Apo-Nicotinic Acid

البلد: نيوزيلاندا

اللغة: الإنجليزية

المصدر: Medsafe (Medicines Safety Authority)

العنصر النشط:

Nicotinic acid 504.79mg

متاح من:

Apotex NZ Ltd

INN (الاسم الدولي):

Nicotinic acid 504.79 mg

جرعة:

500 mg

الشكل الصيدلاني:

Tablet

تركيب:

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

الوحدات في الحزمة:

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

الفئة:

Prescription

نوع الوصفة الطبية :

Prescription

المصنعة من قبل:

Lonza AG

ملخص المنتج:

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

تاريخ الترخيص:

1969-12-31

خصائص المنتج

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