COZAVAN losartan potassium 25 mg film-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

losartan potassium, Quantity: 25 mg

Available from:

Alphapharm Pty Ltd

INN (International Name):

Losartan potassium

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: magnesium stearate; pregelatinised maize starch; lactose monohydrate; microcrystalline cellulose; titanium dioxide; hypromellose; hyprolose

Administration route:

Oral

Units in package:

30 tablets, 10 tablets, 60 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Hypertension: COZAVAN is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents (e.g. thiazide diuretics). Renal Protection in Type 2 Diabetic Patients with Proteinuria: COZAVAN is indicated to delay the progression of renal disease in hypertensive type 2 diabetics with proteinuria, defined as urinary albumin to creatinine ratio greater than or equal to 300mg/g.

Product summary:

Visual Identification: white to off white, oval shaped biconvex film-coated tablet with "A" engraved on one side and "25" on the other side.; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2010-06-28

Patient Information leaflet

COZAVAN
_losartan potassium_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about COZAVAN.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking COZAVAN
against the benefits expected for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT COZAVAN IS
USED FOR
COZAVAN belongs to a group of
medicines, called angiotensin II
receptor antagonists. It works to
lower high blood pressure (which
doctors call hypertension) by
relaxing your blood vessels. In
addition, COZAVAN slows the
progression of kidney disease in
people who have type 2 diabetes
mellitus (also known as non-insulin
dependent diabetes) with protein in
their urine (which doctors call
proteinuria).
HYPERTENSION:
Everyone has blood pressure. This
pressure helps get your blood all
around your body. Your blood
pressure may be different at various
times of the day, depending on how
busy or worried you are.
You have hypertension (high blood
pressure) when your blood pressure
stays high, even when you are calm
and relaxed.
There are usually no symptoms of
hypertension. The only way of
knowing that you have hypertension
is to have your blood pressure
checked on a regular basis. If high
blood pressure is not treated it can
lead to serious health problems. You
may feel fine and have no symptoms,
but eventually hypertension can
cause stroke, heart disease or kidney
failure. COZAVAN helps to lower
your blood pressure.
TYPE 2 DIABETES MELLITUS:
Type 2 diabetes mellitus is a
condition in which the body's cells
do not respond to the effects of
insulin or too little insulin is
produced, resulting in an elevated
blood (sugar) level, known as
hyperglycaemia.
Insulin maintains the appropriate
level of glucose in the blood by
transporting it into the body's cells so

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
COZAVAN
®
_losartan potassium _
1
NAME OF THE MEDICINE
Active ingredient: losartan potassium
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each COZAVAN film-coated tablet contains losartan potassium 25 mg or
50 mg as the active ingredient.
Losartan potassium is a white to off-white free-flowing crystalline
powder. It is freely soluble in water, soluble
in alcohols, and slightly soluble in common organic solvents, such as
acetonitrile and methyl ethyl ketone.
Excipients with known effect:
•
Lactose monohydrate
For the full list of excipients, see
SECTION 6.1 LIST OF EXCIPIENTS
.
3
PHARMACEUTICAL FORM
COZAVAN 25 mg film-coated tablet – white to off white, oval shaped
biconvex film-coated tablet with “A”
engraved on one side and “25” on the other side
COZAVAN 50 mg film-coated tablet – white to off white, oval shaped
biconvex film-coated tablet with “A50”
engraved on one side and a central break line on the other side
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
HYPERTENSION
COZAVAN is indicated for the treatment of hypertension.
It may be used alone or in combination with other antihypertensive
agents (e.g. thiazide diuretics).
RENAL PROTECTION IN TYPE 2 DIABETIC PATIENTS WITH PROTEINURIA
COZAVAN is indicated to delay the progression of renal disease in
hypertensive type 2 diabetics with proteinuria,
defined as urinary albumin to creatinine ratio ≥ 300 mg/g.
4.2
DOSE AND METHOD OF ADMINISTRATION
The usual starting and maintenance dose is 50 mg once daily for most
patients. The maximal antihypertensive
effect is attained 3-6 weeks after initiation of therapy.
If the antihypertensive effect using 50 mg once daily is inadequate,
25 mg twice daily is recommended prior to
increasing the dose.
For patients with intravascular volume-depletion (e.g., those treated
with high-dose diuretics), a starting dose of
25 mg once daily should be considered (see
SECTION 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
).
COZAVAN can be administered once or twice daily. The total dail