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.
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.
|
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Tradenames and packages
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Netherlands
Dabigatran etexilaat · 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 Medical Valley 110 mg harde capsules · Dabigatran etexilaat Medical Valley 150 mg harde capsules · Dabigatran etexilaat Medical Valley 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 · Dabigatranetexilaat · Dabigatranetexilaat Teva 110 mg harde capsules · Dabigatranetexilaat Teva 150 mg harde capsules · Dabigatranetexilaat Teva 75 mg harde capsules · Dabiperel · Dabiperel 110 mg harde capsules · Dabiperel 150 mg harde capsules · Dabiperel 75 mg harde capsules · Pradaxa · 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 · Tuxanuva 110 mg, harde capsules · Tuxanuva 150 mg, harde capsules · Tuxanuva 75 mg, harde capsulesBelgium
Dabigatran · Dabigatran Etexilate Accord 110 mg gél. · Dabigatran Etexilate Accord 150 mg gél. · Dabigatran Etexilate Accord 75 mg gél. · Dabigatran Etexilate EG 110 mg gél. · Dabigatran Etexilate EG 150 mg gél. · Dabigatran Etexilate EG 75 mg gél. · Dabigatran Etexilate Eurogenerics 110 mg gél. · Dabigatran Etexilate Eurogenerics 150 mg gél. · Dabigatran Etexilate Eurogenerics 75 mg gél. · Dabigatran Etexilate Liconsa 110 mg gél. · Dabigatran Etexilate Liconsa 150 mg gél. · Dabigatran Etexilate Liconsa 75 mg gél. · Dabigatran Etexilate Sandoz 110 mg gél. · Dabigatran Etexilate Sandoz 150 mg gél. · Dabigatran Etexilate Sandoz 75 mg gél. · Dabigatran Etexilate Teva 110 mg gél. · Dabigatran Etexilate Teva 150 mg gél. · Dabigatran Etexilate Teva 75 mg gél. · Dabigatran Etexilate Viatris 110 mg gél. · Dabigatran Etexilate Viatris 150 mg gél. · Dabigatran Etexilate Viatris 75 mg gél. · Dabigatran Etexilaat · Dabigatran Etexilaat HCS 110 mg gél. · Dabigatran Etexilaat HCS 150 mg gél. · Dabigatran Etexilaat HCS 75 mg gél. · Pradaxa · Pradaxa 110 mg gél. · Pradaxa 110 mg gran. enr. sachet · Pradaxa 150 mg gél. · 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 gél.United Kingdom
Dabigatran · Dabigatran etexilate 110mg capsule · Dabigatran etexilate 110mg capsules · Dabigatran etexilate 150mg capsule · Dabigatran etexilate 150mg capsules · Dabigatran etexilate 75mg capsules · Pradaxa · Pradaxa 110mg capsules · Pradaxa 110mg granules sachets · Pradaxa 150mg capsules · Pradaxa 150mg granules sachets · Pradaxa 20mg granules sachets · Pradaxa 30mg granules sachets · Pradaxa 40mg granules sachets · Pradaxa 50mg granules sachets · Pradaxa 75mg capsulesDenmark
Dabigatran · Dabigatran etexilate "Glenmark" · Dabigatran etexilate "Krka" · Dabigatran etexilate "Orion" · Dabigatran etexilate "Sandoz" · Dabigatran etexilate Accord · Dabigatran etexilate Leon Farma · Misbadi · PradaxaNorway
Dabigatran Etexilate Accord · Dabigatran etexilate Sandoz · PradaxaPoland
Abagat · Bigetra · Dabigatran Eteksylan Leon Farma · Dabigatran eteksylan Polpharma · Dabigatran Eteksylan Stada · Dabigatran etexilate +pharma · Dabigatran Etexilate Accord · Dabigatran Etexilate Adamed · Dabigatran etexilate Orion · Dabigatran Etexilate Viatris · Danengo · Daroxomb · Daxanlo · Gribero · Mirexan · Pradaxa · Sianta · Telexer · Tuxanuva · Wasedoc · ZaliLuxembourg
Dabigatran · Dabigatran Etexilate EG · Dabigatran Etexilate Eurogenerics · Dabigatran Etexilate Viatris · PradaxaIceland
Dabigatran · Dabigatran Etexilate Accord · Dabigatran etexilate Krka · Dabigatran Etexilate Leon Farma · Dabigatran etexilate Sandoz · Dabigatran etexilate STADA · Dabigatran etexilate STADA Nordic · Dabigatran Etexilate Viatris · Misbadi · PradaxaFinland
Dabigatran · Dabigatran etexilate Leon Farma · 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 · PradaxaLatvia
Bigetra · Dabigatran · Dabigatran Etexilate Accord · Dabigatran etexilate Polpharma · Dabigatran Etexilate Stada · Dabigatran etexilate TAD · Dabigatran etexilate Teva · Dabigatran Etexilate Viatris · Danengo · Daxanlo · Gribero · Pradaxa · TelexerSerbia
BEREVIN · BEREVIN® · Daxanlo · Galipeks · Galipeks® · Pradaxa · Pradaxa®
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