Simcor (Niacin / Simvastatin)

Prescription medicineOnly Available By Prescription

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Strength Pack Size Qty
Strength
500/20mg
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Generics are less expensive because generic manufacturers don't have to invest large sums of money to develop a drug. When the brand-name patent expires, generic companies can manufacture a copy of the brand-name and sell it at a substantial discount.

Description

Simcor is an oral tablet that combines extended-release niacin and simvastatin. It is prescribed alongside a healthy diet to treat high cholesterol and triglycerides when either medicine alone is not enough. The two medicines work in different ways to improve blood-fat levels. Simvastatin reduces the liver’s production of LDL, often called “bad” cholesterol, while niacin can lower triglycerides and LDL while raising HDL, or “good” cholesterol. Simcor is an extended-release, film-coated tablet.

Fact Table

Formula

C6H5NO2 (Niacin); C25H38O5 (Simvastatin)

License

US FDA (NDA 022078; approval withdrawn April 18, 2016)

Bioavailability

Niacin: dose-dependent and highly variable; Simvastatin: <5% systemic availability

Legal status

Formerly Rx only; withdrawn from the U.S. market

Chemical Name

Nicotinic Acid (Niacin) / Simvastatin

Elimination half-life

Niacin: rapidly eliminated, specific half-life not established in SIMCOR labeling; Simvastatin: 4.2–4.9 hours; Simvastatin acid: 4.6–5.0 hours

Dosage (Strength)

500mg/20mg, 500mg/40mg, 750mg/20mg, 1000mg/20mg, 1000mg/40mg; dose range 500mg/20mg to 2000mg/40mg once daily at bedtime

Pregnancy

Contraindicated during pregnancy under SIMCOR labeling (former Pregnancy Category X)

Brands

Simcor (discontinued)

Protein binding

Niacin: not established; Simvastatin and its ß-hydroxyacid metabolite: approximately 95%

PubChem CID

9893536 (Simcor mixture); 938 (Niacin); 54454 (Simvastatin)

MedlinePlus

a682518 (Niacin); a692030 (Simvastatin)

ChEBI

15940 (Niacin); 9150 (Simvastatin)

ATC code

C10AD02 (Niacin); C10AA01 (Simvastatin)

DrugBank

DB00627 (Niacin); DB00641 (Simvastatin)

KEGG

D00049 (Niacin); D00434 (Simvastatin)

Routes of administration

Oral

Directions

Take Simcor once daily at bedtime with a low-fat snack, such as low-fat yogurt, a banana, or crackers and low-fat milk. This may help reduce flushing and stomach upset caused by niacin. Swallow the tablet whole. Do not break, crush, or chew it.

People new to niacin usually start at 500 mg/20 mg daily, with the dose increased gradually. Do not take more than 2,000 mg/40 mg per day. Flushing is often strongest during the first few weeks and usually improves over time. Taking aspirin or another pain reliever about 30 minutes before the dose may help, but ask your prescriber first.

Avoid alcohol, hot drinks, and spicy foods near the time you take Simcor, and contact your prescriber before restarting if you miss several days of treatment.

Ingredients

The active ingredients in Simcor are niacin extended-release and simvastatin. Inactive ingredients may include hypromellose, povidone, stearic acid, polyethylene glycol, butylated hydroxyanisole, FDandC Blue #2, lactose monohydrate, titanium dioxide, triacetin, and iron oxide.

Cautions

  • Before using this medication, you may want to consult a healthcare provider about the following:
    • Any existing health conditions
    • Any allergies
    • A list of all medications currently being taken
  • Statins may cause muscle injuries, which may become severe enough to harm the kidneys. Report unexplained muscle pain, tenderness, weakness, or dark tea-coloured urine to a healthcare provider.
  • The muscle risk increases with higher simvastatin doses, older age past 65, and an underactive thyroid or reduced kidney function.
  • Liver enzymes need checking before treatment starts and periodically afterward, as both ingredients may affect them.
  • Never switch to a different sustained-release niacin product at the same dose, since severe liver toxicity has been reported in such cases. Anyone switching from another niacin product should start at the lowest Simcor dose.
  • Blood sugar may increase, so people with diabetes or prediabetes need closer glucose monitoring, particularly over the first several months.
  • Several medications should not be combined with Simcor, including strong CYP3A4 inhibitors such as itraconazole, ketoconazole, clarithromycin, HIV protease inhibitors, cyclosporine, danazol, gemfibrozil, and fenofibrate. People who take amiodarone or verapamil may need dose adjustments.
  • Grapefruit juice in large quantities increases simvastatin levels and is best avoided.
  • Alcohol adds to the strain on the liver and worsens flushing, so intake should be modest at most.
  • Flushing, warmth, redness, itching, or tingling of the face and upper body is the most common complaint with niacin, and standing up quickly during an episode can bring on dizziness or fainting.
  • Uric acid can rise, which matters for anyone with gout, and niacin may lower phosphorus and platelet counts.
  • Tell a surgeon or dentist about Simcor ahead of a procedure, and mention it if you are hospitalized for a serious illness or injury.

Contraindications

Avoid taking or using this medication if any of the following apply:

  • Active liver disease, including unexplained liver enzyme levels that stay elevated
  • An active stomach or duodenal ulcer
  • Bleeding from an artery
  • Pregnancy, or the possibility of becoming pregnant
  • Breastfeeding
  • A known hypersensitivity to niacin, simvastatin, or anything else in the tablet

Side Effects

Common side effects of Simcor include:

  • Flushing, with redness and warmth of the face and neck
  • Headache
  • Back pain
  • Diarrhea
  • Nausea
  • Itching

Seek medical care for unexplained muscle pain, tenderness, or weakness, particularly alongside a fever or a general feeling of illness. Get in touch with a healthcare provider about yellowing of the eyes or skin, urine that looks unusually dark, pale stools, ongoing nausea, appetite loss, or pain in the upper right abdomen, any of which may indicate liver injury. Black or tarry stools, vomit that looks like coffee grounds, or sharp stomach pain could mean bleeding in the digestive tract and need immediate care. Seek immediate medical help for fainting, a rash with peeling or blistering skin, or swelling of the face, lips, or throat with trouble breathing.

References

Simcor Prescribing Information. North Chicago, IL: Abbott Laboratories; 2012.

Simcor Drug Label Information. Tulsa, OK: Physicians Total Care, Inc.; 2010.




IMPORTANT NOTE: The information provided above is for general awareness and educational purposes only. It is not intended to diagnose, treat, or replace professional medical or veterinary advice. Always consult your physician, pharmacist, or veterinarian regarding the safety, suitability, and proper use of any medication for yourself or your pet.

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