Folenda Special Precautions

During the use of Propofol 10 mg/mL for sedation for surgical and diagnostic procedures, the patient must be continually monitored for the first signs of a decrease in blood pressure, respiratory tract obstruction and oxygen deficiency.
As is also the case with other sedatives, spontaneous movements of the patient during surgical procedures may occur with the use of Propofol 10 mg/mL for sedation. For procedures that require an immobile patient, these movements may jeopardize the success of the operation.
Misuse and dependency on Propofol has been reported, primarily among healthcare personnel. As with all medications for general anesthesia, it may not be used without securing an airway; otherwise, there is the risk of deadly respiratory complications.
After the use of Propofol 10 mg/mL, it should be ensured that the patient has fully recovered from the anesthesia prior to discharge.
In individual cases, a postoperative unconsciousness phase can occur with the use of Propofol 10 mg/mL, which may be accompanied by increased muscle tone. The occurrence of this is dependent on whether or not the patient was previously awake. Even though the patient will spontaneously regain consciousness, an unconscious patient should be kept under intensive observation.
The impairments caused by Propofol 10 mg/mL are usually not observed for longer than 12 hours. When explaining the effect of Propofol 10 mg/mL to the patient, and when making the following recommendations, the doctor should take into consideration the type of procedure, the concomitant medication, the age and the condition of the patient.
The patient should only return home when accompanied by another person.
The patient should be made aware of when manual activities or activities requiring dexterity/risky activities (e.g. operating a motor vehicle) can be carried out again.
The patient should be made aware that taking other sedatives (e.g. Benzodiazepine, Opiates, alcohol) may prolong and increase the impairments.
As with other intravenous anesthetics, Propofol 10 mg/mL should be administered in a slower manner than usual and used with particular caution in patients with cardiac, respiratory, renal and hepatic disorders, hypovolemia or who are in a reduced general state of health.
Heart, circulatory and respiratory insufficiency as well as hypovolemia should be compensated prior to administration of the drug, if possible.
In the case of patients with severe cardiac damage, Propofol 10 mg/mL must be administered with corresponding caution and in combination with intensive monitoring.
A pronounced drop in blood pressure may necessitate the administration of plasma substitutes, possibly of vasoconstrictors, and slower administration of Propofol 10 mg/mL. The possibility of a massive drop in blood pressure should be taken into consideration for patients with reduced coronary or cerebral perfusion or with hypovolemia. The Propofol clearance is dependent on the blood flow. Therefore, if drugs are used at the same time that reduce the cardiac output, the Propofol clearance will also be reduced.
Propofol does not have a vagolytic effect. The use has been associated with the occurrence of bradycardia with an occasionally severe outcome (cardiac arrest). Therefore, in situations where there is pre-existing high vagal tone or when Propofol 10 mg/mL is administered with other drugs, which may decrease the heart rate, intravenous administration of an anticholinergic agent should be considered before or during anesthesia with Propofol 10 mg/mL.
When using Propofol 10 mg/mL in people with epilepsy, it is possible for a seizure to be triggered.
Before repeated or longer (>3 hours) use of Propofol in small children (<3 years of age) and pregnant women, the benefits and risks of the planned procedure should be taken into account, since there are reports of neurotoxicity from preclinical studies.
Notes regarding intensive medical care: The use of infusions with Propofol emulsion for sedation as part of intensive care is associated with a series of metabolic disorders and organ failure, which may lead to death.
In addition, combined occurrence of the following undesirable effects has also been reported: metabolic acidosis, rhabdomyolysis, hyperkalemia, hepatomegaly, renal failure, hyperlipidemia, heart arrhythmia, Brugada-type ECG (saddle or tent shaped ST segment elevations in the right precordial leads [V1-V3] and concave T waves) and/or quickly progressing heart failure, which was usually not able to be treated with supportive inotropic therapeutic measures.
The combination of these events is also called "Propofol infusion syndrome".
These events were most frequently observed in patients with severe head injuries and in children with respiratory tract infections, which had received higher doses than is foreseen for adults for the purpose of sedation during intensive care.
The following factors are believed to be significant risk factors for the development of this complication: Low oxygen saturation in tissue, severe neurological damage and/or sepsis; high doses of one or more of the following listed drugs: vasoconstrictors, steroids, inotropic agents and/or Propofol (usually at dosages of >4 mg Propofol/kg of body mass per hour for more than 48 hours).
The prescribing doctor should be aware of these possible undesired effects in patients with the risk factors described previously and immediately discontinue the use of Propofol if signs of the symptoms described previously occur. All sedatives and drugs, which are used during intensive care, should be titrated in such a way that optimal oxygen supply is ensured and the hemodynamic parameters remain optimized. In the case of these changes in therapy, patients with elevated intracranial pressure should receive an appropriate treatment that supports cerebral perfusion. The treating doctor should make sure that the recommended dosage of 4 mg Propofol/kg of body mass per hour is not exceeded, to the greatest extent possible.
Attention must be paid to lipid metabolism disorders or other disorders, as a result of which fat-containing emulsions should be used with caution.
A check of the lipid metabolism parameters is recommended if Propofol 10 mg/mL is used in patients, where there is the suspicion of elevated blood lipid values. The administration of Propofol 10 mg/mL should be adjusted accordingly if the analysis indicates a lipid metabolism disorder. In the case of patients that are simultaneously receiving parenteral nutrition, the quantity of lipids administered as a result of Propofol 10 mg/mL should be taken into account. 1.0 mL Propofol 10 mg/mL contains 0.1 g of fat.
Additional precaution: Patients with mitochondrial disorders should be treated with caution. These patients could experience an exacerbation of their disease if anesthesia is used on them or a surgical procedure or intensive care treatment is administered. It is recommended that a normal body temperature be maintained for these patients, that carbohydrates by administered and that they be provided with sufficient fluids. The early signs of an exacerbation of a mitochondrial disorder and Propofol infusion syndrome may be similar.
Propofol 10 mg/ml does not contain any antimicrobial preservation media, and the growth of microorganisms is facilitated due to its composition.
If Propofol 10 mg/mL is administered in combination with Lidocaine, it should be noted that Lidocaine may not be administered to patients with hereditary acute porphyria.
Propofol 10 mg/mL contains soybean oil, which may trigger severe allergic reactions very rarely.
This medicinal product contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially 'sodium-free'.
Effects on Ability to Drive and Use Machines: After the administration of Propofol 10 mg/mL, the patient should be observed for an appropriate period of time. Patients should be made aware of fact that the ability to participate in traffic and use machinery may be impaired for some time after the administration of Propofol 10 mg/mL. The impairments caused by Propofol 10 mg/mL are usually not observed for longer than 12 hours (see as previously mentioned). The patient may only return home when accompanied by another person and may not drink any alcohol.
Use in Children: The use of Propofol 10 mg/mL in newborns is not recommended, since this patient group has not been sufficiently evaluated. Pharmacokinetic data indicate that the clearance of Propofol is considerably reduced in newborns and varies widely per individual. When using doses that are recommended for older children, an overdose occur and lead to severe circulatory and respiratory depression (see Adverse Reactions).
Propofol may not be used for sedation in patients 16 years of age or younger during intensive care, since the safety and efficacy of Propofol has not been validated for sedation in this age group (see Contraindications).