Dextrose Monohydrate, Sodium Chloride, Potassium Acetate, and Magnesium Acetate

INDICATIONS AND USAGE Normosol-M and 5% Dextrose Injection (Multiple Electrolytes and 5% Dextrose Injection Type 1, USP) is indicated for parenteral maintenance of routine daily fluid and electrolyte requirements with minimal carbohydrate calories from dextrose. Magnesium in the formula may help to prevent iatrogenic magnesium deficiency in patients receiving prolonged parenteral therapy.

DOSAGE AND ADMINISTRATION Normosol-M and 5% Dextrose Injection is administered by intravenous infusion. The dose is dependent upon the age, weight and clinical condition of the patient. A daily total amount of 1500 mL/M 2 of body surface will meet the usual adult daily requirements for water and principal electrolytes in patients unable to take anything by mouth. The usual daily maintenance amount for an average adult (70 kg and 1.8 square meters of body surface) is approximately three liters. As reported in the literature, the dosage and constant infusion rate of intravenous dextrose must be selected with caution in pediatric patients, particularly neonates and low birth weight infants, because of the increased risk of hyperglycemia/hypoglycemia. Drug Interactions Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store. To avoid precipitation of calcium salts that may occur when certain drugs are added, Normosol-M and 5% Dextrose Injection does not contain calcium. Parenteral drug products should be inspected visually for particulate matter or discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS . INSTRUCTIONS FOR USE To Open Tear outer wrap at notch and remove solution container. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. If supplemental medication is desired, follow directions below before preparing for administration. To Add Medication Prepare additive port. Using aseptic technique and an additive delivery needle of appropriate length, puncture resealable additive port at target area, inner diaphragm and inject. Withdraw needle after injecting medication. The additive port may be protected by covering with an additive cap. Mix container contents thoroughly. To Administer Attach administration set per manufacturer’s instructions. Regulate rate of administration per institutional policy. WARNING: Do not use flexible container in series connections.

WARNINGS 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 exists edema with sodium retention. Solutions which contain potassium 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. Solutions containing acetate should be used with great care in patients with metabolic or respiratory alkalosis, and in those conditions in which there is an increased level or an impaired utilization of acetate, such as severe hepatic insufficiency. Administration of this solution can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentrations of administered parenteral solutions. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of such solutions.

CONTRAINDICATIONS None known.

ADVERSE REACTIONS Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia. If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.

CLINICAL PHARMACOLOGY When administered intravenously, Normosol-M and 5% Dextrose Injection provides water and electrolytes (with dextrose as a readily available source of carbohydrate) for maintenance of daily fluid and electrolyte requirements, plus minimal carbohydrate calories. The electrolyte composition approaches that of the principal ions of normal plasma (extracellular fluid). The electrolyte concentration is hypotonic (112 mOsmol/liter) in relation to the extracellular fluid (280 mOsmol/liter). One liter provides approximately one-third of the average adult daily requirement for water and principal electrolytes in balanced proportions, with acetate as a bicarbonate alternate, plus 170 calories from dextrose. Solutions containing carbohydrate in the form of dextrose restore blood glucose levels and supply calories. Carbohydrate in the form of dextrose may aid in minimizing liver glycogen depletion and exerts a protein-sparing action. Dextrose injected parenterally undergoes oxidation to carbon dioxide in water. Sodium chloride in water dissociates to provide sodium (Na + ) and chloride (Cl − ) ions. Sodium (Na + ) is the principal cation of the extracellular fluid and plays a large part in the therapy of fluid and electrolyte disturbances. Chloride (Cl − ) has an integral role in buffering action when oxygen and carbon dioxide exchange occurs in the red blood cells. The distribution and excretion of sodium (Na + ) and chloride (Cl − ) are largely under the control of the kidney which maintains a balance between intake and output. Potassium acetate in water dissociates to provide potassium (K + ) and acetate (CH 3 COO − ) ions. Potassium is the chief cation of body cells (160 mEq/liter of intracellular water). It is found in low concentration in plasma and extracellular fluids (3.5 to 5.0 mEq/liter) in a healthy adult and child over 10 days old; 3.5 to 6.0 mEq/liter in a child less than 10 days old. Potassium plays an important role in electrolyte balance. Normally about 80 to 90% of the potassium intake is excreted in the urine; the remainder in the stools and to a small extent, in the perspiration. The kidney does not conserve potassium well so that during fasting or in patients on a potassium-free diet, potassium loss from the body continues resulting in potassium depletion. Magnesium acetate in water dissociates to provide magnesium (Mg ++ ) and acetate (CH 3 COO − ) ions. Magnesium is the second most plentiful cation of the intracellular fluids. It is an important cofactor for enzymatic reactions and plays an important role in neurochemical transmission and muscular excitability. Normal plasma concentration ranges from 1.5 to 2.5 or 3.0 mEq per liter. Magnesium is excreted solely by the kidney at a rate proportional to the plasma concentration and glomerular filtration. Acetate anion (CH 3 COO − ), a source of hydrogen ion acceptors, serves as an alternate source of bicarbonate (HCO 3 − ) by metabolic conversion in the liver. This has been shown to proceed readily even in the presence of severe liver disease. Thus, acetate anion exerts a mild systemic antiacidotic action that may be advantageous during fluid and electrolyte replacement therapy. Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. Average normal adult daily requirement ranges from two to three liters (1.0 to 1.5 liters each for insensible water loss by perspiration and urine production). Average normal pediatric daily requirements are based on the child’s weight as described in the table below: Weight Fluid Requirements Up to 10 kg 100 mL/kg 11 to 20 kg 1,000 mL + 50 mL/kg for each kg above 10 kg Above 20 kg 1,500 mL + 20 mL/kg for each kg above 20 kg Water balance is maintained by various regulatory mechanisms. Water distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (Na + ) plays a major role in maintaining physiologic equilibrium.