Nicotinex (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 triglyceride levels 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 during regular visits. This will help your doctor see if the medicine is working correctly to lower your cholesterol and triglycerides and whether you should keep taking it. Blood and urine tests may be needed to check for unwanted effects.

Contact your doctor immediately 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 lead to kidney problems.

Contact your doctor right away if you experience 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 indicate a serious liver issue.

This medicine may affect blood sugar levels. If you notice a change in your blood or urine sugar test results or have any questions, speak with your doctor.

This medicine may make you feel dizzy or faint, especially when getting up from a lying or sitting position. Getting up slowly may help. This effect should lessen after a week or two as your body adjusts to the medicine. However, if the problem continues or worsens, contact 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 recommend a special diet to help prevent this.

Before undergoing 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 unless you have discussed them with your doctor. This is especially true for vitamins or dietary supplements that contain niacin or similar ingredients.

In deciding to use this medicine, you and your doctor need to weigh the risks against the benefits. Here are some important points to consider:

Allergies

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

Pediatric

Studies so far have not shown specific issues that would limit the use of niacin extended-release tablets in children. However, safety and effectiveness have not been proven 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 old, as cholesterol is important for normal development.

Geriatric

Studies done to date have not shown any specific problems in older adults that would limit the usefulness of niacin extended-release tablets.

Breast Feeding

There are no sufficient studies in women to determine the risk to infants when using this medication while breastfeeding. Weigh the potential benefits against the potential risks before taking 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 occur. In these cases, your doctor may adjust the dose or take other precautions. It is important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions are based on their potential significance and may not include all possibilities.

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you take one or both of the 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 using both may be the best option for you. If both medicines are prescribed together, your doctor may change the dose or how often you take one or both of the medicines.

• Warfarin

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used around the time of eating or with certain types of food because interactions can happen. Using alcohol or tobacco with certain medicines may also cause interactions. The following interactions are based on their potential significance and may not include all possibilities.

Using this medicine with any of the following may increase the risk of certain side effects, but it may be unavoidable in some cases. If used together, your doctor may change the dose or how often you take this medicine, or provide special instructions regarding food, alcohol, or tobacco use.

• Ethanol

Other Medical Problems

Other medical problems may affect how you can use this medicine. Make sure to inform your doctor if you have any other medical issues, 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 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 necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, you might 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. Your health care professional may also be able to tell you how to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, 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?