Generic name: sitagliptin and simvastatin
Dosage form: tablet, film coated
This dosage information does not include all the information needed to use Juvisync safely and effectively. See full prescribing information for Juvisync.
The information at Drugs.com is not a substitute for medical advice. ALWAYS consult your doctor or pharmacist.
The dosages for therapy with JUVISYNC are 100 mg/10 mg, 100 mg/20 mg, and 100 mg/40 mg (sitagliptin/simvastatin) once daily. JUVISYNC should be taken as a single daily dose in the evening. JUVISYNC should be swallowed whole. The tablets must not be split, crushed, or chewed before swallowing.
The recommended starting dose is 100 mg/40 mg per day. For patients already taking simvastatin (10, 20, or 40 mg daily) with or without sitagliptin 100 mg daily, JUVISYNC may be initiated at the dose of 100 mg sitagliptin and the dose of simvastatin already being taken.
After initiation or titration of JUVISYNC, lipid levels may be analyzed after 4 or more weeks and dosage adjusted, if needed.
Patients with Renal Impairment
JUVISYNC is not recommended in patients with moderate or severe renal impairment or ESRD. JUVISYNC can be used in patients with normal renal function or mild renal impairment (creatinine clearance [CrCl] ≥50 mL/min, approximately corresponding to serum creatinine levels of ≤1.7 mg/dL in men and ≤1.5 mg/dL in women). Because simvastatin does not undergo significant renal excretion, modification of the dose of the simvastatin component should not be necessary in patients with mild renal impairment.
Assessment of renal function is recommended prior to initiation of JUVISYNC and periodically thereafter. Creatinine clearance can be estimated from serum creatinine using the 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.
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).]
Coadministration with Other Drugs
Patients taking Verapamil, or Diltiazem
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.
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).]