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UTILYCAINE, LIGNOKENT, LIGNOSPAN SPECIAL, EUROCAINE is a brand name for Epinephrine (also known as Adrenaline). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Production of local anaesthesia for dental procedures by infiltration or nerve block injection. LIGNOSPAN SPECIAL is indicated in adults, children and adolescents.
Verbatim from this product's MHRA label. Tap a section to expand.
For professional use by dentists and stomatologists only.
Posology:
As with any anaesthetic, doses vary and depend on the area to be anaesthetised, on the vascularity of tissues, on the number of nerve segments to be blocked, on the individual tolerance (degree of muscular relaxation and condition of the patient) and on the technique and depth of anaesthesia.
The lowest dose leading to efficient anaesthesia should be used. The necessary dosage must be determined on an individual basis. • Adults: The maximum recommended dose is 7 mg/kg of body weight for a healthy adult above 50 kg of body weight with an absolute maximum dose of 500 mg of lidocaine or 200 micrograms of adrenaline.
However, due to this product’s fixed component of adrenaline 1:80,000, the latter will determine the maximum administered quantity to be 16 ml solution (containing 200 micrograms of adrenaline) which must not be exceeded. 3 • Adolescents (12 to 18 years of age) and children (4 to 11 years of age) 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 20mg to 30mg lidocaine hydrochloride per session. 33. Do not exceed the equivalent of 5 mg of lidocaine hydrochloride per kilogram of body weight. 7 • Special populations Due to the lack of clinical data, particular precaution should be used in order to administer the lowest dose leading to effective anaesthesia in elderly patients over 70 years old and in patients with renal or hepatic impairment.
Method of administration:
Infiltration or nerve block injection. Before injection, aspiration should always be performed to avoid intravascular injection and if required, the needle repositioned until no return of blood can be elicited by aspiration. The absence of blood in the syringe does not guarantee that intravascular injection has been avoided.
Major systemic reactions as a result of accidental intravascular injection can be avoided in most cases by an injection technique after aspiration with a slow injection: the rate of injection should not exceed 1 ml of solution per minute.
a) Summary of the safety profile Adverse reactions following administration of the product are similar to those observed with other amide local anaesthetics combined with vasoconstrictors. These adverse reactions are, in general, dose-related and may result from high plasma levels caused by overdose, rapid absorption or unintended intra- vascular injection.
They may also result from hypersensitivity, idiosyncrasy, or diminished tolerance by the specific patient. Nervous system disorders, cardiac disorders and vascular disorders are the most frequently occurring adverse reactions. Serious adverse reactions are generally systemic.
The presence of adrenaline increases the product’s safety profile due to its sympathomimetic effects. b) Tabulated list of adverse reactions The reported adverse reactions come from spontaneous reporting, clinical studies and literature.
By convention, frequency of initial signs of CNS or CVS toxicity is considered as rare.
The frequencies classification follows the convention:
Very common (≥ 1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very Rare (<1/10,000) and “Not known (cannot be estimated from the available data)”. MedDRA system Organ Class Frequency Adverse Reactions Infections and infestations Not known Gingivitis Immune system disorders Rare Hypersensitivity1 Anaphylactic / anaphylactoid reactions1 Rare Confusional statePsychiatric disorders Very rare Euphoric mood Anxiety/Nervousness/Agitation/Restlessness Common Neuropathy peripheral2: Neuralgia (neuropathic pain) Headache Dizziness (light headedness) Tremor Nervous system disorders Rare Deep CNS depression: Loss of consciousness Convulsion (including tonic clonic seizure) Somnolence Eye disorders4 Rare Visual impairment Vision blurred Accommodation disorder Ear and labyrinth disorders Very rare Tinnitus Common Palpitations Tachycardia Cardiac disorders Very rare Conduction disorders, atrioventricular block Bradyarrhythmia Cardiac arrest Tachyarrhytmia (including ventricular extrasystoles and ventricular fibrillation)5 Common Hypotension (with possible circulatory collapse) Hypertension Pallor (local, regional, general) Vascular disorders Very rare Vasodilatation Vasoconstriction Hot flush Common Dyspnoea Rare Bronchospasm / asthma Respiratory, thoracic and mediastinal disorders Not known Respiratory depression3 Apnoea (respiratory arrest) Uncommon Nausea Vomiting Gastrointestinal disorders Not known Gingival/oral mucosal exfoliation (sloughing)/ ulceration/ necrosis6 Dysphagia1Recurrent aphthous stomatitis, glossitis7 Diarrhoea Uncommon Rash (eruption) Pruritus (itching) Rare Angioedema1 (oedema of face / tongue / lip / throat / larynx / periorbital oedema) Urticaria Skin and subcutaneous tissue disorders Very rare Hyperhidrosis Swelling face Musculoskeletal and connective tissue disorders Uncommon Myalgia Arthralgia Common Injection site reaction8 Very rare Injection site pain General disorders and administration site conditions Not known Injection site swelling Malaise Pyrexia c) Description of selected adverse reactions 1 Hypersensitivity (anaphylactic or anaphylactoid reactions) may characteristically occur with various symptoms of rash (eruption), urticarial, pruritus, bronchospasm/asthma, wheezing, and angiodema.
9).
Special warnings This product must be used with caution in:
Patients with cardiovascular disorders: - Peripheral vascular disease. - Arrhythmias particularly of ventricular origin; - Heart failure; - Hypotension. The product should be administered with caution in patients with impaired cardiac function since they may be less able to compensate changes due to the prolongation of atrio-ventricular conduction.
Patients with myasthenia gravis:
The lowest dose leading to effective anaesthesia should be used as these patients are particularly sensible to the effect of local anaesthetics.
Patients with epileptic disease:
Because of their convulsive actions, all local anaesthetics should be used very cautiously. 2.
Patients with renal disease:
The lowest dose leading to effective anaesthesia should be used.
Patients with thyrotoxicosis:
The lowest dose leading to effective anaesthesia should be used.
Patients with coronary artery disease and valvular cardiac disease:
The lowest dose leading to effective anaesthesia should be used.
Patients receiving treatment with antiplatelets / anticoagulants:
The increased risk of severe bleeding after accidental vessel puncture and during oro-maxillo-facial surgery should be considered. INR monitoring should be increased in patients under anticoagulants.
Patients with uncontrolled diabetes:
1. , severe bradycardia, 2nd / 3rd degree AV blocks) • Acute intermittent porphyria; Due to adrenaline: • Uncontrolled /severe hypertension, • Persistent / refractory tachyarrhythmia • Pheochromocytoma.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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g. hepatitis transmission), syringe and needles used to draw up the solution must always be fresh and sterile. For single use. Any unused solution should be discarded. The medicinal product should not be used if cloudy or discoloured. 6.
Angioedema include oedema of face / tongue / lip / throat / larynx / periorbital oedema. Laryngo-pharyngeal oedema may characteristically occur with hoarseness and / or dysphagia. Bronchospasm (bronchoconstriction) may characteristically occur with dyspnoea; 2 These neural pathologies may occur with the various symptoms of abnormal sensations of the lips, tongue, and oral tissues.
5) 6 Necrosis is due to excessive local effect of the vasoconstrictor and mostly occurs in patients with underlying ischemic diseases; 7 This may be the sign of an injury to the lingual nerve 8 Procedural pain, post procedural pain and contusion are symptoms that may be associated to injection site reaction Because of the presence of adrenaline, precautions and monitoring should be enhanced in the following situations: patients stressed prior dental procedure.
Any previous knowledge of such underlying conditions in patients requiring dental anaesthesia should be minded and a minimal dose of local anaesthetic with vasoconstrictor used. d) Paediatric population The safety profile was similar in children and adolescents from 4 to 18 years old compared to adults.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard
This product should be used cautiously due to hyperglycemic effect of adrenaline.
Patients with susceptibility of acute angle-closure glaucoma:
This product should be used cautiously due to the presence of adrenaline.
Patients under the influence of illicit drug:
The efficacy of this product may be decreased in these patients.
Elderly patients:
Dosages should be reduced in elderly patients over 70 years old (lack of clinical data).
The product must be used safely and effectively under appropriate conditions:
Adrenaline impairs the flow of blood in the gums, potentially causing local tissue necrosis. The local anaesthetic effects may be reduced if the product is injected into an inflamed or infected area. Risk of biting trauma (lips, cheeks, mucosa, and tongue) exists, especially in children; the patient should be told to avoid chewing gum or eating until sensation is restored.
, convulsions, followed by central nervous system or cardiorespiratory depression and coma, progressing ultimately to respiratory arrest, due to the sudden high level of adrenaline and / or lidocaine in the systemic circulation.
Risk associated with intraneural injection:
Accidental intraneural injection may lead the drug to move in retrograde manner along the nerve. In order to avoid intraneural injection and to prevent nerve injuries in connection with nerve blockades, the needle should always be slightly withdrawn if electric shock sensation is felt by the patient during injection or if the injection is particularly painful.
If needle nerve injuries occur, the neurotoxic effect could be aggravated by lidocaine’s potential chemical neurotoxicity and the presence of adrenaline as it may impair the perineural blood supply and prevent lidocaine local wash-out.
Risk of Takotsubo cardiomyopathy or stress-induced cardiomyopathy:
Stress cardiomyopathy induced by injected catecholamines has been reported. g. an administered dose higher than recommended or in case of an accidental intravascular injection. Any previous knowledge of such underlying conditions in patients requiring dental anaesthesia should be minded and a minimal dose of local anaesthetic with vasoconstrictor used.
The medicinal product contains potassium metabisulfite, a sulfite that may rarely cause hypersensitivity reactions and bronchospasm. e. essentially ‘potassium-free’. 602 mg/ml) sodium (main component of cooking/table salt). 665% of the recommended maximum daily dietary intake of sodium for an adult.
65% of the recommended maximum daily intake of sodium for an adult. 5).