Niacin XR and Lovastatin

Niacin XR and lovastatin is a prescription medication used to lower cholesterol.  It is a single product containing 2 medications: lovastatin and niacin extended-release.

Lovastatin belongs to a group of medications called HMG-CoA reductase inhibitors. Niacin is a nicotinic acid. Together, these medications lower cholesterol.

This medication comes in tablet form and is usually taken once a day at bedtime with a low-fat snack.  Niacin XR and lovastatin tablets should be taken whole and should not be broken, crushed, or chewed before swallowing.

Common side effects of niacin XR and lovastatin include flushing, nausea, and diarrhea.

Niacin XR and lovastatin is a prescription medication used to treat high cholesterol, known medically as hypercholesterolemia.  

This medication may be prescribed for other uses.  Ask your doctor or pharmacist for more information.

Niacin XR and Lovastatin may be found in some form under the following brand names:

• Advicor

Serious side effects have been reported with niacin XR and lovastatin.  See the "Niacin XR and lovastatin Precautions" section.

Common side effects of niacin XR and lovastatin include the following:

• flushing
• headache
• infection
• rash/itching
• nausea
• diarrhea
• high blood sugar (hyperglycemia)
• stomach pain

This is not a complete list of niacin XR and lovastatin side effects.  Ask your doctor or pharmacist for more information.  Tell your doctor if you have any side effect that bothers you or that does not go away.  Call your doctor for medical advice about side effects.  You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.  Especially tell your doctor if you take:

• medications for blood pressure
• aspirin
• bile acid sequestrants (colestipol and cholestyramine)
• macrolide antibiotics
  • clarithromycin
  • telithromycin
• HIV protease inhibitors
  • indinavir
  • nelfinavir
  • ritonavir
  • saquinavir
• azole antifungals
  • ketoconazole
  • itraconazole
  • posaconazole
  • voriconazole
• nefazodone
• erythromycin
• gemfibrozil
• cyclosporine
• verapamil
• diltiazem
• amiodarone
• warfarin
• colchicine
• digoxin
• alcohol

This is not a complete list of niacin XR and lovastatin drug interactions.  Ask your doctor or pharmacist for more information.

Serious side effects have been reported with niacin XR and lovastatin including the following:

• Liver Dysfunction. Cases of severe hepatic toxicity, including fulminant hepatic necrosis, have occurred in patients who have substituted sustained-release niacin products for immediate-release niacin at equivalent doses. Niacin XR and lovastatin should be used with caution in patients who consume substantial quantities of alcohol and/or have a past history of liver disease.  Active liver disease or unexplained transaminase elevations are contraindications to the use of niacin XR and lovastatin. Niacin preparations and lovastatin have been associated with abnormal liver tests. It is recommended that liver enzyme tests be obtained prior to initiating therapy with niacin XR and lovastatin and repeated as clinically indicated.
• Myopathy/Rhabdomyolysis. Lovastatin occasionally cause myopathy, which is manifested as muscle pain or weakness associated with grossly elevated creatine kinase. Rhabdomyolysis, with or without acute renal failure secondary to myogobinuria, has been reported rarely and can occur at any time. The risk of rhabdomyolysis is increased by concomitant use of lovastatin with the following:
  • strong inhibitors of CYP3A4: itraconazole, ketoconazole, posaconazole, erythromycin, clarithromycin, telithromycin, boceprevir, telaprevir, nefazodone, large quantities of grapefruit juice (>1 quart daily).  
  • gemfibrozil: The combined use of lovastatin with gemfibrozil should be avoided.
  • other fibrates: The benefit of further alterations in lipid levels by the combined use of lovastatin with other fibrates should be carefully weighed against the potential risks of this combination.
  • cyclosporine: The combined use of lovastatin and cyclosporine should be avoided
  • danazol, diltiazem, or verapamil with higher doses of lovastatin:  The dose of lovastatin should not exceed 20mg as the risk of myopathy increases at higher doses
  • amiodarone: The dose of lovastatin should not exceed 40mg.
  • colchicine: Use caution
  • Ranolazine: Dose adjustment of lovastatin may be considered.

Do not take niacin XR and lovastatin if you:

• are allergic to niacin, lovastatin, or any component of this medication
• have active liver disease or unexplained elevations in serum transaminases
• have active peptic ulcer disease
• have arterial bleeding
• are pregnant or breastfeeding

Grapefruit and grapefruit juice may interact with niacin XR and lovastatin and lead to potentially dangerous effects.  Discuss the use of grapefruit products with your doctor.

Before taking niacin XR and lovastatin, tell your doctor about all of your medical conditions.  Especially tell your doctor if you:

• are allergic to niacin XR and lovastatin or to any of its ingredients
• have liver problems
• have heart problems
• have diabetes
• have a past history of jaundice, hepatobiliary disease, or peptic ulcer
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant. The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to clarify the possible risks to an unborn baby when a medication is taken during pregnancy.

Niacin XR and lovastatin falls into category X. It has been shown that women taken niacin XR and lovastatin during pregnancy may have babies born with problems. There are no situations where the benefits of the medication for the mother outweigh the risks of harm to the baby. These medicines should never be used by pregnant women.

Tell your doctor if you are breastfeeding or plan to breastfeed. No studies have been conducted with niacin XR and lovastatin in nursing mothers. Because of the potential for serious adverse reactions in nursing infants from lipid-altering doses of niacin and lovastatin, this medication should not be taken while a woman is breastfeeding.

Niacin has been reported to be excreted in human milk. It is not known whether lovastatin is excreted in human milk.

Take niacin XR and lovastatin exactly as prescribed.  

Niacin XR and lovastatin comes in tablet form and is taken once a day at bedtime, with a low-fat snack. Niacin XR and lovastatin tablets should be taken whole and should not be broken, crushed, or chewed before swallowing.

If you miss a dose, take the missed dose as soon as your remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of niacin XR and lovastatin at the same time.

Take this medication exactly as prescribed by your doctor.  Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your height
• your weight
• your age
• your gender

Patients not currently on Niaspan must start niacin XR and lovastatin at the lowest initial dose, a single 500mg/20mg tablet once daily at bedtime. The dose of niacin XR and lovastatin should not be increased by more than 500mg daily (based on the Niaspan component) every 4 weeks. The dose of niacin XR and lovastatin should be individualized based on targeted goals for cholesterol and triglycerides, and on patient response. Doses greater than 2000mg/40mg daily are not recommended. If niacin XR and lovastatin therapy is discontinued for an extended period greater than 7 days, reinitiation of therapy should begin with the lowest dose.

If you take too much niacin XR and lovastatin, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If niacin XR and lovastatin is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur.  However, if overdose is suspected, seek emergency medical attention.

• Store niacin XR and lovastatin at room temperature.
• Keep this and all medicines out of the reach of children.