Cozaar

Country: Նոր Զելանդիա

language: անգլերեն

source: Medsafe (Medicines Safety Authority)

active_ingredient:

Losartan potassium 50mg;  

MAH:

Merck Sharp & Dohme (New Zealand) Limited

INN:

Losartan potassium 50 mg

dosage:

50 mg

pharmaceutical_form:

Film coated tablet

composition:

Active: Losartan potassium 50mg   Excipient: Carnauba wax Hyprolose Hypromellose Lactose monohydrate Magnesium stearate Microcrystalline cellulose Pregelatinised maize starch Titanium dioxide

units_in_package:

Blister pack, 15 tablets

class:

Prescription

prescription_type:

Prescription

manufactured_by:

Divi's Laboratories Limited

therapeutic_indication:

Hypertension COZAAR is indicated for the treatment of hypertension. Reduction in the Risk of Cardiovascular Morbidity and Mortality in Hypertensive Patients with Left Ventricular Hypertrophy COZAAR is indicated to reduce the risk of cardiovascular morbidity and mortality as measured by the combined incidence of cardiovascular death, stroke, and myocardial infarction in hypertensive patients with left ventricular hypertrophy Heart Failure COZAAR is indicated for the treatment of heart failure in patients who cannot tolerate an ACE inhibitor. Switching patients with heart failure who are stable on an ACE inhibitor to COZAAR is not recommended. Renal Protection in Type 2 Diabetic Patients with Proteinuria COZAAR is indicated to delay the progression of renal disease as measured by a reduction in the combined incidence of doubling of serum creatinine, end stage renal disease (need for dialysis or renal transplantation) or death; and to reduce proteinuria.

leaflet_short:

Package - Contents - Shelf Life: Blister pack, - 15 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, - 30 tablets - 36 months from date of manufacture stored at or below 30°C

authorization_date:

1993-12-23

PIL

CONSUMER MEDICINE INFORMATION
COZAAR
TM
_losartan potassium _
12.5 mg, 25 mg, 50 mg and 100 mg tablets
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. If
you have high
blood pressure and a thickening of the left ventricle, the heart’s
main pumping chamber,
your doctor has prescribed COZAAR to help lower the risk of
cardiovascular events, such
as stroke. It is also used to treat heart failure.
COZAAR also provides kidney protection by delaying the worsening of
kidney disease in
type 2 diabetic patients with protein in their urine (proteinuria).
Kidney disease can be
measured by testing the urine for protein.
HIGH BLOOD PRESSURE
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.
THICKENING OF THE LEFT CHAMBER OF THE HEART
High blood pressure causes the heart to work harder. Over time, this
may cause the heart
to thicken.
A thickenin

SPC

NEW ZEALAND DATA SHEET
1 PRODUCT NAME
COZAAR™ 12.5 mg tablet
COZAAR™ 25 mg tablet
COZAAR™ 50 mg tablet
COZAAR™ 100 mg tablet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
COZAAR 12.5 mg tablet:
Each tablet contains 12.5 mg of losartan potassium.
COZAAR 25 mg tablet:
Each tablet contains 25 mg of losartan potassium.
COZAAR 50 mg tablet:
Each tablet contains 50 mg of losartan potassium.
COZAAR 100 mg tablet:
Each tablet contains 100 mg of losartan potassium.
LIST OF EXCIPIENTS WITH KNOWN EFFECT:
•
lactose (as monohydrate).
For the full list of excipients, see Section 6.1.
Losartan potassium is a white to off-white free-flowing crystalline
powder with a molecular
weight of 461.01. It is freely soluble in water, soluble in alcohols,
and slightly soluble in
common organic solvents, such as acetonitrile and methyl ethyl ketone.
Oxidation of the 5-hydroxymethyl group on the imidazole ring results
in the active metabolite
of losartan.
3 PHARMACEUTICAL FORM
COZAAR 12.5 mg tablet: An oval blue tablet marked 11 on one side and
plain on the other,
containing 12.5 mg of losartan potassium. Dimensions are 8.178 mm x
4.419 mm.
COZAAR 25 mg tablet: An oval white tablet marked 951 on one side and
plain on the other,
containing 25 mg of losartan potassium. Dimensions are 8.18 mm x 4.42
mm.
COZAAR 50 mg tablet: An oval white scored tablet marked 952 on one
side and plain on the
other, containing 50 mg of losartan potassium. Dimensions are 10.312
mm x 5.563 mm.
S-WPC-MK0954-T-032018
Page 1 of 14
NEW ZEALAND DATA SHEET
COZAAR 100 mg tablet: A teardrop shaped white tablet marked 960 on one
side and plain
on the other, containing 100 mg of losartan potassium. Dimensions are
11.633 mm x 7.112
mm.
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
HYPERTENSION
COZAAR is indicated for the treatment of hypertension.
REDUCTION IN THE RISK OF CARDIOVASCULAR MORBIDITY AND MORTALITY IN
HYPERTENSIVE
PATIENTS WITH LEFT VENTRICULAR HYPERTROPHY
COZAAR is indicated to reduce the risk of cardiovascular morbidity and
mortality as
measured by t