Ringers 33 mg/100mL
sodium chloride, calcium chloride, potassium chloride, · IRRIGANT · Baxter Healthcare Corporation
Ringers is a irrigant containing sodium chloride, calcium chloride, potassium chloride, at 33 mg/100mL, taken irrigation. Manufactured by Baxter Healthcare Corporation.
Key Facts
- Brand Name
- Ringers
- Generic Name
- sodium chloride, calcium chloride, potassium chloride,
- NDC Code (Product)
0338-0104- Manufacturer
- Baxter Healthcare Corporation
- Strength
- 33 mg/100mL
- Dosage Form
- IRRIGANT
- Route
- IRRIGATION
- Marketing Status
- Application #
- NDA018495
- Marketing Start
- 02/19/1982
Recall History
Pharmakon Pharmaceuticals, Inc.
Lack of Assurance of Sterility
Sentara Enterprises
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Sentara Enterprises
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Central Admixture Pharmacy Services, Inc.
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
SCA Pharmaceuticals, LLC
Lack Of Assurance Of Sterility.
Pharmakon Pharmaceuticals, Inc.
Lack of Assurance of Sterility
Pharmakon Pharmaceuticals, Inc.
Lack of Assurance of Sterility
Sentara Infusion Services
Lack of sterility assurance
Zions RX Formulations Services LLC dba RX Formuations Serv.
Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to lack of assurance of sterility from poor aseptic practices observed at the firm.
Baxter Healthcare Corp.
Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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 & 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 …
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 )
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) ]. Hyponatrem…
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/…
Frequently Asked Questions
What is Ringers used for?
Ringers contains sodium chloride, calcium chloride, potassium chloride,. It is a irrigant taken irrigation. Consult your doctor for specific uses.
Is Ringers a controlled substance?
Ringers is not classified as a controlled substance by the DEA.
What is the generic name for Ringers?
The generic name for Ringers is sodium chloride, calcium chloride, potassium chloride,. There are 1 other brand versions of sodium chloride, calcium chloride, potassium chloride,.
What is the NDC code for Ringers 33 mg/100mL?
The NDC (National Drug Code) for Ringers 33 mg/100mL is 0338-0104, listed by Baxter Healthcare Corporation.