Niacin

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

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.

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.

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

Especially tell your doctor if you take:

• supplements or medications containing niacin or nicotinamide
• other medicines to lower cholesterol or triglycerides
• aspirin
• insulin or medications for diabetes
• blood pressure medicines
• anticoagulants ("blood thinners") such as warfarin (Coumadin, Jantoven)
• bile acid-binding resins such as colestipol (Colestid) or cholestyramine (Questran)
• large amounts of alcohol

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

Take niacin 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

The recommeded dose range of niacin for the treatment of high cholesterol is 500 mg to 2000 mg daily. The maximum recommended dose of niacin is 2000 mg daily.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For niacin, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to niacin or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of niacin extended-release tablets in children. However, safety and efficacy have not been established in children 16 years of age and younger.

There is no specific information comparing the use of niacin for high cholesterol in children with use in other age groups. However, use is not recommended in children under 2 years of age since cholesterol is needed for normal development.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of niacin extended-release tablets in the elderly.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

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. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking niacin, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using niacin with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Atorvastatin
• Cerivastatin
• Lovastatin
• Pitavastatin
• Rosuvastatin
• Simvastatin

Using niacin with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using niacin with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use niacin, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Other Medical Problems

The presence of other medical problems may affect the use of niacin. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol, excessive use or
• Angina (severe chest pain) or
• Glaucoma or
• Gout or
• Heart attack, acute or
• Heart disease or
• Hypotension (low blood pressure) or
• Jaundice, history of or
• Kidney disease or
• Muscle pain or tenderness, history of or
• Muscle weakness, history of or
• Stomach ulcers, history of—Use with caution. May make these conditions worse.

• Bleeding problems or
• Liver disease or
• Stomach ulcers—Should not be used in patients with these conditions.

• Diabetes or
• Hypothyroidism (underactive thyroid) or
• Kidney failure—Use with caution. May cause side effects to become worse.

Use niacin only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may increase the chance of unwanted effects.

niacin should come with a patient information insert. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Remember that niacin will not cure your condition but it does help control it. You must continue to take it as directed if you expect to keep your cholesterol levels down.

Carefully follow the special diet your doctor gave you. This is the most important part of controlling your condition, and is necessary if the medicine is to work properly.

If niacin upsets your stomach, it may be taken with meals or milk. If stomach upset continues, check with your doctor.

For patients taking the extended-release capsules:

• Swallow the capsule whole. Do not crush, break, or chew it. If the capsule is too large to swallow, you may mix the contents of the capsule with jam or jelly and swallow without chewing.

For patients taking the extended-release tablets:

• Swallow the tablet whole. If the tablet is scored, it may be broken, but not crushed or chewed, before being swallowed.
• Niaspan® should be taken at bedtime after a low-fat snack.
• To decrease flushing or redness of your face, take aspirin or ibuprofen (eg, Advil®, Motrin®) 30 minutes before taking Niaspan®.
• Avoid drinking alcohol or hot drinks or eating spicy foods around the time you take Niaspan®. This helps decrease flushing of your face.
• If you stop taking niacin for any period of time, contact your doctor prior to restarting taking niacin.

If you are also using cholestyramine, colestipol, or colesevelam, you must take niacin 4 to 6 hours after you take these medicines.

Dosing

The dose of niacin will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of niacin. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For high cholesterol and triglycerides:
  • For oral dosage forms (extended-release capsules, oral solution, or regular tablets):
    • Adults—500 to 2000 milligrams (mg) one to three times a day.
    • Children—Use and dose must be determined by your doctor.
  • For oral dosage form (extended-release tablets):
    • Adults and children older than 16 years of age—At first, 500 milligrams (mg) per day, taken at bedtime. After 4 weeks, your doctor will increase your dose to 1000 mg per day, taken at bedtime. However, the dose is usually not more than 2000 mg per day.
    • Children 16 years of age and younger—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of niacin, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

• 500 mg light orange to orange colored, round shaped, film-coated tablets debossed with ‘AN 321’ on one side and plain on the other side.
• 1000 mg light orange to orange colored, capsule shaped, film-coated tablets debossed with ‘AN 323’ on one side and plain on the other side

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

Clinical Studies Experience

In the placebo-controlled clinical trials database of 402 patients (age range 21 to 75 years, 33% women, 89% Caucasians, 7% Blacks, 3% Hispanics, 1% Asians) with a median treatment duration of 16 weeks, 16% of patients on Niacin extended-release and 4% of patients on placebo discontinued due to adverse reactions. The most common adverse reactions in the group of patients treated with Niacin extended-release that led to treatment discontinuation and occurred at a rate greater than placebo were flushing (6% vs. 0%), rash (2% vs. 0%), diarrhea (2% vs. 0%), nausea (1% vs. 0%), and vomiting (1% vs. 0%). The most commonly reported adverse reactions (incidence >5% and greater than placebo) in the Niacin extended-release controlled clinical trial database of 402 patients were flushing, diarrhea, nausea, vomiting, increased cough and pruritus.

In the placebo-controlled clinical trials, flushing episodes (i.e., warmth, redness, itching and/or tingling) were the most common treatment-emergent adverse reactions (reported by as many as 88% of patients) for Niacin extended-release. Spontaneous reports suggest that flushing may also be accompanied by symptoms of dizziness, tachycardia, palpitations, shortness of breath, sweating, burning sensation/skin burning sensation, chills, and/or edema, which in rare cases may lead to syncope. In pivotal studies, 6% (14/245) of Niacin extended-release patients discontinued due to flushing. In comparisons of immediate-release (IR) Niacin and Niacin extended-release tablets, although the proportion of patients who flushed was similar, fewer flushing episodes were reported by patients who received Niacin extended-release. Following 4 weeks of maintenance therapy at daily doses of 1500 mg, the incidence of flushing over the 4-week period averaged 8.6 events per patient for IR Niacin versus 1.9 following Niacin extended-release.

Other adverse reactions occurring in ≥5% of patients treated with Niacin extended-release and at an incidence greater than placebo are shown in Table 2 below.

Table 2. Treatment-Emergent Adverse Reactions by Dose Level in ≥ 5% of Patients and at an Incidence Greater than Placebo; Regardless of Causality Assessment in Placebo-Controlled Clinical Trials

In general, the incidence of adverse events was higher in women compared to men.

Atherothrombosis Intervention in Metabolic Syndrome with Low HDL/High Triglycerides:

Impact on Global Health Outcomes (AIM-HIGH)

In AIM-HIGH involving 3414 patients (mean age of 64 years, 15% women, 92% Caucasians, 34% with diabetes mellitus) with stable, previously diagnosed cardiovascular disease, all patients received simvastatin, 40 to 80 mg per day, plus ezetimibe 10 mg per day if needed, to maintain an LDL-C level of 40 to 80 mg/dL, and were randomized to receive Niacin extended-release 1500 to 2000 mg/day (n=1718) or matching placebo (IR Niacin, 100 to 150 mg, n=1696). The incidence of the adverse reactions of “blood glucose increased” (6.4% vs. 4.5%) and “diabetes mellitus” (3.6% vs. 2.2%) was significantly higher in the simvastatin plus Niacin extended-release group as compared to the simvastatin plus placebo group. There were 5 cases of rhabdomyolysis reported, 4 (0.2%) in the simvastatin plus Niacin extended-release group and one (<0.1%) in the simvastatin plus placebo group [see Warnings and Precautions (5.1)].

Postmarketing Experience

Because the below reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

The following additional adverse reactions have been identified during post-approval use of Niacin extended-release:

Hypersensitivity reactions, including anaphylaxis, angioedema, urticaria, flushing, dyspnea, tongue edema, larynx edema, face edema, peripheral edema, laryngismus, and vesiculobullous rash; maculopapular rash; dry skin; tachycardia; palpitations; atrial fibrillation; other cardiac arrhythmias; syncope; hypotension; postural hypotension; blurred vision; macular edema; peptic ulcers; eructation; flatulence; hepatitis; jaundice; decreased glucose tolerance; gout; myalgia; myopathy; dizziness; insomnia; asthenia; nervousness; paresthesia; dyspnea; sweating; burning sensation/skin burning sensation; skin discoloration, and migraine.

Clinical Laboratory Abnormalities

Chemistry: Elevations in serum transaminases [see Warnings and Precautions (5.3)], LDH, fasting glucose, uric acid, total bilirubin, amylase and creatine kinase, and reduction in phosphorus.

Hematology: Slight reductions in platelet counts and prolongation in prothrombin time [see Warnings and Precautions (5.4)].

To report SUSPECTED ADVERSE REACTIONS contact AvKARE, Inc. at 1-855-361-3993; email drugsafety@avkare.com; or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Niacin extended-release tablets contains Niacin, USP, which at therapeutic doses is an antihyperlipidemic agent. Niacin, USP (nicotinic acid, or 3-pyridinecarboxylic acid) is a white, crystalline powder, very soluble in water, with the following structural formula:

Niacin extended-release tablets are unscored, film-coated tablets for oral administration and are available in two tablet strengths containing 500 mg and 1000 mg Niacin. The 500 mg is light orange to orange colored, round shaped, coated tablets debossed with ‘AN 321’ on one side and plain on the other side. The 1000 mg is light orange to orange colored, capsule shaped, coated tablets debossed with ‘AN 323’ on one side and plain on the other side. Niacin extended-release tablets also contain the following inactive ingredients: FD&C yellow #6/sunset yellow FCF aluminum lake, hydroxyethyl cellulose, hypromellose, iron oxide red, iron oxide yellow, polyethylene glycol 400, stearic acid and titanium dioxide.

• Nicotinic Acid
• Vitamin B3

• Antilipemic Agent, Miscellaneous
• Vitamin, Water Soluble

Refer to adult dosing.

Frequency not defined.

Cardiovascular: Atrial fibrillation, cardiac arrhythmia, edema, flushing, hypotension, orthostatic hypotension, palpitations, tachycardia

Central nervous system: Chills, dizziness, headache, insomnia, migraine, myasthenia, nervousness, pain, paresthesia

Dermatologic: Acanthosis nigricans, burning sensation of skin, diaphoresis, hyperpigmentation, maculopapular rash, pruritus, skin discoloration, skin rash, urticaria, xeroderma

Endocrine & metabolic: Decreased glucose tolerance, decreased serum phosphate, gout, hyperuricemia, increased amylase, increased lactate dehydrogenase

Gastrointestinal: Abdominal pain, diarrhea, dyspepsia, eructation, flatulence, nausea, peptic ulcer, vomiting

Hematologic & oncologic: Decreased platelet count, prolonged prothrombin time

Hepatic: Hepatitis, increased serum bilirubin, increased serum transaminases (dose-related), jaundice,

Neuromuscular & skeletal: Increased creatine phosphokinase, leg cramps, myalgia, myopathy (with concurrent HMG-CoA reductase inhibitor), weakness

Ophthalmic: Blurred vision, cystoid macular edema, toxic amblyopia

Respiratory: Cough, dyspnea

<1%, postmarketing, and/or case reports: Hepatic necrosis, hypersensitivity reaction (includes anaphylaxis, angioedema, laryngismus, vesiculobullous rash), rhabdomyolysis (with concurrent HMG-CoA reductase inhibitor), syncope

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience flushing, itching, diarrhea, cough, nausea, or vomiting. Have patient report immediately to prescriber signs of high blood sugar (confusion, fatigue, increased thirst, increased hunger, polyuria, flushing, fast breathing, or breath that smells like fruit), signs of liver problems (dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or jaundice), muscle pain, muscle weakness, angina, severe dizziness, passing out, shortness of breath, or sweating a lot (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

Avoid drinking hot beverages shortly after taking niacin. Hot drinks can worsen the 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 this medicine.

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.

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

Ask a doctor or pharmacist if it is safe for you to use niacin if you are also using any of the following drugs:

• a blood thinner such as warfarin (Coumadin, Jantoven);

• multivitamins or mineral supplements that contain niacin;

• blood pressure or heart medications such as amlodipine (Norvasc, Caduet, Exforge, Lotrel, Tekamlo, Tribenzor, Twynsta, Amturnide), diltiazem (Cardizem, Cartia, Dilacor, Diltia, Diltzac, Taztia, Tiazac), 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 other drugs may interact with niacin. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.