GNH USA

Europe — EMA

Icothera

GNH USA supplies Icothera (Icodextrin), an osmotic agent for peritoneal dialysis in ESRD. Request a quote for supply to hospitals and dialysis centres.

Icodextrin, Magnesium Chloride Hexahydrate, Sodium Chloride, Calcium Chloride Dihydrate, Sodium Lact

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What is 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 USA 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.

What is Icodextrin, Magnesium Chloride Hexahydrate, Sodium Chloride, Calcium Chloride Dihydrate, Sodium Lact used for?

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.

What are the side effects of Icodextrin, Magnesium Chloride Hexahydrate, Sodium Chloride, Calcium Chloride Dihydrate, Sodium Lact?

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.

What precautions apply to Icodextrin, Magnesium Chloride Hexahydrate, Sodium Chloride, Calcium Chloride Dihydrate, Sodium Lact?

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.

What does Icodextrin, Magnesium Chloride Hexahydrate, Sodium Chloride, Calcium Chloride Dihydrate, Sodium Lact interact with?

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

What is Icothera used for?+
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.
How does icodextrin work in peritoneal dialysis?+
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.
What is the usual dose of Icothera?+
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.
Is Icothera safe to use during pregnancy or breastfeeding?+
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.
How do I order Icothera from GNH USA?+
To order Icothera, submit an enquiry on the product page at gnh-usa.com, specifying the required quantity. GNH USA 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.
How does Icothera compare with glucose‑based dialysis solutions?+
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.
How should Icothera be stored and handled?+
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.
How is Icothera administered to the patient?+
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.
What are the most serious risks to watch for with Icothera?+
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.
Who should not use Icothera?+
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.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.
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Product details

Drug
Icodextrin, Magnesium Chloride Hexahydrate, Sodium Chloride, Calcium Chloride Dihydrate, Sodium Lact
Route
Intraperitoneal Use
Manufacturer
Vivisol S.R.L.
Origin
EU