Nicosyl, 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. Nicosyl is also present in many multiple vitamins and nutritional supplements.
Nicosyl is used to treat and prevent a lack of natural Nicosyl 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. Nicosyl is sometimes used to treat coronary artery disease (also called atherosclerosis).
Nicosyl may also be used for purposes not listed in this medication guide.
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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. Nicosyl, USP 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.
Nicosyl Extended-Release Tablets USP are 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.
In patients with a history of myocardial infarction and hyperlipidemia, Nicosyl, USP is indicated to reduce the risk of recurrent nonfatal myocardial infarction.
In patients with a history of coronary artery disease (CAD) and hyperlipidemia, Nicosyl, USP, in combination with a bile acid binding resin, is indicated to slow progression or promote regression of atherosclerotic disease.
Nicosyl Extended-Release Tablets USP in combination with a bile acid binding resin are indicated to reduce elevated TC and LDL-C levels in adult patients with primary hyperlipidemia.
Nicosyl, USP is also indicated as adjunctive therapy for treatment of adult patients with severe hypertriglyceridemia who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them.
Limitations of Use
Addition of Nicosyl Extended-Release Tablets USP did not reduce cardiovascular morbidity or mortality among patients treated with simvastatin in a large, randomized controlled trial (AIM-HIGH).
How should I use Nicosyl?
Use Nicosyl controlled-release tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.
An extra patient leaflet is available with Nicosyl controlled-release tablets. Talk to your pharmacist if you have questions about this information.
To minimize flushing and upset stomach, take Nicosyl controlled-release tablets at bedtime after a low-fat snack (eg, low-fat yogurt, banana, crackers with a glass of milk) unless your doctor directs otherwise. Do not take Nicosyl controlled-release tablets on an empty stomach. Do not take Nicosyl controlled-release tablets with alcohol, a hot drink, or spicy foods.
Do not take bile acid sequestrants (eg, colestipol, cholestyramine) within 4 to 6 hours of taking Nicosyl controlled-release tablets.
Swallow Nicosyl controlled-release tablets whole. Do not break, crush, or chew before swallowing.
If you miss a dose of Nicosyl controlled-release tablets, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. If you miss several doses, contact your doctor.
Ask your health care provider any questions you may have about how to use Nicosyl controlled-release tablets.
Uses of Nicosyl in details
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
Nicosyl (nicotinic acid) is used to prevent and treat Nicosyl deficiency (pellagra). Nicosyl deficiency may result from certain medical conditions (such as alcohol abuse, malabsorption syndrome, Hartnup disease), poor diet, or long-term use of certain medications (such as isoniazid).
Nicosyl deficiency can cause diarrhea, confusion (dementia), tongue redness/swelling, and peeling red skin. Nicosyl is also known as vitamin B3, one of the B-complex vitamins. Vitamins help to support the body's ability to make and break down natural compounds (metabolism) needed for good health. Niacinamide (nicotinamide) is a different form of vitamin B3 and does not work the same as Nicosyl. Do not substitute unless directed by your doctor.
Check the ingredients on the label even if you have used the product before. The manufacturer may have changed the ingredients. Also, products with similar names may contain different ingredients meant for different purposes. Taking the wrong product could harm you.
OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug, but may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.
Nicosyl may also be used to improve cholesterol and lower fat levels (triglycerides) in the blood under the care of your doctor. It is generally used after non-drug treatments have not been fully successful at lowering cholesterol. Doses for treating these blood fat problems are usually much higher than for dietary problems.
How to use B-3 Nicosyl
Take this medication by mouth with a low-fat meal or snack as directed by your doctor, usually 1-3 times daily. Taking Nicosyl on an empty stomach increases side effects (such as flushing, upset stomach). Follow all directions on the product package. If your doctor has prescribed this medication, take it as directed. If you are uncertain about any of the information, consult your doctor or pharmacist.
Nicosyl is available in different formulations (such as immediate and sustained release). Do not switch between strengths, brands, or forms of Nicosyl. Severe liver problems may occur.
Swallow extended-release capsules whole. Do not crush or chew extended-release capsules or tablets. Doing so can release all of the drug at once, increasing the risk of side effects. Also, do not split extended-release tablets unless they have a score line and your doctor or pharmacist tells you to do so. Swallow the whole or split tablet without crushing or chewing.
To lessen the chance of side effects such as flushing, avoid alcohol, hot beverages, and eating spicy foods near the time you take Nicosyl. Taking a plain (non-enteric coated, 325 milligram) aspirin or a nonsteroidal anti-inflammatory drug (such as ibuprofen, 200 milligrams) 30 minutes before taking Nicosyl may help prevent flushing. Ask your doctor if this treatment is right for you.
If you also take certain other drugs to lower cholesterol (bile acid-binding resins such as cholestyramine or colestipol), take Nicosyl at least 4 to 6 hours before or after taking these medications. These products interact with Nicosyl, preventing its full absorption. Continue to take other medications to lower your cholesterol as directed by your doctor.
The dosage is based on your medical condition and response to treatment. If you are taking this for lipid problems, your doctor may direct you to start this medication at a low dose and gradually increase your dose to reduce your risk of side effects. Your dose will need to be increased slowly even if you are already taking Nicosyl and are being switched from another Nicosyl product to this product. Follow your doctor's instructions carefully.
Do not stop taking this medicine unless instructed by your doctor. If you stop taking Nicosyl, you may need to return to your original dose and gradually increase it again. Ask your doctor or pharmacist for instructions on restarting your dose if you have not taken your medication for several days.
Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time(s) each day.
It is very important to continue to follow your doctor's advice about diet and exercise.
If your condition persists or worsens, or if you think you may have a serious medical problem, get medical help right away.
A water-soluble vitamin of the B complex occurring in various animal and plant tissues. It is required by the body for the formation of coenzymes NAD and NADP. It has pellagra-curative, vasodilating, and antilipemic properties. [PubChem]
Nicosyl Extended-Release Tablets should be taken at bedtime, after a low-fat snack, and doses should be individualized according to patient response. Therapy with Nicosyl Extended-Release Tablets 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 Table 1 below.
Table 1. Recommended Dosing
Nicosyl Extended-Release Tablets Dosage
1 to 4
1 Nicosyl Extended-Release 500 mg Tablet at bedtime
5 to 8
1 Nicosyl Extended-Release 1000 mg Tablet or
2 Nicosyl Extended-Release 500 mg Tablets at bedtime
2 Nicosyl Extended-Release 750 mg Tablets or
3 Nicosyl Extended-Release 500 mg Tablets at bedtime
2 Nicosyl Extended-Release 1000 mg Tablets or
4 Nicosyl Extended-Release 500 mg Tablets at bedtime
* After Week 8, titrate to patient response and tolerance. If response to 1000 mg daily is inadequate, increase dose to 1500 mg daily; may subsequently increase dose to 2000 mg daily. Daily dose should not be increased more than 500 mg in a 4-week period, and doses above 2000 mg daily are not recommended. Women may respond at lower doses than men.
The daily dosage of Nicosyl Extended-Release Tablets 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 Nicosyl Extended-Release Tablet 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 Nicosyl Extended-Release Tablet 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 Nicosyl 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 Nicosyl Extended-Release Tablet ingestion.
Equivalent doses of Nicosyl Extended-Release Tablets should not be substituted for sustained-release (modified-release, timed-release) Nicosyl preparations or immediate-release (crystalline) Nicosyl. Patients previously receiving other Nicosyl products should be started with the recommended Nicosyl Extended-Release Tablet titration schedule, and the dose should subsequently be individualized based on patient response.
If Nicosyl Extended-Release Tablet therapy is discontinued for an extended period, reinstitution of therapy should include a titration phase.
Nicosyl Extended-Release 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 Nicosyl Extended-Release Tablets in patients with renal or hepatic impairment has not been studied. Nicosyl Extended-Release Tablets are contraindicated in patients with significant or unexplained hepatic dysfunction. Nicosyl Extended-Release Tablets should be used with caution in patients with renal impairment.
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
Some products that may interact with this drug include: "blood thinners" (such as warfarin, heparins).
Check all prescription and nonprescription medicine labels carefully since vitamins/dietary supplements may also contain Nicosyl or niacinamide (nicotinamide). These may increase your risk of side effects if taken together. Ask your doctor or pharmacist for more details.
This medication may interfere with certain laboratory tests (including urine or blood catecholamines, copper-based urine glucose tests), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.
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 Nicosyl extended-release tablets and 4% of patients on placebo discontinued due to adverse reactions. The most common adverse reactions in the group of patients treated with Nicosyl extended-release tablets 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 Nicosyl extended-release tablets 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 Nicosyl extended-release tablets. 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 Nicosyl extended-release tablet patients discontinued due to flushing. In comparisons of immediate-release (IR) Nicosyl and Nicosyl extended-release tablets, although the proportion of patients who flushed was similar, fewer flushing episodes were reported by patients who received Nicosyl extended-release tablets. 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 Nicosyl versus 1.9 following Nicosyl extended-release tablets.
Other adverse reactions occurring in ≥ 5% of patients treated with Nicosyl extended-release tablets 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
Pooled results from placebo-controlled studies; for Nicosyl extended-release tablets, n = 245 and median treatment duration = 16 weeks. Number of Nicosyl extended-release tablet patients (n) are not additive across doses.
Adverse reactions are reported at the initial dose where they occur.
The 500 mg/day dose is outside the recommended daily maintenance dosing range.
10 patients discontinued before receiving 500 mg, therefore they were not included.
Nicosyl Extended-Release Tablets Treatment*
(n = 157)
(n = 87)
(n = 110)
(n = 136)
(n = 95)
Skin and Subcutaneous Tissue Disorders
Note: Percentages are calculated from the total number of patients in each column.
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 Nicosyl extended-release tablets 1500 to 2000 mg/day (n = 1718) or matching placebo (IR Nicosyl, 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 Nicosyl extended-release tablets group as compared to the simvastatin plus placebo group. There were 5 cases of rhabdomyolysis reported, 4 (0.2%) in the simvastatin plus Nicosyl extended-release tablets group and one (< 0.1%) in the simvastatin plus placebo group.
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 Nicosyl extended-release tablets:
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