Clobazam

Structural formula
General
Non-proprietary name	Clobazam
other names	7-chloro-1,5-dihydro-1-methyl-5-phenyl-1,5-benzodiazepine-2,4 (3 H ) -dione ( IUPAC )
Molecular formula	C 16 H 13 ClN 2 O 2
External identifiers / databases
EC number	244-908-7
ECHA InfoCard	100.040.810
PubChem	2789
DrugBank	DB00349
Wikidata	Q412164
Drug information
ATC code	N05 BA09
Drug class	Benzodiazepines
properties
Molar mass	300.74 g · mol -1
safety instructions
	Please note the exemption from the labeling requirement for drugs, medical devices, cosmetics, food and animal feed
GHS labeling of hazardous substances	no GHS pictograms
	no GHS pictograms
H and P phrases	H: no H-phrases
	P: no P-phrases
Toxicological data	6000 mg kg −1 ( LD 50 , rat , oral )
	As far as possible and customary, SI units are used. Unless otherwise noted, the data given apply to standard conditions .

Clobazam (trade name Frisium ; manufacturer: Sanofi-Aventis ) is a drug from the group of benzodiazepines . It is used in the treatment of states of tension , excitement and anxiety as well as for the treatment of seizure disorders ( antiepileptic , anticonvulsant ).

Clinical information

application areas

Clobazam is approved as a

Sedatives for the symptomatic treatment of acute and chronic states of tension, excitement and anxiety and
Anticonvulsant in addition to standard treatment for patients with epilepsy who are not seizure-free.

Contraindications

Clobazam must not be used in:

Hypersensitivity to clobazam
Dependence on medicines , alcohol, or other drugs
breastfeeding women
acute intoxication with alcohol or other CNS-active substances
Myasthenia gravis
severe liver damage
Sleep apnea
severe breathing disorders .

Clobazam may only be given after careful risk-benefit assessment and, if necessary, with a reduced dose if:

ataxias originating from the spinal cord or cerebellum

First trimester pregnancy
chronic or acute respiratory failure.

Development and marketing

Clobazam was synthesized by the Italian company Laboratori Farmaceutici Maestretti in Milan in the late 1960s and later developed into a medicinal product at Hoechst . It has been on the market in many countries since the mid / late 1970s, initially as a sedative and anxiolytic and later as an anticonvulsant.

Legal situation in Germany

Clobazam is subject to the legislation of the Narcotics Act ( BtMG ). Here it has been included in Appendix III (marketable and prescription narcotics ); This does not include preparations that contain no more than 20 mg of the active ingredient and no other anesthetics per divided form (tablet, suppository, ampoule). Up to this dose, the active ingredient is only available on prescription .

Trade names

Frisium (D, A), Urbanyl (CH)

Web links

Individual evidence

↑ ^a ^b ^c Clobazam data sheet from Sigma-Aldrich , accessed on June 15, 2011 ( PDF ).

^ ^A ^b ^c Sanofi-Aventis: Fachinformation Frisium (Germany). Status: March 2017.

↑ S. Rossi, O. Pirola, R. Maggi: Sintesi di 1,2,4,5-tetraidro-2,4-dicheto-3H-l, benzodiazepine. 5 In: Chim Ind. 51, 1969, pp. 479-483.

↑ Drug databases of the approval authorities ( BfArM / PEI / BVL , AGES , swissmedic ), as of October 2019.

[Sigma-1] Clobazam data sheet from Sigma-Aldrich , accessed on June 15, 2011 ( PDF ).

[FI_Frisium-2] A ^b ^c Sanofi-Aventis: Fachinformation Frisium (Germany). Status: March 2017.

[3] S. Rossi, O. Pirola, R. Maggi: Sintesi di 1,2,4,5-tetraidro-2,4-dicheto-3H-l, benzodiazepine. 5 In: Chim Ind. 51, 1969, pp. 479-483.

[4] Drug databases of the approval authorities ( BfArM / PEI / BVL , AGES , swissmedic ), as of October 2019.