Simvastatin

Table of contents

  • Brand Names
  • Drug Combinations
  • Chemistry
  • Pharmacologic Category
  • Mechanism of Action
  • Therapeutic Use
  • Pregnancy and Lactation Implications
  • Contraindications
  • Warnings and Precautions
  • Adverse Reactions
  • Caution and personalized dose adjustment in patients with the following genotypes
  • Other genes that may be involved
  • Substrate of
  • Inhibits
  • Induces
  • Drug Interactions
  • Nutrition/Nutraceutical Interactions
  • Dosage
  • Pharmacokinetics and Pharmacodynamics
  • Special Considerations

Brand Names

Europe

Austria: Gerosim, Nyzoc, Simvarcana, Simvastabene, Simvastad, Simvastatin, Simvatin, Simzol, Stadastatin, Zocord; Belgium: Cholemed, Simvafour, Simvastatin, Simvastatine, Zocor; Bulgaria: Actalipid, Hollesta, Neosimva, Simgal, Simvacor, SimvaHexal, Simvastatin, Vabadin, Vasilip, Zeplan, Zocor, Zostatin; Cyprus: Amvestin, Kymazol, Priacin, Simva Tad, Simvastatin, Vasilip, Zocor; Czech Republic: Apo-Simva, Coralip, Corsim, Egilipid, Gensi, Sim, Simbela, Simgal, Simirex, Simva, Simvacard, Simvastatin, Simvax, Simvor, Vabadin, Vasilip, Zocor; Denmark: Perichol, Simvacop, Simvastatin, Zocor; Estonia: Simgal, Simvacor, Simvagamma, Simvastatin, Simvor, Vabadin, Vasilip, Zocor; Finland: Lipcut, Simvastatin, Zocor; France: Lodales, Simvastatine, Zocor; Germany: Simvastatin, Sigalip, Simva, Simvabeta, Simvacard, Simvacor, SimvaDo, Simvadoc, Simvadura, SimvaFr, Simvagamma, Simbahexal, Simvakreuz, Simvalip, SimvaMi, Simvastatin, Vytorin, Zeklen, Zocor; Greece: Antichol, Arstatin, Avatratin, Bevostatin, Christatin, Doctiverine, Extrastatin, Glipal, Goldastatin, Iamastatin, Ipramid, Kymazol, Lepur, Lip-Down, Lipexal, Lipomin, Lipopess, Liporex, Lipozid, Lowcholid, Lusimva, Medistatin-Raldex, Nezatin, Nitastin, Normotherin, Placol, Pravostin, Prelon, Priacin, Prizelip, Raptor, Ravostan, Redusterol, Simvacor, Simvalark, Simvalid, Simvaprol, Simvastatin, Simvasterol, Simvastil, Simvatin, Sivinar, Sotovastin, Starezin, Stasiva, Statinal, Statinum, Stativer, Statosan, Stazor, Sterylip, Symstin, Tremital, Vassor, Vastatin, Velkastatin, Veristin, Veritrat, Zocor, Zurocid; Hungary: Andever, Awestatin, Sicor, Simvacol, Simvagamma, Simvastatin, Simvep, Simvor, Statonex, Vasilip, Zavixin, Zocor; Ireland: Ritechol, Simator, Simcovas, Simtan, Simvastatin, Simzor, Sivatin, Zocor; Italy: Alpheus, Krustat, Lipenil, Liponorm, Medipo, Omistat, Quibus, Setorilin, Simbatrix, Simvastat, Sincol, Sinvacor, Sinvat, Sivastin, Turstat, Vastin, Xipocol, Zocor; Latvia: Simgal, Simvacor, Simvagamma, Simvalimit, Simvastatin, Vabadin, Vasilip, Zocor; Lithuania: Simgal, Simvacor, Simvastatin, Vabadin, Vasilip; Luxembourg: Docsimvasta, Simvahexal, Simvastatin, Simvastatine, Zocor; Malta: Ritechol, Simvacor, Sivacor, Simvastatin; Netherlands: Marsim, Simvalip, Simvastad, Simvastatine, Vabadin, Zocor; Poland: Angiolip, Apo-Simva, Cardin, Corr, Egilipid, Simcovas, Simgal, Simratio, Simredin, Simvacard, Simvachol, Simvacor, Simvagamma, Simvagen, SimvaHexal, Simvalip, Simvastatin, Simvastatinum, Simvasterol, SimvaTeva, Simvor, Sorfox, Symwastatyna, Vabadin, Vasilip, Vastan, Ximve, Zavinyx, Zifam, Zocor; Portugal: Actalipid, Dislipina, Jabastatina, Simvacol, Simvasim, Sinpor, Sinvastatina, Sinvastil, Zera, Zocor; Romania: Clerivas, Ranvor, Simcor, Simgal, Simva Tad, Simvacard, Simvagamma, Simvahexal, Simvastatin, Simvastatina, Sintenal, Vabadin, Vasilip, Zaredil, Zeplan, Zocor; Slovakia: Gensi, Simgal, Simva, Simvacard, Simvastatin, Simvor, Vabadin, Vasilip, Zocor; Slovenia: Actalipid, Simvastain; Spain: Alcosin, Arudel, Belmalip, Colemin, Glutasey, Histop, Lipociden, Pantok, Simvastatina, Zocor; Sweden: Simvastatin, Vabadin, Vasta, Zocord; UK: Simvador, Simvastatin, Zocor.

North America

Canada: Simvastatin, Zocor; USA: Simvastatin, Zocor.

Latin America

Argentina: Coleflux, Colesterminol, Dosavastatín, Gemistatín, Klonastín, Labistatín, Lipoblock, Lipomax, Lisac, Nivelipol, Nosterol, Redusterol, Salvaxil, Sevacol, Several, Simvastatín, Simvastatina, Simvastec, Sistatin, Tanavat, Vasotenal, Zocor; Brazil: Clinfar, Lipotex, Liptrat, Menocol, Mivalen, Revastín, Sinvalip, Sinvane, Sinvascor, Sinvastamed, Sinvastatina, Sinvaston, Sinvatrox, Sinvax, Vaslip, Vastatil, Zocor; Mexico: Apomastina, Colesken, Cotritev, Diskolestina, Imbistad, Nafatab, Nodolip, Pulsar-At-Dual, Ranvor, Simvastatina, Sinncord, Sitatinal, Xintilan, Zeid, Zocor, Zorced.

Asia

Japan: Lipoaut, Lipoblock, Lipodown, Lipokoban, Lipola M, Lipo-off, Lipovas, Lipovatol, Lipozart, Ramian, Silovastin, Simvamerck, Simvastatin, Sinstatin.

Drug combinations

Simvastatin and Ezetimibe

Simvastatin and Niacin (Vitamin B~3~)

Chemistry

Simvastatin: C~25~H~38~O~5~. Mw: 418.57. (1) Butanoic acid, 2,2-dimethyl-, 1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),8aβ]]-; (2) 2,2-Dimethylbutyric acid, 8-ester with (4R,6R)-6-[2-[(1S,2S,6R,8S,8aR)-1,2,6,7,8,8a-hexahydro-8-hydroxy-2,6-dimethyl-1-naphthyl]ethyl]tetrahydro-4-hydroxy-2H-pyran-2-one. CAS-79902-63-9 (1987).

Pharmacologic Category

Antilipemic Agents; HMG-CoA Reductase Inhibitors. (ATC-Code: C10AA01).

Mechanism of action

Prodrug requiring hydrolysis in vivo for activity. Inhibits HMG-CoA reductase, causing subsequent reduction in hepatic cholesterol synthesis. Reduces serum concentrations of total cholesterol, LDL-C, Apo B, and triglycerides. Statins may slow progression and/or induce regression of atherosclerosis in coronary and/or carotid arteries, modulate blood pressure in hypercholesterolemic patients with hypertension, and possess anti-inflammatory activity.

Therapeutic use

Secondary prevention of cardiovascular events in hypercholesterolemic patients with established coronary heart disease or at high risk for coronary heart disease. Hyperlipidemias (primary hypercholesterolemia, homozygous familial hypercholesterolemia, heterozygous familial hypercholesterolemia).

Pregnancy and lactiation implications

Contraindicated in pregnancy and lactation. Administer to women of childbearing potential only when conception is highly unlikely.

Unlabeled use

Contraindications

Hypersensitivity to simvastatin or any component of the formulation. Active liver disease. Unexplained persistent elevations of serum transaminases. Pregnancy. Breast-feeding.

Warnings and precautions

Patients receiving HMG-CoA reductase inhibitors developed rhabdomyolysis with acute renal failure and/or myopathy. Temporarily discontinue for elective major surgery, acute medical or surgical conditions, or in any patient experiencing acute or serious condition predisposing to renal failure (e.g. sepsis, hypotension, trauma, uncontrolled seizures). Based upon current evidence, HMG-CoA reductase inhibitor therapy should be continued in perioperative period unless risk outweighs cardioprotective benefit. Use caution in renal impairment, inadequately treated hypothyroidism, and patients taking other drugs associated with myopathy (e.g. colchicine). Use with caution in patients who consume large amounts of ethanol or have history of liver disease. Use contraindicated with active liver disease and with unexplained transaminase elevations. Use with caution in patients taking strong CYP3A4 inhibitors, and in advanced age (risk for myopathy).

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