Isolyte S In Dextrose
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Questions & Answers
Side Effects & Adverse Reactions
The administration of intravenous solutions can cause fluid and/or solute overload resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentration. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentration.
Solutions containing sodium ions should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency, and in clinical states in which there is sodium retention with edema.
Solutions containing potassium ions should be used with great care, if at all, in patients with hyperkalemia, severe renal failure, and in conditions in which potassium retention is present.
In patients with diminished renal function, administration of solutions containing sodium or potassium ions may result in sodium or potassium retention.
Solutions containing acetate should be used with great care in patients with metabolic or respiratory alkalosis. The administration of acetate or gluconate ions should be done with great care in those conditions in which there is an increased level or an impaired utilization of these ions, such as severe hepatic insufficiency.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
This solution is indicated for use in adults as a source of electrolytes, calories and water for hydration, and as an alkalinizing agent.
History
There is currently no drug history available for this drug.
Other Information
Each 100 mL of Isolyte® S (Multi-Electrolyte Injection) in 5% Dextrose contains:
Hydrous Dextrose USP 5 g; Sodium Chloride USP 0.53 g
Sodium Gluconate USP 0.5 g; Sodium Acetate Trihydrate USP 0.37 g
Potassium Chloride USP 0.037 g
Magnesium Chloride Hexahydrate USP 0.03 g
Water for Injection USP qs
pH adjusted with Hydrochloric Acid NF
pH: 5.0 (4.0–6.0) Calories per liter: 170
Calculated Osmolarity: 550 mOsmol/liter, hypertonic
Concentration of Electrolytes (mEq/liter): Sodium 140; Chloride 106
Acetate (CH3COO−) 27; Gluconate (HOCH2(CHOH)4COO−) 23
Potassium 5; Magnesium 3
Isolyte® S in 5% Dextrose is sterile, nonpyrogenic, and contains no bacteriostatic or antimicrobial agents or added buffers. This product is intended for intravenous administration in a single dose container.
The formulas of the active ingredients are:
| Ingredients | Molecular Formula | Molecular Weight |
|---|---|---|
| Sodium Acetate Trihydrate USP | CH3COONa•3H2O | 136.08 |
| Sodium Chloride USP | NaCl | 58.44 |
| Potassium Chloride USP | KCl | 74.55 |
| Magnesium Chloride Hexahydrate USP | MgCl2•6H2O | 203.30 |
| Hydrous Dextrose USP |  |
198.17 |
| Sodium Gluconate USP |  |
218.14 |
The EXCEL® Container is Latex-free, PVC-free, and DEHP-free.
The plastic container is made from a multilayered film specifically developed for parenteral drugs. It contains no plasticizers. The solution contact layer is a rubberized copolymer of ethylene and propylene. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary. 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.
Addition of medication should be accomplished using complete aseptic technique.
The closure system has two ports; the one for the administration set has a tamper evident plastic protector and the other is a medication site. Refer to the Directions for Use of the container.
Sources
Isolyte S In Dextrose Manufacturers
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B. Braun Medical Inc.
![Isolyte S In Dextrose (Hydrous Dextrose, Sodium Chloride, Sodium Gluconate, Sodium Acetate Trihydrate, Potassium Chloride And Magnesium Chloride Hexahydrate) Injection, Solution [B. Braun Medical Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Isolyte S In Dextrose | B. Braun Medical Inc.
This solution is for intravenous use only.
Dosage is to be directed by a physician and is dependent upon age, weight, clinical condition of the patient and laboratory determinations. Frequent laboratory determinations and clinical evaluation are essential to monitor changes in blood glucose and electrolyte concentrations, and fluid and electrolyte balance during prolonged parenteral therapy.
When a hypertonic solution is to be administered peripherally, it should be slowly infused through a small bore needle, placed well within the lumen of a large vein to minimize venous irritation. Carefully avoid infiltration.
Fluid administration should be based on calculated maintenance or replacement fluid requirements for each patient.
The presence of magnesium ions in this solution should be considered when phosphate is present in the additive solution, in order to avoid precipitation.
Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Directions for Use of EXCEL® Container To OpenTear overwrap down at notch and remove solution container. Check for minute leaks by squeezing solution container firmly. If leaks are found, discard solution as sterility may be impaired. If supplemental medication is desired, follow directions below before preparing for administration.
Before use, perform the following checks:
Inspect each container. Read the label. Ensure solution is the one ordered and is within the expiration date. Invert container and carefully inspect the solution in good light for cloudiness, haze, or particulate matter. Any container which is suspect should not be used. Use only if solution is clear and container and seals are intact. Preparation for Administration Remove plastic protector from sterile set port at bottom of container. Attach administration set. Refer to complete directions accompanying set. To Add Medication Before Solution Administration Prepare medication site. Using syringe with 18–22 gauge needle, puncture medication port and inner diaphragm and inject. Squeeze and tap ports while ports are upright and mix solution and medication thoroughly. To Add Medication During Solution Administration Close clamp on the set. Prepare medication site. Using syringe with 18–22 gauge needle of appropriate length (at least 5/8 inch), puncture resealable medication port and inner diaphragm and inject. Remove container from IV pole and/or turn to an upright position. Evacuate both ports by tapping and squeezing them while container is in the upright position. Mix solution and medication thoroughly. Return container to in use position and continue administration.
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