"June 9, 2011 -- The FDA today tightened its rules on who should take the highest approved dose of the statin drug simvastatin.
Simvastatin, which lowers LDL "bad" cholesterol, is sold under the brand name Zocor and as a generic drug. "...
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 is indicated to reduce Total-C, LDL-C, Apo B, non-HDL-C, TG, or to increase HDL-C in patients with primary hypercholesterolemia and mixed dyslipidemia when treatment with simvastatin monotherapy or niacin extended-release monotherapy is considered inadequate.
SIMCOR is indicated to reduce TG in patients with hypertriglyceridemia 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.
Niacin extended-release, one of the components of SIMCOR, at doses of 1,500 – 2,000 mg/day, in combination with simvastatin, did not reduce the incidence of cardiovascular events more than simvastatin in a randomized controlled trial of patients with cardiovascular disease and mean baseline LDL-C levels of 74 mg per deciliter [see WARNINGS AND PRECAUTIONS].
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. Patients already taking simvastatin 20 to 40 mg who need additional management of their lipid levels may be started on a SIMCOR dose of 500/40 mg once 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.
Table 1: Recommended niacin extended-release dosing
|Week(s)||Daily dose of niacin extended-release|
|Initial Titration Schedule||1 to 4||500 mg|
|5 to 8||1000 mg|
|* 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.|
The recommended maintenance dose for SIMCOR is 1000/20 mg to 2000/40 mg (two 1000/20 mg 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.
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 up to the recommended dose of 325 mg (taken 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. Concomitant alcoholic, hot drinks or spicy foods may increase the side effects of flushing and pruritus and should be avoided around the time of SIMCOR ingestion.
Coadministration with Other Drugs
Patients taking Amiodarone, Amlodipine or Ranolazine
- The dose of SIMCOR should not exceed 1000/20 mg/day [see WARNINGS AND PRECAUTIONS, DRUG INTERACTIONS, and CLINICAL PHARMACOLOGY].
Chinese Patients Taking SIMCOR
Because of an increased risk for myopathy in Chinese patients taking simvastatin 40 mg coadministered with lipid-modifying doses ( ≥ 1 g/day niacin) of niacin-containing products, caution should be used when prescribing SIMCOR in doses that exceed 1000/20 mg/day to Chinese patients. The cause of the increased risk of myopathy is not known. It is also unknown if the risk for myopathy with coadministration of simvastatin with lipid-modifying doses of niacin-containing products observed in Chinese patients applies to other Asian patients [see WARNINGS AND PRECAUTIONS].
Dosage Forms And Strengths
SIMCOR tablets are formulated for oral administration in the following strength combinations:
Table 2: SIMCOR Tablet Strengths
|500 mg/20 mg||500 mg/40 mg||750 mg/20 mg||1000 mg/20 mg||1000 mg/40 mg|
|Niacin extended-release equivalent (mg)||500||500||750||1000||1000|
|simvastatin equivalent (mg)||20||40||20||20||40|
Storage And Handling
SIMCOR 500 mg/20 mg, 750 mg/20 mg and 1000 mg/20 mg tablets are available as blue, unscored, tablets, printed with black ink and packaged in bottles of 90 tablets. SIMCOR 500 mg/40 mg and 1000 mg/40 mg tablets are available as dark blue, unscored, tablets, printed with white ink and packaged in bottles of 90 tablets. Each tablet is printed on one side with the Abbott “A” and a code number specific to the tablet strength. Please see the table below:
|SIMCOR Tablet Strength||Printed ID||NDC Number|
|500 mg/20 mg||A 500-20||0074-3312-90|
|500 mg/40 mg||A 500-40||0074-3459-90|
|750 mg/20 mg||A 750-20||0074-3315-90|
|1000 mg/20 mg||A 1000-20||0074-3455-90|
|1000 mg/40 mg||A 1000-40||0074-3457-90|
Storage: Store at controlled room temperature 20°-25°C (68°-77°F).
Manufactured by Abbott Pharmaceuticals PR Ltd., Barceloneta, PR 00617 for Abbott Laboratories, North Chicago, IL 60064, U.S.A. Revised: Feb 2013
Last reviewed on RxList: 3/7/2013
This monograph has been modified to include the generic and brand name in many instances.
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