1 Answers
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.
Renal Impairment:
- Mild to moderate impairment: There are no dosage adjustments provided in the manufacturer’s labeling (combination has not been studied); use with caution. Also see individual agents.
- Severe renal impairment: There are no dosage adjustments provided in the manufacturer’s labeling (combination has not been studied). Use with extreme caution or avoid unless patient already tolerating simvastatin doses ≥10 mg. Also see individual agents.
Hepatic Impairment: There are no dosage adjustments provided in the manufacturer's labeling (combination has not been studied). Contraindicated in patients with active liver disease or unexplained persistent elevations of serum transaminases. Also see individual agents.
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