Terrell (Page 4 of 4)

OVERDOSAGE

In the event of overdosage, or what may appear to be overdosage, the following action should be taken, as appropriate:

Stop drug administration, establish a clear airway, and initiate assisted or controlled ventilation with pure oxygen. Monitor cardiovascular function and manage signs of poor end-organ perfusion as clinically indicated

DOSAGE & ADMINISTRATION

Isoflurane 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.

Isoflurane is administered by inhalation. Isoflurane should be delivered from a vaporizer specifically designed for use with isoflurane.

The minimum alveolar concentration (MAC) of isoflurane decreases with increasing patient age.

Dosage for induction and maintenance must be individualized and titrated to the desired effect according to the patient’s age and clinical status.

Premedication: Premedication should be selected according to the need of the individual patient, taking into account that secretions are weakly stimulated by isoflurane, and the heart rate tends to be increased.

Induction: Induction with isoflurane in oxygen or in combination with oxygen-nitrous oxide mixtures may produce coughing, breath holding, laryngospasm and bronchospasm, which increases with the concentration of isoflurane. These difficulties may be avoided by the use of a hypnotic dose of an ultra-short-acting barbiturate. Inspired concentrations of 1.5 to 3.0% isoflurane usually produce surgical anesthesia in 7 to 10 minutes.

Maintenance:

Isoflurane MAC values according to age are shown below:

Age

Average MAC

Value In 100% Oxygen

Average MAC Value

In 30% Oxygen and

70% N 2 O

Preterm neonates

˂32 weeks gestational age

1.28%

Preterm neonates

32-37 weeks gestational age

1.41%

0-1 month

1.60%

1-6 months

1.87%

6-12 months

1.80%

1-5 years

1.60%

6-10 years

1.45%

11-18 years

1.38%

19-30 years

1.28%

0.56%

31-55 years

1.15%

0.50%

55-83 years

1.05%

0.37%

Dosage for induction and maintenance must be individualized and titrated to the desired effect according to the patient’s age and clinical status.

Surgical levels of anesthesia may be sustained with a 1.0 to 2.5% concentration when nitrous oxide is used concomitantly. An additional 0.5 to 1.0% may be required when isoflurane is given using oxygen alone. If added relaxation is required, supplemental doses of muscle relaxants may be used.

The level of blood pressure during maintenance is an inverse function of isoflurane concentration in the absence of other complicating problems. Excessive decreases may be due to depth of anesthesia and in such instances may be corrected by lightening anesthesia.

HOW SUPPLIED

Terrell (isoflurane, USP) is packaged in 100 mL and 250 mL amber-colored bottles.

100 mL — NDC 66794-011-10

250 mL — NDC 66794-011-25

Safety and Handling

Safety and Handling

OCCUPATIONAL CAUTION

There is no specific work exposure limit established for Isoflurane. However, the National Institute for Occupational Safety and Health Administration (NIOSH) recommends that no worker should be exposed at ceiling concentrations greater than 2 ppm of any halogenated anesthetic agent over a sampling period not to exceed one hour.

The predicted effects of acute overexposure by inhalation of Isoflurane include headache, dizziness or (in extreme cases) unconsciousness. There are no documented adverse effects of chronic exposure to halogenated anesthetic vapors ( Waste Anesthetic Gases or WAGs) in the workplace. Although results of some epidemiological studies suggest a link between exposure to halogenated anesthetics and increased health problems (particularly spontaneous abortion), the relationship is not conclusive. Since exposure to WAGs is one possible factor in the findings for these studies, operating room personnel, and pregnant women in particular, should minimize exposure. Precautions include adequate general ventilation in the operating room, the use of a well-designed and well-maintained scavenging system, work practices to minimize leaks and spills while the anesthetic agent is in use, and routine equipment maintenance to minimize leaks. (See PRECAUTIONS).

Storage

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Preserve in tight containers. Isoflurane contains no additives and has been demonstrated to be stable at room temperature for periods in excess of five years.

ANIMAL TOXICOLOGY AND/OR PHARMACOLOGY

Published studies in animals demonstrate that the use of anesthetic agents during the period of rapid brain growth or synaptogenesis results in widespread neuronal and oligodendrocyte cell loss in the developing brain and alterations in synaptic morphology and neurogenesis. Based on comparisons across species, the window of vulnerability to these changes is believed to correlate with exposures in the third trimester through the first several months of life, but may extend out to approximately 3 years of age in humans.

In primates, exposure to 3 hours of an anesthetic regimen that produced a light surgical plane of anesthesia did not increase neuronal cell loss, however, treatment regimens of 5 hours or longer increased neuronal cell loss. Data in rodents and in primates suggest that the neuronal and oligodendrocyte cell losses are associated with subtle but prolonged cognitive deficits in learning and memory. The clinical significance of these nonclinical findings is not known, and healthcare providers should balance the benefits of appropriate anesthesia in neonates and young children who require procedures against the potential risks suggested by the nonclinical data. (see WARNINGS /Pediatric Neurotoxicity and PRECAUTIONS/ Pregnancy, Pediatric Use).

Manufactured By:

Piramal Critical Care, Inc.

3950 Schelden Circle

Bethlehem, PA 18017

(888) 822-8431

Revised: January 2022

© 2022 Piramal Critical Care, Inc.

Bottle Label — 100 ml

BOTTLE LABEL

NDC 66794-011-10

Terrell TM

ISOFLURANE, USP

Liquid for Inhalation

100ml

Rx Only

100-ml-label
(click image for full-size original)

Bottle Label — 250 ml

BOTTLE LABEL

NDC 66794-011-25

TerrellTM

ISOFLURANE, USP

Liquid for Inhalation

250ml

Rx Only

250-ml-label
(click image for full-size original)
TERRELL
isoflurane liquid
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66794-011
Route of Administration RESPIRATORY (INHALATION) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ISOFLURANE (ISOFLURANE) ISOFLURANE 1 mL in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66794-011-10 100 mL in 1 BOTTLE, GLASS None
2 NDC:66794-011-25 250 mL in 1 BOTTLE, GLASS None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074416 02/28/2010
Labeler — Piramal Critical Care Inc (805600439)
Registrant — Piramal Critical Care Inc (805600439)
Establishment
Name Address ID/FEI Operations
Piramal Critical Care Inc 805600439 manufacture (66794-011)

Revised: 06/2022 Piramal Critical Care Inc

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