DOSAGE AND ADMINISTRATION
SIMCOR should be taken as a single daily dose at bedtime, with a low fat snack. Patients not currently on niacin extended-release and patients currently on niacin products other than niacin extended-release should start SIMCOR at a single 500/20 mg tablet daily at bedtime [See Warnings and Precautions ]. The dose of niacin extended-release should not be increased by more than 500 mg daily every 4 weeks - see Table 1. The recommended maintenance dose for SIMCOR is 1000/20 mg to 2000/40 mg (two 1000/20 tablets) once daily depending on patient tolerability and lipid levels. The efficacy and safety of doses of SIMCOR greater than 2000/40 mg daily have not been studied and are therefore not recommended. If SIMCOR therapy is discontinued for an extended period of time (> 7 days), re-titration as tolerated is recommended. SIMCOR tablets should be taken whole and should not be broken, crushed, or chewed before swallowing.
Table 1. Recommended niacin extended-release dosing
| Week(s) || Daily dose of niacin extended-release |
|* After Week 8, titrate to patient response and tolerance. If response to 1000 mg daily is inadequate, increase dose to 1500 mg daily; may subsequently increase dose to 2000 mg daily. Daily dose should not be increased more than 500 mg in a 4-week period, and doses above 2000 mg daily are not recommended.|
|Initial Titration Schedule ||1 to 4||500 mg|
|5 to 8||1000 mg|
Due to the increased risk of hepatotoxicity with other modified-release (sustained-release or time-release) niacin preparations or immediate-release (crystalline) niacin, SIMCOR should only be substituted for equivalent doses of niacin extended-release (NIASPAN).
Flushing [See Adverse Reactions ] may be reduced in frequency or severity by pretreatment with aspirin or other non-steroidal anti-inflammatory drugs (approximately 30 minutes prior to SIMCOR dose). Flushing, pruritus, and gastrointestinal distress are also reduced by gradually increasing the dose of niacin (refer to Table 1) and avoiding administration on an empty stomach.
DOSAGE FORMS AND STRENGTHS
SIMCOR tablets are formulated for oral administration in the following strength combinations:
Table 2. SIMCOR Tablet Strengths
|Niacin extended-release equivalent (mg)||500||750||1000|
|simvastatin equivalent (mg) ||20||20||20|
· 500 mg/20 mg blue unscored tablets debossed with 021 on one side and KOS on the other
· 750 mg/20 mg blue unscored tablets debossed with 022 on one side and KOS on the other
· 1000 mg/20 mg blue unscored tablets debossed with 023 on one side and KOS on the other