FDA label 31d4876a-87c4-c0ab-e063-6294a90ada57

Special warnings and precautions for use The administration of intravenous solutions can cause fluid and/or solute overload resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. The risk of dilution is inversely proportional to the electrolyte concentration. The risk of congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentration. The solution contains 154 mmol/l sodium (Na+) and 154 mmol/l chloride (Cl-); the osmolarity is about 308 mOsm/l and the pH is 5.5 (4.5-7.0). Careful clinical monitoring is required at the beginning of any intravenous infusion. Administrations should be periodically and carefully monitored. Clinical and biological parameters, in particular serum electrolyte concentrations should be monitored. In preterm or term neonates, sodium retention can be seen because renal function is not yet fully developed. Repeated infusions of sodium chloride in neonates should therefore only be given after determination of the serum sodium levels. Sodium-containing solutions should be used with caution in cases of hypertension, heart failure, peripheral or pulmonary edema, impaired renal function, preeclampsia, aldosteronism or other conditions and treatments with sodium accumulation (e.g. corticosteroid therapy). Pseudohyponatremia is a condition in which plasma sodium is falsely low as measured by conventional methods in spite of the fact that it is not actually low. This may occur when large molecules are at a high concentration at an abnormally high level and, consequently, when the plasma water ratio falls abnormally. It has been reported that associated hyperlipemia and hyperproteinemia can also be seen in patients with diabetes mellitus. Real values can be obtained by evaluating the concentration based on plasma/water ratio. Excessive administration of potassium-free solutions may result in significant hypokalemia. Serum potassium levels should be maintained and potassium supplemented as required. To minimize the risk of possible incompatibilities arising from mixing any of these solutions with other additives that may be prescribed, the final mixture should be inspected for cloudiness or precipitation immediately after mixing, prior to administration and periodically during administration. 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. Use only if solution is clear and container and seals are intact. Laboratory tests: 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 normalization of these values with alternative solutions. Warnings and precautions for pediatric use: In neonates or in very small infants even small volumes of fluid may affect fluid and electrolyte balance. Care must be exercised in treatment of neonates, especially pre-term neonates, whose renal function may be immature and whose ability to excrete fluid and solute loads may be limited. Fluid intake, urine output, and serum electrolytes should be monitored closely. Warnings and precautions for use in elderly: In general, dose selection for an elderly patient should be cautious. Starting at the low end of the dosing range is recommended in elderly considering the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Undesirable effects are not expected in normal conditions of treatment. Undesirable effects 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. 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. Injudicious intravenous sodium chloride therapy (e.g. post-operatively and in patients with impaired cardiac or renal function) may cause hypernatraemia. Osmotically induced water shifts decrease intracellular volume, resulting in dehydration of internal organs, especially the brain, which may lead to thrombosis and haemorrhage. If administered sub-cutaneously, any addition to the isotonic solution could render it hypertonic and cause pain at the site of injection. Administration of large doses may give rise to sodium accumulation, oedema, and hyperchloraemic acidosis. If an adverse reaction does occur during administration, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures. The displayed frequency categories use the following convention: Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated form the available data). The following adverse reactions are those that may result in an excess of sodium or chloride due to overdose, or may be due to administration technique. The frequency of these side effects is not known (it can be seen in as few patients as cannot be identified with the available data). Blood and lymphatic system disorders Not known: Thrombosis; hemorrhage Metabolism and nutrition disorders Not known: Sodium accumulation; Water retention and edema; Exacerbation of congestive heart failure (due to hypernatremia); Hyperchloremic acidosis. Nervous system disorders Not known: Headache, dizziness, restlessness, irritation, convulsions, coma and death (dehydration of the brain associated with hypernatremia). Cardiac disorders Not known: Tachycardia (associated with hypernatremia). Vascular disorders Not known: Hypertension (associated with hypernatremia). Respiratory, thoracic and mediastinal disorders Not known: Pulmonary edema, respiratory depression and respiratory arrest (associated with hypernatremia). Gastrointestinal disorders Not known: Nausea, vomiting, diarrhea, abdominal cramps, feeling of thirst, decreased salivation (associated with hypernatremia). Skin and subcutaneous tissue disorders Not known: Decreased perspiration (associated with hypernatremia). Musculoskeletal and connective tissue disorders Not known: Muscle twitching and rigidity (associated with hypernatremia). Renal and urinary disorders Not known: Renal failure (associated with hypernatremia) General disorders and administration site conditions Not known: Fever; Fatigue (due to hypernatremia); Pain at the injection site (due to subcutaneous administration of hypertonic solution with additions). Surgical and medical procedures Not known: Febrile reactions; infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection; extravasation and hypervolemia (adverse effects that can be seen due to the technique of administration).