FDA records indicate that there are no current recalls for this drug.
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Isolyte P In Dextrose Recall
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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.
Infuse solutions containing phosphate slowly to avoid phosphate intoxication. Infusing high concentrations of phosphate may cause hypocalcemia and tetany. Serum phosphorus and calcium levels should be monitored frequently.
Solutions containing acetate should be used with great care in patients with metabolic or respiratory alkalosis. The administration of acetate should be done with great care in those conditions in which there is an increased level or an impaired utilization of acetate, 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® P (Multi-Electrolyte Injection) in 5% Dextrose contains:
Hydrous Dextrose USP 5 g; Sodium Acetate Trihydrate USP 0.32 g
Potassium Chloride USP 0.13 g; Magnesium Chloride Hexahydrate USP 0.031 g
Dibasic Potassium Phosphate USP 0.026 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: 340 mOsmol/liter
Concentration of Electrolytes (mEq/liter): Sodium 23; Chloride 29
Acetate (CH3COO-) 23; Potassium 20; Magnesium 3; 1Phosphate (HPO) 3
Isolyte® P in 5% Dextrose is sterile, nonpyrogenic, and contains no bacteriostatic or antimicrobial agents or added buffers. This product is intended for intravenous administration.
The formulas of the active ingredients are:
Ingredients | Molecular Formula |
Molecular Weight |
---|---|---|
Sodium Acetate Trihydrate USP | CH3COONa•3H2O | 136.08 |
Potassium Chloride USP | KCl | 74.55 |
Magnesium Chloride Hexahydrate USP | MgCl2•6H2O | 203.30 |
Dibasic Potassium Phosphate USP | K2HPO4 | 174.18 |
Hydrous Dextrose USP | |
198.17 |
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.
- 1
- 1.5 mmole P/liter
Sources
Isolyte P In Dextrose Manufacturers
-
B. Braun Medical Inc.
Isolyte P 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.
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.
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