The dose is dependent upon the capacity or surface area of the structure to be irrigated and the nature of the procedure. When used as a vehicle for other drugs, the manufacturer's recommendations should be followed. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permits. See PRECAUTIONS.
Ringer's Irrigation USP is a sterile, nonpyrogenic, solution of electrolytes in water for injection intended only for sterile irrigation, washing and rinsing purposes. Each 100 mL contains: Sodium Chloride USP 0.86 g; Potassium Chloride USP 0.03 gCalcium Chloride Dihydrate USP 0.033 g; Water for Injection USP qs pH: 5.8 (5.0���7.5). The solution is isotonic (310 mOsmol/liter, calc.) and has the following electrolyte content (mEq/liter): Na147; K4 Ca4.5; Cl156 The solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only for use as a 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. The formulas of the active ingredients are: The plastic container is a copolymer of ethylene and propylene formulated and developed for parenteral drugs. The copolymer contains no plasticizers and exhibits virtually no leachability. The plastic container is also virtually impermeable to vapor transmission and therefore, requires no overwrap to maintain the proper drug concentration. The safety of the plastic container has been confirmed by biological evaluation procedures. The material passes Class Vl testing as specified in the U.S. Pharmacopeia for Biological Tests���Plastic Containers. These tests have shown that the container is nontoxic and biologically inert.
Ringer's Irrigation USP exerts a mechanical cleansing action for sterile irrigation of body cavities, tissues or wounds, indwelling urethral catheters and surgical drainage tubes, and for washing, rinsing or soaking surgical dressings, instruments and laboratory specimens. It also serves as a vehicle for drugs used for irrigation or other pharmaceutical preparations. Ringer's Irrigation USP provides an isotonic irrigation with the same ionic constituents as Ringer's Injection USP, a modification of Ringer's solution (also called Ringer's mixture) originally used only as a topical physiologic salt solution. Ringer's Irrigation USP is considered generally compatible with living tissues and organs. Calcium Chloride in water dissociates to provide calcium (Ca) and chloride (Cl) ions. They are normal constituents of the body fluids and are dependent on various physiologic mechanisms for maintenance of balance between intake and output. Approximately 80% of body calcium is excreted in the feces as insoluble salts; urinary excretion accounts for the remaining 20%. Potassium chloride in water dissociates to provide potassium (K) and chloride (Cl) ions. Potassium is the chief cation of body cells (160 mEq/liter of intracellular water). It is found in low concentration in plasma and extracellular fluids (3.5 to 5.0 mEq/liter in a healthy adult). Potassium plays an important role in electrolyte balance. Normally about 80 to 90% of the potassium intake is excreted in the urine; the remainder in the stools and to a small extent, in the perspiration. The kidney does not conserve potassium well so that during fasting or in patients on a potassium free diet, potassium loss from the body continues resulting in potassium depletion. Sodium chloride in water dissociates to provide sodium (Na) and chloride (Cl) ions. Sodium (Na) is the principal cation of the extracellular fluid and plays a large part in the therapy of fluid and electrolyte disturbances. Chloride (Cl) has an integral role in buffering action when oxygen and carbon dioxide exchange occurs in the red blood cells. The distribution and excretion of sodium (Na) and chloride (Cl) are largely under the control of the kidney which maintains a balance between intake and output. Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. Average normal adult daily requirement ranges from two to three liters (1.0 to 1.5 liters each for insensible water loss by perspiration and urine production). Water balance is maintained by various regulatory mechanisms. Water distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (Na) plays a major role in maintaining physiologic equilibrium.
NOT FOR INJECTION BY USUAL PARENTERAL ROUTES. An electrolyte solution should not be used for irrigation during electrosurgical procedures.
Ringer's Irrigation USP is supplied sterile and nonpyrogenic in PIC���(Plastic Irrigation Containers). The 1000 mL containers are packaged 16 per case and the 2000 mL containers are packaged 8 per case. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25��C); however, brief exposure up to 40��C does not adversely affect the product. Do not warm above 150��F (66��C).
In the event of overhydration or solute overload, re-evaluate the patient and institute appropriate corrective measures. See WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS.
Sodium chloride, potassium chloride and calcium chloride
Possible adverse effects arising from the irrigation of body cavities, tissues, or indwelling catheters and tubes are usually avoidable when proper procedures are followed. Displaced catheters or drainage tubes can lead to irrigation or infiltration of unintended structures or cavities. Excessive volume or pressure during irrigation of closed cavities may cause undue distention or disruption of tissues. Accidental contamination from careless technique may transmit infection. Should any adverse reaction occur, discontinue the irrigant, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.
Ringer's Irrigation USP is indicated for all general irrigation, washing and rinsing purposes which permit use of a sterile, nonpyrogenic electrolyte solution.