Cockcroft-Gault formula. [See Warnings and Precautions (5.4); Clinical Pharmacology (12.3).] There have been postmarketing reports of worsening renal function in patients with renal impairment treated with sitagliptin, some of whom were prescribed inappropriate doses of sitagliptin.
2.3 Concomitant Use with an Insulin Secretagogue (e.g., Sulfonylurea) or with Insulin
When JUVISYNC is used in combination with an insulin secretagogue (e.g., sulfonylurea) or with insulin, a lower dose of the insulin secretagogue or insulin may be required to reduce the risk of hypoglycemia. [See Warnings and Precautions (5.5).]
2.4 Coadministration with Other Drugs
Patients taking Verapamil, or Diltiazem
The dose of JUVISYNC should not exceed 100 mg/10 mg per day [see Warnings and Precautions (5.2); Drug Interactions (7.3); Clinical Pharmacology (12.3)].
Patients taking Amiodarone, Amlodipine or Ranolazine
The dose of JUVISYNC should not exceed 100 mg/20 mg per day [see Warnings and Precautions (5.2); Drug Interactions (7.3); Clinical Pharmacology (12.3)].
2.5 Patients with Homozygous Familial Hypercholesterolemia
The recommended dosage is 100 mg/40 mg per day in the evening. JUVISYNC should be used as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) in these patients or if such treatments are unavailable.
2.6 Chinese Patients Taking Lipid-Modifying Doses (≥1 g/day Niacin) of Niacin-Containing Products
Because of an increased risk for myopathy in Chinese patients taking simvastatin 40 mg coadministered with lipid-modifying doses (≥1 g/day niacin) of niacin-containing products, caution should be used when treating Chinese patients with JUVISYNC 100 mg/40 mg per day coadministered with lipid-modifying doses of niacin-containing products. The cause of the increased risk of myopathy is not known. It is also unknown if the risk for myopathy with coadministration of JUVISYNC with lipid-modifying doses of niacin-containing products observed in Chinese patients applies to other Asian patients. [See Warnings and Precautions (5.2).]
3 DOSAGE FORMS AND STRENGTHS
JUVISYNC 100 mg/10 mg tablets are pink-beige, bi-convex round, film-coated tablets, coded with the Merck logo and "753" on one side and plain on the other.
JUVISYNC 100 mg/20 mg tablets are pink-beige, bi-convex modified capsule-shaped, film-coated tablets, coded with the Merck logo and "757" on one side and plain on the other.
JUVISYNC 100 mg/40 mg tablets are orange-beige, bi-convex modified capsule-shaped, film-coated tablets, coded with the Merck logo and "773" on one side and plain on the other.
4 CONTRAINDICATIONS
JUVISYNC is contraindicated in the following conditions:
History of a serious hypersensitivity reaction, such as anaphylaxis or angioedema, to any component of this medication. [See Warnings and Precautions (5.6); Adverse Reactions (6.2).]
Concomitant administration of strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, posaconazole, HIV protease inhibitors, boceprevir, telaprevir, erythromycin, clarithromycin, telithromycin and nefazodone) [see Warnings and Precautions (5.2)].
Concomitant administration of gemfibrozil, cyclosporine, or danazol [see Warnings and Precautions (5.2)].
Active liver disease, which may include unexplained persistent elevations in hepatic transaminase levels [see Warnings and Precautions (5.3)].
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