MONOPRIL fosinopril sodium 10mg tablet

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

유효 성분:

fosinopril sodium, Quantity: 10 mg

제공처:

Bristol-Myers Squibb Australia Pty Ltd

약제 형태:

Tablet, uncoated

구성:

Excipient Ingredients: crospovidone; sodium stearylfumarate; lactose; povidone; microcrystalline cellulose

관리 경로:

Oral

패키지 단위:

10 tablets, 30 tablets, 5 tablets

처방전 유형:

(S4) Prescription Only Medicine

치료 징후:

HYPERTENSION: MONOPRIL is indicated in the treatment of mild to moderate hypertension. MONOPRIL is effective alone as initial therapy or in combination with other antihypertensive agents. The antihypertensive effects of MONOPRIL and diuretics used concomitantly are approximately additive. Data have not been provided to support the use of MONOPRIL in severe or renovascular hypertension. HEART FAILURE: MONOPRIL is indicated for the management of heart failure when added to conventional therapy, including diuretics.

제품 요약:

Visual Identification: White to off-white, biconvex, flat-end diamond shape with "158" on one side and a star design on the other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

승인 상태:

Registered

승인 날짜:

1993-10-26

환자 정보 전단

MONOPRIL
®
_Fosinopril Sodium (FOS-in-O-pril)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING MONOPRIL.*
This leaflet answers some common
questions about MONOPRIL. It does
not contain all the available
information. Some of the information
it contains may not apply to you. It
does not take the place of talking to
your doctor or pharmacist.
KEEP THIS LEAFLET.
You may need to refer to it again
later.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING MONOPRIL, ASK YOUR
DOCTOR OR PHARMACIST.
WHAT IS MONOPRIL
USED FOR
MONOPRIL is used for treating high
blood pressure (hypertension) or
heart failure. Both of these are long
term (chronic) diseases so it is
important that you continue to take
your MONOPRIL every day.
HIGH BLOOD PRESSURE
(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. If you have
hypertension (high blood pressure),
this means that your blood pressure
stays higher than is needed, even
when you are 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,
including stroke, heart disease and
kidney failure.
HEART FAILURE:
Heart failure means that the heart
muscle cannot pump blood strongly
enough to supply all the blood
needed throughout the body. Heart
failure is not the same as heart attack
and does not mean that the heart
stops. Heart failure may start off with
no symptoms, but as the condition
progresses, patients feel short of
breath or may get tired easily after
light physical activity such as
walking. Some patients may wake up
short of breath at night. Fluid may
collect in different parts of the body,
often first noticed as swollen ankles
and feet.
HOW MONOPRIL
WORKS
MONOPRIL contains fosinopril
sodium. Fosinopril sodium

제품 특성 요약

AU_PI_MONOPRIL_V10.0
1
AUSTRALIAN PRODUCT INFORMATION –MONOPRIL
®
(FOSINOPRIL SODIUM)
1
NAME OF THE MEDICINE
Fosinopril sodium.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each MONOPRIL tablet contains 10 mg of fosinopril sodium.
List of excipients with known effect: lactose.
For the full list of excipients, see Section 6.1 List of
excipients’.
3
PHARMACEUTICAL FORM
MONOPRIL tablets are white to off white in colour, biconvex, diamond
shaped, marked with “158” on
one side and a star design on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
HYPERTENSION
MONOPRIL is indicated in the treatment of mild to moderate
hypertension.
MONOPRIL is effective alone as initial therapy or in combination with
other antihypertensive agents.
The antihypertensive effects of MONOPRIL and diuretics used
concomitantly are approximately
additive.
Data have not been provided to support the use of MONOPRIL in severe
or renovascular hypertension.
HEART FAILURE
MONOPRIL is indicated for the management of heart failure when added
to conventional therapy,
including diuretics.
4.2
DOSE AND METHOD OF ADMINISTRATION
HYPERTENSION
FOR HYPERTENSIVE PATIENTS NOT BEING TREATED WITH DIURETICS
:
The recommended initial dose of
MONOPRIL is 10mg once a day. The usual dose range required to maintain
blood pressure control is
10 to 40mg per day administered as a single dose. MONOPRIL should be
taken at the same time each
day. Dosage should then be adjusted according to blood pressure
response. If blood pressure is not
adequately controlled with MONOPRIL alone, a diuretic may be added.
FOR HYPERTENSIVE PATIENTS CURRENTLY BEING TREATED WITH DIURETICS:
_ _
(or who may be volume
depleted): The diuretic should preferably be discontinued for several
days prior to beginning therapy
with MONOPRIL in order to reduce the risk of an excessive hypotensive
response. (See 4.4 Special
warnings and precautions for use). If blood pressure is inadequately
controlled after an observation
period of approximately 4 weeks, diuretic therapy may be resum