"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.
Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.
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.
In patients with diminished renal function, administration of solutions containing sodium ions may result in sodium retention.
The intravenous administration of this solution (after appropriate dilution) can cause fluid and/or solute overloading resulting in dilution of other serum electrolyte concentrations, overhydration, congested states or pulmonary edema.
Excessive administration of potassium-free solutions may result in significant hypokalemia.
Sodium Lactate (sodium lactate injection in aviva) Injection must be suitably diluted before infusion to avoid a sudden increase in the level of sodium or lactate.Too rapid administration and overdosage should be avoided.
The potentially large loads of sodium given with lactate require that caution be exercised in patients with congestive heart failure or other edematous or sodium-retaining states, as well as in patients with oliguria or anuria.
Caution must be exercised in the administration of parenteral fluids especially those containing sodium ions, to patients receiving corticosteroids or corticotropin.
Do not administer unless solution is clear and seal is intact. Discard unused portion.
Pregnancy Category C
Animal reproduction studies have not been conducted with sodium lactate (sodium lactate injection in aviva) . It is also not known whether sodium lactate (sodium lactate injection in aviva) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium lactate (sodium lactate injection in aviva) should be given to a pregnant woman only if clearly needed.
Last reviewed on RxList: 1/16/2009
This monograph has been modified to include the generic and brand name in many instances.
Additional Sodium Lactate Information
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