Sodium Chloride, Sodium Gluconate, Sodium Acetate, Potassium Chloride, And Magnesium Chloride

FDA Drug Information • Also known as: Isolyte S, Multiple Electrolytes Ph 5.5, Multiple Electrolytes Ph 7.4, Physiolyte, Plasma-Lyte A

Brand Names: Isolyte S, Multiple Electrolytes Ph 5.5, Multiple Electrolytes Ph 7.4, Physiolyte, Plasma-Lyte A
Route: IRRIGATION
Dosage Form: IRRIGANT
Product Type: HUMAN PRESCRIPTION DRUG

Description

DESCRIPTION Multiple Electrolytes Injection, Type 1, USP, pH 5.5 is a sterile, nonpyrogenic isotonic solution in a single dose container for intravenous administration. Each 100 mL contains 526 mg of Sodium Chloride, USP (NaCl); 502 mg of Sodium Gluconate (C 6 H 11 NaO 7 ); 368 mg of Sodium Acetate Trihydrate, USP (C 2 H 3 NaO 2

3H 2 O); 37 mg of Potassium Chloride, USP (KCl); and 30 mg of Magnesium Chloride, USP (MgCl 2

6H 2 O). It contains no antimicrobial agents. The pH is adjusted with hydrochloric acid. The pH is 5.5 (4.0 to 8.0). Multiple Electrolytes Injection, Type 1, USP, pH 5.5 administered intravenously has value as a source of water, electrolytes, and calories. One liter has an ionic concentration of 140 mEq sodium, 5 mEq potassium, 3 mEq magnesium, 98 mEq chloride, 27 mEq acetate, and 23 mEq gluconate. The osmolarity is 294 mOsmol/L (calc). Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L. The caloric content is 21 kcal/L. The flexible plastic container is fabricated from a specially formulated non-plasticized, film containing polypropylene and thermoplastic elastomers ( free flex ® bag). 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. 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.

What Is Sodium Chloride, Sodium Gluconate, Sodium Acetate, Potassium Chloride, And Magnesium Chloride Used For?

INDICATIONS AND USAGE Multiple Electrolytes Injection, Type 1, USP, pH 5.5 is indicated as a source of water and electrolytes or as an alkalinizing agent.

Dosage and Administration

DOSAGE AND ADMINISTRATION Important Administration Instructions Multiple Electrolytes Injection, Type 1, USP, pH 5.5 is intended for intravenous administration using sterile equipment. Do not connect flexible plastic containers in series in order to avoid air embolism due to possible residual air contained in the primary container. Set the vent to the closed position on a vented intravenous administration set to prevent air embolism. Use a dedicated line without any connections to avoid air embolism. Do not pressurize intravenous solutions contained in flexible plastic containers to increase flow rates in order to avoid air embolism due to incomplete evacuation of residual air in the container. Prior to infusion, visually inspect the solution for particulate matter and discoloration. The solution should be clear and there should be no precipitates. Do not administer unless solution is clear, and container is undamaged. Multiple Electrolytes Injection, Type 1, USP, pH 5.5 is compatible with blood or blood components. It may be administered prior to or following the infusion of blood through the same administration set (i.e., as a priming solution), added to or infused concurrently with blood components, or used as a diluent in the transfusion of packed erythrocytes. Multiple Electrolytes Injection, Type 1, USP, pH 5.5 and 0.9% Sodium Chloride Injection, USP are equally compatible with blood or blood components. Dosing Information The choice of product, dosage, volume, rate, and duration of administration is dependent upon the age, weight and clinical condition of the patient and concomitant therapy, and administration should be determined by a physician experienced in intravenous fluid therapy. Introduction of Additives Additives may be incompatible. Evaluate all additions to the plastic container for compatibility and stability of the resulting preparation. Consult with a 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. After addition, if there is a discoloration and/or the appearance of precipitates, insoluble complexes or crystals, do not use. Do not store solutions containing additives. Discard any unused portion.

Side Effects (Adverse Reactions)

ADVERSE REACTIONS Post-marketing Adverse Reactions The following adverse reactions associated with the use of Multiple Electrolytes Injection, Type 1, USP were identified in clinical trials or postmarketing reports. Because postmarketing reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency, reliably, or to establish a causal relationship to drug exposure. Hypersensitivity and Infusion Reactions : tachycardia, palpitations, chest pain, chest discomfort, dyspnea, flushing, hyperemia, asthenia, feeling abnormal, piloerection, edema peripheral, pyrexia, hypotension, wheezing, urticaria, cold sweat, chills. General Disorders and Administration Site Conditions : infusion site pain, burning sensation. Metabolism and nutrition disorders : hyperkalemia, hyponatremia. Nervous System Disorders : hyponatremic encephalopathy. To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Warnings and Precautions

WARNINGS Hypersensitivity Reactions Hypersensitivity and infusion reactions have been reported with Multiple Electrolytes Injection, Type 1, USP. See ADVERSE REACTIONS . Stop the infusion immediately if signs or symptoms of a hypersensitivity reaction develop, such as tachycardia, chest pain, dyspnea and flushing. Institute appropriate therapeutic countermeasures as clinically indicated. Electrolyte Imbalances Fluid Overload Depending on the volume and rate of infusion, the intravenous administration of Multiple Electrolytes Injection, Type 1, USP can cause electrolyte disturbances such as overhydration and congested states, including pulmonary congestion and edema. Avoid Multiple Electrolytes Injection, Type 1, USP in patients with or at risk for fluid and/or solute overloading. If use cannot be avoided, monitor fluid balance, electrolyte concentrations, and acid base balance, as needed and especially during prolonged use. Hyponatremia Multiple Electrolytes Injection, Type 1, USP may cause hyponatremia. Hyponatremia can lead to acute hyponatremic encephalopathy characterized by headache, nausea, seizures, lethargy, and vomiting. Patients with brain edema are at particular risk of severe, irreversible and life-threatening brain injury. The risk of hospital-acquired hyponatremia is increased in patients with cardiac or pulmonary failure, and in patients with non-osmotic vasopressin release (including SIADH) treated with high volume of hypotonic Multiple Electrolytes Injection, Type 1, USP. Avoid Multiple Electrolytes Injection, Type 1, USP in hypervolemic or overhydrated patients. If use cannot be avoided, monitor serum sodium concentrations. Hypernatremia Hypernatremia may occur with Multiple Electrolytes Injection, Type 1, USP. Conditions that may increase the risk of hypernatremia, fluid overload and edema (central and peripheral), include patients with: primary hyperaldosteronism; secondary hyperaldosteronism associated with, for example, hypertension, congestive heart failure, liver disease (including cirrhosis), renal disease (including renal artery stenosis, nephrosclerosis); and pre-eclampsia. Certain medications, such as corticosteroids or corticotropin, may also increase risk of sodium and fluid retention, see PRECAUTIONS . Avoid Multiple Electrolytes Injection, Type 1, USP in patients with, or at risk for, hypernatremia. If use cannot be avoided, monitor serum sodium concentrations. Hypermagnesemia Avoid solutions containing magnesium, including Multiple Electrolytes Injection, Type 1, USP in patients with or predisposed to hypermagnesemia, including patients with severe renal impairment and those patients receiving magnesium therapy (e.g., treatment of eclampsia and myasthenia gravis). Multiple Electrolytes Injection, Type 1, USP is not indicated for the treatment of hypomagnesemia. Acidosis Multiple Electrolytes Injection, Type 1, USP is not for use for the treatment of lactic acidosis or severe metabolic acidosis in patients with...

Drug Interactions

Drug Interactions Other Products that Affect Fluid and/or Electrolyte Balance Administration of Multiple Electrolytes Injection, Type 1, USP to patients treated concomitantly with drugs associated with sodium and fluid retention may increase the risk of hypernatremia and volume overload. Avoid use of Multiple Electrolytes Injection, Type 1, USP in patients receiving such products, such as corticosteroids or corticotropin. If use cannot be avoided, monitor serum electrolytes, fluid balance and acid-base balance. Other Drugs that Increase the Risk of Hyponatremia Administration of Multiple Electrolytes Injection, Type 1, USP in patients treated concomitantly with medications associated with hyponatremia may increase the risk of developing hyponatremia. Avoid use of Multiple Electrolytes Injection, Type 1, USP in patients receiving products, such as diuretics, and certain antiepileptic and psychotropic medications. Drugs that increase the vasopressin effect reduce renal electrolyte free water excretion and may also increase the risk of hyponatremia following treatment with intravenous fluids. If use cannot be avoided, monitor serum sodium concentrations. Lithium Renal clearance of lithium may be increased during administration of Multiple Electrolytes Injection, Type 1, USP. Monitor serum lithium concentrations during concomitant use. Other Products that Increase the Risk of Hyperkalemia Because of its potassium content, avoid use of Multiple Electrolytes Injection, Type 1, USP in patients receiving products that can cause hyperkalemia or increase the risk of hyperkalemia, such as potassium sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, or the immunosuppressants tacrolimus and cyclosporine. If use cannot be avoided, monitor serum potassium concentrations. Drugs with pH Dependent Renal Elimination Due to its alkalinizing effect (formation of bicarbonate), Multiple Electrolytes Injection, Type 1, USP may interfere with the elimination of drugs with pH dependent renal elimination. Renal clearance of acidic drugs may be increased. Renal clearance of alkaline drugs may be decreased.

Contraindications

CONTRAINDICATIONS Multiple Electrolytes Injection, Type 1, USP, pH 5.5 is contraindicated in patients with a known hypersensitivity to the product. See WARNINGS .

Pregnancy and Breastfeeding

Pregnancy Teratogenic Effects Animal reproduction studies have not been conducted with Multiple Electrolytes Injection, Type 1, USP. It is also not known whether Multiple Electrolytes Injection, Type 1, USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Multiple Electrolytes Injection, Type 1, USP should be given to a pregnant woman only if clearly needed.

Nursing Mothers It is not known where this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Multiple Electrolytes Injection, Type 1, USP is administered to a nursing mother.

Overdosage

OVERDOSAGE Excessive administration of Multiple Electrolytes Injection, Type 1, USP, pH 5.5 can cause: fluid overload with a risk of edema (peripheral and/or pulmonary), particularly when renal sodium excretion is impaired. hypernatremia and hyperkalemia, especially in patients with severe renal impairment. hypermagnesemia. See WARNINGS and ADVERSE REACTIONS metabolic alkalosis with or without hypokalemia and decreased ionized serum calcium and magnesium concentrations. When assessing an overdose, any additives in the solution must also be considered. The effects of an overdose may require immediate medical attention and treatment. Interventions include discontinuation of Multiple Electrolytes Injection, Type 1, USP, pH 5.5, dose reduction, and other measures as indicated for the specific clinical constellation (e.g., monitoring of fluid balance, electrolyte concentrations and acid base balance).

How Supplied

HOW SUPPLIED Multiple Electrolytes Injection, Type 1, USP, pH 5.5 in free flex ® plastic containers is available as shown below: Product Code Unit of Use Unit of Sale 387150 NDC 65219-387-00 One 500 mL free flex ® Bag NDC 65219-387-05 Package of 20 free flex ® Bags 387100 NDC 65219-387-02 One 1000 mL free flex ® Bag NDC 65219-387-10 Package of 10 free flex ® Bags Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Brief exposure up to 40°C does not adversely affect the product. The container closure is not made with natural rubber latex. Non-PVC, Non-DEHP, Sterile.

About This Information

This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.

What are side effects?

Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.

What are drug interactions?

Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.