Sojourn

Sojourn Special Precautions

sevoflurane

Manufacturer:

Piramal

Distributor:

Indochina Healthcare
Full Prescribing Info
Special Precautions
During the maintenance of anesthesia, increasing the concentration of sevoflurane produces dose-dependent decreases in blood pressure. Due to sevoflurane's insolubility in blood, these hemodynamic changes may occur more rapidly than with other volatile anesthetics. Excessive decreases in blood pressure or respiratory depression may be related to depth of anesthesia and may be corrected by decreasing the inspired concentration of sevoflurane.
Rare cases of seizures have been reported in association with sevoflurane use (see Use in Children in the following text and Adverse Reactions).
The recovery from general anesthesia should be assessed carefully before a patient is discharged from the post-anesthesia care unit.
Carcinogenesis, Mutagenesis, Impairment of Fertility: Studies on carcinogenesis have not been performed for either sevoflurane or Compound A. No mutagenic effect of sevoflurane was noted in the Ames test, mouse micronucleus test mouse lymphomas mutagenicity assay, human lymphocyte culture assay, mammalian cell transformation assay, 32P DNA adduct assay, and no chromosomal aberrations were induced in cultured mammalian cells.
Similarly, no mutagenic effect of Compound A was noted in the Ames test, the Chinese hamster chromosomal aberration assay and in the in vivo mouse micronucleus assay. However, positive responses were observed in the human lymphocyte chromosome aberration assay. These responses were seen only at high concentrations and in the absence of metabolic activation (human S-9).
Use in Children: Induction and maintenance of general anesthesia with sevoflurane have been established in controlled clinical trials in pediatric patients aged 1 to 18 years (see Pharmacology: Pharmacodynamics: Clinical Trials under Actions and Adverse Reactions).
Sevoflurane has a non-pungent odor and is suitable for mask induction in pediatric patients.
The concentration of sevoflurane required for maintenance of general anesthesia is age dependent. When used in combination with nitrous oxide, the MAC equivalent dose of sevoflurane should be reduced in pediatric patients. MAC in premature infants has not been determined. (See Precautions, Interactions, Dosage & Administration for recommendations in pediatric patients 1 day of age and older).
The use of sevoflurane has been associated with seizures (see Precautions and Adverse Reactions). The majority of these have occurred in children and young adults starting from 2 months of age, most of whom had no predisposing risk factors. Clinical judgement should be exercised when using sevoflurane in patients who may be at risk for seizures.
Use in the Elderly: MAC decreases with increasing age. The average concentration of sevoflurane to achieve MAC in an 80-year-old is approximately 50% of that required in a 20-year-old.
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