Lidonostrum 10% wv Topical Spray

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

LIDOCAINE

Boleh didapati daripada:

SCHMIDT BIOMEDTECH SDN BHD

INN (Nama Antarabangsa):

LIDOCAINE

Unit dalam pakej:

80 gm

Dikeluarkan oleh:

SIDEFARMA

Ciri produk

PATIENT INFORMATION LEAFLET
LIDONOSTRUM 10% W/V TOPICAL SPRAY
Lidocaine (100 mg/ml)
ACTIVE INGREDIENT
Lidocaine.
EXCIPIENTS
- Ethanol (solvent and preservative);
- Polyethylene glycol 400;
- Banana flavour (containing propylene glycol);
- Menthol;
- Saccharin;
- Purified water.
DOSAGE FORM
Topical spray.
PRODUCT DESCRIPTION
Lidonostrum 10% w/v Topical Spray is a clear, colourless to yellowish
liquid with a
characteristic odour and taste to banana. The active substance is
dissolved in a
mixture of water, ethanol and polyethylene glycol 400.
PHARMACODYNAMICS
Lidocaine, like other local anaesthetics, causes a reversible blockade
of impulse
propagation along nerve fibres by preventing the inward movement of
sodium ions
through the nerve membrane. Local anaesthetics of the amide type are
thought to
act within the sodium channels of the nerve membrane.
Local anaesthetic drugs may also have similar effects on excitable
membranes in
the brain and myocardium. If excessive amounts of drug reach the
systemic
circulation rapidly, symptoms and signs of toxicity will appear,
emanating from the
central nervous and cardiovascular systems.
Central nervous system toxicity usually precedes the cardiovascular
effects since
it occurs at lower plasma concentrations.
Direct effects of local anaesthetics on the heart include slow
conduction, negative
inotropism and eventually cardiac arrest.
PHARMACOKINETICS
ABSORPTION
Lidocaine is absorbed following topical administration to mucous
membranes, its
rate and extent of absorption being dependent upon the concentration
and total
dose administered, the specific site of application, and duration of
exposure. In
general, the rate of absorption of local anaesthetic agents following
topical
application is most rapid after intratracheal and bronchial
administration. Lidocaine
is also well-absorbed from the gastrointestinal tract, although little
of the intact drug
appears in the circulation because of biotransformation in the liver.
DISTRIBUTION
The plasma protein binding of lidocaine is dependen