Pyridoxine multichem

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Pyridoxine hydrochloride 50mg (+1.8% (0.9mg) overage);  ;  ;  

Available from:

Multichem NZ Limited

INN (International Name):

Pyridoxine hydrochloride 50 mg (+1.8% (0.9mg) overage)

Dosage:

50 mg

Pharmaceutical form:

Tablet

Composition:

Active: Pyridoxine hydrochloride 50mg (+1.8% (0.9mg) overage)       Excipient: Calcium hydrogen phosphate dihydrate Colloidal silicon dioxide Croscarmellose sodium Magnesium stearate Microcrystalline cellulose

Units in package:

Bottle, plastic, HDPE bottle with polypropylene cap (100 tablets), 100 tablets

Class:

General sale

Prescription type:

General sale

Manufactured by:

DSM Nutritional Products GmbH

Product summary:

Package - Contents - Shelf Life: Bottle, plastic, HDPE bottle with polypropylene cap - 100 tablets - 48 months from date of manufacture stored at or below 30°C - Bottle, plastic, HDPE bottle with polypropylene 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
PYRIDOXINE MULTICHEM
Page 1 of 5
1.
NAME OF THE MEDICINAL PRODUCT
Pyridoxine multichem, 50mg, tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 50mg tablet contains 50mg of pyridoxine hydrochloride.
Excipients with known effect
Pyridoxine is lactose and gluten free.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Pyridoxine multichem 50mg tablets are white, round, 8.7mm in diameter,
biconvex, engraved
with “APO” on one side and “PYR” over “50” on the other
side. Each tablet contains 50mg
pyridoxine hydrochloride and typically weighs 235mg.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
The prevention and management of vitamin B6 deficiency.
Treatment of sideroblastic anaemias, homocystinuria or primary
hyperoxaluria.
Vitamin B6 dependency in infants.
Pyridoxine has been widely used in premenstrual syndrome despite
controversy over its
effectiveness.
4.2
Dose and Method of administration
Dose
In preventing vitamin deficiencies adequate dietary intake is
preferred over supplementation
whenever possible. An adequate human diet in most circumstances is one
containing between
1 and 2 mg vitamin B6 daily.
Doses of up to 150mg daily have been used in general deficiency
states.
Doses of up to 100mg daily from either the onset of symptoms or for 14
days prior to the start
of menstruation have been used.
Method of administration
Higher doses of between 200-600mg daily have been used in the
treatment of sideroblastic
anaemias,
with
similar
doses
being
used
to
treat
certain
metabolic
disorders
such
as
homocystinuria
or
primary
hyperoxaluria.
Lifelong
supplementation
may
be
required
to
prevent reoccurrence.
NEW ZEALAND DATA SHEET
PYRIDOXINE MULTICHEM
Page 2 of 5
Some infants require IM or IV administration for seizures due to
vitamin B6 dependency and
some may require lifelong supplementation with oral doses of 2-100mg.
4.3
Contraindications
Hypersensitivity to pyridoxine hydrochloride.
4.4
Special warnings and precautions for use
Vitamin B6 is relatively