COZAAR losartan potassium 50mg tablet blister pack

Страна: Австралія

мова: англійська

Джерело: Department of Health (Therapeutic Goods Administration)

Активний інгредієнт:

losartan potassium, Quantity: 50 mg

Доступна з:

ORGANON PHARMA PTY LTD

Фармацевтична форма:

Tablet, film coated

Склад:

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

Адміністрація маршрут:

Oral

Одиниць в упаковці:

15 tablets, 30 tablets, 8 tablets

Тип рецепту:

(S4) Prescription Only Medicine

Терапевтичні свідчення:

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

Огляд продуктів:

Visual Identification: White scored oval film-coated tablets, marked "952".; Container Type: Blister Pack; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Статус Авторизація:

Registered

Дата Авторизація:

1996-03-28

інформаційний буклет

COZAAR
®
_Losartan potassium_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about COZAAR. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking COZAAR
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 COZAAR IS USED
FOR
COZAAR lowers high blood
pressure, which doctors call
hypertension.
COZAAR is also used to slow 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 different
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. COZAAR 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
that they can produce energy or store
glucose until it's needed.
Hyperglycaemia can lead to serious
problems

Характеристики продукта

Page 1 of 18
AUSTRALIAN PRODUCT INFORMATION
COZAAR®
(LOSARTAN POTASSIUM)
TABLETS
1
NAME OF THE MEDICINE
losartan potassium
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
COZAAR (losartan potassium) 50 mg tablets.
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.
List of excipients with known effect:
•
lactose monohydrate
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
COZAAR (losartan potassium) 50 mg tablet: White, oval scored tablet,
marked “952".
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
HYPERTENSION
COZAAR 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
COZAAR 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.
Page 2 of 18
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).
COZAAR can be administered once or twice daily. The total daily dose
ranges from 25 mg to
100 mg.
No initial dosage adjustment is necessary for elderly patients or for
patients with renal
impairment, including patients on dialysis. A lower dose should be
considered for patients
with a history of hepatic impairment (see SECTION 4.4 SPECIAL WARNINGS
AND PRECA