SUPRANE (desflurane, USP)

SUPRANE (desflurane, USP)

Instructions for Use

The information contained in this page is intended for U.S. healthcare professionals only.

Indications & Usage

Suprane (desflurane, USP) is indicated as an inhalation agent for induction and/or maintenance of general anesthesia for inpatient and outpatient surgery in adults.

Suprane (desflurane, USP) is not recommended for induction of anesthesia in pediatric patients because of a high incidence of moderate to severe upper airway adverse events. After induction of anesthesia with agents other than Suprane (desflurane, USP), and tracheal intubation, Suprane (desflurane, USP) is indicated for maintenance of anesthesia in infants and children.

Suprane (desflurane, USP) should be administered only by persons trained in the administration of general anesthesia, using a vaporizer specifically designed and designated for use with desflurane. Facilities for maintenance of a patent airway, artificial ventilation, oxygen enrichment, and circulatory resuscitation must be immediately available. Hypotension and respiratory depression increase as anesthesia is deepened.

Important Risk Information

Suprane (desflurane, USP) should not be used in patients with a known or suspected genetic susceptibility to malignant hyperthermia, or known sensitivity to Suprane (desflurane, USP) or to other halogenated agents.

Use of inhaled anesthetic agents has been associated with rare increases in serum potassium levels that have resulted in cardiac arrhythmias and death in pediatric patients during the postoperative period. Patients with latent as well as overt neuromuscular disease, particularly Duchenne muscular dystrophy, appear to be most vulnerable. Concomitant use of succinylcholine has been associated with most, but not all of these cases.

Suprane (desflurane, USP) is not recommended for induction of general anesthesia via mask in infants or children because of the high incidence of moderate to severe respiratory adverse reactions (laryngospasm, coughing, breathholding, increase in secretions and oxyhemoglobin desaturation).

Concentrations of desflurane exceeding 1 MAC may increase heart rate. Thus, an increased heart rate may not be a sign of inadequate anesthesia.

The average MAC for Suprane (desflurane, USP) in a 70 year old patient is two-thirds the MAC for a 20 year old patient.

All volatile anesthetics may increase intracranial pressure in patients with intracranial space occupying lesions. In these patients, Suprane (desflurane, USP) should be administered at 0.8 MAC or less, in conjunction with barbiturate induction and hyperventilation.

Suprane (desflurane, USP) should not be used as the sole agent for anesthetic induction in patients with coronary artery disease or patients where increases in heart rate or blood pressure are undesirable.

Suprane (desflurane, USP), like some other inhalational anesthetics, can react with desiccated carbon dioxide (CO2) absorbents to produce carbon monoxide which may result in elevated levels of carboxyhemoglobin in some patients. Case reports suggest that barium hydroxide lime and soda lime become desiccated when fresh gases are passed through the CO2 absorber canister at high flow rates over many hours or days.

As with other halogenated anesthetic agents, Suprane (desflurane, USP) may cause sensitivity hepatitis in patients who have been sensitized by previous exposure to halogenated anesthetics.

In clinical trials, the most frequently reported adverse events during induction in adults were respiratory events (coughing, breathholding, apnea, laryngospasm). The most frequently reported adverse events during maintenance/recovery in adults and intubated pediatric patients were nausea, vomiting, and respiratory events.

Additional adverse reactions that have been reported in the post-marketing setting include: cardiac arrest, respiratory arrest, convulsions, hepatic failure, hepatic necrosis, rhabdomyolysis as well as others which are all detailed in the full prescribing information

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Material Safety Data Sheet

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Resources

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