Monograph N06AX11 - Mirtazapine
Propably not porphyrinogenic
PNP
Rationale
Mirtazapine is not an inhibitor or an inducer of CYP2C9, CYP2C19 or CYP3A4.
Risk for gastrointestinal adverse events in the form of diarrhoea, nausea and vomiting motivates vigilance against insufficient intake of food, especially of carbohydrate.
Chemical description
Mirtazapine is a centrally active presynaptic α2-antagonist. It is a racemate and both enantiomers are pharmacologically active (Spina 2012).
Therapeutic characteristics
Mirtazapine is indicated for the treatment of depression.
Common side effects that can be potentially porphyrinogenic through reduction in carbohydrate intake and that also can be confused with an acute porphyria attack are diarrhoea, nausea and vomiting. Other common side effects are insomnia, somnolence, dizziness, tremor, arthralgia, myalgia, back pain and fatigue.
Metabolism and pharmacokinetics
Mirtazapine is metabolised by CYP2D6, CYP3A4 and CYP1A2 (Timmer 2000). The mean half-life elimination is 20-40 hours.
When co-administrated mirtazapine did not have any effect on the pharmacokinetics of carbamazepine (Sitsen 2001 and Spina 2012), a CYP3A4 substrate, which indicates that mirtazapine does not inhibit or induce CYP3A4.
Mirtazapine did not significantly affect the AUC of phenytoin, substrate of CYP2C9 and CYP2C19 (Norsk legemiddelhåndbok), when co-administrated (Spaans 2002). This indicates that mirtazapine is not an inhibitor or an inducer of CYP2C9 or CYP2C19.
IPNet drug reports
Uneventful use reported in 7 patients with acute porphyria.
Similar drugs
References #
Citation details
PMID
* Scientific articles 1.
Inhibition and induction of human cytochrome P450 enzymes: current status.
Pelkonen O, Turpeinen M, et al. Arch Toxicol. 2008 Oct;82(10):667-715.
18618097 2.
Drug-drug interaction studies with mirtazapine and carbamazepine in healthy male subjects.
Sitsen J, Maris F, Timmer C. Eur J Drug Metab Pharmacokinet. 2001 Jan-Jun;26(1-2):109-21.
11554425 3.
Concomitant use of mirtazapine and phenytoin: a drug-drug interaction study in healthy male subjects.
Spaans E, van den Heuvel MW, et al. Eur J Clin Pharmacol. 2002 Sep;58(6):423-9.
12242602 4.
Clinically significant drug interactions with newer antidepressants.
Spina E, Trifiro G, Caraci F. CNS Drugs. 2012 Jan 1;26(1):39-67.
22171584 5.
Clinical pharmacokinetics of mirtazapine.
Timmer CJ, Sitsen JM, Delbressine LP. Clin Pharmacokinet. 2000 Jun;38(6):461-74.
10885584 * Drug reference publications 6.
Norsk legemiddelhåndbok. Fenytoin
* Summary of Product Characteristics 7.
Norwegian medicines agency. Summary of Product Characteristics (SPC). Mirtazapine.
Tradenames
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Mirtazapine Amarox 15 mg filmomhulde tabletten · Mirtazapine Amarox 30 mg filmomhulde tabletten · Mirtazapine Amarox 45 mg filmomhulde tabletten · Mirtazapine Aurobindo 15 mg filmomhulde tabletten · Mirtazapine Aurobindo 15 mg orodispergeerbare tabletten, orodispergeerbare tabletten · Mirtazapine Aurobindo 30 mg filmomhulde tabletten · Mirtazapine Aurobindo 30 mg orodispergeerbare tabletten, orodispergeerbare tabletten · Mirtazapine Aurobindo 45 mg filmomhulde tabletten · Mirtazapine Aurobindo 45 mg orodispergeerbare tabletten, orodispergeerbare tabletten · Mirtazapine CF 15 mg, filmomhulde tabletten · Mirtazapine orodispergeerbare tablet 15 mg, orodispergeerbare tabletten · Mirtazapine orodispergeerbare tablet 30 mg, orodispergeerbare tabletten · Mirtazapine orodispergeerbare tablet 45 mg, orodispergeerbare tabletten · Mirtazapine ratiopharm dispergeerbaar 15 mg, orodispergeerbare tabletten · Mirtazapine ratiopharm dispergeerbaar 30 mg, orodispergeerbare tabletten · Mirtazapine ratiopharm dispergeerbaar 45 mg, orodispergeerbare tabletten · Mirtazapine Sandoz 15 mg, filmomhulde tabletten · Mirtazapine Sandoz 15, filmomhulde tabletten 15 mg · Mirtazapine Sandoz 30 mg, filmomhulde tabletten · Mirtazapine Sandoz 30, filmomhulde tabletten 30 mg · Mirtazapine Sandoz 45 mg, filmomhulde tabletten · Mirtazapine Sandoz 45, filmomhulde tabletten 45 mg · Mirtazapine Sandoz orodispergeerbare tablet 15 mg, orodispergeerbare tabletten · Mirtazapine Sandoz orodispergeerbare tablet 30 mg, orodispergeerbare tabletten · Mirtazapine Sandoz orodispergeerbare tablet 45 mg, orodispergeerbare tabletten · Mirtazapine SDZ 15 mg, filmomhulde tabletten · Mirtazapine SDZ 30 mg, filmomhulde tabletten · Mirtazapine SDZ 45 mg, filmomhulde tabletten · Mirtazapine SmeltTab Viatris 15 mg, orodispergeerbare tablet · Mirtazapine SmeltTab Viatris 30 mg, orodispergeerbare tablet · Mirtazapine SmeltTab Viatris 45 mg, orodispergeerbare tablet · Mirtazapine Teva 15 mg, filmomhulde tabletten · Mirtazapine Teva 30 mg, filmomhulde tabletten · Mirtazapine Teva 45 mg, filmomhulde tabletten · Mirtazapine Viatris 15 mg, filmomhulde tabletten · Mirtazapine Viatris 30 mg, filmomhulde tabletten · Mirtazapine Viatris 45 mg, filmomhulde tabletten · Mirzasna 15 mg orodispergeerbare tabletten · Mirzasna 30 mg orodispergeerbare tabletten · Mirzasna 45 mg orodispergeerbare tabletten · Mitabor disper 15 mg, orodispergeerbare tabletten · Mitabor disper 30 mg, orodispergeerbare tabletten · Mitabor disper 45 mg, orodispergeerbare tabletten · Remeron 15 mg, filmomhulde tabletten · Remeron 30 mg, filmomhulde tabletten · Remeron 45 mg, filmomhulde tabletten · Remeron SolTab 15 mg, orodispergeerbare tabletten · Remeron SolTab 30 mg, orodispergeerbare tabletten · Remeron SolTab 45 mg, orodispergeerbare tabletten Mirtazapine AB 15 mg compr. orodisp. · Mirtazapine AB 30 mg compr. orodisp. · Mirtazapine AB 45 mg compr. orodisp. · Mirtazapine EG 15 mg (Orifarm) compr. pellic. · Mirtazapine EG 15 mg (PI Pharma) compr. pellic. · Mirtazapine EG 15 mg compr. pellic. · Mirtazapine EG 30 mg (Orifarm) compr. pellic. · Mirtazapine EG 30 mg compr. pellic. · Mirtazapine EG 45 mg compr. pellic. · Mirtazapine EG Instant 15 mg compr. orodisp. · Mirtazapine EG Instant 30 mg compr. orodisp. · Mirtazapine Sandoz 15 mg compr. orodisp. · Mirtazapine Sandoz 30 mg compr. orodisp. · Mirtazapine Sandoz 45 mg compr. orodisp. · Mirtazapine Viatris 15 mg compr. pellic. · Mirtazapine Viatris 30 mg compr. pellic. · Mirtazapine Viatris 45 mg compr. pellic. · Remergon Soltab 15 mg compr. orodisp. · Remergon Soltab 30 mg compr. orodisp. · Remergon Soltab 45 mg compr. orodisp. 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MIRTAZAPINA AUROVITAS 30 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG · Mirtazapina Aurovitas Spain 15 mg Comprimidos Bucodispersables efg · Mirtazapina Aurovitas Spain 30 mg Comprimidos Bucodispersables efg · Mirtazapina Aurovitas Spain 45 mg Comprimidos Bucodispersables efg · Mirtazapina Cinfa 15 mg Comprimidos Recubiertos con Pelicula efg · MIRTAZAPINA CINFA 30 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG · MIRTAZAPINA COMBINO PHARM 30 mg COMPRIMIDOS EFG · Mirtazapina Combix 15 mg Comprimidos Recubiertos con Pelicula efg · MIRTAZAPINA COMBIX 30 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG · Mirtazapina Combix 45 mg Comprimidos Recubiertos con pel?Cula efg · MIRTAZAPINA DAVUR 30 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG · MIRTAZAPINA ETHYPHARM 15 mg COMPRIMIDOS BUCODISPERSABLES EFG · MIRTAZAPINA ETHYPHARM 30 mg COMPRIMIDOS BUCODISPERSABLES EFG · MIRTAZAPINA ETHYPHARM 45 mg COMPRIMIDOS BUCODISPERSABLES EFG · MIRTAZAPINA FLAS ALTER 15 mg COMPRIMIDOS BUCODISPERSABLES EFG · MIRTAZAPINA 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SANDOZ FARMAC?UTICA 15 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG · MIRTAZAPINA SANDOZ FARMAC?UTICA 30 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG · MIRTAZAPINA SANDOZ FARMACEUTICA 45 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG · MIRTAZAPINA STADA 30 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG · MIRTAZAPINA TARBIS 15 mg COMPRIMIDOS BUCODISPERSABLES EFG · Mirtazapina Tarbis 15 mg Comprimidos Recubiertos con pel?Cula efg · MIRTAZAPINA TARBIS 30 mg COMPRIMIDOS BUCODISPERSABLES EFG · Mirtazapina Tarbis 30 mg Comprimidos Recubiertos con pel?Cula efg · Mirtazapina Tarbis 45 mg Comprimidos Recubiertos con pel?Cula efg · MIRTAZAPINA TECNIGEN 15 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG · MIRTAZAPINA TECNIGEN 30 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG · MIRTAZAPINA TEVA 15 mg COMPRIMIDOS BUCODISPERSABLES EFG · MIRTAZAPINA TEVA 30 mg COMPRIMIDOS RECUBIERTOS CON PEL?CULA EFG · Mirtazapina Teva-Ratio 15 mg Comprimidos Recubiertos con Pelicula efg · MIRTAZAPINA TEVAGEN 15 mg COMPRIMIDOS BUCODISPERSABLES EFG · MIRTAZAPINA TEVAGEN 30 mg COMPRIMIDOS BUCODISPERSABLES EFG · Mirtazapina Viatris Pharmaceuticals 30 mg Comprimidos Recubiertos con pel?Cula efg · MIRTAZAPINA ZENTIVA 15 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG · MIRTAZAPINA ZENTIVA 30 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG · Rexer · REXER FLAS 15 mg COMPRIMIDOS BUCODISPERSABLES · REXER FLAS 30 mg COMPRIMIDOS BUCODISPERSABLES Mirtazapina · Remeron · Zapin MIRTAZAPIN ARENA 15 mg · MIRTAZAPIN ARENA 30 mg · MIRTAZAPIN ARENA 45 mg · Mirzaten · MIRZATEN? 30 mg · PHARMATAZ 30 mg · REMERON SOLTAB 30 mg · ZULIN 30 mg Mirtazapine · Zispin · Zispin SolTab Combar · Emir · Mirtazapin Actavis · Mirtazapin Alternova · Mirtazapin Bluefish · Mirtazapin HEXAL · Mirtazapin KRKA · Mirtazapin Orion · Mirtazapin Paranova · Mirtazapin Sandoz · Mirtazapin Stada · Mirtazapin Teva · Mirtazapin Teva B.V. · Mirtazapin Teva Pharma · Mirtazapin Viatris · Mirtin · Punglydep Mirtazapin Bluefish · Mirtazapin Hexal · Mirtazapin Orion · Mirtazapine aurobindo · Remeron · Remeron-S AuroMirta ORO · Mirtagen · Mirtazapine Bluefish · Mirtor · Mirzaten · Mirzaten 30 mg · Mirzaten 45 mg · Mirzaten Q-Tab · Remirta Oro Mirtazapin-Ratiopharm · Mirtazapin-ratiopharm_ · Mirtazapine EG · Remergon Soltab M?ron · M?ron Smelt · Míron · Mirtazapin Bluefish · Mirtazapin Krka · Mirtazapin Sandoz Mirtazapin Actavis · Mirtazapin Hexal · Mirtazapin Krka · Mirtazapin Orion · Mirtazapin ratiopharm · Mirtazapin Sandoz Mirtastad · Mirzaten Calixta® · Mirzaten® · Remeron® · Remirta®