Sodium Lactate

Dosage Forms & Strengths

infusion solution

• 5 mEq/mL (560 mg/mL)

Alkalinizing Agent

As directed by physician (based on severity of metabolic acidosis)

Dosage Forms & Strengths

infusion solution

• 500mL
• 1000mL

Alkalinizing Agent

As directed by physician (based on severity of metabolic acidosis)

Pregnancy Category: C

Lactation: use caution

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

• It is used to treat or prevent acid problems in the blood.

• If you have an allergy to sodium lactate or any other part of sodium lactate.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have high sodium levels or swelling.
• If you have any of these health problems: Beriberi, heart failure, or low blood oxygen levels.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take sodium lactate with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using sodium lactate while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Lactate anion [CH3CH(OH)COO−] serves the important purpose of providing "raw material" for subsequent regeneration of bicarbonate (HCO3−) and thus acts as a source (alternate) of bicarbonate when normal production and utilization of lactic acid is not impaired as a result of disordered lactate metabolism. Lactate anion is usually present in extracellular fluid at a level of less than 1 mEq/liter, but may attain a level of 10 mEq/liter during exercise. It is seldom measured as such and thus is one of the "unmeasured anions" ("anion gap") in determinations of the ionic composition of plasma.

Since metabolic conversion of lactate to bicarbonate is dependent on the integrity of cellular oxidative processes, lactate may be inadequate or ineffective as a source of bicarbonate in patients suffering from acidosis associated with shock or other disorders involving reduced perfusion of body tissues. When oxidative activity is intact, one to two hours time is required for conversion of lactate to bicarbonate.

The lactate anion is in equilibrium with pyruvate and has an alkalizing effect resulting from simultaneous removal by the liver of lactate and hydrogen ions. In the liver, lactate is metabolized to glycogen which is ultimately converted to carbon dioxide and water by oxidative metabolism.

The sodium (Na+) ion combines with bicarbonate ion produced from carbon dioxide of the body and thus retains bicarbonate to combat metabolic acidosis (bicarbonate deficiency). The normal plasma level of lactate ranges from 0.9 to 1.9 mEq/liter.

Sodium is the principal cation of extracellular fluid. It comprises more than 90% of total cations at its normal plasma concentration of approximately 140 mEq/liter. The sodium ion exerts a primary role in controlling total body water and its distribution.

Sodium Lactate Injection, USP 50 mEq is contraindicated in patients suffering from hypernatremia or fluid retention.

It should not be used in conditions in which lactate levels are increased (e.g., shock, congestive heart failure, respiratory alkalosis) or in which utilization of lactate is diminished (e.g., anoxia, beriberi).

NOT FOR USE IN THE TREATMENT OF LACTIC ACIDOSIS.

Sodium Lactate Injection, USP 50 mEq 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.

Solutions containing lactate ions should be used with caution as excess administration may result in metabolic alkalosis.

Do not administer unless solution is clear and seal is intact. Discard unused portion.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies with Sodium Lactate Injection have not been performed to evaluate carcinogenic potential, mutagenic potential or effects on fertility.

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 Sodium Lactate Injection is administered to a nursing mother.

Pregnancy Category C. Animal reproduction studies have not been conducted with Sodium Lactate. It is also not known whether Sodium Lactate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Lactate should be given to a pregnant woman only if clearly needed.

Pediatric Use

The safety and effectiveness of Sodium Lactate have not been established in pediatric patients. Its limited use has been inadequate to fully define proper dosage and limitations for use.

Geriatric Use

An evaluation of current literature revealed no clinical experience identifying differences in response 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 greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Sodium ions are known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug 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.

Consult your pharmacist.

How to use Sodium Lactate Solution, Non-

Consult your pharmacist.