Minipress 5mg tablets

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

prazosin hydrochloride, Quantity: 5.476 mg (Equivalent: prazosin, Qty 5 mg)

Available from:

Pfizer Australia Pty Ltd

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: calcium hydrogen phosphate; microcrystalline cellulose; magnesium stearate; sodium lauryl sulfate; maize starch

Administration route:

Oral

Units in package:

100 tablets

Class:

Medicine Registered

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

INDICATIONS AS AT 31 APRIL 2004: In Patients with Hypertension. MINIPRESS (prazosin hydrochloride) is indicated in the treatment of hypertension of varied aetiology and all grades of severity. It can be used as the initial and sole agent or it may be employed in a treatment programme in conjunction with other antihypertensive agents. Renal blood flow and glomerular filtration rate are not impaired by long-term oral administration. MINIPRESS can be used with safety in hypertensive patients with impaired renal function. In Patients with Congestive Heart Failure. MINIPRESS is indicated in the treatment of severe refractory congestive heart failure. MINIPRESS may be added to the therapeutic regime in those patients who have become refractory to conventional therapy with cardiac glycosides and diuretics. In Patients with Raynaud's Phenomenon and Raynaud's Disease. MINIPRESS is indicated in the treatment of Raynaud's Phenomenon and Raynaud's disease. Benign Prostatic Hyperplasia. MINIPRESS is indicated as an adjunc

Product summary:

Visual Identification: White, diamond-shaped tablet, scored both sides with "MNP 5" on one side.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

1991-07-19

Patient Information leaflet

MINIPRESS
®
M
I
N
I
P
R
E
S
S
®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING MINIPRESS?
Minipress contains the active ingredient prazosin. Minipress is used
to treat high blood pressure, also called hypertension, benign
prostatic hyperplasia or BPH ('prostrate trouble') in men waiting for
prostate surgery, Raynaud's disease where the fingers become
white and painful when cold, and certain types of heart failure.
For more information, see Section 1. Why am I using Minipress? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE MINIPRESS?
Do not take if you have ever had an allergic reaction to Minipress or
any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any
other medicines, or are pregnant or plan to become pregnant
or are breastfeeding.
For more information, see Section 2. What should I know before I use
Minipress? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Minipress and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE MINIPRESS?
•
Start with a low dose of 0.5 mg (half a 1 mg tablet) taken twice a
day.
More instructions can be found in Section 4. How do I use Minipress?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING MINIPRESS?
THINGS YOU
SHOULD DO
•
Remind any doctor or dentist you visit that you are using Minipress.
•
If you experience continued dizziness, lightheadedness, painful
erections, or become pregnant, tell your
doctor immediately.
•
Take care during exercise or hot weather or if you have to stand for a
long time.
THINGS YOU
SHOULD NOT DO
•
Do not stop taking this medicine or lower the dosage, without checking
with your doctor.
DRIVING
OR USING
MACHINES
•
Be careful driving or operating machinery until you know how Minipress
affects you.
DRI

Summary of Product characteristics

Version: pfpminit11119
Supersedes: pfpminit10315
Page 1 of 12
AUSTRALIAN
PRODUCT
INFORMATION
–
MINIPRESS
® (PRAZOSIN HYDROCHLORIDE)
1.
NAME OF THE MEDICINE
Prazosin hydrochloride
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Prazosin hydrochloride equivalent to 1 mg, 2 mg and 5 mg prazosin
base.
3.
PHARMACEUTICAL FORM
Tablet.
MINIPRESS 1 mg tablets: orange, capsule-shaped with MNP 1 on one side
and scored on the
other.
MINIPRESS 2 mg tablets: white, round, scored, marked with MNP 2 on the
scored side.
MINIPRESS 5 mg tablets: white, diamond-shaped, scored on both sides,
marked with MNP 5
on one side.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
IN PATIENTS WITH HYPERTENSION
MINIPRESS (prazosin hydrochloride) is indicated in the treatment of
hypertension of varied
aetiology and all grades of severity. It can be used as the initial
and sole agent or it may be
employed in a treatment programme in conjunction with other
antihypertensive agents.
Renal
blood
flow
and
glomerular
filtration
rate
are
not
impaired
by
long-term
oral
administration. MINIPRESS can be used with safety in hypertensive
patients with impaired
renal function.
IN PATIENTS WITH CONGESTIVE HEART FAILURE
MINIPRESS is indicated in the treatment of severe refractory
congestive heart failure.
MINIPRESS may be added to the therapeutic regime in those patients who
have become
refractory to conventional therapy with cardiac glycosides and
diuretics.
IN PATIENTS WITH RAYNAUD’S PHENOMENON AND RAYNAUD’S DISEASE
MINIPRESS is indicated in the treatment of Raynaud’s phenomenon and
Raynaud’s Disease.
Version: pfpminit11119
Supersedes: pfpminit10315
Page 2 of 12
BENIGN PROSTATIC HYPERPLASIA
MINIPRESS is indicated as an adjunct in the symptomatic treatment of
urinary obstruction
caused by benign prostatic hyperplasia in patients awaiting prostatic
surgery.
4.2 DOSE AND METHOD OF ADMINISTRATION
GENERAL COMMENTS
There is evidence that patient toleration is best when therapy is
initiated with a low starting
dose. The dose is to be adjusted on the basis o