of acute coronary events with lovastatin in men and women with average cholesterol levels: results of AFCAPS/TexCAPS. If you notice any other effects, check with your healthcare professional. It can also reduce the risk of heart disease. All material on this website is protected by copyright, Copyright 1994-2023 by WebMD LLC. Take NIASPAN 1 time a day at bedtime after a low-fat snack. For patients switching from immediate-release niacin to NIASPAN, therapy with NIASPAN should be initiated with low doses (i.e., 500 mg at bedtime) and the NIASPAN dose should then be titrated to the desired therapeutic response [see DOSAGE AND ADMINISTRATION]. Shepherd J, Cobbe SM, Ford I et al. men: NHANES I epidemiologic follow-up study. Immediately contact their healthcare professional if they experience muscle pain, tenderness or weakness, dark or red colored urine, or unexplained tiredness. If patients become pregnant, they should stop taking Niaspan and consult with their doctor. Incident type 2 diabetes mellitus in African American and white adults: the Atherosclerosis Mean Baseline and Mean Percent Change from Baseline*. Cardiovascular events and their reduction with pravastatin Using these medicines together with ezetimibe and simvastatin may increase your risk of muscle injury and could result in kidney problems. Table 6. In addition to these new limitations, FDA is requiring changes to the simvastatin label to add new contraindications (should not be used with certain medications) and dose limitations for using simvastatin with certain medicines. are breastfeeding or plan to breastfeed. Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. Nicotinamide is further metabolized to at least N-methylnicotinamide (MNA) and nicotinamide-N-oxide (NNO). * After Week 8, titrate to patient response and tolerance. May interact with several other medications (see below). Hypertension. Erectile dysfunction (ED), formerly known as impotence, is a condition that affects roughly 40% of people with penises over the age of 40 and 70% over the age of 70. The potential for embryofetal toxicity with the doses of niacin in NIASPAN is unknown. Make sure you tell your doctor if you have any other medical problems, especially: Take this medicine only as directed by your doctor. Patients previously receiving other niacin products should be started with the recommended NIASPAN titration schedule (see Table 1), and the dose should subsequently be individualized based on patient response. Lipid Response in Dose-Escalation Study. Caution should be observed when NIASPAN is administered concomitantly with anticoagulants; platelet counts should be monitored closely in such patients. All rights reserved. The findings from the SEARCH trial are supported by analyses of the FDA's Adverse Event Reporting System (AERS) database, which show that the level of reporting of fatal rhabdomyolysis associated with the 80-mg dose of simvastatin has been higher in comparison with lower doses of simvastatin or lower doses of most other statins. 2001;103:163-182. Report side effects from the use of simvastatin-containing medicines to the FDA MedWatch program, using the information in the "Contact Us" box at the bottom of this page. Write a review. Ask your healthcare professional how you should dispose of any medicine you do not use. A second lipid-lowering trial, Pravastatin or Atorvastatin Evaluation and Infection Therapy -- Thrombolysis in Myocardial Infarction 22 (PROVE-IT TIMI 22),[20] was the first clinical-event trial comparing different statins; however, the trial population was again predominantly white An in vitro study results suggest that the bile acid-binding resins have high niacin binding capacity. 2.1 When your blood pressure is low, you may feel dizzy or faint. Circulation. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Niacins ability to reduce mortality and the risk of definite, nonfatal myocardial infarction (MI) has been assessed in long-term studies. They should discuss all medication, both prescription and over the counter, with their physician. Treatment of hypercholesterolemia is not generally necessary during pregnancy. Store NIASPAN at room temperature between 68F to 77F (20C to 25C). Table 4. Simvastatin should not be taken during pregnancy or while breastfeeding. 1 FDA has revised the drug labels for simvastatin and Vytorin to include the new dosing restriction for the 80-mg dose. Flushing happens when tiny blood vessels near the surface of the skin (especially on the face, neck, chest and/or back) open wider. The patient should be informed of the following: NIASPAN tablets should be taken at bedtime, after a low-fat snack. If dosing is interrupted for any length of time, their physician should be contacted prior to restarting therapy; re-titration is recommended. Mayo Clinic is a nonprofit organization and proceeds from Web advertising help support our mission. MNA is further metabolized to two other compounds, N-methyl- 2-pyridone-5-carboxamide (2PY) and N-methyl-4-pyridone-5-carboxamide (4PY). Flushing may vary in severity and is more likely to occur with initiation of therapy, or during dose increases. This medicine will reduce the absorption of cholesterol from foods and the production of cholesterol in your body. Supportive measures should be undertaken in the event of an overdose. A. The suspension is usually taken once a day in the evening on an empty stomach. It remains important to aggressively treat Medicines that interact with simvastatin may either decrease its effect, affect how long it works for, increase side effects, or have less of an effect when taken with simvastatin. Because of the potential for serious adverse reactions in breastfeeding infants, including hepatotoxicity, advise patients not to breastfeed during treatment with NIASPAN. 5705185. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine. . The most common side effects of NIASPAN include: Flushing is the most common side effect of NIASPAN. NIASPAN should not be taken on an empty stomach. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. The ALLHAT Officers and Coordinators for the ALLHAT Collaborative Research Group. guide physicians in choosing specific treatment strategies to lower risk in their African-American patients. If you need to stop taking NIASPAN, call your doctor before you start taking NIASPAN again. Patients should be advised to adhere to their National Cholesterol Education Program (NCEP) recommended diet, a regular exercise program, and periodic testing of a fasting lipid panel. In an ITT analysis, there were 42 cases of first occurrence of ischemic stroke reported, 27 (1.6%) in the simvastatin plus NIASPAN group and 15 (0.9%) in the simvastatin plus placebo group, a non-statistically significant result (HR 1.79, [95%CI = 0.95-3.36], p=0.071). */, Patients taking simvastatin 80 mg daily have an increased risk of myopathy compared to patients taking lower doses of this drug or other drugs in the same class. In addition, clinical trial data from other long-term statin trials show higher overall rates of myopathy and rhabdomyolysis in patients treated with simvastatin 80 mg versus lower doses of simvastatin or other statins. No patient with normal serum transaminase levels (AST, ALT) at baseline experienced elevations to more than 3 times the upper limit of normal (ULN) during treatment with NIASPAN. NIASPAN is indicated to reduce elevated TC, LDL-C, Apo B and TG levels, and to increase HDL-C in patients with primary hyperlipidemia and mixed dyslipidemia. Using this medicine with any of the following medicines is not recommended. Patients Reaching NCEP ATP III LDL-C Goal[21]. 1995;155:1900-1906. Call your doctor right away if you have any symptoms of a heart attack. Manufactured by AbbVie LTD, Barceloneta, PR 00617. Vitamins or other nutritional supplements containing large doses of niacin or related compounds such as nicotinamide may potentiate the adverse effects of NIASPAN. You can ask your pharmacist or doctor for information about NIASPAN that is written for health professionals. Brancati FL, Kao WH, Folsom AR, et al. Do not break, crush or chew NIASPAN tablets before swallowing. Sever PS, Dahlof B, Poulter NR, et al, for the ASCOT investigators. SEARCH was a seven-year, randomized, double-blind clinical trial comparing the efficacy and safety of simvastatin 80 mg to simvastatin 20 mg, with or without vitamin B12 and folate, in survivors of myocardial infarction. Graham DJ, Staffa JA, Shatin D, Andrade SE, Schech SD, La Grenade L. Incidence of hospitalized rhabdomyolysis in patients treated with lipid-lowering drugs. Results of the Cholesterol Reduction in 2004;8(2)2004 Copyright 2023 by RxList Inc. An Internet Brands company. All forms of niacin are not the same as NIASPAN. Ferdinand KC, Clark LT, Neal RC, et al. Diabetic patients may experience a dose-related increase in glucose intolerance. It was against Avoid taking with >20 mg simvastatin (or 40 mg for patients who have previously taken 80 mg simvastatin chronically, e.g., for 12 months or more, without evidence of muscle toxicity), based on clinical experience: Lomitapide: 60 mg QD for 7 days: 40 mg single dose: simvastatin acid : 1.7: 1.6: simvastatin: 2: 2: Lomitapide: 10 mg QD for 7 days Data from the clinical trials suggest that women have a greater hypolipidemic response than men at equivalent doses of NIASPAN. Single-dose bioavailability studies have demonstrated that the 500 mg and 1000 mg tablet strengths are dosage form equivalent but the 500 mg and 750 mg tablet strengths are not dosage form equivalent. It is estimated that approximately 2.1 million patients in the U.S. were prescribed a product containing 80-mg simvastatin in year 2010. Results are shown below (Table 7). Check with your physician for additional information about side effects. Review their medical history with their healthcare professional, the currently prescribed dose of simvastatin, and a list of their other current medications to determine if the medicines they are taking are appropriate. Do not use ezetimibe and simvastatin combination if you are also taking boceprevir (Victrelis), cobicistat-containing products (Stribild), cyclosporine (Gengraf, Neoral, Sandimmune), danazol (Danocrine), gemfibrozil (Lopid), nefazodone (Serzone), telaprevir (Incivek), certain antibiotics (eg, clarithromycin, erythromycin, itraconazole, ketoconazole, posaconazole, telithromycin, voriconazole, Nizoral), or medicines to treat HIV/AIDS (eg, atazanavir, indinavir, nelfinavir, ritonavir, saquinavir, Crixivan, Kaletra, Lexiva, Norvir, Prezista, Reyataz). [CDATA[/* >