Apo-Terazosin

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Terazosin hydrochloride dihydrate 2.38mg equivalent to terazosin 2 mg

Available from:

Apotex NZ Ltd

INN (International Name):

Terazosin hydrochloride dihydrate 2.38 mg (equivalent to terazosin 2 mg)

Dosage:

2 mg

Pharmaceutical form:

Tablet

Composition:

Active: Terazosin hydrochloride dihydrate 2.38mg equivalent to terazosin 2 mg Excipient: Lactose Magnesium stearate Microcrystalline cellulose Quinoline yellow Starch Sunset yellow aluminium lake

Units in package:

Bottle, plastic, white HDPE, PE cap,100 tablets, 100 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Signa SA de CV

Therapeutic indications:

Latest Regulatory Activity

Product summary:

Package - Contents - Shelf Life: Bottle, plastic, white HDPE, PE cap,100 tablets - 100 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, white HDPE, PE cap,500 tablets - 500 tablets - 36 months from date of manufacture stored at or below 25°C

Authorization date:

2003-04-23

Summary of Product characteristics

NEW ZEALAND DATA SHEET
APO-TERAZOSIN
Please refer to Medsafe website (www.medsafe.govt.nz) for the most
recent datasheet Page 1
1.
PRODUCT NAME
APO-TERAZOSIN (1mg, 2mg and 5mg tablets)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Terazosin 1mg, 2mg & 5mg (as hydrochloride dihydrate)
EXCIPIENT(S) OF KNOWN EFFECT
Apo-Terazosin does not contain gluten.
Apo-Terazosin contains lactose.
If you have been told by your doctor that you have intolerance to some
sugars contact your doctor before
taking this medicinal product.
This should be taken into account in patients with diabetes mellitus.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
APO-TERAZOSIN 1mg tablets are white, round, flat-faced, beveled-edge
tablet, engraved “APO” on one
side and “T1” on the other side. Each tablet typically weighs
approximately 150mg.
APO-TERAZOSIN 2mg tablets are orange, round, flat-faced, beveled edged
tablet, engraved “APO” on one
and “T2” on the other side. Each tablet weighs approximately
150mg.
APO-TERAZOSIN 5mg tablets are tan, round, flat-faced, beveled edged
tablet, engraved “APO” on one
and “T5” on the other side. Each tablet weighs approximately
150mg.
Please note: These tablets are not capable of providing a divided
dose. Do not halve the tablets.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Terazosin is indicated for the symptomatic and pathophysiologic
treatment of benign prostatic hyperplasia
(BPH) when:
prostatectomy is not indicated
patient is not fit for surgery
elective surgery must be postponed (e.g., waiting list)
patient refuses surgical treatment.
(See section 4.5Interactions with other medicines and other forms of
interactions)
Terazosin is also indicated in the treatment of hypertension. It can
be used alone or in combination with
other antihypertensive agents such as diuretics or beta-adrenergic
blocking agents.
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSE
The dose of Terazosin should be adjusted according to the patient’s
responses. The following is a guide to