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
Apo-Nicotinic Acid is indicated as a direct vitamin supplement, to treat conditions caused by nicotinic acid deficiency such as pellagra, and for the treatment of hyperlipidaemia. It is recommended for use only in patients with primary hyperlipidaemia (type IIa, IIb, III, IV or V hyperlipoproteinaemia).
For treatment regime begin with an oral dose of 100mg three times daily, which is gradually increased to an average dose of 1g three times daily with a maximum dose of 6 to 9 grams.
A dose of up to 500mg per day has been used in the treatment and prevention of pellagra. A dose of 10mg-20mg per day is suggested for the treatment of nicotinic acid deficiency.
Use of nicotinic acid in children under 2 years of age is not recommended since cholesterol is required for normal development.
For treatment of Hyperlipidemia begin with an oral dose of 100mg three times daily, which is gradually increased to an average dose of 1g three times daily with a maximum dose of 6 to 9 grams.
A dose of 10mg-20mg per day is suggested for the treatment of nicotinic acid deficiency.
Liver function tests should be conducted frequently in the initial stages of therapy and periodically thereafter.
Periodic blood glucose monitoring is advised especially in the early phase of therapy.
Patients prone to gastric irritation or with a history of peptic ulcer should be closely supervised.
Cutaneous flush, pruritis, vomiting, diarrhoea, dyspepsia, syncope, severe abdominal cramps. Chronic administration of large doses of nicotinic acid have been associated with cystoid maculopathy and cholestatic and hepatocellular liver toxicity
Discontinue nicotinic acid and institute general supportive measures.
48 months from the date of manufacture.
Store below 30°C.
Protect from heat, light and moisture.
APO-NICOTINIC ACID 50mg tablets: HDPE Bottles of 100 or 500 tablets.
APO-NICOTINIC ACID 500mg tablets: HDPE Bottles of 100 or 500 tablets.
Not all pack sizes maybe marketed.
No special requirements for disposal.
Any unused medicine or waste material should be disposed of in accordance with local requirements.
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