Bula do remedy Sevorane

the package insert of the medicine Sevorane. Therapeutic class of Anaesthetics, Systemic. Active principles Sevoflurane.

what For?

the Induction and maintenance of general anesthesia in surgical procedures to outpatient or hospital care, of pediatric patients or adults.


When should I not use?

Sensitivity or known allergy to sevoflurane or any other anaesthetic agent is halogenated. Genetic susceptibility is known or suspected to hyperthermia malignant. Warnings: Sevorane should only be administered by physicians trained in the administration of general anesthesia. Resources for the maintenance of the patency of the airway, artificial ventilation, administering oxygen and resuscitation, blood should be immediately available. Since levels of anesthesia may be altered easily and rapidly, only vaporizers calibrated for sevoflurane must be used. Hypotension and respiratory depression increase as anesthesia is deepened.


How to use?

The pre-medication should be selected according to the individual need of the patient, taking into account that secretions can be lightly stimulated by sevoflurane. The employment of agents anticholinergics with sevoflurane depends on the clinical situation and medical decision. Anesthesia surgical: the concentration of sevoflurane delivered by the vaporizer during anesthesia should be known. This can be controlled through the use of calibrated vaporizers specific to sevoflurane. Induction: dosage must be individualized and titrated to the desired effect according to the age and the clinical picture of the patient. Induction with sevoflurane should be performed in oxygen or in mix of oxygen/nitrous oxide/air. The agent is capable of inducing anesthesia in the majority of patients (AD95) to a concentration at the end of the expiration of 2,0-2,1% when administered in oxygen or air/oxygen. The employment of an initial concentration a little high for a few minutes to get an induction fast, accurate and smooth level of anaesthesia satisfactory, it seems to be tolerated without evidence of irritation, unpleasant odor, bucking or other resistance. In adults, a concentration of inspired sevoflurane 0.5-5% usually produces anesthesia surgical 3.5 to 11.1 minutes. In general, the mean time of induction in pediatrics was 3.5 minutes using sevoflurane/N2O/oxygen (mean concentration of 3.3%/58,5%/38,2%, respectively), being 2.7 minutes for babies < 1 year of age, and 3.4 minutes for children 1 to 6 years, and 3.9 minutes for children > 6 years. Eighty-six percent of the children showed lower induction time less than 5 minutes. Maintenance: surgical levels of anesthesia may be sustained with concentrations of approximately 1.5% of sevoflurane in patients > 60 years of age, and concentrations of approximately 2.0% in younger patients. The blood pressure during maintenance is an inverse function of the concentration of sevoflurane in the absence of other complicating condition, and their variations can be corrected by adjustments in the level of anesthesia. – Overdose: in case of overdosage, or what may be related to an overdose, the following conduct should be taken: discontinue administration of the drug, establish the patency of the airway and start ventilation controlled or assisted with pure oxygen.

Side Effects

What are the evils that can cause me?

The adverse events most frequently reported and considered related to the administration of this agent include nausea, vomiting, hypotension, cough increased, somnolence, agitation, chills, bradycardia, hypertension, and dizziness. Body as a whole: chills, fever, headache, hypothermia, lack of effect of the drug. Cardiovascular system: arrhythmia, bradycardia, hypertension, hypotension. Digestive system: nausea, vomiting. Nervous system: agitation, dizziness, drowsiness, increased salivation. Respiratory system: increased cough, hypoxemia, respiratory disorders. Urogenital system: difficulty urinating. It is not known any case of abuse or physical dependence with sevofluorano.

Warnings and Precautions

what should I know before using?

General: due to the low need of anesthesia in the elderly, the dose of sevoflurane should be adjusted in a way that is compatible and cautious for the same. As with other anesthetics, an adequate evaluation and monitoring of the recovery of the patient is required prior to release of the same recovery room. As with all anesthetics, maintenance of hemodynamics is important in order to avoid myocardial ischemia in patients with coronary artery disease. Information to patients: although recovery of consciousness usually occurs within minutes after administration of sevoflurane, the impact on intellectual function for 2 or 3 days after anesthesia was not studied. As with other anesthetics, small changes in behavior and symptoms may persist for several days after administration of the anesthetic. Patients should be advised that performance of activities requiring mental alertness, such as driving motor vehicles or operating heavy machinery, may be impaired for some time after general anesthesia. Carcinogenesis, mutagênese: studies on carcinogenicity have not been performed. No effect mutagenic has been observed, according to a study conducted by the Ames test. Chromosomal aberrations were not induced in cultures of mammalian cells. Use in pregnancy: there are no studies adequate and well controlled in pregnant women and, therefore, the safety of sevoflurane in pregnancy is not established. Sevoflurane is not recommended during pregnancy unless the potential beneficial justifies the potential risk to the mother and to the fetus. Lactation: it is not known whether sevoflurane is excreted in human milk. Due to the fact that many drugs are excreted in human milk, should be careful when administration of sevoflurane the women in the stage of breastfeeding. Hyperthermia malignant: like other inhalational agents, anesthesia with sevoflurane may cause a state hipermetabólico of skeletal muscle in susceptible individuals, leading to a demand for oxygen are high and the clinical syndrome known as hyperthermia malignant. This syndrome includes features nonspecific, such as muscle rigidity, tachycardia, tachypnea, cyanosis, arrhythmias and unstable blood pressure (it should also be noted that many of these signs nonspecific may appear during light anesthesia, hypoxemia, acute, etc.). An increase in overall metabolism may be reflected in a higher temperature (which can rise fast and early, or so late, but usually it is not the first sign of increased metabolism) and elimination increased, as expressed by the increase in the concentration of expired pCO2. Hypoxemia, along with a acidosis hipercalemica and deficit basics, they can occur. Treatment consists of discontinuation of the causative agents (ex.: sevoflurane), administration of dantrolene sodium intravenous and application of measures of support. These measures include efforts to restore body temperature to normal, support the circulatory and respiratory as indicated, and control of disorders acidobásicos and electrolyte (refer to the package insert for dantrolene sodium intravenous for additional information about the control of the patient). Kidney failure may appear later, and urine flow should be maintained to the extent possible. Malignant hyperthermia has been observed with exposure to sevoflurane in pigs susceptible to this occurrence. Drug interactions: sevoflurane enhances the effects of the muscle relaxants do not despolarizantes, requiring a reduction in dose of these agents during anesthesia. As well as with other agents halogenated, sevoflurane may prolong the recovery of the neuromuscular blockade induced by muscle relaxants do not despolarizantes. The CAM of sevoflurane is reduced with the concomitant administration of nitrous oxide.