XYLESTESIN-A INJECTION [SIN06177P]

Product Info

XYLESTESIN-A INJECTION

[SIN06177P]

THERAPEUTIC INDICATIONS
Infiltration anaesthesia and nerve-block in dentistry.
Xylestesin-A is indicated in adults, children and adolescents.

POSOLOGY AND METHOD OF ADMINISTRATION
Xylestesin-A is exclusively recommended for use in dentistry.

Posology
The smallest possible volume of solution which will lead to an effective anaesthesia should be used.

Adults:
The dosage should be determined on an individual basis, according to the technique used and particularities of the specific case.
In oral infiltration and/or mandibular block, initial dosages of 1.0 – 4.0 ml are usually sufficient.

Special populations:
Elderly population: Increased plasma levels of Xylestesin-A can occur in older patients due to diminished metabolic processes and reduced distribution volume. The risk of accumulation of Xylestesin-A is increased after repeated administration in particular.
Dosages should be reduced from adult recommendations, taking into consideration any cardiac or liver disease (see section Special warnings and precautions for use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Patients with hepatic impairment: Lidocaine is metabolized in the liver. Lower doses of lidocaine may be required in patients with hepatic dysfunction, due to prolonged effects and systemic accumulation (see section Special warnings and precautions for use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Patients with renal impairment: Lidocaine and its metabolites are mainly eliminated in urine. Lower doses of lidocaine may be required in patients with severe renal dysfunction, due to prolonged effects and systemic accumulation (see section Special warnings and precautions for use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Other relevant special populations: The dose has to be similarly reduced in patients with certain pre-existing diseases (angina pectoris, arteriosclerosis, see section Contraindications and section Special warnings and precautions for use) and in patients concurrently taking medications known to interact with lidocaine and/or epinephrine (see section Special warnings and precautions for use and section Interactions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Dose recommendation for special populations: A lower dosage range is thus recommended in all such cases (i.e. minimum volume of Xylestesin-A for sufficient anaesthetic effect).

Paediatric population:
Xylestesin-A is indicated in adults, children and adolescents. Special care has to be exercised when treating children below 4 years. The quantity to be injected should be determined by the age and weight of the child and the magnitude of the operation. The anaesthesia technique should be selected carefully. Painful anaesthesia techniques should be avoided. The behaviour of the child during treatment has to be monitored carefully. The average dose to be used is in the range of 20 mg to 30 mg lidocaine hydrochloride per session. The dose in mg of lidocaine hydrochloride which can be administered in children may alternatively be calculated from the expression: child’s weight (in kilograms) x 1.33.

Dose recommendation for children and adolescents:

Due to the fact that lidocaine diffuses rapidly into tissues and the bone density is lower in children than in adults, infiltration anaesthesiacan be used instead of conduction anaesthesia in the paediatric population.

Maximum Recommended Dosage:
Adults:
For healthy adults, the maximum dose of the active ingredient lidocaine hydrochloride with vasoconstrictor admixture is 7mg/kg body weight.
Example: The maximum dose for a 70 kg patient is 500 mg. However, due to the addition of epinephrine 1:80,000, a maximum administered quantity of 16 ml solution for injection or 9 cartridges (equivalent to 0.2 mg epinephrine, maximum dose) must not be exceeded.

Children:
The quantity to be injected should be determined by the age and weight of the child and the magnitude of the operation. Do not exceed the equivalent of 5 mg lidocaine hydrochloride/kg BW or 0.250 ml Xylestesin-A/kg BW.

Maximum recommended dosage of Xylestesin-A in children and adolescents:

Method of administration
Dental use

To avoid intravascular injection, aspiration control at least in two planes (rotation of the needle by 180°) must always be carefully undertaken, although a negative aspiration result does not safely rule out an unintentional and unnoticed intravascular injection.

The injection rate should not exceed 0.5 ml in 15 seconds, i.e. 1 cartridge per minute.

Major systemic reactions as a result of accidental intravascular injection can be avoided in most cases by an injection technique – after aspiration slow injection of 0.1 – 0.2 ml and slow application of the rest – after allowing an interval of at least 20 – 30 seconds.

Opened cartridges must not be used in other patients. Residues must be discarded.

CONTRAINDICATIONS
Xylestesin-A must not be used in the event of

• hypersensitivity to the active substances, sodium sulphite (E221) or to any of the other excipients.

Due to the active substance lidocaine, Xylestesin-A must not be used in the event of

• known allergy or hypersensitivity to local anaesthetics of the amide type,

• severe, uncontrolled or untreated excitation and conduction disorders of the heart (e.g. grade II and III AV block, pronounced bradycardia),

• acutely decompensated heart failure,

• severe hypotension.

Due to the content of epinephrine as a vasoconstrictor admixture, Xylestesin-A must not be used in the event of

• Heart diseases such as:

  • unstable angina pectoris,

  • recent myocardial infarction,

  • recent coronary artery bypass surgery,

  • refractory arrhythmias and paroxysmal tachycardia or high-frequency, continuous arrhythmia,

  • untreated or uncontrolled severe hypertension,

  • untreated or uncontrolled congestive heart failure,

• concomitant treatment, or treatment during the past 14 days with monoamine oxidase (MAO) inhibitors or tricyclic antidepressants (see section Interactions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• Xylestesin-A must not be used in acra of extremities.

Due to the content of sulphite as excipient, Xylestesin-A must not be used in the event of

• allergy or hypersensitivity to sulphite,

• severe bronchial asthma.

Xylestesin-A can provoke acute allergic reactions with anaphylactic symptoms (e.g. bronchospasm).

Precaution for use and Pregnancy/lactation see separate section – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information