Doxazosin

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Doxazosin mesilate 4.87mg equivalent to 4 mg doxazosin;  

Available from:

Clinect NZ Pty Limited

INN (International Name):

Doxazosin mesilate 4.87 mg (equivalent to 4 mg doxazosin)

Dosage:

4 mg

Pharmaceutical form:

Tablet

Composition:

Active: Doxazosin mesilate 4.87mg equivalent to 4 mg doxazosin   Excipient: Croscarmellose sodium Lactose monohydrate Magnesium stearate Microcrystalline cellulose

Units in package:

Blister pack, PVC/PE/PVdC, 30 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Srini Pharmaceuticals Pvt Ltd

Therapeutic indications:

Doxazosin is indicated for the treatment of hypertension and can be used as the initial agent to control pressure in the majority of patients. For patients who are not adequately controlled on a singel antihypertensive agent, Doxazosin can be used in combination with another agent such as a thiazide diuretic, a beta-blocker, a calcium antagonist or an angiotensin-converting enzyme inhibitor.

Product summary:

Package - Contents - Shelf Life: Blister pack, PVC/PVdC or PVC/PE/PVdC - 30 tablets - 24 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE bottle, white PP lift n peel cap - 100 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE bottle, blue PP lift n peel cap - 100 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE bottle, blue PP lift n peel cap - 500 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE bottle, white PP lift n peel cap - 500 tablets - 36 months from date of manufacture stored at or below 25°C

Authorization date:

2001-04-06

Patient Information leaflet

DOXAZOSIN TABLET
1
DOXAZOSIN TABLET
_Contains the active ingredient Doxazosin mesilate _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about DOXAZOSIN tablet.
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. More recent information on
this medicine may be available.
ASK YOUR DOCTOR OR PHARMACIST:
•
if there is anything you do not
understand in this leaflet,
•
if you are worried about taking
your medicine, or
•
to obtain the most up-to-date
information.
You can also download the most up
to date leaflet from
www.apotex.com.au.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking this medicine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT THIS MEDICINE IS
USED FOR
DOXAZOSIN tablet is used to treat:
•
Hypertension
•
Benign Prostatic Hyperplasia
It belongs to a group of medicines
called antihypertensive.
Antihypertensive medicines are a
class of drug that help for the
treatment of hypertension.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is available only with
a doctor's prescription.
_USE IN CHILDREN _
There is not enough information to
recommend the use of this medicine
for children.
BEFORE YOU TAKE THIS
MEDICINE
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
any medicine containing
Doxazosin mesilate or
quinazolines.
•
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of

Summary of Product characteristics

1
NEW ZEALAND DATA SHEET
1
DOXAZOSIN TABLETS
Doxazosin 2mg Tablets
Doxazosin 4mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
NAME AND STRENGTH OF THE ACTIVE SUBSTANCE
Doxazosin mesilate is equivalent to Doxazosin 2mg
Doxazosin mesilate is equivalent to Doxazosin 4mg
Chemical Structure:
The chemical name of doxazosin mesilate is
l-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-(l,4-benzodioxan-2-
ylcarbonyl)piperazine methanesulfonate.
The empirical formula is C23H25N5O5• CH4O3S
The molecular weight is 547.6.
Doxazosin mesilate is freely soluble in dimethylsulfoxide, soluble in
dimethylformamide, slightly soluble in
methanol, ethanol, and water and very slightly soluble in acetone and
methylene chloride.
EXCIPIENT WITH KNOWN EFFECT:
Gluten: DOXAZOSIN is gluten free.
Lactose: DOXAZOSIN contains Lactose. If you have been told by your
doctor that you may have intolerance
to some sugars, please contact your doctor before taking this
medicinal product.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
DOXAZOSIN 2mg tablets are white, capsule-shaped, biconvex tablets,
4.5mm x 9mm, engraved APO on
one side and D2 and a partial bisect on the other side. Each tablet
typically weighs 120mg and contains
doxazosin mesilate equivalent to 2mg doxazosin.
DOXAZOSIN 4mg tablets are white, diamond-shaped, biconvex tablets, 9mm
x 12mm, engraved APO on
one side and D4 and scored on the other side. Each tablet typically
weighs 240mg and contains doxazosin
mesilate equivalent to 4mg doxazosin.
2
4
CLINICAL PARTICULARS THERAPEUTIC INDICATIONS
HYPERTENSION
DOXAZOSIN is indicated for the treatment of hypertension and can be
used as the initial agent to control
pressure
in
the
majority
of
patients.
For
patients
who
are
not
adequately
controlled
on
a
single
antihypertensive agent, DOXAZOSIN can be used in combination with
another agent such as a thiazide
diuretic, a beta-blocker, a calcium antagonist or and
angiotensin-converting enzyme inhibitor.
BENIGN PROSTATIC HYPERPLASIA (BPH)
DOXAZOSIN is also indicated for the