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US Brand Name
What are the side effects of niacin and lovastatin?
The most common side effects are:
- warm sensation,
- stomach upset,
- muscle pain, and
- tingling in extremities.
Flushing may be reduced by taking 325 mg of aspirin 30 minutes before the niacin and by increasing the dose of niacin slowly.
Drinking hot liquids or alcohol shortly before or after niacin is taken may increase the occurrence of flushing.
Other important side effects include:
- liver test abnormalities,
- kidney failure,
- muscle pain,
- muscle tenderness,
- increases in HbA1c and fasting serum glucose
- memory loss,
- confusion, and
- memory impairment
Lovastatin shares side effects, such as liver and muscle damage associated with all statins. Serious liver damage caused by statins is rare. More often, statins cause abnormalities of liver tests. Abnormal tests usually return to normal even if a statin is continued, but if the abnormal test value is greater than three times the upper limit of normal, the statin usually is stopped. Liver function tests should be performed at the beginning of treatment then as needed thereafter.
Inflammation of the muscles caused by statins can lead to a serious breakdown of muscle cells called rhabdomyolysis. Rhabdomyolysis causes the release of muscle protein (myoglobin) into the blood. Myoglobin can cause kidney failure and even death. When used alone, statins cause rhabdomyolysis in less than one percent of patients. To prevent the development of rhabdomyolysis, patients taking lovastatin should contact their health care professional immediately if they develop unexplained muscle pain, weakness, or muscle tenderness.
Statins have been associated with increases in HbA1c and fasting serum glucose levels as are seen in diabetes.
There are also post-marketing reports of memory loss, forgetfulness, amnesia, confusion, and memory impairment. Symptoms may start 1 day to years after starting treatment and resolve within a median of 3 weeks after stopping the statin.
How to use
ADVICOR® (niacin extended-release and lovastatin) is intended to facilitate the daily administration of its individual components, Niaspan® and lovastatin, when used together for the intended patient population (see INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATION).
ADVICOR contains niacin extended-release and lovastatin in combination. Lovastatin, an inhibitor of 3hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase, and niacin are both lipid-altering agents.
Niacin is nicotinic acid, or 3-pyridinecarboxylic acid. Niacin is a white, nonhygroscopic crystalline powder that is very soluble in water, boiling ethanol and propylene glycol. It is insoluble in ethyl ether. The empirical formula of niacin is C6H5NO2 and its molecular weight is 123.11. Niacin has the following structural formula:
Lovastatin is [1S -[1(alpha)(R *), 3(alpha), 7(beta), 8(beta)(2S *, 4S *), 8a(beta)]]-1,2,3, 7,8,8a-hexahydro3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl) ethyl]-1-naphthalenyl 2-methylbutanoate. Lovastatin is a white, nonhygroscopic crystalline powder that is insoluble in water and sparingly soluble in ethanol, methanol, and acetonitrile. The empirical formula of lovastatin is C24H36O5 and its molecular weight is 404.55. Lovastatin has the following structural formula:
ADVICOR tablets contain the labeled amount of niacin and lovastatin and have the following inactive ingredients: hypromellose, povidone, stearic acid, polyethylene glycol, titanium dioxide, polysorbate 80.
The individual tablet strengths (expressed in terms of mg niacin/mg lovastatin) contain the following coloring agents:
ADVICOR 500 mg/20 mg - Iron Oxide Yellow, Iron Oxide Red.
ADVICOR 750 mg/20 mg – FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake.
ADVICOR 1000 mg/20 mg - Iron Oxide Red, Iron Oxide Yellow, Iron Oxide Black.
ADVICOR 1000 mg/40 mg – Iron Oxide Red.
Advicor Drug Class
Advicor is part of the drug class:
HMG CoA reductase inhibitors in combination with other lipid modifying agents
Take Advicor exactly as prescribed.
Advicor comes in tablet form and is taken once a day at bedtime, with a low-fat snack. Advicor 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 Advicor at the same time.
- Store Advicor at room temperature.
- Keep this and all medicines out of the reach of children.
Consumer Information Use and Disclaimer
- If your symptoms or health problems do not get better or if they become worse, call your doctor.
- Do not share your drugs with others and do not take anyone else's drugs.
- Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
- Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
- Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
- If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
This information should not be used to decide whether or not to take Advicor or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Advicor. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.
Review Date: October 4, 2017
Drug Abuse and Dependence
Neither niacin nor lovastatin is a narcotic drug. Advicor has no known addiction potential in humans.
Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.
Lovastatin / niacin Breastfeeding Warnings
There are no data on the excretion of lovastatin into human milk. Niacin is excreted in human milk. The effects in the nursing infant are unknown, however, the potential for serious adverse reactions in nursing infants from lipid-altering doses of lovastatin and niacin warrants that the drug(s) not be administered to nursing mothers. Lovastatin-niacin is considered contraindicated during breast-feeding by the American Academy of Pediatrics.