PEXSIG perhexiline maleate 100mg tablet bottle

দেশ: অস্ট্রেলিয়া

ভাষা: ইংরেজি

সূত্র: Department of Health (Therapeutic Goods Administration)

সক্রিয় উপাদান:

perhexiline maleate, Quantity: 100 mg

থেকে পাওয়া:

Aspen Pharma Pty Ltd

ফার্মাসিউটিকাল ফর্ম:

Tablet, uncoated

রচনা:

Excipient Ingredients: maize starch; purified talc; sucrose; lactose monohydrate

প্রশাসন রুট:

Oral

প্যাকেজ ইউনিট:

100 tablets

প্রেসক্রিপশন টাইপ:

(S4) Prescription Only Medicine

থেরাপিউটিক ইঙ্গিত:

To reduce the frequency of moderate to severe attacks of angina pectoris due to coronary artery disease in patients who have not responded to other conventional therapy or in whom such therapy may be contra-indicated. NOTE: Because of the serious nature of potential side effects, perhexiline maleate should be reserved for use in patients with intractable angina who are refactory or intolerant to other agents and who are not suitable canditates for coronary bypass surgery.

পণ্য সারাংশ:

Visual Identification: White to off-white, flat bevelled tablet, one face with break-bar.; Container Type: Bottle; Container Material: Glass; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

অনুমোদন অবস্থা:

Licence status A

অনুমোদন তারিখ:

1995-04-11

তথ্য লিফলেট

Pexsig- Consumer Medicine Information
Page 1 of 3
PEXSIG
_perhexiline maleate _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Pexsig (perhexiline
maleate) tablets. It does not contain
all of the available information
about Pexsig tablets. It does not
replace talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Pexsig tablets
against the expected benefits.
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 PEXSIG IS USED FOR
The name of your medicine is
Pexsig and is available in a 100 mg
strength tablet.
The active ingredient is called
_perhexiline maleate_
. Perhexiline
belongs to a group of medicines
called anti-anginal agents.
These are used to reduce the
frequency of moderate to severe
attacks of angina pectoris (severe
chest pain caused by heart disease).
Pexsig acts by increasing the
efficiency of the heart.
ONLY TAKE PEXSIG WHEN YOUR
DOCTOR PRESCRIBES IT FOR YOU.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY PEXSIG HAS
BEEN PRESCRIBED FOR YOU.
IF YOU HAVE ANY CONCERNS YOU
SHOULD DISCUSS THIS WITH YOUR
DOCTOR.
This medicine is available only with
a doctor’s prescription.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE PEXSIG IF YOU HAVE:
•
LIVER DISEASE
•
KIDNEY DISEASE
•
IF YOU HAVE EVER HAD ANY
UNUSUAL OR ALLERGIC REACTION TO
PEXSIG OR ANY OF ITS INGREDIENTS.
IF YOU ARE NOT SURE, TALK TO YOUR
DOCTOR ABOUT IT.
YOU SHOULD TELL YOUR DOCTOR BEFORE
STARTING TREATMENT WITH PEXSIG IF
YOU:
•
HAVE DIABETES
If you use insulin or take a certain
type of antidiabetic tablet you may
need to adjust your dosage during
the first few days after starting on
Pexsig.
•
HAVE KIDNEY OR LIVER DISEASE
•
ARE TAKING ANY MEDICINES
(WHETHER PRESCRIPTION OR NON-
PRESCRIPTION)
Your doctor needs to know about
other drugs you may be taking,
particularly medicines known a

পণ্য বৈশিষ্ট্য

1
AUSTRALIAN PRODUCT INFORMATION
PEXSIG
(PERHEXILINE MALEATE) TABLET
1
NAME OF THE MEDICINE
Perhexiline maleate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Pexsig tablets contain perhexiline maleate 100 mg as the active
ingredient.
Excipients with known effect include lactose monohydrate and sucrose.
For the full list of
excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
White to off-white tablet scored on one side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
To reduce the frequency of moderate to severe attacks of angina
pectoris due to coronary
artery disease in patients who have not responded to other
conventional therapy or in whom
such therapy may be contra-indicated.
Note: Because of the serious nature of potential side effects,
perhexiline maleate should be
reserved for use in patients with intractable angina who are
refractory or intolerant to other
agents and
are not suitable candidates for coronary bypass surgery.
4.2
D
OSE AND METHOD OF ADMINISTRATION
_Adults: _
Commence therapy with 100 mg daily. Adjust progressively, up or down,
at 2 to 4 weekly
intervals based on the results of plasma level monitoring. It is
generally advised not to
administer more than 300 mg per day, in divided doses, but in certain
cases it may be
necessary to use 400 mg per day. The maintenance dose must be the
minimum dose that is
effective and well tolerated.
_ _
_Geriatric:_ As for adults - but see Section 4.3 CONTRAINDICATIONS.
_ _
_Paediatric:_ Not recommended for use in children as safety and
efficacy in this age group has
not been established.
2
_M_
_ONITORING OF PLASMA LEVELS_
_ _
Plasma perhexiline concentrations should be maintained between 0.15
and 0.60
µ
g/mL.
Because of perhexiline's slow and variable clearance, the marked
inter-subject variability in
metabolism of the drug and the potential for serious toxicity, regular
monitoring of plasma
levels of perhexiline is essential commencing at the end of the first
week of use. Dosage
should not be increased unless the plasma concentrations ar