What happens if I overdose Niacin?
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local, or emergency room immediately. Symptoms may include flushing.
Proper storage of Niacin:
Store Niacin at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Niacin out of the reach of children and away from pets.
Overdose of Niacin in details
If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
Notes
If you are taking this for high cholesterol, in addition to eating a proper diet (such as a low-cholesterol/low-fat diet), other lifestyle changes that may help this medication work better include exercising, losing weight if overweight, and stopping smoking. Consult your doctor for more details.
Remember that it is best to get your vitamins and minerals from food whenever possible. Maintain a well-balanced diet, and follow any dietary guidelines as directed by your doctor. B vitamins (including Niacin) are found in meat, fish, poultry, enriched/whole grain bread products, and fortified cereals. Eat more of these foods to increase the amount of Niacin in your diet if you have a Niacin deficiency.
There are many Niacin products available. Some can be purchased without a prescription. Consult your doctor or pharmacist about the best product for you.
Laboratory tests (such as blood lipids, blood sugar, liver function tests, uric acid levels) may be performed (especially if prescribed for cholesterol/triglyceride control) to monitor your progress or check for side effects. Consult your doctor for more details.
Do not share this medication with others.
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 away from moisture and light. Do not store in the bathroom. Refer to storage information printed on the package. If you have any questions about storage, ask your pharmacist. Keep all medications 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.
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.
Niacin warnings
Niacin extended-release tablet preparations should not be substituted for equivalent doses of immediate-release (crystalline) Niacin. For patients switching from immediate-release Niacin to Niacin extended-release tablets, therapy with Niacin extended-release tablets should be initiated with low doses (i.e., 500 mg at bedtime) and the Niacin extended-release tablet dose should then be titrated to the desired therapeutic response.
Caution should also be used when Niacin extended-release tablets are 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. Niacin extended-release tablets are 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 Niacin extended-release tablet therapy.
Mortality and Coronary Heart Disease Morbidity
Niacin extended-release tablets have not been shown to reduce cardiovascular morbidity or mortality among patients already treated with a statin.
The Atherothrombosis Intervention in Metabolic Syndrome with Low HDL/High Triglycerides: Impact on Global Health Outcomes (AIM-HIGH) trial was a randomized placebo-controlled trial of 3414 patients with stable, previously diagnosed cardiovascular disease. Mean baseline lipid levels were LDL-C 74 mg/dL, HDL-C 35 mg/dL, non-HDL-C 111 mg/dL and median triglyceride level of 163 to 177 mg/dL. Ninety-four percent of patients were on background statin therapy prior to entering the trial. All participants 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 tablets 1500 to 2000 mg/day (n = 1718) or matching placebo (IR Niacin, 100 to 150 mg, n = 1696). On-treatment lipid changes at two years for LDL-C were -12% for the simvastatin plus Niacin extended-release tablets group and -5.5% for the simvastatin plus placebo group. HDL-C increased by 25% to 42 mg/dL in the simvastatin plus Niacin extended-release tablets group and by 9.8% to 38 mg/dL in the simvastatin plus placebo group (P < 0.001). Triglyceride levels decreased by 28.6% in the simvastatin plus Niacin extended-release tablets group and by 8.1% in the simvastatin plus placebo group. The primary outcome was an ITT composite of the first study occurrence of coronary heart disease death, nonfatal myocardial infarction, ischemic stroke, hospitalization for acute coronary syndrome or symptom-driven coronary or cerebral revascularization procedures. The trial was stopped after a mean follow-up period of 3 years owing to a lack of efficacy. The primary outcome occurred in 282 patients in the simvastatin plus Niacin extended-release tablets group (16.4%) and in 274 patients in the simvastatin plus placebo group (16.2%) (HR 1.02 [95% CI, 0.87 to 1.21], P = 0.79. In an ITT analysis, there were 42 cases of first occurrence of ischemic stroke reported, 27 (1.6%) in the simvastatin plus Niacin extended-release tablets group and 15 (0.9%) in the simvastatin plus placebo group, a non-statistically significant result (HR 1.79, [95%CI = 0.95 to 3.36], p = 0.071). The on-treatment ischemic stroke events were 19 for the simvastatin plus Niacin extended-release tablets group and 15 for the simvastatin plus placebo group.
Skeletal Muscle
Cases of rhabdomyolysis have been associated with concomitant administration of lipid-altering doses (≥ 1 g/day) of Niacin and statins. Elderly patients and patients with diabetes, renal failure, or uncontrolled hypothyroidism are particularly at risk. 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. 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.
Liver Dysfunction
Cases of severe hepatic toxicity, including fulminant hepatic necrosis, have occurred in patients who have substituted sustained-release (modified-release, timed-release) Niacin products for immediate-release (crystalline) Niacin at equivalent doses.
Niacin extended-release tablets 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 Niacin extended-release tablets.
Niacin preparations have been associated with abnormal liver tests. In three placebo-controlled clinical trials involving titration to final daily Niacin extended-release tablet doses ranging from 500 to 3000 mg, 245 patients received Niacin extended-release tablets for a mean duration of 17 weeks. No patient with normal serum transaminase levels (AST, ALT) at baseline experienced elevations to more than 3 times the upper limit of normal (ULN) during treatment with Niacin extended-release tablets. In these studies, fewer than 1% (2/245) of Niacin extended-release tablet patients discontinued due to transaminase elevations greater than 2 times the ULN.
Liver-related tests should be performed on all patients during therapy with Niacin extended-release tablets. Serum transaminase levels, including AST and ALT (SGOT and SGPT), should be monitored before treatment begins, every 6 to 12 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 3 times ULN and are persistent, or if they are associated with symptoms of nausea, fever, and/or malaise, the drug should be discontinued.
Laboratory Abnormalities
Increase in Blood Glucose: Niacin treatment can increase fasting blood glucose. Frequent monitoring of blood glucose should be performed to ascertain that the drug is producing no adverse effects. Diabetic patients may experience a dose-related increase in glucose intolerance. Diabetic or potentially diabetic patients should be observed closely during treatment with Niacin extended-release tablets, particularly during the first few months of use or dose adjustment; adjustment of diet and/or hypoglycemic therapy may be necessary.
Reduction in Platelet Count: Niacin extended-release tablets have been associated with small but statistically significant dose-related reductions in platelet count (mean of -11% with 2000 mg). Caution should be observed when Niacin extended-release tablets are administered concomitantly with anticoagulants; platelet counts should be monitored closely in such patients.
Increase in Prothrombin Time (PT): Niacin extended-release tablets have been associated with small but statistically significant increases in prothrombin time (mean of approximately +4%); accordingly, patients undergoing surgery should be carefully evaluated. Caution should be observed when Niacin extended-release tablets are administered concomitantly with anticoagulants; prothrombin time should be monitored closely in such patients.
Increase in Uric Acid: Elevated uric acid levels have occurred with Niacin therapy, therefore use with caution in patients predisposed to gout.
Decrease in Phosphorus: In placebo-controlled trials, Niacin extended-release tablets have been associated with small but statistically significant, dose-related reductions in phosphorus levels (mean of -13% with 2000 mg). Although these reductions were transient, phosphorus levels should be monitored periodically in patients at risk for hypophosphatemia.
What should I discuss with my healthcare provider before taking Niacin?
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
| Pregnancy Category | Explanation | |
|---|---|---|
| All Trimesters | C | Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. |
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.
Niacin precautions
Niacin extended-release tablet preparations should not be substituted for equivalent doses of immediate-release (crystalline) Niacin. For patients switching from immediate-release Niacin to Niacin extended-release tablets, therapy with Niacin extended-release tablets should be initiated with low doses (i.e., 500 mg at bedtime) and the Niacin extended-release tablet dose should then be titrated to the desired therapeutic response.
Caution should also be used when Niacin extended-release tablets are 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. Niacin extended-release tablets are 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 Niacin extended-release tablet therapy.
Mortality and Coronary Heart Disease Morbidity
Niacin extended-release tablets have not been shown to reduce cardiovascular morbidity or mortality among patients already treated with a statin.
The Atherothrombosis Intervention in Metabolic Syndrome with Low HDL/High Triglycerides: Impact on Global Health Outcomes (AIM-HIGH) trial was a randomized placebo-controlled trial of 3414 patients with stable, previously diagnosed cardiovascular disease. Mean baseline lipid levels were LDL-C 74 mg/dL, HDL-C 35 mg/dL, non-HDL-C 111 mg/dL and median triglyceride level of 163 to 177 mg/dL. Ninety-four percent of patients were on background statin therapy prior to entering the trial. All participants 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 tablets 1500 to 2000 mg/day (n = 1718) or matching placebo (IR Niacin, 100 to 150 mg, n = 1696). On-treatment lipid changes at two years for LDL-C were -12% for the simvastatin plus Niacin extended-release tablets group and -5.5% for the simvastatin plus placebo group. HDL-C increased by 25% to 42 mg/dL in the simvastatin plus Niacin extended-release tablets group and by 9.8% to 38 mg/dL in the simvastatin plus placebo group (P < 0.001). Triglyceride levels decreased by 28.6% in the simvastatin plus Niacin extended-release tablets group and by 8.1% in the simvastatin plus placebo group. The primary outcome was an ITT composite of the first study occurrence of coronary heart disease death, nonfatal myocardial infarction, ischemic stroke, hospitalization for acute coronary syndrome or symptom-driven coronary or cerebral revascularization procedures. The trial was stopped after a mean follow-up period of 3 years owing to a lack of efficacy. The primary outcome occurred in 282 patients in the simvastatin plus Niacin extended-release tablets group (16.4%) and in 274 patients in the simvastatin plus placebo group (16.2%) (HR 1.02 [95% CI, 0.87 to 1.21], P = 0.79. In an ITT analysis, there were 42 cases of first occurrence of ischemic stroke reported, 27 (1.6%) in the simvastatin plus Niacin extended-release tablets group and 15 (0.9%) in the simvastatin plus placebo group, a non-statistically significant result (HR 1.79, [95%CI = 0.95 to 3.36], p = 0.071). The on-treatment ischemic stroke events were 19 for the simvastatin plus Niacin extended-release tablets group and 15 for the simvastatin plus placebo group.
Skeletal Muscle
Cases of rhabdomyolysis have been associated with concomitant administration of lipid-altering doses (≥ 1 g/day) of Niacin and statins. Elderly patients and patients with diabetes, renal failure, or uncontrolled hypothyroidism are particularly at risk. 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. 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.
Liver Dysfunction
Cases of severe hepatic toxicity, including fulminant hepatic necrosis, have occurred in patients who have substituted sustained-release (modified-release, timed-release) Niacin products for immediate-release (crystalline) Niacin at equivalent doses.
Niacin extended-release tablets 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 Niacin extended-release tablets.
Niacin preparations have been associated with abnormal liver tests. In three placebo-controlled clinical trials involving titration to final daily Niacin extended-release tablet doses ranging from 500 to 3000 mg, 245 patients received Niacin extended-release tablets for a mean duration of 17 weeks. No patient with normal serum transaminase levels (AST, ALT) at baseline experienced elevations to more than 3 times the upper limit of normal (ULN) during treatment with Niacin extended-release tablets. In these studies, fewer than 1% (2/245) of Niacin extended-release tablet patients discontinued due to transaminase elevations greater than 2 times the ULN.
Liver-related tests should be performed on all patients during therapy with Niacin extended-release tablets. Serum transaminase levels, including AST and ALT (SGOT and SGPT), should be monitored before treatment begins, every 6 to 12 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 3 times ULN and are persistent, or if they are associated with symptoms of nausea, fever, and/or malaise, the drug should be discontinued.
Laboratory Abnormalities
Increase in Blood Glucose: Niacin treatment can increase fasting blood glucose. Frequent monitoring of blood glucose should be performed to ascertain that the drug is producing no adverse effects. Diabetic patients may experience a dose-related increase in glucose intolerance. Diabetic or potentially diabetic patients should be observed closely during treatment with Niacin extended-release tablets, particularly during the first few months of use or dose adjustment; adjustment of diet and/or hypoglycemic therapy may be necessary.
Reduction in Platelet Count: Niacin extended-release tablets have been associated with small but statistically significant dose-related reductions in platelet count (mean of -11% with 2000 mg). Caution should be observed when Niacin extended-release tablets are administered concomitantly with anticoagulants; platelet counts should be monitored closely in such patients.
Increase in Prothrombin Time (PT): Niacin extended-release tablets have been associated with small but statistically significant increases in prothrombin time (mean of approximately +4%); accordingly, patients undergoing surgery should be carefully evaluated. Caution should be observed when Niacin extended-release tablets are administered concomitantly with anticoagulants; prothrombin time should be monitored closely in such patients.
Increase in Uric Acid: Elevated uric acid levels have occurred with Niacin therapy, therefore use with caution in patients predisposed to gout.
Decrease in Phosphorus: In placebo-controlled trials, Niacin extended-release tablets have been associated with small but statistically significant, dose-related reductions in phosphorus levels (mean of -13% with 2000 mg). Although these reductions were transient, phosphorus levels should be monitored periodically in patients at risk for hypophosphatemia.
What happens if I miss a dose of Niacin?
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.
Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
References
- DailyMed. "NIACIN: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- DrugBank. "nicotinic acid". http://www.drugbank.ca/drugs/DB00627 (accessed September 17, 2018).
- MeSH. "Vitamin B Complex". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
