Monograph
N06AX21 - Duloxetine |
Propably not porphyrinogenic |
PNP |
Rationale
The drug is metabolized by CYPs 1A2 and 2D6. It is not a substrate of, and thus not an inducer of or an inhibitor of CYP 3A4. There are therefore no non-clinical findings suggesting porphyrogenicity, nor are there any reports of interference with CYP3A4-metabolism of other drugs. There is one published report of duloxetine and an acute attack of porphyria variagata, but the clinical data question the causality of this observation.
Chemical description
(+)-(S)-N-Methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. M =333.9. There are no chemical moieties within the drug pointing to capacity for action as CYP suicide substrate.
Therapeutic characteristics
Duloxetine is a combined serotonin (5-HT) and norepinephrine (NE) reuptake inhibitor (SNRI), which weakly inhibits dopamine reuptake. The common side effects may mimic symptoms of acute porphyria, i.e. tachycardia, agitation, abdominal pain, nausea, vomiting, obstipation, musculoskeletal pain, paraesthesias. Should these occur, for sake of safety PBG excretion should be monitored for a few days, or (perhaps preferably) the patient should be instructed to initially observe the color of urine and without delay report reddish discoloration.
Hepatic exposure
With a daily peroral dose of 60 mg there is significant hepatic exposure, i.e > 1 micromolar.
Metabolism and pharmacokinetics
Duloxetine is extensively metabolised, primarily by the liver. The bioavailability is 32-80 percent. Duloxetine is metabolised by CYP 1A2 and CYP 2D6, it moderatly inhibits CYP 2D6, it does not affect the CYP 3A4 isoenzyme (European public assessment report, 2005). Large difference in exposure between women and men, with women having twice as large exposure to the drug.
Preclinical data
No published information.
Published experience
There is one published report of duloxetine and an acute attack of porphyria variagata. The symptoms which the patient had experienced such as painful and ulcerating red rash, severe abdominal pain with constipation and vomiting, paresthesias, and worsening depression and anxiety, along with hallucinations, paranoia and suicidality ( Loper T et al. 2007 ) are all side effects of duloxetine ( Marindale ). But in the case report the side effects of duloxetine were suspected to be the symptoms of acute porphyria. Since this case report lacks biochemical evidence such as measurements of PBG excretion for a couple of days etc., the causality could not be established.
IPNet drug reports
1 report of uneventful use in acute porphyria.
Similar drugs
References
| # | Citation details | PMID |
|---|---|---|
| * | Scientific articles | |
| 1. | An acute attack of porphyria in a patient taking duloxetine.
Loper T, Touchet B. Psychosomatics. 2007;48(2):179-80. |
|
| * | Drug reference publications | |
| 2. | Martindale
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| * | Government bodies | |
| 3. | European Public Assessment Report, Cymbalta (Scientific discussion).European Medicines Agency. emea.europa.eu.
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| * | Other sources | |
| 4. | Norwegian National Formulary
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Tradenames
This list comprises raw data collected from different countries.
In some cases, a more comprehensive list of available drug packages is included.
Consequently, very similar terms may therefore appear multiple times.
Bold names are the searchable terms, while 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.
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Cymbalta 30 mg, maagsapresistente capsule, hard · Cymbalta 60 mg, maagsapresistente capsules, hard · Dulasolan 30 mg harde maagsapresistente capsules · Dulasolan 60 mg harde maagsapresistente capsules · Dulodet 30 mg harde maagsapresistente capsules · Dulodet 60 mg harde maagsapresistente capsules · Duloxetine Accord 30 mg harde maagsapresistente capsules · Duloxetine Accord 60 mg harde maagsapresistente capsules · Duloxetine Amarox 20 mg, harde maagsapresistente capsules · Duloxetine Amarox 30 mg, harde maagsapresistente capsules · Duloxetine Amarox 40 mg, harde maagsapresistente capsules · Duloxetine Amarox 60 mg, harde maagsapresistente capsules · Duloxetine Aurobindo 30 mg, harde maagsapresistente capsules · Duloxetine Aurobindo 60 mg, harde maagsapresistente capsules · Duloxetine CF 30 mg, harde maagsapresistente capsules · Duloxetine CF 60 mg, harde maagsapresistente capsules · Duloxetine Krka 30 mg harde maagsapresistente capsules · Duloxetine Krka 60 mg harde maagsapresistente capsules · Duloxetine Laboratorios Liconsa 30 mg harde maagsapresistente capsules · Duloxetine Laboratorios Liconsa 60 mg harde maagsapresistente capsules · Duloxetine Liconsa 120 mg harde maagsapresistente capsules · Duloxetine Liconsa 90 mg harde maagsapresistente capsules · Duloxetine Lilly 30 mg, maagsapresistente capsules, hard · Duloxetine Lilly 60 mg, maagsapresistente capsules, hard · Duloxetine Pensa 30 mg harde maagsapresistente capsules · Duloxetine Pensa 60 mg harde maagsapresistente capsules · Duloxetine Sandoz 20 mg, maagsapresistente harde capsules · Duloxetine Sandoz 40 mg, maagsapresistente harde capsules · Duloxetine Sandoz 60 mg, harde maagsapresistente capsules · Duloxetine Teva 30 mg, harde maagsapresistente capsules · Duloxetine Teva 60 mg, harde maagsapresistente capsules · Duloxetine Viatris 30 mg, harde maagsapresistente capsules · Duloxetine Viatris 60 mg, harde maagsapresistente capsules · Duloxetine Xiromed 30 mg harde maagsapresistente capsule · Duloxetine XIromed 60 mg harde maagsapresistente capsule · Duloxetine Zentiva 30 mg, harde maagsapresistente capsules · Duloxetine Zentiva 60 mg, harde maagsapresistente capsules · Dutilox 30 mg harde maagsapresistente capsules · Dutilox 60 mg harde maagsapresistente capsules · Onelar 20mg harde maagsapresistente capsule · Onelar 30mg harde maagsapresistente capsule · Onelar 40mg harde maagsapresistente capsule · Onelar 60mg harde maagsapresistente capsule · Xeristar 60 mg, maagsapresistente capsule, hard · Yentreve 20 mg, maagsapresistente capsules · Yentreve 40 mg, maagsapresistente capsules 
Cymbalta · Cymbalta 30 mg g?l. gastro-r?sist. · Cymbalta 60 mg g?l. gastro-r?sist. · Dulox?tine Viatris 30 mg g?l. gastro-r?sist. · Dulox?tine Viatris 60 mg g?l. gastro-r?sist. · Duloxetin · Duloxetin AB 30 mg g?l. gastro-r?sist. · Duloxetin AB 60 mg g?l. gastro-r?sist. · Duloxetine · Duloxétine · Duloxetine Aurobindo 20 mg g?l. gastro-r?sist. · Duloxetine Aurobindo 40 mg g?l. gastro-r?sist. · Duloxetine EG 30 mg g?l. gastro-r?sist. · Duloxetine EG 60 mg g?l. gastro-r?sist. · Duloxetine Eurogenerics 30 mg g?l. gastro-r?sist. · Duloxetine Eurogenerics 60 mg g?l. gastro-r?sist. · Duloxetine Krka 30 mg g?l. gastro-r?sist. · Duloxetine Krka 60 mg g?l. gastro-r?sist. · Duloxetine Liconsa 120 mg g?l. gastro-r?sist. · Duloxetine Liconsa 90 mg g?l. gastro-r?sist. · Duloxetine Lilly 30 mg g?l. gastro-r?sist. · Duloxetine Lilly 60 mg g?l. gastro-r?sist. · Duloxetine Sandoz 30 mg g?l. gastro-r?sist. · Duloxetine Sandoz 60 mg g?l. gastro-r?sist. · Duloxetine Teva 30 mg g?l. gastro-r?sist. · Duloxetine Teva 60 mg g?l. gastro-r?sist. · Duloxetine Zentiva 30 mg g?l. gastro-r?sist. · Duloxetine Zentiva 60 mg g?l. gastro-r?sist. · Dutilox · Dutilox 30 mg g?l. gastro-r?sist. · Dutilox 60 mg g?l. gastro-r?sist. · Yentreve · Yentreve 20 mg g?l. gastro-r?sist. · Yentreve 40 mg g?l. gastro-r?sist. 
Cymbalta 30 mg Capsulas Duras Gastrorresistentes · Cymbalta 60 mg Capsulas Duras Gastrorresistentes · Dedulox 30 mg Capsulas Duras Gastrorresistentes efg · Dedulox 60 mg Capsulas Duras Gastrorresistentes efg · Dulotex · Dulotex 120 mg Capsulas Duras Gastrorresistentes · Dulotex 30 mg Capsulas Duras Gastrorresistentes efg · Dulotex 60 mg Capsulas Duras Gastrorresistentes efg · Dulotex 60 mg Comprimidos Gastrorresistentes · Dulotex 90 mg Capsulas Duras Gastrorresistentes · Duloxetina · Duloxetina Almus 30 mg Capsulas Duras Gastrorresistentes efg · Duloxetina Alter 30 mg Capsulas Duras Gastrorresistentes efg · Duloxetina Alter 60 mg Capsulas Duras Gastrorresistentes efg · Duloxetina Alter Genericos 30 mg Capsulas Duras Gastrorresistentes efg · Duloxetina Alter Genericos 60 mg Capsulas Duras Gastrorresistentes efg · Duloxetina Apotex ag 30 mg Capsulas Duras Gastrorresistentes efg · Duloxetina Apotex ag 60 mg Capsulas Duras Gastrorresistentes efg · Duloxetina Aristo 30 mg Capsulas Duras Gastrorresistentes efg · Duloxetina Aristo 60 mg Capsulas Duras Gastrorresistentes efg · Duloxetina Aurovitas 30 mg Capsulas Duras Gastrorresistentes efg · Duloxetina Aurovitas 60 mg Capsulas Duras Gastrorresistentes efg · Duloxetina Cinfa 60 mg Capsulas Duras Gastrorresistentes efg · Duloxetina Cinfamed 120 mg Capsulas Duras Gastrorresistentes · Duloxetina Cinfamed 30 mg Capsulas Duras Gastrorresistentes efg · Duloxetina Cinfamed 60 mg Capsulas Duras Gastrorresistentes efg · Duloxetina Combix 60 mg Capsulas Duras Gastrorresistentes efg · Duloxetina Durban 60 mg Capsulas Duras Gastrorresistentes efg · Duloxetina Eignapharma 30 mg Casulas Duras Gastrorresistentes efg · Duloxetina Genesis 30 mg Capsulas Duras Gastrorresistentes efg · Duloxetina Genesis 60 mg Capsulas Duras Gastrorresistentes efg · Duloxetina Kern Pharma 20 mg Capsulas Duras Gastrorresistentes efg · Duloxetina Kern Pharma 30 mg c?Psulas Duras Gastrorresistentes efg · Duloxetina Kern Pharma 40 mg Capsulas Duras Gastrorresistentes efg · Duloxetina Kern Pharma 60 mg c?Psulas Duras Gastrorresistentes efg · Duloxetina Krka 30 mg Capsulas Duras Gastrorresistentes efg · Duloxetina Krka 60 mg Capsulas Duras Gastrorresistentes efg · Duloxetina Liconsa 120 mg c?Psulas Duras Gastrorresistentes · Duloxetina Liconsa 90 mg c?Psulas Duras Gastrorresistentes · Duloxetina Mabo 20 mg Capsulas Duras Gastrorresistentes efg · Duloxetina Mabo 30 mg Capsulas Duras Gastrorresistentes efg · Duloxetina Mabo 40 mg Capsulas Duras Gastrorresistentes efg · Duloxetina Mabo 60 mg Capsulas Duras Gastrorresistentes efg · Duloxetina Mabo Farma 60 mg Capsulas Duras Gastrorresistentes efg · Duloxetina Normon 120 mg Capsulas Duras Gastrorresistentes · Duloxetina Normon 30 mg Capsulas Duras Gastrorresistentes efg · Duloxetina Pensa Pharma 30 mg Capsulas Duras Gastrorresistentes efg · Duloxetina Pensa Pharma 60 mg Capsulas Duras Gastrorresistentes efg · Duloxetina Pharmakern 30 mg Capsulas Duras Gastrorresistentes efg · Duloxetina Pharmakern 60 mg Capsulas Duras Gastrorresistentes efg · Duloxetina Qualigen 30 mg Capsulas Duras Gastrorresistentes efg · Duloxetina Qualigen 60 mg Capsulas Duras Gastrorresistentes efg · Duloxetina Ratio 30 mg Capsulas Duras Gastrorresistentes efg · Duloxetina Ratio 60 mg Capsulas Duras Gastrorresistentes efg · Duloxetina Ratiopharm 30 mg Capsulas Duras Gastrorresistentes efg · Duloxetina Ratiopharm 60 mg Capsulas Duras Gastrorresistentes efg · Duloxetina Rodio 30 mg Capsulas Duras Gastrorresistentes efg · Duloxetina Rodio 60 mg Capsulas Duras Gastrorresistentes efg · Duloxetina Sandoz 30 mg Capsulas Duras Gastrorresistentes efg · Duloxetina Sandoz 60 mg Capsulas Duras Gastrorresistentes efg · Duloxetina spi 30 mg Capsulas Duras Gastrorresistentes efg · Duloxetina spi 60 mg Capsulas Duras Gastrorresistentes efg · Duloxetina Stada 30 mg Capsulas Duras Gastrorresistentes efg · Duloxetina Stada 60 mg Capsulas Duras Gastrorresistentes efg · Duloxetina Stadagen 60 mg Capsulas Gastrorresistentes efg · Duloxetina Tarbis 30 mg Capsulas Duras Gastrorresistentes efg · Duloxetina Tarbis 60 mg Capsulas Duras Gastrorresistentes efg · Duloxetina Tarbis Farma 60 mg Capsulas Duras Gastrorresistentes efg · Duloxetina Tecnigen 30 mg Capsulas Duras Gastrorresistentes efg · Duloxetina Tecnigen 60 mg Capsulas Duras Gastrorresistentes efg · Duloxetina Teva 30 mg Capsulas Duras Gastrorresistentes efg · Duloxetina Teva 60 mg Capsulas Duras Gastrorresistentes efg · Duloxetina Tevagen 30 mg Capsulas Duras Gastrorresistentes efg · Duloxetina Tevagen 60 mg Capsulas Duras Gastrorresistentes efg · Duloxetina Tillomed 30 mg Capsulas Duras Gastrorresistentes efg · Duloxetina Viatris Pharmaceuticals 30 mg Capsulas Duras Gastrorresistentes efg · Duloxetina vir 30 mg Capsulas Duras Gastrorresistentes efg · Duloxetina vir 60 mg Capsulas Duras Gastrorresistentes efg · Duloxetina Zentiva 30 mg Capsulas Duras Gastrorresistentes efg · Duloxetina Zentiva 60 mg Capsulas Duras Gastrorresistentes efg · DULVAS 30 mg CAPSULAS DURAS GASTRORRESISTENTES EFG · DULVAS 60 mg CAPSULAS DURAS GASTRORRESISTENTES EFG · Dulxetenon 30 mg Capsulas Duras Gastrorresistentes efg · Dulxetenon 60 mg Capsulas Duras Gastrorresistentes efg · Lasdul · Lasdul 30 mg Capsulas Duras Gastrorresistentes efg · Ludotim · Ludotim 90 mg Capsulas Duras Gastrorresistentes · Nixenca 30 mg Capsulas Duras Gastrorresistentes efg · Nixenca 60 mg Capsulas Duras Gastrorresistentes efg · Nodetrip 30 mg Capsulas Duras Gastrorresistentes · Nodetrip 60 mg Capsulas Duras Gastrorresistentes · Oxitril · Oxitril 30 mg Comprimidos Gastrorresistentes · Oxitril 60 mg Comprimidos Gastrorresistentes · Oxitril 90 mg Capsulas Duras Gastrorresistentes · Uxagam 30 mg Capsulas Duras Gastrorresistentes · Uxagam 60 mg Capsulas Duras Gastrorresistentes · Xeristar · Xeristar 30 mg Capsulas Duras Gastrorresistentes efg · Xeristar 60 mg Capsulas Duras Gastrorresistentes efg · Xeristar 90 mg Capsulas Duras Gastrorresistentes · YENTREVE 20 mg CAPSULAS DURAS GASTRORRESISTENTES · YENTREVE 40 mg CAPSULAS DURAS GASTRORRESISTENTES 
Alikres · Cymbalta · Dulex · Duloxetina · Dulxetenon · Ezequa · Siloxezol 
CYMBALTA 30mg · CYMBALTA 60mg · DULOXETINA DR. REDDY'S 30 mg · DULOXETINA DR. REDDY'S 60 mg · DULOXETINA STADA 30 mg · DULOXETINA STADA 60 mg · DULOXETINA TERAPIA 30 mg · DULOXETINA TERAPIA 60 mg · DULOXETINE ZENTIVA 30 mg · DULOXETINE ZENTIVA 60 mg · DULSEVIA 30 mg · DULSEVIA 60 mg · DULSEVIA 90 mg · ONELAR 20 mg · ONELAR 30 mg · ONELAR 40 mg · ONELAR 60 mg · ZATINEX 30 mg · ZATINEX 60 mg 
Cymbalta · Depalta · Duciltia · Duloxetine · Dutor · Yentreve 
Ariclaim · Aritavi · Cymbalta · Duciltia · Duloxetin Hexal · Duloxetin Krka · Duloxetin Lilly · Duloxetin Stada · Duloxetin Stada Arzneimittel AG · Duloxetine Accord · Duloxetine Medical Valley · Duloxetine Mylan · Duloxetine Orion · Duloxetine Zentiva · Loxentia · Xeristar · Yentreve 
Cymbalta · Duloxetin Pensa · Duloxetine Medical Valley · Duloxetine Viatris · Yentreve 
AuroDulox · Cymbalta · Depratal · Dulofor · Duloxetine +pharma · Duloxetine Lilly · Duloxetine Medical Valley · Duloxetine Mylan · Duloxetine Sandoz · Duloxetine Zentiva · Dulsevia · Dulxetenon · Dutilox · Yentreve 
Cymbalta · Dulox?tine Mylan · Duloxétine · Duloxetine Eurogenerics · Duloxetine Liconsa · Yentreve 
Aritavi · Cymbalta · Duloxetin Krka · Duloxetin W&H · Duloxetine Lilly · Duloxetine Medical Valley · Duloxetine Mylan · Duloxetine Zentiva · Yentreve 
Cymbalta · Duloxetin Stada · Duloxetine Accord · Duloxetine Accordpharma · Duloxetine Krka · Duloxetine Liconsa · Duloxetine Lilly · Duloxetine Orion · Duloxetine Viatris · Duloxetine Zentiva · Loxentia · Yentreve 
Cymbalta · Duloxetine Lilly · Duloxetine Viatris · Duloxetine Zentiva · Dulsevia · Onelar · Yentreve 
Dulsevia® · Duxet® · Nexetin® · Taita® · Tenia®
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