SUPRANE 240 mL/240mL
desflurane · LIQUID · Baxter Healthcare Corporation
SUPRANE is a liquid containing desflurane at 240 mL/240mL, taken respiratory (inhalation). Manufactured by Baxter Healthcare Corporation.
Key Facts
- Brand Name
- SUPRANE
- Generic Name
- desflurane
- NDC Code (Product)
10019-641- Manufacturer
- Baxter Healthcare Corporation
- Strength
- 240 mL/240mL
- Dosage Form
- LIQUID
- Route
- RESPIRATORY (INHALATION)
- Marketing Status
- Application #
- NDA020118
- Drug Class
- General Anesthetic [EPC]
- Marketing Start
- 09/18/1992
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE SUPRANE, a general anesthetic, is an inhalation agent indicated: • for induction and/or maintenance of anesthesia in adults ( 1.1 ) • for maintenance of anesthesia in pediatric patients following induction with agents other than SUPRANE and intubation. 1.1 Induction of Anesthesia SUPRANE is indicated as an inhalation agent for induction of anesthesia for inpatient and outpatient surgery in adults. SUPRANE 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. 1.2 Maintenance of Anesthesia SUPRANE is indicated as an inhalation agent for maintenance of anesthesia for inpatient and outpatient surgery in adults and in pediatric patients. After induction of anesthesia with agents other than SUPRANE, and tracheal intubation, SUPRANE is indicated for maintenance of anesthesia in infants and children. SUPRANE 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 [ See Warnings and Precautions (5.3) and Clinical Studies …
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Only persons trained in the administration of general anesthesia should administer SUPRANE. Only a vaporizer specifically designed and designated for use with desflurane should be utilized for its administration. Facilities for maintenance of a patent airway, artificial ventilation, oxygen enrichment, and circulatory resuscitation must be immediately available. SUPRANE 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 is deepened. The minimum alveolar concentration (MAC) of SUPRANE decreases with increasing patient age. The MAC for SUPRANE is also reduced by concomitant N 2 O administration ( see Table 1 ). The dose should be adjusted accordingly. The following table provides mean relative potency based upon age and effect of N 2 O in predominately ASA physical status I or II patients. Benzodiazepines and opioids decrease the MAC of SUPRANE [ See Drug Interactions (7.1, Table 3) ]. SUPRANE also decreases the doses of neuromuscular blocking agents required [ See Drug Interactions (7.2, Table 4) ]. The dos…
Contraindications
4 CONTRAINDICATIONS The use of SUPRANE is contraindicated in the following conditions: • Known or suspected genetic susceptibility to malignant hyperthermia [see Warnings and Precautions (5.1) , Clinical Pharmacology (12.5) ] . • Patients in whom general anesthesia is contraindicated. • Induction of anesthesia in pediatric patients. • Patients with known sensitivity to SUPRANE or to other halogenated agents [ See Warnings and Precautions (5.5) ]. • Patients with a history of moderate to severe hepatic dysfunction following anesthesia with SUPRANE or other halogenated agents and not otherwise explained [ See Warnings and Precautions (5.5) ]. • Patients with known or suspected genetic susceptibility to malignant hyperthermia ( 4 ) • Patients in whom general anesthesia is contraindicated ( 4 ) • Induction of anesthesia in pediatric patients ( 4 ) • Patients with known sensitivity to halogenated agents ( 4 ) • Patients with a history of moderate to severe hepatic dysfunction following anesthesia with halogenated agents and not otherwise explained. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS No clinically significant adverse interactions with commonly used preanesthetic drugs, or drugs used during anesthesia (muscle relaxants, intravenous agents, and local anesthetic agents) were reported in clinical trials. The effect of SUPRANE on the disposition of other drugs has not been determined. Similar to isoflurane, SUPRANE does not predispose to premature ventricular arrhythmias in the presence of exogenously infused epinephrine in swine. • Concomitant use of N 2 O, benzodiazepines and/or opioids reduces the MAC of SUPRANE. Adjust dose accordingly. ( 7.1 , 7.3 ) • SUPRANE decreases the doses of neuromuscular blocking agents required. Adjust dose accordingly. (7.2) 7.1 Benzodiazepines and Opioids (MAC Reduction) Benzodiazepines and opioids decrease the amount of desflurane (MAC) needed to produce anesthesia. This effect is shown in Table 3 for intravenous midazolam (25-50 µg/kg) and intravenous fentanyl (3-6 µg/kg) in patients of two different age groups. Table 3 SUPRANE MAC with Fentanyl or Midazolam Mean ± SD (percent reduction) Dose 18-30 years 31-65 years No fentanyl 6.4 ± 0.0 6.3 ± 0.4 3 µg/kg fentanyl 3.5 ± 1.9 (46%) 3.1 ± 0.6 (51%) 6 µg/kg fentanyl…
Adverse Reactions
6 ADVERSE REACTIONS Most common adverse reactions (incidence> 10%) are coughing, breath holding, apnea, nausea, vomiting. (6) To report SUSPECTED ADVERSE REACTIONS, contact Baxter Healthcare Corporation at 1-800-262-3784 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse event information is derived from controlled clinical trials, the majority of which were conducted in the United States. The studies were conducted using a variety of premedications, other anesthetics, and surgical procedures of varying length. Most adverse events reported were mild and transient, and may reflect the surgical procedures, patient characteristics (including disease) and/or medications administered. Of the 2,143 patients exposed to SUPRANE in clinical trials, 370 adults and 152 children were induced with desflurane alone and 987 patients were maintained principally with desflurane. The frequencies given …
Frequently Asked Questions
What is SUPRANE used for?
SUPRANE contains desflurane. It is a liquid taken respiratory (inhalation). Consult your doctor for specific uses.
Is SUPRANE a controlled substance?
SUPRANE is not classified as a controlled substance by the DEA.
What is the generic name for SUPRANE?
The generic name for SUPRANE is desflurane. There are 4 other brand versions of desflurane.
What is the NDC code for SUPRANE 240 mL/240mL?
The NDC (National Drug Code) for SUPRANE 240 mL/240mL is 10019-641, listed by Baxter Healthcare Corporation.