PHYSIONEAL

What it is

PHYSIONEAL 40 is indicated for use in peritoneal dialysis in patients with acute or chronic renal failure. PHYSIONEAL 40 is a sterile, clear, colourless solution. It contains glucose, calcium chloride dihydrate, magnesium chloride hexahydrate, sodium chloride, sodium lactate and sodium bicarbonate. The pH of the final solution is 7.4.

Approved indications

— Peritoneal dialysis in patients with acute renal failure — Peritoneal dialysis in patients with chronic renal failure

Dosing overview

The mode of therapy, frequency of treatment, exchange volume, duration of dwell and length of dialysis should be selected by the physician. Patients on continuous ambulatory peritoneal dialysis (CAPD) typically perform 4 cycles per day (24 hours), while patients on automated peritoneal dialysis (APD) typically perform 4–5 cycles at night and up to 2 cycles during the day. The fill volume depends on body size, usually from 2.0 to 2.5 litres. PHYSIONEAL 40 is available in three glucose concentrations. The 1.36% glucose formulation has an osmolarity of 344 mOsmol/L, the 2.27% glucose formulation has an osmolarity of 395 mOsmol/L, and the 3.86% glucose formulation has an osmolarity of 483 mOsmol/L. To avoid the risk of severe dehydration, hypovolemia and to minimise the loss of proteins, it is advisable to select the peritoneal dialysis solution with the lowest level of osmolarity consistent with fluid removal requirements for each exchange.

Key safety warnings

Encapsulating Peritoneal Sclerosis (EPS) is a known, rare complication of peritoneal dialysis therapy, and has been reported in patients using peritoneal dialysis solutions including PHYSIONEAL. Solutions containing glucose should be used with caution in patients with a known allergy to corn or corn products, as hypersensitivity reactions such as those due to a corn starch allergy, including anaphylactic/anaphylactoid reactions, may occur. If any signs or symptoms of a suspected hypersensitivity reaction develop, the infusion should be stopped immediately and the solution drained from the peritoneal cavity, and appropriate therapeutic countermeasures must be instituted as clinically indicated. Patients with elevated lactate levels should use lactate-containing peritoneal dialysis solutions with caution, and patients with conditions known to increase the risk of lactic acidosis (such as severe hypotension or sepsis, inborn errors of metabolism, or treatment with certain drugs) must be monitored for occurrence of lactic acidosis before and during treatment with lactate-based peritoneal dialysis solutions. Serum potassium levels should be monitored carefully in patients with cardiac glycosides due to the risk of digitalis intoxication, and diabetics require careful monitoring of blood glucose levels during and following dialysis with glucose-containing solutions.

Contraindications

PHYSIONEAL is contraindicated for use in patients with uncorrectable mechanical defects that prevent effective peritoneal dialysis or increase the risk of infection, and in patients with documented loss of peritoneal function or extensive adhesions that compromise peritoneal function.

Regulatory history

PHYSIONEAL 40 Glucose PD Solution in PVC bag was first approved on 12 May 2005, and PHYSIONEAL 40 Glucose PD Solution 5L in Clear Flex bag was first approved on 21 June 2013. Six strengths are registered on the Australian Register of Therapeutic Goods, all first listed on 31 May 2005, comprising three formulations (1.36%, 2.27% and 3.86% glucose) available in both single bag and twin bag presentations.