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Simcor (Simvastatin / Niacin) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate.

Patients with Hypercholesterolemia Requiring Modifications of Lipid Profiles

SIMCOR

SIMCOR is indicated to reduce total-C, LDL-C, Apo B, non-HDL-C, or TG, or to increase HDL-C in patients with primary hypercholesterolemia and mixed dyslipidemia (Fredrickson type IIa and IIb) when treatment with simvastatin monotherapy or niacin extended-release monotherapy is considered inadequate.

SIMCOR is indicated to reduce TG in patients with hypertriglyceridemia (Fredrickson type IV hyperlipidemia) when treatment with simvastatin monotherapy or niacin extended-release monotherapy is considered inadequate.

Limitations of use

No incremental benefit of SIMCOR on cardiovascular morbidity and mortality over and above that demonstrated for simvastatin monotherapy and niacin monotherapy has been established.

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 4500 mg
5 to 81000 mg
*1500 mg
*2000 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
500mg/20mg750mg/20mg1000mg/20mg
Niacin extended-release equivalent (mg)5007501000
simvastatin equivalent (mg) 202020

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

HOW SUPPLIED/STORAGE AND HANDLING

SIMCOR tablets are available as blue, unscored, tablets, packaged in bottles of 90 tablets. Each tablet has KOS debossed on one side and a code number specific to the tablet strength on the other. Please see the table below:

SIMCOR Tablet StrengthDebossed IDNDC Number
500mg/20mgKOS/0210074-3312-90
750mg/20mgKOS/0220074-3315-90
1000mg/20mgKOS/0230074-3316-90

Storage: Store at controlled room temperature 20-25C (68-77F).

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