h average/high transporter patients. The declines in serum
sodium and chloride may be related to dilution resulting from the presence of icodextrin metabolites in plasma.
An apparent decrease in serum amylase activity has been observed in patients administered EXTRANEAL.
Investigations indicate that icodextrin and its metabolites interfere with enzymatic-based amylase assays, resultingin inaccurately low values. This should be taken into account when eva luating serum amylase levels for diagnosis ormonitoring of pancreatitis in patients using EXTRANEAL.
6.2 Post-Marketing Experience
The following adverse reactions have been identified during post-approval use of EXTRANEAL, or in conjunctionwith performing the peritoneal dialysis procedure. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to estimate their frequency reliably or to establish a causal relationshipto drug exposure.
INFECTIONS AND INFESTATIONS: Fungal peritonitis, Peritonitis bacterial, Catheter related infection
BLOOD AND LYMPHATIC SYSTEM DISORDERS: Thrombocytopenia, Leukopenia, LeukocytosisIMMUNE SYSTEM DISORDERS: Vasculitis, Serum sickness, Hypersensitivity
METABOLISM AND NUTRITION DISORDERS: Hypoglycemic shock, Dehydration NERVOUS SYSTEM DISORDERS: Hypoglycemic coma, Burning sensationEYE DISORDERS: Vision blurred
RESPIRATORY, THORACIC, AND MEDIASTINAL DISORDERS: Bronchospasm, StridorGASTROINTESTINAL DISORDERS: Encapsulating peritoneal sclerosis, Aseptic peritonitis, Ileus, Ascites,Inguinal hernia
SKIN AND SUBCUTANEOUS DISORDERS: Toxic epidermal necrolysis, Angioedema, Urticaria generalized,Prurigo, Dermatitis (including bullous, allergic and contact), Erythema, Onychomadesis, Dry skin, Skin chapped,Blister
MUSCULOSKELETAL, CONNECTIVE TISSUE DISORDERS: Musculoskeletal pain
REPRODUCTIVE SYSTEM AND BREAST DISORDERS: Penile edema, Scrotal edema
GENERAL DISORDERS AND ADMINISTRATIVE SITE CONDITIONS: Pyrexia, Chills, Malaise, Catheter siteerythema, Catheter site inflammation, Infusion related reaction (including Infusion site pain, Instillation site pain)INVESTIGATIONS: Liver function test abnormal, Urine output decreased
7. DRUG INTERACTIONS
As with other dialysis solutions, blood concentrations of dialyzable drugs may be reduced by dialysis. Dosageadjustment of concomitant medications may be necessary. In patients using cardiac glycosides (digoxin and others),plasma levels of calcium, potassium and magnesium must be carefully monitored [see Warnings and Precautions
(5.7)].
Insulin: Patients with insulin-dependent diabetes may require modification of insulin dosage following initiation oftreatment with EXTRANEAL. Monitor blood glucose and adjust insulin, if needed [see Boxed Warning].
8. USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Pregnancy Category CAnimal reproduction studies have not been conducted with EXTRANEAL or icodextrin. It is also not knownwhether EXTRANEAL can cause fetal harm when administered to a pregnant woman or can affect reproduction
capacity.
8.3 Nursing Mothers
It is not known whether icodextrin or its metabolites are excreted in human milk. Because many drugs are excretedin human milk, caution should be exercised when EXTRANEAL is administered to a nursing woman.
8.4 Pediatric Use
Safety and effectiveness in pediatric patients have not been establ |
