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Simastin N Tablet (Extended Release) contains Niacin + Simvastatin
Simastin N Tablet (Extended Release) uses for
Primary hypercholesterolemia / mixed dyslipidemia / hypertriglyceridemia: Reduce total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (apo B), non-high-density lipoprotein cholesterol (non-HDL-C), triglycerides (TG), or increase high-density lipoprotein cholesterol (HDL-C) in patients with primary hypercholesterolemia, mixed dyslipidemia, or hypertriglyceridemia in combination with standard cholesterol-lowering diet when simvastatin or niacin monotherapy is inadequate
Primary hypercholesterolemia / mixed dyslipidemia / hypertriglyceridemia:
Initial dose: Not for use as initial therapy of dyslipidemias. Doses should be individualized according to the baseline LDL-cholesterol levels, the recommended goal of therapy, and the patient's response.
Patients naïve to niacin ER therapy or currently on immediate-release niacin: Niacin ER 500 mg/simvastatin 20 mg once daily at bedtime; increase dose every 4 weeks as needed in increments of not more than 500 mg of niacin.
Patients currently on simvastatin (20 to 40 mg daily): Niacin ER 500 mg/simvastatin 40 mg once daily at bedtime; increase dose every 4 weeks as needed in increments of not more than 500 mg of niacin.
Maintenance dose: Niacin ER 1,000 to 2,000 mg/simvastatin 20 to 40 mg once daily (maximum daily dose: niacin ER 2,000 mg/simvastatin 40 mg).
Note: If therapy is interrupted for >7 days, reinstitution of therapy should begin with the lowest dose followed by retitration as tolerated. May be substituted for equivalent dose of niacin extended-release, however, manufacturer does not recommend direct substitution with immediate-release preparations.Dosage adjustment with concomitant medications:
- Amiodarone, amlodipine, or ranolazine: Maximum: Niacin ER 1,000 mg/simvastatin 20 mg per day
- Lomitapide: Reduce simvastatin dose by 50% when initiating lomitapide. Simvastatin dose should not exceed 20 mg/day (or 40 mg daily for those who previously tolerated simvastatin 80 mg daily for ≥1 year without evidence of muscle toxicity).
Administer tablets whole; do not break, crush or chew. Administer with a low-fat snack at bedtime. To attenuate flushing symptoms, may premedicate with aspirin 30 minutes before dose; avoid ingestion of alcohol, hot or spicy foods/liquids concurrently with niacin.
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