APO-CARVEDILOL carvedilol 25 mg tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

carvedilol, Quantity: 25 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

Carvedilol

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: magnesium stearate; microcrystalline cellulose; lactose monohydrate; colloidal anhydrous silica; crospovidone; povidone; titanium dioxide; macrogol 8000; hypromellose; polydextrose; triethyl citrate

Administration route:

Oral

Units in package:

60 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Carvedilol is indicated for the treatment of hypertension. Data have not been provided to support the use of this drug in renovascular disease. Carvedilol is indicated for the treatment of patients with symptomatic mild to severe (NYHA class II to IV) congestive heart failure (CHF) as an adjunct to conventional treatments (e.g. diuretics, digoxin, ACE inhibitors and vasodilators).

Product summary:

Visual Identification: White, oval shaped, film-coated tablets, imprinted '25' on one side and 'P' logo on the other side; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2006-11-15

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
APO- CARVEDILOL (CARVEDILOL) TABLETS
1
NAME OF THE MEDICINE
Carvedilol.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 3.125 mg, 6.25 mg, 12.5 mg or 25 mg of carvedilol
as the active
ingredient.
EXCIPIENTS WITH KNOWN EFFECT
Sugars as lactose monohydrate
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
3.125 MG TABLETS
White oval shaped, film-coated tablets, imprinted with « P » logo on
one side and plain on the
other side.
6.25 MG TABLETS
White oval shaped, film-coated tablets, imprinted « 6.25 » on one
side and « P » logo on the
other side
12.5 MG TABLETS
White oval shaped, film-coated tablets, imprinted « 12.5 » on one
side and « P » logo on the
other side
25 MG TABLETS
White oval shaped, film-coated tablets, imprinted « 25 » on one side
and « P » logo on the
other side
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Carvedilol is indicated for the treatment of hypertension. Data have
not been provided to
support the use of this drug in renovascular disease.
Carvedilol is indicated for the treatment of patients with symptomatic
mild to severe (NYHA
class II to IV) congestive heart failure (CHF) as an adjunct to
conventional treatments (e.g.
diuretics, digoxin, ACE inhibitors and vasodilators).
2
4.2
DOSE AND METHOD OF ADMINISTRATION
APO- Carvedilol tablets are intended for oral administration.
DOSAGE
HYPERTENSION
Once daily dosing is recommended.
Adults
The recommended dose for initiation of therapy is 12.5 mg once a day
for the first two days.
Thereafter the recommended dosage is 25 mg once a day. If necessary,
the dosage may
subsequently be increased at intervals of at least two weeks up to the
recommended maximum
daily dose of 50 mg given once a day or twice daily.
Elderly
The recommended dose for initiation of therapy is 12.5 mg once daily,
which has provided
satisfactory control in some patients. If the response is inadequate,
the dose may be titrated
at intervals of at least two weeks up to the reco