Drugplain

FORANE 1 mL/mL

isoflurane · INHALANT · Baxter Healthcare Corporation

No Recall History
Plain English

Forane is a general anesthetic inhaled through the lungs used to put patients to sleep during surgery and medical procedures. It is administered by a healthcare provider in a controlled medical setting such as an operating room or facility equipped for anesthesia.

Key Facts

Brand Name
FORANE
Generic Name
isoflurane
NDC Code (Product)
10019-360
Manufacturer
Baxter Healthcare Corporation
Strength
1 mL/mL
Dosage Form
INHALANT
Route
RESPIRATORY (INHALATION)
Marketing Status
Application #
NDA017624
Drug Class
General Anesthetic [EPC]
Marketing Start
12/18/1979

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

hypotension235 reports
drug ineffective175 reports
renal failure158 reports
pain149 reports
injury136 reports
anxiety128 reports
unevaluable event123 reports
drug interaction121 reports
off label use113 reports
fear110 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE FORANE (isoflurane, USP) may be used for induction and maintenance of general anesthesia. Adequate data have not been developed to establish its application in obstetrical anesthesia. FORANE, a general anesthetic, is an inhalation agent indicated for induction and maintenance of general anesthesia. ( 1 )

Dosage & Administration

2 DOSAGE AND ADMINISTRATION • FORANE should be administered only by persons trained in the administration of general anesthesia. FORANE should only be delivered using a vaporizer specifically designed and designated for use with isoflurane. ( 2 ) • The administration of general anesthesia must be individualized and titrated based on the patient’s age and clinical status. ( 2 ) 2.1 Important Dosage and Administration Information FORANE should be administered only by persons trained in the administration of general anesthesia. Facilities for maintenance of a patent airway, artificial ventilation, oxygen enrichment, and circulatory resuscitation must be immediately available. FORANE is administered by inhalation. FORANE should be delivered from a vaporizer specifically designed for use with FORANE. Dosage for induction and maintenance must be individualized and titrated to the desired effect according to the patient’s age and clinical status. With the exception of neonates, the minimum alveolar concentration (MAC) of isoflurane decreases with increasing patient age. Nitrous oxide decreases the MAC of FORANE (see Table 1 ). Opioids decrease the MAC of FORANE [see Drug Interactions (7) …

Contraindications

4 CONTRAINDICATIONS FORANE is contraindicated in patients: • in whom general anesthesia is contraindicated. • with known sensitivity to FORANE or to other halogenated agents [see Warnings and Precautions (5.3) ] . • with known or suspected genetic susceptibility to malignant hyperthermia [see Warnings and Precautions (5.1) , Clinical Pharmacology (12.5) ] . • with a history of confirmed hepatitis due to a halogenated inhalational anesthetic or a history of unexplained moderate to severe hepatic dysfunction (e.g., jaundice associated with fever and/or eosinophilia) after anesthesia with isoflurane or other halogenated inhalational anesthetics. • Patients in whom general anesthesia is contraindicated ( 4 ) • Patients with known sensitivity to FORANE or other halogenated agents ( 4 ) • Patients with known or suspected genetic susceptibility to malignant hyperthermia ( 4 ) • Patients with a history of confirmed hepatitis due to a halogenated inhalational anesthetic or a history of unexplained moderate to severe hepatic dysfunction (e.g., jaundice associated with fever and/or eosinophilia) after anesthesia with FORANE or other halogenated inhalational anesthetics ( 4 )

Drug Interactions

7 DRUG INTERACTIONS • Concomitant use of N 2 O and/or opioids reduces the MAC of FORANE. Adjust dose accordingly. ( 7.1 , 7.2 ) • FORANE decreases the doses of neuromuscular blocking agents required. Adjust dose accordingly. ( 7.3 ) 7.1 Opioids Opioids decrease the Minimum Alveolar Concentration (MAC) of FORANE. Opioids such as fentanyl and its analogues, when combined with FORANE, may lead to a synergistic fall in blood pressure and respiratory rate. 7.2 Nitrous Oxide Nitrous oxide decreases the MAC of FORANE [see Dosage and Administration (2.1) ] . 7.3 Neuromuscular Blocking Agents FORANE potentiates the muscle relaxant effect of all neuromuscular blocking agents and decreases the required doses of neuromuscular blocking agents. In general, anesthetic concentrations of FORANE at equilibrium reduce the ED 95 of succinylcholine, atracurium, pancuronium, rocuronium and vecuronium by approximately 25 to 40% or more compared to N 2 O/opioid anesthesia. If added relaxation is required, supplemental doses of neuromuscular blocking agents may be used. 7.4 Adrenaline FORANE is similar to sevoflurane in the sensitization of the myocardium to arrhythmogenic effect of exogenously administere…

Adverse Reactions

6 ADVERSE REACTIONS Most common adverse reactions (incidence ≥ 5%) are agitation, cough, breath holding, nausea, chills/shivering, vomiting, laryngospasm, delirium. ( 6.1 ) 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 The following adverse reactions were identified from controlled clinical trials of adult and pediatric subjects exposed to FORANE. The trials were conducted using a variety of pre-medications, other anesthetics, and surgical procedures of varying lengths. The most serious reported adverse reactions in alphabetical order are agitation, arrhythmia, breath holding, elevated liver enzyme, hypotension and laryngospasm. The most frequent adverse reactions (incidence ≥ 5%) described in Table 1 are agitation, breath holding, chills/shivering, cough, delirium, laryngospasm, nausea, and vomiting. Adverse reactions with an incidence between 1% and 5% are provided in Table 2 . Adverse reactions with an incidence less than 1% are provided in Table 3 . Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed…

Frequently Asked Questions

What is FORANE used for?

Forane is a general anesthetic inhaled through the lungs used to put patients to sleep during surgery and medical procedures. It is administered by a healthcare provider in a controlled medical setting such as an operating room or facility equipped for anesthesia.

Is FORANE a controlled substance?

FORANE is not classified as a controlled substance by the DEA.

What is the generic name for FORANE?

The generic name for FORANE is isoflurane. There are 9 other brand versions of isoflurane.

What is the NDC code for FORANE 1 mL/mL?

The NDC (National Drug Code) for FORANE 1 mL/mL is 10019-360, listed by Baxter Healthcare Corporation.

Product NDC

10019-360

Package NDC

10019-360-40

Other Isoflurane Brands

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