Niacin/simvastatin

What is Niacin/simvastatin?

• Niacin/simvastatin (SIMCOR) is a combination of simvastatin, an HMG-Co-A reductase inhibitor, and niacin extended-release (NIASPAN), nicotinic acid used for the treatment of dyslipidemia.

Simvastatin EPh

Simvastatin3Dan

Niacin

Niacin-3D-balls

What are the uses of this medicine?

SIMCOR is used to:

• Reduce elevated 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.
• 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.

How does this medicine work?

Niacin

• Niacin functions in the body after conversion to nicotinamide adenine dinucleotide (NAD) in the NAD coenzyme system.
• The mechanism by which niacin alters lipid profiles is not completely understood and may involve several actions, including partial inhibition of release of free fatty acids from adipose tissue, and increased lipoprotein lipase activity (which may increase the rate of chylomicron triglyceride removal from plasma).
• Niacin decreases the rate of hepatic synthesis of VLDL-C and LDL-C, and does not appear to affect fecal excretion of fats, sterols, or bile acids.

Simvastatin

• Simvastatin is a prodrug and is hydrolyzed to its active ß-hydroxyacid form, simvastatin acid, after administration.
• Simvastatin is a specific inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase, the enzyme that catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in the biosynthetic pathway for cholesterol.
• In addition, simvastatin reduces VLDL and TG and increases HDL-C.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• Active liver disease
• with active peptic ulcer disease
• with arterial bleeding
• who are pregnant
• Nursing mothers
• with a known hypersensitivity

What drug interactions can this medicine cause?

• SIMCOR should not be used with potent inhibitors of CYP3A4.
• SIMCOR should be avoided in combination with Cyclosporine.
• SIMCOR should be avoided in combination with Danazol.
• SIMCOR should be avoided in combination with Gemfibrozil.
• SIMCOR should be avoided in combination Fenofibrate.
• Combination of Amiodarone with SIMCOR should be limited to the 20 mg once daily dose of simvastatin.
• Combination of Verapamil with SIMCOR should be limited to the 20 mg once daily dose of simvastatin.
• Coumarin anticoagulants combination prolongs INR. Achieve stable INR prior to starting SIMCOR. Monitor INR frequently until stable upon initiation or alteration of SIMCOR therapy.

Is this medicine FDA approved?

• Initial U.S. Approval: 2008

How should this medicine be used?

Recommended dosage:

• Dose range: 500/20 mg to 2000/40 mg once daily.
• Initial dose for patients naïve to or switching from immediate-release niacin: 500/20 mg once daily.
• The initial dose for patients already receiving niacin extended-release should not exceed 2000/40 mg once daily.
• Maintenance dose: 1000/20 mg to 2000/40 mg once daily.
• Doses greater than 2000/40 mg daily are not recommended.

Administration:

• SIMCOR should be taken at bedtime with a low-fat snack.
• SIMCOR tablets should be taken whole and should not be broken, crushed, or chewed before swallowing.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form: As Unscored film-coated tablets:

• 500 mg niacin extended-release/20 mg simvastatin
• 500 mg niacin extended-release/40 mg simvastatin
• 750 mg niacin extended-release/20 mg simvastatin
• 1000 mg niacin extended-release/20 mg simvastatin
• 1000 mg niacin extended-release/40 mg simvastatin

This medicine is available in fallowing brand namesː

• SIMCOR

What side effects can this medication cause?

The most common side effects of this medicine include:

• flushing
• headache
• back pain
• diarrhea
• nausea
• pruritis

What special precautions should I follow?

• Skeletal muscle effects (e.g., myopathy and rhabdomyolysis) may occur. Risks increase with higher doses, advanced age (≥ 65), hypothyroidism, renal impairment, and concomitant use of cyclosporine, danazol, gemfibrozil, amiodarone, and verapamil and potent CYP3A4 inhibitors.
• Cases of severe hepatic toxicity, including fulminant hepatic necrosis, have occurred in patients who have substituted sustained-release (modified-release, timed-release) niacin products for immediate-release (crystalline) niacin at equivalent doses. Persistent elevations in hepatic transaminase can occur. Monitor liver enzymes before and during treatment.
• Severe hepatic toxicity has occurred in patients substituting sustained-release niacin for immediate-release niacin at equivalent doses. If switching from niacin preparations other than niacin extended-release (NIASPAN), initiate with lowest SIMCOR dose; niacin extended-release can be converted at equivalent doses.
• Niacin extended-release can increase serum glucose levels. Glucose levels should be closely monitored in diabetic or potentially diabetic patients particularly during the first few months of use.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• A few cases of overdosage with simvastatin have been reported; the maximum dose taken was 3.6 g.

Treatment of overdosage:

• Supportive measures should be taken in the event of an overdose.
• The dialyzability of niacin, or of simvastatin and its metabolites, is not known.

Can this medicine be used in pregnancy?

• SIMCOR is contraindicated in women who are or may become pregnant.

Can this medicine be used in children?

• The safety and effectiveness of SIMCOR in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• SIMVASTATIN
• NIACIN

Inactive ingredients:

• HYPROMELLOSE
• POVIDONE
• STEARIC ACID
• POLYETHYLENE GLYCOL
• BUTYLATED HYDROXYANISOLE
• FERROSOFERRIC OXIDE
• FD&C BLUE NO. 2
• LACTOSE MONOHYDRATE
• TITANIUM DIOXIDE
• TRIACETIN

Who manufactures and distributes this medicine?

• Manufactured by Abbott Pharmaceuticals PR Ltd., Barceloneta, PR

for Abbott Laboratories North Chicago, IL 60064, U.S.A.

What should I know about storage and disposal of this medication?

• Store at controlled room temperature 20º-25ºC (68º-77ºF).

• Dailymed label info on Niacin/simvastatin
• FDA Niacin/simvastatin

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