Ringers - IMCURE

What is Ringers?

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

Uses of Ringers

Established uses

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 )

How Ringers works

In more detail: 12.1 Mechanism of Action Ringer’s Injection is a source of water, and electrolytes. Sodium, the major cation of the extracellular fluid, functions primarily in the control of water distribution, fluid balance, and osmotic pressure of body fluids. Sodium is also associated with chloride and bicarbonate in the regulation of the acid-base equilibrium of body fluid. Potassium, the principal cation of intracellular fluid, participates in carbohydrate utilization and protein synthesis and is critical in the regulation of nerve conduction and muscle contraction, particularly in the heart. Chloride, the major extracellular anion, closely follows the metabolism of sodium, and changes in the acid-base balance of the body are reflected by changes in the chloride concentration. Calcium, an important cation, provides the framework of bones and teeth in the form of calcium phosphate and calcium carbonate. In the ionized form, calcium is essential for the functional mechanism of the clotting of blood, normal cardiac function, and regulation of neuromuscular irritability.

How to take Ringers

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

Dosage

Follow the dose prescribed by your doctor or pharmacist. The ranges below are general information, not a personal prescription.

Adults: 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

Side effects of Ringers

Common

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/

Warnings and who should not take it

Who should NOT take Ringers?

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 )

Overdose

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 )].

Safety at a glance

PregnancyCaution

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.

Children and elderly

Children

8.4 Pediatric Use Ringer’s Injection is contraindicated in neonates (28 days of age or younger) who are receiving ceftriaxone due to reported deaths that occurred when neonates received ceftriaxone and intravenous calcium-containing solutions concomitantly [see Warnings and Precautions (5.1) ]. The safety and effectiveness of Ringer’s Injection for use as a source of water and electrolytes have been established in pediatric patients of all ages, including neonates. Closely monitor plasma electrolyte concentrations in young pediatric patients with immature kidney function who may have decreased ability to maintain fluid and electrolyte balance [see Warnings and Precautions ( 5.4 , 5.5 , 5.6 , 5.7 )].

Elderly

8.5 Geriatric Use Geriatric patients treated with Ringer’s Injection are at increased risk of developing electrolyte imbalances. Ringer’s Injection is substantially excreted by the kidney, and the risk of adverse reactions to Ringer’s Injection may be greater in patients with renal impairment than in patients with normal renal function. Because geriatric patients are more likely to have decreased renal function, consider monitoring renal function in geriatric patients and consider starting the infusion at the low end of the dosing range.

Interactions

Medicine and medicine

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 .

Frequently asked questions

What is Ringers 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 ).

How should I take Ringers?

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

What are the common side effects?

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/.

Who should not take Ringers?

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 ).

Can I take Ringers during pregnancy?

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.

Can children take Ringers?

8.4 Pediatric Use Ringer’s Injection is contraindicated in neonates (28 days of age or younger) who are receiving ceftriaxone due to reported deaths that occurred when neonates received ceftriaxone and intravenous calcium-containing solutions concomitantly [see Warnings and Precautions (5.1) ]. The safety and effectiveness of Ringer’s Injection for use as a source of water and electrolytes have been established in pediatric patients of all ages, including neonates. Closely monitor plasma electrolyte concentrations in young pediatric patients with immature kidney function who may have decreased ability to maintain fluid and electrolyte balance [see Warnings and Precautions ( 5.4 , 5.5 , 5.6 , 5.7 )].

Does Ringers interact with other medicines?

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 ..