Slo-Niacin

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, herbal supplements or other nutritional supplements containing niacin or nicotinamide. Niacin and other medicines may affect each other causing side effects. Niacin may affect the way other medicines work, and other medicines may affect how niacin works.

Especially tell your doctor if you take:

• other medicines to lower cholesterol or triglycerides
• aspirin
• blood pressure medicines
• blood thinner medicines
• large amounts of alcohol

Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

• Store niacin at 68ºF to 77ºF (20ºC to 25ºC).
• Keep niacin and all medicines out of the reach of children.

You should not take this medication if you are allergic to niacin, or if you have severe liver disease, a stomach ulcer, or active bleeding.

To make sure you can safely take niacin, tell your doctor if you have any of these other conditions:

• liver or kidney disease;

• heart disease or uncontrolled angina (chest pain);

• a stomach ulcer;

• diabetes;

• gout; or

• a muscle disorder such as myasthenia gravis.

FDA pregnancy category C. Niacin may be harmful to an unborn baby when the medication is taken at doses to treat high cholesterol or other conditions. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Niacin can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Niacin is sometimes taken at bedtime with a low-fat snack. Follow your doctor's instructions.

Niacin can cause certain side effects, such as flushing (warmth, itching, redness, or tingly feeling under your skin). These effects can be made worse if you drink alcohol or hot beverages shortly after you take niacin. These effects should disappear over time as you keep taking the medication.

Take niacin with a full glass of cold or cool water. Taking the medication with a hot drink may increase your risk of side effects such as flushing.

Do not crush, chew, break, or open an extended-release tablet or capsule. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time.

Niacin extended-release tablets and capsules contain higher strengths of the medicine than the regular niacin tablets. Take only the dose that is correct for the type of niacin tablet or capsule you are using.

Niacin can cause you to have unusual results with certain medical tests (urine tests). Tell any doctor who treats you that you are using niacin.

If you stop taking niacin for any length of time, talk with your doctor before starting the medication again. You may need to restart the medication at a lower dose.

While using niacin, you may need blood tests at your doctor's office. Your kidney or liver function may also need to be checked. Visit your doctor regularly.

Niacin is only part of a complete program of treatment that may also include diet, exercise, weight control, and other medications. Follow your diet, medication, and exercise routines very closely.

Store at room temperature away from moisture and heat.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

• feeling like you might pass out;

• fast, pounding, or uneven heart beats;

• feeling short of breath;

• swelling;

• jaundice (yellowing of your skin or eyes); or

• muscle pain, tenderness, or weakness with fever or flu symptoms and dark colored urine.

If you are diabetic, tell your doctor about any changes in your blood sugar levels.

Less serious side effects of niacin include:

• mild dizziness;

• warmth, redness, or tingly feeling under your skin;

• itching, dry skin;

• sweating or chills;

• nausea, diarrhea, belching, gas;

• muscle pain, leg cramps; or

• sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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

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

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 this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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

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

• It is used to lower bad cholesterol and raise good cholesterol (HDL).
• It is used to lower triglycerides.
• This vitamin is used to treat niacin deficiency.
• It may be given to you for other reasons. Talk with the doctor.

• If you have an allergy to niacin, niacinamide, or any other part of Slo-Niacin (niacin controlled-release capsules and controlled-release tablets).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have any of these health problems: Bleeding problems, liver problems or rise in liver enzymes, or ulcer disease.
• If you are breast-feeding or plan to breast-feed.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Slo-Niacin with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Applies to niacin: compounding powder, oral capsule, oral capsule extended release, oral liquid, oral tablet, oral tablet extended release

Cardiovascular

Very common (10% or more): Flushing (i.e., warmth, redness, itching, and/or tingling) (up to 88%)
Frequency not reported: Tachycardia, palpitations, atrial fibrillation, other cardiac arrhythmias, syncope, hypotension, postural hypotension[Ref]

Dermatologic

Common (1% to 10%): Rash, pruritus
Frequency not reported: Sweating, skin burning sensation, maculopapular rash, dry skin
Postmarketing reports: Skin discoloration[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (up to 14%), nausea (up to 11%)
Common (1% to 10%): Vomiting
Frequency not reported: Peptic ulcers, eructation, flatulence[Ref]

Hematologic

Postmarketing reports: Slight reductions in platelet counts, prothrombin time prolonged[Ref]

Hypersensitivity

Postmarketing reports: Hypersensitivity reactions (e.g., anaphylaxis, angioedema, urticaria, flushing, dyspnea, tongue edema, larynx edema, face edema, peripheral edema, laryngismus, vesiculobullous rash)[Ref]

Hepatic

Postmarketing reports: Hepatitis, jaundice[Ref]

Metabolic

Frequency not reported: Decreased glucose tolerance, gout[Ref]

Musculoskeletal

Frequency not reported: Myalgia, myopathy[Ref]

Nervous system

Frequency not reported: Dizziness, syncope
Postmarketing reports: Migraine, asthenia, paresthesia[Ref]

Ocular

Postmarketing reports: Blurred vision, macular edema[Ref]

Psychiatric

Postmarketing reports: Insomnia, nervousness[Ref]

Other

Frequency not reported: Chills, edema[Ref]

Respiratory

Common (1% to 10%): Cough increased
Frequency not reported: Dyspnea[Ref]

Some side effects of Slo-Niacin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.