Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/2413
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DIANEAL with Dextrose (Injection, Solution)
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DIANEAL Low Calcium
peritoneal dialysis 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 physicianresponsible 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 judgment 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.<br/>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).<br/>Continuous
Ambulatory Peritoneal Dialysis (CAPD) and Continuous Cyclic
Peritoneal Dialysis (CCPD): For
maintenance dialysis of chronic renal failure patients. In CAPD,
typically 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 containing solution 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 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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DIANEAL Low Calcium
peritoneal dialysis solutions are sterile, nonpyrogenic solutions in
AMBU-FLEX III containers with flanged port for intraperitoneal
administration only. They contain no bacteriostatic or antimicrobial
agents or added buffers. Composition,
calculated osmolarity, pH and ionic concentrations are shown in Table 1. Potassium is
omitted from peritoneal dialysis 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. In some patients
calcium carbonate is used as a phosphate binder. Because serum calcium
levels have been observed to be elevated in these patients (Slatopolsky
et al. 1986), the calcium concentration of DIANEAL Low Calcium
peritoneal dialysis solutions has been reduced to 2.5 mEq/L. Serum
calcium levels should be monitored and if low, the amount of oral
calcium carbonate phosphate binder may be increased or peritoneal
dialysis solutions containing higher calcium concentrations may be used.
If serum calcium levels rise, adjustments to the dosage of the calcium
carbonate phosphate binder and/or vitamin D analogs should be considered by the physician. 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 beused. 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 DIANEAL Low Calcium peritoneal dialysis solutions has
been raised to 40 mEq/L. Serum bicarbonate levels should be monitored. The osmolarities
shown in Table 1 are calculated values. Calculated osmolarity of DIANEAL
Low Calcium peritoneal dialysis solution with 1.5% dextrose is 344
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 overpouch 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.
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Peritoneal dialysis
is a procedure for removing toxic substances and metabolites normally
excreted by the kidneys, and for aiding in the regulation of fluid and
electrolyte balance. The procedure is accomplished by instilling peritoneal dialysis fluid through a conduit
into the peritoneal cavity. With the exception of lactate, present as a
bicarbonate precursor, electrolyte concentrations in the fluid have been
formulated in an attempt to normalize plasma electrolyte concentrations
resulting from osmosis and diffusion across the peritoneal membrane
(between the patient's plasma and the dialysis fluid). Toxic substances
and metabolites, present in high concentrations in the blood, cross the
peritoneal membrane into the dialyzing fluid. Dextrose in the dialyzing
fluid is used to produce a solution hyperosmolar to the plasma, creating
an osmotic gradient which facilitates fluid removal from the patient's
plasma into the peritoneal cavity. After a period of time (dwell time),
the fluid is drained by gravity from the cavity.
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None
known.
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DIANEAL Low Calcium
peritoneal dialysis solutions in AMBU-FLEX III containers are available
in nominal size flexible containers with fill volumes as indicated in
Table 1. All DIANEAL Low
Calcium 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.<br/>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.<br/>To Open: Tear overpouch 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 forminute leaks by squeezing container
firmly.<br/>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.<br/>Preparation for Administration: Discard unused portion.
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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 antibioticsmay 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 heatingmay 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.<br/>Pregnancy:<br/>Teratogenic
Effects:
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dailymed-instance:genericMe... |
Sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose
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DIANEAL with Dextrose (Injection, Solution)
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dailymed-instance:adverseRe... |
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. When prescribing
the solution to be used for an individual patient, consideration should
be given to the potential interaction between the dialysis treatment and
therapy directed at other existing illnesses. For example, rapid
potassium removal may create arrhythmias in cardiac patients using
digitalis or similar drugs; digitalis toxicity maybe masked by elevated
potassium or magnesium, or by hypocalcemia. Correction of electrolytes
by dialysis may precipitate signs and symptoms of digitalis excess.
Conversely, toxicity may occur at suboptimal dosages of digitalis if
potassium is low or calcium high. Azotemic diabetics require careful
monitoring of insulin requirements during and following dialysis with
dextrose containing solutions.
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dailymed-instance:warning |
Peritoneal dialysis
should be done with great care, if at all, in patients with a number of
abdominal conditions including disruption of the peritoneal membrane or
diaphragm by surgery or trauma, extensive adhesions, bowel distention,
undiagnosed abdominal disease, abdominal wall infection, hernias or
burns, fecal fistula or colostomy, tense ascites, obesity, and large
polycystic kidneys (Vaamonde and Perez 1977). Other conditions include recent aortic graft replacement and severe pulmonary disease. When
assessing peritoneal dialysis as the mode of therapy in such extreme
situations, the benefits to the patient must be weighed against the
possible complications. An accurate fluid
balance record must be kept and the weight of the patient carefully
monitored to avoid over or under hydration with severe consequences
including congestive heart failure, volume depletion, and shock. Excessive use of
DIANEAL Low Calcium peritoneal dialysis solution with 3.5% or 4.25%
dextrose during a peritoneal dialysis treatment can result in
significant removal of water from the patient. Stable patients
undergoing maintenance peritoneal dialysis should have routine periodic
evaluation of blood chemistries and hematologic factors, as well as
other indicators of patient status. In some patients
calcium carbonate is used as a phosphate binder. Because serum calcium
levels have been observed to be elevated in these patients (Slatopolsky
et al. 1986), the calcium concentration of DIANEAL Low Calcium
peritoneal dialysis solutions has been reduced to 2.5 mEq/L. Serum
calcium levels should be monitored and if low, the amount of oral
calcium carbonate phosphate binder may be increased or peritoneal
dialysis solutions containing higher calcium concentrations may be used.
If serum calcium levels rise, adjustments to the dosage of the calcium
carbonate phosphate binder and/or vitamin D analogs should be considered
by thephysician. 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 DIANEAL Low Calcium peritoneal dialysis solutions hasbeen raised to 40 mEq/L. Serum bicarbonate levels should be monitored. Not for use in the
treatment of lactic acidosis. Potassium is
omitted from DIANEAL Low Calcium peritoneal dialysis solutions because
dialysis may be performed to correct hyperkalemia. Addition of potassium
chloride should be made after careful evaluation of serum and total body
potassium and only under the direction of a physician. The use of 5 or 6
liters of dialysis solution is not indicated in a single exchange. Do not use 6 liter
product with Pac-X or Pac-Xtra hardware. Refer to
manufacturer's directions accompanying drugs to obtain full information
on additives. If the resealable
rubber plug on the medication port is missing or partially removed, do
not use product if medication is to be added. After removing
overpouch, check for minute leaks by squeezing container firmly. If
leaks are found, discard the solution because the sterility may be
impaired. 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.
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DIANEAL Low Calcium
peritoneal dialysis solutions are indicated for use in chronic renal
failure patients being maintained on peritoneal dialysis.
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DIANEAL with Dextrose
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