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Questions & Answers
Side Effects & Adverse Reactions
FOR IRRIGATION ONLY. NOT FOR INJECTION.
Irrigating fluids have been demonstrated to enter the systemic circulation in relatively large volumes; thus this irrigation must be regarded as a systemic drug. Absorption of large amounts 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.
Do not heat over 66° C (150° F).
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FDA Safety Alerts
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FDA Labeling Changes
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Ringer’s Irrigation, USP is indicated for all general irrigation, washing and rinsing purposes which permit use of a sterile, nonpyrogenic electrolyte solution.
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These products are sterile, nonpyrogenic solutions of electrolytes in water for injection intended only for sterile irrigation, washing and rinsing purposes.
Each 100 mL of Ringer’s Irrigation, USP contains: Sodium chloride 860 mg; potassium chloride 30 mg; calcium chloride dihydrate 33 mg. The pH is 5.7 (5.0 — 7.5). The solution is isotonic (309 mOsmol/liter, calc.) and has the following electrolyte content (mEq/liter): Na+ 147.5; K+ 4; Ca++ 4.5; Cl− 156.
The solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only for use as single-dose or short procedure irrigation. When smaller volumes are required the unused portion should be discarded. Ringer’s Irrigation, USP may be classified as a sterile irrigant, wash, rinse and pharmaceutical vehicle.
Calcium Chloride, USP is chemically designated calcium chloride dihydrate (CaCl2 • 2H2O), white fragments or granules freely soluble in water.
Potassium Chloride, USP is chemically designated KCl, a white granular powder freely soluble in water.
Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water.
Water for Injection, USP is chemically designated H2O.
The semi-rigid container is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The container requires no vapor barrier to maintain the proper drug concentration.
Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials.
Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.