Product Dossier
SUPRANE
Product Dossier for SUPRANE (desflurane, Baxter Healthcare). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.
- Sponsor: Baxter Healthcare
- Active ingredient: desflurane
- Therapeutic area: Other
- Related brand: PIRAMAL
- Same area: APO-CLONIDINE
- Same area: DIAMOX
What it is
SUPRANE is desflurane 1g/g, supplied as a liquid for inhalation. Desflurane is a halogenated methylethylether administered by inhalation that produces a dose-related, reversible loss of consciousness and of pain sensations, suppression of voluntary motor activity, modification of autonomic reflexes and sedation of respiration and the cardiovascular system.
Approved indications
— Inhalation agent for maintenance of anaesthesia.
Dosing overview
The minimum alveolar concentration (MAC) of SUPRANE is age-specific and decreases with increasing patient age, ranging from 8.95–10.65% in 100% oxygen for patients aged 0–1 year to 5.17 ± 0.6% for patients over 65 years. Surgical levels of anaesthesia may be sustained with 2 to 6% end-tidal concentration when nitrous oxide is used concomitantly, or 2.5 to 8.5% when administered using oxygen or oxygen enriched air. In children, surgical levels of anaesthesia may be maintained with end-tidal concentrations of 5.2 to 10% SUPRANE with or without the concomitant use of nitrous oxide. Opioids or benzodiazepines decrease the amounts of SUPRANE required to produce anaesthesia.
Key safety warnings
SUPRANE is not recommended for mask induction of anaesthesia because of a high incidence of moderate to severe upper airway adverse events such as laryngospasm, apnoea, increase in secretions, breath-holding and coughing, especially in children and infants and with high concentrations of SUPRANE. SUPRANE may interact with dry carbon dioxide absorbents to form carbon monoxide that may result in elevated levels of carboxyhaemoglobin in some patients; fresh (moist) CO₂ absorbents should be used, with soda lime moisture content greater than 5% water and Baralyme greater than 10% water. SUPRANE should not be used as the sole anaesthetic in patients with coronary artery disease or in patients where increases in heart rate or blood pressure are undesirable; when SUPRANE is used in patients with coronary artery disease, it should always be used in combination with other medicines such as intravenous opioids or hypnotics and should not be used for induction. SUPRANE may produce a dose-dependent increase in cerebrospinal fluid or intracranial pressure in patients with space occupying lesions; in such patients, desflurane should be administered at 0.8 MAC or less in conjunction with a barbiturate or propofol induction and hyperventilation in the period before cranial decompression, with appropriate attention to maintain cerebral perfusion pressure. SUPRANE is a potential trigger of malignant hyperthermia; if malignant hyperthermia occurs, discontinue the triggering agent and administration of intravenous dantrolene sodium will be indicated to reverse this hyperthermia, as well as application of supportive therapy. Use of inhaled anaesthetic agents including desflurane has been associated with rare increases in serum potassium levels that have resulted in cardiac arrhythmias, some fatal, in patients during the postoperative period, particularly in patients with latent or overt muscular dystrophies such as Duchenne Muscular Dystrophy; early and aggressive intervention to treat hyperkalaemia and resistant arrhythmias is recommended.
Contraindications
SUPRANE should not be used for patients in whom general anaesthesia is contraindicated; it is contraindicated in patients with known sensitivity to halogenated agents and in patients with known or genetic susceptibility to malignant hyperthermia, a history of malignant hyperthermia, or in whom liver dysfunction, hepatitis or jaundice with unexplained fever, leucocytosis and/or eosinophilia has occurred after a previous halogenated anaesthetic administration. SUPRANE is contraindicated for use as an inhalation induction agent in paediatric patients because of the frequent occurrence of cough, breath-holding, apnoea, laryngospasm and increased secretions.
Regulatory history
SUPRANE was first listed on the ARTG on 20 August 1997.