Product image of Icothera (Icodextrin, Magnesium Chloride Hexahydrate, Sodium Chloride, Calcium Chloride Dihydrate, Sodium Lact) supplied by GNH India

Icothera

Active Ingredient:
Icodextrin, Magnesium Chloride Hexahydrate, Sodium Chloride, Calcium Chloride Dihydrate, Sodium Lact
Origin:
EU

Icothera (Icodextrin, Magnesium Chloride Hexahydrate, Sodium Chloride, Calcium Chloride Dihydrate, Sodium Lact)

Icodextrin, the active ingredient in Icothera, is an osmotic agent presented as a sterile solution for intraperitoneal infusion. It creates an osmotic gradient that enhances ultrafiltration during peritoneal dialysis in patients with end‑stage renal disease.

GNH India supplies Icothera as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, transplant centres and dialysis clinics worldwide, providing reliable access to this peritoneal dialysis solution for renal care programs. Manufactured under EU regulations, the product meets stringent quality standards for safety and efficacy.

Manufacturer / TM Owner

Vivisol S.R.L.

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Indications & Clinical Uses

  • Icothera, an osmotic agent used in peritoneal dialysis, is indicated for renal replacement therapy in end‑stage renal disease.
  • End‑stage renal disease (ESRD): supports fluid removal and solute clearance during peritoneal dialysis.
  • Continuous ambulatory peritoneal dialysis (CAPD): provides sustained ultrafiltration over multiple exchanges.
  • Automated peritoneal dialysis (APD): enables efficient ultrafiltration during nighttime cycles.

How It Works

  • Icodextrin acts as a high‑molecular‑weight osmotic agent that remains in the peritoneal cavity, generating an osmotic gradient across the peritoneal membrane. This gradient draws water and small solutes from the bloodstream into the dialysate, achieving ultrafiltration without relying on glucose metabolism, thereby maintaining prolonged fluid removal during dialysis exchanges.

Side Effects

Common Side Effects

  • Abdominal discomfort or pain during exchanges.
  • Nausea or mild gastrointestinal upset.
  • Headache or dizziness.
  • Cough or mild respiratory irritation.
  • Skin rash or localized erythema.
  • Transient increase in peritoneal transport rates.

Serious or Rare Side Effects

  • Severe allergic reaction or anaphylaxis.
  • Peritonitis with abdominal pain, fever, and cloudy effluent.
  • Metabolic acidosis or significant electrolyte imbalance.
  • Hyperosmolar state leading to hypotension.
  • Severe hyperglycemia in diabetic patients.
  • Rare cases of pulmonary edema due to fluid overload.

Precautions & Warnings

  • Precautions should be observed when using Icothera for peritoneal dialysis.
  • Monitor fluid balance: assess patient weight and ultrafiltration volume regularly.
  • Assess peritoneal membrane function: evaluate transport characteristics before and during therapy.
  • Avoid concurrent high‑glucose dialysis solutions: may diminish icodextrin efficacy.
  • Caution in hepatic impairment: altered metabolism may increase systemic exposure.
  • Hypersensitivity: discontinue if signs of allergic reaction appear.
  • Store at controlled room temperature: keep in original container, protect from light and freeze.

Avoid Interactions

Potential drug interactions must be considered when prescribing Icothera.

Major Interactions (Avoid)

  • Known hypersensitivity to icodextrin or any excipient: contraindicated.
  • Co‑administration with maltose‑containing dialysis solutions: may cause false hyperglycemia readings.
  • Concurrent use of systemic hyperosmolar agents (e.g., mannitol): risk of excessive fluid shifts.

Moderate Interactions (Monitor Closely)

  • Alpha‑glucosidase inhibitors (e.g., acarbose): may increase icodextrin metabolites.
  • High‑glucose peritoneal solutions: can reduce icodextrin ultrafiltration efficiency.
  • Certain antibiotics administered intraperitoneally: monitor for peritoneal irritation.

Frequently Asked Questions

Icothera is a sterile solution containing icodextrin that is used as an osmotic agent in peritoneal dialysis. It helps patients with end‑stage renal disease remove excess fluid and waste products by creating a sustained osmotic gradient within the peritoneal cavity.

Icodextrin is a high‑molecular‑weight polymer that remains in the peritoneal cavity after infusion. It generates an osmotic gradient across the peritoneal membrane, drawing water and small solutes from the bloodstream into the dialysate, thereby achieving continuous ultrafiltration without relying on glucose metabolism.

The prescribed dose of Icothera is determined by the treating nephrologist based on the patient’s dialysis regimen, body size, and fluid removal goals. Dosing is individualized and should follow the clinician’s instructions and the product’s prescribing information.

Safety data for icodextrin in pregnancy or lactation are limited. The product’s pregnancy category is not established, and it should only be used if the potential benefit justifies any potential risk to the fetus or infant. Consultation with a healthcare professional is essential.

To order Icothera, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including any cold‑chain requirements) and import documentation.

Unlike glucose‑based solutions, icodextrin provides a prolonged osmotic effect with less rapid absorption, allowing longer dwell times and more consistent ultrafiltration. It also reduces the risk of hyperglycemia and glucose‑related peritoneal membrane changes, making it advantageous for patients who require extended exchanges.

Icothera should be stored at controlled room temperature, typically below 25 °C, in its original sealed container. Protect the solution from direct sunlight, moisture, and freezing. Once opened, use according to the manufacturer’s aseptic guidelines and discard any unused portion after the recommended time.

Icothera is administered by intraperitoneal infusion using a sterile catheter. The solution is introduced into the peritoneal cavity, where it remains for a prescribed dwell period before being drained. Administration follows the dialysis protocol set by the treating clinician, whether for continuous ambulatory or automated exchanges.

The most serious risks include severe allergic reactions such as anaphylaxis, peritonitis indicated by cloudy effluent and abdominal pain, metabolic acidosis, and significant electrolyte disturbances. Patients should be monitored closely for signs of infection, hypersensitivity, and fluid overload during therapy.

Icothera should be avoided in individuals with known hypersensitivity to icodextrin or any component of the formulation. It is also contraindicated in patients with active peritonitis, uncontrolled infections, or those who cannot tolerate intraperitoneal solutions. Clinical judgment is required for patients with severe hepatic impairment.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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