Contraindications
4 CONTRAINDICATIONS EXTRANEAL is contraindicated in patients with: • known hypersensitivity to icodextrin [see Warnings and Precautions ( 5.3 )] • maltose or isomaltose intolerance • glycogen storage disease • severe lactic acidosis, as EXTRANEAL contains lactate which may contribute to worsening acidosis if conversion to bicarbonate is impaired and may be associated with hyperventilation, lethargy, hypotension or irregular heart rhythms. • Known hypersensitivity to icodextrin • Maltose or isomaltose intolerance • Glycogen storage disease • Pre-existing severe lactic acidosis
Pregnancy & Breastfeeding
8.1 Pregnancy Risk Summary EXTRANEAL is a pharmacologically inactive solution. While there are no adequate and well controlled studies in pregnant women, appropriate administration of EXTRANEAL with monitoring of hematology, blood chemistry, and fluid status is not expected to cause fetal harm. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Plasma levels of calcium, potassium and magnesium must be carefully monitored in patients using cardiac glycosides like digoxin due to dialysis effects on electrolyte concentrations.
Source: NLP:icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride
Patients with insulin-dependent diabetes may require modification of insulin dosage following initiation of EXTRANEAL treatment. Blood glucose must be monitored and insulin adjusted if needed.
Source: NLP:icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride