Lactated Ringers

Lactated Ringer’s Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment in single dose containers for intravenous administration. It contains no antimicrobial agents. Composition, osmolarity, pH, ionic concentration and caloric content are shown in Table 1.

The VIAFLEX plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.

Lactated Ringer’s Injection, USP has value as a source of water and electrolytes. It is capable of inducing diuresis depending on the clinical condition of the patient.

Lactated Ringer’s Injection, USP produces a metabolic alkalinizing effect. Lactate ions are metabolized ultimately to carbon dioxide and water, which requires the consumption of hydrogen cations.

As for other calcium-containing infusion solutions, concomitant administration of ceftriaxone and Lactated Ringer’s Injection, USP is contraindicated in newborns (≤ 28 days of age), even if separate infusion lines are used (risk of fatal ceftriaxone-calcium salt precipitation in the neonate’s bloodstream).

In patients older than 28 days (including adults), ceftriaxone must not be administered simultaneously with intravenous calcium-containing solutions, including Lactated Ringer’s Injection, USP, through the same infusion line (e.g., via Y-connector).
If the same infusion line is used for sequential administration, the line must be thoroughly flushed between infusions with a compatible fluid.

Lactated Ringer’s Injection, USP is contraindicated in patients with a known hypersensitivity to sodium lactate.

Although Lactated Ringer’s Injection, USP has a potassium concentration similar to the concentration in plasma, it is insufficient to produce a useful effect in case of severe potassium deficiency; therefore, it should not be used for this purpose.

Lactated Ringer’s Injection, USP is not for use for the treatment of lactic acidosis or severe metabolic acidosis.

Lactated Ringer’s Injection, USP should not be administered simultaneously with citrate anticoagulated/preserved blood through the same administration set because of the likelihood of coagulation.

The infusion must be stopped immediately if any signs or symptoms of a suspected hypersensitivity reaction develop. Appropriate therapeutic countermeasures must be instituted as clinically indicated. Hypersensitivity reactions are reported more frequently during pregnancy.

Depending on the volume and the rate of infusion, the intravenous administration of Lactated Ringer’s Injection, USP can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states, pulmonary edema or acid-base imbalance. The risk of dilutional states is inversely proportional to the electrolyte concentrations of the injections. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of the injections.

Clinical evaluation and periodic laboratory determinations may be necessary to monitor changes in fluid balance, electrolyte concentrations, and acid base balance during prolonged parenteral therapy or whenever the condition of the patient or the rate of administration warrants such evaluation.

Lactated Ringer’s Injection, USP should be administered with particular caution, if at all, to patients with hyperkalemia or conditions predisposing to hyperkalemia (such as severe renal impairment or adrenocortical insufficiency, acute dehydration, or extensive tissue injury or burns) and in patients with cardiac disease.

Lactated Ringer’s Injection, USP should be administered with particular caution, if at all, to patients with alkalosis or at risk for alkalosis. Because lactate is metabolized to bicarbonate, administration may result in, or worsen, metabolic alkalosis.

Lactated Ringer’s Injection, USP should be administered with particular caution, if at all, to patients with severe renal impairment, hypervolemia, overhydration, or conditions that may cause sodium and/or potassium retention, fluid overload, or edema.

Container Label

Container Label

LOT

EXP

2B2322

NDC 0338-0117-02

Lactated Ringer’s
Injection USP

250 mL

Each100 mL contains
600 mg Sodium
Chloride USP 310 mg Sodium Lactate
30 mg Potassium Chloride USP 20 mg
Calcium Chloride USP pH 6.5 (6.0 to
7.5) mEq/L Sodium 130 Potassium 4
Calcium 2.7 Chloride 109 Lactate 28
Osmolarity 273 mOsmol/L (calc)
Sterile Nonpyrogenic Single dose
container Not for use in the treatment
of lactic acidosis Additives may be
incompatible Consult with pharmacist
if available When introducing additives
use aseptic technique Mix thoroughly
Do not store Dosage Intravenously as
directed by a physician See directions
Cautions Squeeze and inspect inner
bag which maintains product sterility
Discard if leaks are found Must not be

used in series connections Do not
administer simultaneously with blood
Do not use unless solution is clear Rx
Only Store unit in moisture barrier
overwrap at room temperature
(25°C/77°F) until ready to use Avoid
excessive heat See insert

Viaflex container
PL 146 plastic

BAXTER Viaflex and PL 146 are trademarks of Baxter International Inc

Baxter
Baxter Healthcare Corporation
DeerfieldIL60015 USA

Made in USA

For product information
1-800-933-0303

LOT

EXP

2B2324

NDC 0338-0117-04

Lactated Ringer’s
Injection USP

1000 mL

Each100 mL contains 600 mg Sodium Chloride
USP 310 mg Sodium Lactate 30 mg Potassium
Chloride USP 20 mg Calcium Chloride USP pH
6.5 (6.0 to 7.5) mEq/L Sodium 130 Potassium 4
Calcium 2.7 Chloride 109 Lactate 28 Osmolarity
273 mOsmol/L (calc) Sterile Nonpyrogenic
Single dose container Not for use in the treatment
of lactic acidosis Additives may be incompatible
Consult with pharmacist if available When
introducing additives use aseptic technique Mix
thoroughly Do not store Dosage Intravenously
as directed by a physician See directions Cautions
Squeeze and inspect inner bag which maintains
product sterility Discard if leaks are found Must
not be used in series connections Do not administer
simultaneously with blood Do not use unless
solution is clear Rx Only Store unit in moisture
barrier overwrap at room temperature (25°C/77°F)
until ready to use Avoid excessive heat See insert

Viaflex container
PL 146 plastic

BAXTER VIAFLEX and PL 146 are trademarks of Baxter International Inc

For Product Information 1-800-933-0303

Baxter
Baxter Healthcare Corporation
DeerfieldIL60015 USA

Made in Mexico

Carton Label

Carton Label

FOR HI-RES INK JET:

2B2322Q
36-250 ML

VIAFLEX® CONTAINER
LACTATED RINGER’S INJECTION, USP

EXP

XXXXX

SECONDARY BAR CODE
(17) YYMM00 (10) XXXXX

LOT

XXXXX

PRIMARY BAR CODE

(01)50303380117029

2B2B2322Q 2B2322QQ

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Missed Dose

Consult your pharmacist.

Storage

Consult your pharmacist.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2016. Copyright(c) 2016 First Databank, Inc.