B-3-50

Name: B-3-50

B-3-50 Dosage

Niacin is available both as a tablet and an extended release tablet (Niacin ER). The regular tablet is sometimes taken 2 to 3 times daily with meals. Niacin ER is usually taken once daily at bedtime with a low-fat snack. Take Niacin exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

What is the most important information I should know about B-3-50 (niacin)?

You should 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.

What should I avoid while taking B-3-50 (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 B-3-50 (niacin)?

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.

For the Consumer

Applies to niacin: oral capsule, oral capsule extended release, oral elixir, oral tablet, oral tablet extended release

Along with its needed effects, niacin (the active ingredient contained in B-3-50) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking niacin:

Less common
  • Darkening of urine
  • light gray-colored stools
  • loss of appetite
  • severe stomach pain
  • yellow eyes or skin

Some side effects of niacin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common
  • Abdominal or stomach pain
  • cough
  • diarrhea
  • feeling of warmth
  • flushing or redness of the skin, especially on the face and neck
  • headache
  • nausea or vomiting
  • rash or itching
  • runny nose
  • sneezing
  • stuffy nose
Incidence not known
  • Dizziness or faintness
  • dryness of the skin
  • fever
  • frequent urination
  • joint pain
  • muscle aching or cramping
  • side, lower back, or stomach pain
  • swelling of the feet or lower legs
  • unusual thirst
  • unusual tiredness or weakness
  • unusually fast, slow, or irregular heartbeat

Usual Adult Dose for Hyperlipoproteinemia Type V (Elevated Chylomicrons + VLDL)

Immediate-release:
-Initial dose: 250 mg orally once a day following the evening meal; increase frequency and/or dose every 4 to 7 days to the desired effect or first-level therapeutic dose (1.5 to 2 g/day in 2 to 3 divided doses); if the response is inadequate after 2 months, the dose can be increased at 2 to 4 week intervals to 1
-Maintenance dose: 1 to 2 g orally 2 to 3 times a day
-Maximum dose: 6 g/day (in 2 to 3 divided doses)

Sustained-release:
-Weeks 1 to 4: 500 mg orally at bedtime
-Weeks 5 to 8: 1000 mg orally at bedtime
-After week 8: Titrate to patient response and tolerance; if response to 1000 mg a day is inadequate, increase to 1500 mg a day; may subsequently increase to 2000 mg a day: daily dose should not be increased more than 500 mg in a 4-week period
-Maintenance dose: 1000 to 2000 mg orally at bedtime
-Maximum dose: 2000 mg/day

Comments:
-Individualize doses according to patient response.
-Women may respond at lower doses than men.
-Tolerance to flushing develops rapidly over the course of several weeks; flushing, pruritus, and GI distress can be reduced by slowly increasing the dose and avoiding administration on an empty stomach.
-Concomitant alcoholic drinks, hot drinks, or spicy foods may increase the side effects of flushing and pruritus and should be avoided near the time this drug is taken.
-If therapy with the extended-release formulation is discontinued for an extended period, reinstitution of therapy should include a titration phase.
-The extended-release formulation should be taken whole and should not be broken, crushed, or chewed before swallowing.
-Flushing can be minimized by pretreatment with aspirin or nonsteroidal anti-inflammatory drugs.
-Flushing, pruritus, and GI distress can be reduced by slowly increasing the dose and avoiding administration on an empty stomach.

Uses:
-To reduce elevated TC, LDL-C, Apo B and TG, and to increase HDL-C in patients with primary hyperlipidemia and mixed dyslipidemia; to reduce the risk of recurrent nonfatal myocardial infarction in patients with a history of myocardial infarction and hyperlipidemia
-In combination with a bile acid binding resin: Slows progression or promotes regression of atherosclerotic disease in patients with a history of coronary artery disease (CAD) and hyperlipidemia
-As an adjunct to diet to reduce elevated TC and LDL-C in adult patients with primary hyperlipidemia
-To reduce TG in adult patients with severe hypertriglyceridemia

Usual Adult Dose for Vitamin/Mineral Supplementation

Recommended Dietary Allowance (RDA):
-Males: 16 mg/day
-Females: 14 mg/day
-Pregnancy: 18 mg/day
-Lactation: 17 mg/day

Comments:
-Niacin may be given orally and also parenterally as a component of injectable multivitamin additives contained in parenteral nutrition products.
-The best way to get the daily requirement of essential vitamins is to eat a balanced diet that contains a variety of foods.

Uses:
-Recommended Dietary Allowance (RDA): Average daily level of intake that is enough to meet the nutrient requirements of nearly all (97 to 98%) healthy people.

Renal Dose Adjustments

Data not available

Other Comments

Administration advice:
-Switching from immediate release to extended release products: Patients previously receiving other niacin products should be started with the recommended niacin extended-release tablets titration schedule, and the dose should subsequently be individualized based on patient response.
-This drug should be administered at bedtime following a snack.
-Concomitant alcohol or hot drinks may increase flushing and pruritus and should be avoided at the time of dosing.

General:
-Equivalent doses of niacin extended-release tablets should not be substituted for sustained-release (modified-release, timed-release) niacin preparations or immediate-release (crystalline) niacin.
-Extended-release formulations should not be broken, crushed, or chewed before swallowing.

(web3)