID: CHEMBL2093872 Sources: https://www.ncbi.nlm.nih.gov/pubmed/22145708	Activator 1430

Conditions

Condition	Modality	Targets	Highest Phase	Product
Lennox-Gastaut syndrome 4 Sources: http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202067s002,203993s002lbl.pdf	Secondary		Approved 8429	ONFI Approved Use Indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older. Launch Date 2011

C_max

Value	Dose	Co-administered	Analyte	Population
641 μg/L EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/6529527/	30 mg single, oral dose: 30 mg route of administration: Oral experiment type: SINGLE co-administered:		CLOBAZAM plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED

AUC

Value	Dose	Co-administered	Analyte	Population
13741 μg × h/L EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/6529527/	30 mg single, oral dose: 30 mg route of administration: Oral experiment type: SINGLE co-administered:		CLOBAZAM plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED

T_1/2

Value	Dose	Co-administered	Analyte	Population
36 h DRUG LABEL https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202067s005,203993s007lbl.pdf	30 mg 1 times / day unknown, oral dose: 30 mg route of administration: Oral experiment type: UNKNOWN co-administered:		CLOBAZAM plasma	Homo sapiens population: UNKNOWN age: ADULT sex: FEMALE / MALE food status: UNKNOWN

F_unbound

Value	Dose	Co-administered	Analyte	Population
10% DRUG LABEL https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202067s005,203993s007lbl.pdf	30 mg 1 times / day unknown, oral dose: 30 mg route of administration: Oral experiment type: UNKNOWN co-administered:		CLOBAZAM plasma	Homo sapiens population: UNKNOWN age: ADULT sex: FEMALE / MALE food status: UNKNOWN

Doses

Dose	Population	Adverse events
80 mg 2 times / day steady, oral Highest studied dose Dose: 80 mg, 2 times / day Route: oral Route: steady Dose: 80 mg, 2 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202067Orig1s000MedR.pdf Page: p. 69-70	healthy n = 70 Health Status: healthy Population Size: 70 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202067Orig1s000MedR.pdf Page: p. 69-70	Disc. AE: Somnolence, Depressed mood... Other AEs: Delirium... AEs leading to discontinuation/dose reduction: Somnolence (1 patient) Depressed mood (1 patient) Libido decreased (1 patient) Erectile dysfunction (1 patient) Insomnia (1 patient) Dysarthria (1 patient) Unsteady gait (1 patient) Dizziness (1 patient) Other AEs: Delirium (2 patients) Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202067Orig1s000MedR.pdf Page: p. 69-70
10 mg 2 times / day steady, oral Dose: 10 mg, 2 times / day Route: oral Route: steady Dose: 10 mg, 2 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202067Orig1s000MedR.pdf Page: p. 69	healthy n = 24 Health Status: healthy Population Size: 24 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202067Orig1s000MedR.pdf Page: p. 69	Disc. AE: Transaminases increased... AEs leading to discontinuation/dose reduction: Transaminases increased (1 patient) Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202067Orig1s000MedR.pdf Page: p. 69
15 mg 2 times / day steady, oral Dose: 15 mg, 2 times / day Route: oral Route: steady Dose: 15 mg, 2 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202067Orig1s000MedR.pdf Page: p. 69	healthy n = 24 Health Status: healthy Population Size: 24 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202067Orig1s000MedR.pdf Page: p. 69	Disc. AE: Transaminases increased... AEs leading to discontinuation/dose reduction: Transaminases increased (1 patient) Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202067Orig1s000MedR.pdf Page: p. 69
20 mg 2 times / day steady, oral Dose: 20 mg, 2 times / day Route: oral Route: steady Dose: 20 mg, 2 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202067Orig1s000MedR.pdf Page: p. 70	healthy n = 70 Health Status: healthy Population Size: 70 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202067Orig1s000MedR.pdf Page: p. 70	Disc. AE: Transaminases increased... AEs leading to discontinuation/dose reduction: Transaminases increased (2 patients) Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202067Orig1s000MedR.pdf Page: p. 70
60 mg 2 times / day steady, oral Dose: 60 mg, 2 times / day Route: oral Route: steady Dose: 60 mg, 2 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202067Orig1s000MedR.pdf Page: p. 69	healthy n = 24 Health Status: healthy Population Size: 24 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202067Orig1s000MedR.pdf Page: p. 69	Disc. AE: Somnolence... AEs leading to discontinuation/dose reduction: Somnolence (1 patient) Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202067Orig1s000MedR.pdf Page: p. 69
70 mg 2 times / day steady, oral Dose: 70 mg, 2 times / day Route: oral Route: steady Dose: 70 mg, 2 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202067Orig1s000MedR.pdf Page: p. 69	healthy n = 24 Health Status: healthy Population Size: 24 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202067Orig1s000MedR.pdf Page: p. 69	Disc. AE: Dizziness, Somnolence... AEs leading to discontinuation/dose reduction: Dizziness (1 patient) Somnolence (1 patient) Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202067Orig1s000MedR.pdf Page: p. 69

AEs

Overview

CYP3A4	CYP2C9	CYP2D6	hERG
inducer 781 substrate 1737 inhibitor 1587	inhibitor 1767	inhibitor 1852	inhibitor 1612

OverviewOther

Other Inhibitor	Other Substrate	Other Inducer
CYP1A2 1524 CYP2C8 911 CYP2C19 1478 UGT1A1 204 UGT1A4 77 UGT1A6 108 UGT2B4 19 P-gp 1461	CYP2C19 991 CYP2B6 664 P-gp 1537 OAT 1	UGT1A1 69

Drug as perpetrator

Target	Modality	Activity	Clinical evidence
CYP1A2 1692	inhibitor 3277 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202067s000lbl.pdf Page: 16.0	no
CYP2C19 1553	inhibitor 3277 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202067s000lbl.pdf Page: 16.0	no
CYP2C8 965	inhibitor 3277 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202067s000lbl.pdf Page: 16.0	no
CYP2C9 1819	inhibitor 3277 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202067s000lbl.pdf Page: 16.0	no
CYP3A4 1925	inhibitor 3277 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202067s000lbl.pdf Page: 16.0	no
P-gp 1650	inhibitor 3277 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202067s000lbl.pdf Page: 17.0	no
UGT1A1 254	inhibitor 3277 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202067s000lbl.pdf Page: 16.0	no
UGT1A4 80	inhibitor 3277 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202067s000lbl.pdf Page: 16.0	no
UGT1A6 141	inhibitor 3277 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202067s000lbl.pdf Page: 16.0	no
UGT2B4 19	inhibitor 3277 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202067s000lbl.pdf Page: 16.0	no
CYP2D6 1891	inhibitor 3277 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202067s000lbl.pdf Page: 16.0	no	yes (co-administration study) Comment: clobazam increased dextromethorphan cmax 90%, auc 59% Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202067s000lbl.pdf Page: 16.0
UGT1A1 254	inducer 1573 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202067s000lbl.pdf Page: 17.0	weak
CYP3A4 1925	inducer 1573 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202067s000lbl.pdf Page: 9.0	weak	yes (co-administration study) Comment: clobazam decreased midazolam auc 27%, cmax 24% Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202067s000lbl.pdf Page: 9.0

Drug as victim

Target	Modality	Activity	Clinical evidence
CYP3A4 1737	substrate 3367 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202067s000lbl.pdf Page: 15.0	major	yes (co-administration study) Comment: ketoconazole increased clobazam auc 54%, no effect on cmax Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202067s000lbl.pdf Page: 15.0
CYP2B6 664	substrate 3367 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202067s000lbl.pdf Page: 15.0	minor
CYP2C19 991	substrate 3367 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202067s000lbl.pdf Page: 15.0	minor	yes (co-administration study) Comment: omeprazole increased clobazam auc 30-36%, no effect on cmax Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202067s000lbl.pdf Page: 15.0
OAT 1	substrate 3367 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202067Orig1s000ClinPharmR.pdf Page: 96.0	no
P-gp 1537	substrate 3367 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202067s000lbl.pdf Page: 17.0	yes	yes (co-administration study) Comment: verapamil reduced clobazam transport >96% Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202067s000lbl.pdf Page: 17.0

Tox targets

Target	Modality	Activity	Metabolite	Clinical evidence
hERG 1647	inhibitor 1626 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202067Orig1s000CrossR.pdf Page: 20.0

Sourcing

Vendor/Aggregator	ID	URL
ChEBI	CHEBI:31413	https://www.ebi.ac.uk/chebi/searchId.do?chebiId=CHEBI:31413
ZINC	ZINC000000001175	http://zinc15.docking.org/substances/ZINC000000001175
eMolecules	536528	https://www.emolecules.com/cgi-bin/more?vid=536528

PubMed

Title	Date	PubMed
[Psychomotor slowness of a mentally retarded woman].	2001	12116722
[A pharmacological profile of clobazam (Mystan), a new antiepileptic drug].	2001 Aug	11530681
Evaluation of native GABA(A) receptors containing an alpha 5 subunit.	2001 Feb 9	11173064
Simple and sensitive high-performance liquid chromatographic method for the determination of 1,5-benzodiazepine clobazam and its active metabolite N-desmethylclobazam in human serum and urine with application to 1,4-benzodiazepines analysis.	2001 Jan 5	11204222
Psychosomatic reactions to a stressful environment and an attempt at pharmacological modification.	2001 Sep-Oct	11535941
On the use of tranquillisers in epilepsy.	2002	11903479
Pharmacological and endocrinological characterisation of stress-induced hyperthermia in singly housed mice using classical and candidate anxiolytics (LY314582, MPEP and NKP608).	2002 Jan 25	11821022
A case of nonconvulsive status epilepticus associated with focal cortical dysplasia.	2003 Apr	12689702
Direct injection HPLC method for the determination of selected benzodiazepines in plasma using a Hisep column.	2003 Dec 4	14656604
Prophylactic use of clobazam in hot water epilepsy.	2003 Jan	12693453
Use of clobazam for the treatment of refractory complex partial seizures.	2003 Jul	12810340
Clobazam monotherapy in drug naïve adult patients with epilepsy.	2003 Jun	12763470
[Idiopathic epilepsies: some therapeutic aspects].	2004 Jan 16-31	14752722
Forensic intoxication with clobazam: HPLC/DAD/MSD analysis.	2004 Jul 16	15240045
Affinity of various benzodiazepine site ligands in mice with a point mutation in the GABA(A) receptor gamma2 subunit.	2004 Oct 15	15451405
The difficulty in diagnosing non-convulsive status epilepticus during routine medical practice.	2004 Sep	15315926
Properties of antiepileptic drugs in the treatment of idiopathic generalized epilepsies.	2005	16302888
[Subacute encephalitis with anti-glutamate receptor antibodies presented with epilepsia partialis continua].	2005 Aug	16180713
Clobazam as add-on therapy for temporal lobe epilepsy and hippocampal sclerosis.	2005 Feb	15825553
Treatment of electrical status epilepticus during slow-wave sleep with high-dose corticosteroid.	2005 Jan	15607609
Stiripentol, a putative antiepileptic drug, enhances the duration of opening of GABA-A receptor channels.	2006 Apr	16650136
Safety and efficacy of clobazam versus phenytoin-sodium in the antiepileptic drug treatment of solitary cysticercus granulomas.	2006 Jun	16804259
Abusive prescription of psychostimulants: a study of two cases.	2006 Mar	16566781
Oxidative stress in children receiving valproic acid.	2006 Nov	17095346

Patents

Sample Use Guides

In Vivo Use Guide

Patients ≤30 kg body weight: Initiate at 5 mg daily and titrate as tolerated up to 20 mg daily. Patients > 30 kg body weight: Initiate at 10 mg daily and titrate as tolerated up to 40 mg daily. For doses above 5 mg/day administer in two divided doses. Dosage adjustment needed in following groups: Geriatric patients. Known CYP2C19 poor metabolizers. Mild or moderate hepatic impairment; no information for severe hepatic impairment.

Route of Administration: Oral

In Vitro Use Guide

Recurrent ictal-like seizures (ILEs, four per hour) were generated in intact corticohippocampal formations (CHFs) of P7-8 rats, and extracellular recordings were performed in the hippocampus and neocortex. Clobazam was applied at clinically relevant concentrations (at least two), during 30 min after the third ILE. Clobazam prevented the occurrence of seizures in recurrent ictal-like seizures.

Substance Class	Chemical Created by `admin` on `Fri Dec 15 15:11:45 GMT 2023` Edited by `admin` on `Fri Dec 15 15:11:45 GMT 2023`
Record UNII	2MRO291B4U
Record Status	`Validated (UNII)`
Record Version

Download

Name

Type

Language

CLOBAZAM

Official Name

English

CLOBAZAM [MI]

Common Name

English

CLOBAZAM [JAN]

Common Name

English

URBADAN

Brand Name

English

1H-1,5-BENZODIAZEPINE-2,4(3H,5H)-DIONE, 7-CHLORO-1-METHYL-5-PHENYL-

Systematic Name

English

CLOBAZAM [ORANGE BOOK]

Common Name

English

CLOBAZAM [VANDF]

Common Name

English

FRISIUM

Brand Name

English

URBANYL

Brand Name

English

ONFI

Brand Name

English

LM 2717

Code

English

LM-2717

Code

English

COLBAZAM [VANDF]

Common Name

English

NSC-336279

Code

English

HR-376

Code

English

MYSTAN

Brand Name

English

H 4723

Code

English

HR 376

Code

English

CLOBAZAM [EP MONOGRAPH]

Common Name

English

CLOBAZAM [MART.]

Common Name

English

7-Chloro-1-methyl-5-phenyl-1H-1,5-benzodiazepine-2,4-(3H,5H)-dione

Common Name

English

SYMPAZAN

Brand Name

English

H-4723

Code

English

clobazam [INN]

Common Name

English

CLOBAZAM [USAN]

Common Name

English

Clobazam [WHO-DD]

Common Name

English

Classification Tree Code System Code

DEA NO.

2751

Created by admin on Fri Dec 15 15:11:45 GMT 2023 , Edited by admin on Fri Dec 15 15:11:45 GMT 2023

FDA ORPHAN DRUG

248307

Created by admin on Fri Dec 15 15:11:45 GMT 2023 , Edited by admin on Fri Dec 15 15:11:45 GMT 2023

LIVERTOX

NBK548865

Created by admin on Fri Dec 15 15:11:45 GMT 2023 , Edited by admin on Fri Dec 15 15:11:45 GMT 2023

WHO-ATC

N05BA09

Created by admin on Fri Dec 15 15:11:45 GMT 2023 , Edited by admin on Fri Dec 15 15:11:45 GMT 2023

NCI_THESAURUS

C28197

Created by admin on Fri Dec 15 15:11:45 GMT 2023 , Edited by admin on Fri Dec 15 15:11:45 GMT 2023

WHO-VATC

QN05BA09

Created by admin on Fri Dec 15 15:11:46 GMT 2023 , Edited by admin on Fri Dec 15 15:11:46 GMT 2023

NDF-RT

N0000175694

Created by admin on Fri Dec 15 15:11:45 GMT 2023 , Edited by admin on Fri Dec 15 15:11:45 GMT 2023

Code System Code Type Description

CAS

22316-47-8

Created by admin on Fri Dec 15 15:11:45 GMT 2023 , Edited by admin on Fri Dec 15 15:11:45 GMT 2023

PRIMARY

CHEBI

31413

Created by admin on Fri Dec 15 15:11:45 GMT 2023 , Edited by admin on Fri Dec 15 15:11:45 GMT 2023

PRIMARY

WIKIPEDIA

CLOBAZAM

Created by admin on Fri Dec 15 15:11:46 GMT 2023 , Edited by admin on Fri Dec 15 15:11:46 GMT 2023

PRIMARY

MESH

C012255

Created by admin on Fri Dec 15 15:11:45 GMT 2023 , Edited by admin on Fri Dec 15 15:11:45 GMT 2023

PRIMARY

EPA CompTox

DTXSID2046759

Created by admin on Fri Dec 15 15:11:45 GMT 2023 , Edited by admin on Fri Dec 15 15:11:45 GMT 2023

PRIMARY

PUBCHEM

2789

Created by admin on Fri Dec 15 15:11:46 GMT 2023 , Edited by admin on Fri Dec 15 15:11:46 GMT 2023

PRIMARY

NSC

336279

Created by admin on Fri Dec 15 15:11:46 GMT 2023 , Edited by admin on Fri Dec 15 15:11:46 GMT 2023

PRIMARY

INN

3055

Created by admin on Fri Dec 15 15:11:45 GMT 2023 , Edited by admin on Fri Dec 15 15:11:45 GMT 2023

PRIMARY

DAILYMED

2MRO291B4U

Created by admin on Fri Dec 15 15:11:45 GMT 2023 , Edited by admin on Fri Dec 15 15:11:45 GMT 2023

PRIMARY

DRUG BANK

DB00349

Created by admin on Fri Dec 15 15:11:45 GMT 2023 , Edited by admin on Fri Dec 15 15:11:45 GMT 2023

PRIMARY

EVMPD

SUB06673MIG

Created by admin on Fri Dec 15 15:11:45 GMT 2023 , Edited by admin on Fri Dec 15 15:11:45 GMT 2023

PRIMARY

SMS_ID

100000084299

Created by admin on Fri Dec 15 15:11:46 GMT 2023 , Edited by admin on Fri Dec 15 15:11:46 GMT 2023

PRIMARY

ChEMBL

CHEMBL70418

Created by admin on Fri Dec 15 15:11:45 GMT 2023 , Edited by admin on Fri Dec 15 15:11:45 GMT 2023

PRIMARY

HSDB

8343

Created by admin on Fri Dec 15 15:11:45 GMT 2023 , Edited by admin on Fri Dec 15 15:11:45 GMT 2023

PRIMARY

FDA UNII

2MRO291B4U

Created by admin on Fri Dec 15 15:11:45 GMT 2023 , Edited by admin on Fri Dec 15 15:11:45 GMT 2023

PRIMARY

NCI_THESAURUS

C81615

Created by admin on Fri Dec 15 15:11:45 GMT 2023 , Edited by admin on Fri Dec 15 15:11:45 GMT 2023

PRIMARY

ECHA (EC/EINECS)

244-908-7

Created by admin on Fri Dec 15 15:11:45 GMT 2023 , Edited by admin on Fri Dec 15 15:11:45 GMT 2023

PRIMARY

LACTMED

Clobazam

Created by admin on Fri Dec 15 15:11:45 GMT 2023 , Edited by admin on Fri Dec 15 15:11:45 GMT 2023

PRIMARY

RXCUI

21241

Created by admin on Fri Dec 15 15:11:46 GMT 2023 , Edited by admin on Fri Dec 15 15:11:46 GMT 2023

PRIMARY

RxNorm

MERCK INDEX

m3626

Created by admin on Fri Dec 15 15:11:45 GMT 2023 , Edited by admin on Fri Dec 15 15:11:45 GMT 2023

PRIMARY

Merck Index

NDF-RT

N0000182137

Created by admin on Fri Dec 15 15:11:45 GMT 2023 , Edited by admin on Fri Dec 15 15:11:45 GMT 2023

PRIMARY

Cytochrome P450 2D6 Inhibitors [MoA]

IUPHAR

7149

Created by admin on Fri Dec 15 15:11:45 GMT 2023 , Edited by admin on Fri Dec 15 15:11:45 GMT 2023

PRIMARY

DRUG CENTRAL

682

Created by admin on Fri Dec 15 15:11:45 GMT 2023 , Edited by admin on Fri Dec 15 15:11:45 GMT 2023

PRIMARY

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					3K27XX5A6B

3-METHYLCLOBAZAM

IMPURITY -> PARENT

Amount:


					5VX8UQX64W

Methyl 3-((4-chloro-2-(phenylamino)phenyl)(methyl)amino)-3-oxopropanoate

IMPURITY -> PARENT

Amount:


					7Q5N4K3YV9

Deschloroclobazam

IMPURITY -> PARENT

Amount:


					3J42JT2XJM

5-Chloro-1,2-dimethyl-3-phenyl-1H-benzimidazolium

IMPURITY -> PARENT

Amount:

Related Record Type Details


					2MRO291B4U

CLOBAZAM

ACTIVE MOIETY

Name	Property Type	Parameters
Biological Half-life	PHARMACOKINETIC

Volume of Distribution	PHARMACOKINETIC

Tmax	PHARMACOKINETIC	SINGLE- OR MULTIPLE-DOSE ADMINISTRATIONS

AE	Significance	Dose	Population
Depressed mood	1 patient Disc. AE	80 mg 2 times / day steady, oral Highest studied dose Dose: 80 mg, 2 times / day Route: oral Route: steady Dose: 80 mg, 2 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202067Orig1s000MedR.pdf Page: p. 69-70	healthy n = 70 Health Status: healthy Population Size: 70 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202067Orig1s000MedR.pdf Page: p. 69-70
Dizziness	1 patient Disc. AE	80 mg 2 times / day steady, oral Highest studied dose Dose: 80 mg, 2 times / day Route: oral Route: steady Dose: 80 mg, 2 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202067Orig1s000MedR.pdf Page: p. 69-70	healthy n = 70 Health Status: healthy Population Size: 70 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202067Orig1s000MedR.pdf Page: p. 69-70
Dysarthria	1 patient Disc. AE	80 mg 2 times / day steady, oral Highest studied dose Dose: 80 mg, 2 times / day Route: oral Route: steady Dose: 80 mg, 2 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202067Orig1s000MedR.pdf Page: p. 69-70	healthy n = 70 Health Status: healthy Population Size: 70 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202067Orig1s000MedR.pdf Page: p. 69-70
Erectile dysfunction	1 patient Disc. AE	80 mg 2 times / day steady, oral Highest studied dose Dose: 80 mg, 2 times / day Route: oral Route: steady Dose: 80 mg, 2 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202067Orig1s000MedR.pdf Page: p. 69-70	healthy n = 70 Health Status: healthy Population Size: 70 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202067Orig1s000MedR.pdf Page: p. 69-70
Insomnia	1 patient Disc. AE	80 mg 2 times / day steady, oral Highest studied dose Dose: 80 mg, 2 times / day Route: oral Route: steady Dose: 80 mg, 2 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202067Orig1s000MedR.pdf Page: p. 69-70	healthy n = 70 Health Status: healthy Population Size: 70 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202067Orig1s000MedR.pdf Page: p. 69-70
Libido decreased	1 patient Disc. AE	80 mg 2 times / day steady, oral Highest studied dose Dose: 80 mg, 2 times / day Route: oral Route: steady Dose: 80 mg, 2 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202067Orig1s000MedR.pdf Page: p. 69-70	healthy n = 70 Health Status: healthy Population Size: 70 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202067Orig1s000MedR.pdf Page: p. 69-70
Somnolence	1 patient Disc. AE	80 mg 2 times / day steady, oral Highest studied dose Dose: 80 mg, 2 times / day Route: oral Route: steady Dose: 80 mg, 2 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202067Orig1s000MedR.pdf Page: p. 69-70	healthy n = 70 Health Status: healthy Population Size: 70 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202067Orig1s000MedR.pdf Page: p. 69-70
Unsteady gait	1 patient Disc. AE	80 mg 2 times / day steady, oral Highest studied dose Dose: 80 mg, 2 times / day Route: oral Route: steady Dose: 80 mg, 2 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202067Orig1s000MedR.pdf Page: p. 69-70	healthy n = 70 Health Status: healthy Population Size: 70 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202067Orig1s000MedR.pdf Page: p. 69-70
Delirium	2 patients	80 mg 2 times / day steady, oral Highest studied dose Dose: 80 mg, 2 times / day Route: oral Route: steady Dose: 80 mg, 2 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202067Orig1s000MedR.pdf Page: p. 69-70	healthy n = 70 Health Status: healthy Population Size: 70 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202067Orig1s000MedR.pdf Page: p. 69-70
Transaminases increased	1 patient Disc. AE	10 mg 2 times / day steady, oral Dose: 10 mg, 2 times / day Route: oral Route: steady Dose: 10 mg, 2 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202067Orig1s000MedR.pdf Page: p. 69	healthy n = 24 Health Status: healthy Population Size: 24 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202067Orig1s000MedR.pdf Page: p. 69
Transaminases increased	1 patient Disc. AE	15 mg 2 times / day steady, oral Dose: 15 mg, 2 times / day Route: oral Route: steady Dose: 15 mg, 2 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202067Orig1s000MedR.pdf Page: p. 69	healthy n = 24 Health Status: healthy Population Size: 24 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202067Orig1s000MedR.pdf Page: p. 69
Transaminases increased	2 patients Disc. AE	20 mg 2 times / day steady, oral Dose: 20 mg, 2 times / day Route: oral Route: steady Dose: 20 mg, 2 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202067Orig1s000MedR.pdf Page: p. 70	healthy n = 70 Health Status: healthy Population Size: 70 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202067Orig1s000MedR.pdf Page: p. 70
Somnolence	1 patient Disc. AE	60 mg 2 times / day steady, oral Dose: 60 mg, 2 times / day Route: oral Route: steady Dose: 60 mg, 2 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202067Orig1s000MedR.pdf Page: p. 69	healthy n = 24 Health Status: healthy Population Size: 24 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202067Orig1s000MedR.pdf Page: p. 69
Dizziness	1 patient Disc. AE	70 mg 2 times / day steady, oral Dose: 70 mg, 2 times / day Route: oral Route: steady Dose: 70 mg, 2 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202067Orig1s000MedR.pdf Page: p. 69	healthy n = 24 Health Status: healthy Population Size: 24 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202067Orig1s000MedR.pdf Page: p. 69
Somnolence	1 patient Disc. AE	70 mg 2 times / day steady, oral Dose: 70 mg, 2 times / day Route: oral Route: steady Dose: 70 mg, 2 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202067Orig1s000MedR.pdf Page: p. 69	healthy n = 24 Health Status: healthy Population Size: 24 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202067Orig1s000MedR.pdf Page: p. 69

Details

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PubMed

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Drug as perpetrator