Apo-Candesartan

Land: New Zealand

Sprog: engelsk

Kilde: Medsafe (Medicines Safety Authority)

Aktiv bestanddel:

Candesartan cilexetil 32mg;  

Tilgængelig fra:

Apotex NZ Ltd

INN (International Name):

Candesartan cilexetil 32 mg

Dosering:

32 mg

Lægemiddelform:

Tablet

Sammensætning:

Active: Candesartan cilexetil 32mg   Excipient: Carmellose calcium Hyprolose Iron oxide red Lactose monohydrate Magnesium stearate Maize starch Purified water Triacetin

Enheder i pakken:

Blister pack, PVC/PVdC/Al, 7 tablets

Klasse:

Prescription

Recept type:

Prescription

Fremstillet af:

Apotex Pharmachem India Pvt. Ltd.

Terapeutiske indikationer:

Treatment of hypertension.

Produkt oversigt:

Package - Contents - Shelf Life: Blister pack, PVC/PVdC/Al - 7 tablets - 12 months from date of manufacture stored at or below 30°C - Blister pack, PVC/PVdC/Al - 28 tablets - 12 months from date of manufacture stored at or below 30°C - Blister pack, PVC/PVdC/Al - 30 tablets - 12 months from date of manufacture stored at or below 30°C - Bottle, plastic, HDPE - 28 tablets - 12 months from date of manufacture stored at or below 30°C - Bottle, plastic, HDPE - 30 tablets - 12 months from date of manufacture stored at or below 30°C - Bottle, plastic, HDPE - 100 tablets - 12 months from date of manufacture stored at or below 30°C

Autorisation dato:

2012-12-10

Produktets egenskaber

NEW ZEALAND DATA SHEET
APO-CANDESARTAN
CANDESARTAN CILEXETIL 4 MG, 8 MG, 16 MG AND 32 MG TABLETS
Please refer to Medsafe website (
www.medsafe.govt.nz
) for the most recent datasheet
Page 1
PRESENTATION
APO-CANDESARTAN Tablets 4 mg: White to off white coloured, round shaped, biconvex tablets,
engraved “APO” on one side and “CA” scored “4” on the other side.
APO-CANDESARTAN Tablets 8 mg: Pink to light pink coloured, round shaped, biconvex tablets,
engraved “APO” on one side and “CA” bisect “8” on the other side.
APO-CANDESARTAN Tablets 16 mg: Pink to light pink coloured, round shaped, biconvex
tablets, engraved “APO” on one side and “CA” bisect “16” on the other side.
APO-CANDESARTAN Tablets 32 mg: Pink to light pink coloured, round shaped, biconvex
tablets, engraved “APO” on one side and “CA” bisect “32” on the other side.
Do not halve tablet. Dose equivalence when the tablet is divided has not been established.
INDICATIONS
Hypertension.
Treatment of patients with heart failure and left ventricular systolic dysfunction. Treatment with
APO-CANDESARTAN reduces mortality, reduces hospitalisation due to heart failure, and
improves symptoms.
DOSAGE AND ADMINISTRATION
DOSAGE IN HYPERTENSION
The recommended initial and maintenance dose of candesartan is 8 mg once daily. The dose
may be increased to 16 mg once daily. In patients who require further blood pressure reduction,
the dose may be increased to 32 mg once daily.
Therapy should be adjusted according to blood pressure response. The maximal antihypertensive
effect is attained within 4 weeks after initiation of treatment.
In patients with less than optimal blood pressure reduction on candesartan combination with a
thiazide diuretic is recommended.
USE IN THE ELDERLY
No initial dosage�