With the administration of KABIVEN® and PERIKABIVEN®, hyperglycemia and hyperosmolar syndrome may result. Diabetes/Hyperglycemia: KABIVEN® and PERIKABIVEN® should be used with caution in patients with diabetes mellitus or hyperglycemia.Thiamine deficiency and fluid retention may also develop. Refeeding Syndrome: Refeeding severely undernourished patients with parenteral nutrition may result in the refeeding syndrome, characterized by the intracellular shift of potassium, phosphorus, and magnesium as the patient becomes anabolic.A reduced or limited ability to metabolize lipids accompanied by prolonged plasma clearance may result in a syndrome characterized by a sudden deterioration in the patient’s condition accompanied by fever, anemia, leukopenia, thrombocytopenia, coagulation disorders, hyperlipidemia, liver fatty infiltration (hepatomegaly), deteriorating liver function, and central nervous system manifestations (e.g., coma). Fat Overload Syndrome: Fat overload syndrome is a rare condition that has been reported with intravenous lipid emulsions.Monitor for signs and symptoms (including fever and chills) of early infections, including laboratory test results (including leukocytosis and hyperglycemia) and frequent checks of the parenteral access device. Decrease the risk of septic complications. Infection and sepsis may occur as a result of the use of intravenous catheters to administer parenteral nutrition, poor maintenance of catheters, or immunosuppressive effects of illness, drugs, and parenteral formulations. Infections: Patients who require parenteral nutrition are at high risk of infections due to malnutrition and their underlying disease state.Signs or symptoms may include: tachypnea, dyspnea, hypoxia, bronchospasm, tachycardia, hypotension, cyanosis, vomiting, nausea, headache, sweating, dizziness, altered mentation, flushing, rash, urticaria, erythema, pyrexia and chills. Hypersensitivity Reactions: Stop infusion immediately and treat patient accordingly if signs or symptoms of a hypersensitivity or allergic reaction develop.KABIVEN® and PERIKABIVEN® is not recommended for use in pediatric patients under the age of 2 years including preterm infants. The safe and effective use of KABIVEN® and PERIKABIVEN® injection in pediatric patients, including preterm infants, has not been established. Preterm and small for gestational age infants have poor clearance of intravenous lipid emulsion and increased free fatty acid plasma levels following lipid emulsion infusion. Autopsy findings included intravascular lipid accumulation in the lungs.
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