NITROSOL SUBLINGUAL AEROSOL SPRAY 400mcgactuation

Land: Maleisië

Taal: Engels

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

Werkstoffen:

GLYCERYL TRINITRATE

Beschikbaar vanaf:

Vitamode Sdn.bhd

INN (Algemene Internationale Benaming):

GLYCERYL TRINITRATE

Eenheden in pakket:

1 (100 actuations) Units; 1 (200 actuations) Units

Geproduceerd door:

Beximco Pharmaceuticals Ltd.

Bijsluiter

Please refer to section E12

Productkenmerken

NITROSOL
®
Sublingual Aerosol Spray 400 mcg/actuation
VASODILATOR
Each Actuation Delivers:
GLYCERYL TRINITRATE BP 400 MCG
PRODUCT DESCRIPTION
It is a clear solution of Glyceryl Trinitrate which is filled into
aluminium
can fitted onto a valve. The propellant 1, 1, 1, 2- Tetrafluoroethane
(HFA 134a) is then filled into the can through valve. The can fitted
with
valve is then again fitted with an actuator, collar and safety hood.
This
is then packed inside an inner carton with leaflet inside.
PHARMACODYNAMICS
Glyceryl trinitrate relieves angina pectoris by reduction of cardiac
work and dilation of the coronary arteries. In this way, not only is
there
a
lessening
in
arterial
oxygen
requirement
but
the
amount
of
oxygenated blood reaching the ischaemic heart is increased.
PHARMACOKINETICS
The
pharmacokinetics
of
glyceryl
trinitrate
are
complex;
venous
plasma levels of the drug show wide and variable fluctuations and are
not predictive of clinical effect. In a human pharmacodynamic study,
pharmacological activity had commenced one minute after dosing
and was obvious by two minutes.
INDICATION
For
the
treatment
and
prophylaxis
of
angina
pectoris
and
the
treatment of variant angina.
RECOMMENDED DOSE
At the onset of an attack, one or two metered sprays should be
administered on or under the tongue. A spray may
be repeated
approximately every 5 minutes as needed. No more than 3 metered
sprays are recommended within a 15 minute period. If chest pain
persists
after
a
total
of
3
sprays,
prompt
medical
attention
is
recommended.
Nitrosol
®
may
be
used
prophylactically
5
to
10
minutes before engaging in activities that might precipitate an acute
attack.
MODE OF ADMINISTRATION
_SUBLINGUAL_
During use the patient should rest, ideally in the sitting position.
The
container should be held vertically with the valve head uppermost and
the spray orifice as close to the mouth as possible. The dose should
preferably be sprayed into the mouth on or under the tongue by
pressing
the
button
firmly
and
the
mouth
should
be
closed
immediately