Hytrin

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Terazosin hydrochloride dihydrate 11.87mg equivalent to 10 mg Terazosin

Available from:

Abbott Laboratories (NZ) Ltd

INN (International Name):

Terazosin hydrochloride dihydrate 11.87 mg (= 10 mg Terazosin)

Dosage:

10 mg

Pharmaceutical form:

Tablet

Composition:

Active: Terazosin hydrochloride dihydrate 11.87mg equivalent to 10 mg Terazosin Excipient: Indigo carmine Lactose monohydrate Magnesium stearate Maize starch Purified talc

Units in package:

Blister pack, 28 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Abbott Laboratories Inc

Product summary:

Package - Contents - Shelf Life: Blister pack, - 28 tablets - 36 months from date of manufacture stored at or below 30°C - Bottle, plastic, HDPE - 30 tablets - 36 months from date of manufacture stored at or below 30°C

Authorization date:

1989-02-09

Summary of Product characteristics

Hytrin Datasheet 
14 April 2010 
Page 1 of 13 
Version 04 

DATA SHEET 
HYTRIN 
HYTRIN (TERAZOSIN MONOHYDROCHLORIDE DIHYDRATE) TABLETS 1 MG, 2 MG, 5
MG 

PRESENTATION 
Terazosin hydrochloride tablets are round, flat with bevelled edges,
7.1 mm in 
diameter and embossed with the Abbott logo. Hytrin tablets are
available as follows: 
1 mg white tablet; 2 mg pale yellow tablet; 5 mg tan tablet. 
Please note: These tablets are not capable of providing a divided
dose. Do not halve 
the tablets. 
USES 
ACTIONS 
Hytrin (terazosin hydrochloride) for benign prostatic hyperplasia, is
an alpha-1-
selective adrenoceptor blocking agent. 
Studies suggest that alpha-1-adrenoceptor blockade is useful in
improving the 
urodynamics in patients with chronic bladder outlet obstruction, such
as in Benign 
Prostatic Hyperplasia (BPH). 
The symptoms of BPH are caused mainly by the presence of an enlarged
prostate and 
by the increased smooth muscle tone of the bladder outlet and the
prostate, which is 
regulated by alpha-1-adrenergic receptors. 
In in vitro experiments, terazosin has been shown to antagonize
phenylephrine-
induced contractions in human prostatic tissue. In clinical trials
terazosin has been 
shown to improve the urodynamics and symptomatology in patients with
BPH. 
Terazosin also decreases blood pressure gradually within 15 minutes
following oral 
administration. 
The systolic and diastolic blood pressures are lowered in both the
supine and standing 
positions. The effect is most pronounced on the diastolic blood
pressure. These 
changes are usually not accompanied by reflex tachycardia. A greater
blood pressure 
effect associated with peak plasma concentrations (first few hours
after dosing) 
appears somewhat more position-dependent (greater in the erect
position) than the  
effect of terazosin at 24 hours, and in the erect position there
is also a 6-10 beat per 
minute increase in heart rate in the first few hours after dosing. 
Hytrin Datash