APO-Prazosin

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Prazosin hydrochloride 2.2mg equivalent to 2 mg prazosin;  

Available from:

Arrotex Pharmaceuticals (NZ) Limited

INN (International Name):

Prazosin hydrochloride 2.2 mg (equivalent to 2 mg prazosin)

Dosage:

2 mg

Pharmaceutical form:

Tablet

Composition:

Active: Prazosin hydrochloride 2.2mg equivalent to 2 mg prazosin   Excipient: Croscarmellose sodium Lactose monohydrate Magnesium stearate Microcrystalline cellulose Polysorbate 80

Units in package:

Blister pack, 100, 100 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Standard Chem & Pharm Co Ltd

Therapeutic indications:

Hypertension: Prazosin is effective in the management of primary hypertension, and also secondary hypertension from various causes. Prazosin may be used as the sole agent, but it is generally more effective if used in combination with a diuretic. Prazosin can be used successfully with other antihypertensive agents. Prazosin may be used safely by hypertensive patients with impaired renal function. Congestive Cardiac Failure: Prazosin may be added to the therapeutic regime of patients who have become refactory to conventional therapy with cardiac glycosides and diuretics. Raynaud's phenomenon and Raynaud's disease Benign prostatic hyperplasia: An adjunct in the symptomatic treatment of urinary obstruction caused by BPH in patients waiting for prostatic surgery

Product summary:

Package - Contents - Shelf Life: Blister pack, - 100 tablets - 2 years from date of manufacture stored at or below 30°C - Blister pack, - 500 tablets - 2 years from date of manufacture stored at or below 30°C - Blister pack, - 1000 tablets - 2 years from date of manufacture stored at or below 30°C - Bottle, plastic, - 100 tablets - 2 years from date of manufacture stored at or below 30°C - Bottle, plastic, - 500 tablets - 2 years from date of manufacture stored at or below 30°C - Bottle, plastic, - 1000 tablets - 2 years from date of manufacture stored at or below 30°C

Authorization date:

1993-10-01

Patient Information leaflet

APO-PRAZOSIN TABLETS
1
APO-PRAZOSIN TABLETS
_Contains the active ingredient prazosin hydrochloride _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE.
ASK YOUR DOCTOR OR PHARMACIST IF
YOU DO NOT UNDERSTAND ANYTHING OR
ARE WORRIED ABOUT TAKING YOUR
MEDICINE.
This leaflet answers some common
questions about prazosin.
It does not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
The information in this leaflet was
last updated on the date listed on the
last page. Some more recent
information on the medicine may be
available. Speak to your pharmacist
or doctor to obtain the most up to
date information on the medicine.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will have for you.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is Apo-
Prazosin. It contains the active
ingredient, prazosin (as prazosin
hydrochloride).
It is used to treat:
•
high blood pressure
(hypertension)
•
prostate problems, such as benign
prostatic hyperplasia (BPH) in
men waiting for prostate surgery
•
Raynaud's disease, where the
fingers become white and very
painful when cold
•
certain types of heart failure.
Ask your doctor if you have any
questions about why this medicine
has been prescribed for you. Your
doctor may have prescribed this
medicine for another reason.
This medicine is available only with
a doctor's prescription
_HOW IT WORKS _
Prazosin works by relaxing the
muscles in the walls of blood vessels
and making it easier for blood to
flow. They also relax the muscles in
the prostate gland and increase the
flow of urine.
When use to treat high blood
pressure or heart failure, prazosin is
often used together with other
medicines.
There is no known evidence to show
that this medicine is addictive.
_USE IN CHILDREN _
There is not enough information

Summary of Product characteristics

1
NEW ZEALAND DATA SHEET
1. APO-PRAZOSIN
(1MG, 2MG AND 5MG TABLETS)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Prazosin Hydrochloride 1mg, 2mg and 5mg tablets
Excipient(s) of known effect
APO-PRAZOSIN tablets contain lactose and gluten free.
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
APO-PRAZOSIN 1 mg tablets are white, capsule shaped tablets, bevelled
edge, 5.1 mm
x 10.2 mm, identified APO above scoreline P1 on one side. Each tablet
contains prazosin
hydrochloride equivalent to 1mg prazosin and typically weighs 140 mg.
APO-PRAZOSIN 2 mg tablets are white, round, biconvex tablets, 7.9 mm
in diameter,
identified
APO
above
scoreline
P2
on
one
side.
Each
tablet
contains
prazosin
hydrochloride equivalent to 2 mg prazosin and typically weighs 160 mg.
APO-PRAZOSIN 5 mg tablets are white, diamond-shaped, biconvex tablets,
identified
APO over P5 on one side. Each tablet contains prazosin hydrochloride
equivalent to 5 mg
of prazosin and typically weighs 400 mg.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hypertension:
Prazosin is effective in the management of primary hypertension, and
also secondary
hypertension from various causes. Prazosin may be used as the sole
agent, but it is
generally more effective if used in combination with a diuretic.
Prazosin can be used
successfully
with
other
antihypertensive
agents.
Prazosin
may
be
used
safely
by
hypertensive patients with impaired renal function.
Congestive Cardiac Failure:
Prazosin may be added to the therapeutic regime of patients who have
become refactory
to conventional therapy with cardiac glycosides and diuretics.
Raynaud’s phenomenon and Raynaud’s disease
Benign prostatic hyperplasia:
An adjunct in the symptomatic treatment of urinary obstruction caused
by BPH in patients
waiting for prostatic surgery.
2
4.2
DOSE AND METHOD OF ADMINISTRATION
Treatment should be initiated in low doses to ensure better tolerance
of any potential
adverse effects. Dosage should be adjusted on the basis of the
patient’s response.
Response is us