Niacin (Systemic)

This monograph includes information on the following:

1) Niacin
2) Niacinamide


INN:
Niacin— Nicotinic acid
Niacinamide— Nicotinamide

VA CLASSIFICATION
Primary: VT130
Secondary: CV359;

Commonly used brand name(s): Endur-Acin1; Nia-Bid1; Niac1; Niacels1; Niacor1; Nico-4001; Nicobid Tempules1; Nicolar1; Nicotinex Elixir1; Novo-Niacin1; Slo-Niacin1.

Other commonly used names are:
Nicotinamide [Niacinamide] Nicotinic acid [Niacin] Vitamin B 3 [Niacin; Niacinamide]
Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).



Category:

Note: Niacin and niacinamide (vitamin B 3) are water-soluble vitamins.



Nutritional supplement (vitamin)—Niacin; Niacinamide;

Antihyperlipidemic—Niacin;

Indications

Accepted

Niacin deficiency (prophylaxis and treatment)—Niacin and niacinamide are indicated for prevention and treatment of vitamin B 3 deficiency states. Vitamin B 3 deficiency may occur as a result of inadequate nutrition or intestinal malabsorption but does not occur in healthy individuals receiving an adequate balanced diet. Simple nutritional deficiency of individual B vitamins is rare since dietary inadequacy usually results in multiple deficiencies. For prophylaxis of niacin deficiency, dietary improvement, rather than supplementation, is advisable. For treatment of niacin deficiency, supplementation is preferred. {47}
—Deficiency of niacin may lead to pellagra. {30}
—Recommendended intakes may be increased and/or supplementation may be necessary in the following persons or conditions (based on documented niacin deficiency):

• Diabetes mellitus


• Fever, chronic


• Gastrectomy


• Hartnup disease {08} {30}


• Hepatic-biliary tract disease—cirrhosis {49}


• Hyperthyroidism {49}


• Infection, chronic {49}


• Intestinal diseases—celiac disease, persistent diarrhea, tropical sprue, regional enteritis


• Malabsorption syndromes associated with pancreatic insufficiency


• Malignancy


• Oropharyngeal lesions


• Stress, continuing

—Some unusual diets (e.g., reducing diets that drastically restrict food selection) may not supply minimum daily requirements of niacin. Supplementation is necessary in patients receiving total parenteral nutrition (TPN) or undergoing rapid weight loss or in those with malnutrition, because of inadequate dietary intake.
—Recommended intakes for all vitamins and most minerals are increased during pregnancy. Many physicians recommend that pregnant women receive multivitamin and mineral supplements, especially those pregnant women who do not consume an adequate diet and those in high-risk categories (i.e., women carrying more than one fetus, heavy cigarette smokers, and alcohol and drug abusers). {34} However, taking excessive amounts of a multivitamin and mineral supplement may be harmful to the mother and/or fetus and should be avoided.
—Recommended intakes for all vitamins and most minerals are increased during breast-feeding. {44}

Hyperlipidemia (treatment)—Niacin (but not niacinamide) is also indicated in the treatment of hyperlipidemia. Niacin is recommended for use only in patients with primary hyperlipidemia (type IIa, IIb, III, IV, or V hyperlipoproteinemia) and a significant risk of coronary artery disease who have not responded to other measures alone. It is one of the drugs of first choice for initiating therapy to reduce low density lipoprotein (LDL)–cholesterol concentrations and triglycerides, and to increase high density lipoprotein (HDL)–cholesterol concentrations. {05} {07}
—Studies have suggested that control of elevated cholesterol and triglycerides may not lessen the danger of cardiovascular disease and mortality, although incidence of nonfatal myocardial infarctions may be decreased.
—For additional information on initial therapeutic guidelines related to the treatment of hyperlipidemia, see Appendix III.

Unaccepted
Niacin is not useful for treatment of schizophrenia and other mental disorders not related to niacin deficiency. {31} {49} Niacin also has not been proven effective for treatment of acne, alcohol dependence {11}, drug-induced hallucinations {11}, hyperkinesis {11}, leprosy {11}, livedoid vasculitis {11}, peripheral vascular disease, motion sickness {11}, or for prevention of heart attacks.


Pharmacology/Pharmacokinetics

Physicochemical characteristics:
{48}Molecular weight—
    Niacin: 123.11
    Niacinamide: 122.13

pKa—
    Niacin: 4.85
    Niacinamide: 0.5 and 3.35

Mechanism of action/Effect:

Nutritional supplement—Niacin, after conversion to niacinamide, is a component of two coenzymes, nicotinamide adenine dinucleotide (NAD) and nicotinamide adenine dinucleotide phosphate (NADP), which are necessary for tissue respiration; glycogenolysis; {11} and lipid, amino acid, protein, and purine metabolism. {08}

Antihyperlipidemic—Niacin lowers serum cholesterol and triglyceride concentrations by inhibiting the synthesis of very low density lipoproteins (VLDL), which are precursors to the formation of low-density lipoproteins, the principal carrier of blood cholesterol. {06} {26}


Other actions/effects:

Niacin (but not niacinamide) causes direct peripheral vasodilation. {11}

Absorption:

The B vitamins, including niacin and niacinamide, are readily absorbed from the gastrointestinal tract, {30} except in malabsorption syndromes. {02}

Biotransformation:

Hepatic. {11} Dietary tryptophan is converted by intestinal bacteria to niacin and niacinamide (about 60 mg of tryptophan is equivalent to 1 mg of niacin). {11} Niacin is also converted to niacinamide as needed.

Half-life:

Elimination—Approximately 45 minutes. {02}

Onset of action:

Reduced cholesterol concentrations—Oral: Several days.

Reduced triglyceride concentrations—Oral: Several hours.

Time to peak serum concentration

Oral—45 minutes. {02}

Elimination:
    Renal (almost entirely as metabolites). Excess beyond daily needs is excreted, largely unchanged, in urine. {30}


Precautions to Consider

Pregnancy/Reproduction

Problems in humans have not been documented with intake of normal daily recommended amounts. Studies have not been done in humans.

Studies have not been done in animals.

Breast-feeding

Problems in humans have not been documented with intake of normal daily recommended amounts.

Pediatrics

Problems in pediatrics have not been documented with intake of normal daily recommended amounts. Appropriate studies of niacin as an antihyperlipidemic have not been performed in the pediatric population. However, use of niacin as an antihyperlipidemic in children under 2 years of age is not recommended since cholesterol is required for normal development.


Geriatrics


Problems in geriatrics have not been documented with intake of normal daily recommended amounts.

Drug interactions and/or related problems
The following drug interactions and/or related problems have been selected on the basis of their potential clinical significance (possible mechanism in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):

Chenodiol or{32}
Ursodiol{33}    (effect may be decreased when chenodiol or ursodiol is used concurrently with antihyperlipidemics, which tend to increase cholesterol saturation of bile)


HMG-CoA reductase inhibitors    (concurrent use with niacin may be associated with an increased risk of rhabdomyolysis and acute renal failure; combined therapy with lovastatin, pravastatin, or simvastatin should include careful monitoring for symptoms of myopathy or rhabdomyolysis {20} {21} {27} {28} {35} {36})



Laboratory value alterations
The following have been selected on the basis of their potential clinical significance (possible effect in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):


Note: Usually occur only with large doses.

With diagnostic test results
Urinary catecholamine concentration, measurements by fluorimetric methods    (niacin may produce fluorescent substances and falsely elevated results {11} {12})


Urine glucose determinations using cupric sulfate (Benedict's reagent)    (niacin may produce false-positive reactions {11})

With physiology/laboratory test values
Uric acid concentrations in blood    (may be increased by large doses of niacin {05} {12} {49})


Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).


Risk-benefit should be considered when the following medical problems exist
» Arterial bleeding or hemorrhage{01} or
Glaucoma{01}    (these conditions may be exacerbated)


» Diabetes mellitus    (large doses of niacin may cause impaired glucose tolerance {29} {49})


Gout    (large doses may cause hyperuricemia {29} {49})


» Hepatic disease    (large doses may cause hepatic damage {49})


Hypotension    (may worsen due to vasodilating effects of niacin {11})


» Peptic ulcer    (large doses may activate peptic ulcer {49})


Sensitivity to niacin or niacinamide

Patient monitoring
The following may be especially important in patient monitoring (other tests may be warranted in some patients, depending on condition; » = major clinical significance):

Cholesterol concentrations, serum    (determinations recommended at periodic intervals during antihyperlipidemic therapy)


Glucose concentrations, blood and
Hepatic function determinations and
Uric acid concentrations{05}{18}    (determinations recommended at periodic intervals in patients receiving high doses of niacin or niacinamide for prolonged periods)




Side/Adverse Effects

Note: Flushing and pruritus may be reduced with the extended-release dosage form of niacin. {23} {24}

The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:

Those indicating need for medical attention
Incidence rare
    
Allergic reaction, anaphylactic (skin rash or itching; wheezing)—after intravenous administration{49}

With long-term use of extended-release niacin
    
Hepatotoxicity or cholestasis (darkening of urine; light gray-colored stools; loss of appetite; severe stomach pain; yellow eyes or skin){12}{13}{14}{15}{25}



Those indicating need for medical attention only if they continue or are bothersome
Incidence less frequent
—with niacin only    
Feeling of warmth {49}
    
flushing or redness of skin, especially on face and neck
    
headache {49}

With high oral doses
    
Cardiac arrhythmias (unusually fast, slow, or irregular heartbeat)
    
diarrhea
    
dizziness or faintness
    
dryness of skin or eyes {07}
    
hyperglycemia (frequent urination or unusual thirst){49}—may occasionally be fatal
    
hyperuricemia (joint pain; side, lower back, or stomach pain; swelling of feet or lower legs){49}
    
myalgia (fever; muscle aching or cramping; unusual tiredness or weakness)
    
nausea or vomiting {49}
    
peptic ulcer, aggravation of (stomach pain)
    
pruritus (itching of skin)—may be severe
Note: Rarely, along with markedly elevated creatine kinase (CK) concentrations, fever, muscle aching or cramping, or unusual tiredness or weakness may be symptoms of myositis or rhabdomyolysis; incidence may be increased in patients treated concurrently with lovastatin, pravastatin, or simvastatin. {16} {20} {21}







Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Niacin (Vitamin B 3) (Systemic) or Niacin—For High Cholesterol (Systemic).

In providing consultation, consider emphasizing the following selected information (» = major clinical significance):

Description of use
Description should include function in the body, signs of deficiency, and unproven uses


Importance of diet

For use as a vitamin supplement
Importance of proper nutrition; supplement may be needed because of inadequate dietary intake

Food sources of niacin; effects of processing

Not using vitamins as substitute for balanced diet

Recommended daily intake for niacin

Before using this medication

For use as a vitamin supplement
See Indications for conditions and medications affecting requirements.

For use as an antihyperlipidemic (niacin only)
Diet as preferred therapy
»   Conditions affecting use, especially:
Sensitivity to niacin or niacinamide





Use in children—Not recommended as antihyperlipidemic in children under 2 years of age since cholesterol is required for normal development

Other medical problems, especially arterial bleeding or hemorrhage, diabetes mellitus, hepatic disease, or peptic ulcer

Proper use of this medication
Possibility of stomach upset; taking with meals or milk; checking with physician if stomach upset continues

Proper administration of extended-release dosage forms: Swallowing whole without crushing, breaking, or chewing; contents of capsule may be mixed with jam or jelly and swallowed without chewing

» Proper storage

For use as a vitamin supplement

» Proper dosing
Missed dose: No cause for concern because of length of time necessary for depletion; remembering to take as directed

For use as an antihyperlipidemic (niacin only)
» Importance of not taking more or less medication than prescribed

Niacin does not cure the condition but instead helps control it

» Importance of following prescribed diet

Missed dose: Taking as soon as possible; not taking if almost time for next dose; not doubling doses

Precautions while using this medication
Caution if dizziness or faintness occurs

For use as an antihyperlipidemic (niacin only)
» Importance of close monitoring by physician to check progress

» Checking with physician before discontinuing medication; blood lipid concentrations may increase significantly


Side/adverse effects
Signs of potential side effects, especially anaphylactic reaction with injection only; hepatotoxicity or cholestasis with high doses of extended-release niacin


General Dosing Information
Dosages of niacin and niacinamide as vitamin supplements are equal; some clinicians prefer niacinamide because of its lack of vasodilating effect.

Because of the infrequency of single B vitamin deficiencies, combinations are commonly administered. Many commercial combinations of B vitamins are available.

When used for treatment of pellagra, niacin or niacinamide is usually given in combination with 5 mg each of thiamine, riboflavin, and pyridoxine.

For parenteral dosage forms only
In most cases, parenteral administration is indicated only when oral administration is not acceptable (for example, in nausea, vomiting, and preoperative and postoperative conditions) or possible (for example, in malabsorption syndromes or following gastric resection).

When administered intravenously, niacin or niacinamide should be given at a rate not exceeding 2 mg per minute.

Diet/Nutrition
Niacin or niacinamide may be taken with meals or milk if nausea, vomiting, or diarrhea occurs. A physician should be consulted if stomach upset continues.

Recommended dietary intakes for niacin are defined differently worldwide.



For U.S.:
The Recommended Dietary Allowances (RDAs) for vitamins and minerals are determined by the Food and Nutrition Board of the National Research Council and are intended to provide adequate nutrition in most healthy persons under usual environmental stresses. In addition, a different designation may be used by the FDA for food and dietary supplement labeling purposes, as with Daily Value (DV). DVs replace the previous labeling terminology United States Recommended Daily Allowances (USRDAs). {44} {45}



For Canada:
Recommended Nutrient Intakes (RNIs) for vitamins, minerals, and protein are determined by Health and Welfare Canada and provide recommended amounts of a specific nutrient while minimizing the risk of chronic diseases. {46}

Daily recommended intakes for niacin are generally defined as follows:

Persons
U.S.
(mg)
Canada
(mg)
Infants and children
Birth to 3 years of age
5–9
4–9
4 to 6 years of age
12
13
7 to 10 years of age
13
14–18
Adolescent and adult males
15–20
14–23
Adolescent and adult females
13–15
14–16
Pregnant females
17
14–16
Breast-feeding females
20
14–16


These are usually provided by adequate diets.

Best dietary sources of niacin include meats, eggs, and milk and dairy products; dietary tryptophan (from protein) is converted to niacin. There is little loss of niacin from foods with ordinary cooking.


For treatment of adverse effects
Tolerance to the vasodilating and gastrointestinal effects of niacin usually occurs within 2 weeks.

The severe flushing, pruritus, and gastrointestinal effects may be minimized by starting therapy with a low dose and increasing the dosage gradually, and by taking niacin with meals or milk. {07}

Persistent flushing may sometimes be controlled with 300 mg of aspirin taken 30 minutes before each niacin dose. {07} {17}

NIACIN


Oral Dosage Forms

NIACIN EXTENDED-RELEASE CAPSULES

Note: Dose-related hepatotoxicity may be more prevalent with high doses of the extended-release dosage form of niacin. {12} {13} {14} {15} {25}
Flushing and pruritus may be reduced with the extended-release dosage form of niacin. {23} {24}


Usual adult and adolescent dose
Antihyperlipidemic
Initial: Oral, 1 gram {03} three times a day, the dosage being increased in increments of 500 mg a day every two to four weeks as needed.

Note: Some clinicians may begin with 500 mg per day and gradually increase the dosage to 4 grams a day. {26}

Maintenance: Oral, 1 to 2 grams three times a day.

Deficiency (prophylaxis)
Oral, amount based on normal daily recommended intakes:

Persons
U.S.
(mg)
Canada
(mg)
Adolescent and adult males
15–20
14–23
Adolescent and adult females
13–15
14–16
Pregnant females
17
14–16
Breast-feeding females
20
14–16


Deficiency (treatment)
Treatment dose is individualized by prescriber based on severity of deficiency.


Usual adult prescribing limits
Oral, 6 grams a day.

Usual pediatric dose
Dosage form is not recommended for use in children.

Strength(s) usually available
U.S.—


125 mg (OTC) [Nicobid Tempules{38}{41}][Generic]{39}{40}


250 mg [Nicobid Tempules{38}{41} (OTC)][Generic]{39}{40}


300 mg (OTC) [Niac]


400 mg [Nia-Bid (OTC)] [Niacels (OTC)] [Nico-400 (OTC){41}][Generic]{39}{40}


500 mg [Nicobid Tempules{38} (OTC)][Generic]{38}{39}{40}

Canada—
Not commercially available.

Note: For use as a dietary supplement, some strengths of these niacin preparations may exceed the dosage range recommended by USP DI Advisory Panels based on the amount necessary to meet normal nutritional needs.


Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), in a well-closed container, unless otherwise specified by manufacturer.

Auxiliary labeling:
   • Swallow capsules whole.
   • Take with meals or milk.

Note: Contents of capsule may be mixed with jelly or jam and swallowed without chewing.



NIACIN ORAL SOLUTION

Usual adult and adolescent dose
Antihyperlipidemic
Initial: Oral, 1 gram {03} three times a day, the dosage being increased in increments of 500 mg a day every two to four weeks as needed.
Maintenance: Oral, 1 to 2 grams three times a day.

Deficiency (prophylaxis or treatment)
See Niacin Extended-release Capsules.


Usual adult prescribing limits
Oral, 6 grams a day.

Usual pediatric dose
Deficiency (prophylaxis)
Oral, amount based on normal daily recommended intakes:

Persons
U.S.
(mg)
Canada
(mg)
Infants and children
Birth to 3 years of age
5–9
4–9
4 to 6 years of age
12
13
7 to 10 years of age
13
14–18


Deficiency (treatment)
Treatment dose is individualized by prescriber based on severity of deficiency.


Strength(s) usually available
U.S.—


50 mg per 5 mL (OTC) [Nicotinex Elixir (alcohol 14%)]{02}

Canada—
Not commercially available.

Note: For use as a dietary supplement, the strength of this niacin preparation may exceed the dosage range recommended by USP DI Advisory Panels based on the amount necessary to meet normal nutritional needs.


Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), in a tight container, unless otherwise specified by manufacturer. Protect from freezing.

Auxiliary labeling:
   • Take with meals or milk.


NIACIN TABLETS USP

Usual adult and adolescent dose
Antihyperlipidemic
Initial: Oral, 1 gram three times a day, the dosage being increased in increments of 500 mg a day every two to four weeks as needed.

Note: Some clinicians may begin with 100 mg per day and gradually increase the dosage to 4 grams per day. {26}

Maintenance: Oral, 1 to 2 grams three times a day.

Deficiency (prophylaxis or treatment)
See Niacin Extended-release Capsules.


Usual adult prescribing limits
Oral, 6 grams a day.

Usual pediatric dose
Deficiency (prophylaxis or treatment)
See Niacin Oral Solution .


Strength(s) usually available
U.S.—


25 mg (OTC)[Generic]


50 mg (OTC)[Generic]


100 mg (OTC)[Generic]


125 mg (OTC)[Generic]{39}


250 mg (OTC)[Generic]


400 mg (OTC)[Generic]{39}


500 mg [Niacor (Rx) (scored){37}] [Nicolar (Rx) (scored) (tartrazine)][Generic]{40}

Canada—


50 mg (OTC) [Novo-Niacin][Generic]{43}


100 mg (OTC)[Generic]{43}


500 mg (OTC)[Generic]{43}

Note: For use as a dietary supplement, some strengths of these niacin preparations may exceed the dosage range recommended by USP DI Advisory Panels based on the amount necessary to meet normal nutritional needs.


Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a well-closed container.

Auxiliary labeling:
   • Take with meals or milk.


NIACIN EXTENDED-RELEASE TABLETS

Note: Dose-related hepatotoxicity may be more prevalent with high doses of the extended-release dosage form. {12} {13} {14} {15} {25}
Flushing and pruritus may be reduced with the extended-release dosage form of niacin. {23} {24}


Usual adult and adolescent dose
Antihyperlipidemic
Initial: Oral, 1 gram {03} three times a day, the dosage being increased in increments of 500 mg a day every two to four weeks as needed and tolerated.

Note: Some clinicians may begin with 500 mg per day and gradually increase the dosage to 3 grams a day. {26}

Maintenance: Oral, 1 to 2 grams three times a day.

Note: Some clinicians may use a maintenance dose of 500 mg to 1 gram two to three times a day. {26}


Deficiency (prophylaxis and treatment)
See Niacin Extended-release Capsules.


Usual adult prescribing limits
Oral, 6 grams a day.

Usual pediatric dose
Dosage form is not recommended for use in children.

Strength(s) usually available
U.S.—


125 mg (Rx)[Generic]{39}


250 mg [Endur-Acin (OTC)] [Slo-Niacin (OTC) (scored)][Generic]{39}{40}{04}


400 mg (OTC)[Generic]


500 mg [Endur-Acin (OTC)] [Slo-Niacin (OTC) (scored)][Generic]{39}{40}


750 mg [Slo-Niacin (OTC) (scored)][Generic]{39}{40}


1000 mg (OTC)[Generic]{39}

Canada—


500 mg (OTC)[Generic]{42}

Note: For use as a dietary supplement, some strengths of these niacin preparations may exceed the dosage range recommended by USP DI Advisory Panels based on the amount necessary to meet normal nutritional needs.


Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), in a well-closed container, unless otherwise specified by manufacturer.

Auxiliary labeling:
   • Swallow tablets whole.
   • Take with meals or milk.

Note: If tablets are scored, they may be broken, but not crushed or chewed, before swallowing.




Parenteral Dosage Forms

NIACIN INJECTION USP

Usual adult and adolescent dose
Deficiency (prophylaxis)
Intravenous infusion, as part of total parenteral nutrition solutions, the specific amount determined by individual patient need.

Deficiency (treatment)
Intramuscular, 50 to 100 mg five or more times a day.
Intravenous (slow), 25 to 100 mg two or more times a day.


Usual pediatric dose
Deficiency (prophylaxis)
Intravenous infusion, as part of total parenteral nutrition solutions, the specific amount determined by individual patient need.

Deficiency (treatment)
Intravenous (slow), up to 300 mg a day.


Strength(s) usually available
U.S.—


100 mg per mL (Rx)[Generic]

Canada—
Not commercially available.

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Protect from freezing.

Preparation of dosage form:
For administration by the intravenous route, niacin injection should be diluted to a strength of 2 mg per mL or added to 500 mL of sodium chloride injection and administered at a rate not exceeding 2 mg per minute.


NIACINAMIDE


Oral Dosage Forms

NIACINAMIDE TABLETS USP

Usual adult and adolescent dose
Deficiency (prophylaxis)
Oral, amount based on normal daily recommended intakes:

Persons
U.S.
(mg)
Canada
(mg)
Adolescent and adult males
15–20
14–23
Adolescent and adult
females
13–15
14–16
Pregnant females
17
14–16
Breast-feeding females
20
14–16


Deficiency (treatment)
Treatment dose is individualized by prescriber based on severity of deficiency.


Usual pediatric dose
Deficiency (prophylaxis)
Oral, amount based on normal daily recommended intakes:

Persons
U.S.
(mg)
Canada
(mg)
Infants and children
Birth to 3 years of age
5–9
4–9
4 to 6 years of age
12
13
7 to 10 years of age
13
14–18


Deficiency (treatment)
Treatment dose is individualized by prescriber based on severity of deficiency.


Strength(s) usually available
U.S.—


50 mg (OTC)[Generic]


100 mg (OTC)[Generic]


125 mg (OTC)[Generic]{38}


250 mg (OTC)[Generic]{38}


500 mg (Rx/OTC)[Generic]{39}

Canada—


100 mg (OTC)[Generic]{43}


500 mg (OTC)[Generic]{43}

Note: For use as a dietary supplement, some strengths of these niacinamide preparations may exceed the dosage range recommended by USP DI Advisory Panels based on the amount necessary to meet normal nutritional needs.


Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight container.



Parenteral Dosage Forms

NIACINAMIDE INJECTION USP

Usual adult and adolescent dose
Deficiency (prophylaxis)
Intravenous infusion, as part of total parenteral nutrition solutions, the specific amount determined by individual patient need.

Deficiency (treatment)
Intramuscular, 50 to 100 mg five or more times a day.
Intravenous (slow), 25 to 100 mg two or more times a day.


Usual pediatric dose
Deficiency (prophylaxis)
Intravenous infusion, as part of total parenteral nutrition solutions, the specific amount determined by individual patient need.

Deficiency (treatment)
Intravenous (slow), up to 300 mg a day.


Strength(s) usually available
U.S.—


100 mg per mL (Rx)[Generic]

Canada—
Not commercially available.

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Protect from freezing.



Revised: 07/11/1995



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