Simvastatindosage

Important Dosage and Administration Information: Take simvastatin tablets orally once daily in the evening. Maximum recommended dosage is simvastatin tablets 40 mg once daily. An 80 mg daily dosage of simvastatin tablets are restricted to patients who have been taking simvastatin tablets 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 simvastatin tablets 40 mg daily, prescribe alternative LDL-C lowering treatment. Assess LDL-C when clinically appropriate, as early as 4 weeks after initiating, and adjust the dosage if necessary.

Adults: Recommended dosage is 20 mg to 40 mg once daily. Pediatric Patients Aged 10 Years and Older with HeFH: Recommended dosage is 10 mg to 40 mg once daily. Patients with Severe Renal Impairment: Recommended starting dosage is simvastatin 5 mg once daily. See full prescribing information for simvastatin tablets dosage modifications due to drug interactions.

2.1 Important

Dosage and Administration Information Take simvastatin tablets orally once daily in the evening. The maximum recommended dosage is simvastatin tablets 40 mg once daily. An 80 mg daily dosage of simvastatin tablets are restricted to patients who have been taking simvastatin 80 mg daily chronically (e.g., for 12 months or more) without evidence of muscle toxicity. If as dose is missed, take the missed dose as soon as possible. Do not double the next dose. For patients that require a high-intensity statin or are unable to achieve their LDL-C goal receiving simvastatin tablets 40 mg daily, prescribe alternative LDL-C-lowering treatment. Assess LDL-C when clinically appropriate, as early as 4 weeks after initiating simvastatin tablets, and adjust the dosage if necessary.

2.2 Recommended

Dosage in Adult Patients The recommended dosage range of simvastatin tablets are 20 mg to 40 mg once daily.

2.3 Recommended

Dosage in Pediatric Patients 10 Years of Age and Older with HeFH The recommended dosage range of simvastatin tablets are 10 mg to 40 mg daily.

2.4 Recommended

Dosage in Patients with Renal Impairment For patients with severe renal impairment [creatinine clearance (CLcr) 15 to 29 mL/min], the recommended starting dosage of simvastatin is 5 mg once daily. There are no dosage adjustment recommendations for patients with mild or moderate renal impairment.

2.5 Dosage Modifications

Due to Drug Interactions Concomitant use of simvastatin tablets with the following drugs requires dosage modification of simvastatin tablets. Patients taking Lomitapide Reduce the dosage of simvastatin tablets by 50%. Do not exceed simvastatin tablets 20 mg once daily (or 40 mg once daily for patients who have previously taken an 80 mg daily dosage of simvastatin tablets chronically while taking lomitapide). Patients taking Verapamil, Diltiazem, or Dronedarone Do not exceed simvastatin tablets 10 mg once daily. Patients taking Amiodarone, Amlodipine, or Ranolazine Do not exceed simvastatin tablets 20 mg once daily.