TEVA 7584 Pill — WHITE OVAL, 9mm — Simvastatin

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ImprintTEVA / 7584
ColourWHITE
ShapeOVAL
Size9
StrengthEZETIMIBE 10 mg;SIMVASTATIN 10 mg
Dosage formTablet
ManufacturerGolden State Medical Supply, Inc.
NDC60429-879
Schedule—
Availability—
IngredientsEZETIMIBE[EZETIMIBE];SIMVASTATIN[SIMVASTATIN]

What does this imprint mean?

The imprint "TEVA 7584" is a code stamped or printed on the tablet or capsule by the manufacturer, used to identify the drug, its strength and the maker.

Active ingredient

Simvastatin

Uses and warnings

No boxed warning present. Major safety concerns include: Myopathy/Rhabdomyolysis (risk factors include age >=65, renal impairment, drug interactions; "discontinue simvastatin if markedly elevated CK levels occur or myopathy is diagnosed or suspected"); Immune-Mediated Necrotizing Myopathy (IMNM), a rare autoimmune condition requiring discontinuation if suspected; Hepatic Dysfunction - "rare reports of fatal and non-fatal hepatic failure have occurred," monitor liver enzymes before and during therapy.

Simvastatin is indicated to: "Reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke" in high-risk patients with established cardiovascular disease or diabetes; lower LDL cholesterol in primary hyperlipidemia and familial hypercholesterolemia; treat hypertriglyceridemia and primary dysbetalipoproteinemia as dietary adjunct.

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Official references

Source: FDA Structured Product Label via NLM Pillbox archive (retired 2021); source file 9350e6bd-7384-2034-e053-2a95a90a266b.xml