Monograph B01AE07 - Dabigatran Etexilate
Propably not porphyrinogenic
PNP
Rationale
Dabigratan is not a substrate, an inhibitor or an inducer of CYP isoenzymes.
Risk for gastrointestinal adverse events in the form of nausea and diarrhoea motivates vigilance against insufficient intake of food, especially of carbohydrate.
Therapeutic characteristics
Rivaroxoban is indicated for the prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery.
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 abdominal pain, diarrhoea, dyspepsia and nausea. Less common side effects are vomiting and elevated liver enzymes.
Metabolism and pharmacokinetics
Dabigatran etexilate is hydrolysed to dabigatran, which is the active form in plasma, by esterases. It is then subject to conjugation forming pharmacologically active acylglucuronides which accounts for less than 40% of the total dabigatran in plasma. Dabigatran is eliminated primarily in the unchanged form in the urine (SPC and Stangier 2008). Dabigatran etexilate is not a substrate, an inhibitor, or an inducer of CYP isoenzymes (Stangier 2008, 2009 and SPC).
A randomized, open label, three-way cross over design study showed that atorvastatin (a substrate and inhibitor of CYP3A4) had no influence on the pharmacokinetics and pharmacodynamic profile of dabigatran, and vice versa, dabigratan etexilate had no impact on the pharmacokinetics and pharmacodynamics profile of atorvastatin (Stangier 2009). This study confirms that dabigatran is not a substrate, an inhibitor or an inducer of CYP3A4.
Similar drugs
References #
Citation details
PMID
* Scientific articles 1.
Coadministration of dabigatran etexilate and atorvastatin: assessment of potential impact on pharmacokinetics and pharmacodynamics.
Stangier J, Rathgen K, et al. Am J Cardiovasc Drugs. 2009;9(1):59-68
19178132 2.
Clinical pharmacokinetics and pharmacodynamics of the oral direct thrombin inhibitor dabigatran etexilate.
Stangier J. Clin Pharmacokinet. 2008;47(5):285-95.
18076218 * Summary of Product Characteristics 3.
Norwegian medicines agency. Summary of Product Characteristics (SPC). dabigratanetexilat.
Tradenames
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Dabigatran etexilaat 1A Pharma 110 mg, harde capsules · Dabigatran etexilaat 1A Pharma 150 mg, harde capsules · Dabigatran etexilaat 1A Pharma 75 mg, harde capsules · Dabigatran etexilaat Accord 110 mg harde capsules · Dabigatran etexilaat Accord 150 mg harde capsules · Dabigatran etexilaat Accord 75 mg harde capsules · Dabigatran Etexilaat Adamed 110 mg harde capsules · Dabigatran Etexilaat Adamed 150 mg harde capsules · Dabigatran Etexilaat Adamed 75 mg harde capsules · Dabigatran etexilaat Biocon 110 mg harde capsules · Dabigatran etexilaat Biocon 150 mg harde capsules · Dabigatran etexilaat Biocon 75 mg harde capsules · Dabigatran etexilaat Centrafarm 110 mg, harde capsules · Dabigatran etexilaat Centrafarm 150 mg, harde capsules · Dabigatran etexilaat Centrafarm 75 mg, harde capsules · Dabigatran etexilaat CF 110 mg, harde capsules · Dabigatran etexilaat CF 150 mg, harde capsules · Dabigatran etexilaat CF 75 mg, harde capsules · Dabigatran etexilaat HCS 110 mg harde capsules · Dabigatran etexilaat HCS 150 mg harde capsules · Dabigatran etexilaat HCS 75 mg harde capsules · Dabigatran etexilaat Sandoz 110 mg, harde capsules · Dabigatran etexilaat Sandoz 150 mg, harde capsules · Dabigatran etexilaat Sandoz 75 mg, harde capsules · Dabigatran etexilaat STADA 110 mg, harde capsules · Dabigatran etexilaat STADA 150 mg, harde capsules · Dabigatran etexilaat STADA 75 mg, harde capsules · Dabigatran etexilaat Viatris 110 mg harde capsules · Dabigatran etexilaat Viatris 150 mg harde capsules · Dabigatran etexilaat Viatris 75 mg harde capsules · Dabigatran etexilaat Xiromed 110 mg harde capsules · Dabigatran etexilaat Xiromed 150 mg harde capsules · Dabigatran etexilaat Xiromed 75 mg harde capsules · Dabigatran Teva 110 mg harde capsules · Dabigatran Teva 150 mg harde capsules · Dabigatran Teva 75 mg harde capsules · Dabiperel 110 mg harde capsules · Dabiperel 150 mg harde capsules · Dabiperel 75 mg harde capsules · Pradaxa 110 mg harde capsules · Pradaxa 110 mg omhuld granulaat · Pradaxa 150 mg harde capsules · Pradaxa 150 mg omhuld granulaat · Pradaxa 20 mg omhuld granulaat · Pradaxa 30 mg omhuld granulaat · Pradaxa 40 mg omhuld granulaat · Pradaxa 50 mg omhuld granulaat · Pradaxa 75 mg harde capsules · Tuxanuva 110 mg, harde capsules · Tuxanuva 150 mg, harde capsules · Tuxanuva 75 mg, harde capsules Dabigatran · Dabigatran Etexilaat · Dabigatran Etexilaat HCS 110 mg g?l. · Dabigatran Etexilaat HCS 150 mg g?l. · Dabigatran Etexilaat HCS 75 mg g?l. · Dabigatran Etexilate Accord 110 mg g?l. · Dabigatran Etexilate Accord 150 mg g?l. · Dabigatran Etexilate Accord 75 mg g?l. · Dabigatran Etexilate EG 110 mg g?l. · Dabigatran Etexilate EG 150 mg g?l. · Dabigatran Etexilate EG 75 mg g?l. · Dabigatran Etexilate Eurogenerics 110 mg g?l. · Dabigatran Etexilate Eurogenerics 150 mg g?l. · Dabigatran Etexilate Eurogenerics 75 mg g?l. · Dabigatran Etexilate Liconsa 110 mg g?l. · Dabigatran Etexilate Liconsa 150 mg g?l. · Dabigatran Etexilate Liconsa 75 mg g?l. · Dabigatran Etexilate Sandoz 110 mg g?l. · Dabigatran Etexilate Sandoz 150 mg g?l. · Dabigatran Etexilate Sandoz 75 mg g?l. · Dabigatran Etexilate Teva 110 mg g?l. · Dabigatran Etexilate Teva 150 mg g?l. · Dabigatran Etexilate Teva 75 mg g?l. · Dabigatran Etexilate Viatris 110 mg g?l. · Dabigatran Etexilate Viatris 150 mg g?l. · Dabigatran Etexilate Viatris 75 mg g?l. · Pradaxa · Pradaxa 110 mg g?l. · Pradaxa 110 mg gran. enr. sachet · Pradaxa 150 mg g?l. · Pradaxa 150 mg gran. enr. sachet · Pradaxa 20 mg gran. enr. sachet · Pradaxa 30 mg gran. enr. sachet · Pradaxa 40 mg gran. enr. sachet · Pradaxa 50 mg gran. enr. sachet · Pradaxa 75 mg g?l. Bigetra · Bigetra 75 mg Capsulas Duras efg · Dabidose 110 mg Capsulas Duras efg · Dabidose 150 mg Capsulas Duras efg · Dabidose 75 mg Capsulas Duras efg · Dabigatr?n Etexilato Normon 110 mg c?Psulas Duras efg · Dabigatr?n Etexilato Normon 150 mg c?Psulas Duras efg · Dabigatr?n Etexilato Normon 75 mg c?Psulas Duras efg · Dabigatr?n Etexilato Pensa 110 mg c?Psulas Duras efg · Dabigatr?n Etexilato Stada 110 mg Capsulas Duras efg · Dabigatr?n Etexilato Stada 150 mg Capsulas Duras efg · Dabigatr?n Etexilato Stada 75 mg Capsulas Duras efg · Dabigatran Etexilato · Dabigatrán Etexilato · Dabigatran Etexilato Accord 110 mg Capsulas Duras efg · Dabigatran Etexilato Accord 150 mg Capsulas Duras efg · Dabigatran Etexilato Accord 75 mg Capsulas Duras efg · Dabigatran Etexilato Adamed 110 mg Capsulas Duras efg · Dabigatran Etexilato Adamed 150 mg Capsulas Duras · Dabigatran Etexilato Adamed 75 mg Capsulas Duras efg · Dabigatran Etexilato Cinfa 110 mg Capsulas Duras efg · Dabigatran Etexilato Combix 110 mg Capsulas Duras efg · Dabigatran Etexilato Combix 75 mg Capsulas Duras efg · Dabigatran Etexilato Krka 110 mg Capsulas Duras efg · Dabigatran Etexilato Krka 150 mg Capsulas Duras efg · Dabigatran Etexilato Krka 75 mg Capsulas Duras efg · Dabigatran Etexilato Liconsa 110 mg Capsulas Duras efg · Dabigatran Etexilato Liconsa 150 mg Capsulas Duras efg · Dabigatran Etexilato Pensa 150 mg Capsulas Duras efg · Dabigatran Etexilato Pensa 75 mg Capsulas Duras efg · Dabigatran Etexilato Sandoz 110 mg Capsulas Duras efg · Dabigatran Etexilato Sandoz 150 mg Capsulas Duras efg · Dabigatran Etexilato Sandoz 75 mg Capsulas Duras efg · Dabigatran Etexilato Stadafarma 110 mg Capsulas Duras efg · Dabigatran Etexilato Stadafarma 75 mg Capsulas Duras efg · Dabigatran Etexilato Tecnigen 150 mg Capsulas Duras efg · Dabigatran Etexilato Teva 110 mg Capsulas Duras efg · Dabigatran Etexilato Teva 150 mg Capsulas Duras efg · Dabigatran Etexilato Tevagen 110 mg Capsulas Duras efg · Dabigatran Etexilato Tevagen 75 mg Capsulas Duras efg · Dabigatran Etexilato Viatris 110 mg c?Psulas Duras efg · Dabigatran Etexilato Viatris 150 mg c?Psulas Duras efg · Dabiprax · Dabiprax 150 mg Capsulas Duras efg · Dabiprax 75 mg Capsulas Duras efg · Pradaxa · PRADAXA 110 mg CAPSULAS DURAS · Pradaxa 110 mg Granulado Recubierto · PRADAXA 150 mg CAPSULAS DURAS · Pradaxa 150 mg Granulado Recubierto · Pradaxa 20 mg Granulado Recubierto · Pradaxa 30 mg Granulado Recubierto · Pradaxa 40 mg Granulado Recubierto · Pradaxa 6,25 mg/ml Polvo y Disolvente Para Solucion Oral · PRADAXA 75 mg CAPSULAS DURAS · Privenax · Privenax 150 mg Capsulas Duras efg · Privenax 75 mg Capsulas Duras efg · Sinplak 110 mg Capsulas Duras efg · Sinplak 150 mg Capsulas Duras efg · Sinplak 75 mg Capsulas Duras efg Dabigatran · Dabigatran Etexilato · Pradaxa DABIGATRAN ETEXILAT LABORATORIOS LICONSA 110 mg · DABIGATRAN ETEXILAT LABORATORIOS LICONSA 150 mg · DABIGATRAN ETEXILAT LABORATORIOS LICONSA 75 mg · DABIGATRAN ETEXILAT LICONSA 110 mg · DABIGATRAN ETEXILAT LICONSA 150 mg · DABIGATRAN ETEXILAT LICONSA 75 mg · DABIGATRAN ETEXILAT VIATRIS 110 mg · DABIGATRAN ETEXILAT VIATRIS 150 mg · DABIGATRAN ETEXILAT VIATRIS 75 mg · DABIGATRAN ETEXILATE ACCORD 110 mg · DABIGATRAN ETEXILATE ACCORD 150 mg · DABIGATRAN ETEXILATE ACCORD 75 mg · DABIGATRAN ETEXILATE ADAMED 110 mg · DABIGATRAN ETEXILATE ADAMED 150 mg · DABIGATRAN ETEXILATE ADAMED 75 mg · DAROXOMB 110 mg · DAROXOMB 150 mg · DAROXOMB 75 mg · DAXANLO 110 mg · DAXANLO 150 mg · DAXANLO 75 mg · GRIBERO 110 mg · GRIBERO 150 mg · GRIBERO 75 mg · PRADAXA 110 mg · PRADAXA 110mg · PRADAXA 150 mg · PRADAXA 150mg · PRADAXA 20 mg · PRADAXA 30 mg · PRADAXA 40 mg · PRADAXA 50 mg · PRADAXA 6,25 mg/ml · PRADAXA 75mg · SIANTA 110 mg · SIANTA 150 mg · SIANTA 75 mg · TELEXER 110 mg · TELEXER 150 mg · WASEDOC 110 mg · WASEDOC 150 mg · WASEDOC 75 mg Dabigatran · Pradaxa Dabigatran etexilate Accord · Dabigatran etexilate Glenmark · Dabigatran etexilate Krka · Dabigatran etexilate Medical Valley · Dabigatran etexilate Orion · Dabigatran etexilate Sandoz · Dabigatran etexilate Stada · Dabigatran etexilate Stada Nordic · Dabigatran etexilate Teva · Dabigatran etexilate Viatris · Dabigatran etexilate Zentiva · Misbadi · Pradaxa Dabigatran Etexilate Accord · Dabigatran etexilate Sandoz · Dabigatran etexilate Zentiva · Pradaxa Abagat · Bigetra · Dabigatran Eteksylan Leon Farma · Dabigatran eteksylan Polpharma · Dabigatran Eteksylan Stada · Dabigatran etexilate +pharma · Dabigatran Etexilate Accord · Dabigatran Etexilate Adamed · Dabigatran etexilate G.L. · Dabigatran etexilate Orion · Dabigatran etexilate Teva · Dabigatran Etexilate Viatris · Danengo · Daroxomb · Daxanlo · Gribero · Mirexan · Pradaxa · Sianta · Telexer · Tuxanuva · Wasedoc · Zali Dabigatran Etexilate EG · Dabigatran Etexilate Eurogenerics · Dabigatran Etexilate Viatris · Pradaxa Dabigatran Etexilate Accord · Dabigatran etexilate Krka · Dabigatran etexilate Medical Valley · Dabigatran etexilate Sandoz · Dabigatran etexilate STADA · Dabigatran etexilate STADA Nordic · Dabigatran Etexilate Teva · Dabigatran Etexilate Viatris · Misbadi · Pradaxa Dabigatran Etexilate Accord · Dabigatran etexilate Glenmark · Dabigatran etexilate Krka · Dabigatran etexilate Orion · Dabigatran etexilate Sandoz · Dabigatran etexilate STADA · Dabigatran etexilate STADA Nordic · Dabigatran etexilate Teva · Dabigatran etexilate Viatris · Misbadi · Pradaxa Bigetra · Dabigatran Etexilate Accord · Dabigatran etexilate Polpharma · Dabigatran Etexilate Stada · Dabigatran etexilate TAD · Dabigatran etexilate Teva · Dabigatran Etexilate Viatris · Danengo · Daxanlo · Gribero · Pradaxa · Telexer Berevin® · Daxanlo · Galipeks® · Pradaxa®