Apo-Nicotinic Acid

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Nicotinic acid 504.79mg

Available from:

Apotex NZ Ltd

INN (International Name):

Nicotinic acid 504.79 mg

Dosage:

500 mg

Pharmaceutical form:

Tablet

Composition:

Active: Nicotinic acid 504.79mg Excipient: Colloidal silicon dioxide Croscarmellose sodium Ethanol Lactose monohydrate Magnesium stearate Povidone

Units in package:

Bottle, plastic, HDPE bottle with polypropylene or HDPE cap, 100 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Lonza AG

Product summary:

Package - Contents - Shelf Life: Bottle, plastic, HDPE bottle with polypropylene or HDPE cap - 100 tablets - 48 months from date of manufacture stored at or below 30°C - Bottle, plastic, HDPE bottle with polypropylene or HDPE cap - 500 tablets - 48 months from date of manufacture stored at or below 30°C

Authorization date:

1969-12-31

Summary of Product characteristics

NEW ZEALAND DATA SHEET
APO-NICOTINIC ACID
Please refer to Medsafe website (www.medsafe.govt.nz) for the most
recent datasheet
Page 1 of 8
1. APO-NICOTINIC ACID (50MG & 500MG TABLETS)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
NAME AND STRENGTH OF THE ACTIVE SUBSTANCE
Nicotinic acid 50 mg
Nicotinic acid 500 mg
Excipient with known effect
Lactose
Apo-Nicotinic acid contain Lactose. If you have been told by your
doctor that you have an
intolerance to some sugars, contact your doctor before taking this
medicinal product.
Apo-Nicotinic acid is gluten free.
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
APO-NICOTINIC ACID 50mg tablets are white, round, 7mm in diameter,
flat faced with
beveled edged. Each tablet contains 50mg nicotinic acid and typically
weighs 130mg.
APO-NICOTINIC ACID 500mg tablets are white, round, biconvex tablets,
12.5mm in
diameter. Each tablet contains 500mg nicotinic acid and typically
weighs 623mg.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
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).
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSE
Hyperlipidaemia
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.
Nicotinic Acid Deficiency
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.
APO-NICOTINIC ACID
Please refer to Medsafe website (www.medsafe.govt.nz) for the most
recent datasheet
Page 2 of 8
Use of nicotinic acid in children under 2 years of age is not
recommended since cholesterol
is required for normal development.
METHOD OF ADMINISTRATION
MAXIMUM TOLERATED DA