Myonit Insta Sublingual Tablets USP 0.5mg

País: Malàisia

Idioma: anglès

Font: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

ingredients actius:

NITROGLYCERIN

Disponible des:

UNIMED SDN BHD

Designació comuna internacional (DCI):

NITROGLYCERIN

Unidades en paquete:

30s x 5 x 10s Tablets; 30s x 5 Tablets

Fabricat per:

TROIKAA PHARMACEUTICALS LTD

Informació per a l'usuari

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
MYONIT INSTA SUBLINGUAL TABLETS USP 0.5MG
Nitroglycerin 0.5mg
Fexofenadine Hydrochloride Tablets USP 180mg
1
WHAT IS IN THIS LEAFLET
1.
What MYONIT INSTA is used for
2.
How MYONIT INSTA works
3.
Before you use MYONIT INSTA
4.
How to use MYONIT INSTA
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of MYONIT
INSTA
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT MYONIT INSTA IS USED FOR
Nitroglycerin is used to: -
-
Improve
blood
flow
in
heart
(widening of blood vessels).
-
Prevent
or
treat
chest
pain
and
discomfort caused by heart muscle
spasm
(angina
pectoris)
or
heart
failure.
HOW MYONIT INSTA WORKS
Myonit Insta tablet contains 0.5mg of
nitroglycerin.
It relaxes muscles surrounding
blood
vessels (arteries and veins) of the heart.
This reduces heart constrain by making
it easier to pump blood.
BEFORE YOU USE MYONIT INSTA
-
_When you must not use it_
Do not use MYONIT INSTA:
•
If
you
have
known
allergic
reaction
to
Nitroglycerin
or
any
other ingredient of Myonit Insta.
•
You
have
anemia,
head
trauma,
bleeding
in
the
brain
or
closed
angle glaucoma (an eye problem)
•
You
have
coronary
thrombosis
(blood
clot
inside
heart
blood
vessel)
•
You
are
taking
medicines
for
erectile dysfunction, like sildenafil
•
If
you
have
Phenylketonuria
(disorder that causes phenylalanine
to build up in the body), do not use
this
product,
as
it
contains
aspartame.
-
_Before you start to use it_
Tell your doctor or pharmacist if you:
•
Are
allergic
to
nitroglycerin,
nitrates or any ingredients in the
tablet.
•
have
severe
liver
or
kidney
problem
•
have
hypothyroidism
(underproduction
of
thyroid
hormone)
•
Have had a recent heart attack or
any heart problem.
•
Not recommended for genetically
inherited
metabolic
(phenylketonuria)
due
to
the
substance aspartame.
-
_Taking other medicines_
Please tell your doctor if you are taking
or
have
recently
taken
any
other
medicines,
including
medicines
obtained
withou

Fitxa tècnica

FRONT
D.I.MYT.MAL.E-05
Prescribing Information
For Use by Registered Medical
Practitioner or Hospital or Laboratory Only
Nitroglycerin Sublingual Tablets USP 0.5 mg.
Pharmacokinetics:
Nitroglycerin
is
readily
absorbed
from
the
oral
mucosa, but rapidly metabolised so that it only has a
fleeting duration of action.
Nitroglycerin
is
also
readily
absorbed
from
the
gastrointestinal tract, but owing to the extensive first-
pass
metabolism
in
the
liver,
its
bioavailability
is
reduced (short plasma half-life).
Nitroglycerin
is
metabolised
by
hydrolysis
to
dinitrates
and
the
mononitrate,
which
is
the
main
urinary metabolite.
The effects of Nitroglycerin occur in approximately
2-3
minutes
and
its
action
lasts
for
about
30-60
minutes.
INDICATION:
As a short-acting vasodilator in the prophylaxis and
continued treatment of:
1)
Angina pectoris
2)
Congestive heart failure
RECOMMENDED DOSAGE:
1-2 tablets (0.5-1.0mg) should be placed under the
tongue
and
allowed
to
dissolve
slowly;
this
dose
should
be
repeated
as
required.
Dosage
should
be
adjusted
according
to
the
response obtained by the individual patient and the
severity of the anginal pain.
Tolerance may develop with daily use, but withdrawal
for a week re-establishes the original sensitivity.
Discard remaining tablets after 8 weeks of opening of
bottle, if unused.
ROUTE OF ADMINISTRATION:
Oral-Sublingual
CONTRAINDICATIONS:
Nitroglycerin should not be used in patients with
marked anaemia, head trauma, cerebral
haemorrhage or closed angle glaucoma.
Nitroglycerin is also contraindicated in patients with
coronary thrombosis or in those who are sensitive to
nitrates.
Sildenafil has been shown to potentiate the
hypotensive effects of nitrates, and its co-
administration with nitrates or nitric oxide donors is
therefore contraindicated.
WARNINGS AND PRECAUTIONS:
Development of tolerance may occur with all forms of
nitrate therapy particularly with the long acting
preparations that maintain continuously high plasma
nitrate concentration.
Not recommended for phenyketonuric due to th