Vytorin

• As an adjunct to diet to reduce elevated low density lipoprotein cholesterol (LDL-C):
  • In adults with primary hyperlipidemia.
  • 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).

• Important Dosage and Administration Information:
  • Take VYTORIN orally once daily in the evening with or without food.
  • Maximum recommended dosage is VYTORIN 10/40 mg once daily. VYTORIN 10/80 mg daily dosage is restricted to patients who have been taking VYTORIN 10/80 mg daily chronically (e.g., for 12 months or more) without evidence of muscle toxicity.
  • For patients that require a high-intensity statin or are unable to achieve their LDL-C goal receiving VYTORIN 10/40 mg daily, prescribe alternative LDL-C-lowering treatment.
  • If as dose is missed, take the missed dose as soon as possible. Do not double the next dose.
  • Assess LDL-C when clinically appropriate, as early as 2 weeks after initiating VYTORIN, and adjust the dosage if necessary.
• Adults:
  Recommended dosage range of 10/10 mg to 10/40 mg once daily.
• See full prescribing information for VYTORIN dosage modifications due to drug interactions.
• Patients with Renal Impairment:
  Doses exceeding 10/20 mg should be used with caution and close monitoring in patients with moderate to severe renal impairment.

VYTORIN tablets:

• 10/10, (ezetimibe 10 mg and simvastatin 10 mg tablets) are white to off-white capsule-shaped and debossed with “311” on one side.
• 10/20, (ezetimibe 10 mg and simvastatin 20 mg tablets) are white to off-white capsule-shaped and debossed with “312” on one side.
• 10/40, (ezetimibe 10 mg and simvastatin 40 mg tablets) are white to off-white capsule-shaped and debossed with “313” on one side.
• 10/80, (ezetimibe 10 mg and simvastatin 80 mg tablets) are white to off-white capsule-shaped and debossed with “315” on one side.

• Pregnancy:
  May cause fetal harm
• Lactation:
  Breastfeeding not recommended during treatment with VYTORIN.