APO-VALSARTAN valsartan 320 mg tablets bottle
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Summary of Product characteristics
(SPC)
24-08-2020
Public Assessment Report
(PAR)
28-11-2017
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Active ingredient:
valsartan, Quantity: 320 mg
Available from:
Arrotex Pharmaceuticals Pty Ltd
INN (International Name):
Valsartan
Pharmaceutical form:
Tablet
Composition:
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
Administration route:
Oral
Units in package:
500, 100, 28
Prescription type:
(S4) Prescription Only Medicine
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 Clinical Trials).
Product summary:
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
Authorization status:
Licence status A
Authorization date:
2012-04-05
Summary of Product characteristics
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
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