Ezetimibe and simvastatin is the generic equivalent of the brand-name drug Ezetimibe and Simvastatin. Licensed pharmacies, clinics, doctor's offices, and veterinary practices can source wholesale Ezetimibe and simvastatin through Premier Pharma with same-day fulfillment on in-stock SKUs.
FDA Drug Information
Indications & Usage
1 INDICATIONS AND USAGE Ezetimibe and Simvastatin Ezetimibe and simvastatin is a combination of simvastatin and ezetimibe indicated: • As an adjunct to diet to reduce elevated low density lipoprotein cholesterol (LDL-C): o In adults with primary hyperlipidemia. o In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). • As an adjunct to other LDL-C-lowering therapies to reduce elevated LDL-C in adults with homozygous familial hypercholesterolemia (HoFH). Simvastatin Simvastatin, when used as a component of ezetimibe and simvastatin, is indicated to reduce the risk of total mortality by reducing risk of coronary heart disease death, non…
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the label: Myopathy and Rhabdomyolysis [see Warnings and Precautions ( 5.1 )] Immune-Mediated Necrotizing Myopathy [see Warnings and Precautions ( 5.2 )] Hepatic Dysfunction [see Warnings and Precautions ( 5.3 )] Increases in HbA1c and Fasting Serum Glucose Levels [see Warnings and Precautions ( 5.4 )] Common (incidence ≥2% and greater than placebo) adverse reactions in clinical trial…
Drug Interactions
7 DRUG INTERACTIONS Ezetimibe and Simvastatin Tablets See full prescribing information for details regarding concomitant use of ezetimibe and simvastatin with other drugs or grapefruit juice that increase the risk of myopathy and rhabdomyolysis. ( 2.3 , 7.1 ) Cholestyramine: Combination decreases exposure of ezetimibe. ( 2.3 , 7.2 ) Coumarin Anticoagulants: Obtain INR before ezetimibe and simvastatin initiation and monitor INR during ezetimibe and simvastatin dosage initiation or adjustment. ( 7…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Important Dosage and Administration Information: (2.1) Take ezetimibe and simvastatin orally once daily in the evening with or without food. Maximum recommended dosage is ezetimibe and simvastatin 10/40 mg once daily. Ezetimibe and simvastatin 10/80 mg daily dosage is restricted to patients who have been taking ezetimibe and simvastatin 10/80 mg daily chronically (e.g., for 12 months or more) without evidence of muscle toxicity. For patients that require a high-intens…
Patient Counseling Information
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Myopathy and Rhabdomyolysis Advise patients that ezetimibe and simvastatin tablets may cause myopathy and rhabdomyolysis. Inform patients taking the 80 mg daily dose of simvastatin that they are at an increased risk. Inform patients that the risk is also increased when taking certain types of medication or consuming grapefruit juice and they should discuss all medication, both prescription and over the counter, with their healthcare provider. Instruct patients to inform other h…
Source: FDA. For professional use only. Not a substitute for prescribing information.
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