DIANEAL PD-2 with Dextrose

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Overview

What is DIANEAL PD-2 with Dextrose?

DIANEAL peritoneal dialysis solutions are sterile, nonpyrogenic solutions in flexible containers for intraperitoneal administration only. The peritoneal dialysis solutions contain no bacteriostatic or antimicrobial agents.

DIANEAL solutions are hyperosmolar solutions.

Table 6 -

DIANEAL Low Calcium Peritoneal Dialysis Solution Plastic container with pull ring for APD therapy

The plastic container is fabricated from polyvinyl chloride (PVC Plastic). Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. The amount of water that can permeate from inside the solution container into the overwrap is insufficient to affect the solution significantly.

Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g. di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million; however, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by cell culture toxicity studies.

What does DIANEAL PD-2 with Dextrose look like?

What are the available doses of DIANEAL PD-2 with Dextrose?

DIANEAL solutions are available in multiple combinations of ingredients and in composition, calculated osmolarity, pH, and ionic concentrations. See full prescribing information for detailed descriptions of each formulation. ()

What should I talk to my health care provider before I take DIANEAL PD-2 with Dextrose?

How should I use DIANEAL PD-2 with Dextrose?

DIANEAL peritoneal dialysis solutions are indicated for patients in acute or chronic renal failure.

DIANEAL peritoneal dialysis solutions are intended for intraperitoneal administration only. Not for intravenous administration.

Select mode of therapy, frequency of treatment, formulation, fill volume, duration of dwell, and length of dialysis based on the patient’s clinical condition, fluid, electrolyte and specific needs.The fill volume depends on body size, usually from 2.0 to 2.5 liters per 1.73m for adults.

DIANEAL peritoneal dialysis solutions are intended for use in Continuous Ambulatory Peritoneal Dialysis (CAPD) or Automated Peritoneal Dialysis (APD). Refer to directions accompanying ancillary equipment for CAPD and APD system preparation.

Product Selection

To avoid the risk of severe dehydration and hypovolemia and to minimize the loss of protein, it is advisable to select the peritoneal dialysis solution with the lowest level of osmolarity consistent with the fluid removal requirements for that exchange. As the patient’s body weight becomes closer to the ideal dry weight, lowering the dextrose concentration of DIANEAL solution is recommended. DIANEAL 4.25% dextrose-containing solution has the highest osmolarity of the DIANEAL solutions and using it for all exchanges may cause dehydration [see ].

What interacts with DIANEAL PD-2 with Dextrose?

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What are the warnings of DIANEAL PD-2 with Dextrose?

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What are the precautions of DIANEAL PD-2 with Dextrose?

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What are the side effects of DIANEAL PD-2 with Dextrose?

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What should I look out for while using DIANEAL PD-2 with Dextrose?

DIANEAL peritoneal dialysis solutions are contraindicated in patients with severe lactic acidosis.

What might happen if I take too much DIANEAL PD-2 with Dextrose?

There is a potential for overdose resulting in hypervolemia, hypovolemia, electrolyte disturbances or hyperglycemia. Excessive use of DIANEAL peritoneal dialysis solution with 4.25% dextrose during a peritoneal dialysis treatment can result in significant removal of water from the patient.

How should I store and handle DIANEAL PD-2 with Dextrose?

Store at 20º to 25ºC (68º to 77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [see USP Controlled Room Temperature].DIANEAL peritoneal dialysis solutions are available in the following single-dose containers and fill volumes as shown in Tables 7-8:All DIANEAL peritoneal dialysis solutions have overfills which are declared on container labeling.Freezing of solution may occur at temperatures below 0°C (32°F). Allow to thaw naturally in ambient conditions and thoroughly mix contents by shaking.Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at room temperature (25°C/77°F): brief exposure up to 40°C (104°F) does not adversely affect the product.Store in moisture barrier overwrap and in carton until ready to use.DIANEAL peritoneal dialysis solutions are available in the following single-dose containers and fill volumes as shown in Tables 7-8:All DIANEAL peritoneal dialysis solutions have overfills which are declared on container labeling.Freezing of solution may occur at temperatures below 0°C (32°F). Allow to thaw naturally in ambient conditions and thoroughly mix contents by shaking.Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at room temperature (25°C/77°F): brief exposure up to 40°C (104°F) does not adversely affect the product.Store in moisture barrier overwrap and in carton until ready to use.DIANEAL peritoneal dialysis solutions are available in the following single-dose containers and fill volumes as shown in Tables 7-8:All DIANEAL peritoneal dialysis solutions have overfills which are declared on container labeling.Freezing of solution may occur at temperatures below 0°C (32°F). Allow to thaw naturally in ambient conditions and thoroughly mix contents by shaking.Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at room temperature (25°C/77°F): brief exposure up to 40°C (104°F) does not adversely affect the product.Store in moisture barrier overwrap and in carton until ready to use.DIANEAL peritoneal dialysis solutions are available in the following single-dose containers and fill volumes as shown in Tables 7-8:All DIANEAL peritoneal dialysis solutions have overfills which are declared on container labeling.Freezing of solution may occur at temperatures below 0°C (32°F). Allow to thaw naturally in ambient conditions and thoroughly mix contents by shaking.Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at room temperature (25°C/77°F): brief exposure up to 40°C (104°F) does not adversely affect the product.Store in moisture barrier overwrap and in carton until ready to use.DIANEAL peritoneal dialysis solutions are available in the following single-dose containers and fill volumes as shown in Tables 7-8:All DIANEAL peritoneal dialysis solutions have overfills which are declared on container labeling.Freezing of solution may occur at temperatures below 0°C (32°F). Allow to thaw naturally in ambient conditions and thoroughly mix contents by shaking.Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at room temperature (25°C/77°F): brief exposure up to 40°C (104°F) does not adversely affect the product.Store in moisture barrier overwrap and in carton until ready to use.

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Clinical Information

Chemical Structure

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Clinical Pharmacology

DIANEAL peritoneal dialysis solutions are a pharmacologically inactive, hypertonic peritoneal dialysis solution containing dextrose, a monosaccharide, as the primary osmotic agent. An osmotic gradient must be created between the peritoneal membrane and the dialysis solution in order for ultrafiltration to occur. The hypertonic concentration of glucose in DIANEAL solutions exert an osmotic pressure across the peritoneal membrane resulting in transcapillary ultrafiltration. Like other peritoneal dialysis solutions, DIANEAL solutions contain electrolytes to facilitate the correction of electrolyte abnormalities. DIANEAL solutions contain a buffer, lactate, to help normalize acid-base abnormalities.

Non-Clinical Toxicology

DIANEAL peritoneal dialysis solutions are contraindicated in patients with severe lactic acidosis.

The renal effects of nephrotoxic compounds may be potentiated by carboplatin.

Peritonitis has been associated with DIANEAL peritoneal dialysis solution use. Following use, inspect the drained fluid for the presence of fibrin or cloudiness, which may indicate the presence of peritonitis. Improper clamping or priming sequence may result in infusion of air into the peritoneal cavity, which may result in abdominal pain and/or peritonitis. If peritonitis occurs, treat with appropriate therapy.

Encapsulating Peritoneal Sclerosis (EPS), sometimes fatal, is a complication of peritoneal dialysis therapy and has been reported in patients using DIANEAL solutions.

The following adverse reactions are discussed elsewhere in the label:

Peritonitis and Encapsulating Peritoneal Sclerosis [see ]

Electrolyte and Fluid Imbalances [see ]

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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