Source: FDA, National Drug Code (US) Revision Year: 2020
Intravenous Sodium DIURIL is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy.
Intravenous Sodium DIURIL has also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure.
Routine use of diuretics during normal pregnancy is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy and there is no satisfactory evidence that they are useful in the treatment of toxemia.
Edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy. Thiazides are indicated in pregnancy when edema is due to pathologic causes, just as they are in the absence of pregnancy (see PRECAUTIONS, Pregnancy). Dependent edema in pregnancy, resulting from restriction of venous return by the gravid uterus, is properly treated through elevation of the lower extremities and use of support stockings. Use of diuretics to lower intravas-cular volume in this instance is illogical and unnecessary. During normal pregnancy there is hypervolemia which is not harmful to the fetus or the mother in the absence of cardiovascular disease. However, it may be associated with edema, rarely generalized edema. If such edema causes discomfort, increased recumbency will often provide relief. Rarely this edema may cause extreme discomfort which is not relieved by rest. In these instances, a short course of diuretic therapy may provide relief and be appropriate.
Intravenous Sodium DIURIL should be reserved for patients unable to take oral medication or for emergency situations.
Therapy should be individualized according to patient response. Use the smallest dosage necessary to achieve the required response.
Intravenous use in infants and children has been limited and is not generally recommended.
When medication can be taken orally, therapy with DIURIL tablets or oral suspension may be substituted for intravenous therapy, using the same dosage schedule as for the parenteral route.
Intravenous Sodium DIURIL may be given slowly by direct intravenous injection or by intravenous infusion.
Extravasation must be rigidly avoided. Do not give subcutaneously or intramuscularly.
The usual adult dosage is 0.5 to 1 g once or twice a day. Many patients with edema respond to intermittent therapy, i.e., administration on alternate days or on three to five days each week. With an intermittent schedule, excessive response and the resulting undesirable electrolyte imbalance are less likely to occur.
Use aseptic technique. Because Intravenous Sodium DIURIL contains no preservative, a fresh solution should be prepared immediately prior to each administration, and the unused portion should be discarded.
Add 18 mL of Sterile Water for Injection to the vial to form an isotonic solution for intravenous injection. Never add less than 18 mL. When reconstituted with 18 mL of Sterile Water, the final concentration of Intravenous Sodium DIURIL is 28 mg/mL. The reconstituted solution is clear and essentially free from visible particles. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to use whenever solution and container permit. The solution is compatible with dextrose or sodium chloride solutions for intravenous infusion. Avoid simultaneous administration of solutions of chlorothiazide with whole blood or its derivatives.
The most common signs and symptoms observed are those caused by electrolyte depletion (hypokalemia, hypochloremia, hyponatremia) and dehydration resulting from excessive diuresis. If digitalis has also been administered, hypokalemia may accentuate cardiac arrhythmias.
In the event of overdosage, symptomatic and supportive measures should be employed. Correct dehydration, electrolyte imbalance, hepatic coma and hypotension by established procedures. If required, give oxygen or artificial respiration for respiratory impairment.
The degree to which chlorothiazide sodium is removed by hemodialysis has not been established.
The intravenous LD50 of chlorothiazide in the mouse is 1.1 g/kg.
Store at 20° to 25°C (68° to 77°F). See USP Controlled Room Temperature.
For single dose only. Use solution immediately after reconstitution (see DOSAGE AND ADMINISTRATION, Directions for Reconstitution). Discard unused portion of the reconstituted solution.
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