Sodium Chloride, Calcium Chloride, And Potassium Chloride
FDA Drug Information • Also known as: Ringers
- Brand Names
- Ringers
- Route
- INTRAVENOUS
- Dosage Form
- INJECTION, SOLUTION
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
11 DESCRIPTION Ringer’s Injection USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment in a single-dose container for intravenous administration. Composition, osmolarity, pH, ionic concentration and caloric content are shown in Table 1. Table 1 Size (mL) Composition (g/L) Osmolarity Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L. (mOsmol/L) (calc) pH Ionic Concentration (mEq/L) Caloric Content (kcal/L) Sodium Chloride, USP Calcium Chloride, USP Potassium Chloride, USP Sodium Potassium Calcium Chloride Ringer’s Injection, USP 1000 8.6 0.33 0.3 310 5.8 (5.0 to 7.5) 147 4 4.5 156 0 The chemical name, structural formula, and molecular weight of the active ingredients are shown in Table 2. Table 2 Ingredients Molecular Formula Molecular Weight Sodium Chloride USP 58.44 Potassium Chloride USP 74.55 Calcium Chloride Dihydrate USP 147.02 Not made with natural rubber latex, PVC or DEHP. The plastic container is made from a multilayered film developed for parenteral drugs. It contains no plasticizers and has minimal leachables. The solution contact layer is a rubberized copolymer of ethylene and propylene. 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. 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 [see Dosage and Administration (2.3) ]. Sodium Chloride USP Potassium Chloride USP Calcium Chloride Dihydrate USP
What Is Sodium Chloride, Calcium Chloride, And Potassium Chloride Used For?
1 INDICATIONS AND USAGE Ringer’s Injection is indicated for use as a source of water and electrolytes in adults and pediatric patients. Ringer’s Injection is indicated for use as a source of water and electrolytes in adults and pediatric patients. ( 1 )
Dosage and Administration
2 DOSAGE AND ADMINISTRATION The recommended dosage and duration are based on the patient’s age, weight, clinical condition, and concomitant therapy. ( 2.1 ) To reduce the risk of air embolism, adhere to the preparation instructions. ( 2.2 , 5.2 ) Ringer’s Injection is for intravenous use ( 2.3 ) Do not administer Ringer’s Injection simultaneously with ceftriaxone in neonates (28 days of age or younger) due to serious risks. ( 2.4 ) See full prescribing information for information dosage considerations, preparation, administration, and drug incompatibilities. ( 2 ) 2.1 Dosage Considerations The recommended dosage and duration of Ringer’s Injection is based on the patient’s age, weight, clinical condition, and concomitant therapy. Evaluate the patient’s clinical status and monitor changes in electrolyte concentrations especially during prolonged use of Ringer’s Injection to optimize clinical status. Fluid administration should be based on calculated maintenance or replacement fluid requirements for each patient. 2.2 Important Preparation Instructions Visually inspect the Ringer’s Injection solution for particulate matter and discoloration. Do not administer Ringer’s Injection unless the solution is clear and the container seals are intact. If additives are determined to be compatible with Ringer’s Injection, then using aseptic technique, mix thoroughly; do not store solutions containing additives. After mixing, do not use if there is discoloration or formation of precipitates. To reduce the risk of air embolism, adhere to the following Ringer’s Injection preparation instructions [see Warnings and Precautions (5.2) ] : Use a non-vented infusion set or close the vent on a vented set. Use a dedicated line without any connections (do not connect flexible containers in series). The use of pressure infusion is not recommended as a method to increase flow rates. However, if pressure infusion is required, ensure that any air within the bag is fully evacuated prior to initiation of infusion. If using a pumping device to administer Ringer’s Injection, turn off the pump before the container is empty. Preparation Instructions for EXCEL ® Containers Tear overwrap down at notch and remove solution container. Check for minute leaks by squeezing solution container firmly. If leaks are found, discard solution as sterility may be impaired. If supplemental medication is desired, follow directions below before preparing for administration. Inspect each container. Read the label. Ensure solution is the one ordered and is within the expiration date. Invert container and carefully inspect the solution in good light for cloudiness, haze, or particulate matter. Any container which is suspect should not be used. If supplemental medication is desired, follow directions below [see Dosage and Administration (2.3) ] . Preparation for Administration Remove plastic protector from sterile set port at bottom of container. Attach administration set according to its accompanying...
Side Effects (Adverse Reactions)
6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the labeling: Serious Risk with Concomitant Use with Ceftriaxone [see Warnings and Precautions (5.1) ] Air Embolism [see Warnings and Precautions (5.2) ] Hypersensitivity Reactions [see Warnings and Precautions (5.3) ] Potassium Imbalances [see Warnings and Precautions (5.4) ] Hyponatremia [see Warnings and Precautions (5.5) ] Hypercalcemia [see Warnings and Precautions (5.6) ] Fluid Overload [see Warnings and Precautions (5.7) ] The following adverse reactions have been identified during postapproval use of Ringer’s Products. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: General Disorders and Administration Site Conditions : Phlebitis, extravasation, infusion site inflammation, infusion site swelling, infusion site rash, infusion site pruritus, infusion site erythema, infusion site pain, infusion site burning, and infusion site hypoaesthesia. Hypersensitivity Reactions and Infusion Reactions : Angioedema, chest pain/discomfort, bradycardia or tachycardia, hypotension, respiratory distress, bronchospasm, dyspnea, cough, urticaria, rash, pruritus, erythema, flushing, throat irritation, paresthesia, oral hypoesthesia, dysgeusia, nausea, anxiety, pyrexia, headache, laryngeal edema, sneezing, and injection site infection. Metabolism and Nutrition Disorders : Hyperkalemia, hyponatremia, and hypervolemia. Nervous System Disorders : Hyponatremic encephalopathy. Common adverse reactions include infusion site reactions and symptoms of hypersensitivity reactions (e.g., pruritus, dyspnea, urticaria, rash, cough). ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact B. Braun Medical Inc. at 1-833-425-1464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Drug Interactions
7 DRUG INTERACTIONS Drugs that Affect Electrolyte and/or Fluid Balance : Avoid concomitant use. If concomitant use cannot be avoided, closely monitor electrolyte concentrations and fluid balance. ( 7.1 ) Lithium : Avoid concomitant use. If concomitant use is unavoidable monitor serum lithium concentrations more frequently. ( 7.2 ) Digoxin : Consider reducing the volume or rate of Ringer’s Injection due to the increased risk of digoxin toxicity with calcium-containing solutions. ( 7.3 ) 7.1 Drugs that Affect Electrolyte and/or Fluid Balance Hyperkalemia Administration of Ringer’s Injection to patients concomitantly treated or recently treated with drugs that are associated with hyperkalemia increases the risk of severe and potentially fatal hyperkalemia, especially in the presence of other hyperkalemia risk factors . Avoid use of Ringer’s Injection in patients receiving drugs that are associated with hyperkalemia (e.g., potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, or calcineurin inhibitors). If concomitant use cannot be avoided, closely monitor serum potassium concentrations during concomitant use [see Warnings and Precautions (5.4) ]. Hyponatremia Administration of Ringer’s Injection to patients treated concomitantly with drugs associated with hyponatremia may increase the risk of developing hyponatremia. These drugs include diuretics and those that cause SIADH (e.g., arginine vasopressin analogs, certain antiepileptic, psychotropic, or cytotoxic drugs). Avoid use of Ringer’s Injection in patients receiving such drugs. If use cannot be avoided, closely monitor serum sodium concentrations during concomitant use [see Warnings and Precautions (5.5) ] . Hypercalcemia Avoid the use of Ringer’s Injection in patients treated with thiazide diuretics or vitamin D because these drugs can increase the risk of hypercalcemia. If use cannot be avoided, closely monitor serum calcium concentrations during concomitant use [see Warnings and Precautions (5.6) ]. Hypernatremia and Fluid Retention Administration of Ringer’s Injection to patients treated concomitantly with drugs associated with sodium and fluid retention (e.g., corticosteroids or corticotropin) may increase the risk of hypernatremia and volume overload. Avoid use of Ringer’s Injection in patients receiving such drugs. If use cannot be avoided, closely monitor serum electrolytes, fluid balance, and acid-base balance during concomitant use. 7.2 Lithium Renal sodium and lithium clearance may be increased during concomitant use of Ringer’s Injection and lithium and may result in decreased lithium concentrations. Avoid use of Ringer’s Injection in patients receiving lithium. If use cannot be avoided, increase the frequency of monitoring of serum lithium concentrations during concomitant use. 7.3 Digoxin Administration of calcium via use of Ringer’s Injection may increase digoxin’s effects and lead to digoxin toxicity including serious or fatal cardiac arrhythmias. In...
Contraindications
4 CONTRAINDICATIONS Ringer’s Injection is contraindicated in: Neonates (28 days of age or younger) who are receiving concomitant treatment with ceftriaxone, even if separate infusion lines are used, due to the risk of fatal ceftriaxone-calcium salt precipitation in the neonate’s bloodstream [see Warnings and Precautions (5.1) and Specific Populations (8.4) ] . Patients with known hypersensitivity to any components of Ringer’s Injection [see Warnings and Precautions (5.3) ]. Concomitant treatment with ceftriaxone in neonates (28 days of age or younger). ( 4) Patients with known hypersensitivity to Ringer’s Injection. ( 4 )
Pregnancy and Breastfeeding
8.1 Pregnancy Risk Summary Exposure to Ringer’s Injection during pregnancy is not expected to cause major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with this drug. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Overdosage
10 OVERDOSAGE Excessive administration of Ringer’s Injection can cause: Hyperkalemia and hypernatremia, especially in patients with severe renal impairment. Fluid overload (which can lead to pulmonary and/or peripheral edema). Hypercalcemia Overdose interventions include Ringer’s Injection discontinuation, treatment of electrolyte imbalances, and close monitoring of fluid balance and electrolyte concentrations [see Warnings and Precautions ( 5.4 , 5.5 , 5.6 , 5.7 )].
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Ringer’s Injection USP is supplied sterile and nonpyrogenic in single-dose EXCEL ® Containers packaged 12 per case. It is available in the following presentation: NDC REF Size 0264-7780-00 L7800 1000 mL Canada DIN 01936034 Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature.] Minimize exposure of Ringer’s Injection USP to heat. Avoid excessive heat. Protect from freezing.
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.