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FULL PRESCRIBING INFORMATION: CONTENTS*
* Sections or subsections omitted from the full prescribing information are not listed
1 INDICATIONS AND USAGE
1.1 Sitagliptin
1.2 Simvastatin
1.3 Important Limitations of Use
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosing
2.2 Patients with Renal Impairment
2.3 Concomitant Use with an Insulin Secretagogue (e.g., Sulfonylurea) or with Insulin
2.4 Coadministration with Other Drugs
2.5 Patients with Homozygous Familial Hypercholesterolemia
2.6 Chinese Patients Taking Lipid-Modifying Doses (≥1 g/day Niacin) of Niacin-Containing Products
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Pancreatitis
5.2 Myopathy/Rhabdomyolysis
5.3 Liver Dysfunction
5.4 Renal Impairment
5.5 Use with Medications Known to Cause Hypoglycemia
5.6 Hypersensitivity Reactions
5.7 Endocrine Function
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Postmarketing Experience
7 DRUG INTERACTIONS
7.1 Strong CYP3A4 Inhibitors, Cyclosporine, or Danazol
7.2 Lipid-Lowering Drugs That Can Cause Myopathy When Given Alone
7.3 Amiodarone, Ranolazine, or Calcium Channel Blockers
7.4 Niacin
7.5 Digoxin
7.6 Coumarin Anticoagulants
7.7 Colchicine
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Renal Impairment
8.7 Hepatic Impairment
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
13.2 Animal Toxicology and/or Pharmacology
14 CLINICAL STUDIES
14.1 Sitagliptin Clinical Studies
14.2 Simvastatin Clinical Studies
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
17.1 Instructions
17.2 Laboratory Tests
17.3 Muscle Pain
17.4 Pregnancy
17.5 Breastfeeding
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FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
JUVISYNC™ (sitagliptin and simvastatin) is indicated in patients for whom treatment with both sitagliptin and simvastatin is appropriate.
1.1 Sitagliptin
Sitagliptin is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. [See Clinical Studies (14.1).]
1.2 Simvastatin
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. In patients with coronary heart disease (CHD) or at high risk of CHD, simvastatin can be started simultaneously with diet.
Reductions in Risk of CHD Mortality and Cardiovascular Events
In patients at high risk of coronary events because of existing coronary heart disease, diabetes, peripheral vessel disease, history of stroke or other cerebrovascular disease, simvastatin is indicated to:
Redu |
