Sodium Chloride, Sodium Lactate, Potassium Chloride, Calcium Chloride, And Dextrose Monohydrate
FDA Drug Information • Also known as: Lactated Ringers And Dextrose
- Brand Names
- Lactated Ringers And Dextrose
- Route
- INTRAVENOUS
- Dosage Form
- INJECTION, SOLUTION
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
DESCRIPTION These products are sterile, nonpyrogenic solutions each containing isotonic concentrations of electrolytes (with or without dextrose) in water for injection. The solutions containing dextrose and electrolytes are hypertonic; those containing only electrolytes are isotonic. They are administered by intravenous infusion for parenteral replacement of extracellular losses of fluid and electrolytes, with or without minimal carbohydrate calories. Each 100 mL of Lactated Ringer's Injection, USP contains sodium chloride 600 mg, sodium lactate, anhydrous 310 mg, potassium chloride 30 mg and calcium chloride, dihydrate 20 mg. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment. A liter provides 9 calories (from lactate), sodium (Na + ), 130 mEq, potassium (K + ) 4 mEq, calcium (Ca ++ ) 3 mEq, chloride (Cl − ) 109 mEq and lactate [CH 3 CH(OH) COO − ] 28 mEq. The electrolyte content is isotonic (273 mOsmol/liter, calc.) in relation to the extracellular fluid (approx. 280 mOsmol/liter). The pH of the solution is 6.6 (6.0 − 7.5). Each 100 mL of Lactated Ringer's and 5% Dextrose Injection, USP contains dextrose, hydrous 5 g plus the same ingredients and mEq values as Lactated Ringer's Injection, USP (contains only hydrochloric acid for pH adjustment). A liter provides 179 calories (from dextrose and lactate) and has a hypertonic osmolar concentration of 525 mOsmol (calc.). The pH is 4.9 (4.0 − 6.5). The solutions contain no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and each is intended only for use as a single-dose injection. When smaller doses are required the unused portion should be discarded. The solutions are parenteral fluid, nutrient and/or electrolyte replenishers. Dextrose, USP is chemically designated D-glucose, monohydrate (C 6 H 12 O 6
What Is Sodium Chloride, Sodium Lactate, Potassium Chloride, Calcium Chloride, And Dextrose Monohydrate Used For?
INDICATIONS AND USAGE These solutions are indicated for parenteral replacement of extracellular losses of fluid and electrolytes, with or without minimal carbohydrate calories, as required by the clinical condition of the patient.
Dosage and Administration
DOSAGE AND ADMINISTRATION The dose is dependent upon the age, weight and clinical condition of the patient. As reported in the literature, the dosage and constant infusion rate of intravenous dextrose must be selected with caution in pediatric patients, particularly neonates and low birth weight infants, because of the increased risk of hyperglycemia/hypoglycemia. Drug Interactions Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store. The presence of calcium limits their compatibility with certain drugs that form precipitates of calcium salts, and also prohibits their simultaneous infusion through the same administration set as blood because of the likelihood of coagulation. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS .
Side Effects (Adverse Reactions)
ADVERSE REACTIONS Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia. If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.
Warnings and Precautions
WARNINGS Solutions containing calcium ions should not be administered simultaneously through the same administration set as blood because of the likelihood of coagulation. Solutions which contain potassium 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. 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 or potassium ions may result in sodium or potassium retention. Solutions containing lactate ions should be used with great care in patients with metabolic or respiratory alkalosis. The administration of lactate ions should be done with great care where there is an increased level or an impaired utilization of lactate ions, as in severe hepatic insufficiency. The intravenous administration of these solutions can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentrations of administered parenteral solutions. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of such solutions.
Drug Interactions
Drug Interactions Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store. The presence of calcium limits their compatibility with certain drugs that form precipitates of calcium salts, and also prohibits their simultaneous infusion through the same administration set as blood because of the likelihood of coagulation. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS .
Contraindications
CONTRAINDICATIONS Solutions containing lactate are NOT FOR USE IN THE TREATMENT OF LACTIC ACIDOSIS.
Pregnancy and Breastfeeding
Pregnancy Category C. Animal reproduction studies have not been conducted with Ringer's Injection, USP, Ringer's and Dextrose Injection, USP, Lactated Ringer's Injection, USP or Lactated Ringer's and Dextrose Injection, USP. It is also not known whether these injections can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. These injections should be given to a pregnant woman only if clearly needed.
Overdosage
OVERDOSAGE In the event of overhydration or solute overload, re-evaluate the patient and institute appropriate corrective measures. See WARNINGS , PRECAUTIONS , and ADVERSE REACTIONS .
How Supplied
HOW SUPPLIED These solutions are supplied in single-dose flexible plastic containers as follows: NDC No. Product Name Container Size (mL) 0409-7953-02 Manufactured by ICU Medical, Inc., Lake Forest, Illinois, 60045, USA Lactated Ringer's Inj., USP 250 0990-7953-02 Lactated Ringer's Inj., USP 250 0409-7953-03 Manufactured for ICU Medical, Inc., Lake Forest, Illinois, 60045, USA Lactated Ringer's Inj., USP 500 0990-7953-03 , Lactated Ringer's Inj., USP 500 0409-7953-09 , Lactated Ringer's Inj., USP 1000 0990-7953-09 , Lactated Ringer's Inj., USP 1000 0409-7929-03 Lactated Ringer's and 5% Dextrose Inj., USP 500 0990-7929-03 , Lactated Ringer's and 5% Dextrose Inj., USP 500 0409-7929-09 , Lactated Ringer's and 5% Dextrose Inj., USP 1000 0990-7929-09 , Lactated Ringer's and 5% Dextrose Inj., USP 1000 ICU Medical is transitioning NDC codes from "0409" to a"0990" labeler code. Both NDC codes are expected to be in the market for a period of time. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. Revised: April, 2020 IFU0000184
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.