LIGNOSPAN 2% Special 2.2ml is a Prescription Medicine only administered by a dentist. Contains Lidocaine hydrochloride (2%), adrenaline tartrate (1/80.000), injection solution 2.2mL Lidocaine solutions are indicated for the production of local anaesthesia in routine dental procedures and oral surgery by means of infiltration and nerve block techniques.Lidocaine solutions with adrenaline are recommended for oral surgery requiring prolonged duration of anaesthesia and haemostasis.
Contraindications: These may be of three types: a. contraindications to Lidocaine :- specific allergies to Lidocaine or to other anaesthetics of amide type,- allergies of cross type procaine – lidocaine. b. contraindications to the vasoconstrictor :- cerebral arteriosclerosis, - arterial hypertension, - coronary disease, - valvular cardiac disease (particularly sequelae to acute rheumatic fever).
- thyrotoxicosis, untreated, - known sensitivity to sympathomimetic amines. c. - hypersensitivity to sulfites (potassium metabisulfite is present in the formula as an antioxidant),- injection by intravenous route, - inflammation or sepsis in the region of the proposed injection.
Special warnings and precautions for use: - General precautions- WHEN ANY LOCAL ANAESTHETIC AGENT IS USED, RESUSCITATIVE EQUIPMENT AND DRUGS, INCLUDING OXYGEN, SHOULD BE IMMEDIATELY AVAILABLE IN ORDER TO MANAGE POSSIBLE ADVERSE REACTIONS INVOLVING THE CARDIOVASCULAR, RESPIRATORY OR CENTRAL NERVOUS SYSTEMS. BECAUSE OF THE POSSIBILITY OF HYPOTENSION AND BRADYCARDIA FOLLOWING MAJOR BLOCKS, AN IV CANNULA SHOULD BE INSERTED BEFORE THE LOCAL ANAESTHETIC IS INJECTED. DELAY IN PROPER MANAGEMENT OF DOSE-RELATED TOXICITY, UNDER VENTILATION FROM ANY CAUSE AND/OR ALTERED SENSITIVITY MAY LEAD TO THE DEVELOPMENT OF ACIDOSIS, CARDIAC ARREST AND DEATH. INJECTION SHOULD ALWAYS BE MADE SLOWLY WITH
FREQUENT ASPIRATIONS TO AVOID INADVERTENT INTRAVASCULAR INJECTION WHICH CAN PRODUCE CEREBRAL SYMPTOMS EVEN AT LOW DOSES.
Note, however, that the absence of blood in the syringe does not assure that intravascular injection will be avoided. There should be careful monitoring of cardiovascular and respiratory vital signs after each injection.
Use with caution in the following circumstances: - the lowest dosage that results in effective anaesthesia should be used to avoid high plasma levels and serious adverse effects. - Lidocaine should be used with caution in patients with epilepsy, bradycardia, digitalis intoxication, severe shock or heart block. - Inadvertent intravascular injection of small doses of Lidocaine injected into the head or neck area, including retrobulbar, dental and stellate injection blocks, may produce adverse effects similar to systemic toxicity seen with unintentional intravascular injection of larger doses. - Lidocaine should be used with caution in patients with hepatic or renal disease, since amide-type local anaesthetics are metabolised by the liver and excreted via kidneys - Lidocaine should be used with caution in persons with known drug sensitivities. - Solutions containing adrenaline should be used with extreme caution in patients with severe or untreated hypertension, arteriosclerotic heart disease, heart block, cerebral vascular insufficiency, thyrotoxicosis, advanced diabetes or any other pathological condition that might be aggravated by the effects of adrenaline.
Interaction with other medicines and other forms of interaction: The administration of local anaesthetic solutions containing adrenaline or noradrenaline to patients receiving monoamine oxidase inhibitors, butyrophenones, tricyclic antidepressants or phenothiazines may produce severe prolonged hypotension or hypertension. Concurrent use of these agents should generally be avoided. In situations when concurrent therapy is necessary, careful patient monitoring is essential. Concurrent administration of vasopressor drugs and ergot-type oxytocic drugs may cause severe, persistent hypertension or cerebrovascular accidents.
Fertility, pregnancy and lactation: - Carcinogenicity and mutagenicity: Studies of Lidocaine in animals to evaluate the carcinogenic and mutagenic potential or the effect on fertility have not been conducted. Use in pregnancy (category A): The safe use of Lidocaine during pregnancy has not been established. Lidocaine has however been used extensively for dental procedure during pregnancy with no proven increase in frequency of malformations or of harmful effects to mother or foetus.
Use in lactation : Lidocaine passes into breast milk. The amount of Lidocaine appearing in breast milk from a breastfeeding mother receiving parental Lidocaine is unlikely to lead to significant accumulation of the parent drug in the breast-fed infant. The remote possibility of an idiosyncratic or allergic reaction in the breast-fed infant from Lidocaine remains to be determined.
Dose:
The lowest dosage that results in effective anaesthesia for the planned treatment should be used.
For adults, a single cartridge (2.2 mL) is generally sufficient. Two cartridges (4.4 mL) may be used in case of large interventions.
For adolescents between 14 and 17 years, usual dosage one cartridge (2.2 mL). Do not exceed 2 cartridges (4.4 mL) in general cases.
For children between 6 and 14, usual dose 3/4 of the cartridge (1.65 mL). Do not exceed 1 1/2 cartridges (3.3 mL) in usual cases.
For children between 3 and 6, between 1/2 to 1 cartridge (1.1 mL to 2.2 mL).
Do not use on children under three years of age.
Undesirable effects - Common reactions (≥ 1 % and < 10%): Excluding post procedural dental pain, local reactions at the injection site are the most common adverse events: infection, gingivitis, pain and edema. Headache, paresthesia and hyperaesthesia are also reported after use of anaesthetic injections during dental procedures.
For full information on dosage, contraindications, precautions, interactions and adverse effects please refer to the data sheet available at www.medsafe.govt.nz or by clicking on the link provided with this product. NZ Sponsor: IVOCLAR VIVADENT Ltd, AUCKLAND, NEW ZEALAND
NP21449 - Aug 2024