Monograph
G04BD08 - Solifenacin |
Propably not porphyrinogenic |
PNP |
Rationale
Solifenacin is extensively metabolized by Cyp3A4, but it has no capacity for Cyp-induction or significant Cyp-inhibition.
Chemical description
Dihydroisoquinoline tertiary amine.
Therapeutic characteristics
Solifenacin is an anticholinergic spasmolytic used in the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and increased urinary frequency.
It is administered orally.
Common adverse reactions of solifenacin that can be confused with an acute porphyric attack are constipation, nausea and abdominal pain.
Side effects such as nausea may be potentially porphyrinogenic through reduction in caloric intake.
Urinary infection is an uncommon side effect but may also potentially be porphyrinogenic.
Metabolism and pharmacokinetics
Solifenacin is eliminated mainly via hepatic metabolism by Cyp3A4, and only 3-13 % is excreted as unchanged drug in urine.
The absolute bioavailability is about 90%. Solifenacin has a high fraction of plasma protein-binding (93-96%). Solifenacin doses not influence the activities of Cyps 1A1, 1A2, 2C9, 2D6 and 3A4, but shows weak and clinically insignificant inhibitory potential for Cyp 2C19 and p-glycoprotein.(Doroshyenko 2009). In a well-controlled therapeutic trial solifenacin did not interact with the metabolism of ethinyl estradiol or levonorgestrel administered in oral contraception. (Taekema-Roelvink 2005).
IPNet drug reports
Uneventful use reported in 2 patients with acute porphyria.
References
# | Citation details | PMID |
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* | Scientific articles | |
1. | Doroshyenko, O., Fur, U. Clinical pharmacokinetics and pharmacodynamics of solifenacin.
Clin Pharmacokinet. 2009;48(5):281-302 |
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2. | E.J., Swart P.J., Pharmacokinetic interaction of solifenacin with an oral contraceptive containing ethinyl estradiol and levonorgestrel in healthy women: a double-blind, placebo-controlled study.
Taekema-Roelvink M. Clin Ther. 2005;27(9):1403-10. |
16291413 |
* | Drug reference publications | |
3. | Sweetman SC, editor. Martindale: The complete drug reference. Solifenacin succinate. Pharmaceutical Press 2009.
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* | Summary of Product Characteristics | |
4. | Norwegian medicines agency. Summary of Product Characteristics (SPC). Vesicare.
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5. | The electronic Medicines Compendium (emc). Summary of Product Characteristics (SPC). Vesicare.
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Similar drugs
Tradenames and packages
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Netherlands
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Pelvicare · Pelvicare 10 mg compr. pellic. · Pelvicare 5 mg compr. pellic. · Solifenacin · Solifenacin Krka 10 mg compr. pellic. · Solifenacin Krka 5 mg compr. pellic. · Solifenacin Sandoz 10 mg compr. pellic. · Solifenacin Sandoz 5 mg compr. pellic. · Solifenacine · Solifenacine AB 10 mg compr. pellic. · Solifenacine AB 5 mg compr. pellic. · Solifenacine EG 10 mg compr. pellic. · Solifenacine EG 5 mg compr. pellic. · Solifenacine Teva 10 mg compr. pellic. · Solifenacine Teva 5 mg compr. pellic. · Solifenacine Viatris 10 mg compr. pellic. · Solifenacine Viatris 5 mg compr. pellic. · Vesicare · Vesicare 1 mg/ml susp. buv. · Vesicare 10 mg compr. pellic. · Vesicare 5 mg compr. pellic.United Kingdom
Giraxine · Giraxine 10mg tablets · Giraxine 5mg tablets · Solifenacin · Solifenacin 10mg tablets · Solifenacin 10mg/5ml oral solution · Solifenacin 10mg/5ml oral suspension · Solifenacin 5mg tablets · Solifenacin 5mg/5ml oral solution sugar free · Vesicare · Vesicare 10mg tablets · Vesicare 1mg/ml oral suspension · Vesicare 5mg tabletsDenmark
Solifenacin · Solifenacin "Krka" · Solifenacin "Medical Valley" · Solifenacin "Sandoz" · Solifenacin "Stada" · Solifenacin "Viatris" · Solifenacinsuccinat · Solifenacinsuccinat "Accord" · Solifenacinsuccinat "Teva" · Soliteva · Vesacin · VesicareNorway
Solifenacin Accord · Solifenacin Krka · Solifenacin Sandoz · Solifenacin Viatris · VesicarePoland
Adablok · Afenix · Anturin · Asolfena · Aurosolin · Belaristo · Beloflow · Nifelox · Silamil · Solifenacin Medreg · Solifenacin PMCS · Solifenacin Sandoz · Solifenacin Stada · Solifenacin US Pharmacia · Solifenacin Vivanta · Solifurin · Solinco · Soreca · Urocare · Uronorm · Veloxsol · Vesicare · Vesicare 10 mg · Vesicare 5 mg · Vesisol · Vesoligo · ZevesinLuxembourg
Pelvicare · Solifenacin · Solifenacin-ratiopharm · Solifenacine · Solifenacine EG · Solifenacine Viatris · VesicareIceland
Solifenacin · Solifenacin Alvogen 10 mg Filmuhúðuð tafla · Solifenacin Alvogen 5 mg Filmuhúðuð tafla · Solifenacin Krka · Solifenacin Viatris · VesicareFinland
Solifenacin Accord · Solifenacin Krka · Solifenacin Mylan · Solifenacin Orion · Solifenacin Ratiopharm · Solifenacin Sandoz · Solifenacin Stada · VesicareLatvia
Asolfena · Gardurin · Solifenacin · Solifenacin NOBEL · Solifenacin PMCS · Tamisten · Vesicare · ZevesinSerbia
Saurus · Saurus® · Solifenacin · Solifenacin Aristo · Solysan · Solysan® · Vesicare · Vesicare™ · Vesifix · Vesifix®
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