Monograph

N05BA01 - Diazepam

Propably not porphyrinogenic

Rationale

Diazepam is metabolized by Cytochrome P450 enzymes, but there are no in vitro or clinical observations pointing to significant capacity for CYP-induction or irreversible CYP-inhibition. There are 18 EPNET reports on uneventful use of diazepam.

Chemical description

The chemical name for diazepam is chlorometylphenyl benzodiazepin-2-one.

Therapeutic characteristics

Diazepam has anticonvulsant, anxiolytic, sedative and muscle relaxant properties, and is used in the treatment of anxiety syndrome, acute alcohol abstinence symptoms, central and peripheral muscle spasms, epileptic state, tetanus, acute excitation and sedation prior to operation or diagnostic measures. Diazepam can be administered via oral, parenteral or rectal formulations.

Metabolism and pharmacokinetics

Diazepam is mainly metabolized by CYP 2C19 under generation of the desmethyl metabolite norazepam, temazepam and oaxzepam, which are eliminated in glucuronide forms. There are no pharmacokinetic or drug interaction data in support of capacity for diazepam or its metabolites for significant CYP-induction or irreversible CYP-inhibition.

Personal communication

Thunell S: 3 reports of uneventful use.

Published experience

Kauppinen (1992): used uneventfully by two patients with acute porphyria. Diazepam have been suspected to have contributed to cause porphyrick attacks in two AIP patients (Shipton (1984) and Stiefelhagen (2000)), but the attacks where poorly documented and other factors could have contributed to the attacks. These reports have therefore not been taken into account in the judgement of the porphyrinogenicity of diazepam.

IPNet drug reports

Uneventful use reported in 18 patients with acute porphyria.

References

#	Citation details	PMID
*	Scientific articles
1.	Preissner S, Kroll K, et al: SuperCYP: a comprehensive database on Cytochrome P450 enzymes including a tool for analysis of CYP-drug interactions. Nucleic Acids Res. 2010 Jan;38 (Database issue):D237-43. Epub 2009 Nov 24
2.	Zhou, S.F., Zhou, Z.W. et al. Substrates, Inducers, Inhibitors and Structure-Activity Relationships of Human Cytochrome P450 2C9 and Implications in Drug Development. Current Medicinal Chem 2009; 16: 3480-3675.
3.	Effects of genetic polymorphism of cytochrome P450 enzymes on the pharmacokinetics of benzodiazepines. Fukasawa T, Suzuki A, et al. J Clin Pharm Ther. 2007 Aug;32(4):333-41.	17635335
4.	Prognosis of acute porphyria: occurrence of acute attacks, precipitating factors, and associated diseases. Medicine (Baltimore). 1992 Jan;71(1):1-13. Kauppinen R, Mustajoki P.	1549056
5.	Anaesthesia in a patient with variegate porphyria undergoing coronary bypass surgery. A case report. Shipton EA, Roelofse JA. S Afr Med J. 1984 Jan 14;65(2):53-4.
6.	[Abdominal pain after taking drug tablets. Acute intermittent porphyria]. Stiefelhagen P. MMW Fortschr Med. 2000 Feb 3;142(5):47-8	10715942
*	Drug reference publications
7.	Sweetman SC, editor. Martindale: The complete drug reference. Diazepam. Pharmaceutical Press 2009.

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Tradenames and packages

From some sources, we get a list of packages (United Kingdom, Ireland, Estonia). Other sources contain more or less "clean" versions of the trade name (Denmark, Finland, Iceland, Lithuania, Norway). What you see here is the raw data we get from each country, so there will appear to be duplicates. The bold names are the searchable terms. The gray names that follow are all mapped to the bolded term.

Note: The cleaning is done automatically by a proprietary algorithm, and it may produce errors. We strive to improve it continuously.

Netherlands

Dalpam · Dalpam 10 mg tabletten · Dalpam 2 mg tabletten · Dalpam 5 mg tabletten · Diazepam · Diazepam Accord 10 mg, tabletten · Diazepam Accord 2 mg, tabletten · Diazepam Accord 5 mg, tabletten · Diazepam Allgen rektiole 10 mg, oplossing voor rectaal gebruik 10 mg/2,5 ml · Diazepam Allgen rektiole 5 mg, oplossing voor rectaal gebruik 5 mg/2,5 ml · Diazepam Auro 10 mg, tabletten · Diazepam Auro 2 mg, tabletten · Diazepam Auro 5 mg, tabletten · Diazepam Aurobindo 10 mg, tabletten · Diazepam Aurobindo 2 mg, tabletten · Diazepam Aurobindo 5 mg, tabletten · Diazepam CF 10 mg, tabletten · Diazepam CF 2 mg, tabletten · Diazepam CF 5 mg, tabletten · Diazepam CF 5 mg/ml, oplossing voor injectie · Diazepam STADA 10 mg tabletten · Diazepam STADA 2 mg tabletten · Diazepam STADA 5 mg tabletten · Diazepam Teva 10 mg, tabletten · Diazepam Teva 2 mg, tabletten · Diazepam Teva 5 mg, tabletten · Stesolid · Stesolid 10 mg/2,5 ml rektiolen, oplossing voor rectaal gebruik · Stesolid 5 mg/2,5 ml rektiolen, oplossing voor rectaal gebruik

Belgium

Diazepam · Diazepam AB 10 mg comp. · Diazepam AB 2 mg comp. · Diazepam AB 5 mg comp. · Diazepam EG 10 mg (PI Pharma) comp. · Diazepam EG 10 mg comp. · Diazepam Eurogenerics 10 mg comp. · Diazepam Eurogenerics 5 mg comp. · Diazepam Teva 10 mg (PI Pharma) comp. · Diazepam Teva 10 mg comp. · Diazepam Teva 2 mg comp. · Diazepam Teva 5 mg (PI Pharma) comp. · Diazepam Teva 5 mg comp. · Diazetop · Diazetop 10 mg comp. · Diazetop 2 mg comp. · Diazetop 5 mg comp. · Valium · Valium 10 mg (Impexeco) comp. · Valium 10 mg comp. · Valium 10 mg/2 ml sol. inj. i.v./i.m. amp. · Valium 5 mg comp.

United Kingdom

Diazemuls · Diazemuls 10mg/2ml emulsion for injection ampoules · Diazepam · Diazepam 10mg RecTubes · Diazepam 10mg suppositories · Diazepam 10mg tablets · Diazepam 10mg/2.5ml rectal solution tube · Diazepam 10mg/2ml solution for injection ampoules · Diazepam 10mg/5ml oral solution · Diazepam 10mg/5ml oral suspension · Diazepam 15mg/5ml oral solution · Diazepam 1mg/5ml oral solution · Diazepam 2.5mg RecTubes · Diazepam 2.5mg/1.25ml rectal solution tube · Diazepam 2.5mg/5ml oral solution · Diazepam 2.5mg/5ml oral suspension · Diazepam 25mg/5ml oral solution · Diazepam 2mg tablets · Diazepam 2mg/5ml oral solution · Diazepam 2mg/5ml oral solution sugar free · Diazepam 2mg/5ml oral solution sugar-free · Diazepam 2mg/5ml oral suspension · Diazepam 2mg/5ml oral suspension sugar free · Diazepam 5mg RecTubes · Diazepam 5mg tablets · Diazepam 5mg/2.5ml rectal solution tube · Diazepam 5mg/5ml oral solution · Diazepam 5mg/5ml oral suspension · Stesolid · Stesolid 10mg rectal tube · Stesolid 5mg rectal tube · Tensium · Tensium 10mg tablets · Tensium 2mg tablets · Valclair · Valclair 10mg suppositories

Denmark