SUPRANE (desflurane, USP)

SUPRANE (desflurane, USP)

Instructions for Use

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Suprane (desflurane, USP) Volatile Liquid for Inhalation Indications

Suprane (desflurane, USP) is indicated as an inhalation agent for induction of anesthesia for inpatient and outpatient surgery in adults. Suprane (desflurane, USP) is contraindicated as an inhalation agent for the induction of anesthesia in pediatric patients because of a high incidence of moderate to severe upper airway adverse events.

Suprane (desflurane, USP) is indicated as an inhalation agent for maintenance of anesthesia for inpatient and outpatient surgery in adults and pediatric patients. 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) is not approved for maintenance of anesthesia in non-intubated children due to an increased incidence of respiratory adverse reactions, including coughing, laryngospasm, and secretions.

Suprane (desflurane, USP) Volatile Liquid for Inhalation Important Risk Information

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. Suprane (desflurane, USP) is administered by inhalation. The administration of general anesthesia must be individualized based on the patient's response. Hypotension and respiratory depression increase as anesthesia with Suprane (desflurane, USP) is deepened.

Suprane (desflurane, USP) is contraindicated: in patients with a known or suspected genetic susceptibility to malignant hyperthermia; in whom general anesthesia is contraindicated; for the induction of anesthesia in pediatric patients: in patients with a known sensitivity to Suprane (desflurane, USP) or to other halogenated agents.

In susceptible individuals, potent inhalation anesthetic agents may trigger a skeletal muscle hypermetabolic state leading to high oxygen demand and the clinical syndrome known as malignant hyperthermia.

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 approved for maintenance of anesthesia in non-intubated children due to an increased incidence of respiratory adverse reactions, including coughing, laryngospasm and secretions. Caution should be exercised when Suprane (desflurane, USP) is used for maintenance of anesthesia with laryngeal mask airway (LMATM mask) in children 6 years old or younger because of the increased potential for adverse respiratory events, e.g., coughing and laryngospasm, especially with removal of the LMATM mask under deep anesthesia.

Concentrations of Suprane (desflurane, USP) exceeding 1 MAC may increase heart rate. With this drug, an increased heart rate may not be a reliable sign of inadequate anesthesia.

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) may produce a dose-dependent increase in cerebrospinal fluid pressure (CSFP) in patients with intracranial space occupying lesions. In these patients, Suprane (desflurane, USP) should be administered at 0.8 MAC or less, and in conjunction with a barbiturate induction and hyperventilation (hypocapnia) until cerebral decompression in patients with known or suspected increases in CSFP.

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 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. As with all halogenated anesthetics, repeated anesthesia within a short period of time should be approached with caution.

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

In clinical trials, the most frequently reported adverse events greater than 1% during induction (use as a mask inhalation agent) in adults were: coughing, breath holding, apnea, increased secretions, laryngospasm, oxyhemoglobin desaturation (SpO2 <90%), pharyngitis. The most frequently reported adverse events greater than 1% during maintenance/recovery in adults and intubated pediatric patients were: headache, bradycardia, hypertension, nodal arrhythmia, tachycardia, nausea, vomiting, increased salivation, apnea, breath holding, cough increased, laryngospasm, pharyngitis and conjunctivitis.

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