Terazosin

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Terazosin hydrochloride dihydrate 2.38mg equivalent to 2 mg terazosin;  

Available from:

Teva Pharma (New Zealand) Limited

INN (International Name):

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

Dosage:

2 mg

Pharmaceutical form:

Tablet

Composition:

Active: Terazosin hydrochloride dihydrate 2.38mg equivalent to 2 mg terazosin   Excipient: Lactose monohydrate Magnesium stearate Maize starch Purified talc Quinoline yellow

Units in package:

Blister pack, PVC/PVdC-aluminium starter (not marketed), 7 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Aurobindo Pharma Limited

Therapeutic indications:

TERAZOSIN TABLETS are 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. 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.

Product summary:

Package - Contents - Shelf Life: Blister pack, PVC/PVdC-aluminium starter - 7 tablets - 24 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVdC-aluminium - 28 tablets - 24 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE with polypropylene child-resistant cap - 100 tablets - 30 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE with polypropylene child-resistant cap - 500 tablets - 30 months from date of manufacture stored at or below 25°C

Authorization date:

2004-09-30

Summary of Product characteristics

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NEW ZEALAND DATA SHEET
1 NAME OF THE MEDICINE
Terazosin, 1 mg, tablets
Terazosin, 2 mg tablets
Terazosin, 5mg, tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1 mg, 2 mg or 5 mg terazosin as terazosin
hydrochloride dihydrate.
Excipient with known effect: Lactose
For the full list of excipients, see Section 6.1 List of excipients.
3 PHARMACEUTICAL FORM
Tablets 1 mg: White coloured, round, flat uncoated tablets with
bevelled edges, approximately
7.1mm in diameter and a bisecting line on one side of the tablet.
Tablets 2mg: Yellow coloured, round, flat uncoated tablets with
bevelled edges, approximately
7.1mm in diameter and a bisecting line on one side of the tablet.
Tablets 5mg: Light pink coloured, round, flat uncoated tablets with
bevelled edges, approximately
7.1mm in diameter and a bisecting line on one side of the tablet.
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Terazosin Tablets are 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.
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
The dose of terazosin should be adjusted according to the patient's
responses. The following is a guide
to its administration:
INITIAL DOSE
1 mg at bedtime is the recommended starting dose for all patients, and
this dose should not be
exceeded. This initial dosing regimen should be strictly observed to
minimize the potential for severe
hypotensive effects.
SUBSEQUENT DOSES
_BENIGN PROSTATIC HYPERPLASIA _
The dose may be slowly increased to achieve the desired clinical
response in BPH patients. The usual
recommended dose range is 5 to 10 mg administered once a day. Urine
flow rate measur