ezetimibe and simvastatin 10 mg/1
ezetimibe and simvastatin · TABLET · NORTHSTAR RX LLC
ezetimibe and simvastatin is a tablet containing ezetimibe and simvastatin at 10 mg/1, taken oral. Manufactured by NORTHSTAR RX LLC.
Key Facts
- Brand Name
- ezetimibe and simvastatin
- Generic Name
- ezetimibe and simvastatin
- NDC Code (Product)
16714-779- Manufacturer
- NORTHSTAR RX LLC
- Strength
- 10 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA208699
- Drug Class
- HMG-CoA Reductase Inhibitor [EPC]; Dietary Cholesterol Absorption Inhibitor [EPC]
- Marketing Start
- 08/19/2019
Recall History
Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Golden State Medical Supply Inc.
Failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured using an excipient found to be OOS for conductivity and some Ezetimibe and Simvastatin Tablets, 10 mg/10 mg were found in the bottle
Dr. Reddy's Laboratories, Inc.
Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
Dr. Reddy's Laboratories, Inc.
Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
Dr. Reddy's Laboratories, Inc.
Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
Dr. Reddy's Laboratories, Inc.
Failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured using an excipient found to be OOS for conductivity and some Ezetimibe and Simvastatin Tablets, 10 mg/10 mg were found in the bottle
Golden State Medical Supply Inc.
Failed Excipient Specification; product manufactured using an excipient found to be OOS for conductivity
Dr. Reddy's Laboratories, Inc.
Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
Merck Sharp & Dohme, Wilson Facility
Presence of Foreign Tablet/Capsule: Vytorin 10 mg/40 mg tablets were found in bottles of Vytorin 10 mg/20 mg tablets.
Dr. Reddy's Laboratories, Inc.
Presence of Foreign Substance: Product complaint of black speckles observed on tablets.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. Ezetimibe and simvastatin tablets, which contain a cholesterol absorption inhibitor and an HMG-CoA reductase inhibitor (statin), are indicated as adjunctive therapy to diet to: • reduce elevated total-C, LDL-C, Apo B, TG, and non-HDL-C, and to increase HDL-C in patients with primary (heterozygous familial and non-familial) hyperlipidemia or mixed hyperlipidemia. ( 1.1 ) • reduce elevated total-C and LDL-C in patients with homozygous familial hypercholesterolemia (HoFH), as an adjunct to other lipid-lowering treatments. ( 1.2 ) Limitations of Use ( 1.3 ) • No incremental benefit of ezetimibe and simvastatin tablets on cardiovascular morbidity and mortality over and above that demonstrated for simvastatin has been established. • Ezetimibe and simvastatin tablets have not…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION • Dose range is 10 mg/10 mg/day to 10 mg/40 mg/day. ( 2.1 ) • Recommended usual starting dose is 10 mg/10 mg or 10 mg/20 mg/day. ( 2.1 ) • Due to the increased risk of myopathy, including rhabdomyolysis, use of the 10 mg/80 mg dose of ezetimibe and simvastatin tablets should be restricted to patients who have been taking ezetimibe and simvastatin tablets 10 mg/80 mg chronically (e.g., for 12 months or more) without evidence of muscle toxicity. ( 2.2 ) • Patients who are currently tolerating the 10 mg/80 mg dose of ezetimibe and simvastatin tablets who need to be initiated on an interacting drug that is contraindicated or is associated with a dose cap for simvastatin should be switched to an alternative statin or statin-based regimen with less potential for the drug-drug interaction. ( 2.2 ) • Due to the increased risk of myopathy, including rhabdomyolysis, associated with the 10 mg/80 mg dose of ezetimibe and simvastatin tablets, patients unable to achieve their LDL-C goal utilizing the 10 mg/40 mg dose of ezetimibe and simvastatin tablets should not be titrated to the 10 mg/80 mg dose, but should be placed on alternative LDL-C-lowering treatment(s) that…
Contraindications
4 CONTRAINDICATIONS Ezetimibe and simvastatin tablets are contraindicated in the following conditions: • Concomitant administration of strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, posaconazole, voriconazole, HIV protease inhibitors, boceprevir, telaprevir, erythromycin, clarithromycin, telithromycin, nefazodone, and cobicistat-containing products) [ see Warnings and Precautions ( 5.1 ) ]. • Concomitant administration of gemfibrozil, cyclosporine, or danazol [ see Warnings and Precautions ( 5.1 ) ]. • Hypersensitivity to any component of this medication [ see Adverse Reactions ( 6.2 ) ]. • Active liver disease or unexplained persistent elevations in hepatic transaminase levels [ see Warnings and Precautions ( 5.3 ) ]. • Women who are pregnant or may become pregnant. Serum cholesterol and triglycerides increase during normal pregnancy, and cholesterol or cholesterol derivatives are essential for fetal development. Because HMG-CoA reductase inhibitors (statins), such as simvastatin, decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol, ezetimibe and simvastatin tablets may cause fetal harm when admini…
Drug Interactions
7 DRUG INTERACTIONS [ See Clinical Pharmacology ( 12.3 ). ] Ezetimibe and Simvastatin Tablets Drug Interactions Associated With Increased Risk of Myopathy/Rhabdomyolysis ( 2.3 , 2.4 , 4 , 5.1 , 7.1 , 7.2 , 7.3 , 7.8 , 12.3 ) Interacting Agents Prescribing Recommendations Strong CYP3A4 Inhibitors, (e.g., itraconazole, ketoconazole, posaconazole, voriconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, boceprevir, telaprevir, nefazodone, cobicistat-containing products), gemfibrozil, cyclosporine, danazol Contraindicated with ezetimibe and simvastatin tablets Niacin (≥1 g/day) For Chinese patients, not recommended with ezetimibe and simvastatin tablets Verapamil, diltiazem, dronedarone Do not exceed 10 mg/10 mg ezetimibe and simvastatin tablets, daily Amiodarone, amlodipine, ranolazine Do not exceed 10 mg/20 mg ezetimibe and simvastatin tablets, daily Lomitapide For patients with HoFH, do not exceed 10 mg/20 mg ezetimibe and simvastatin tablets 1 Daptomycin Temporally suspend ezetimibe and simvastatin tablets Grapefruit juice Avoid grapefruit juice 1. For patients with HoFH who have been taking 80 mg simvastatin chronically (e.g., for 12 months or more) with…
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the label: • Rhabdomyolysis and myopathy [ see Warnings and Precautions ( 5.1 ) ] • Liver enzyme abnormalities [ see Warnings and Precautions ( 5.3 ) ] • Common (incidence ≥ 2% and greater than placebo) adverse reactions in clinical trials: headache, increased ALT, myalgia, upper respiratory tract infection, and diarrhea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Dr. Reddy’s Laboratories, Inc. at 1-888-375-3784 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Ezetimibe and Simvastatin Tablets Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In the ezetimibe and simvastatin tablet placebo-controlled clinical trials database of 1,420 patients (age range 20 to 83 years, 52% women, 87% Caucasians, 3% Blacks, 5% Hispanics, 3% Asians) with a median treatment duration of 27 weeks, 5% of patients on ezetimibe and simvastat…
Frequently Asked Questions
What is ezetimibe and simvastatin used for?
ezetimibe and simvastatin contains ezetimibe and simvastatin. It is a tablet taken oral. Consult your doctor for specific uses.
Is ezetimibe and simvastatin a controlled substance?
ezetimibe and simvastatin is not classified as a controlled substance by the DEA.
What is the generic name for ezetimibe and simvastatin?
The generic name for ezetimibe and simvastatin is ezetimibe and simvastatin. There are 9 other brand versions of ezetimibe and simvastatin.
What is the NDC code for ezetimibe and simvastatin 10 mg/1?
The NDC (National Drug Code) for ezetimibe and simvastatin 10 mg/1 is 16714-779, listed by NORTHSTAR RX LLC.
Other ezetimibe and simvastatin Dosages
Other Ezetimibe Brands
See all →- Ezetimibe and Simvastatin10 mg/150090-4772
- Ezetimibe and Simvastatin10 mg/167877-507
- Ezetimibe and Simvastatin10 mg/159651-835
- Ezetimibe and Simvastatin10 mg/169238-1155
- Ezetimibe and Simvastatin10 mg/169238-1156
- Ezetimibe and Simvastatin10 mg/169238-1158
- Ezetimibe and Simvastatin10 mg/151407-190
- Ezetimibe and Simvastatin10 mg/151407-191
- Ezetimibe and Simvastatin10 mg/159651-838
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)