Dextrose and Electrolyte No. 48

DEXTROSE AND ELECTROLYTE NO. 48- dextrose monohydrate, sodium lactate, potassium chloride, magnesium chloride, potassium phosphate, monobasic and sodium chloride injection
Baxter Healthcare Corporation

in VIAFLEX Plastic Container

DESCRIPTION

5% Dextrose and Electrolyte No. 48 Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment and caloric supply in a single dose container for intravenous administration. Each 100 mL contains 5 g Dextrose Hydrous, USP*, 260 mg Sodium Lactate (C3 H5 NaO3 ), 141 mg Potassium Chloride, USP (KCl), 31 mg Magnesium Chloride, USP (MgCl2 •6H2 0), 20 mg Monobasic Potassium Phosphate, NF (KH2 PO4 ), and 12 mg Sodium Chloride, USP (NaCl). It contains no antimicrobial agents. The pH is 5.0 (4.0 to 6.5).

Structural Formula

5% Dextrose and Electrolyte No. 48 Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) administered intravenously has value as a source of water, electrolytes, and calories. One liter has an ionic concentration of 25 mEq sodium, 20 mEq potassium, 3 mEq magnesium, 24 mEq chloride, 23 mEq lactate and 3 mEq phosphate (as HPO4 2-). The osmolarity is 348 mOsmol/L (calc). Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L. Administration of substantially hypertonic solutions (≥ 600 mOsmol/L) may cause vein damage. The caloric content is 180 kcal/L.

Dextrose is derived from corn.

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.

CLINICAL PHARMACOLOGY

5% Dextrose and Electrolyte No. 48 Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) has value as a source of water, electrolytes and calories. They are capable of inducing diuresis depending on the clinical condition of the patient.

5% Dextrose and Electrolyte No. 48 Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) produce a metabolic alkalinizing effect. Lactate ions are metabolized ultimately to carbon dioxide and water, which requires the consumption of hydrogen cations.

INDICATIONS AND USAGE

5% Dextrose and Electrolyte No. 48 Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) is indicated as a source of water, electrolytes, and calories or as an alkalinizing agent.

CONTRAINDICATIONS

5% Dextrose and Electrolyte No. 48 Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) is contraindicated in patients

with a known hypersensitivity to the product (see WARNINGS)
with clinically significant hyperglycemia (see WARNINGS)

WARNINGS

Hypersensitivity Reactions

Hypersensitivity and infusion reactions have been reported with 5% Dextrose and Electrolyte No. 48 Injection (Multiple Electrolytes and Dextrose 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 5% Dextrose and Electrolyte No. 48 Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) can cause electrolyte disturbances such as overhydration and congested states, including pulmonary congestion and edema.

Avoid 5% Dextrose and Electrolyte No. 48 Injection (Multiple Electrolytes and Dextrose 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

5% Dextrose and Electrolyte No. 48 Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) may cause hyponatremia. 5% Dextrose and Electrolyte No. 48 Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) is a hypertonic solution. In the body, however, glucose containing fluids can become extremely physiologically hypotonic due to rapid glucose metabolization. Monitoring of serum sodium is particularly important for hypotonic fluids.

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 physiologically hypotonic 5% Dextrose and Electrolyte No. 48 Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP).

Avoid 5% Dextrose and Electrolyte No. 48 Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) in hypervolemic or overhydrated patients. If use cannot be avoided, monitor serum sodium concentrations.

Hyperglycemia and Hyperosmolar Hyperglycemic State

Administration of solutions containing dextrose and lactate in patients with impaired glucose tolerance or diabetes mellitus may worsen hyperglycemia (see PRECAUTIONS, Pediatric Use). Administration of dextrose at a rate exceeding the patient’s utilization rate may lead to hyperglycemia, coma, and death.

Hyperglycemia is associated with an increase in serum osmolality, resulting in osmotic diuresis, dehydration and electrolyte losses.

Patients with underlying central nervous system disease and renal impairment who receive dextrose infusions, may be at greater risk of developing hyperosmolar hyperglycemic state.

Monitor blood glucose concentrations and treat hyperglycemia to maintain concentrations within normal limits while administering 5% Dextrose and Electrolyte No. 48 Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP). Insulin may be administered or adjusted to maintain optimal blood glucose concentrations.

Hypernatremia

Hypernatremia may occur with 5% Dextrose and Electrolyte No. 48 Injection (Multiple Electrolytes and Dextrose 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 5% Dextrose and Electrolyte No. 48 Injection (Multiple Electrolytes and Dextrose 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 5% Dextrose and Electrolyte No. 48 Injection (Multiple Electrolytes and Dextrose 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).

5% Dextrose and Electrolyte No. 48 Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) is not indicated for the treatment of hypomagnesemia.

Acidosis

5% Dextrose and Electrolyte No. 48 Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) is not for use for the treatment of lactic acidosis or severe metabolic acidosis in patients with severe liver and/or renal impairment.

Alkalosis

Excess administration of 5% Dextrose and Electrolyte No. 48 Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) can result in metabolic alkalosis. Avoid 5% Dextrose and Electrolyte No. 48 Injection (Multiple Electrolytes Injection, Type 1, USP) in patients with alkalosis or at risk for alkalosis.

5% Dextrose and Electrolyte No. 48 Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) is not indicated for the treatment of hypochloremic hypokalemic alkalosis. Avoid use in patients with hypochloremic hypokalemic alkalosis.

Hypocalcemia

5% Dextrose and Electrolyte No. 48 Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) contains no calcium, and an increase in plasma pH due to its alkalinizing effect may lower the concentration of ionized (not-protein bound) calcium. Avoid 5% Dextrose and Electrolyte No. 48 Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) in patients with hypocalcemia.

Hyperkalemia

Potassium-containing solutions, including 5% Dextrose and Electrolyte No. 48 Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) may increase the risk of hyperkalemia.

Patient’s at increased risk of developing hyperkalemia include those:

With conditions predisposing to hyperkalemia and/or associated with increased sensitivity to potassium, such as patients with severe renal impairment, acute dehydration, extensive tissue injury or burns, certain cardiac disorders such as congestive heart failure.
Treated concurrently or recently with agents or products that cause or increase the risk of hyperkalemia (see PRECAUTIONS).

Avoid 5% Dextrose and Electrolyte No. 48 Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) in patients with, or at risk for hyperkalemia. If use cannot be avoided, monitor serum potassium concentrations.

Hyperphosphatemia

5% Dextrose and Electrolyte No. 48 Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) may increase the risk of hyperphosphatemia. Avoid use in patients with hyperphosphatemia or conditions predisposing to hyperphosphatemia, such as patients with severe renal or adrenal impairment.

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