Consumer medicine information

Nicotinic Acid

Nicotinic acid

BRAND INFORMATION

Brand name

Nicotinic Acid

Active ingredient

Nicotinic acid

Schedule

S3

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Nicotinic Acid.

SUMMARY CMI

NICOTINIC ACID

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about taking this medicine, speak to your doctor or pharmacist.

1. Why am I taking NICOTINIC ACID?

The active ingredient in this medicine is Nicotinic Acid (also known as niacin/vitamin B3). NICOTINIC ACID is used to treat high levels of cholesterol and triglycerides, and pellagra, a nicotinic acid deficiency. For more information, see Section 1. Why am I taking NICOTINIC ACID? in the full CMI.

2. What should I know before I take NICOTINIC ACID?

Do not take if you have ever had an allergic reaction to nicotinic acid or any of the ingredients listed at the end of the CMI. Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding. For more information, see Section 2. What should I know before I take NICOTINIC ACID? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with NICOTINIC ACID and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I take NICOTINIC ACID?

  • Your doctor or pharmacist will tell you how many tablets you will need to take each day. This depends on your condition and whether or not you are taking any other medicines.
  • Swallow the tablets whole with a glass of water. Do not chew the tablets.

More instructions can be found in Section 4. How do I take NICOTINIC ACID? in the full CMI.

5. What should I know while taking NICOTINIC ACID?

Things you should do
  • Remind any doctor, dentist or pharmacist you visit that you are taking NICOTINIC ACID.
  • If you are about to have any blood or urine tests, tell your doctor that you are taking this medicine.
  • Tell your doctor or pharmacist immediately if you are pregnant.
Things you should not do
  • Do not give this medicine to anyone else, even if they have the same condition as you.
  • Do not take the medicine to treat any other complaints unless your doctor or pharmacist tells you to.
  • Do not stop taking the medicine, or lower the dosage, without checking with your doctor or pharmacist.
Drinking alcohol
  • Avoid alcohol and hot drinks when you take NICOTINIC ACID.
  • Alcohol and hot drinks can increase side effects such as flushing and itching.
Looking after your medicine
  • Keep the tablets in the bottle, in a cool, dry place below 30°C.
  • Keep your tablets where children cannot reach it.

For more information, see Section 5. What should I know while taking NICOTINIC ACID? in the full CMI.

6. Are there any side effects?

Tell your doctor or pharmacist if you notice any of the following: skin flushing (warmth, redness, itching or tingling that typically occurs on the face, neck, chest and back), irregular or rapid heart beat, headache, dizziness, itch, rash, dry or scaly skin, boils, darkening or thickening of the skin, nausea (feeling sick), vomiting, diarrhoea, heartburn or flatulence, nervousness. Tell your doctor as soon as possible if you notice any of the following: yellowing of the skin and/or eyes, shortness of breath, signs of gout, e.g. painful swollen joints, difficulty seeing, fainting, dizziness when getting up from a sitting or lying position. Tell your doctor immediately or go to Accident and Emergency at the nearest hospital if you notice any of the following: signs of an allergic reaction including swelling of the face, lips, mouth, throat or neck which may cause difficulty swallowing or breathing. For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.



FULL CMI

NICOTINIC ACID

Active ingredient(s): nicotinic acid


Consumer Medicine Information (CMI)

This leaflet provides important information about taking NICOTINIC ACID. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about taking NICOTINIC ACID.

Where to find information in this leaflet:

1. Why am I taking NICOTINIC ACID?
2. What should I know before I take NICOTINIC ACID?
3. What if I am taking other medicines?
4. How do I take NICOTINIC ACID?
5. What should I know while taking NICOTINIC ACID?
6. Are there any side effects?
7. Product details

1. Why am I taking NICOTINIC ACID?

Nicotinic acid (also known as niacin) is vitamin B3, which occurs naturally in food. Used as a medicine, it can improve levels of blood fats (lipids) such as cholesterol and triglycerides.

Nicotinic acid works by reducing the amount of 'bad' cholesterol and triglycerides made by the liver.

In most people, there are no symptoms of high cholesterol or triglycerides. Your doctor can measure your cholesterol and triglycerides with a simple blood test.

NICOTINIC ACID is used to treat:

  • high levels of cholesterol and triglycerides which are fat-like substances in the blood
  • pellagra, a nicotinic acid deficiency which is very rare in Australia. Symptoms of pellagra include loss of appetite, lethargy, weakness, diarrhoea, dermatitis and mental changes.

Cholesterol and triglycerides

Everyone has cholesterol in their blood. It is a type of blood fat needed by the body for many things, such as making bile acids (which help to digest food) and some hormones.

Some people have a family history of high cholesterol.

However, having too much cholesterol in the blood can contribute to the development of heart disease.

Cholesterol is present in many foods and is also made in your body by the liver. If your body does not balance the amount of cholesterol it needs with the amount of cholesterol eaten, then your cholesterol becomes too high.

There are different types of cholesterol, called LDL (low-density lipoprotein) and HDL (high-density lipoprotein). LDL cholesterol is the 'bad' cholesterol that can block your blood vessels. HDL cholesterol is the 'good' cholesterol that is thought to remove the 'bad' cholesterol from the blood vessels.

There is another type of fat called triglyceride, which is a source of energy. High levels of triglyceride can be associated with a low level of 'good' cholesterol and may increase your risk of heart disease.

Having high levels of 'bad' cholesterol and triglycerides can be a problem. Over time, this can form hard areas, called plaque, on the walls of your blood vessels, making it more difficult for the blood to flow. This blocking of your blood vessels can lead to heart disease (such as heart attack or angina), and stroke.

Treating high cholesterol and triglycerides

High cholesterol and triglyceride levels can be treated in two main ways:

Lifestyle changes:

  • this includes a low-fat diet, increasing physical exercise, and weight management.

Medicines:

  • such as cholesterol-lowering agents.

Ask your doctor if you have any questions about why this medicine has been prescribed for you.

Your doctor may have prescribed it for another reason.

Do not give NICOTINIC ACID to a child.

The safety and effectiveness of this medicine have not been established in this age group.

NICOTINIC ACID is not addictive.

2. What should I know before I take NICOTINIC ACID?

Warnings

Do not take NICOTINIC ACID if:

  • you are allergic to nicotinic acid, or any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction include:
    - shortness of breath
    - wheezing or difficulty breathing
    - swelling of the face, lips, tongue or other parts of the body
    - rash, itching or hives on the skin.
    Always check the ingredients to make sure you can take this medicine.
  • you have or have had:
    - significant liver problems
    - bleeding of any artery (a blood vessel)
    - recent heart attack.
  • the expiry date printed on the pack has passed or if the packaging is torn or shows signs of tampering.
    If it has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should start taking this medicine talk to your doctor or pharmacist.

Check with your doctor if you:

  • have allergies to any other medicines, foods, preservatives or dyes
  • have or have had liver disease
    Your doctor will do a blood test to make sure you have no problems with your liver.
  • have or have had any of the following medical conditions:
    - heart attack
    - heart, gallbladder, kidney or liver problems
    - bleeding problems
    - glaucoma (increased pressure in the eye)
    - stomach ulcer
    - diabetes
    - gout.
  • take any medicines for any other condition.

If you have not told your doctor or pharmacist about any of the above, tell them before you start taking this medicine.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Do not take this medicine if you are pregnant.

It may affect your developing baby if you take it during pregnancy.

Check with your doctor if you are pregnant or intend to become pregnant.

Do not take this medicine if you are breast-feeding.

This medicine passes into breast milk and may affect your baby.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with NICOTINIC ACID and affect how it works. These include:

  • certain medicines used to lower high blood pressure
  • insulin or other medicines used to treat diabetes
  • aspirin
  • 'statins', medicines used to lower cholesterol, e.g. pravastatin, simvastatin
  • colestipol, a medicine used to lower cholesterol
  • nicotine patches
  • isoniazid, a medicine used for tuberculosis
  • clonidine, a medicine used for high blood pressure and migraine.

These medicines may be affected by NICOTINIC ACID, or may affect how well it works. You may need different amounts of your medicine, or you may need to take different medicines.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect NICOTINIC ACID.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking NICOTINIC ACID.

4. How do I take NICOTINIC ACID?

Carefully follow all directions given to you by your doctor or pharmacist.

They may differ from the information contained in this leaflet.

If you do not understand the instructions, ask your doctor or pharmacist for help.

How much to take

In adults:

Pellagra:

One tablet twice a day.

High cholesterol and triglyceride levels:

Initially one tablet three times a day; increased by one tablet every four days to a maximum daily dose of 12-18 tablets or as directed by your doctor.

Your doctor or pharmacist will tell you how many tablets you will need to take each day. This depends on your condition and whether or not you are taking any other medicines.

How to take NICOTINIC ACID

  • Swallow the tablets whole with a glass of water. Do not chew the tablets.

When to take NICOTINIC ACID

  • Take NICOTINIC ACID after meals.

How long to take NICOTINIC ACID

Continue taking your medicine for as long as your doctor or pharmacist tells you.

NICOTINIC ACID helps lower your cholesterol and triglyceride. It does not cure your condition. Therefore, you must continue to take it as directed by your doctor or pharmacist to keep your cholesterol and triglyceride levels controlled. If you stop taking it, your cholesterol and triglyceride levels may become out of control.

If you forget to take NICOTINIC ACID

NICOTINIC ACID should be used regularly at the same time each day.

If you miss your dose at the usual time, take the dose as soon as you remember, and then go back to taking your medicine as directed.

Do not take a double dose to make up for the dose that you missed.

This may increase the chance of you getting an unwanted side effect.

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering to take your medicine, ask your pharmacist for some hints.

If you take too much NICOTINIC ACID

If you think that you or anyone else may have taken too much NICOTINIC ACID, urgent medical attention may be needed.

You should immediately:

  • phone the Poisons Information Centre
    (Australia telephone 13 11 26) for advice, or
  • contact your doctor, or
  • go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

Too much NICOTINIC ACID may cause red or itchy skin, vomiting, diarrhoea, stomach discomfort or cramps, or fainting.

5. What should I know while taking NICOTINIC ACID?

Things you should do

  • If you are about to be started on any new medicine, tell your doctor or pharmacist that you are taking NICOTINIC ACID.
  • Tell any other doctors, dentists, and pharmacists who are treating you that you are taking this medicine.
  • If you are about to have any blood or urine tests, tell your doctor that you are taking this medicine.
    NICOTINIC ACID may affect the results of some tests.
  • Keep all of your doctor's appointments so that your progress can be checked.
    Your doctor may recommend that you have regular blood tests while taking NICOTINIC ACID to monitor the effect on your blood cholesterol and triglyceride levels.
  • If you are taking this medicine to lower your blood cholesterol and triglyceride levels, maintain a low fat diet and exercise program to control your weight.
    When you are taking this medicine, it will be easier to control your cholesterol and triglyceride levels if you also exercise and follow a low fat diet, including plenty of fruit and vegetables.

Call your doctor straight away if you:

  • become pregnant while taking this medicine.

Things you should not do

  • Do not give this medicine to anyone else, even if they have the same condition as you.
  • Do not take the medicine to treat any other complaints unless your doctor or pharmacist tells you to.
  • Do not stop taking the medicine, or lower the dosage, without checking with your doctor or pharmacist.

Drinking alcohol

Avoid alcohol and hot drinks when you take NICOTINIC ACID.

Alcohol and hot drinks can increase side effects such as flushing and itching.

Looking after your medicine

  • Store below 30°C
  • Keep your tablets in the bottle until it is time to take them. If you take the tablets out of the bottle they may not keep as well.

Follow the instructions in the carton on how to take care of your medicine properly.

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

  • in the bathroom or near a sink, or
  • in the car or on window sills.

Keep it where young children cannot reach it.

A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Getting rid of any unwanted medicine

If you no longer need to take this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not take this medicine after the expiry date.

6. Are there any side effects?

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking NICOTINIC ACID.

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

Do not be alarmed by the following lists of side effects.

You may not experience any of them.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Less serious side effectsWhat to do
  • skin flushing (warmth, redness, itching or tingling that typically occurs on the face, neck, chest and back).
    Flushing is the most common side effect of nicotinic acid products. For most patients, the flushing episodes will become less frequent and milder within a few weeks after starting therapy, or may stop altogether.
  • irregular or rapid heart beat
  • headache
  • dizziness
  • itch, rash
  • dry or scaly skin, boils
  • darkening or thickening of the skin
  • nausea (feeling sick), vomiting
  • diarrhoea
  • heartburn or flatulence
  • nervousness
Speak to your doctor or pharmacist if you have any of these less serious side effects and they worry you.
This list includes the more common side effects of your medicine.

Serious side effects

Serious side effectsWhat to do
  • yellowing of the skin and/or eyes
  • shortness of breath
  • signs of gout, e.g. painful swollen joints
  • difficulty seeing
  • fainting, dizziness when getting up from a sitting or lying position.
Tell your doctor as soon as possible if you notice any of the following serious side effects:
This list includes serious side effects, which may require medical attention. Serious side effects are rare.

Very serious side effects

Very serious side effectsWhat to do
  • signs of an allergic reaction include swelling of the face, lips, mouth, throat or neck which may cause difficulty swallowing or breathing.
Tell your doctor immediately or go to Accident and Emergency at the nearest hospital if you notice any of the following:
This list includes very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are very rare.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Some side effects can only be found when your doctor does blood, urine or other tests from time to time to check your progress.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is available from your pharmacist without a doctor's prescription.

What NICOTINIC ACID contains

Active ingredient
(main ingredient)
Nicotinic acid 250 mg
Other ingredients
(inactive ingredients)
  • lactose monohydrate
  • wheat starch
  • povidone
  • purified talc
  • magnesium stearate
Potential allergensGluten, sulfites and sugars as lactose

Do not take this medicine if you are allergic to any of these ingredients.

What NICOTINIC ACID looks like

NICOTINIC ACID tablets are white, bevelled edge tablets with a breakline on one side (AUST R 27193).

NICOTINIC ACID is available in bottles of 100 tablets.

Who distributes NICOTINIC ACID

Alphapharm Pty Ltd trading as Viatris
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
www.viatris.com.au
Phone: 1800 274 276

This leaflet was prepared in January 2025.

NICOTINIC ACID_cmi\Jan25/00

Published by MIMS February 2025

BRAND INFORMATION

Brand name

Nicotinic Acid

Active ingredient

Nicotinic acid

Schedule

S3

 

1 Name of Medicine

Nicotinic acid 250 mg.

2 Qualitative and Quantitative Composition

Each tablet contains 250 mg of nicotinic acid as the active ingredient.

Excipients with known effect.

Gluten, sulfites and sugars as lactose.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Nicotinic Acid tablets are white, bevelled edge tablet with breakline on one side.

4 Clinical Particulars

4.1 Therapeutic Indications

1. The treatment of hyperlipidaemia, hypertriglyceridaemia and Frederickson-Lees Levy hyperlipoproteinaemia type II, IIB, III, IV and V (as adjunctive therapy in addition to diet and other measures); and
2. Pellagra (note: pellagra in Australia is limited to special situations not typical of the general lifestyle. A variety of other non-nutritional factors may also lead to the development of the disease.)

4.2 Dose and Method of Administration

In adults.

Pellagra.

250 mg (one tablet) twice a day.

Hypercholesterolaemia, hypertriglyceridaemia.

250 mg three times daily increased by 250 mg increments every fourth day until a final daily dose of 3 to 4.5 g is reached.
Individual dosage is recommended because lipid reduction is dose related. Initially, plasma cholesterol and triglyceride levels should be monitored.
Tablets should be taken orally after meals.
Following oral administration, nicotinic acid induced vasodilation occurs within 20 minutes and persists for about 20 to 60 minutes.

4.3 Contraindications

Nicotinic acid may exacerbate hepatic dysfunction and large doses may exacerbate peptic ulcer, overt diabetes mellitus, gout or hyperuricaemia.
Large doses of nicotinic acid should not be used by persons with heart or gall bladder disease, arterial bleeding or glaucoma.
Contraindicated in cases of recent myocardial infarction.
Nicotinic acid is contraindicated in patients with severe idiosyncratic reactions to it or those who exhibit a sudden fall in peripheral vascular resistance.

4.4 Special Warnings and Precautions for Use

Identified precautions.

Antihypertensive drugs.

Patients taking antihypertensive drugs should consult a physician before taking nicotinic acid. Antihypertensive drugs may have an additive vasodilating effect and produce postural hypotension.

Liver function.

Frequent monitoring of liver function should be performed during therapy to ascertain that the drug has no adverse effects.

Glucose tolerance.

As decreased glucose tolerance may occur, glucose tolerance tests should be performed regularly. Adjustment of diet and/or hypoglycaemic therapy may be necessary.

Serum uric acid levels.

Frequent monitoring of serum uric acid levels is advised as elevated uric acid levels may occur during long-term therapy.

Gastrointestinal irritation or peptic ulcer history.

Nicotinic acid causes release of histamine from the mast cells to stimulate gastric secretion of hydrochloric acid. Therefore, patients prone to gastrointestinal irritation or with a history of peptic ulcer should be closely supervised.

Myocardial infarction.

Nicotinic acid therapy should be withdrawn if the patient has a myocardial infarction.

Use in the elderly.

No data available.

Paediatric use.

No data available.

Effects on laboratory tests.

Nicotinic acid may cause false elevation in fluorometric determinations of urinary catecholamines and false positive tests for urinary glucose when Benedict's reagent is used. Nicotinic acid has also been reported to give false positive results for blood bilirubin tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Adrenergic blocking agents.

Due to an additive vasodilating effect, postural hypotension may occur when nicotinic acid is added to the regimen of patients taking adrenergic blocking agents.

Antihyperglycaemic therapy.

Because nicotinic acid can cause hyperglycaemia, dosage adjustment of insulin or oral antihyperglycaemic therapy may be required in diabetic patients.

Aspirin.

Concurrent use of aspirin and nicotinic acid may result in a reduction of the warmth and flushing associated with nicotinic acid use. Also, concurrent use of aspirin may result in an increased and prolonged nicotinic acid concentration, and so the potential for nicotinic acid toxicity may exist.

Clonidine.

Concomitant nicotinic acid and clonidine has been reported to result in reduction in flushing of skin secondary to nicotinic acid.

Colestipol.

Nicotinic acid absorption may be affected by administration with colestipol. Combined use of these two drugs resulted in lower plasma cholesterol concentrations than were achieved with colestipol alone.

Glipizide.

Concomitant administration of glipizide and nicotinic acid may result in loss of blood glucose control since nicotinic acid can cause hyperglycaemia.

Isoniazid.

Concomitant administration of isoniazid and nicotinic acid may cause nicotinic acid requirements to be increased, but pellagra is rare, only occurring in patients with an underlying nicotinic acid deficiency.

Lovastatin/ pravastatin/ simvastatin.

The concurrent use of lovastatin, pravastatin or simvastatin and nicotinic acid may be associated with myopathy and an increased risk of rhabdomyolysis, and acute renal failure. Symptoms of myopathy and rhabdomyolysis should be monitored.

Nicotine.

If nicotinic acid and transdermal nicotine are used concurrently, flushing and dizziness after each nicotinic acid dose may occur.

Alcohol.

In one case report concomitant alcohol and nicotinic acid therapy resulted in delirium (paranoid ideation and asterixis) and lactic acidosis.

4.6 Fertility, Pregnancy and Lactation

(Category B2)
Category B2: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed.
Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage.
Contraindicated.
Contraindicated.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

Cardiovascular.

Acute flush, pounding in the head, sensation of heat, headache, hypotension. Atrial fibrillation and other arrhythmias in patients with CHD.

Dermatological.

Pruritus, dryness with mild epidermal exfoliation, brown pigmentation, hyperkeratosis, urticaria, furunculosis, rash. All these adverse reactions are reversible on cessation of drug therapy.

Endocrine.

Increased insulin requirements in diabetic patients, hypothyroidism.

Gastrointestinal.

Nausea, vomiting, diarrhoea, heartburn, flatulence, activation of peptic ulcer.

Hepatic.

Cholestatic jaundice, elevated liver function tests, ascites, hepatomegaly, patchy fibrosis, areas of necrosis, cholestasis and lymphocyte infiltration around the bile ducts.

Nervous system.

Nervousness.

Others.

Hyperuricaemia, toxic amblyopia.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.9 Overdose

Symptoms.

Cutaneous flush, pruritus, vomiting, diarrhoea, dyspepsia, syncope, severe abdominal cramps.

Treatment.

Discontinue drug and institute general supportive measures.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

Nicotinic acid is a water-soluble B complex vitamin which is able to reduce serum lipids.

5.1 Pharmacodynamic Properties

Mechanism of action.

Nicotinic Acid lowers serum cholesterol and triglyceride concentrations by inhibiting the synthesis of very low density lipoproteins (VLDL) which are the precursors to the formation of low density lipoproteins, the principal carrier of blood cholesterol. Several possible modes of action have been proposed, including inhibition of hepatic synthesis of lipoproteins containing apolipoprotein B-100, promotion of lipoprotein lipase activity, and reduction of free fatty acid mobilisation from adipose tissue with an increase in faecal output of sterols. Oral therapy produces reduced triglyceride concentrations within several hours and reduced cholesterol concentrations within several days.
Nicotinic acid also has a vasodilation effect when administered in large doses, identified by flushing of the skin while plasma nicotinic acid levels are rising. This process is believed to be mediated by prostacyclin. Vasodilation occurs within 20 minutes of an oral dose and persists for about 20-60 minutes.
Nicotinic acid has been reported to stimulate histamine release resulting in increased gastric motility and acid production which may activate peptic ulcer. Reports have also indicated that large doses of nicotinic acid may decrease uric acid excretion and impair glucose tolerance. These effects may result in precipitation of an episode of gout in susceptible patients and may necessitate adjustment of diet and antihyperglycaemic therapy in diabetic patients.
The normal physiological role of nicotinic acid is as a component of the coenzymes NAD and NADP which are essential for oxidation/ reduction reactions in tissue respiration. Nicotinamide, a metabolite of nicotinic acid, possesses similar function as a vitamin but has no pharmacological value in reducing lipids.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption and distribution.

Nicotinic acid is readily absorbed from the gastrointestinal tract following oral administration and is widely distributed in the body tissues.

Metabolism and excretion.

It is metabolised in the liver to nicotinamide when taken in physiological doses but when therapeutic doses are taken only a portion is converted to nicotinamide with the remainder eventually being excreted unchanged in the urine. Nicotinamide is widely distributed in the body and is further metabolised in the liver to N-methylnicotinamide and the 2-pyridone and 4-pyridone derivatives with some nicotinuric acid also being formed before being excreted in the urine. The elimination half-life is approximately 45 minutes, and time to peak serum concentration after oral administration is also 45 minutes.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Lactose monohydrate, wheat starch, povidone, purified talc and magnesium stearate.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 30°C.

6.5 Nature and Contents of Container

Container type.

Glass bottle.

Pack sizes.

Available in bottles of 100's or 200's.
Some strengths, pack sizes and/or pack types may not be marketed.

Australian register of therapeutic goods (ARTG).

AUST R 27193 - Nicotinic Acid 250 mg.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking it to your local pharmacy.

6.7 Physicochemical Properties

Chemical structure.

Structural formula:
Molecular weight: 123.1.

CAS number.

59-67-6.

7 Medicine Schedule (Poisons Standard)

S3 (Pharmacist only medicine).

Summary Table of Changes