Drug: Dianeal PD-2

DIANEAL PD-2 peritoneal dialysis solutions in AMBU-FLEX containers are sterile, nonpyrogenic solutions for intraperitoneal administration only. They contain no bacteriostatic or antimicrobial agents or added buffers.
Dextrose Hydrous, USP (D-Glucopyranose monohydrate) Composition, calculated osmolarity, pH, and ionic concentrations are shown in Table 1. Table 1.
  Composition/100 mL Osmolarity
(mOsmol/L) (calc) pH Ionic Concentration
(mEq/L) How Supplied Sodium Calcium Magnesium Chloride Lactate Fill Volume (mL) Container Size (mL) Code NDC *Dextrose, Hydrous, USP Sodium Chloride, USP
(NaCl) Sodium Lactate
(C3H5 NaO3) Calcium Chloride, USP
(CaCl2•2H2O) Magnesium Chloride, USP
(MgCl2•6H2O) Dianeal® PD-2 Peritoneal Dialysis 1.5% Dextrose AMBU-FLEX II CONTAINER 1.5 g 538 mg 448 mg 25.7 mg 5.08 mg 346 5.2
(4.0 to 6.5) 132 3.5 0.5 96 40 1000 1000 L5B5163 NDC 0941-0411-05 2000 3000 L5B5166 NDC 0941-0411-06 2500 3000 L5B5168 NDC 0941-0411-08 3000 3000 L5B5169 NDC 0941-0411-04 5000 6000 L5B5193 NDC 0941-0411-07 6000 6000 L5B9710 NDC 0941-0411-11 Dianeal® PD-2 Peritoneal Dialysis 1.5% Dextrose AMBU-FLEX III CONTAINER 1.5 g 538 mg 448 mg 25.7 mg 5.08 mg 346 5.2
(4.0 to 6.5) 132 3.5 0.5 96 40 250 500 5B5160 NDC 0941-0411-40 500 1000 5B5161 NDC 0941-0411-41 750 1000 5B5162 NDC 0941-0411-42 1000 1000 5B5163 NDC 0941-0411-43 1500 2000 5B5165 NDC 0941-0411-45 2000 2000 5B5166 NDC 0941-0411-46 2500 3000 5B5168 NDC 0941-0411-48 3000 3000 5B5169 NDC 0941-0411-49 5000 5000 5B5193 NDC 0941-0411-25 6000 6000 5B9710 NDC 0941-0411-28 Dianeal® PD-2 Peritoneal Dialysis 2.5% Dextrose AMBU-FLEX II CONTAINER 2.5 g 538 mg 448 mg 25.7 mg 5.08 mg 396 5.2
(4.0 to 6.5) 132 3.5 0.5 96 40 1000 1000 L5B5173 NDC 0941-0413-05 2000 3000 L5B5177 NDC 0941-0413-06 2500 3000 L5B5178 NDC 0941-0413-08 3000 3000 L5B5179 NDC 0941-0413-04 5000 6000 L5B5194 NDC 0941-0413-07 6000 6000 L5B9711 NDC 0941-0413-01 Dianeal® PD-2 Peritoneal Dialysis 2.5% Dextrose AMBU-FLEX III CONTAINER 2.5 g 538 mg 448 mg 25.7 mg 5.08 mg 396 5.2
(4.0 to 6.5) 132 3.5 0.5 96 40 250 500 5B5170 NDC 0941-0413-40 500 1000 5B5171 NDC 0941-0413-41 750 1000 5B5172 NDC 0941-0413-42 1000 1000 5B5173 NDC 0941-0413-43 1000 2000 5B5174 NDC 0941-0413-44 1500 2000 5B5175 NDC 0941-0413-45 2000 3000 5B5177 NDC 0941-0413-47 2500 3000 5B5178 NDC 0941-0413-48 3000 3000 5B5179 NDC 0941-0413-49 5000 5000 5B5194 NDC 0941-0413-25 6000 6000 5B9711 NDC 0941-0413-28 Dianeal® PD-2 Peritoneal Dialysis Solution with 3.5% Dextrose 3.5 g 538 mg 448 mg 25.7 mg 5.08 mg 447 5.2
(4.0 to 6.5) 132 3.5 0.5 96 40 2500 3000 5B4804 NDC 0941-0423-48 Dianeal® PD-2 Peritoneal Dialysis Solution with 4.25% Dextrose AMBU-FLEX II CONTAINER 4.25 g 538 mg 448 mg 25.7 mg 5.08 mg 485 5.2
(4.0 to 6.5) 132 3.5 0.5 96 40 1000 1000 L5B5183 NDC 0941-0415-05 2000 3000 L5B5187 NDC 0941-0415-06 2500 3000 L5B5188 NDC 0941-0415-08 3000 3000 L5B5189 NDC 0941-0415-04 5000 6000 L5B5195 NDC 0941-0415-07 6000 6000 L5B9712 NDC 0941-0415-01 Dianeal® PD-2 Peritoneal Dialysis 4.25% Dextrose AMBU-FLEX III CONTAINER 4.25 g 538 mg 448 mg 25.7 mg 5.08 mg 485 5.2
(4.0 to 6.5) 132 3.5 0.5 96 40 250 500 5B5180 NDC 0941-0415-40 500 1000 5B5181 NDC 0941-0415-41 750 1000 5B5182 NDC 0941-0415-42 1000 1000 5B5183 NDC 0941-0415-43 1000 2000 5B5184 NDC 0941-0415-44 1500 2000 5B5185 NDC 0941-0415-45 2000 3000 5B5187 NDC 0941-0415-47 2500 3000 5B5188 NDC 0941-0415-48 3000 3000 5B5189 NDC 0941-0415-49 5000 5000 5B5195 NDC 0941-0415-25 6000 6000 5B9712 NDC 0941-0415-28 Potassium is omitted from DIANEAL solutions because dialysis may be performed to correct hyperkalemia. In situations in which there is a normal serum potassium level or hypokalemia, the addition of potassium chloride (up to a concentration of 4 mEq/L) may be indicated to prevent severe hypokalemia. Addition of potassium chloride should be made after careful evaluation of serum and total body potassium and only under the direction of a physician. Frequent monitoring of serum electrolytes is indicated. Because average plasma magnesium levels in some chronic CAPD patients have been observed to be elevated (Nolph et al. 1981), the magnesium concentration of this formulation has been reduced to 0.5 mEq/L. Average plasma magnesium levels have not been reported for chronic IPD and CCPD patients. Serum magnesium levels should be monitored and if low, oral magnesium supplements, oral magnesium containing phosphate binders, or peritoneal dialysis solutions containing higher magnesium concentrations may be used. Because average serum bicarbonate levels in some chronic CAPD patients (Nolph et al. 1981), some chronic IPD patients (La Greca et al. 1980), and some chronic CCPD patients (Diaz-Buxo et al. 1983) have been observed to be somewhat lower than normal values, the bicarbonate precursor (lactate) concentration of this formulation has been raised to 40 mEq/L. Serum bicarbonate levels should be monitored. The osmolarities shown in Table 1 are calculated values. As an example, measured osmolarity by freezing point depression determination of DIANEAL PD-2 (peritoneal dialysis solution) peritoneal dialysis solution with 1.5% dextrose is approximately 334 mOsmol/L, compared with measured values in normal human serum of 280 mOsmol/L. The plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). The amount of water that can permeate from inside the 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 tissue culture toxicity studies.Last reviewed on RxList: 2/17/2009
This monograph has been modified to include the generic and brand name in many instances.

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Adverse reactions to peritoneal dialysis include mechanical and solution related problems as well as the results of contamination of equipment or improper technique in catheter placement. Abdominal pain, bleeding, peritonitis, subcutaneous infection around a chronic peritoneal catheter, catheter blockage, difficulty in fluid removal, and ileus are among the complications of the procedure. Solution related adverse reactions may include electrolyte and fluid imbalances, hypovolemia, hypervolemia, hypertension, hypotension, disequilibrium syndrome, and muscle cramping. Read the Dianeal PD-2 (peritoneal dialysis solution) Side Effects Center for a complete guide to possible side effectsLearn More »

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DIANEAL PD-2 (peritoneal dialysis solution) solutions are intended for intraperitoneal administration only. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. The mode of therapy (Intermittent Peritoneal Dialysis [IPD], Continuous Ambulatory Peritoneal Dialysis [CAPD], or Continuous Cyclic Peritoneal Dialysis [CCPD]), frequency of treatment, formulation, exchange volume, duration of dwell, and length of dialysis should be selected by the physician responsible for and supervising the treatment of the individual patient. 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. Peritoneal dialysis solutions may be warmed in the overpouch to 37°C (98.6°F) to enhance patient comfort. However, only dry heat (for example, heating pad) should be used. (See Directions for Use) The addition of heparin to the dialysis solution may be indicated to aid in prevention of catheter blockage in patients with peritonitis, or when the solution drainage contains fibrinous or proteinaceous material (Ribot et al. 1966). 1000 to 2000 USP units of heparin per liter of solution has been recommended for adults (Furman et al. 1978). For children, 50 units of heparin per 100 mL of dialysis fluid has been recommended (Irwin et al. 1981). Additives may be incompatible. Complete information is not available. Those additives known to be incompatible should not be used. Consult with pharmacist, if available. If, in the informed judgement of the physician, it is deemed advisable to introduce additives, use aseptic technique. Mix thoroughly when additives have been introduced. Do not store solutions containing additives. Intermittent Peritoneal Dialysis (IPD) For maintenance dialysis of chronic renal failure patients. The cycle of instillation, dwell and removal of dialysis fluid is repeated sequentially over a period of hours (8 to 36 hours) as many times per week as indicated by the condition of the patient. For chronic renal failure patients, maintenance dialysis is often accomplished by periodic dialysis (3 to 5 times weekly) for shorter time periods (8 to 14 hours per session) (Mattocks and El-Bassiouni 1971). Continuous Ambulatory Peritoneal Dialysis (CAPD) and Continuous Cyclic Peritoneal Dialysis (CCPD) For maintenance dialysis of chronic renal failure patients. In CAPD, 1.5 to 3.0 liters of dialysis solution (depending upon patient size) are instilled into the peritoneal cavity of adults and the peritoneal access device is then clamped (Kim et al. 1984; Twardowski and Janicka 1981; Twardowski and Burrows 1984). For children, 30 to 50 mL/kg body weight with a maximum of 2 liters has been recommended (Potter et al. 1981; Irwin et al. 1981). The solution remains in the cavity for dwell times of 4 to 8 hours during the day and 8 to 12 hours overnight. At the conclusion of each dwell period, the access device is opened, the solution drained and fresh solution instilled. The procedure is repeated 3 to 5 times per day, 6 to 7 days per week. Solution exchange volumes and frequency of exchanges should be individualized for adequate biochemical and fluid volume control (Moncrief et al. 1982; Twardowski et al. 1983). The majority of exchanges will utilize 1.5% or 2.5% dextrose containing peritoneal dialysis solutions, with 3.5% or 4.25% dextrose containing solutions being used when extra fluid removal is required. Patient weight is used as the indicator of the need for fluid removal (Popovich et al. 1978). In CCPD, the patient receives 3 or 4 dialysis exchanges during the night which range from 2-1/2 to 3 hours dwell duration. Typically 1.5 to 2.0 liters of dialysis solution (depending upon patient size) are delivered each cycle by an automatic peritoneal dialysis cycler machine. After the last outflow during the night, an additional exchange is infused by the cycler machine into the peritoneum. The equipment is then disconnected from the patient, and the dialysate remains in the peritoneum for 14 to 15 hours during the day until the next nocturnal cycle (Diaz-Buxo et al. 1981). Combinations of 1.5% or 2.5% dextrose containing peritoneal dialysis solutions are usually used for the nighttime exchanges, while 3.5% or 4.25% dextrose is used when extra fluid removal is required such as during the daytime exchange. Patient weight is used as the indicator of the need for fluid removal (Popovich et al. 1978) so therapy should be individualized according to the patient's need for ultrafiltration. It is recommended that adult patients being placed on chronic peritoneal dialysis or, in the case of pediatric patients, the selected caretaker, (as well as the patient, when suitable), should be appropriately trained in a program which is under the supervision of a physician. Training materials are available from Baxter Healthcare Corporation, Deerfield, IL 60015, USA to facilitate this training.

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No information provided. Last reviewed on RxList: 2/17/2009
This monograph has been modified to include the generic and brand name in many instances.

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Peritoneal dialysis is indicated for patients in acute or chronic renal failure when nondialytic medical therapy is judged to be inadequate (Vaamonde and Perez 1977). It may also be indicated in the treatment of certain fluid and electrolyte disturbances, and for patients intoxicated with certain poisons and drugs (Knepshield et al. 1977). However, for many substances other methods of detoxification have been reported to be more effective than peritoneal dialysis (Vaamonde and Perez 1977; Chang 1977).

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None known Last reviewed on RxList: 2/17/2009
This monograph has been modified to include the generic and brand name in many instances.

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No information provided.

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DIANEAL PD-2 peritoneal dialysis solutions in AMBU-FLEX II and AMBU-FLEX lll containers are available in nominal size flexible containers with fill volumes and dextrose concentrations as indicated in Table 1. All DIANEAL PD-2 peritoneal dialysis solutions have overfills which are declared on container labeling. 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. Directions for Use Use aseptic technique. For complete system preparation, see directions accompanying ancillary equipment. Peritoneal dialysis solutions may be warmed in the overpouch to 37°C (98.6°F) to enhance patient comfort. However, only dry heat (for example, heating pad) should be used. Solutions should not be heated in water due to an increased risk of infection. Microwave ovens should not be used to heat solutions because there is a potential for damage to the solution container. Moreover, microwave oven heating may potentially cause overheating and/or non-uniform heating of the solution that may result in patient injury or discomfort. To Open Tear overwrap down side at slit and remove solution container. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. If supplemental medication is desired, follow directions below before preparing for administration. Check for minute leaks by squeezing container firmly. To Add Medication Additives may be incompatible. If the resealable rubber plug on the medication port is missing or partially removed, do not use product if medication is to be added.
  1. Put on mask. Clean and/or disinfect hands.
  2. Prepare medication site using aseptic technique.
  3. Using a syringe with a 1 inch long 19 to 25 gauge needle, puncture resealable medication port and inject medication.
  4. Position container with ports up and evacuate the medication port by squeezing and tapping it.
  5. Mix solution and medication thoroughly.
Preparation for Administration
  1. Put on mask. Clean and/or disinfect hands.
  2. Place solution container on work surface.
  3. Remove pull ring from connector of the solution container. If continuous fluid flow from connector is observed, discard solution container.
  4. Remove tip protector from tubing set and immediately attach to connector of the solution container.
  5. Continue with therapy set-up as instructed in user manual or directions accompanying tubing sets.
  6. Upon completion of therapy, discard unused portion.
References Diaz-Buxo, J.A. et al. 1981. Continuous cyclic peritoneal dialysis: a preliminary report. Int Soc Artif Organs 81:157-161. Diaz-Buxo, J.A. et al. 1983. Observations on inadequate base buffer concentrations in peritoneal dialysis solutions. ASAIO Abstracts 43. Furman, K.l. et al. 1978. Activity of intraperitoneal heparin during peritoneal dialysis. Clinical Nephrology 9:15-18. Irwin, M.A. et al. 1981. Continuous ambulatory peritoneal dialysis in pediatrics. AANNT J 8:11-13,44. Kim, D. et al. 1984. Continuous ambulatory peritoneal dialysis with three-liter exchanges: a prospective study. Peritoneal Dial Bull 4:82-85. La Greca, G. et al. 1980. Acid base balance on peritoneal dialysis. Clinical Nephrology 16(1):1- 6. Mattocks, A.M. and El-Bassiouni, E.A. 1971. Peritoneal dialysis: a review. J Pharm Sci 60:1767-1782. Moncrief, J.W. et al. 1982. CAPD: Are three exchanges per day adequate? AANNT J 9:39-43. Nolph, K.D. et al. 1981. Considerations for dialysis solution modifications. In Peritoneal Dialysis, eds. Robert C. Atkins et al. Chapter 25. New York: Churchill Livingston. Popovich, R.P. et al. 1978. Continuous ambulatory peritoneal dialysis. Ann Intern Med 8:449-456. Potter, D.E. et al. 1981. Continuous ambulatory dialysis (CAPD) in children. Trans Am Soc Artif Intern Organs 27:64-67. Ribot, S. et al. 1966. Complications of peritoneal dialysis. Am J Med Sci 252:505-517. Twardowski, Z.J. and Janicka, L. 1981. Three exchanges with a 2.5 liter volume for continuous ambulatory peritoneal dialysis. Kidney Int 20:281-284. Twardowski, Z.J. et al. 1983. High volume low frequency continuous ambulatory peritoneal dialysis. Kidney Int 23:64-70. Twardowski, Z.J. and Burrows, L. 1984. Two year experience with high volume, low frequency continuous ambulatory peritoneal dialysis. Peritoneal Dial Bull 4:S67. Vaamonde, C.A. and Perez, G.O. 1977. Peritoneal dialysis today. Kidney 10:31-36. Baxter Healthcare Corporation Deerfield, IL 60015 USA. FDA Rev date: 12/19/2008 Last reviewed on RxList: 2/17/2009
This monograph has been modified to include the generic and brand name in many instances.

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Aseptic technique must be used throughout the procedure and at its termination in order to reduce the possibility of infection. If peritonitis occurs, the choice and dosage of antibiotics should be based upon the results of identification and sensitivity studies of the isolated organism(s) when possible. Prior to identification of the involved organism(s), broad-spectrum antibiotics may be indicated. Peritoneal dialysis solutions may be warmed in the overpouch to 37°C (98.6°F) to enhance patient comfort. However, only dry heat (for example, heating pad) should be used. Solutions should not be heated in water due to an increased risk of infection. Microwave ovens should not be used to heat solutions because there is a potential for damage to the solution container. Moreover, microwave oven heating may potentially cause overheating and/or non-uniform heating of the solution that may result in patient injury or discomfort. Significant losses of protein, amino acids and water soluble vitamins may occur during peritoneal dialysis. Replacement therapy should be provided as necessary. Pregnancy:Teratogenic Effects Pregnancy Category C. Animal reproduction studies have not been conducted with DIANEAL peritoneal dialysis solutions. It is also not known whether DIANEAL peritoneal dialysis solutions can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. DIANEAL peritoneal dialysis solutions should be given to a pregnant woman only if clearly needed. Do not administer unless solution is clear and seal is intact. Last reviewed on RxList: 2/17/2009
This monograph has been modified to include the generic and brand name in many instances.

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