Niacor (Niacin Tablets)
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Niacor (Niacin Tablets)

NIACOR®
(niacin) Tablets,USP 500 mg

DRUG DESCRIPTION

Niacin or nicotinic acid, a water-soluble B-complex vitamin and antihyperlipidemic agent, is 3-pyridinecarboxylic acid. It is a white, crystalline powder, sparingly soluble in water. It has the following structural formula:

NIACOR®
  (Niacin) Structural Formula Illustration

MW 123.11       C6H5NO2

Each NIACOR® (niacin tablets) Tablet, for oral administration, contains 500 mg of nicotinic acid. In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, hydrogenated vegetable oil, magnesium stearate and microcrystalline cellulose.

What are the possible side effects of niacin ?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • feeling light-headed, fainting;
  • fast, pounding, or uneven heart beats;
  • feeling short of breath;
  • swelling;
  • jaundice (yellowing of your skin or eyes); or
  • muscle pain, tenderness, or weakness with fever or flu symptoms and dark colored urine.

If you are diabetic, tell your doctor about any changes in your...

Read All Potential Side Effects and See Pictures of Niacor »

What are the precautions when taking niacin tablets (Niacor)?

Before taking niacin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: very low blood pressure, current liver disease, increase in liver enzymes, current ulcer, current bleeding.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: alcohol use, bleeding problems (e.g., low platelets), diabetes, gallbladder disease, glaucoma, gout, heart disease (e.g., recent heart attack, unstable angina), kidney...

Read All Potential Precautions of Niacor »

Last reviewed on RxList: 10/27/2008
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

  1. Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in those individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Nicotinic acid, alone or in combination with a bile-acid binding resin, is indicated as an adjunct to diet for the reduction of elevated total and LDL cholesterol levels in patients with primary hypercholesterolemia (Types IIa and IIb), when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate (see also the NCEP treatment guidelines6). Prior to initiating therapy with nicotinic acid, secondary causes for hypercholesterolemia (e.g., poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alcoholism) should be excluded, and a lipid profile performed to measure total cholesterol, HDL cholesterol, and triglycerides.
  2. Nicotinic acid is also indicated as adjunctive therapy for the treatment of adult patients with very high serum triglyceride levels (Types IV and V hyperlipidemia) who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them. Such patients typically have serum triglyceride levels over 2000 mg/dL and have elevations of VLDL cholesterol as well as fasting chylomicrons (Type V hyperlipidemia)†. Subjects who consistently have total serum or plasma triglycerides below 1000 mg/dL are unlikely to develop pancreatitis. Therapy with nicotinic acid may be considered for those subjects with triglyceride elevations between 1000 and 2000 mg/dL who have a history of pancreatitis or of recurrent abdominal pain typical of pancreatitis. Some Type IV patients with triglycerides under 1000 mg/dL may, through dietary or alcoholic indiscretion, convert to a Type V pattern with massive triglyceride elevations accompanying fasting chylomicronemia, but the influence of nicotinic acid therapy on the risk of pancreatitis in such situations has not been adequately studied. Drug therapy is not indicated for patients with Type I hyperlipoproteinemia, who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of VLDL. Inspection of plasma refrigerated for 14 hours is helpful in distinguishing Types I, IV, and V hyperlipoproteinemia7.

Classification of Hyperlipoproteinemias

  Lipoproteins Lipid Elevations
Type Elevated Major Minor
I (rare) Chylomicrons TG &uarrr;→ C
IIa LDL C .....
IIb LDL, VLDL C TG
III (rare) IDL C/TG .....
IV VLDL TG &uarrr;→ C
V (rare) Chylomicrons, VLDL TG &uarrr;→C
C = cholesterol, TG = triglycerides
LDL = low-density lipoprotein
VLDL = very low-density lipoprotein
IDL = intermediate-density lipoprotein

DOSAGE AND ADMINISTRATION

The usual adult dosage of nicotinic acid is 1 to 2 grams two or three times a day. Doses should be individualized according to the patient's response. Start with one-half tablet (250 mg) as a single daily dose following the evening meal. The frequency of dosing and total daily dose can be increased every four to seven days until the desired LDL cholesterol and/or triglyceride level is achieved or the first-level therapeutic dose of 1.5 to 2 grams/day is reached. If the patient's hyperlipidemia is not adequately controlled after 2 months at this level, the dosage can then be increased at two to four week intervals to 3 grams/day (1 gram three times per day). In patients with marked lipid abnormalities, a higher dose is occasionally required, but generally should not exceed 6 grams/day.

Flushing of the skin appears frequently and can be minimized by pretreatment with aspirin or non-steroidal anti-inflammatory drugs. Tolerance to this flushing develops rapidly over the course of several weeks. Flushing, pruritus, and gastrointestinal distress are also greatly reduced by slowly increasing the dose of nicotinic acid and avoiding administration on an empty stomach.

Sustained-release (modified-release, timed-release) nicotinic acid preparations should not be substituted for equivalent doses of immediate-release (crystalline) nicotinic acid.

HOW SUPPLIED

NIACOR® (Niacin Tablets, USP) 500 mg.

Each tablet is a white, capsule-shaped, scored, uncoated tablet, debossed "US" to the left and "67" to the right of the score, with "500" strength on the unscored side.

NIACOR® (niacin tablets) is available in bottles of 100 tablets (NDC 0245-0067-11).

Dispense in a tight container as defined in the USP, with a child-resistant closure.

Store at controlled room temperature, 15-30°C (59-86°F).

REFERENCES

6. Report of the National Cholesterol Education Program Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol. Arch Int Med 1988; 148:36-69.

7. Nikkila EA: Familial lipoprotein lipase deficiency and related disorders of chylomicron metabolism. In Stanbury JB et al. (eds.): The Metabolic Basis of Inherited Disease, 5th ed., McGraw-Hill, 1983, Chap. 30, pp. 622-642.

Manufactured by: UPSHER-SMITH LABORATORIES, INC. Minneapolis, MN 55447. Rev. 0200. FDA Rev date: 12/19/2002

Last reviewed on RxList: 10/27/2008
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

Cardiovascular: Atrial fibrillation and other cardiac arrhythmias, orthostasis, hypotension.

Gastrointestinal: Dyspepsia, vomiting, diarrhea, peptic ulceration, jaundice, abnormal liver function tests. Skin: Mild to severe cutaneous flushing, pruritus, hyperpigmentation, acanthosis nigricans, dry skin. Metabolic: Decreased glucose tolerance, hyperuricemia, gout.

Eye: Toxic amblyopia, cystoid macular edema.

Nervous System/Psychiatric:Headache.

Read the Niacor (niacin tablets) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

HMG-CoA Reductase Inhibitors: See WARNINGS, Skeletal Muscle.

Antihypertensive Therapy:Nicotinic acid may potentiate the effects of ganglionic blocking agents and vasoactive drugs resulting in postural hypotension.

Aspirin: Concomitant aspirin may decrease the metabolic clearance of nicotinic acid. The clinical relevance of this finding is unclear.

Other: Concomitant alcohol or hot drinks may increase the side effects of flushing and pruritus and should be avoided at the time of drug ingestion.

Last reviewed on RxList: 10/27/2008
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

Liver Dysfunction

Cases of severe hepatic toxicity, including fulminant hepatic necrosis have occurred in patients who have substituted sustained-release (modified-release, timed-release) nicotinic acid products for immediate-release (crystalline) nicotinic acid at equivalent doses.

Liver function tests should be performed on all patients during therapy with nicotinic acid. Serum transaminase levels, including ALT (SGPT), should be monitored before treatment begins, every six weeks to twelve weeks for the first year, and periodically thereafter (e.g., at approximately 6 month intervals). Special attention should be paid to patients who develop elevated serum transaminase levels, and in these patients, measurements should be repeated promptly and then performed more frequently. If the transaminase levels show evidence of progression, particularly if they rise to three times the upper limit of normal and are persistent, the drug should be discontinued. Liver biopsy should be considered if elevations persist beyond discontinuation of the drug.

Nicotinic acid should be used with caution in patients who consume substantial quantities of alcohol and/or have a past history of liver disease. Active liver diseases or unexplained transaminase elevations are contraindications to the use of nicotinic acid.

Skeletal Muscle

Rare cases of rhabdomyolysis have been associated with concomitant administration of lipid-altering doses ( ≥ 1 g/day) of nicotinic acid and HMG-CoA reductase inhibitors. Physicians contemplating combined therapy with HMG-CoA reductase inhibitors and nicotinic acid should carefully weigh the potential benefits and risks and should carefully monitor patients for any signs and symptoms of muscle pain, tenderness, or weakness, particularly during the initial months of therapy and during any periods of upward dosage titration of either drug. Periodic serum creatine phosphokinase (CPK) and potassium determinations should be considered in such situations, but there is no assurance that such monitoring will prevent the occurrence of severe myopathy.

PRECAUTIONS

General

Before instituting therapy with nicotinic acid, an attempt should be made to control hyperlipidemia with appropriate diet, exercise, and weight reduction in obese patients, and to treat other underlying medical problems (see INDICATIONS).

Patients with a past history of jaundice, hepatobiliary disease, or peptic ulcer should be observed closely during nicotinic acid therapy. Frequent monitoring of liver function tests and blood glucose should be performed to ascertain that the drug is producing no adverse effects on these organ systems. Diabetic patients may experience a dose-related rise in glucose intolerance, the clinical significance of which is unclear. Diabetic or potentially diabetic patients should be observed closely. Adjustment of diet and/or hypoglycemic therapy may be necessary.

Caution should also be used when nicotinic acid is used in patients with unstable angina or in the acute phase of myocardial infarction, particularly when such patients are also receiving vasoactive drugs such as nitrates, calcium channel blockers, or adrenergic blocking agents.

Elevated uric acid levels have occurred with nicotinic acid therapy, therefore use with caution in patients predisposed to gout.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Nicotinic acid administered to mice for a lifetime as a 1% solution in drinking water was not carcinogenic. The mice in this study received approximately 6-8 times a human dose of 3000 milligrams/day as determined on a milligram/square meter basis. Nicotinic acid was negative for mutagenicity in the Ames test. No studies on impairment of fertility have been performed.

Pregnancy

Pregnancy Category C.

Animal reproduction studies have not been conducted with nicotinic acid. It is also not known whether nicotinic acid at doses typically used for lipid disorders can cause fetal harm when administered to pregnant women or whether it can affect reproductive capacity. If a woman receiving nicotinic acid for primary hypercholesterolemia (Types IIa or IIb) becomes pregnant, the drug should be discontinued. If a woman being treated with nicotinic acid for hypertriglyceridemia (Types IV or V) conceives, the benefits and risks of continued drug therapy should be assessed on an individual basis.

NursingOkay Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from lipid-altering doses of nicotinic acid, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in children and adolescents have not been established.

Last reviewed on RxList: 10/27/2008
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

Supportive measures should be undertaken in the event of an overdose.

CONTRAINDICATIONS

Nicotinic acid is contraindicated in patients with a known hypersensitivity to any component of this medication; significant or unexplained hepatic dysfunction; active peptic ulcer disease; or arterial bleeding.

Last reviewed on RxList: 10/27/2008
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

The role of low-density lipoprotein (LDL) cholesterol in atherogenesis is supported by pathological observations, clinical studies, and many animal experiments. Observational epidemiological studies have clearly established that high total or LDL cholesterol and low high-density lipoprotein (HDL) cholesterol are risk factors for coronary heart disease. The Coronary Drug Project1, completed in 1975, was designed to assess the safety and efficacy of nicotinic acid and other lipid-altering drugs in men 30 to 64 years old with a history of myocardial infarction (MI). Over an observation period of five years, nicotinic acid showed a statistically significant benefit in decreasing nonfatal, recurrent myocardial infarctions. The incidence of definite, nonfatal MI was 8.9% for the 1,119 patients randomized to nicotinic acid versus 12.2% for the 2,789 patients who received placebo (p < 0.004). Though total mortality was similar in the two groups at five years (24.4% with nicotinic acid versus 25.4% with placebo; p=N.S.), in a fifteen-year cumulative follow-up there were 11% (69) fewer deaths in the nicotinic acid group compared to the placebo cohort (52.0% versus 58.2%; p=0.0004)2.

The Cholesterol-Lowering Atherosclerosis Study (CLAS) was a randomized, placebo-controlled, angiographic trial testing combined colestipol and nicotinic acid therapy in 162 non-smoking males with previous coronary bypass surgery3. The primary, per subject cardiac endpoint was global coronary artery change score. After two years, 61% of patients in the placebo cohort showed disease progression by global change score (N=82), compared with only 38.8% of drug-treated subjects (N=80), when both native arteries and grafts were considered (p < 0.005). In a follow-up to this trial in a subgroup of 103 patients treated for four years, again, significantly fewer patients in the drug-treated group demonstrated progression than in the placebo cohort (48% versus 85%, respectively; p < 0.0001)4.

The Familial Atherosclerosis Treatment Study (FATS) in 146 men ages 62 and younger with apolipoprotein B levels ≥ 125 mg/dL, established coronary artery disease, and family histories of vascular disease, assessed change in severity of disease in the proximal coronary arteries by quantitative arteriography5. Patients were given dietary counseling and randomized to treatment with either conventional therapy with double placebo (or placebo plus colestipol if the LDL cholesterol was elevated); lovastatin plus colestipol; or nicotinic acid plus colestipol. In the conventional therapy group, 46% of patients had disease progression (and no regression) in at least one of nine proximal coronary segments. In contrast, progression (as the only change) was seen in only 25% in the nicotinic acid plus colestipol group. Though not an original endpoint of the trial, clinical events (death, myocardial infarction, or revascularization for worsening angina) occurred in 10 of 52 patients who received conventional therapy, compared with 2 of 48 who received nicotinic acid plus colestipol.

Nicotinic acid (but not nicotinamide) in gram doses produces an average 10-20% reduction in total and LDL cholesterol, a 30-70% reduction in triglycerides, and an average 20-35% increase in HDL cholesterol. The magnitude of individual lipid and lipoprotein responses may be influenced by the severity and type of underlying lipid abnormality. The increase in total HDL is associated with a shift in the distribution of HDL subfractions (as defined by ultra-centrifugation) with an increase in the HDL2:HDL3 ratio and an increase in apolipoprotein A-I content. The mechanism by which nicotinic acid exerts these effects is notentirely understood, but may involve several actions, including a decrease in esterification of hepatic triglycerides. Nicotinic acid treatment also decreases the serum levels of apolipoprotein B-100 (apo B), the major protein component of the very low-density lipoprotein (VLDL) and LDL fractions, and of lipoprotein a [Lp(a)], a variant form of LDL independently associated with coronary risk. The effect of nicotinic acid-induced changes in lipids/lipoproteins on cardiovascular morbidity or mortality in individuals without pre-existing coronary disease has not been established.

Pharmacokinetics

Following an oral dose, the pharmacokinetic profile of nicotinic acid is characterized by rapid absorption from the gastrointestinal tract and a short plasma elimination half-life. At a 1 gram dose, peak plasma concentrations of 15 to 30 µg/mL are reached within 30 to 60 minutes. Approximately 88% of an oral pharmacologic dose is eliminated by the kidneys as unchanged drug and nicotinuric acid, its primary metabolite. The plasma elimination half-life of nicotinic acid ranges from 20 to 45 minutes.

REFERENCES

1. The Coronary Drug Project Research Group. Clofibrate and Niacin in Coronary Heart Disease. JAMA 1975; 231:360-81.

2. Canner PL et al. Fifteen Year Mortality in Coronary Drug Project Patients: Long-Term Benefit with Niacin. JACC 1986; 8(6):1245-55.

3. Blankenhorn DH et al. Beneficial Effects of Combined Colestipol-Niacin Therapy on Coronary Atherosclerosis and Coronary Venous Bypass Grafts. JAMA 1987; 257(23):3233-40.

4. Cashin-Hemphill et al. Beneficial Effects of Colestipol-Niacin on Coronary Atherosclerosis. JAMA 1990; 264(23):3013-17.

5. Brown G et al. Regression of Coronary Artery Disease as a Result of Intensive Lipid-Lowering Therapy in Men with High Levels of Apolipoprotein B. NEJM1990; 323:1289-98.

Last reviewed on RxList: 10/27/2008
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

Last reviewed on RxList: 10/27/2008
This monograph has been modified to include the generic and brand name in many instances.

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PATIENT INFORMATION

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

Last reviewed on RxList: 10/27/2008
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Niacor Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

NIACIN - ORAL (ANTILIPEMIC)

(NYE-a-sin)

COMMON BRAND NAME(S): Niacor

USES: Niacin is used in addition to a proper diet and exercise to help control levels of fats in the blood. It can help lower "bad" cholesterol and fats (LDL, triglycerides) and raise "good" cholesterol (HDL). In general, this drug is used after your blood fat levels have not been fully controlled by other treatment (e.g., diet changes, exercise, decreasing alcohol intake, stopping smoking, weight loss if overweight, and controlling blood sugar if diabetic). It may be used with or without other medications.

Lowering "bad" cholesterol/triglycerides and raising "good" cholesterol may help decrease the risk for strokes and heart attacks. Lowering fats may also help reduce the risk of pancreas problems (pancreatitis) in people at risk. Niacin is also known as vitamin B-3 (nicotinic acid), one of the B-complex vitamins.

HOW TO USE: Take this medication by mouth with food, usually 1-3 times daily or as directed by your doctor. If you take this medicine once daily, take it with your evening meal. Taking niacin on an empty stomach increases side effects (e.g., flushing, upset stomach).

Niacin is available in different formulations (e.g., immediate and sustained release). Do not switch other strengths, brands, or forms of niacin with this product. Severe liver problems may occur.

Dosage is based on your medical condition and response to therapy. Generally, your doctor will start you at a low dose and gradually increase your dose in order to minimize side effects. Your dose will need to be increased slowly, even if you are already taking niacin and are being switched from another niacin product (e.g., extended-release) to this product. Follow your doctor's instructions carefully.

If you also take certain other drugs to lower your cholesterol (bile acid-binding resins such as cholestyramine or colestipol), take niacin at least 4-6 hours before or after taking these medications. These products can react with niacin, preventing its full absorption. Continue to take other medications to lower your cholesterol as directed by your doctor.

To lessen the chance of side effects such as flushing, avoid alcohol and hot beverages near the time you take niacin. Taking a plain (non-enteric coated, 325 milligram) aspirin or a nonsteroidal anti-inflammatory drug (e.g., ibuprofen, 200 milligrams) 30 minutes before taking niacin may help prevent flushing. Ask your doctor if this treatment is right for you.

Use this medication regularly in order to get the most benefit from it. Remember to take it at the same time each day. It is important to continue taking this medication even if you feel well. Most people with high cholesterol do not feel sick.

Do not stop taking this medicine unless instructed by your doctor. If niacin is stopped, you may need to return to your original dose and gradually increase it again. Consult your doctor or pharmacist for instructions on restarting your dose if you have not taken your medication for several days.

It is very important to continue to follow your doctor's advice about diet and exercise.

Disclaimer

Niacor Consumer (continued)

SIDE EFFECTS: Flushing of the face and neck along with warmth, headache, itching, burning, sweating, chills, or tingling may occur within 20 minutes of taking this medication. Flushing may persist for a few hours after use. These effects should improve or go away as your body adjusts to the medication. Dizziness, stomach upset, heartburn, nausea, vomiting, and diarrhea may also occur. If these effects persist or worsen, notify your doctor promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: severe dizziness/fainting, fast/irregular heartbeat, severe headache (migraine), unusual joint pain, swelling of legs/arms, vision problems.

Tell your doctor immediately if any of these rare but very serious side effects occur: severe stomach/abdominal pain, black/tarry stools, easy bruising/bleeding, unexplained muscle pain/tenderness/weakness, persistent nausea/vomiting, change in the amount of urine, dark urine, vomit that looks like coffee grounds, yellowing eyes/skin.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, persistent itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the Niacor (niacin tablets) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: Before taking niacin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: very low blood pressure, current liver disease, increase in liver enzymes, current ulcer, current bleeding.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: alcohol use, bleeding problems (e.g., low platelets), diabetes, gallbladder disease, glaucoma, gout, heart disease (e.g., recent heart attack, unstable angina), kidney disease, liver disease, untreated mineral imbalance (low phosphate levels), history of stomach/intestinal ulcers, underactive thyroid (hypothyroidism).

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

To minimize dizziness and lightheadedness, get up slowly when rising from a sitting or lying position. This is very important if you are also taking medication to lower your blood pressure.

Before having surgery, tell your doctor or dentist that you are taking this medication.

If you have diabetes, this drug may increase your blood sugar levels. Check your blood glucose levels regularly as directed by your doctor. Tell your doctor immediately if you have symptoms of high blood sugar such as increased thirst and urination. Your anti-diabetic medication or diet may need to be adjusted.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

This medication passes into breast milk. Consult your doctor before breast-feeding.

Disclaimer

Niacor Consumer (continued)

DRUG INTERACTIONS: See also the How to Use section.

Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: "blood thinners" (e.g., warfarin), drugs that affect your blood pressure (e.g., calcium channel blockers such as diltiazem, alpha blockers such as prazosin), other drugs that cause flushing (e.g., nitrates), vitamins/dietary supplements/products that also contain niacin or nicotinamide.

Serious muscle injury (e.g., myopathy, rhabdomyolysis) may infrequently occur if the following drugs are combined with niacin (1 gram per day or more): fibrates (e.g., gemfibrozil, fenofibrate), "statins" (e.g., lovastatin, atorvastatin).

Seek immediate medical attention if you experience any muscle pain, weakness or tenderness.

Limit alcoholic beverages. Alcohol can increase the side effects of this medication.

This product can affect the results of certain lab tests (e.g., urine or blood catecholamines, copper-based urine glucose tests). Make sure laboratory personnel and all your doctors know you use this drug.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly.

NOTES: Do not share this medication with others.

Laboratory tests (e.g., blood lipids, blood sugar, liver function tests) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

For best results, this medication should be used along with doctor-approved plans for low-fat/low-cholesterol diet, exercise, and weight control. Talk to your doctor or pharmacist about lifestyle changes that might benefit you.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised October 2010. Copyright(c) 2010 First Databank, Inc.

Niacor Patient Information Including Side Effects

Brand Names: B-3-50, B3-500-Gr, Niacin SR, Niacor, Niaspan ER, Slo-Niacin

Generic Name: niacin (nicotinic acid) (Pronunciation: NYE a sin (NIK oh TIN ik AS id))

What is niacin (Niacor)?

Niacin, also called nicotinic acid, is a B vitamin (vitamin B3). It occurs naturally in plants and animals, and is also added to many foods as a vitamin supplement. Niacin is also present in many multiple vitamins and nutritional supplements.

Niacin is used to treat and prevent a lack of natural niacin in the body, and to lower cholesterol and triglycerides (types of fat) in the blood. It is also used to lower the risk of heart attack in people with high cholesterol who have already had a heart attack. Niacin is sometimes used to treat coronary artery disease (also called atherosclerosis).

Niacin may also be used for purposes other than those listed in this medication guide.

Niacin SR 125 mg-URL

brown/clear

Niaspan 500 mg

oblong, white, imprinted with KOS, 500

Niaspan ER 1000 mg

oblong, white, imprinted with 1000, KOS

Niaspan ER 750 mg

oblong, white, imprinted with 750, KOS

What are the possible side effects of niacin ?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • feeling light-headed, fainting;
  • fast, pounding, or uneven heart beats;
  • feeling short of breath;
  • swelling;
  • jaundice (yellowing of your skin or eyes); or
  • muscle pain, tenderness, or weakness with fever or flu symptoms and dark colored urine.

If you are diabetic, tell your doctor about any changes in your blood sugar levels.

Less serious side effects of niacin include:

  • mild dizziness;
  • warmth, redness, or tingly feeling under your skin;
  • itching, dry skin;
  • sweating or chills;
  • nausea, diarrhea, belching, gas;
  • muscle pain, leg cramps; or
  • sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the Niacor (niacin tablets) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about niacin?

Do not take this medication if you are allergic to niacin, or if you have severe liver disease, a stomach ulcer, or active bleeding.

Niacin can cause certain side effects, such as flushing (warmth, itching, redness, or tingly feeling under your skin). These effects can be made worse if you drink alcohol or hot beverages shortly after you take niacin. These effects should disappear over time as you keep taking the medication.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Avoid taking colestipol (Colestid) or cholestyramine (Locholest, Prevalite, Questran) at the same time you take niacin. If you take either of these other medications, take them at least 4 to 6 hours before or after you take niacin.

Niacin is only part of a complete program of treatment that may also include diet, exercise, weight control, and other medications. Follow your diet, medication, and exercise routines very closely.

Side Effects Centers

Niacor Patient Information including How Should I Take

What should I discuss with my healthcare provider before taking niacin ?

Do not take this medication if you are allergic to niacin, or if you have severe liver disease, a stomach ulcer, or active bleeding.

Before taking niacin, tell your doctor if you are allergic to any drugs, or if you have:

  • liver or kidney disease;
  • heart disease or uncontrolled angina (chest pain);
  • a stomach ulcer;
  • diabetes;
  • gout; or
  • a muscle disorder such as myasthenia gravis.

If you have any of these conditions, you may not be able to use niacin, or you may need dosage adjustments or special tests during treatment.

FDA pregnancy category C. Niacin may be harmful to an unborn baby when the medication is taken at doses to treat high cholesterol or other conditions. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Niacin can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take niacin ?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Niacin is sometimes taken at bedtime with a low-fat snack. Follow your doctor's instructions.

Niacin can cause certain side effects, such as flushing (warmth, itching, redness, or tingly feeling under your skin). These effects can be made worse if you drink alcohol or hot beverages shortly after you take niacin. These effects should disappear over time as you keep taking the medication.

Take niacin with a full glass of cold or cool water. Taking the medication with a hot drink may increase your risk of side effects such as flushing.

Do not crush, chew, break, or open an extended-release tablet or capsule. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking or opening the pill would cause too much of the drug to be released at one time.

Niacin extended-release tablets and capsules contain higher strengths of the medicine than the regular niacin tablets. Take only the dose that is correct for the type of niacin tablet or capsule you are using.

Niacin can cause you to have unusual results with certain medical tests (urine tests). Tell any doctor who treats you that you are using niacin.

If you stop taking niacin for any length of time, talk with your doctor before starting the medication again. You may need to restart the medication at a lower dose.

Niacin is only part of a complete program of treatment that may also include diet, exercise, weight control, and other medications. Follow your diet, medication, and exercise routines very closely.

To be sure this medication is not causing harmful effects, your blood will need to be tested on a regular basis. Your kidney or liver function may also need to be tested. Do not miss any scheduled appointments.

Store niacin at room temperature away from moisture and heat.

Side Effects Centers

Niacor Patient Information including If I Miss a Dose

What happens if I miss a dose?

Take the missed dose as soon as you remember. Be sure to take the missed dose with food if you normally take your niacin dose with a meal or snack.

If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include nausea, dizziness, itching, vomiting, upset stomach, and flushing.

What should I avoid while taking niacin ?

Avoid drinking hot beverages shortly after taking niacin. Hot drinks can worsen niacin's flushing effect (warmth, itching, redness, or tingly feeling under your skin).

Avoid drinking alcohol while taking niacin. Alcohol may increase your risk of liver damage, and can also worsen the flushing effects of niacin.

Avoid taking colestipol (Colestid) or cholestyramine (Locholest, Prevalite, Questran) at the same time you take niacin. If you take either of these other medications, take them at least 4 to 6 hours before or after you take niacin.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

What other drugs will affect niacin ?

Tell your doctor about all other cholesterol-lowering drugs you are taking with niacin, especially atorvastatin (Lipitor), fluvastatin (Lescol), lovastatin (Mevacor), pravastatin (Pravachol), or simvastatin (Zocor).

Before taking niacin, tell your doctor if you are also using any of the following drugs:

  • a blood thinner such as warfarin (Coumadin);
  • multivitamins or mineral supplements that contain niacin;
  • blood pressure or heart medications such as amlodipine (Norvasc), diltiazem (Tiazac, Cartia, Cardizem), felodipine (Plendil), nicardipine (Cardene), nifedipine (Procardia, Adalat), nimodipine (Nimotop), nisoldipine (Sular), or verapamil (Calan, Covera, Isoptin, Verelan); or
  • heart medications such as doxazosin (Cardura), isosorbide (Dilatrate, Imdur, Isordil, Monoket, Sorbitrate), nitroglycerin (Nitro-Bid, Nitro-Dur, Nitrostat), prazosin (Minipress), or terazosin (Hytrin).

This list is not complete and there may be other drugs that can interact with niacin. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about niacin.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 8.03. Revision date: 12/15/2010.

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