SCANDONEST

What it is

Mepivacaine hydrochloride is a local anaesthetic. SCANDONEST 2% Special contains mepivacaine hydrochloride 2% (20 mg/mL) with adrenaline (epinephrine) 1:100,000. SCANDONEST 3% contains mepivacaine hydrochloride 3% (30 mg/mL). SCANDONEST 2% Special is supplied in sterile aqueous injection cartridges of 1.8 mL and 2.2 mL. SCANDONEST 3% is a sterile aqueous injection solution. Adrenaline (epinephrine) in SCANDONEST 2% Special is a vasoconstrictor.

Approved indications

— SCANDONEST 2% Special is recommended for oral surgery requiring prolonged duration of anaesthesia and haemostasis. — SCANDONEST 3% is indicated for the production of local anaesthesia in routine dental procedures and oral surgery by means of infiltration and nerve block techniques.

Dosing overview

The lowest dosage that results in effective anaesthesia for the planned treatment should be used. Dosing differs between the two strengths.

For SCANDONEST 2% Special: A single cartridge (2.2 mL) is generally sufficient for adults, with a maximum of three cartridges (6.6 mL). Adolescents aged 14–17 years typically receive one cartridge (2.2 mL), not exceeding 2 cartridges (4.4 mL) in general cases. Children aged 6–14 years usually receive 1.35 mL, not exceeding 2.7 mL. Children aged 3–6 years must not exceed 1.8 mL. For SCANDONEST 3%: A single cartridge (2.2 mL) is generally sufficient for adults, with a maximum of three cartridges (6.6 mL). Adolescents aged 14–17 years typically receive one cartridge (2.2 mL), not exceeding 2 cartridges (4.4 mL). Children aged 6–14 years usually receive 1.35 mL, not exceeding 2.7 mL. Children aged 3–6 years must not exceed 1.8 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 IV 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. 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. Since amide-type local anaesthetics are metabolised by the liver and excreted via kidneys, SCANDONEST should be used with caution in patients with hepatic or renal disease, as patients with severe hepatic disease or renal impairment are at greater risk of developing toxic plasma concentration. Due to the presence of adrenaline (epinephrine) in SCANDONEST 2% Special, the product is not advised for diabetic subjects or for patients with thyrotoxicosis. Mepivacaine with adrenaline solutions contain sodium metabisulfite, a sulfite that may cause allergic type reactions including anaphylactic symptoms and asthmatic episodes, and sulfite sensitivity is seen more frequently in asthmatic than non-asthmatic people.

Contraindications

Contraindications to mepivacaine include specific allergies to mepivacaine or to other anaesthetics of amide type, and allergies of cross type procaine–mepivacaine. Contraindications to adrenaline (epinephrine) in SCANDONEST 2% Special include cerebral arteriosclerosis, arterial hypertension, coronary disease, valvular cardiac disease (particularly sequelae to acute rheumatic fever), thyrotoxicosis (untreated), and known sensitivity to sympathomimetic amines. Hypersensitivity to sulfites (potassium metabisulfite is present in SCANDONEST 2% Special), injection by intravenous route, inflammation or sepsis in the region of the proposed injection, hypersensitivity to any other component, patients receiving monoamine oxidase inhibitors (or who have received such an agent within two weeks) or tricyclic antidepressants, and patients in whom there is a possibility that general anaesthesia might be required to complete the procedure are all contraindicated. Do not use on children under three years of age.

PBS listing

SCANDONEST is not listed on the Pharmaceutical Benefits Scheme. The product is registered on the Australian Register of Therapeutic Goods for private dispensing.

Regulatory history

SCANDONEST 3% mepivacaine 54 mg/1.8 mL injection cartridge (ARTG 49310) was first listed on 13 July 1994. SCANDONEST 3% mepivacaine 66 mg/2.2 mL injection cartridge (ARTG 49313) was first listed on 13 July 1994.