XYLONOR solution for oromucosal spray 150mg1.5mg per g

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

CETRIMIDE; LIGNOCAINE

Available from:

N.K. LUCK (S) PTE LTD

ATC code:

D04AB

Dosage:

0.15 g/100 g

Pharmaceutical form:

SPRAY

Composition:

CETRIMIDE 0.15 g/100 g; LIGNOCAINE 15 g/100 g

Administration route:

BUCCAL

Prescription type:

Pharmacy Only

Manufactured by:

SEPTODONT

Authorization status:

ACTIVE

Authorization date:

1992-09-25

Summary of Product characteristics

XYLONOR, 150 MG / 1.5 MG PER G, OROMUCOSAL SPRAY, SOLUTION
IDENTIFICATION OF THE PRODUCT
Quantitative and qualitative composition
LIDOCAINE
................................................................................
150.00 mg
CETRIMIDE
.................................................................................
1.5 mg
EXCIPIENTS: _ saccharin (E954), spearmint flavour (mixture of mint and
eucalyptus essential oils), _
_dipropylene glycol, ethanol (96 per cent) _
QS ad 1 g of solution for dental use
One metered dose contains 10 mg of lidocaine.
Description
Oromucosal spray, solution – 36 g in an atomizer.
Clear liquid, not more intensely coloured than slightly yellow with a
characteristic odour of spearmint.
PHARMACOLOGICAL PROPERTIES
PHARMACODYNAMIC PROPERTIES
Pharmacotherapeutic group: local anaesthetics / Lidocaine combinations
ATC code: N01BB52.
The medicinal product is an association of:
•
Lidocaine: a local amide anaesthetic. When applied to the oral mucous
membrane, it provides
surface anaesthesia by controlling painful stimulation occurring in or
just beneath the mucosa. The
local anaesthetic effect of lidocaine occurs via reversible blockade
of nerve fiber impulse
propagation.
•
Cetrimide: a quaternary ammonium disinfectant with antiseptic
properties. This action occurs via
protein denaturation, enzyme inactivation and membrane damage of
bacteria.
Lidocaine in combination with cetrimide has an onset of action of 2 to
5 minutes and 10 to 20 minutes
as duration of action.
PHARMACOKINETIC PROPERTIES
_Lidocaine _
Absorption
Results from published studies performed in patients using various
topical lidocaine-based preparations
applied to healthy oral mucosa show that measured serum lidocaine
levels remain well below the toxic
range. (< 5 μg/mL). The peak serum level of lidocaine is dose
dependent and was found to be between
0.016 μg/mL and 0.35 μg/mL.
Distribution
Lidocaine is 60% to 80% protein-bound to alpha-1-acid glycoprotein.
Biotransformation
Lidocaine is principally metabolized in the