Nicotinamide

122.12500

122.12

202-713-4

25X51I8RD4

1405

1703

759115|27452|13128

DTXSID2020929

C2327

White, powder, needles from benzene|Colorless crystalline solid|White, crystalline powder|Colorless needles

A11HA01|A - Alimentary tract and metabolism

2933399090

55.98000

0.88080

Nicotinamide is a white powder. (NTP, 1992)

1.400 g/cm³ @ Temp: 25 °C

130 °C

157 °C @ Press: 5 x 10^-4 Torr

182°C

1.4660 (estimate)

1000 g/L (20 ºC)

Keep container tightly closed in a dry and well-ventilated place. Keep in a dry place.

Vapour pressure, kPa at 35°C: 3.1

Relative vapour density (air = 1): 4.2

LD50 s.c. in rats: 1.68 g/kg (Brazda, Coulson)

Odorless

Bitter taste

10% "wt in vol" solution in water is neutral to litmus

3.35(at 20 °C)

Henry's Law constant = 2.90X10-12 atm-cu m/mol at 25 °C (est)

3.35 (at 20 °C)|pKa = 3.35 (conjugate acid)|kb1 = 2.24X10-11; kb2 = 3.16X10-14

125.3 Ų [M+H]+ [CCS Type: DT, Method: single field calibrated with Agilent tune mix (Agilent)]|129.32 Ų [M+H]+ [CCS Type: DT, Method: stepped-field]|137.3 Ų [M+Na]+ [CCS Type: DT, Method: stepped-field]|118 Ų [M+H]+ [CCS Type: TW, Method: calibrated with polyalanine]|125.3 Ų [M+H]+ [CCS Type: DT, Method: single field calibrated with ESI Low Concentration Tuning Mix (Agilent)]|121.7 Ų [M+H]+ [CCS Type: TW, Method: calibrated with polyalanine and drug standards]|125.2 Ų [M+H]+ [CCS Type: DT, Method: single field calibrated]|126.7 Ų [M+H]+

Readily hydrolyzed to free acid by heating in acid or alkaline solution|Forms crystalline salts with acids|Hydroxyl radical reaction rate constant = 2.34X10-12 cu cm/molec sec at 25 °C (est)

Water soluble.

Amides and Imides

An amine and amide. Acts as a weak base in solution. Amines are chemical bases. They neutralize acids to form salts plus water. These acid-base reactions are exothermic. The amount of heat that is evolved per mole of amine in a neutralization is largely independent of the strength of the amine as a base. Amines may be incompatible with isocyanates, halogenated organics, peroxides, phenols (acidic), epoxides, anhydrides, and acid halides. Flammable gaseous hydrogen is generated by amines in combination with strong reducing agents, such as hydrides. Organic amides/imides react with azo and diazo compounds to generate toxic gases. Flammable gases are formed by the reaction of organic amides/imides with strong reducing agents. Amides are very weak bases (weaker than water). Imides are less basic yet and in fact react with strong bases to form salts. That is, they can react as acids. Mixing amides with dehydrating agents such as P2O5 or SOCl2 generates the corresponding nitrile. The combustion of these compounds generates mixed oxides of nitrogen (NOx).

480 °C

Dust explosion possible if in powder or granular form, mixed with air.

1

26-36-37/39-45-36/37-16-7

QS3675000

Xi,T,F

Separated from oxidants.

Stable. Incompatible with strong oxidizing agents.

P261, P264, P271, P280, P302+P352, P304+P340, P305+P351+P338, P312, P321, P332+P313, P337+P313, P362, P403+P233, P405, P501

H315

SRP: Recycle any unused portion of the material for its approved use or return it to the manufacturer or supplier. Ultimate disposal of the chemical must consider: the material's impact on air quality; potential migration in air, soil or water; effects on animal, aquatic and plant life; and conformance with environmental and public health regulations. If it is possible or reasonable use an alternative chemical product with less inherent propensity for occupational harm/injury/toxicity or environmental contamination.|SRP: Wastewater from contaminant suppression, cleaning of protective clothing/equipment, or contaminated sites should be contained and evaluated for subject chemical or decomposition product concentrations. Concentrations shall be lower than applicable environmental discharge or disposal criteria. Alternatively, pretreatment and/or discharge to a permitted wastewater treatment facility is acceptable only after review by the governing authority and assurance that "pass through" violations will not occur. Due consideration shall be given to remediation worker exposure (inhalation, dermal and ingestion) as well as fate during treatment, transfer and disposal. If it is not practicable to manage the chemical in this fashion, it must be evaluated in accordance with EPA 40 CFR Part 261, specifically Subpart B, in order to determine the appropriate local, state and federal requirements for disposal.|Product: Offer surplus and non-recyclable solutions to a licensed disposal company. Contact a licensed professional waste disposal service to dispose of this material. Contaminated packaging: Dispose of as unused product.

Nicotinamide-ascorbic acid complex may be safely used in accordance with the following prescribed conditions: (a) The additive is the product of the controlled reaction between ascorbic acid and nicotinamide, melting in the range 141 °C to 145 °C. (b) It is used as a source of ascorbic acid and nicotinamide in multivitamin preparations. /Nicotinamide-Ascorbic Acid Complex/|Substance added directly to human food affirmed as generally recognized as safe (GRAS).|Drug products containing certain active ingredients offered over-the-counter (OTC) for certain uses. A number of active ingredients have been present in OTC drug products for various uses ... . However, based on evidence currently available, there are inadequate data to establish general recognition of the safety and effectiveness of these ingredients for the specified uses: niacinamide is included in orally administered menstrual drug products and weight control drug products.|Niacinamide used as a nutrient and/or dietary supplement in animal drugs, feeds, and related products is generally recognized as safe when used in accordance with good manufacturing or feeding practice.

Cosmetic Ingredient Review (CIR) Expert Panel; Final Report of the Safety Assessment of Niacinamide and Niacin; Intl J of Toxicology 24 (Suppl 5): 1-31 (2005)

Combustible. Gives off irritating or toxic fumes (or gases) in a fire. Finely dispersed particles form explosive mixtures in air.

|Warning|H315 (28.18%): Causes skin irritation [Warning Skin corrosion/irritation]|P261, P264, P271, P280, P302+P352, P304+P340, P305+P351+P338, P312, P321, P332+P313, P337+P313, P362, P403+P233, P405, and P501|Aggregated GHS information provided by 1057 companies from 21 notifications to the ECHA C&L Inventory. Each notification may be associated with multiple companies.|H315: Causes skin irritation [Warning Skin corrosion/irritation]

SMALL SPILLS AND LEAKAGE: If you spill this chemical, you should dampen the solid spill material with water, then transfer the dampened material to a suitable container. Use absorbent paper dampened with water to pick up any remaining material. Seal your contaminated clothing and the absorbent paper in a vapor-tight plastic bag for eventual disposal. Wash all contaminated surfaces with a soap and water solution. Do not reenter the contaminated area until the Safety Officer (or other responsible person) has verified that the area has been properly cleaned. STORAGE PRECAUTIONS: You should store this material in a refrigerator. (NTP, 1992)

RECOMMENDED RESPIRATOR: Where the neat test chemical is weighed and diluted, wear a NIOSH-approved half face respirator equipped with an organic vapor/acid gas cartridge (specific for organic vapors, HCl, acid gas and SO2) with a dust/mist filter. (NTP, 1992)|Eye/face protection: Safety glasses with side-shields conforming to EN166. Use equipment for eye protection tested and approved under appropriate government standards such as NIOSH (US) or EN 166(EU).|Skin protection: Handle with gloves.|Body Protection: Impervious clothing. The type of protective equipment must be selected according to the concentration and amount of the dangerous substance at the specific workplace.|Respiratory protection: For nuisance exposures use type P95 (US) or type P1 (EU EN 143) particle respirator.For higher level protection use type OV/AG/P99 (US) or type ABEK-P2 (EU EN 143) respirator cartridges. Use respirators and components tested and approved under appropriate government standards such as NIOSH (US) or CEN (EU).|Wear protective gloves and clothing to prevent any reasonable probability of skin contact. ... All protective clothing (suits, gloves, footwear, headgear) should be clean, available each day, and put on before work. ... Wear dust proof chemical goggles and face shield unless full face piece respiratory protection is worn. ... Provide emergency showers and eyewash.

This chemical is a noncombustible solid.

Suitable extinguishing media: Use water spray, alcohol-resistant foam, dry chemical or carbon dioxide.|Advice for firefighters: Wear self contained breathing apparatus for fire fighting if necessary.|... Use dry chemical, carbon dioxide, water spray, or alcohol foam extinguishers. ... If material of contaminated runoff enters waterways, notify downstream users of potentially contaminated waters. Notify local health and fire officials and pollution control agencies. From a secure, explosion-proof location, use water spray to cool exposed containers. If cooling streams are ineffective (venting sound increase in volume and pitch, tank discolors, or shows any signs of deforming), withdraw immediately to a secure position. If employees are expected to fight fires, they must be trained and equipped in OSHA 1910.156. The only respirators recommended for firefighting are self-contained breathing apparatuses that have full face-pieces and are operated in a pressure-demand or other positive-pressure mode.

ACCIDENTAL RELEASE MEASURES: Personal precautions, protective equipment and emergency procedures: Use personal protective equipment. Avoid dust formation. Avoid breathing vapors, mist or gas. Ensure adequate ventilation. Evacuate personnel to safe areas. Avoid breathing dust. Environmental precautions: Do not let product enter drains. Methods and materials for containment and cleaning up: Pick up and arrange disposal without creating dust. Sweep up and shovel. Keep in suitable, closed containers for disposal.|Evacuate persons not wearing protective equipment from area of spill or leak until clean up is complete. Remove all ignition sources. Use HEPA vacuum or wet method to reduce dust during cleanup. Do not dry sweep. Collect powdered material in the most convenient and safe manner and deposit in sealed containers. Ventilate after clean up is complete. It may be necessary to contain and dispose of this chemical as a hazardous waste. If material of contaminated runoff enters waterways, notify downstream users of potentially contaminated waters.

... Employees should wash immediately with soap when skin is wet or contaminated. ...|ACCIDENTAL RELEASE MEASURES: Personal precautions, protective equipment and emergency procedures: Use personal protective equipment. Avoid dust formation. Avoid breathing vapors, mist or gas. Ensure adequate ventilation. Evacuate personnel to safe areas. Avoid breathing dust. Environmental precautions: Do not let product enter drains.|Precautions for safe handling: Avoid contact with skin and eyes. Avoid formation of dust and aerosols.Further processing of solid materials may result in the formation of combustible dusts. The potential for combustible dust formation should be taken into consideration before additional processing occurs. Provide appropriate exhaust ventilation at places where dust is formed.|Appropriate engineering controls: Handle in accordance with good industrial hygiene and safety practice. Wash hands before breaks and at the end of workday.|For more Preventive Measures (Complete) data for Nicotinamide (7 total), please visit the HSDB record page.

Personal protection: particulate filter respirator adapted to the airborne concentration of the substance. Sweep spilled substance into covered containers. If appropriate, moisten first to prevent dusting. Wash away remainder with plenty of water.

Separated from oxidants.

A nuisance-causing concentration of airborne particles can be reached quickly when dispersed, especially if powdered.

The substance is irritating to the eyes.

Prevent deposition of dust. Closed system, dust explosion-proof electrical equipment and lighting.

PREVENT DISPERSION OF DUST!

Avoid inhalation of dust.

Protective gloves.

Wear safety goggles.

Nicotinamide is a component of tobacco, tobacco smoke and tobacco substitute smoke(1).

IDENTIFICATION AND USE: Nicotinamide is a white, crystalline powder. Nicotinamide is used to prevent niacin deficiency and to treat pellagra. Nicotinamide is also used in cosmetics as a hair and skin conditioning agent. It has been used in the enrichment of bread, flour, and other grain-derived products. Animal feed is routinely supplemented with nicotinamide. It is also used in multi-vitamin preparations. Nicotinamide and niacin are similarly effective as a vitamin because they can be converted into each other within the organism. The blanket term vitamin B(3) is used for both. Niacinamide is a component of important coenzymes involved in hydrogen transfer. HUMAN STUDIES: In humans, nicotinamide is required for lipid metabolism, tissue respiration, and glycogenolysis. In vivo, nicotinamide is formed from conversion of niacin. In addition, some dietary tryptophan is oxidized to niacin and then to nicotinamide in vivo. Nicotinamide is incorporated into 2 coenzymes: nicotinamide adenine dinucleotide (NAD) and nicotinamide adenine dinucleotide phosphate (NADP). NAD and NADP act as hydrogen-carrier molecules in glycogenolysis, tissue respiration, and lipid metabolism. In a study with 6 volunteers (single dose between 3 and 9 g/day) toxic symptoms associated with nicotinamide were mild and consisted mainly of nausea. The effect of 2 mM nicotinamide on unscheduled DNA synthesis on resting human lymphocytes was studied. In cells treated with UV irradiation or with N-methyl-N-nitro- N-nitrosoguanidine, nicotinamide caused a two-fold stimulation of unscheduled DNA synthesis. ANIMAL STUDIES: Application of 0.1 g nicotinamide to the eyes of rabbits induced reversible irritation. It did not produced sensitization in guinea pig test. Single ip injection of nicotinamide (100 mg/kg) to male rats was shown to significantly induce all components of the hepatic microsomal mixed function oxidase system as well as activities of drug-metabolizing enzymes. Groups of 12 male rats were fed nicotinamide in their diet for a period of 8 to 12 weeks. At 0.1% of the diet (100 mg/kg bw per day), nicotinamide caused no significant change in the growth rate, at 0.2%, growth rate was enhanced, but at 0.4%, a marked inhibition of growth rate resulted. Almost complete growth inhibition occurred in rats fed 1% nicotinamide. Lifelong treatment with 1% nicotinamide had no carcinogenic effect in mice. However, nicotinamide promoted diethylnitrosamine-induced renal tubular cell tumorigenesis in rats. In mice nicotinamide in doses of 500-2000 mg/kg depresses orientation reflexes and exploring behavior, and has antiaggressive and anticonvulsant properties. Nicotinamide supplementation in pregnant rats led to a decrease in placental and fetal hepatic genomic DNA methylation and genomic uracil contents (a factor modifying DNA for diversity) in the placenta and fetal liver and brain, which could be completely or partially prevented by betaine. Moreover, nicotinamide supplementation induced tissue-specific alterations in the mRNA expression of the genes encoding nicotinamide N-methyltransferase, DNA methyltransferase 1, catalase and tumor protein p53 in the placenta and fetal liver. High-dose nicotinamide supplementation increased fetal hepatic a-fetoprotein mRNA level, which was prevented by betaine supplementation. It is concluded that maternal nicotinamide supplementation can induce changes in fetal epigenetic modification and DNA base composition. Nicotinamide was negative in an Ames test performed with Salmonella strains TA 98, TA 100, TA 1535, TA 1537 and TA 1538 both with and without metabolic activation. Nicotinamide was not mutagenic in Saccharomyces stain D4. It was reported that nicotinamide at concentrations of 3 mg/mL (25 mM) induced large structural chromosome aberrations in vitro in Chinese hamster ovary cells.

Addition of 0.5 mg of nicotinamide reduced the action of dicrotophos on cultured chick embryo tibiae.|Nicotinamide will prevent depletion of NAD coenzymes by alkylating agents.|Renal oncogenic activity of Streptozotocin in male rats was significantly decreased by nicotinamide.|Oral or iv administered nicotinamide prevented Streptozotocin-induced diabetes in Rhesus monkeys and dogs.|For more Interactions (Complete) data for Nicotinamide (25 total), please visit the HSDB record page.

LD50 Rat oral 3500 mg/kg|LD50 Rat sc 1680 mg/kg|LD50 Mouse oral 2500 mg/kg|LD50 Mouse ip 2050 mg/kg|For more Non-Human Toxicity Values (Complete) data for Nicotinamide (9 total), please visit the HSDB record page.

Large doses of niacin or niacinamide should be administered with caution to patients with gallbladder disease or a history of jaundice or liver disease, diabetes mellitus, gout, peptic ulcer, or allergy. Niacin and niacinamide are contraindicated in patients with liver disease, active peptic ulcer, or hypersensitivity to the drugs.

Nicotinamide is a precursor of the coenzymes NAD and NADP(1). Nicotinamide and nicotinic acid occur in nature almost exclusively in the bound form. In plants, nicotinic acid is prevalent whereas in animals nicotinamide is the predominant form. This nicotinamide is exclusively in the form of NAD and NADP(2).

Nicotinamide's production and use as a dietary supplement and administration as a medicine(1) and in cosmetics as a hair and skin conditioning agent(2) may result in its release to the environment through various waste streams(SRC).

TERRESTRIAL FATE: Based on a classification scheme(1), an estimated Koc value of 8(SRC), determined from a structure estimation method(2), indicates that nicotinamide is expected to have very high /mobility in soil(SRC). Volatilization of nicotinamide from moist soil surfaces is not expected to be an important fate process(SRC) given an estimated Henry's Law constant of 2.9X10-12 atm-cu m/mole(SRC), developed using a fragment constant estimation method(2). Nicotinamide is not expected to volatilize from dry soil surfaces(SRC) based upon an estimated vapor pressure of 4.2X10-4 mm Hg at 25 °C(SRC), determined from a fragment constant method(2). Nicotinamide was determined to be readily biodegradable in an aerobic screening test(3) suggesting that biodegradation may be an important environmental fate process in soil(SRC).|AQUATIC FATE: Based on a classification scheme(1), an estimated Koc value of 8(SRC), determined from a structure estimation method(2), indicates that nicotinamide is not expected to adsorb to suspended solids and sediment(SRC). Volatilization from water surfaces is not expected(3) based upon an estimated Henry's Law constant of 2.9X10-12 atm-cu m/mole(SRC), developed using a fragment constant estimation method(2). According to a classification scheme(4), an estimated BCF of 3(SRC), from its log Kow of -0.37(5) and a regression-derived equation(2), suggests the potential for bioconcentration in aquatic organisms is low(SRC). Nicotinamide was determined to be readily biodegradable in an aerobic screening test(6) suggesting that biodegradation may be an important environmental fate process in water(SRC).|ATMOSPHERIC FATE: According to a model of gas/particle partitioning of semivolatile organic compounds in the atmosphere(1), nicotinamide, which has an estimated vapor pressure of 4.2X10-4 mm Hg at 25 °C(SRC), determined from a fragment constant method(2), will exist in both the vapor and particulate phases in the ambient atmosphere. Vapor-phase nicotinamide is degraded in the atmosphere by reaction with photochemically-produced hydroxyl radicals(SRC); the half-life for this reaction in air is estimated to be 6 days(SRC), calculated from its rate constant of 2.5X10-12 cu cm/molecule-sec at 25 °C(SRC) that was derived using a structure estimation method(2). Particulate-phase nicotinamide may be removed from the air by wet and dry deposition(SRC). Nicotinamide absorbs UV light at wavelengths >300 nm(3) and, therefore, may be susceptible to direct photolysis by sunlight(SRC).

The rate constant for the vapor-phase reaction of nicotinamide with photochemically-produced hydroxyl radicals has been estimated as 2.5X10-12 cu cm/molecule-sec at 25 °C(SRC) using a structure estimation method(1). This corresponds to an atmospheric half-life of about 6 days at an atmospheric concentration of 5X10+5 hydroxyl radicals per cu cm(1). Some hydrolysis of nicotinamide may occur; however, amides are only slowly hydrolyzed under environmental conditions(2). The rate constant for the reaction of hydroxyl radicals in aqueous solutions at pH 5.9 and 9.0 is 1.4X10+9 and 1.5X10+9 L/mol-sec, respectively(3); this corresponds to aquatic half-lives of 1.6 and 1.5 yrs, respectively, at an aquatic concentration of 1X10-17 hydroxyl radicals per liter(4). Nicotinamide absorbs UV light at wavelengths >300 nm(5) and, therefore, may be susceptible to direct photolysis by sunlight(SRC).

An estimated BCF of 3 was calculated in fish for nicotinamide(SRC), using a log Kow of -0.37(1) and a regression-derived equation(2). According to a classification scheme(3), this BCF suggests the potential for bioconcentration in aquatic organisms is low(SRC).

Using a structure estimation method based on molecular connectivity indices(1), the Koc of nicotinamide can be estimated to be 8(SRC). According to a classification scheme(2), this estimated Koc value suggests that nicotinamide is expected to have very high mobility in soil(SRC).

The Henry's Law constant for nicotinamide is estimated as 2.9X10-12 atm-cu m/mole(SRC) developed using a fragment constant estimation method(1). This Henry's Law constant indicates that nicotinamide is expected to be essentially nonvolatile from water and moist soil surfaces(2). Nicotinamide is not expected to volatilize from dry soil surfaces(SRC) based upon an estimated vapor pressure of 4.2X10-4 mm Hg(SRC), determined from a fragment constant method(1).

Nicotinamide is prevalent in many common foodstuffs and is especially concentrated in brewer's yeast, wheat germ and liver(1).|Nicotinic Acid and Nicotinamide (Vitamin B3) Foodstuff Content(1).|Nicotinic Acid and Nicotinamide (Vitamin B3) in Coffee(1).

According to the 2016 TSCA Inventory Update Reporting data, 2 reporting facilities estimate the number of persons reasonably likely to be exposed during the manufacturing, processing, or use of nicotinamide in the United States may be as low as 25 workers and as high as 50 workers per plant; the data may be greatly underestimated due to confidential business information (CBI) or unknown values(1).|NIOSH (NOES Survey 1981-1983) has statistically estimated that 64,950 workers (44,524 of these are female) are potentially exposed to nicotinamide in the US(1). Occupational exposure to nicotinamide may occur through inhalation of dust and dermal contact with this compound at workplaces where nicotinamide is produced or used(SRC). Monitoring data indicate that the general population may be exposed to nicotinamide via ingestion of food and smoking cigarettes. Exposure to nicotinamide will also occur by direct medical treatment(SRC).

Vitamin B refers to several water soluble vitamins often found together in foods, all of which are necessary for normal growth and metabolism, but none of which are synthesized in adequate amounts by humans. The common forms of vitamin B include vitamin B1 (thiamine), B2 (riboflavin), B3 (niacin), B6 (pyridoxine) and B12 (cyanocobalamin). Except for niacin (when given in high doses), there is no evidence that the other B vitamins, in physiologic or even super-physiologic high doses cause liver injury or jaundice. The major forms of vitamin B and selected other water soluble vitamins (biotin, pantothenic acid, choline) are discussed briefly in this record.

Vitamins

Vitamin B Complex|/CLINICAL TRIALS/ ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world. The Web site is maintained by the National Library of Medicine (NLM) and the National Institutes of Health (NIH). Each ClinicalTrials.gov record presents summary information about a study protocol and includes the following: Disease or condition; Intervention (for example, the medical product, behavior, or procedure being studied); Title, description, and design of the study; Requirements for participation (eligibility criteria); Locations where the study is being conducted; Contact information for the study locations; and Links to relevant information on other health Web sites, such as NLM's MedlinePlus for patient health information and PubMed for citations and abstracts for scholarly articles in the field of medicine. Nicotinamide is included in the database.|Niacin and niacinamide are used to prevent niacin deficiency and to treat pellagra. Some clinicians prefer niacinamide for the treatment of pellagra because it lacks vasodilating effects. Pellagra may result from dietary deficiency, isoniazid therapy, or from decreased conversion of tryptophan to niacin in Hartnup disease or carcinoid tumors. /Included in US product label/|Although niacin and niacinamide have not been shown by well-controlled trials to have therapeutic value, the drugs have been used for the management of schizophrenic disorder, drug-induced hallucinations, chronic brain syndrome, hyperkinesis, unipolar depression, motion sickness, alcohol dependence, livedoid vasculitis, acne, and leprosy. /NOT included in US product label/|For more Therapeutic Uses (Complete) data for Nicotinamide (14 total), please visit the HSDB record page.

Blood glucose concentration should be monitored periodically in patients receiving niacin or niacinamide, especially early in the course of therapy. Dosage requirements for antidiabetic agents (e.g., insulin, oral sulfonylureas) may change in diabetic patients.|Potential adverse effects on fetus: Higher levels in fetus than mother, but no fetal anomalies reported. Potential side effects on breast-fed infant: No adverse effects known . FDA Category: C (C = Studies in laboratory animals have revealed adverse effects on the fetus (teratogenic, embryocidal, etc.), but there are no controlled studies in pregnant women. The benefits from use of the drug in pregnant women may be acceptable despite its potential risks, or there are no laboratory animal studies or adequate studies in pregnant women.) /from table II/|Niacinamide /was administered/ daily as a liquid formulation to head and neck cancer patients receiving a 5- to 7-week course of radiotherapy. Niacinamide was administered orally 1.5 hr before irradiation. The daily dose was 80 mg/kg bw to a maximum of 6 g. A dose reduction to 60 mg/kg was introduced for patients with severe side-effects. ... Side-effects of niacinamide were monitored. In all patients, peak concentrations greater than 700 nM/mL could be obtained 0.25-3 hr after drug intake. During the first week of treatment, plasma concentrations at the time of irradiation were adequate in 82% of the samples. Nausea, with or without vomiting, occurred in 65% of patients. Tolerance improved after a 25% reduction of the dose in six of seven patients but plasma concentrations at the time of irradiation decreased below 700 nM/mL in four out of six patients. Other niacinamide side effects included gastrointestinal symptoms, flushing, dizziness, sweating, fatigue, and headache. The most powerful single predictor for severe niacinamide toxicity was the mean of the plasma concentration measured at the time of irradiation during the first week.|Abnormal liver function test results (including increased serum concentrations of bilirubin, AST [SGOT], ALT [SGPT], and LDH), jaundice, and chronic liver damage have occurred during niacin and niacinamide therapy. Abnormal prothrombin time and hypoalbuminemia have also been reported.|For more Drug Warnings (Complete) data for Nicotinamide (6 total), please visit the HSDB record page.

A group of water-soluble vitamins, some of which are COENZYMES. (See all compounds classified as Vitamin B Complex.)

14(C)Niacinamide was incorporated into an oil-in-water (o/w) skin cream and into a 30% (w/w) soap base and applied to the skin of female Colworth Wistar rats. The final concentration of niacinamide in the soap solution was approximately 0.3% (w/v) and was 1% (w/w) in the skin cream. Application of the skin cream and soap paste was made to rat skin at approximately 20 mg/sq cm. The cream was carefully massaged over 10 sq cm of skin for up to 5 min before covering with polythene-lined occlusive protective patches. The rats were placed in metabolism cages for 48 hr during which time all excreta was collected. At 48 hr, the animals were killed and the patch, carcass, and treated area of skin were assayed for 14(C). Up to 32% 14(C) was recovered in excreta and in the carcasses from rats treated with skin cream containing 14(C)Niacinamide and up to 30% from those treated with soap paste.|Nicotinamide is efficiently absorbed from the gastrointestinal tract. At low doses, absorption is mediated via sodium-dependent facilitated diffusion. Passive diffusion is the principal mechanism of absorption at higher doses. Doses of up to three to four grams of nicotinamide are almost completely absorbed. Nicotinamide is transported via the portal circulation to the liver and via the systemic circulation to the various tissues of the body. Nicotinamide enters most cells by passive diffusion and enters erythrocytes by facilitated transport.|Niacinamide is widely distributed /throughout/ body tissues.|Niacin and niacinamide are readily absorbed from the GI tract following oral administration, and niacinamide (no longer commercially available in the US) is readily absorbed from subcutaneous and IM injection sites.|For more Absorption, Distribution and Excretion (Complete) data for Nicotinamide (16 total), please visit the HSDB record page.

In amounts needed for physiologic function as a coenzyme (12-18 mg daily), niacin is converted to niacinamide; larger doses of niacin are converted to niacinamide to only a minor degree. Niacinamide is metabolized in the liver to N-methylniacinamide, other N-methylated derivatives, and nicotinuric acid (the glycine conjugate of niacin). These metabolites are excreted in urine. Following administration of physiologic doses of niacin or niacinamide, only a small amount of niacinamide is excreted unchanged in urine; however, following administration of larger doses, a greater proportion of niacin and niacinamide is excreted unchanged.|N1-Methyl-4-pyridone-3-carboxamide was detected on chromatograms of plasma extracts after oral administration of niacinamide to two human subjects.|6-Hydroxynicotinamide and 6-hydroxynicotinic acid /were detected/ as urinary metabolites by comparison of ultraviolet, infrared, and mass spectra following intraperitoneal injections of 14(C)Niacin or 14(C)Niacinamide into rats.|N1-methyl-4- pyridone-3-carboxamide is a major metabolite of niacin and niacinamide which has been found to be synthesized from N1- methylnicotinamide.|For more Metabolism/Metabolites (Complete) data for Nicotinamide (7 total), please visit the HSDB record page.

The mean half life values were 2.7 hr, 5.9 hr, and 8.1 hr after taking 1, 3, or 6 g of Niacinamide, respectively.

EYES: First check the victim for contact lenses and remove if present. Flush victim's eyes with water or normal saline solution for 20 to 30 minutes while simultaneously calling a hospital or poison control center. Do not put any ointments, oils, or medication in the victim's eyes without specific instructions from a physician. IMMEDIATELY transport the victim after flushing eyes to a hospital even if no symptoms (such as redness or irritation) develop. SKIN: IMMEDIATELY flood affected skin with water while removing and isolating all contaminated clothing. Gently wash all affected skin areas thoroughly with soap and water. If symptoms such as redness or irritation develop, IMMEDIATELY call a physician and be prepared to transport the victim to a hospital for treatment. INHALATION: IMMEDIATELY leave the contaminated area; take deep breaths of fresh air. If symptoms (such as wheezing, coughing, shortness of breath, or burning in the mouth, throat, or chest) develop, call a physician and be prepared to transport the victim to a hospital. Provide proper respiratory protection to rescuers entering an unknown atmosphere. Whenever possible, Self-Contained Breathing Apparatus (SCBA) should be used; if not available, use a level of protection greater than or equal to that advised under Protective Clothing. INGESTION: DO NOT INDUCE VOMITING. If the victim is conscious and not convulsing, give 1 or 2 glasses of water to dilute the chemical and IMMEDIATELY call a hospital or poison control center. Be prepared to transport the victim to a hospital if advised by a physician. If the victim is convulsing or unconscious, do not give anything by mouth, ensure that the victim's airway is open and lay the victim on his/her side with the head lower than the body. DO NOT INDUCE VOMITING. IMMEDIATELY transport the victim to a hospital. (NTP, 1992)

Fresh air, rest.

Rinse skin with plenty of water or shower.

Rinse with plenty of water (remove contact lenses if easily possible).

/SRP:/ Immediate first aid: Ensure that adequate decontamination has been carried out. If patient is not breathing, start artificial respiration, preferably with a demand valve resuscitator, bag-valve-mask device, or pocket mask, as trained. Perform CPR if necessary. Immediately flush contaminated eyes with gently flowing water. Do not induce vomiting. If vomiting occurs, lean patient forward or place on left side (head-down position, if possible) to maintain an open airway and prevent aspiration. Keep patient quiet and maintain normal body temperature. Obtain medical attention. /Poisons A and B/|/SRP:/ Basic treatment: Establish a patent airway (oropharyngeal or nasopharyngeal airway, if needed). Suction if necessary. Watch for signs of respiratory insufficiency and assist ventilations if needed. Administer oxygen by nonrebreather mask at 10 to 15 L/min. Monitor for pulmonary edema and treat if necessary ... . Monitor for shock and treat if necessary ... . Anticipate seizures and treat if necessary ... . For eye contamination, flush eyes immediately with water. Irrigate each eye continuously with 0.9% saline (NS) during transport ... . Do not use emetics. For ingestion, rinse mouth and administer 5 mL/kg up to 200 mL of water for dilution if the patient can swallow, has a strong gag reflex, and does not drool ... . Cover skin burns with dry sterile dressings after decontamination ... . /Poisons A and B/|/SRP:/ Advanced treatment: Consider orotracheal or nasotracheal intubation for airway control in the patient who is unconscious, has severe pulmonary edema, or is in severe respiratory distress. Positive-pressure ventilation techniques with a bag valve mask device may be beneficial. Consider drug therapy for pulmonary edema ... . Consider administering a beta agonist such as albuterol for severe bronchospasm ... . Monitor cardiac rhythm and treat arrhythmias as necessary ... . Start IV administration of D5W TKO /SRP: "To keep open", minimal flow rate/. Use 0.9% saline (NS) or lactated Ringer's (LR) if signs of hypovolemia are present. For hypotension with signs of hypovolemia, administer fluid cautiously. Watch for signs of fluid overload ... . Treat seizures with diazepam (Valium) or lorazepam (Ativan) ... . Use proparacaine hydrochloride to assist eye irrigation ... . /Poisons A and B/

/HUMAN EXPOSURE STUDIES/ In studies with diabetic and at-risk-of-diabetes patients who were treated for several years with 1.5 to 3 g nicotinamide daily (25 and 42 mg/kg/day, respectively) no effect on a range of biochemical parameters including liver and kidney function was observed.|/HUMAN EXPOSURE STUDIES/ In a study with 6 volunteers (single dose between 3 and 9 g/day) toxic symptoms associated with nicotinamide were mild and consisted mainly of nausea.|/GENOTOXICITY/ The effect of 2 mM Niacinamide on unscheduled DNA synthesis on resting human lymphocytes /was studied/. In cells treated with UV irradiation or with N-methyl-N-nitro- N-nitrosoguanidine, niacinamide caused a two-fold stimulation of unscheduled DNA synthesis and retarded the rate of NAD+ lowering caused by these treatments. Niacinamide also reduced the burst of poly(ADP-ribose) synthesis caused by N-methyl-N-nitro- N-nitrosoguanidine treatment. The effect of niacinamide on unscheduled DNA synthesis was shown to be independent of protein or polyamine synthesis.

3 Pyridinecarboxamide

Stimulant compounds previously excepted|Mediatric|1405|Schedule III - Substances in the DEA Schedule III have a potential for abuse less than substances in Schedules I or II and abuse may lead to moderate or low physical dependence or high psychological dependence.|No

Cough.

Redness. Pain.

APPROX 80% BY ITSELF AS AN ESSENTIAL B VITAMIN; APPROX 20% AS AN ESSENTIAL B VITAMIN IN OTHER APPLICATIONS SUCH AS FLOUR, BAKED GOODS & CEREAL PRODUCTS, & PHARMACEUTICALS (1973)

Table: Niacinamide Preparations [Table#3044]|Grades: United States Pharmacopeia; Food Chemical Codex; also available as the hydrochloride.

Food, beverage, and tobacco product manufacturing|3-Pyridinecarboxamide: ACTIVE|Niacin is a naturally occurring substance. Nicotinic acid is the form present in food of plant origin, whereas nicotinamide occurs in animal products.|The terms niacin, Vitamin B3, and Vitamin PP have been used to refer to both nicotinamide and nicotinic acid.|As feed additive esp for pigs, humans, and rats on diet rich in cereal grain or their by-products since vitamin appears to be trapped within indigestible cellulose and lignin components of foods.

AOAC Method 975.41. Niacin and Niacinamide in cereal products. Automated method.|AOAC Method 961.14. Niacin and Niacinamide in drugs, foods, and feeds. Colorimetric method.|AOAC Method 985.34. Niacin and niacinamide (nicotinic acid and nicotinamide) in ready-to-feed milk-based infant formula. Microbiological-turbidimetric method.|AOAC Method 968.32. Niacinamide in multivitamin preparations by spectrophotometic method.|For more Analytic Laboratory Methods (Complete) data for Nicotinamide (6 total), please visit the HSDB record page.

Human Drugs -> FDA Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) -> Active Ingredients|Cosmetics -> Smoothing