APO-VALSARTAN valsartan 320 mg tablets bottle

Negara: Australia

Bahasa: Inggris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

valsartan, Quantity: 320 mg

Tersedia dari:

Arrotex Pharmaceuticals Pty Ltd

INN (Nama Internasional):

Valsartan

Bentuk farmasi:

Tablet

Komposisi:

Excipient Ingredients: powdered cellulose; calcium hydrogen phosphate dihydrate; croscarmellose sodium; colloidal anhydrous silica; magnesium stearate; hypromellose; macrogol 8000; titanium dioxide; iron oxide yellow; iron oxide red; purified water; hyprolose; iron oxide black

Rute administrasi :

Oral

Unit dalam paket:

500, 100, 28

Jenis Resep:

(S4) Prescription Only Medicine

Indikasi Terapi:

Treatment of Hypertension. Treatment of Heart failure (NYHA class II-IV) in patients receiving usual therapy (e.g. diuretics, digitalis) who are intolerant to ACE inhibitors. To improve survival following myocardial infarction in clinically stable patients with clinical or radiological evidence of left ventricular failure and/or with left ventricular systolic dysfunction (see Clinical Trials).

Ringkasan produk:

Visual Identification: Dark grey-violet, oval shaped, film-coated tablets, engraved 'APO' on one side and 'VA320' on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Status otorisasi:

Licence status A

Tanggal Otorisasi:

2012-04-05

Karakteristik produk

1
AUSTRALIAN PRODUCT INFORMATION
APO-VALSARTAN (VALSARTAN) TABLETS
1
NAME OF THE MEDICINE
Valsartan
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 40, 80, 160 or 320 mg of valsartan as the active
ingredient.
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
VALSARTAN 40 MG TABLETS
Yellow, modified, capsule shaped, film-coated tablets, engraved
‘APO’ on one side and ‘VA’
scored ‘40’ on the other side.
VALSARTAN 80 MG TABLETS
Pale red, round, biconvex, film-coated tablets, engraved ‘APO’ on
one side and ‘VA’ over ‘80’
on the other side.
VALSARTAN 160 MG TABLETS
Yellow, modified, capsule shaped, film-coated tablets, engraved
‘APO’ on one side and
‘VA160’ on the other side.
VALSARTAN 320 MG TABLETS
Dark grey-violet, oval shaped, film-coated tablets, engraved ‘APO’
on one side and ‘VA320’ on
the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
Treatment of hypertension
•
Treatment of heart failure (NYHA class II-IV) in patients receiving
usual therapy (e.g.
diuretics, digitalis) who are intolerant to ACE inhibitors.
•
To improve survival following myocardial infarction in clinically
stable patients with clinical
or radiological evidence of left ventricular failure and/or with left
ventricular systolic
dysfunction (see section 5.1 PHARMACODYNAMIC PROPERTIES - CLINICAL
TRIALS).
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
DOSAGE IN ADULTS ONLY
Hypertension
The recommended dose of valsartan is 80 mg once daily, irrespective of
race, age or gender.
The maximum antihypertensive effect is seen after 4 weeks. In patients
whose blood pressure
2
is not adequately controlled, the daily dose may be increased to 160
mg. If additional blood
pressure reduction is required, a diuretic may be added or the dose
can be increased further
to a maximum of 320 mg. Valsartan may also be administered with other
antihypertensive
agents.
Heart failure
The recommended starting dose of valsartan is 40 mg twice daily.
Titration u