Isolyte P In Dextrose

Isolyte P In Dextrose

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 (HPOSpecial Character) 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  
Chemical Structure
 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

Isolyte P In Dextrose Manufacturers


  • B. Braun Medical Inc.
    Isolyte P In Dextrose (Dextrose, Sodium Acetate, Potassium Chloride, Magnesium Chloride, And Potassium Phosphate, Dibasic) Injection, Solution [B. Braun Medical Inc.]

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