Niacin (Niaspan)

Trade Name : Niaspan

AbbVie Inc.

TABLET, FILM COATED, EXTENDED RELEASE

Strength 500 mg/1

NIACIN Nicotinic Acid [EPC],Nicotinic Acids [CS]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Niacin (Niaspan) which is also known as Niaspan and Manufactured by AbbVie Inc.. It is available in strength of 500 mg/1 per ml. Read more

Niacin (Niaspan) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hyperlipidemia. Niacin therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate.
  • Limitations of Use
  • Addition of NIASPAN did not reduce cardiovascular morbidity or mortality among patients treated with simvastatin in a large, randomized controlled trial (AIM-HIGH) .
  • NIASPAN contains extended-release niacin (nicotinic acid), and is indicated:
  • Limitations of use:
  • Addition of NIASPAN did not reduce cardiovascular morbidity or mortality among patients treated with simvastatin in a large, randomized controlled trial .
  • To reduce elevated TC, LDL-C, Apo B and TG, and to increase HDL-C in patients with primary hyperlipidemia and mixed dyslipidemia.n
  • To reduce the risk of recurrent nonfatal myocardial infarction in patients with a history of myocardial infarction and hyperlipidemia.n
  • In combination with a bile acid binding resin: n
  • To reduce TG in adult patients with severe hypertriglyceridemia.n
  • NIASPAN should be taken at bedtime, after a low-fat snack, and doses should be individualized according to patient response. Therapy with NIASPAN must be initiated at 500 mg at bedtime in order to reduce the incidence and severity of side effects which may occur during early therapy. The recommended dose escalation is shown in below.
  • Maintenance Dose
  • The daily dosage of NIASPAN should not be increased by more than 500 mg in any 4-week period. The recommended maintenance dose is 1000 mg (two 500 mg tablets or one 1000 mg tablet) to 2000 mg (two 1000 mg tablets or four 500 mg tablets) once daily at bedtime. Doses greater than 2000 mg daily are not recommended. Women may respond at lower NIASPAN doses than men .
  • Single-dose bioavailability studies have demonstrated that two of the 500 mg and one of the 1000 mg tablet strengths are interchangeable but three of the 500 mg and two of the 750 mg tablet strengths are not interchangeable.
  • Flushing of the skin may be reduced in frequency or severity by pretreatment with aspirin (up to the recommended dose of 325 mg taken 30 minutes prior to NIASPAN dose). 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 niacin and avoiding administration on an empty stomach. Concomitant alcoholic, hot drinks or spicy foods may increase the side effects of flushing and pruritus and should be avoided around the time of NIASPAN ingestion.
  • Equivalent doses of NIASPAN should not be substituted for sustained-release (modified-release, timed-release) niacin preparations or immediate-release (crystalline) niacin . Patients previously receiving other niacin products should be started with the recommended NIASPAN titration schedule (see ), and the dose should subsequently be individualized based on patient response.
  • If NIASPAN therapy is discontinued for an extended period, reinstitution of therapy should include a titration phase (see ).
  • NIASPAN tablets should be taken whole and should not be broken, crushed or chewed before swallowing.
  • Dosage in Patients with Renal or Hepatic Impairment
  • Use of NIASPAN in patients with renal or hepatic impairment has not been studied. NIASPAN is contraindicated in patients with significant or unexplained hepatic dysfunction. NIASPAN should be used with caution in patients with renal impairment .
  • NIASPAN should be taken at bedtime with a low-fat snack. n
  • Dose range: 500 mg to 2000 mg once daily. n
  • Therapy with NIASPAN must be initiated at 500 mg at bedtime in order to reduce the incidence and severity of side effects which may occur during early therapy and should not be increased by more than 500 mg in any four week period. n
  • Maintenance dose: 1000 to 2000 mg once daily. n
  • Doses greater than 2000 mg daily are not recommended. n
  • Unscored film-coated tablets for oral administration: 500, 750 and 1000 mg niacin extended-release. n
  • NIASPAN is contraindicated in the following conditions:
  • Active liver disease, which may include unexplained persistent elevations in hepatic transaminase levels. , n
  • Active peptic ulcer disease. n
  • Arterial bleeding. n
  • Known hypersensitivity to product components. , n
  • NIASPAN preparations should not be substituted for equivalent doses of immediate-release (crystalline) niacin. 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 n
  • Caution should also be used when NIASPAN is used in patients with unstable angina or in the acute phase of an MI, particularly when such patients are also receiving vasoactive drugs such as nitrates, calcium channel blockers, or adrenergic blocking agents.
  • Niacin is rapidly metabolized by the liver, and excreted through the kidneys. NIASPAN is contraindicated in patients with significant or unexplained hepatic impairment and should be used with caution in patients with renal impairment. Patients with a past history of jaundice, hepatobiliary disease, or peptic ulcer should be observed closely during NIASPAN therapy.
  • Severe hepatic toxicity has occurred in patients substituting sustained-release niacin for immediate-release niacin at equivalent doses. n
  • Myopathy has been reported in patients taking NIASPAN. The risk for myopathy and rhabdomyolysis are increased among elderly patients; patients with diabetes, renal failure, or uncontrolled hypothyroidism; and patients being treated with a statin. n
  • Liver enzyme abnormalities and monitoring: Persistent elevations in hepatic transaminase can occur. Monitor liver enzymes before and during treatment. n
  • Use with caution in patients with unstable angina or in the acute phase of an MI. n
  • NIASPAN can increase serum glucose levels. Glucose levels should be closely monitored in diabetic or potentially diabetic patients particularly during the first few months of use or dose adjustment. n
  • 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.
  • Most common adverse reactions (incidence >5% and greater than placebo) are flushing, diarrhea, nausea, vomiting, increased cough, and pruritus.n
  • Flushing of the skin may be reduced in frequency or severity by pretreatment with aspirin (up to the recommended dose of 325 mg taken 30 minutes prior to NIASPAN dose).n n n
  • To report SUSPECTED ADVERSE REACTIONS, contact AbbVie Inc. at 1-800-633u20139110 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • No data
  • Statins: Caution should be used when prescribing niacin with statins as these agents can increase risk of myopathy/rhabdomyolysis. , n
  • Bile Acid Sequestrants: Bile acid sequestrants have a high niacin-binding capacity and should be taken at least 4 - 6 hours before NIASPAN administration. n
  • No data
  • Renal impairment: NIASPAN should be used with caution in patients with renal impairment. , n
  • Hepatic impairment: NIASPAN is contraindicated in active liver disease or significant or unexplained hepatic dysfunction or unexplained elevations of serum transaminases. ,, , n
  • Supportive measures should be undertaken in the event of an overdose.
  • NIASPAN (niacin tablet, film-coated extended-release), contains niacin, which at therapeutic doses is an antihyperlipidemic agent. Niacin (nicotinic acid, or 3-pyridinecarboxylic acid) is a white, crystalline powder, very soluble in water, with the following structural formula:
  • NIASPAN is an unscored, medium-orange, film-coated tablet for oral administration and is available in three tablet strengths containing 500, 750, and 1000 mg niacin. NIASPAN tablets also contain the inactive ingredients hypromellose, povidone, stearic acid, and polyethylene glycol, and the following coloring agents: FD&C yellow #6/sunset yellow FCF Aluminum Lake, synthetic red and yellow iron oxides, and titanium dioxide.
  • No data
  • Niacin administered to mice for a lifetime as a 1% solution in drinking water was not carcinogenic. The mice in this study received approximately 6 to 8 times a human dose of 3000 mg/day as determined on a mg/m basis. Niacin was negative for mutagenicity in the Ames test. No studies on impairment of fertility have been performed. No studies have been conducted with NIASPAN regarding carcinogenesis, mutagenesis, or impairment of fertility.
  • No data
  • NIASPAN tablets are supplied as unscored, medium-orange, film-coated, capsule-shaped (containing 500 or 750 mg of niacin) or oval shaped (containing 1000 mg of niacin) tablets, in an extended-release formulation. Tablets are supplied in bottles of 90 as shown below.
  • Storage: Store at room temperature 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F).
  • 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.
  • Patients should be advised to inform other healthcare professionals prescribing a new medication that they are taking NIASPAN.
  • The patient should be informed of the following:
  • Dosing Time
  • NIASPAN tablets should be taken at bedtime, after a low-fat snack. Administration on an empty stomach is not recommended.
  • Tablet Integrity
  • NIASPAN tablets should not be broken, crushed or chewed, but should be swallowed whole.
  • Dosing Interruption
  • If dosing is interrupted for any length of time, their physician should be contacted prior to restarting therapy; re-titration is recommended.
  • Muscle Pain
  • Notify their physician of any unexplained muscle pain, tenderness, or weakness promptly. They should discuss all medication, both prescription and over the counter, with their physician.
  • Flushing
  • Flushing (warmth, redness, itching and/or tingling of the skin) is a common side effect of niacin therapy that may subside after several weeks of consistent NIASPAN use. Flushing may vary in severity and is more likely to occur with initiation of therapy, or during dose increases. By dosing at bedtime, flushing will most likely occur during sleep. However, if awakened by flushing at night, the patient should get up slowly, especially if feeling dizzy, feeling faint, or taking blood pressure medications. Advise patients of the symptoms of flushing and how they differ from the symptoms of a myocardial infarction.
  • Use of Aspirin Medication
  • Taking aspirin (up to the recommended dose of 325 mg) approximately 30 minutes before dosing can minimize flushing.
  • Diet
  • Avoid ingestion of alcohol, hot beverages and spicy foods around the time of taking NIASPAN to minimize flushing.
  • Supplements
  • Notify their physician if they are taking vitamins or other nutritional supplements containing niacin or nicotinamide.
  • Dizziness
  • Notify their physician if symptoms of dizziness occur.
  • Diabetics
  • If diabetic, to notify their physician of changes in blood glucose.
  • Pregnancy
  • Discuss future pregnancy plans with your patients, and discuss when to stop NIASPAN if they are trying to conceive. Patients should be advised that if they become pregnant, they should stop taking NIASPAN and call their healthcare professional.
  • Breastfeeding
  • Women who are breastfeeding should be advised to not use NIASPAN. Patients, who have a lipid disorder and are breastfeeding, should be advised to discuss the options with their healthcare professional.
  • u00a9 AbbVie Inc. 2018
  • Manufactured by:
  • AbbVie LTD, Barceloneta, PR 00617
  • For AbbVie Inc.
  • North Chicago, IL 60064, USA
  • 03-B838 December, 2018
  • NIASPANu00ae (ny-a-span)
  • (niacin extended-release) tablets
  • Read this information carefully before you start taking NIASPAN and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.
  • What is NIASPAN?
  • NIASPAN is a prescription medicine used with diet and exercise to increase the good cholesterol (HDL) and lower the bad cholesterol (LDL) and fats (triglycerides) in your blood.
  • It is not known if NIASPAN is safe and effective in children 16 years of age and under.
  • Who should not take NIASPAN?
  • Do not take NIASPAN if you have:
  • What should I tell my doctor before taking NIASPAN?
  • Before you take NIASPAN, tell your doctor, if you:
  • Tell your doctor about all the medicines you take,
  • Especially tell your doctor if you take:
  • Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.
  • How should I take NIASPAN?
  • What are the possible side effects of NIASPAN?
  • NIASPAN may cause serious side effects, including:
  • Call your doctor right away if you have any of the side effects listed above.
  • The most common side effects of NIASPAN include:
  • Flushing is the most common side effect of NIASPAN.
  • Flushing does not always happen. If it does, it is usually within 2 to 4 hours after taking a dose of NIASPAN. Flushing may last for a few hours. Flushing is more likely to happen when you first start taking NIASPAN or when your dose of NIASPAN is increased. Flushing may get better after several weeks.
  • If you wake up at night because of flushing, get up slowly, especially if you:
  • To lower your chance of flushing:
  • People with high cholesterol and heart disease are at risk for a heart attack. Symptoms of a heart attack may be different from a flushing reaction from NIASPAN. n
  • The chest pain you have with a heart attack may feel like uncomfortable pressure, squeezing, fullness or pain that lasts more than a few minutes, or that goes away and comes back. Heart attacks may be sudden and intense, but often start slowly, with mild pain or discomfort.
  • Call your doctor right away if you have any symptoms of a heart attack.
  • Tell your doctor if you have any side effect that bothers you or does not go away.
  • These are not all the possible side effects of NIASPAN. For more information, ask your doctor or pharmacist.
  • Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
  • How should I store NIASPAN?
  • Keep NIASPAN and all medicines out of the reach of children.
  • General information about the safe and effective use of NIASPAN.
  • Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use NIASPAN for a condition for which it was not prescribed. Do not give NIASPAN to other people, even if they have the same symptoms that you have. It may harm them.
  • This leaflet summarizes the most important information about NIASPAN. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about NIASPAN that is written for health professionals.
  • For more information, go to www.NIASPAN.com or call AbbVie Inc. Medical Information at 1-800-633-9110.
  • What are the ingredients in NIASPAN?
  • Active ingredient:
  • Inactive Ingredients:
  • This Patient Information has been approved by the U.S. Food and Drug Administration.
  • Manufactured by: AbbVie LTD, Barceloneta, PR 00617
  • For AbbVie Inc.
  • North Chicago, IL 60064, USA
  • 03-B838 December, 2018
  • NDC 0074-3265-90
  • Niaspan Niacin Extended-Release Tablets 500 mg 90 Tablets
  • Rx only abbvie
  • NDC 0074-3274-90
  • Niaspann
  • Niacin Extended-Release Tablets 750 mg 90 Tablets
  • Rx only abbvie
  • NDC 0074-3275-90
  • Niaspann
  • Niacin Extended-Release Tablets 1000 mg 90 Tablets
  • Rx only abbvie
  • NDC 0074u20133074u201330
  • Niaspan Niacin Extended-Release Tablets 500 mg 30 Tablets
  • Rx only abbvie
  • NDC 0074u20133074u201390
  • Niaspan Niacin Extended-Release Tablets 500 mg 90 Tablets
  • Rx only abbvie
  • NDC 0074u20133079u201390
  • Niaspann
  • Niacin Extended-Release Tablets 750 mg 90 Tablets
  • Rx only abbvie
  • NDC 0074u20133080u201390
  • Niaspann
  • Niacin Extended-Release Tablets 1000 mg 90 Tablets
  • Rx only abbvie

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