XYLOCAINE 2% WITH ADRENALINE 1:80000 INJECTION

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Epinephrine; Lidocaine 17.31 mg/ml Eqv Lidocaine Hydrochloride

Available from:

DENTSPLY (SINGAPORE) PTE. LTD.

ATC code:

N01BB52

Dosage:

0.0125 mg/ml

Pharmaceutical form:

INJECTION

Composition:

Epinephrine 0.0125 mg/ml; Lidocaine 17.31 mg/ml Eqv Lidocaine Hydrochloride 20 mg/ml

Administration route:

DENTAL

Prescription type:

Prescription Only

Manufactured by:

Showa Yakuhin Kako Co.,Ltd.

Authorization status:

ACTIVE

Authorization date:

1991-04-08

Patient Information leaflet

LOCAL ANESTHETIC FOR DENTAL USE 

XYLOCAINE 2% 
WITH ADRENALINE 1: 80000 INJECTION 

LIDOCAINE HYDROCHLORIDE, EPINEPHRINE INJECTION 

CONTRAINDICATIONS   
(This drug is contraindicated in the following patients) 
Patients with past
history of hypersensitivity  to components of 
this drug or amide local anesthetics. 
The use of Xylocaine with Adrenaline is contraindicated for 
anesthesia of fingers, toes, tip of nose, ears and penis. 
Xylocaine with adrenaline should not be given intravenously. 

COMPOSITION AND CHARACTERISTICS 

Xylocaine 2% with Adrenaline 1: 80000 Injection 
Per 1 mL 
Per vial 
(1.8mL) 
Ingr
edi
e
nt
/Q
ua
n
tity

Active 
ingredient 
Lidocaine hydrochloride 
20mg 
36mg 
Epinephrine 
0.0125 mg 
0.0225 mg 
Additives 
Hydrochloric acid 
0.4 
µL 
0.72 
µL 
Sodium chloride 
6 mg 
10.8 mg 
Sodium pyrosulfite 
0.55 mg 
0.99 mg 
pH adjustment agent 
Proper 
quantity 
Proper 
quantity 
Dosage form 
Injection 
Color/Characteristic 
Colorless and clear liquid 
pH 
3.3-5.0 
Osmotic pressure ratio (to saline) 
Approx. 1 

INDICATION(S) 

Xylocaine 2% with Adrenaline 1:80,000 is a local anaesthetic 
solution for use in dental infiltration
anaesthesia and all dental 
nerve block techniques. 

DOSAGE AND ADMINISTRATION 

Infiltration - the usual dose is 1 ml. 
Nerve block - the usual dose is 1.5 to 2ml. 

The recommended maximum dose for Xylocaine when given 
with adrenaline is 500mg. 

Children and elderly or debilitated patients require smaller 
doses. 

PRECAUTIONS FOR USE 

1.  This drug should be used with caution in the following 
patients: 
•  Patients with cardiac conduction disturbance. 
•  Patients with impaired respiratory function. 
•  Patients with severe hepatic or renal dysfunction. 
•  Patients with

Summary of Product characteristics

LOCAL ANESTHETIC FOR DENTAL USE
XYLOCAINE 2%
WITH ADRENALINE 1: 80000 INJECTION
LIDOCAINE HYDROCHLORIDE, EPINEPHRINE INJECTION
CONTRAINDICATIONS
(This drug is contraindicated in the following patients)
Patients with past history of hypersensitivity to components of
this drug or amide local anesthetics.
The use of Xylocaine with Adrenaline is contraindicated for
anesthesia of fingers, toes, tip of nose, ears and penis.
Xylocaine with adrenaline should not be given intravenously.
COMPOSITION AND CHARACTERISTICS
Xylocaine 2% with Adrenaline 1: 80000 Injection
Per 1 mL
Per vial
(1.8mL)
Ingredient/Quantity
Active
ingredient
Lidocaine hydrochloride
20mg
36mg
Epinephrine
0.0125 mg
0.0225 mg
Additives
Hydrochloric acid
0.4
µ
L
0.72
µ
L
Sodium chloride
6 mg
10.8 mg
Sodium pyrosulfite
0.55 mg
0.99 mg
pH adjustment agent
Proper
quantity
Proper
quantity
Dosage form
Injection
Color/Characteristic
Colorless and clear liquid
pH
3.3-5.0
Osmotic pressure ratio (to saline)
Approx. 1
INDICATION(S)
Xylocaine 2% with Adrenaline 1:80,000 is a local anaesthetic
solution for use in dental infiltration anaesthesia and all dental
nerve block techniques.
DOSAGE AND ADMINISTRATION
Infiltration - the usual dose is 1 ml.
Nerve block - the usual dose is 1.5 to 2ml.
The recommended maximum dose for Xylocaine when given
with adrenaline is 500mg.
Children and elderly or debilitated patients require smaller
doses.
PRECAUTIONS FOR USE
1.
This drug should be used with caution in the following
patients:
•
Patients with cardiac conduction disturbance.
•
Patients with impaired respiratory function.
•
Patients with severe hepatic or renal dysfunction.
•
Patients
with
hypertension,
cardiac
disease,
hyperthyroidism, or cerebrovascular insufficiency.
•
Patients with past history of vasospasm.
2.
Facilities for resuscitation should be available when local
anesthetics are administered.
3.
Use the smallest necessary dosage. The injection rate should
be as slow as possible.
4.
Confirm that the injection needle is not inserted in the blood
vessel.
X