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SUMMARY OF PRODUCT CHARACTERISTICS

SUMMARY OF PRODUCT CHARACTERISTICS
1. TRADE NAME OF THE MEDICINAL PRODUCT
1.1. Cartridge for dental use
1.2. Spray for topical anaesthesia
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
a) ECOCAIN 20 mg/ml
1 ml of solution contains: Lidocaine hydrochloride 20 mg. Excipents: sodium chloride 6 mg, water for injectables solution
q.s. to 1 ml.
b) ECOCAIN 20 mg/ml with Adrenaline 1:100.000
1 ml solution contains: Lidocaine hydrochloride 20 mg, L-Adrenaline bitartrate equal to L-Adrenaline 10 μg. Excipients:
sodium chloride 4 mg, sodium metabisulphite 1 mg, water for injectables q.s. to 1 ml.
c) ECOCAIN 20 mg/ml with Adrenaline 1:80.000
1 ml solution contains: Lidocaine hydrochloride 20 mg, L-Adrenaline bitartrate equal to L-Adrenaline 12.5 μg. Excipients:
sodium chloride 4 mg, sodium metabisulphite 1 mg, water for injectables q.s. to 1 ml.
d) ECOCAIN 20 mg/ml Adrenaline 1:50.000
1 ml solution contains: Lidocaine hydrochloride 20 mg, L-Adrenaline bitartrate equal to L-Adrenaline 20 μg. Excipients:
sodium chloride 4 mg, sodium metabisulphite 1 mg, water for injectables q.s. to 1 ml.
e) ECOCAIN SPRAY
100 ml contain: Lidocaine hydrochloride 10 g. Excipients: Cetylpyridine chloride, sodium saccharine, polyethylene glycol
400, ethyl alcohol, monobasic sodium phosphate, Sodium hydroxide 1M, purified water q.s. to 100 ml.
3. Pharmaceutical form:
3.1 Injectable solution in 1.8-ml cartridges for dental use
3.2 Solution for topical use in 60 ml spray bottle.
4. PHARMACOLOGICAL AND TOSSICOLOGICAL PROPERTIES AND DATA OF PHARMACOKINETICS
4.1. Pharmacological properties
The active ingredient Lidocaine is an amidic local anaesthetic. Its properties are due to its inhibition of the ionic flow,
which is responsible for impulse generation and propagation in the neuronal membranes. The onset of its anaesthetic action
is rapid. The duration of anaesthetic efficacy depends on the injection site, the concentration and the presence or absence of
a vasoconstrictor.
4.2 Tossicology
LD50
Adrenaline does not modify lidocaine toxicity.
Sub-acute toxicity in rat (4 weeks): 5-15-40-mg/kg/die i.m. administered as 2% lidocaine hydrochloride with adrenaline or
not; 100 mg x 30’ administered via inhalatory as 10% lidocaine. No visible toxic effect except for the maximum dosage (40
mg/kg), where it was seen a rapid decay of the general conditions, excitation and occasionally convulsions. No toxic effect
with spray formulation.
Chronic toxicity in rat (6 months): 2% lidocaine hydrochloride administered via i.m. at the dosages of 5-10-20 mg/kg once
a day, five times a week. The trial showed that the 6-months treatment is well tolerated by rat: only the highest dosage (20
mg/kg) provokes an increase in the weight of the surrenal glands associated to hyperplasia of the cortical.
Toxicity in dog (16 weeks): the administration of 5-10 mg/kg/die of 2% lidocaine hydrochloride via i.m. showed no toxic
effect.
Foetal toxicity: Experimental trials on animals showed that lidocaine does not influence reproductive process and has no
teratogen activity.
4.3. Pharmacokinetic properties
Following i.v. administration, lidocaine is quickly metabolised by liver (main metabolites are: monoethylglycinxylidide and
glycinxylidide). Metabolites and unmetabolised drug are excreted by renal route. Plasmatic proteins binding varies from 60
to 80% when lidocaine concentrations varies from 1 to 4 μg/ml. After administration of a bolus i.v, the elimination half-
life is 1,5-2 hours.
5. CLINIC INFORMATION
5.1. Therapeutics indications
All conservative and surgical operations in dentistry.
5.1.1 ECOCAIN with adrenaline (1:100.000, 1:80.000, 1:50.000) is indicated when the duration of regional anaesthesia
needs to be prolonged or a local ischaemia is required.
5.1.2. ECOCAIN spray preparation is indicated for: before injections, cut of topical abscess, minor surgical procedure,
removal of calculus, extraction of deciduous teeth or moving teeth, preparation of small chamber, remove the tartar, in
dental impressions and X-ray photography, use of plastic material to fast hardening and in the painless adaptation of dental
prosthesis, application of bridges and crowns.
5.2. Contra-indications
Known hypersensitivity towards the ingredients.
The product containing the vasoconstrictor is generally contraindicated in cardiopathic patients, patients affected with
serious arteriopathies or hypertension, patients with ischaemic manifestations of any type and those affected with similar
migraine, hyperthyroidism, diabetes, prostate hypertrophy, acute-angle glaucoma, nephropathy.
Not to be used in known or presumed pregnancy.
5.3. Undesiderable effect
The side effects that may occur with lidocaine administration are similar to those observed with other amidic local
anaesthetics. These effects are generally dose-dependent and may be due to high plasma levels as a result of overdose,
rapid absorption and accidental intervasal injection, or they may be caused by hypersensitivity, idiosyncrasy or diminished
tolerance of the patient.
The following toxic effects of overdose have been reported:
central nervous stimulation with excitation, tremors, disorientation, dizziness, mydriasis, increase in metabolism or body
temperature: and for very high doses: trismus and convulsions. If the medulla oblunga is affected there is involvement of
the cardiovascular, respiratoty and ematic centres with consequent perspiration, arrythmias, hypertension, tachypnea,
bronchodilation, nausea and vomiting. Peripheral effects may involve the cardiovascular apparatus with bradycardia and
vasodilatation.
The allergic reactions are: skin lesions, ulceraria, oedema or anaphylaxis. These reactions may be due to hypersensibility to
the anaesthetic agent or more often to the “parabens” used as preservatives, which are not present in ECOCAIN
preparations. True allergic reactions to lidocaine are in fact extremely rare and, if they occur, they must be treated in the
conventional manner.
Because of its action on the circulation, the vasoconstrictor may provoke the following reactions, especially in patients with
cardiocirculatory disorders: anxiety, perspiration, respiratory distress, cardiac arhythmias, hypertension (particularly serious
in already hypertense and hyperthyroid subjects), acute headache, photophobia, retrosternal and pharyngeal pain, vomiting.
5.4. Special precautions for use
The efficacy and the security of lidocaine in dentistry depend on dose and appropriate technique of administration and on
opportune precautions.
The preparations containing adrenaline must be used with absolute caution in subjects undergoing treatment with MAO-
inhibitors or tricyclics antidepressants.
Before proceeding to treatment the doctor must check the condition of the patient’s circulation.
Any overdose of anaesthetic must be avoided and two maximum doses must be administered only with an interval of at
least 24 h between doses.
It is in any cases necessary to use the lowest doses and concentrations required to obtain the desires effect. The patient must
be kept under strict supervision, and the administration immediately suspended at the first sign of alarm (e.g. modification
of sensorium).
5.5. Pregnancy and lactation
Not to be used in known or presumed pregnancy.
5.6. Interactions with other medicaments and other form of interaction
Significant clinic interactions can be obtained with formulations that have adrenaline, with MAO-inhibitors, and
with tricyclic antidepressants (serious hypertension) or with phenothiazines and with butirrophenones (possible
inversion of the pressory action of adrenaline).
5.7. Posology and method of administration
5.7.1 Cartridges
1-2 ml or more according to the requirements of the operation, by infiltration or by peripheral nerve block. The anaesthetic
solution must be injected in small doses with the administration speed of approx. 1 ml/min, after appropriate aspiration.
Maximum dose: 300 mg of Lidocaine over 24 h.
In the healthy adult, who has received no pre-treatment with sedatives, the maximum doses, given in either a single
administration or repeated administrations over no more than 120 min., is 300 mg of lidocaine hydrochloride and 0.2 mg
of adrenaline. Administer no more than 8.3 cartridges of ECOCAIN, ECOCAIN 1:100.000 or ECOCAIN 1:80.000 and no
more than 5.5 cartridges of ECOCAIN 1:50.000.
For paediatric use reduce the dose in proportion to weight and age.
5.7.2. Spray
Each activation of the metered dose valve delivers 100 μl of solution that correspond to 10 mg of lidocaine without
propellent gas. Not more than 2 spray applications for quadrant of oral mucous. In any case don’t use more than 3 spray
applications for quadrant in an interval of an hour and a half. During the use the bottle spray is kept in vertical position. For
application between soft and hard palate it is necessary to put the head of the patient and the supplying small beak so that
the inhalation is avoided.
Avoid contact with eyes. Do not use in pediatrics.
5.8. Overdose
Emergency due to local anaesthetics are usually related to high plasma levels caused by accidental intravasal injection.
At the first sign of allarm the administration must be interrupted. The patient must be placed in horizontal position and it
must be ascertained that he is breathing freely; if not, oxygen should be administered or artificial respiration applied in
cases of serious dyspnea. Bulbar analeptics must be avoided so as not to worsen the situation by increasing oxygen
consumption. Convulsions may be controlled with diazepam administration in doses of 10-20 mg i.v. Barbiturates are not
recommmended in that they may aggravate bulbar depression. Circulation may be sustained with the administration of
cortisone-based drugs i.v. in appropriate doses. Diluited solutions of alpha-beta stimulants with a vasoconstrictor action
(e.g. mephentermine, metaraminol etc.) or of atropine sulphate may be added. As an anti-acid sodium bicarbonate i.v. may
be employed in suitable doses.
5.9. Warning
Emergency equipment, drugs and staff must be immediately available since serious sometimes fatal reactions have been
very occasionally reported even in absence of individual hypersensitivity in the anamnesis.
The product with vasoconstrictor contains sodium metabisulphite. This substance may provoke allergic reactions in
sensitive subjects, particularly in serious asthmatics.
5.10. Effects on ability to drive and use machines
At the usual dosages the drug does not influence the driving performance meaningfully and for along time. Only doctor
can decide if the patient is able to drive or to use machinary after the operation.
6. PHARMACEUTICAL PARTICULARS
6.1. Incompatibilities
Amphotericin, Methohexitone sodium, Sulfadiazine sodium, Mephentermine hydrochloride, alkali, heavy metals, oxidizing
agents, tannin, air and light.
6.2. Shelf life
ECOCAIN
ECOCAIN 20 mg/ml with adrenaline (1:100.000, 1:80.000, 1:50.000) 6.3. Special precautions for storage
Keep out of the light and at temperatures of no more than 25° C the packaging with adrenaline.
6.4. Nature of container, packages and prices
6.4.1 Cartridges
Class I glass cartridge, with closure consisting at the lower end of a sliding elastomer plunger in chlorobutile, and at the
upper end of a perforable liner with an aluminium crimp seal.
6.4.2. Bottle spray
Class III glass bottle, completely coated in milky-white PVC. It has a dosed dispensing pump and puffer with tongue-
lowering extension. The puffer is supplied sealed in a protective heat-sealed polythene film.
Packages and prices
a)
solution of lidocaine hydrochloride 20 mg/ml solution of lidocaine hydrochloride 20 mg/ml with adrenaline 1:100.000 solution of lidocaine hydrochloride 20 mg/ml with adrenaline 1:80.000 d) solution of lidocaine hydrochloride 20 mg/ml with adrenaline 1:50.000 6.5. MARKETING AUTHORISATION HOLDER
MOLTENI DENTAL srl
Registered and Administration Office:
Via I. Barontini 8, Loc. Granatieri, 50018-Scandicci (Florence)-Italy
6. 6. MARKETING AUTHORISATION NUMBER AND DATE OF FIRST AUTHORISATION
a)
b) ECOCAIN 20 mg/ml with adrenaline 1:100.000 c) ECOCAIN 20 mg/ml with adrenaline 1:80.000 AIC 027388065 d) ECOCAIN 20 mg/ml with adrenaline 1:50.000 AIC 027388089 e) ECOCAIN SPRAY 100 mg/ml Date of first authorisation in ITALY: April 1990
6.7. POSSIBLE TABLE OF BELONGING IN ACCORDANCE WITH DPR 309/90
Not subject.
6.8. DISPENSING PUBLIC SYSTEM
Out of public sale, medicine only for odontoiatric use.

Source: http://www.eurodental.it/it/download/molteni/ECOCAIN.pdf