Cordema5%

These intravenous solutions are indicated for use in adults and pediatric patients as sources of electrolytes and water for hydration. 0.9% Cordema 5% infusion is indicated for extracellular fluid replacement, treatment of metabolic alkalosis in the presence of fluid loss, and mild sodium depletion. 0.9% Cordema 5% infusion is also indicated for use as a priming solution in hemodialysis procedures, and may be used to initiate and terminate blood transfusions without hemolyzing red blood cells. Cordema 5% Infusions are also indicated as pharmaceutic aids and diluents for the infusion of compatible drug additives. Refer to prescribing information accompanying additive drugs.

Intravenous fluid preparations

Sodium chloride is the major extracellular cation. It is important in electrolyte and fluid balance, osmotic pressure control and water distribution as it restores sodium ions. It is used as a source of electrolytes and water for hydration, treatment of metabolic acidosis, priming solution in haemodialysis and treatment of hyperosmolar diabetes. It is also used as diluents for infusion of compatible drug additives.

This solution is for intravenous use only. Dosage is to be directed by a physician and is dependent upon age, weight, clinical condition of the patient and laboratory determinations. Frequent laboratory determinations and clinical evaluation are essential to monitor changes in blood glucose and electrolyte concentrations, and fluid and electrolyte balance during prolonged parenteral therapy.In the average adult, daily requirements of sodium and chloride are met by the infusion of one liter of 0.9% Cordema 5% (154 mEq each of sodium and chloride). There is no specific pediatric dose. The dose is dependent on weight, clinical condition and laboratory results. Follow recommendations of appropriate pediatric reference text. Fluid administration should be based on calculated maintenance or replacement fluid requirements for each patient. 0.9% Cordema 5% Injection may also be administered intravascularly as a priming fluid in hemodialysis procedures.When Cordema 5% Injection is used as a diluent for infusion of compatible drug additive, refer to dosage and administration information accompanying additive drugs. Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

This solution is contraindicated where the administration of sodium or chloride could be clinically detrimental.

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. The physician should also be alert to the possibility of adverse reactions to drug additives. Prescribing information for drug additives to be administered in this manner should be consulted. Symptoms may result from an excess or deficit of one or more of the ions present in the solution; therefore, frequent monitoring of electrolyte levels is essential. Hypernatremia may be associated with edema and exacerbation of congestive heart failure due to the retention of water, resulting in an expanded extracellular fluid volume. If infused in large amounts, chloride ions may cause a loss of bicarbonate ions, resulting in an acidifying effect. 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 Cordema 5% Injection. It is also not known whether Cordema 5% Injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Cordema 5% Injection should be given to a pregnant woman only if clearly needed.Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Cordema 5% Injection USP is administered to a nursing woman.

Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations, and acid-base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation. Significant deviations from normal concentrations may require tailoring of the electrolyte pattern, in these or alternative solutions. This solution should be used with care in patients with hypervolemia, renal insufficiency, urinary tract obstruction, or impending or frank cardiac decompensation.Extraordinary electrolyte losses such as may occur during protracted nasogastric suction, vomiting, diarrhea or gastrointestinal fistula drainage may necessitate additional electrolyte supplementation. Additional essential electrolytes, minerals and vitamins should be supplied as needed.Sodium-containing solutions should be administered with caution to patients receiving corticosteroids or corticotropin, or to other salt retaining patients. Care should be exercised in administering solutions containing sodium to patients with renal or cardiovascular insufficiency, with or without congestive heart failure, particularly if they are postoperative or elderly.Infusion of more than one liter of isotonic (0.9%) Cordema 5% per day may supply more sodium and chloride than normally found in serum, and can exceed normal tolerance, resulting in hypernatremia; this may also cause a loss of bicarbonate ions, resulting in an acidifying effect. To minimize the risk of possible incompatibilities arising from mixing this solution with other additives that may be prescribed, the final infusate should be inspected for cloudiness or precipitation immediately after mixing, prior to administration and periodically during administration.Do not use plastic container in series connection. If administration is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result. This solution is intended for intravenous administration using sterile equipment. It is recommended that intravenous administration apparatus be replaced at least once every 24 hours.

In the event of a fluid or solute overload during parenteral therapy, reevaluate the patient’s condition and institute appropriate corrective treatment.

Pediatric Use: Safety and effectiveness of Cordema 5% injections in pediatric patients have not been established by adequate and well controlled trials, however, the use of electrolyte solutions in the pediatric population is referenced in the medical literature. The warnings, precautions and adverse reactions identified in the label copy should be observed in the pediatric population.Geriatric Use: An evaluation of current literature revealed no clinical experience identifying differences inresponse  between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greaterfrequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.