AVSARTAN irbesartan 150 mg film-coated tablet blister pack

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

유효 성분:

irbesartan, Quantity: 150 mg

제공처:

Arrotex Pharmaceuticals Pty Ltd

INN (국제 이름):

Irbesartan

약제 형태:

Tablet, film coated

구성:

Excipient Ingredients: colloidal anhydrous silica; lactose monohydrate; macrogol 6000; microcrystalline cellulose; sodium starch glycollate type B; hypromellose; magnesium stearate; polysorbate 80

관리 경로:

Oral

패키지 단위:

PVC/ ACLAR-Aluminium blister pack of 30 Blister (3x10T in carton)

처방전 유형:

(S4) Prescription Only Medicine

치료 징후:

Indicated for the treatment of hypertension.,Indicated for delaying the progression of renal disease in hypertensive type II diabetics with persistent micro-albuminuria (equal to or greater than 30mg per 24 hours) or urinary protein in excess of 900mg per 24 hours.

제품 요약:

Visual Identification: White to off-white, oval, biconvex, film-coated tablets, engraved with 150 on one face and plain on the other face.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

승인 상태:

Licence status A

승인 날짜:

2017-01-10

환자 정보 전단

AVSARTAN
75MG, 150MG, 300MG TABLETS
_Irbesartan _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
Read this leaflet carefully before
taking
Avsartan.
This
leaflet
answers
some
common
questions
about
Avsartan.
It
does not contain all the available
information. It does not take the
place of talking to your doctor
or pharmacist. Do not throw this
leaflet away. You may need to
refer to it again later.
ALWAYS FOLLOW THE INSTRUCTIONS
THAT YOUR DOCTOR AND
PHARMACIST GIVE YOU ABOUT
AVSARTAN. IF YOU HAVE ANY
CONCERNS ABOUT TAKING
AVSARTAN, ASK YOUR DOCTOR OR
PHARMACIST.
WHAT IS AVSARTAN
Avsartan is a trade name
(manufacturer's name) for the
medicine, irbesartan. This
medicine is in the tablets your
doctor has prescribed for you.
_WHAT AVSARTAN IS USED FOR _
_ _
Avsartan lowers high blood
pressure, which doctors call
hypertension
Your doctor measured your
blood pressure and found it to be
too high. 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) which means your
blood pressure stays high, even
when you are calm and relaxed.
There are usually no symptoms
of high blood pressure. The only
way of knowing that you have
hypertension is to have your
blood pressure checked on a
regular basis. High blood
pressure, if not treated, can
damage blood vessels in several
organs such as the heart, the
kidneys, the brain and the eyes.
This may lead to heart attacks,
heart or kidney failure, strokes,
or blindness. There are usually
no symptoms of high blood
pressure before damage
occurs, so your doctor needs to
measure your blood pressure to
see if it is too high.
High blood pressure can be
treated and controlled with
medicines such as Avsartan.
Your doctor may also have
recommended that you adjust
your lifestyle to help to lower
your high blood pressure (losing
weight, avoiding smoking,
reducing alcohol consumption
and restricting the amount of

제품 특성 요약

1
AUSTRALIAN PRODUCT INFORMATION AVSARTAN (
IRBESARTAN)
TABLETS
1
NAME OF THE MEDICINE
Irbesartan
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Avsartan 75 mg Film-coated Tablets: Film-coated tablets containing
75mg of Irbesartan.
Avsartan 150 mg Film-coated Tablets: Film-coated tablets containing
150mg of Irbesartan.
Avsartan 300 mg Film-coated Tablets: Film-coated tablets containing
300mg of Irbesartan.
Excipients with known effect: Lactose monohydrate
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
AVSARTAN 75 mg Tablets: White to off-white, oval, biconvex,
film-coated tablets, engraved
with ‘75’ on one face and plain on the other face.
AVSARTAN 150 mg Tablets: White to off-white, oval, biconvex,
film-coated tablets, engraved
with ‘150’ on one face and plain on the other face.
AVSARTAN 300 mg Tablets: White to off-white, oval, biconvex,
film-coated tablets, engraved
with ‘300’ on one face and plain on the other face.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Avsartan is indicated for the treatment of hypertension.
Avsartan is indicated for delaying the progression of renal disease in
hypertensive type II
diabetics with persistent micro-albuminuria (≥ 30mg per 24 hours) or
urinary protein in excess
of 900mg per 24 hours.
2
4.2
D
OSE AND METHOD OF ADMINISTRATION
Irbesartan may be used either alone or in combination with other
antihypertensive agents
(e.g., thiazide diuretic, beta-adrenergic blocking agent, long-acting
calcium-channel blocking
agent).
The usual initial and maintenance dose of Avsartan is 150 mg once
daily. Avsartan may be
administered with or without food. Therapy should be adjusted
according to blood pressure
response. Patients requiring further reduction in blood pressure
should have the dose
increased to 300 mg once daily.
In patients with hypertension and type II diabetic renal disease,
300mg of Avsartan once daily
is the preferred maintenance dose. Although irbesartan slowed the
progression of renal
disease in hypertensive patie