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  • Isoflurane USP, Terrell Tm
    / Pharma Medis


    Active Ingredient
    Isoflurane 100%

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Solution for Inhalation

    100 ml

    partial basket chart

    Solution for Inhalation

    250 ml

    partial basket chart

    Related information


    Dosage

    Vaporisers specially calibrated for isoflurane should be used so that the concentration of anaesthetic delivered can be accurately controlled.
    MAC values for isoflurane vary with age. Please refer to prescribing information for average MAC values for different age groups.
    Premedication: Drugs used for premedication should be selected for the individual patient bearing in mind the respiratory depressant effect of isoflurane. The use of anticholinergic drugs is a matter of choice, but may be advisable for inhalation induction in paediatrics.
    Induction of anaesthesia in adults: A short-acting barbiturate or other intravenous induction agent is usually administered followed by inhalation of the isoflurane mixture. Alternatively, isoflurane with oxygen or with an oxygen/nitrous oxide mixture may be used.
    It is recommended that induction with isoflurane be initiated at a concentration of 0.5%. Concentrations of 1.5 to 3.0% usually produce surgical anaesthesia in 7 to 10 minutes.
    Induction of anaesthesia in children: Isoflurane is not recommended for use as an inhalation induction agent in infants and children because of the occurrence of cough, breath-holding, desaturation, increased secretions and laryngospasm.
    Maintenance: Surgical levels of anaesthesia may be maintained with 1.0-2.5% isoflurane in oxygen/nitrous oxide mixtures. An additional 0.5-1.0% isoflurane may be required when given with oxygen alone.
    For caesarean section, 0.5-0.75% isoflurane in a mixture of oxygen/nitrous oxide is suitable to maintain anaesthesia for this procedure.
    Arterial pressure levels during maintenance tend to be inversely related to alveolar isoflurane concentrations in the absence of other complicating factors. Excessive falls in blood pressure may be due to depth of anaesthesia and in these circumstances, should be corrected by reducing the inspired isoflurane concentration.
    Elderly: As with other agents, lesser concentrations of isoflurane are normally required to maintain surgical anaesthesia in elderly patients. See above for MAC values related to age.


    Indications

    Isoflurane is indicated as a general anaesthetic by inhalation.


    Contra-Indications

    Isoflurane is contraindicated in patients with known sensitivity to isoflurane or other halogenated anaesthetics. It is also contraindicated in patients with known or suspected genetic susceptibility to malignant hyperthermia.


    Special Precautions

    For full details see prescribing information.


    Side Effects

    Adverse reactions encountered in the administration of isoflurane are in general dose dependent extensions of pharmaco-physiologic effects and include respiratory depression, hypotension and arrhythmias. Potential serious undesirable effects include malignant hyperthermia, hyperkalaemia, elevated serum creatine kinase, myoglobinuria, anaphylactic reactions and liver adverse reactions. Shivering, nausea, vomiting , ileus, agitation and delirium have been observed in the post-operative period.
    Cardiac arrest, bradycardia and tachycardia have been observed with general inhalation anaesthetic drugs including isoflurane.
    Reports of QT prolongation, associated with torsade de pointes (in exceptional cases, fatal) have been received.
    For full details see prescribing information.


    Drug interactions

    Combinations advised against:
    Beta-sympathomimetic agents like isoprenaline and alpha- and betasympathomimetic agents like adrenaline and noradrenaline should be used with caution during isoflurane narcosis, due to a potential risk of ventricular arrhythmia.
    Non-selective MAO-inhibitors: Risk of crisis during the operation. Treatment should be stopped 15 days prior to surgery.
    Combinations requiring precautions in using:
    Indirect-acting sympathomimetics (amphetamines and their derivatives, psychostimulants, appetite suppressants, ephedrine and its derivatives): Risk of perioperative hypertension. In patients undergoing elective surgery, treatment should ideally be discontinued several days before surgery.
    Adrenaline, by subcutaneous or gingival injections: risk of serious ventricular arrhythmia as a consequence of increased heart rate, although the myocardial sensitivity with respect to adrenaline is lower with the use of isoflurane than in the case of halothane.
    Cardiovascular compensation reactions may be impaired by beta-blockers.
    Inducers of CYP2E1:
    Medicinal products and compounds that increase the activity of cytochrome P450 isoenzyme CYP2E1, such as isoniazid and alcohol, may increase the metabolism of isoflurane and lead to significant increases in plasma fluoride concentrations.
    Use of isoflurane and isoniazid can increase the risk of potentiation of the hepatotoxic effects.
    Calcium antagonists, in particular dihydropyridine derivates: isoflurane may lead to marked hypotension in patients treated with calcium antagonists.
    Caution should be exercised when calcium antagonists are used concomitantly with inhalation anaesthetics due to the risk of additive negative inotropic effect.
    Opioids, benzodiazepines and other sedative agents are associated with respiratory depression, and caution should be exercised when concomitantly administered with isoflurane.
    Concomitant use of succinylcholine with inhaled anaesthetic agents has been associated with rare increases in serum potassium levels that have resulted in cardiac arrhythmias and death in pediatric patients during the post-operative period.
    All commonly used muscle relaxants are markedly potentiated by isoflurane, the effect being most profound with non-depolarizing agents. Neostigmine has an effect on the non-depolarising relaxants, but has no effect on the relaxing action of isoflurane itself.
    MAC (minimum alveolar concentration) is reduced by concomitant administration of N2O in adults.


    Pregnancy and Lactation

    Use in Pregnancy: There are no or limited amount of data from the use of isoflurane in pregnant women.
    Studies in animals have shown reproductive toxicity. Isoflurane should only be used during pregnancy if the benefit outweighs the potential risk.
    Use in Caesarean Section: Isoflurane, in concentrations up to 0.75%, has been shown to be safe for the maintenance of anaesthesia for caesarean section.
    Nursing Mothers: It is not known whether isoflurane/metabolites are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when isoflurane is administered to a nursing woman.


    Overdose

    As with other halogenated anaesthetics, hypotension and respiratory depression have been observed. Close monitoring of blood pressure and respiration is recommended. Supportive measures may be necessary to correct hypotension and respiratory depression resulting from excessively deep levels of anaesthesia.


    Important notes

    Shelf Life: The recommended shelf life is 5 years.
    Storage: Store below 25°C.


    Manufacturer
    Primal Critical Care, USA
    Licence holder
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