Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Terazosin hydrochloride dihydrate 1.19mg equivalent to 1 mg terazosin;
Teva Pharma (New Zealand) Limited
Terazosin hydrochloride dihydrate 1.19 mg (equivalent to 1 mg terazosin)
1 mg
Tablet
Active: Terazosin hydrochloride dihydrate 1.19mg equivalent to 1 mg terazosin Excipient: Lactose monohydrate Magnesium stearate Maize starch Purified talc
Blister pack, PVC/PVdC-aluminium starter (not marketed), 7 tablets
Prescription
Prescription
Aurobindo Pharma Limited
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.
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
2004-09-30
Version 1.0 Page 1 of 12 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 Read the complete document