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Drug overview for NIACIN INOSITOL (niacin (inositol niacinate)):
Generic name: NIACIN (INOSITOL NIACINATE)
Drug class: Niacin/Niacinamide (Vitamin B-3)
Therapeutic class: Electrolyte Balance-Nutritional Products
Niacin (nicotinic acid) is a water-soluble, B complex vitamin; certain Niacin and niacinamide are water-soluble, B complex vitamins. niacin preparations are used as antilipemic agents. Niacin preparations available as dietary supplements should not be used interchangeably with prescription-only niacin preparations.
Niacin is used as an adjunct to nondrug therapies (i.e., lifestyle modifications) for prevention of cardiovascular events and for the management of dyslipidemias.
Generic name: NIACIN (INOSITOL NIACINATE)
Drug class: Niacin/Niacinamide (Vitamin B-3)
Therapeutic class: Electrolyte Balance-Nutritional Products
Niacin (nicotinic acid) is a water-soluble, B complex vitamin; certain Niacin and niacinamide are water-soluble, B complex vitamins. niacin preparations are used as antilipemic agents. Niacin preparations available as dietary supplements should not be used interchangeably with prescription-only niacin preparations.
Niacin is used as an adjunct to nondrug therapies (i.e., lifestyle modifications) for prevention of cardiovascular events and for the management of dyslipidemias.
DRUG IMAGES
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The following indications for NIACIN INOSITOL (niacin (inositol niacinate)) have been approved by the FDA:
Indications:
Niacin deficiency
Pellagra
Professional Synonyms:
Niacin deficiency syndrome
Indications:
Niacin deficiency
Pellagra
Professional Synonyms:
Niacin deficiency syndrome
The following dosing information is available for NIACIN INOSITOL (niacin (inositol niacinate)):
Dosage of niacin must be carefully adjusted according to the patient's response and tolerance.
Because the pharmacokinetics and, therefore, metabolism of different formulations (i.e., immediate-release, extended-release) of niacin may vary, the manufacturers state that these preparations should not be used interchangeably.
Symptoms of flushing, pruritus, and GI distress associated with niacin therapy may be reduced by initiating therapy with low dosages, gradual escalation of dosage, and avoiding administration of niacin on an empty stomach. Because niacin-induced cutaneous vasodilation appears to be mediated by prostaglandins (e.g., prostacyclin, prostaglandin D2), pretreatment with an inhibitor of prostaglandin synthesis (e.g., aspirin up to the recommended dose of 325 mg administered up to approximately 30 minutes prior to administration of niacin) may reduce flushing.
Niacin should be used with caution in patients with renal or hepatic impairment. In addition, the drug also should be used with caution in patients who consume substantial amounts of alcohol and/or who have a history of liver disease; such patients should be closely monitored. Use of niacin is contraindicated in patients with active liver disease or unexplained, persistent increases in serum aminotransferase concentrations.
Because the pharmacokinetics and, therefore, metabolism of different formulations (i.e., immediate-release, extended-release) of niacin may vary, the manufacturers state that these preparations should not be used interchangeably.
Symptoms of flushing, pruritus, and GI distress associated with niacin therapy may be reduced by initiating therapy with low dosages, gradual escalation of dosage, and avoiding administration of niacin on an empty stomach. Because niacin-induced cutaneous vasodilation appears to be mediated by prostaglandins (e.g., prostacyclin, prostaglandin D2), pretreatment with an inhibitor of prostaglandin synthesis (e.g., aspirin up to the recommended dose of 325 mg administered up to approximately 30 minutes prior to administration of niacin) may reduce flushing.
Niacin should be used with caution in patients with renal or hepatic impairment. In addition, the drug also should be used with caution in patients who consume substantial amounts of alcohol and/or who have a history of liver disease; such patients should be closely monitored. Use of niacin is contraindicated in patients with active liver disease or unexplained, persistent increases in serum aminotransferase concentrations.
Niacin and niacinamide are administered orally. Niacin is administered orally. As an antilipemic agent, immediate-release niacin (Niacor(R)) preferably is administered orally with meals.
Extended-release niacin (Niaspan(R)) should be administered at bedtime following a low-fat snack. In addition, the manufacturers state that Niaspan(R) tablets should be taken whole and should not be broken, crushed, or chewed before swallowing. Concomitant administration of niacin with alcohol, hot drinks, or spicy foods may increase the risk of flushing or pruritus; these beverages or foods should be avoided at the time of drug ingestion.
Extended-release niacin (Niaspan(R)) should be administered at bedtime following a low-fat snack. In addition, the manufacturers state that Niaspan(R) tablets should be taken whole and should not be broken, crushed, or chewed before swallowing. Concomitant administration of niacin with alcohol, hot drinks, or spicy foods may increase the risk of flushing or pruritus; these beverages or foods should be avoided at the time of drug ingestion.
No dosing information available.
No generic dosing information available.
The following drug interaction information is available for NIACIN INOSITOL (niacin (inositol niacinate)):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for NIACIN INOSITOL (niacin (inositol niacinate)):
Drug contraindication overview.
No enhanced Contraindications information available for this drug.
No enhanced Contraindications information available for this drug.
There are 2 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Arterial hemorrhage |
| Disease of liver |
There are 3 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Alcohol use disorder |
| Invasive surgical procedure |
| Peptic ulcer |
There are 8 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| 30 day risk period post-myocardial infarction |
| Diabetes mellitus |
| Disease of liver |
| Gout |
| Hypophosphatemia |
| Hypotension |
| Increased risk of bleeding due to coagulation disorder |
| Unstable angina pectoris |
The following adverse reaction information is available for NIACIN INOSITOL (niacin (inositol niacinate)):
Adverse reaction overview.
No enhanced Common Adverse Effects information available for this drug.
No enhanced Common Adverse Effects information available for this drug.
There are 0 severe adverse reactions.
There are 15 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. |
Cardiac arrhythmia Diarrhea Dizziness Dry eye Dry skin Exacerbation of peptic ulcer Flushing Headache disorder Hyperglycemia Hyperuricemia Myalgia Nausea Pruritus of skin Syncope Vomiting |
| Rare/Very Rare |
|---|
| None. |
The following precautions are available for NIACIN INOSITOL (niacin (inositol niacinate)):
No enhanced Pediatric Use information available for this drug.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Administration of supplementary doses of niacin during pregnancy has not been associated with any adverse effects to the mother or fetus. However, toxicologic studies have not been performed with large doses of niacin, and large doses of the drug should not be used in women who are or may become pregnant unless the possible benefits outweigh the potential risks to the fetus. Animal reproduction studies have not been performed with niacin, and it is also not known whether the drug (at antilipemic dosages) can cause fetal harm or affect reproduction capacity when administered to pregnant women.
Niacin should not be used in women who are or may become pregnant or in nursing women unless the possible benefits outweigh the potential risks. Currently, most experts recommend that hyperlipoproteinemias in pregnant women be managed with dietary measures; consultation with a lipid specialist may be indicated for pregnant women with severe forms of hyperlipidemia. If the patient becomes pregnant while receiving niacin for primary hypercholesterolemia, the drug should be discontinued. If the patient being treated with niacin for hypertriglyceridemia or mixed dyslipidemia becomes pregnant, the benefits and risks of continued therapy should be assessed on an individual basis.
Niacin should not be used in women who are or may become pregnant or in nursing women unless the possible benefits outweigh the potential risks. Currently, most experts recommend that hyperlipoproteinemias in pregnant women be managed with dietary measures; consultation with a lipid specialist may be indicated for pregnant women with severe forms of hyperlipidemia. If the patient becomes pregnant while receiving niacin for primary hypercholesterolemia, the drug should be discontinued. If the patient being treated with niacin for hypertriglyceridemia or mixed dyslipidemia becomes pregnant, the benefits and risks of continued therapy should be assessed on an individual basis.
Administration of supplementary doses of niacin during lactation has not been associated with any adverse effects to the mother or fetus. Niacin is distributed in human milk. Because of the potential for serious adverse effects in nursing infants, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the woman.
No enhanced Geriatric Use information available for this drug.
The following prioritized warning is available for NIACIN INOSITOL (niacin (inositol niacinate)):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for NIACIN INOSITOL (niacin (inositol niacinate))'s list of indications:
| Niacin deficiency | |
| E52 | Niacin deficiency [pellagra] |
| Pellagra | |
| E52 | Niacin deficiency [pellagra] |
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