Monograph
N06AX22 - Agomelatine |
Propably not porphyrinogenic |
PNP |
Side effects
Common adverse reactions of agomelatine that can be confused with an acute porphyric attack are nausea, diarrhoea, constipation, abdominal pain and vomiting. These side effects may potentially be porphyrinogenic if leading to a decrease in carbohydrate intake. Another common side effect of agomelatine is elevations of liver enzymes (ALAT and ASAT), which in rare cases give hepatocellular damage. Care should therefore be taken if starting treatment with agomelatine in patients with hepatic injury risk factors.
Rationale
Agomelatine is not an inducer or a mechanism-based inhibitor of CYP enzymes, and is not observed to alter the metabolism of other CYP metabolized drugs. No pharmacokinetic porphyrinogenic effects are suspected.
Chemical description
Naphthalene
Therapeutic characteristics
Agomelatine is a melatonin receptor agonist and a serotonin receptor antagonist which is used in the treatment of major depressive episodes in adults.
It is administered orally.
Metabolism and pharmacokinetics
Agomelatine is mainly metabolized by CYP1A2 (90 %), but CYP2C9 and CYP2C19 are also involved. The majority of agomelatine is excreted in the urine as metabolites. Agomelatine is not an inducer of CYP450 enzymes (in vivo), and not an inhibitor of CYP1A2 (in vivo) or the other CYP450 enzymes (in vitro) (Carney 2011, SPC).
References
# | Citation details | PMID |
---|---|---|
* | Scientific articles | |
1. | Agomelatine for the treatment of major depressive disorder.
Carney RM, Shelton RC. Expert Opin Pharmacother. 2011 Oct;12(15):2411-9. |
21916789 |
* | Summary of Product Characteristics | |
2. | The electronic Medicines Compendium (emc). Summary of Product Characteristics (SPC). (Valdoxan).
|
Similar drugs
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Netherlands
Agomaval · Agomaval 25 mg, filmomhulde tabletten · Agomelatine · Agomelatine Accord 25 mg filmomhulde tabletten · Agomelatine Aurobindo 25 mg, filmomhulde tabletten · Agomelatine betapharm 25 mg filmomhulde tabletten · Agomelatine Cristers 25 mg filmomhulde tabletten · Agomelatine G.L. Pharma 25 mg filmomhulde tabletten · Agomelatine Glenmark 25 mg filmomhulde tabletten · Agomelatine neuraxpharm 25 mg filmomhulde tabletten · Agomelatine Teva 25 mg, filmomhulde tabletten · Lamegom · Lamegom 25 mg, filmomhulde tabletten · Thymanax · Thymanax 25 mg, filmomhulde tablet · Valdoxan · Valdoxan 25 mg, filmomhulde tabletBelgium
Valdoxan · Valdoxan 25 mg compr. pellic.United Kingdom
Agomelatine · Agomelatine 25mg tablets · Valdoxan · Valdoxan 25mg tabletsDenmark
Agodep · Agomelatin · Agomelatin "2care4" · Agomelatin "Glenmark" · Agomelatin "Mylan" · Agomelatin "Nordic Prime" · Agomelatin "Stada" · Agomelatin "Teva" · ValdoxanNorway
ValdoxanPoland
Agolek · Agomelatine +pharma · Agomelatine Adamed · Agomelatine G.L. Pharma · Agomelatine NeuroPharma · Agomelatyna Egis · Lamegom · SEDIVAL · Thymanax · ValdoxanLuxembourg
VALDOXANIceland
Agomelatine · Agomelatine STADA · ValdoxanFinland
Agomelatine ratiopharm · Agomelatine Stada · Agomelatine Viatris · ValdoxanLatvia
Agomelatine · Agomelatine Viatris · Valdoxan · ZilbeaSerbia
Melaxin · Mentela · Mentela®
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