Sodium Lactate
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Questions & Answers
Side Effects & Adverse Reactions
Sodium Lactate Injection, USP is not for use for the treatment of lactic acidosis or severe metabolic acidosis.
The infusion must be stopped immediately if any signs or symptoms of a suspected hypersensitivity reaction develop. Appropriate therapeutic countermeasures must be instituted as clinically indicated.
Depending on the volume and rate of infusion, the intravenous administration of these injections can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states, pulmonary edema or acid-base imbalance. The risk of dilutional states is inversely proportional to the electrolyte concentrations of the injection. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of the injection.
Clinical evaluation and periodic laboratory determinations may be necessary to monitor changes in fluid balance, electrolyte concentrations, and acid base balance during prolonged parenteral therapy or whenever the condition of the patient or the rate of administration warrants such evaluation.
Excessive administration of Sodium Lactate Injection, USP may result in hypokalemia.
Sodium Lactate Injection, USP should be administered with particular caution, if at all, to patients with alkalosis or at risk for alkalosis. Because lactate is metabolized to bicarbonate, administration may result in, or worsen, metabolic alkalosis.
Sodium Lactate Injection, USP should be administered with particular caution, if at all, to patients with severe renal impairment, hypervolemia, overhydration, or conditions that may cause sodium retention, fluid overload, or edema.
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
Sodium Lactate Injection, USP is indicated as a source of water, electrolytes, and calories or as an alkalinizing agent.
History
There is currently no drug history available for this drug.
Other Information
Sodium Lactate Injection, USP (M/6 Sodium Lactate) is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment and caloric supply in a single dose container for intravenous administration. It contains no antimicrobial agents. The pH may have been adjusted with lactic acid. Composition, osmolarity, pH, ionic concentration and caloric content are shown in Table 1.
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| Size (mL) | Composition (g/L) |
*Osmolarity (mOsmol/L) (calc) |
pH | Ionic Concentration (mEq/L) |
Caloric Content (kcal/L) |
||
| Sodium Lactate (C3H5NaO3) |
Sodium | Lactate | |||||
| Sodium Lactate Injection, USP (M/6 Sodium Lactate) | 500 | 18.7 | 334 | 6.5 (6.0 to 7.3) |
167 | 167 | 54 |
| 1000 | |||||||
The VIAFLEX 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.
Sources
Sodium Lactate Manufacturers
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Baxter Healthcare Corporation
![Sodium Lactate Injection, Solution [Baxter Healthcare Corporation]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Sodium Lactate | Baxter Healthcare Corporation
As directed by a physician. Dosage, rate, and duration of administration are to be individualized and dependent upon the indication for use, patient's age, weight, concomitant treatment and clinical condition of the patient as well as laboratory determinations.
All injections in VIAFLEX plastic containers are intended for intravenous administration using sterile and nonpyrogenic equipment.
After opening the container, the contents should be used immediately and should not be stored for a subsequent infusion. Do not reconnect any partially used containers.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
Do not administer unless the solution is clear and seal is intact.
When making additions to Sodium Lactate Injection, USP, aseptic technique must be used. Mix the solution thoroughly when additives have been introduced. Do not store solutions containing additives.
Additives may be incompatible with Sodium Lactate Injection, USP. As with all parenteral solutions, compatibility of the additives with the solution must be assessed before addition, by checking for a possible color change and/or the appearance of precipitates, insoluble complexes, or crystals. Before adding a substance or medication, verify that it is soluble and/or stable in water and that the pH range of Sodium Lactate Injection, USP is appropriate.
The instructions for use of the medication to be added and other relevant literature must be consulted. Additives known or determined to be incompatible should not be used.
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Hospira, Inc.
Sodium Lactate | Hospira, Inc.
Sodium Lactate Injection, USP 50 mEq (5 mEq/mL) is administered intravenously only after addition to a larger volume of fluid. The amount of sodium ion and lactate ion to be added to larger volume intravenous fluids should be determined in accordance with the electrolyte requirements of each individual patient.
All or part of the content(s) of one (50 mEq in 10 mL) or more vial containers may be added to other intravenous solutions to provide any desired number of milliequivalents of lactate anion (with the same number of milliequivalents of Na+). The contents of one container (50 mEq in 10 mL) added to 290 mL of a nonelectrolyte solution or of sterile water for injection will provide 300 mL of an approximately isotonic (1/6 molar) concentration of sodium lactate (1.9%), containing 167 mEq/liter each of Na+ and lactate anion.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. See CONTRAINDICATIONS.
![Sodium Lactate Injection, Solution, Concentrate [Hospira, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=82428c00-d0da-44e4-4884-a735c150c067&name=sodium-lactate-injection-usp1-figure-1-jRL-0679.jpg)
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