Niacinol (Oral)

Niacin is used by itself or with other medicines to treat high cholesterol and triglyceride (fat-like substances) levels in the blood. This may help prevent pancreatitis (inflammation of the pancreas) and other issues caused by high cholesterol and triglycerides in the blood. Niacin is also used to lower the risk of heart attack in patients who have a history of heart attack and hyperlipidemia.

This medicine is available only with your doctor's prescription.

It is very important for your doctor to check your progress at regular visits. This allows your doctor to see if the medicine is effectively lowering your cholesterol and triglycerides and if you should keep taking it. Blood and urine tests may be needed to check for side effects.

Contact your doctor right away if you have dark-colored urine, diarrhea, a fever, muscle cramps or spasms, muscle pain or stiffness, or feel very tired or weak. These could be signs of a serious muscle issue called rhabdomyolysis, which can harm your kidneys.

Reach out to your doctor immediately if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellowing of the eyes or skin. These could be signs of a serious liver issue.

This medicine might affect blood sugar levels. If you notice a change in your blood or urine sugar test results or have any questions, talk to your doctor.

This medicine may cause you to feel dizzy or faint, especially when you stand up from a lying or sitting position. Getting up slowly may help. This effect should improve after a week or two as your body adjusts to the medicine. However, if the issue continues or worsens, consult your doctor.

Do not stop taking niacin without first consulting your doctor. Stopping this medicine may cause your blood cholesterol levels to rise again. Your doctor may suggest a special diet to help prevent this from happening.

Before you undergo any medical tests, inform the medical doctor in charge that you are taking this medicine. The results of some tests may be influenced by this medicine.

Do not take vitamins or other dietary supplements without discussing them with your doctor. This is especially important for vitamins or dietary supplements that contain niacin or similar ingredients.

In deciding to use a medicine, you and your doctor need to consider the risks of the medicine compared to its benefits. Here are some important points to think about:

Allergies

Inform your doctor if you have ever experienced any unusual or allergic reaction to this medicine or any other medicines. Also, let your health care professional know about any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Current studies have not shown any specific problems in children that would limit the use of niacin extended-release tablets. However, safety and effectiveness have not been established in children 16 years old and younger.

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

Geriatric

Current studies have not shown any specific problems in elderly patients that would limit the use of niacin extended-release tablets.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if an interaction might happen. In such cases, your doctor may adjust the dose or take other precautions. It is very important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions have been chosen for their potential significance and may not include all possible interactions.

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some situations. If both medicines are prescribed, your doctor may adjust the dose or frequency of one or both medicines.

• Atorvastatin
• Cerivastatin
• Levoketoconazole
• Lovastatin
• Methotrexate
• Pitavastatin
• Rosuvastatin
• Simvastatin

Using this medicine with any of the following medicines may increase the risk of certain side effects, but it may still be the best treatment for you. If both medicines are prescribed, your doctor may adjust the dose or frequency of one or both medicines.

• Warfarin

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around mealtimes or with certain foods due to possible interactions. Using alcohol or tobacco with some medicines may also lead to interactions. The following interactions have been selected for their potential significance and may not include all possible interactions.

Using this medicine with any of the following may increase the risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may adjust the dose or frequency of this medicine or provide specific instructions about using food, alcohol, or tobacco.

• Ethanol

Other Medical Problems

Other medical issues may influence the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Excessive alcohol use or
• Angina (severe chest pain) or
• Glaucoma or
• Gout or
• Acute heart attack or
• Heart disease or
• Hypotension (low blood pressure) or
• History of jaundice or
• Kidney disease or
• History of muscle pain or tenderness or
• History of muscle weakness or
• History of stomach ulcers—Use with caution. May worsen these conditions.

• 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 worsen side effects.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do, they may need medical attention.

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

Less common

• Darkening of urine
• Light gray-colored stools
• Loss of appetite
• Severe stomach pain
• Yellow eyes or skin

Some side effects 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

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Niacinol
• Niacor
• Niaspan
• Nicotinex
• Slo-Niacin

Available Dosage Forms:

• Tablet
• Capsule, Extended Release
• Tablet, Extended Release
• Capsule

Therapeutic Class: Antihyperlipidemic

Pharmacologic Class: Vitamin B (class)

Chemical Class: Nicotinic Acid (class)

Use this medicine 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.

This medicine 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 this medicine 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 this medicine 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 this medicine 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 this medicine. 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 this medicine, 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.

• How long does niacin stay in the human system?