INTRALIPID

INTRALIPID infusion may cause a rise in body temperature and, less frequently, shivering, chills, nausea, vomiting, headache, back or chest pain with dyspnea and cyanosis (incidence <1%). Table 1 Frequency of Adverse Drug Reactions SOC According to WHO Frequency Symptom Body as a whole - general disorders Uncommon (>1/1 000, <1/100 Very rare (<1/10 000) Headache, Rise in body temperature, Shivering, Chills, Tiredness Anaphylactic reaction Cardiovascular disorder Very rare (<1/10 000) Circulatory effects (hyper/hypotension) Gastrointestinal disorders Uncommon (>1/1 000 <1/100) Abdominal pain, Nausea, Vomiting Liver & biliary system disorder Very rare (<1/10 000) Transient increase in liver function test Musculoskeletal, connective tissue and bone disorders Very rare (<1/10 000) Abnormal pain Platelet, bleeding & clotting disorders Very rare (<1/10 000) Thrombocytopenia Red blood cell disorders Very rare (<1/10 000) Haemolysis, Reticulocytosis Reproductive disorders, male Very rare (<1/10 000) Priapism Skin and appendages disorders Very rare (<1/10 000) Rash, Urticaria 9 Thrombocytopenia has been reported in association with prolonged treatment with INTRALIPID in infants.

Transient increases in liver function tests after prolonged intravenous nutrition with or without INTRALIPID have also been noted. Increased cholesterol has been observed with infants after long term treatment with Intralipid 10%. The reasons are not clear at present.

Fat overload syndrome:

An impaired capacity to eliminate INTRALIPID may lead to the fat overload syndrome as a result of overdosage. However, this syndrome may appear also at recommended rates of infusion in association with a sudden change in the patient’s clinical condition, such as renal function impairment or infection.

The fat overload syndrome is characterised by hyperlipemia, fever, fat infiltration and disorders in various organs and coma. All symptoms are usually reversible if the infusion of INTRALIPID is discontinued. SYMPTOMS AND TREATMENT OF OVERDOSAGE See Adverse Reactions “Fat overload syndrome”.

Severe overdose of fat emulsions containing triglycerides can, especially if carbohydrates are not administered simultaneously, lead to acidosis. When fat emulsion is given in amounts exceeding the capacity of fat elimination the following symptoms may occur: hyperlipemia, hepatosplenomegaly, jaundice, hemolytic anemia, prolonged clotting time and thrombocytopenia.

All symptoms clear in days to weeks after cessation of fat infusion. For further information on the management of suspected drug overdose, contact your regional Poison Control Centre. 7 mL per kg of INTRALIPID 10%, 20% and 30%, respectively).

In raised energy requirements, the supply of INTRALIPID can be increased but should not, without special precautions, exceed a quantity corresponding to 3 g fat (30 mL, 15 mL and 10 mL of Intralipid 10%, 20% and 30% respectively) per kg body weight/day.