Xylodont 2% with adrenaline 1:80,000
PolandTable of Contents
Package leaflet: Information for the user
Please read the entire leaflet carefully before using this medicine.
- Keep this leaflet for future reference.
- If you have any questions, please consult your doctor or pharmacist.
- This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same.
- If the patient experiences any adverse reactions, including those not listed in this leaflet, inform a doctor or pharmacist immediately.
XYLODONT 2%
(Lidocaini hydrochloridum)
20 mg/ml, solution for injection
XYLODONT 2% with adrenaline 1:100,000
(Lidocaini hydrochloridum + Adrenalinum)
(20 mg + 0.01 mg)/ml, solution for injection
XYLODONT 2% with adrenaline 1:80,000
(Lidocaini hydrochloridum + Adrenalinum)
(20 mg + 0.0125 mg)/ml, solution for injection
XYLODONT 2% with adrenaline 1:50,000
(Lidocaini hydrochloridum + Adrenalinum)
(20 mg + 0.02 mg)/ml, solution for injection
Contents of the leaflet
- What Xylodont is and what it is used for
- Important information before using Xylodont
- How to use Xylodont
- Possible side effects
- How to store Xylodont
- Contents of the pack and other information
1. What Xylodont is and what it is used for
Lidocaine, the active substance in this medicine, is an amide-type local anaesthetic. Its action results from inhibition of ion currents responsible for the generation and propagation of impulses across the neuronal cell membrane. The anaesthetic effect begins rapidly. The duration of effective action depends on the site of injection, concentration of the solution, and the presence or absence of adrenaline, a vasoconstrictor agent. Lidocaine is rapidly metabolized in the liver (its main metabolites are monoethylglycinexylidide and glycinexylidide). Metabolites and unchanged drug are excreted in urine. Protein binding ranges from 60% to 80% at lidocaine concentrations of 1 to 4 μg/ml. After intravenous bolus administration, the half-life is 1.5–2 hours.
Indications:
Local anaesthesia (infiltration and nerve blocks) for all conservative and surgical
procedures in dentistry.
Xylodont with adrenaline 1:100,000 is indicated when prolonged duration of local
anaesthesia is desired. Xylodont with adrenaline 1:80,000 and 1:50,000 should be used
exclusively when local vasoconstriction is required to reduce bleeding.
2. Important information before using Xylodont
When not to use Xylodont:
- If the patient is allergic to lidocaine hydrochloride or to any of the other ingredients of this medicine (listed in section 6).
The use of preparations containing vasoconstrictors is contraindicated in patients with severe heart disease, peripheral arterial disease, hypertension, migraine, hyperthyroidism, diabetes mellitus, prostatic hypertrophy, narrow-angle glaucoma, and nephropathy.
Warnings and precautions
Rare cases of death have been reported in individuals without previously diagnosed hypersensitivity.
Xylodont with adrenaline contains sodium metabisulfite.
This substance may cause allergic reactions and severe asthma attacks in susceptible individuals.
The efficacy and safety of lidocaine in dentistry depend on appropriate dose selection, proper administration technique, and adherence to safety precautions.
Before starting treatment with Xylodont, discuss it with your doctor.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, or suspects she may be pregnant, she should consult a doctor before using this medicine.
Xylodont should not be used during pregnancy.
Driving and operating machinery
Xylodont has minor influence on the ability to drive and operate machinery.
The doctor should decide whether the patient may drive or operate machinery after administration of the medicine.
Xylodont with other medicines
Preparations containing adrenaline should be used with caution in patients receiving monoamine oxidase inhibitors (MAO inhibitors) or tricyclic antidepressants (medicines used, among others, in psychiatry).
In all cases, the lowest effective dose and concentration should be used. The patient must be under close supervision, and administration should be discontinued immediately if any disturbing symptoms occur (e.g. sensory disturbances).
Solutions containing adrenaline may exhibit clinically significant interactions:
- with MAO inhibitors and tricyclic antidepressants (risk of severe hypertension),
- with phenothiazine derivatives or butyrophenones (possible reversal of adrenaline's pressor effect).
Inform your doctor about all medicines currently used, recently used, or planned for use.
3. How to use Xylodont
1 to 2 ml or more, depending on the procedure, administered as infiltration or peripheral nerve block. The anesthetic solution should be injected in small increments at a rate of approximately 1 ml/min, with prior aspiration.
In a healthy adult patient who has not received sedatives, the maximum dose—whether administered as a single injection or in several consecutive injections within a period not exceeding 90 minutes—is 7 mg of lidocaine hydrochloride per kilogram of body weight, up to a total dose not exceeding 550 mg of lidocaine hydrochloride and 0.2 mg of adrenaline. The maximum dose is 1000 mg of lidocaine within 24 hours.
In children, doses should be reduced according to body weight and age.
If the effect of Xylodont seems too strong or too weak, the physician should be informed.
Use of a higher than recommended dose of Xylodont
Overdosing with local anesthetics should be avoided, and two maximum doses should never be administered consecutively if the interval between them is less than 24 hours. Lower concentrations and doses that achieve the desired anesthetic effect are recommended.
The following toxic effects have been reported following overdose:
- Central nervous system stimulation with symptoms of excitation, tremors, disorientation, dizziness, pupil dilation, increased metabolism, and elevated body temperature;
- After very large doses: trismus and convulsions.
Management
At the first sign of any alarming symptoms, administration of the drug must be stopped immediately. The patient should be placed in a horizontal position, and it should be ensured that breathing is unobstructed; if not, oxygen should be administered, and artificial ventilation initiated in case of apnea.
Analeptics acting on the medulla oblongata should be avoided to prevent worsening of the patient's condition due to increased oxygen consumption.
Seizures may be controlled by intravenous administration of diazepam in doses of 10 to 20 mg. Barbiturates are not recommended, as they may exacerbate depression of the medulla oblongata.
Improvement of circulatory function may be achieved by intravenous administration of glucocorticoids. Additionally, diluted solutions of alpha- and beta-receptor agonists with vasoconstrictive properties (e.g., methoxamine, metaraminol, etc.) or atropine sulfate may be used.
An appropriate emergency kit and adequately trained personnel must always be immediately available.
In several cases, following administration of local anesthetics and in the absence of personal hypersensitivity history, severe complications, even with fatal outcomes, have been observed.
Xylodont with adrenaline contains sodium metabisulfite; this compound may cause allergic reactions, including anaphylactic reactions, particularly in individuals with asthma.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will
experience them.
The adverse effects that may occur during the use of lidocaine are similar to those
observed with other amide-type local anaesthetics.
These effects depend on the dose and may result from high plasma concentrations of the
drug, which may be due to overdose, rapid absorption, or accidental intravascular
injection, or may be caused by hypersensitivity, idiosyncrasy, or reduced patient
tolerance.
The following adverse effects have been reported:
Central nervous system disorders:
Central nervous system excitation with symptoms of restlessness, tremors, disorientation,
dizziness, pupil dilation, increased metabolism, and elevated body temperature. After
very high doses: jaw clenching and convulsions.
Vascular disorders:
Vasodilation, hypertension.
Cardiac disorders:
Heart rhythm disturbances, bradycardia.
Immune system disorders:
Allergic reactions (in the most severe cases, anaphylactic shock).
Allergic reactions to lidocaine are very rare (<1/10,000); if they occur, standard treatment
measures should be taken.
Respiratory, thoracic and mediastinal disorders:
Increased respiratory rate, bronchodilation.
Gastrointestinal disorders:
Nausea, vomiting.
Skin and subcutaneous tissue disorders:
Skin changes, urticaria, oedema, sweating.
The vasoconstrictor component may cause the following reactions, especially in patients
with cardiovascular disease: anxiety, sweating, breathing difficulties, cardiac rhythm
disturbances, hypertension (which may be dangerous in patients with established
hypertension and in patients with hyperthyroidism), severe headache, photophobia,
retrosternal pain, vomiting.
If any adverse effects occur, including any not listed in this leaflet, inform your doctor.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or
pharmacist. Adverse effects can be reported directly to the Department of Monitoring
Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical
Devices and Biocidal Products,
Al. Jerozolimskie 181C, 02-222 Warsaw, tel. (22) 49 21 301, fax (22) 49 21 309. Website:
https://smz.ezdrowie.gov.pl. Reporting adverse effects allows more information to be
collected on the safety of the medicine.
5. How to store Xylodont
Store below 25°C.
Store in the original packaging to protect from light.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the container.
The expiry date refers to the last day of the stated month.
6. Contents of the pack and other information
What Xylodont contains
XYLODONT 2%
1 ml of solution contains 20 mg of lidocaine hydrochloride (Lidocaini hydrochloridum).
1.8 ml of solution (1 cartridge) contains 36 mg of lidocaine hydrochloride (Lidocaini hydrochloridum).
XYLODONT 2% with adrenaline 1:100,000
1 ml of solution contains 20 mg of lidocaine hydrochloride (Lidocaini hydrochloridum)
and 0.01 mg of adrenaline as adrenaline bitartrate.
1.8 ml of solution (1 cartridge) contains 36 mg of lidocaine hydrochloride (Lidocaini hydrochloridum)
and 0.018 mg of adrenaline as adrenaline bitartrate.
XYLODONT 2% with adrenaline 1:80,000
1 ml of solution contains 20 mg of lidocaine hydrochloride (Lidocaini hydrochloridum)
and 0.0125 mg of adrenaline as adrenaline bitartrate.
1.8 ml of solution (1 cartridge) contains 36 mg of lidocaine hydrochloride (Lidocaini hydrochloridum)
and 0.0225 mg of adrenaline as adrenaline bitartrate.
XYLODONT 2% with adrenaline 1:50,000
1 ml of solution contains 20 mg of lidocaine hydrochloride (Lidocaini hydrochloridum)
and 0.02 mg of adrenaline as adrenaline bitartrate.
1.8 ml of solution (1 cartridge) contains 36 mg of lidocaine hydrochloride (Lidocaini hydrochloridum)
and 0.036 mg of adrenaline as adrenaline bitartrate.
Inactive ingredients:
Xylodont 2% contains the following excipients: sodium chloride and water for injections.
Xylodont 2% with adrenaline additionally contains sodium metabisulfite.
What the package looks like and contents of the pack:
The cardboard box contains 50 dental cartridges packed in blisters.
Marketing Authorisation Holder:
Molteni Dental s.r.l., Via Ilio Barontini 8, Localita Granatieri 50018 Scandicci (Firenze), Italy
Manufacturer:
Laboratorios Normon S.A., Ronda de Valdecarrizo 6, 28760 Tres Cantos, Madrid, Spain
For further information, please contact:
Molteni Stomat Sp. z o.o.,
30-733 Kraków, ul. Obrońców Modlina 3, Poland
Tel. (012) 653 25 85; Fax. (012) 654 15 60