Metformin

Country: New Zealand

Bahasa: Inggeris

Sumber: Medsafe (Medicines Safety Authority)

Bahan aktif:

Metformin hydrochloride 850mg

Boleh didapati daripada:

Multichem NZ Limited

INN (Nama Antarabangsa):

Metformin hydrochloride 850 mg

Dos:

850 mg

Borang farmaseutikal:

Film coated tablet

Komposisi:

Active: Metformin hydrochloride 850mg Excipient: Magnesium stearate Opadry clear YS-1R-7006 Povidone Purified water

Unit dalam pakej:

Blister pack, PVC/PVDC aluminium, 500 tablets

Kelas:

Prescription

Jenis preskripsi:

Prescription

Dikeluarkan oleh:

Aurobindo Pharma Limited

Tanda-tanda terapeutik:

Metformin is indicated in the treatment of type 2 diabetes mellitus in adults: · particularly in overweight patients, when diatary mangement and exercise alone does not result in adequate glycaemic control · as initial treatment of in sulphonylurea failures either alone or in combination with a sulphonylurea and other oral agents · as an adjuvant therapy in insulin dependent diabetes especially if overweight.

Ringkasan produk:

Package - Contents - Shelf Life: Blister pack, PVC/PVDC aluminium - 500 tablets - 4 years from date of manufacture stored at or below 25°C protect from light and moisture

Tarikh kebenaran:

2010-11-26

Ciri produk

NEW ZEALAND DATA SHEET
METFORMIN
Please refer to Medsafe website (www.medsafe.govt.nz) for the most
recent datasheet Page 1
1
METFORMIN (500MG, 850MG AND 1000MG TABLETS)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Metformin hydrochloride 500mg
Metformin hydrochloride 850mg
Metformin hydrochloride 1000mg
EXCIPIENT OF KNOWN EFFECT
PROPYLENE GLYCOL
This excipient may cause skin irritation.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Metformin 500 mg: White coloured, film coated, round, biconvex tablets
embossed on one face with
‘500’
Metformin 850 mg: White coloured, film coated, round, biconvex tablets
embossed on one face with
‘850’
Metformin 1000mg: White to off white, oval shaped, biconvex, film
coated tablets debossed with '10'
and '00' on either side of deep notch on one side and breakline on
other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS

Treatment of type 2 diabetes mellitus in adults, particularly in
overweight patients, when
dietary management and exercise alone does not result in adequate
glycaemic control.

Metformin may be used as initial treatment or in sulfonylurea failures
either alone or in
combination with a sulfonylurea and other oral agents.

Adjuvant therapy in insulin dependent diabetes especially if
overweight.
4.2
DOSE AND METHOD OF ADMINISTRATION
LIFE THREATENING LACTIC ACIDOSIS CAN OCCUR DUE TO ACCUMULATION OF
METFORMIN. RISK FACTORS
INCLUDE RENAL IMPAIRMENT, OLD AGE AND DOSES OF METFORMIN ABOVE 2 G PER
DAY
(SEE SPECIAL
WARNINGS AND PRECAUTIONS FOR USE).
It is important that the tablets are taken in divided doses with
meals.
MONOTHERAPY AND COMBINATION WITH OTHER ORAL ANTIDIABETIC AGENTS IN
ADULTS WITH NORMAL RENAL
FUNCTION
Initially 500 mg should be taken once or twice a day and, if
necessary, increased over a few weeks
up to a maximum of 1 g three times per day. The dose should be
titrated with gradual dose
increments until the desired effect is obtained. 500 mg three times a
day is often sufficient to obtain
diabetic control. Cont