Source: Medicines and Medical Devices Safety Authority (NZ) Revision Year: 2017 Publisher: Apotex NZ Ltd., 32 Hillside Road, Glenfield, AUCKLAND 0627 Telephone: (09) 444 2073, Fax: (09) 444 2951, E-mail: NZcustomerservice@apotex.com
Previous allergic reaction to nicotinic acid, niacin or nicotinamide is a contraindication or to any of the excipients listed in section 6.1.
Risk/benefit considerations should be taken into account when the following medical problems exist:
Arterial bleeding or haemorrhage, glaucoma: these conditions may be exacerbated.
Diabetes mellitus: large doses of nicotinic acid may cause impaired glucose tolerance.
Gout: large doses of nicotinic acid may cause hyperuricaemia.
Hepatic disease: large doses of nicotinic acid may cause hepatic damage.
Hypotension: may worsen due to vasodilation effects of nicotinic acid.
Peptic ulcer: large doses may activate peptic ulcer.
Patients with gallbladder disease or history of jaundice, liver disease or peptic ulcer should be monitored closely while taking nicotinic acid. Liver function tests should be conducted frequently in the initial stages of therapy and periodically thereafter.
Nicotinic acid may cause hyperglycaemia. Periodic blood glucose monitoring is advised especially in the early phase of therapy.
Elevated uric acid levels have occurred therefore nicotinic acid should be used with caution in patients predisposed to gout. Patients prone to gastric irritation or with a history of peptic ulcer should be closely supervised.
Normal daily vitamin requirements vary according to age. Appropriate studies of nicotinic acid as an antihyperlipidaemic have not been performed in children. Use of nicotinic acid in children under 2 years of age is not recommended since cholesterol is required for normal development.
This medicinal product contains small amounts of ethanol (alcohol), less than 100 mg per dose.
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.
Anti-hyperglycaemic Therapy: Because nicotinic acid can cause hyperglycaemia dosage adjustment of insulin or oral anti-hyperglycaemic 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.
Chenodial/Ursodiol: the effect of nicotinic acid as an antihyperlipidaemic may be decreased with concurrent use of chenodiol or ursodiol, which tend to increase cholesterol saturation of bile.
Chlorpropamide: Nicotinic acid may produce hyperglycaemia and lead to loss of glucose control in patients on oral hypoglycaemics.
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 or 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 for.
Nicotine: if nicotinic acid and transdermal nicotine are used concurrently flushing and dizziness after each nicotinic acid dose may occur.
Tolazamide: nicotinic acid may antagonise the hypoglycaemic effects of tolazamide.
Alcohol/Ethanol: in one case report concomitant ethanol and nicotinic acid therapy resulted in delirium (paranoid ideation and asterixis) and lactic acidosis.
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.
Category B2.
Problems in humans have not been documented with intake of normal daily requirements of nicotinic acid. However, studies have not been conducted in either animals or humans and use in pregnancy should be avoided.
Nicotinic acid is distributed into breast milk. Problems have not been reported with intake at normal daily requirements but there is no information pertaining to higher doses used in the treatment of hyperlipidemia.
Presumed to be safe or unlikely to produce and effect on the ability to drive or use machinery.
The following adverse effects may occur:
Haematological: abnormalities in blood glucose levels.
Cardiovascular: atrial fibrillation, other arrhythmias, hypotension.
Gastrointestinal: stimulation of peptic ulcer, jaundice, nausea, vomiting, abdominal pain, diarrhoea. Taking nicotinic acid with meals may alleviate these gastrointestinal effects.
Kidney/Genitourinary: in patients with non-insulin dependent diabetes mellitus with dyslipidaemia, nicotinic acid treatment may induce a deterioration of glycemic control and a consistent increase in plasma uric acid levels.
Liver: increases in aspartate aminotransferase and alkaline phosphatase which are dose related. Severe hepatotoxicity is rare.
Skin: severe generalised flushing and a sensation of warmth, particularly in the area of the face, neck and ears may occur soon after ingestion. The flushing resolves when plasma nicotinic acid levels are steady or falling. Administration of 325mg to 650mg of aspirin or indomethacin one hour prior to nicotinic acid is recommended to reduce flushing. Keratosis nigrican, pruritis, skin rash and dry skin with itching and tingling may also occur.
Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare professional are asked to report any suspected adverse reactions https://nzphvc.otago.ac.nz/reporting/.
Not applicable.
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