NORMOSOL-M AND DEXTROSE

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.

CONTRAINDICATIONS None known.

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.

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.

Pregnancy Category C. Animal reproduction studies have not been conducted with Normosol-M and 5% Dextrose Injection. It is also not known whether this solution can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. This solution should be given to a pregnant woman only if clearly needed.