Product Dossier
Lignospan Special
Product Dossier for Lignospan Special (adrenaline (epinephrine), lidocaine hydrochloride monohydrate, Specialites Septodont). ARTG record, PBS listing,…
- Sponsor: Specialites Septodont
- Active ingredient: adrenaline (epinephrine), lidocaine hydrochloride monohydrate
- Therapeutic area: Pain Management
- Related brand: ANAPEN
- Related brand: EPIPEN
- Related brand: JEXT
- Same area: PALEXIA
- Same area: OXYCONTIN
What it is
LIGNOSPAN SPECIAL contains a local anaesthetic of amide type, lidocaine hydrochloride monohydrate (2%), combined with a vasoconstrictor, adrenaline (epinephrine) as acid tartrate (1/80,000). LIGNOSPAN SPECIAL is an injection, solution – a clear colourless liquid.
Approved indications
— Production of local anaesthesia in routine dental procedures and oral surgery by means of infiltration and nerve block techniques. — Oral surgery requiring prolonged duration of anaesthesia and haemostasis.
Dosing overview
The lowest dosage that results in effective anaesthesia for the planned treatment should be used. The dosage will depend upon the area of the oral cavity to be anaesthetised, the vascularity of the oral tissues and the technique of anaesthesia. 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.
Key safety warnings
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 intravenous cannula should be inserted before the local anaesthetic is injected. Injection should always be made slowly with frequent aspirations to avoid inadvertent intravascular injection which can produce cerebral symptoms even at low doses. There should be careful monitoring of cardiovascular and respiratory vital signs after each injection. LIGNOSPAN SPECIAL contains sodium metabisulfite, a sulfite that may cause allergic type reactions including anaphylactic symptoms and life threatening or less severe asthmatic episodes in certain susceptible people. Sulfite sensitivity is seen more frequently in asthmatic than non-asthmatic people. Lidocaine should be used with caution in patients with hepatic disease, since amide-type local anaesthetics are metabolised by the liver. Patients with hepatic impairment, because of their inability to metabolise or excrete local anaesthetics normally, are at greater risk of developing toxic plasma concentrations. Lidocaine should be used with caution in patients with renal disease, since amide-type local anaesthetics are excreted via kidneys. Patients with renal impairment, because of their inability to metabolise or excrete local anaesthetics normally, are at greater risk of developing toxic plasma concentrations.
Contraindications
Specific allergies to lidocaine or to other anaesthetics of amide type and hypersensitivity to sulfites (potassium metabisulfite is present in the formula as an antioxidant) are contraindicated. Contraindications to the vasoconstrictor include: cerebral arteriosclerosis, arterial hypertension, coronary disease, valvular cardiac disease (particularly sequelae to acute rheumatic fever), thyrotoxicosis (untreated) and known sensitivity to sympathomimetic amines. Injection by intravenous route and inflammation or sepsis in the region of the proposed injection are also contraindicated.
Regulatory history
LIGNOSPAN SPECIAL was first listed on the Australian Register of Therapeutic Goods on 13 July 1994.