Ringer’s Injectable Solution

Generic Name: SODIUM CHLORIDE, CALCIUM CHLORIDE, AND POTASSIUM CHLORIDE
Brand Name: Ringers
  • Substance Name(s):
  • SODIUM CHLORIDE
  • CALCIUM CHLORIDE
  • POTASSIUM CHLORIDE

WARNINGS

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 dilutional states is inversely proportional to the electrolyte concentration.

The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentration.

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 is sodium retention with edema.

Solutions containing potassium ions should be used with great care, if at all, in patients with hyperkalemia, severe renal failure, and in conditions in which potassium retention is present.

In patients with diminished renal function, administration of solutions containing sodium or potassium ions may result in sodium or potassium retention.

Solutions containing calcium ions should not be administered through the same administration set as blood because of the likelihood of coagulation.

DRUG INTERACTIONS

Drug Interactions Some additives may be incompatible.

Consult with pharmacist.

When introducing additives, use aseptic techniques.

Mix thoroughly.

Do not store.

OVERDOSAGE

In the event of a fluid or solute overload during parenteral therapy, reevaluate the patient’s condition and institute appropriate corrective treatment.

In the event of overdosage with potassium-containing solutions, discontinue the infusion immediately and institute corrective therapy to reduce serum potassium levels.

Treatment of hyperkalemia includes the following: Dextrose Injection USP, 10% or 25%, containing 10 units of crystalline insulin per 20 grams of dextrose administered intravenously, 300 to 500 mL per hour.

Absorption and exchange of potassium using sodium or ammonium cycle cation exchange resin, orally and as retention enema.

Hemodialysis and peritoneal dialysis.

The use of potassium-containing foods or medications must be eliminated.

However, in cases of digitalization, too rapid a lowering of plasma potassium concentration can cause digitalis toxicity.

DESCRIPTION

Each 100 mL of Ringer’s Injection USP contains: Sodium Chloride USP 0.86 g; Calcium Chloride Dihydrate USP 0.033 g; Potassium Chloride USP 0.03 g; Water for Injection USP qs pH: 5.8 (5.0–7.5) Calculated Osmolarity: 310 mOsmol/liter Concentration of Electrolytes (mEq/liter): Sodium 147; Potassium 4; Calcium 4.5; Chloride 156 Ringer’s Injection USP is sterile, nonpyrogenic and contains no bacteriostatic or antimicrobial agents.

This product is intended for intravenous administration in a single dose container.

The formulas of the active ingredients are: Ingredients Molecular Formula Molecular Weight Sodium Chloride USP NaCl 58.44 Potassium Chloride USP KCl 74.55 Calcium Chloride Dihydrate USP CaCl2•2H2O 147.02 Not made with natural rubber latex, PVC or DEHP.

The plastic container is made from a multilayered film specifically developed for parenteral drugs.

It contains no plasticizers and exhibits virtually no leachables.

The solution contact layer is a rubberized copolymer of ethylene and propylene.

The container is nontoxic and biologically inert.

The container-solution unit is a closed system and is not dependent upon entry of external air during administration.

The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary.

Addition of medication should be accomplished using complete aseptic technique.

The closure system has two ports; the one for the administration set has a tamper evident plastic protector and the other is a medication addition site.

Refer to the Directions for Use of the container.

HOW SUPPLIED

Ringer’s Injection USP is supplied sterile and nonpyrogenic in EXCEL® Containers packaged 12 per case.

NDC REF Size Ringer’s Injection USP (Canada DIN 01936034) 0264-7780-00 L7800 1000 mL Exposure of pharmaceutical products to heat should be minimized.

Avoid excessive heat.

Protect from freezing.

It is recommended that the product be stored at room temperature (25°C).

GERIATRIC USE

Geriatric Use Clinical studies of Ringer’s Injection USP did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

Other reported clinical experience has not identified differences in responses between the 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.

INDICATIONS AND USAGE

This solution is indicated for use in adults and pediatric patients as a source of electrolytes and water for hydration.

PEDIATRIC USE

Pediatric Use Safety and effectiveness of Ringer’s Injection USP in pediatric patients have not been established by adequate and well controlled trials, however, the use of electrolyte solutions in the pediatric population is referenced in the medical literature.

The warnings, precautions, and adverse reactions identified in the label copy should be observed in the pediatric population.

PREGNANCY

Pregnancy Teratogenic Effects Pregnancy Category C Animal reproduction studies have not been conducted with Ringer’s Injection USP.

It is also not known whether Ringer’s Injection USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.

Ringer’s Injection USP should be given to a pregnant woman only if clearly needed.

NUSRING MOTHERS

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 Ringer’s Injection USP is administered to a nursing mother.

DOSAGE AND ADMINISTRATION

This solution is for intravenous use only.

Dosage is to be directed by a physician and is dependent upon age, weight, clinical condition of the patient and laboratory determinations.

Frequent laboratory determinations and clinical evaluation are essential to monitor changes in blood glucose and electrolyte concentrations, and fluid and electrolyte balance during prolonged parenteral therapy.

The usual adult dose is one to two liters per day.

In the average adult, daily requirements of sodium and chloride are met by the infusion of one liter of 0.9% sodium chloride (154 mEq each of sodium and chloride).

Fluid administration should be based on calculated maintenance or replacement fluid requirements for each patient.

Some additives may be incompatible.

Consult with pharmacist.

When introducing additives, use aseptic techniques.

Mix thoroughly.

Do not store.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.